This chapter analyses the supply chains of selected medical countermeasures likely to face high demand during major epidemics or pandemics. It presents three case studies: injectable systemic corticosteroids, seasonal influenza vaccines and influenza polymerase chain reaction (PCR) diagnostic tests. For each case, the chapter examines market structure, supplier concentration, demand patterns and the organisation of upstream and downstream supply chains. The analysis draws on commercial sales data, public regulatory information, literature, expert consultations and targeted surveys of manufacturers and notified bodies. It also reviews reported shortage notifications and gathers industry perspectives on supply chain vulnerabilities, production constraints and surge capacity. Finally, the chapter assesses the availability and limitations of data sources that could support routine monitoring of supply chain risks, particularly for medical devices and in vitro diagnostics.
Strengthening the EU’s Medical Supply Chains
Abstract
Monitoring market fluctuations and supply chains for medical products, including medical countermeasures (MCMs), remains challenging. Three MCMs – one vaccine, one therapeutic, and one diagnostic – were selected to explore the feasibility of mapping their supply chains. As no single consolidated data source enables routine, EU-wide mapping of medical product supply chains, the analysis relied on triangulating multiple sources, including commercial datasets, public regulatory information, literature, expert consultations and manufacturer surveys.
Identification of products marketed in the EU and analysis of demand trends depended heavily on commercial data, with uneven coverage across countries. For injectable corticosteroids and influenza vaccines, commercial sales databases were essential to identify products and assess market structures and fluctuations in demand. For RT-PCR tests for influenza, information on sales or use is just unavailable.
Mapping of upstream supply chains was limited as it relies on confidential information. Even when combining diverse data sources with targeted manufacturer surveys, visibility of manufacturing sites and production links was only partial, reflecting the commercially sensitive nature of supply chain information.
Case study 1: Injectable systemic corticosteroids
Parenteral systemic corticosteroids are likely to play an important role in pandemic response. They are mainly used in hospitals, which account for 76% of total sales in the EU/EEA countries with available data in 2024.
Markets are frequently concentrated at both supplier and presentation level (defined as unique combination of product and pack). While 84 companies sell these injectable corticosteroids in EU/EEA countries covered by IQVIA MIDAS® data, national markets often rely heavily on one or two suppliers, with the two largest marketing authorisation holders (MAHs) accounting for more than 80% of sales in most countries.
Only 20 manufacturers were identified as holding certificates to supply active pharmaceutical ingredients (APIs) for injectable corticosteroids marketed in the EU. Of these, six are located in the EU, two in the United States, and the remaining are distributed across China (9), India (2) and Malaysia (1). The respective contributions of each site to the EU market, however, could not be determined.
Supply chain mapping relied on a survey of manufacturers of injectable corticosteroids, with a very low response rate. Based on IQVIA MIDAS sales data for 2024 in EU/EEA countries, respondents accounted for approximately 20% of the injectable dexamethasone market, 19% of hydrocortisone, and only 0.1% of methylprednisolone.
Survey responses point to reliance on non-EU sourcing for some upstream stages and highlight sterile manufacturing, fill-and-finish, and API/intermediate availability as key perceived risk points.
Respondents also indicated that in the event of a sudden increase in demand, substantial expansions of production would require extended preparation, with most reporting that a 50% increase in production would take at least one year. Expansion of production would happen mostly through adjustments of existing production sites, redeployment of capacity, or reallocation from other markets.
Shortage notifications were uneven across countries and did not occur simultaneously, with one country (Czechia) accounting for a large share of notifications. This suggests a combination of domestic dynamics, product-specific issues, and differences in reporting practices rather than single cross-border shocks. Looking ahead, the implementation of the EU pharmaceutical package is expected to strengthen existing obligations for early notification of shortages by requiring MAHs to provide advance notice of planned market cessations or suspensions and, where foreseeable, temporary disruptions in supply.
Case study 2: Seasonal influenza vaccines
The market for seasonal influenza is highly concentrated. Five manufacturers supply influenza vaccines for the EU market, with two of these accounting for over 80% of doses sold.
Bulk vaccine manufacturing is geographically concentrated in a small number of countries, with around two‑thirds of doses produced in three EU Member States and the remainder supplied by facilities in the United States and the United Kingdom.
Seasonality and tight production timelines reduce flexibility, and bottlenecks may arise downstream of bulk production. Manufacturer interviews emphasised that the short, sequential production and release window – combined with concentrated delivery requirements ahead of vaccination campaigns – can constrain buffers. Batch testing and release processes were highlighted as time‑critical steps, particularly when multiple manufacturers coincide on the same release window.
Case study 3: PCR tests for influenza
Eighty-five companies have CE‑marked RT-PCR kits for influenza. Of these, 27.1% are located in 9 EU Member States, 31.8% in China, 9.4% in the United States, 7.2% in Korea, 5.9% in Türkiye, 4.7% in the United Kingdom, and 3.5% in Australia (3.5%), among others. No database allows determining which of these 85 companies actually sell PCR tests in the EU, and in what quantities.
A survey of the 66 manufacturers listed in EUDAMED, to which only six companies responded, showed that test kits sold in the EU may have less than 45% of RT-PCR kits component suppliers based in the EU. The number of suppliers ranges from one to nine, indicating limited supplier diversity and potential risks to supply chains remaining heavily on non-EU suppliers.
Rapid scaling-up production of influenza RT-PCR kits appears feasible, with surveyed manufacturers reporting that a two‑fold increase could take one to six weeks, five‑fold increase one to six months, and a ten‑fold increase at least six months.
The total number of influenza RT-PCRs tests performed or sold in the EU cannot be reliably estimated due to substantial data gaps. Limitations include very limited tracking by public authorities of volumes purchased or used (e.g. procurement or reimbursement claims data), unsuitability of epidemiologic data to estimate the number of tests performed, and low manufacturer response rates to the OECD survey.
Notified bodies have limited information on PCR tests kit manufacturing, especially for Class B influenza PCR kits, which were previously self-certified under the In Vitro Diagnostics Directive (IVDD). Although the new IVDR, applicable from May 2022, requires manufacturers undergoing conformity assessment to provide information on manufacturing sites and relevant suppliers or subcontractors for critical components, it does not require disclosure for all raw materials. Improving the completeness and regular updating of EUDAMED would help identify active manufacturers on the EU market.
This chapter outlines the objectives of the study, the rationale for selecting the three case studies, and the data sources and analytical methods used. It then presents the findings for each case study: injectable corticosteroids (Section 1.2), seasonal influenza vaccines (Section 1.3), and polymerase chain reaction (PCR) tests for influenza (Section 1.4).
1.1.1. Objectives
This study develops three case studies to identify and illustrate vulnerabilities in the supply chains of selected medical countermeasures that are likely to face high demand during a major epidemic or public health emergency, and to assess their degree of preparedness. Each case study addresses the following key questions:
What is the market structure for each case study, including the degree of supplier concentration and diversification?
How are supply chains structured, and where are the main vulnerabilities and bottlenecks?
What is the potential to rapidly scale up manufacturing and delivery of these products in the event of a major emergency or pandemic?
A secondary objective of the study is to map and assess relevant public and commercial data sources that could be used by public authorities on a regular basis to monitor supply chain vulnerabilities. This includes examining the strengths and limitations of existing data and identifying persistent information gaps.
1.1.2. Selection of case studies
The case study subjects were selected to meet both of the following criteria:
They should include products likely to be in high demand in a future crisis, i.e. medical counter measures (MCMs); and
They should be exemplars of diverse types of supply chains: one medicine and one vaccine, which are in the Union list of critical medicines (EMA, 2026[1]), and one in vitro diagnostic (IVD).
The first selection criterion required identification of priority threats for preparedness and medical countermeasures (MCMs). DG HERA conducted a prioritisation exercise, considering existing scientific and epidemiological assessments, and integrating global and EU-level frameworks, including from the WHO and the ECDC. The approach involved an assessment of pandemic potential, the likelihood of an EU-wide public health emergency, the availability of MCMs, and the impact of climate change on the spread and virulence of viral threats. From this exercise, respiratory or contact-based viruses with pandemic potential were assessed as high priorities, and of those, four virus families have been classified as “highest priorities”, posing the most immediate and severe risk to the EU and global health security:
Coronaviridae, including SARS-CoV, MERS-CoV and SARS‑CoV‑2;
Orthomyxoviridae, including Influenza A subtypes such as H1, H2, H3, H5, H6, H7 and H10, comprising both seasonal and potentially pandemic influenza viruses. Although vaccines against seasonal influenza and certain strains of zoonotic influenza are available, their efficacy is limited by antigenic variability and may not provide protection against novel pandemic strains.
Filoviridae, including the Ebola and Marburg viruses, with high fatality rates and the potential to cause large‑scale outbreaks, particularly in sub-Saharan Africa.
Poxviridae, including the monkeypox (causing mpox) and variola virus (causing smallpox).
Discussions between OECD and DG HERA oriented the choice of case studies towards influenza vaccines and PCR diagnostic tests for influenza, as well as parenteral systemic corticosteroids, likely to be in high demand in the management of severe respiratory symptoms. The paragraphs below provide further details of the rationale for the selection of the three case studies.
Injectable systemic corticosteroids
Systemic corticosteroids are central to the management of severe acute illnesses of various types, especially for patients with severe acute respiratory illnesses. Presentations suitable for parenteral administration are particularly useful in severe acute illnesses; their rapid onset of action and predictability of effect are valuable in circumstances where time‑critical anti‑inflammatory effects are needed. This is particularly the case in conditions like acute respiratory distress syndrome (ARDS) or severe pneumonia, where the therapeutic window may be narrow and oral administration unreliable. For patients who are sedated and intubated, or require ventilatory support, parenteral administration allows for precise dosing in settings where continuous monitoring and dose adjustment are essential. The systemic route also produces higher plasma concentrations more rapidly, which may be necessary to counteract the intense inflammatory cascades seen in severe respiratory infections.
The scope of this study was narrowed to injectable dexamethasone, hydrocortisone and methylprednisolone as these are consistently recommended in national and international guidelines for the management of severe COVID‑19 pneumonia and acute respiratory illness.1
Influenza vaccines
This case study focusses on influenza vaccines. Vaccines are critical to attenuating the diffusion of infectious diseases and, in the COVID‑19 pandemic, were successful in preventing millions of excess deaths. They are likely to be an important MCM in the event of a future pandemic and are thus at the heart of preparedness strategies.
Vaccine manufacturing processes vary significantly based on the technology platform, ranging from traditional cultivation of viruses to cell-free, synthetic genetic engineering. These methods are chosen based on the pathogen type, necessary safety protocols, and the desired mechanism of immunity. Seasonal influenza vaccines are typically manufactured using traditional methods. Traditional methods2 rely on growing large quantities of the pathogen to produce either live‑attenuated vaccines or inactivated vaccines:
Egg-based production is used for the majority of the influenza vaccines produced in Europe today. It involves injecting the virus through a hole in eggs incubated for 3 days at 35°C. The virus then multiplies inside the cells that make up the chicken embryo. The embryos are killed overnight at 5°C, then the egg white is purified and recovered. The virus is then killed using chemicals (formaldehyde and/or detergent), purified and fragmented.
Cell-based production is based on a process that uses animal cells to cultivate the virus. Once the virus strains most likely to circulate during the coming flu season have been identified, animal cells such as dog kidney cells are grown in the laboratory. These cells serve as a growth medium for the virus. Once the virus has proliferated sufficiently, it is harvested from the infected cells and then inactivated by chemical treatment.
In the scenario of a pandemic influenza and a sudden surge in vaccination demand, the ability to rapidly scale up existing manufacturing capacity is a key strategic consideration. For this reason, this case study focusses on the best-selling influenza vaccines in the EU, which are predominantly based on established protein-based platforms with proven large‑scale production and distribution capabilities.
PCR tests for influenza
PCR diagnostic tests were selected for their relevance and usefulness in the case of a pandemic. Although Rapid Antigen Tests (RATs) can be readily and cheaply distributed, and used without professional intervention, PCR tests offer several key advantages, demonstrating significantly higher sensitivity, typically detecting 95‑99% of infections compared with 50‑85% sensitivity of RATs, depending on viral load and timing of testing. As a result, PCR tests can identify infections earlier in the disease course and are less likely to produce false negatives, making them particularly valuable for contact tracing, screening asymptomatic individuals, and preventing silent transmission chains. Additionally, PCR tests maintain high accuracy across different viral variants and can detect lower viral loads, which is crucial during periods when individuals may be infectious but not yet showing peak viral shedding. While RATs provide faster results and are more accessible for frequent screening, the higher analytical sensitivity and specificity of PCR testing make it the gold standard for definitive diagnosis, particularly in healthcare settings, outbreak investigations, and situations where false negatives could have serious public health consequences (Ahsan et al., 2024[2]; Smith-Jeffcoat et al., 2024[3]; Egbelowo et al., 2024[4]; COVID-19 Household Transmission Team, 2022[5]; Aboagye et al., 2024[6]).
In the context of an influenza pandemic, meeting a sudden surge in demand for PCR testing depends not only on the production of finished diagnostic kits, but also on the availability of specialised upstream components. From a supply chain perspective, a 2024 report on innovative diagnostics and testing solutions noted that a typical RT-PCR test involves 11 different reagents (composed of >25 different biological and chemical ingredients) and more than 10 types of consumables. Several of these intermediate components used in PCR kits marketed in Europe are highly dependent on Asian sourcing (European Commission, 2024[7]) As a result, even when manufacturing capacity of final kit assembly exists, disruptions in the supply of critical reagents or consumables may create structural vulnerabilities in emergency situations.
1.1.3. Overview of sources and methods to identify and analyse supply chains
Each case study includes the following components:
identification of all individual products marketed in EU Member States;
analysis of sales for the period Q4 2019 – Q1 2025, where possible, to analyse fluctuations in demand, identify top selling products and the degree of market concentration across suppliers in national markets. This period was selected to capture demand patterns before, during and after the COVID‑19 pandemic;
A mapping of upstream supply chains through available databases and/or consultations of companies marketing these products through interviews or surveys; and
An analysis of shortage notifications to identify patterns across products and countries that may indicate higher exposure to supply disruptions.
One of the objectives of this study was to explore the availability of publicly accessible data sources to inform the development of the selected case studies. Unfortunately, consolidated data from all EU markets that would enable the identification of all products together with their respective sales data and supply chains are not readily available.
Information on sales of products funded by public systems is available in some EU countries, at least for products dispensed to outpatients. However, information on sales to hospitals or to public institutions procuring vaccines is most often not available. Searching national consumption databases for injectable corticosteroids (mainly used in hospitals) was therefore not a promising avenue, which led us to the purchase of IQVIA MIDAS® sales data for parenteral systemic corticosteroids and influenza vaccines.
As already mentioned in a European Commission report from 2024, the most reliable public source of information on PCR tests for infectious diseases in the EU is FindDx (described below) (European Commission, 2024[7]), and we did not identify any competing databases. The number of PCR tests undertaken in the diagnosis of influenza is difficult to estimate. Some reimbursement claims data may exist in countries in which laboratories are paid on a fee‑for-service basis for tests performed in outpatient care, but volumes of tests used in hospitals remain unknown.
Public information on upstream supply chains of injectable corticosteroids and influenza vaccines is not available. The 2024 OECD report on medical supply chains (OECD, 2024[8]) showed that National competent authorities (NCAs), who collect this information in manufacturers’ applications for marketing authorisation, are generally not allowed to share it with third parties. NCAs can only share relevant supply chain and manufacturing information with the European Medicines Agency to support EU-level monitoring and crisis response under specific legal frameworks activated during public health emergencies – notably Regulation (EU) 2022/123 (Box 1.1).
During the present study, a survey of European NCAs carried out by the European Medicines Agency (EMA), on behalf of the OECD, to which 11 countries responded, confirmed that detailed manufacturing-site information for injectable corticosteroids is generally treated as commercially confidential. While several authorities can share limited data with governments or EU institutions under confidentiality arrangements, public disclosure is largely restricted by trade‑secret protections. Even where data are legally shareable, regulatory databases often record authorised manufacturing sites rather than those actively supplying the market, and extracting information often requires manual dossier review. When asked about their views on implementing a model similar to that used by Medsafe in New Zealand – where information on product-level manufacturing sites is published online – most authorities considered such an approach to be of limited usefulness. Several indicated that implementation would be challenging in practice due to expected industry resistance. A minority viewed the model as potentially feasible and useful at national level, while others suggested that any value would be greater if applied at EU level and restricted to a limited set of critical products.
Two databases were therefore explored to support the mapping of upstream supply chains, in particular to identify manufacturers of active pharmaceutical ingredients (APIs) and production sites: the European Directorate for the Quality of Medicines and Healthcare’s (EDQM) database for Certificates of Suitability (CEPs) and the private Cortellis Intelligence database.
For IVDs, notified bodies in charge of certification also collect information on manufacturing sites for some of them, but are not allowed to share it with third parties under normal circumstances.
All sources used in the analysis are summarised in Table 1.1, and a more detailed overview is presented in Annex 1.A.
In the aftermath of COVID‑19, the EU launched the European Health Union (EHU), aimed at making the EU better prepared for cross-border health threats and less dependent on external supply chains. The EHU rests on three core Regulations: Regulation (EU) 2022/2371 on serious cross-border health threats; Regulation (EU) 2022/123 on the reinforced role of EMA; and Regulation (EU) 2022/2370 on the reinforced role of ECDC. These are complemented by the establishment of DG HERA within the European Commission, and by the Emergency Framework (Council Regulation (EU) 2022/2372).
Regulation (EU) 2022/2371 on serious cross-border health threats
Regulation (EU) 2022/2371 provides the foundational legal basis for EU-level action on serious cross-border health threats. It establishes mechanisms for joint risk assessment, early warning and co‑ordinated response at Union level, and defines the conditions under which a public health emergency at Union level may be recognised, which may in turn provide the basis for activating other EHU instruments, including the Emergency Framework.
Regulation (EU) 2022/123 reinforcing EMA’s role
Regulation (EU) 2022/123 established a reinforced role for the European Medicines Agency (EMA) in crisis preparedness and management across three main areas: monitoring and mitigating shortages of critical medicinal products and medical devices; providing scientific support to accelerate medicine development during public health emergencies; and providing support to the expert panels for high-risk medical devices designated under Regulation (EU) 2017/745. To support these functions, the Regulation formally established the Medicine Shortages Steering Group (MSSG), the Medical Device Shortages Steering Group (MDSSG), and the Emergency Task Force (ETF), with governance structures that formalise arrangements developed on an ad hoc basis during the COVID‑19 pandemic.
The Regulation also established a framework for the structured exchange of supply-chain and shortage‑related information between national competent authorities (NCAs), marketing authorisation holders and EMA, operating both for ongoing preparedness and during recognised public health emergencies and major events. Under Article 4, EMA – in collaboration with Member States – continuously monitors any event likely to lead to a public health emergency or to a major event affecting the supply of medicinal products, and NCAs report in a timely manner through designated single points of contact on actual or potential shortages. The European Shortages Monitoring Platform (ESMP), established under Article 13, provides the central EU platform for the reporting and monitoring of medicine shortages and related supply information.
Where a public health emergency or major event has been recognised, the framework intensifies. The MSSG adopts a critical medicines list specific to that emergency or major event under Article 6, identifying the medicinal products considered critical in the situation at hand, and EMA may request more detailed information including:
identification of manufacturing sites for active substances and finished products, marketing status, and available stocks;
supply-chain risk information, including potential vulnerabilities, supply forecasts, and shortage prevention and mitigation plans;
details of actual or potential shortages, including estimated start and end dates, suspected or known causes, and geographical scope.
Information shared with EMA under this framework is subject to professional secrecy, commercial confidentiality and data-protection rules, allowing sensitive supply-chain and manufacturing information to be exchanged for both preparedness and crisis-management purposes.
Regulation (EU) 2022/2370 on the reinforced role of ECDC
Regulation (EU) 2022/2370 strengthens the mandate of the European Centre for Disease Prevention and Control (ECDC) in the area of epidemiological surveillance, preparedness planning, and response to cross-border health threats. It enhances ECDC’s capacity to provide timely risk assessments and scientific guidance in support of EU-level decision making during health emergencies, and reinforces its role in co‑ordinating surveillance networks across Member States.
Council Regulation (EU) 2022/2372 on the emergency framework for medical countermeasures
Council Regulation (EU) 2022/2372 established an emergency framework that can be activated by the Council in the event of a public health emergency at Union level, in order to help ensure the supply of crisis-relevant medical countermeasures including medicinal products, medical devices and in vitro diagnostic medical devices needed to respond to serious cross-border health threats.
Once activated, the framework enables the Union to take co‑ordinated measures to identify crisis-relevant medical countermeasures and relevant raw materials, monitor supply and demand, and support emergency procurement, purchase and manufacturing where needed. The Health Emergency Preparedness and Response Authority (DG HERA), established within the European Commission, is the body that operationalises much of the framework in practice, including financial support for the development, procurement and stockpiling of countermeasures. A Health Crisis Board supports co‑ordinated governance at Union level.
Reform of the EU pharmaceutical legislation
In April 2023, the European Commission proposed a comprehensive reform of the EU pharmaceutical legislation through a new Directive and a new Regulation, intended to replace the existing general pharmaceutical regulatory framework. The reform seeks to address systemic shortages and strengthen the security of supply of medicinal products in routine (non-crisis) conditions, extending security of supply beyond the reach of beyond the reach of crisis-time mechanisms. It reinforces requirements for marketing authorisation holders in relation to shortage prevention plans, shortage‑management obligations and reporting, with the aim of improving preparedness and increasing transparency over supply-chain vulnerabilities.
Of particular relevance to supply security, the reform provides for shortage prevention plans and additional reporting requirements intended to improve transparency over supply-chain vulnerabilities and to support earlier identification of risks affecting medicinal products. Together with the ESMP established under Regulation (EU) 2022/123, these provisions are intended to support earlier identification of emerging supply problems across the EU.
The Critical Medicines Act
The Critical Medicines Act (CMA), on which the EU Council and Parliament reached a provisional agreement in May 2026, aims to improve the availability and security of supply of critical medicines, strengthen pharmaceutical manufacturing capacity in the EU, and reduce strategic dependencies.
Source: European Union (2022[9]), “Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices”, https://eur-lex.europa.eu/eli/reg/2022/123/oj. European Union (2022[10]), “Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level”, https://eur-lex.europa.eu/eli/reg/2022/2372/oj. European Commission (2023[11]) “Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use”, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023PC0192. European Commission (2023[12]) “Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use”, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023PC0193 European Union (2022[13]),” Regulation (EU) 2022/2370 of the European Parliament and of the Council of 23 November 2022 amending Regulation (EC) No 851/2004 establishing a European centre for disease prevention and control” https://eur-lex.europa.eu/eli/reg/2022/2370/oj/eng. European Union (2022[14]), “Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU”, https://eur-lex.europa.eu/eli/reg/2022/2371/oj/eng. Council of the European Union (2026[15]), “Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency – Analysis of the final compromise text with a view to agreement”, https://data.consilium.europa.eu/doc/document/ST-6366-2026-INIT/en/pdf. Council of the European Union (2026[16]),“Directive on the Union code relating to medicinal products for human use – Analysis of the final compromise text with a view to agreement”, https://data.consilium.europa.eu/doc/document/ST-6367-2026-INIT/en/pdf. Council of the European Union (2026[17]), “Proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 – Letter to the Chair of the European Parliament Committee on Public Health”, https://data.consilium.europa.eu/doc/document/ST-11059-2026-INIT/en/pdf.
1.2.1. Identification of products and manufacturers selling in the EU/EEA market
IQVIA MIDAS® quarterly volume sales data for 26 EU/EEA countries were used to identify systemic corticosteroid products sold across the countries covered in the analysis. MAHs were identified by matching product names to the European Medicines Agency’s Article 57 database and attributing the MAH in the country where sales occurred. This approach was also necessary to identify the specific chemical form and composition of the active substance(s) in each product, as IQVIA molecule names may be reported at the level of the active moiety (e.g. dexamethasone) rather than the exact form present in the marketed product (e.g. dexamethasone sodium phosphate or dexamethasone acetate), and do not by themselves distinguish combination products.3 Among products sold in 2024, 260 unique Product × Country combinations were identified. Of these, 208 (80%) were successfully matched to an MAH, representing approximately 93% of total standard units sold. In cases where no MAH could be confidently identified, the manufacturer name reported in IQVIA MIDAS® was retained.4 For the remainder of this report, the analysis follows IQVIA’s molecule classification. Products are therefore discussed under the molecule names dexamethasone, hydrocortisone and methylprednisolone, irrespective of the specific chemical form of the corticosteroid or the presence of additional active substances in the product.
Dexamethasone dominated sales of injectable corticosteroids in EU/EEA countries with available data, accounting for 60% of total standard units (SUs) in 2024 (see Figure 1.1). Methylprednisolone represented a significant share (30.5%), while hydrocortisone accounted for a smaller portion (9.9%). The market is overwhelmingly hospital-based, with hospital sales accounting for 76% of total volumes in 2024, consistent with the primary use of these products in acute and inpatient care settings.
Source: Based on IQVIA MIDAS® quarterly volume sales data for the period 2024, reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved.
Table 1.2 presents the number of MAHs and product presentations supplied in EU/EEA countries with available data in 2024. A presentation is defined as a unique combination of product and pack, which means that one company can have multiple presentations of the same product. Across molecules, dexamethasone and methylprednisolone markets appear more diversified than hydrocortisone in terms of the total number of presentations available at EU/EEA level. However, this does not necessarily translate into diversified supply at the national level. In many countries, the market is concentrated around a few presentations and suppliers.
Across all three molecules, 84 unique MAHs were identified, out of which 62 (74%) supply a single country and a further 19 are active in between two and five countries. Only three MAHs have a broad geographic footprint, supplying more than five countries – and just two of these are present in more than ten.
Source: Based on IQVIA MIDAS quarterly volume sales data for the period 2024, reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved; and EMA’s Art. 57 database.
Table 1.3 shows, by molecule and country in 2024, the number of MAHs, the number of product presentations, and the respective market shares of the two top-selling MAHs for injectable corticosteroids. Market structures vary substantially across EU/EEA countries in terms of both the number of MAHs and the range of product presentations available. Larger markets such as Germany, France, Italy and Spain tend to have a larger number of MAHs and presentations. Germany stands out, with a very large number of presentations across molecules and the highest number of distinct MAHs overall. In contrast, several smaller markets – including Croatia, Luxembourg, Belgium and the Netherlands – have only a small number of MAHs across the three molecules, often combined with a limited set of presentations.
Supplier diversity is limited in many national markets. Markets with a unique MAH are rare for dexamethasone (1 of 26 countries) but more common for hydrocortisone (11 of 24 countries with sales data) and methylprednisolone (7 of 26 countries). Market concentration is high across all three molecules. In most countries, the two largest MAHs account for more than 80% of national sales volumes (22 of 26 countries for dexamethasone, 23 of 24 for hydrocortisone, and 23 of 26 for methylprednisolone).
These patterns show that, despite the presence of multiple MAHs in some markets, effective competition is often limited to a small number of suppliers. Hydrocortisone markets are particularly concentrated, with often a single dominant MAH. Dexamethasone and methylprednisolone markets tend to involve more registered suppliers in larger Member States, but sales are still typically concentrated among one or two companies.
Source: Based on IQVIA MIDAS quarterly volume sales data for the period 2024, reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved; and EMA’s Art. 57 database.
Table 1.4 shows, for each country, the market share of the top-selling presentation, the combined market share of the top three presentations and the overall concentration index (HHI) across presentations.5 For dexamethasone, the top three presentations account for more than 80% of national volumes in 21 countries, and for 11 countries they account for 100% or nearly all sales. By contrast, Germany stands out as comparatively diversified, with the top selling presentation accounting for only 12.5% of volumes and the top three for 27.9%, reflected in a very low HHI (0.04).
Hydrocortisone markets tend to be even more concentrated at the presentation level. In most countries, the top three presentations account for virtually all national sales, and in many cases the single largest presentation represents the overwhelming majority of volumes. For example, in Croatia, Estonia, Ireland, Slovenia and Switzerland, one presentation accounts for 100% of recorded hydrocortisone volumes. Only a small number of countries, such as Italy, Lithuania, the Slovak Republic and Portugal show more distributed patterns, with the largest presentation accounting for around one‑third to half of sales and lower HHI values.
Methylprednisolone generally shows lower concentration than the other two molecules. In many countries, the top-selling presentation accounts for between one‑third and two‑thirds of volumes, and the top three presentations typically represent around 70‑90% of national sales. However, this does not necessarily reflect competitive supply. In several countries, the available presentations are supplied by a single MAH. For instance, in Belgium and Luxembourg the top three presentations account for less than 70% of the market, yet both are single‑MAH markets where one supplier accounts for 100% of volumes.
Parallel imports are observed for a small number of markets and presentations but, with the exception of methylprednisolone in Lithuania, and to some extent in Sweden, do not constitute a major share of supply in most countries (see Table 1.5).
Note: The concentration index is calculated as a Herfindahl – Hirschman Index (HHI) across presentations within each country and molecule. The index ranges from 0 to 1, where higher values indicate that sales are concentrated in fewer presentations and lower values indicate a more even distribution across multiple presentations. Cells are colour-coded according to the HHI score: green indicates low concentration below 0.30, amber indicates moderate concentration from 0.30 to below 0.70, and red indicates high concentration at 0.70 or above.
Source: Based on IQVIA MIDAS quarterly volume sales data for the period 2024, reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved; and EMA’s Art. 57 database.
Source: Based on IQVIA MIDAS quarterly volume sales data for the period 2024, reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved.
1.2.2. Demand for injectable corticosteroids in the EU/EEA market
EU/EEA sales of injectable corticosteroids are concentrated in a small number of large markets. The top panel of Figure 1.2, shows that Italy, Germany, France and Spain record the highest sales volumes, ranging from approximately 19 to 22 million standard units (SUs) in 2024. A second tier – including Poland and Romania – represents sizeable but smaller markets, followed by a third group of countries such as Bulgaria, Portugal and Belgium, with volumes between 3 and 6 million SUs. Most remaining countries record fewer than 3 million SUs annually. Population size largely explains the dominance of large markets in absolute terms. However, when adjusting for population, Bulgaria, Lithuania, Croatia and Romania emerge as the highest consumers per 1 000 inhabitants. These differences in population-adjusted consumption may reflect variation in clinical practice, disease burden or treatment guidelines across countries. They may also partly reflect differences in the coverage and completeness of IQVIA data across countries.
The relative mix of molecules varies somewhat across countries, but dexamethasone represents the largest share of volumes in most markets. Methylprednisolone also contributes substantially, while hydrocortisone accounts for a comparatively small share of total volumes in most countries, with the exceptions being Poland, Romania, Portugal and the Slovak Republic.
As shown in the bottom panel of Figure 1.2, quarterly sales since 2019 show a sharp peak in 2020‑2021 driven largely by increased dexamethasone use. Since 2022, volumes have stabilised at a level slightly above the pre‑pandemic baseline, with dexamethasone remaining the main driver of total market variation. There is a noticeable dip in sales in the second quarter of 2020 which is found across most countries, although it has not been possible to establish the cause, as the shortage analysis in Section 1.2.4 shows that with the exceptions of Sweden and Czechia, no other countries reported shortages in 2020.
Source: Based on IQVIA MIDAS quarterly volume sales data for the period 2024, reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved.
1.2.3. Analysis of supply chains for injectable corticosteroids
Although the precise processes and inputs vary across injectable corticosteroid products, their manufacture can be described at a high level using the general GMP framework for API and sterile medicinal product manufacture. In broad terms, the processes comprise the following steps:
API manufacturing consists of producing the corticosteroid active substance and carrying out the GMP-controlled operations needed to obtain the API. This stage requires raw materials, starting materials, intermediates, processing aids and production equipment. API manufacture includes production, packaging, labelling, quality control and release, and becomes subject to progressively stricter GMP requirements as the process advances toward the final steps.
API isolation, purification and physical processing prepare the API for formulation into the final injectable product. This may include isolation, purification, drying, milling, blending or other physical processing steps needed to achieve the required quality attributes for downstream manufacture. Relevant inputs at this stage may include purification and drying equipment, transfer and handling materials, and other processing materials as appropriate.
Sterile finished-dose manufacturing, which is the stage at which the API is formulated into the final sterile injectable product. Depending on the product, this may involve aseptic preparation, sterile filtration, filling, or terminal sterilisation where feasible. This stage requires the formulated bulk product, sterile equipment, controlled manufacturing environments and, where applicable, sterilising filters and water meeting parenteral quality standards.
Lyophilisation, where applicable, is used for products manufactured as sterile powders for reconstitution. It is a critical sterile manufacturing technology requiring specific controls to maintain sterility between filling and completion of the process. Relevant inputs include filled containers and lyophilisation equipment.
Packaging and labelling include filling into the final container system, stoppering, sealing, packaging and labelling, using appropriately controlled containers, closures and packaging components. Relevant materials include vials or other primary containers, stoppers, seals, labels and other packaging materials.
Quality control and batch release cover laboratory controls and testing throughout manufacture, together with final review of manufacturing and quality information prior to batch certification or release of the sterile finished product. This stage requires representative samples, testing materials, laboratory systems and batch documentation.
Note: The precise process and material inputs vary across products and presentations. The stages described here are intended to provide general overview and are not exhaustive.
Source: FDA (2004[18]), Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice (Guidance for Industry), U.S. Food and Drug Administration, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice? (accessed on 24 March 2026); ICH (2000[19]), Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, https://www.gmp-compliance.org/files/guidemgr/3-1-18.pdf; European Commission (2022[20]), The Rules Governing Medicinal Products in the European Union, https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf?.
API manufacturers
The European Directorate for the Quality of Medicines and Healthcare (EDQM) database was used to identify manufacturers of active pharmaceutical ingredients (APIs) holding Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs) for the corticosteroid substances identified in the IQVIA data that were also available in the EDQM database.6 This search yielded 20 unique CEP holders.7 As shown in Figure 1.3, almost half are located in China, and six in the European Union. The remainder are located in India (2), the United States (2) and Malaysia (1). The database, however, presents a number of limitations for the analysis of upstream supply chains:
Holding a CEP does not indicate whether the substance is actually used in a finished product marketed in the EU, and the listed company address may not reflect the location of the manufacturing site but rather that of the CEP holder, which may or may not be a manufacturer.
Obtaining a CEP is not the only regulatory path allowing a manufacturer to sell a product for the European market. The MAH of a finished product may prefer using an Active Substance Masterfile (ASMf) when filing its application for marketing authorisation to the regulatory agency. In that case, the API manufacturer will not be referenced in the EDQM’s CEP database. Experts interviewed during this study estimate that when a monograph is published, CEPs holders represent around 85% of all manufacturers of the substance.
It does not enable to identify CEP holders manufacturing corticosteroids to a standard suitable for injectable use, which requires more complex sterile production to prevent microbial contamination and ensure product safety.8
The Cortellis database includes a field indicating manufacturers’ reported formulation or manufacturing capability, including injectable production. Applying this filter to the list of CEP holders, we identified only one manufacturer with facilities reported to produce injectable‑grade APIs for the corticosteroids in scope (located in the United States and covering dexamethasone, dexamethasone sodium phosphate, hydrocortisone and methylprednisolone). However, survey responses and targeted desk research indicate that additional CEP-holding manufacturers also supply APIs for injectable corticosteroid products. Because of this, the Cortellis injectable capability indicator was not considered sufficiently reliable as a standalone source for identifying injectable API manufacturing capacity. In addition, an interview with a current API manufacturer supplying the EU market confirmed that most of the manufacturers shown in Figure 1.3 are actively producing the products covered in this study.
Therefore, the supply chain analysis was supplemented by a survey sent out to 21 MAHs identified using IQVIA sales data and information from EMA’s Art. 57 database, selected to reflect a combination of manufacturers with the widest geographic market presence and those with high sales volumes. Only six manufacturers responded. Based on IQVIA sales data for 2024 in EU/EEA countries, they accounted for approximately 20% of the injectable dexamethasone market, 19% of hydrocortisone, and 0.1% of methylprednisolone. Findings from this survey are presented in Box 1.3 but can only be interpreted with caution as they cannot be considered representative of the full EU/EEA market and are not generalisable, especially for methylprednisolone, where coverage was minimal. Rather, they provide illustrative insights into the supply chains and risk profiles of a subset of manufacturers active in these markets.
Location of API manufacturers for corticosteroids with CEP certification
Note: Substances covered are hydrocortisone, hydrocortisone acetate, hydrocortisone hydrogen succinate, methylprednisolone, methylprednisolone acetate, methylprednisolone hydrogen succinate, dexamethasone, dexamethasone acetate and dexamethasone sodium phosphate.
Source: Based on information available in the European Directorate for the Quality of Medicines and Healthcare (EDQM) database as of March 2026.
A survey was sent to 21 Marketing Authorisation Holders (MAHs), selected to reflect a combination of manufacturers with the widest geographic market presence and those with high sales volumes, while ensuring representation across countries of different market sizes. Together, these MAHs accounted for approximately 60% of 2024 sales volumes (in standard units) across the 26 EU/EEA countries covered by the IQVIA data – more specifically, 76% of the market for methylprednisolone, 69% for hydrocortisone, and 49% for dexamethasone. In terms of geographic reach, altogether they supply all 26 countries (24 in the case of hydrocortisone). They are also the top seller in the majority of country – molecule combinations – 23 of 26 for methylprednisolone, 19 of 24 for hydrocortisone, and 19 of 26 for dexamethasone.
Six companies responded to the survey, and one additional company reported that its products had been withdrawn from the market. Among the six respondents, one manufactured all three molecules, one produced dexamethasone and hydrocortisone, two produced only dexamethasone, and two only hydrocortisone. Their geographic coverage varied substantially: one company marketed its products in 11 countries, one in 10 countries, one in 5 countries, and the remaining three operated in only a single country.
In terms of representativeness, based on IQVIA sales data for 2024 in EU/EEA countries, these six manufacturers accounted for approximately 20% of the injectable dexamethasone market, 19% of hydrocortisone, and 0.1% of methylprednisolone. These findings are therefore not representative of the overall EU/EEA market and should not be generalised, especially in the case of methylprednisolone.
Vertical integration and geographic distribution of manufacturing activities
Survey responses illustrated in Figure 1.4 point to a supply chain structure in which early-stage production (API and intermediates) is more internationally sourced and frequently outsourced, while later-stage sterile manufacturing and release activities are more often integrated and EU-based. While the EU remains an important location, several responses indicate reliance on sites in India and China, either exclusively or in combination with EU-based facilities. This pattern has implications for exposure to external supply shocks at the upstream level and for the EU’s relative control over final manufacturing and release stages.
Manufacturers’ reported share of global sales in EU markets varied markedly across respondents, ranging from marginal levels (below 1%) to a substantial share of global volumes (around 35‑40% or higher).
Note: The number of manufacturing steps varied across respondents which is why the size of the bars varies. Because certain manufacturers supply multiple molecules, they are counted more than once in the response set.
Source: Based on manufacturers’ responses to survey (see Annex 1.E).
An interview with EUROAPI, a backward-integrated European manufacturer of corticosteroid active pharmaceutical ingredients (APIs) highlights some of the drivers behind the increasingly internationalised sourcing of APIs. The company performs a substantial share of synthesis steps in-house, including the production of key starting materials, enhancing process control and reducing dependence on external intermediates. However, production of these off-patent molecules in the EU also entails elevated fixed costs, high energy consumption and labour-intensive operations. By contrast, Chinese manufacturers were described as benefiting from structurally lower production costs and competing aggressively on price, making it difficult for European producers to remain commercially competitive, particularly in price‑focussed procurement systems.
The manufacturer further indicated that its capacity to respond to a sudden increase in demand would depend on allocation choices and supply of key inputs. Expanding output would typically require six to eight months, depending on the molecule, owing to limitations in the availability of certain raw materials, workforce capacity and the inflexibility inherent in complex, multi-step synthesis processes. The company is investing and receiving public funding to innovate production processes and technologies to modernise and enhance the manufacturing of corticosteroids.
Supply chain vulnerabilities and risk factors
Survey responses indicate that perceived vulnerabilities are concentrated in a limited number of supply chain stages. As shown in Figure 1.5, the vulnerable stage most frequently cited was sterile manufacturing (29% of mentions), followed by fill-and-finish (24%) and API or intermediate sourcing (23%). Downstream activities such as quality control and batch release accounted for a smaller share of responses (6%), as well as sourcing of key starting materials (KSMs) and logistics/cold chain (12% each). This suggests that companies perceive the greatest risks in stages that are either technically complex and capacity-constrained (sterile manufacturing and fill-and-finish) or dependent on upstream external suppliers (APIs and intermediates).
Parts of supply chain most vulnerable to disruption, (n=17 selections of proposed items)
Note: Respondents could select multiple options.
Source: Based on manufacturers’ responses to survey (see Annex 1.E).
Figure 1.6 shows the main underlying reasons for these vulnerabilities. The most frequently cited factor was limited global manufacturing capacity (27%), followed by limited sources of API (18%) and environmental or regulatory constraints (18%). Geopolitical or trade risks, and demand volatility or tendering practices each accounted for 14% of responses, while limited supply of key starting materials accounted for 9%.
Sources of vulnerabilities along the supply chain, (n=22 selections of proposed items)
Note: Respondents could select multiple options.
Source: Based on manufacturers’ responses to survey (see Annex 1.E).
Ability to respond to surges in demand
Most respondents indicated that some capacity exists to increase supply during an emergency. Of the eight company – molecule responses available (one company did not respond to this question), seven reported that output could be increased at existing manufacturing sites. Four indicated that manufacturing capacity could be redeployed from other products, and three reported the possibility of reallocating supply from non-EU markets.
The timelines provided suggest that modest increases in production may be achievable in the short to medium term, whereas larger expansions would require substantially longer lead times. For a 10% increase in output, estimates ranged from three to six months. For a 20% increase, typical timelines were between 6 and 12 months, while scaling production by 50% was generally reported to require at least one year in all cases. Overall, these responses indicate that while limited short-term flexibility exists within current production systems, large‑scale surges in supply would likely require extended preparation periods.
Figure 1.7 shows that the main constraints to expanding production of injectable corticosteroids relate to upstream inputs and specialised manufacturing capacity. API availability was the most frequently cited limitation (five mentions), followed by sterile manufacturing capacity (four mentions). Regulatory requirements were also reported as a constraint in several cases, while other factors were mentioned less often.
Survey responses to the key constraints for scaling up production (n=17 selections of proposed items)
Note: Respondents could select multiple options.
Source: Based on manufacturers’ responses to survey (see Annex 1.E).
Reported policy and market factors affecting supply security
Manufacturers were asked which public policies or practices they considered most likely to affect the supply security of injectable corticosteroids, either positively or negatively. Examples provided included procurement and tendering practices, stockpiling strategies and regulatory requirements. Survey responses highlighted a consistent set of policy, regulatory and market factors perceived as influencing the security of supply:
Procurement and tendering practices. Several respondents indicated that short timelines between tender announcements and award decisions can create difficulties in aligning production planning with awarded volumes, given long manufacturing and sourcing lead times. Some companies suggested that awarding tenders to at least two suppliers per country could help reduce supply risk. While tendering itself was not always seen as inherently problematic, respondents stressed that its design must take manufacturing constraints into account.
Low prevailing market prices were identified as a risk factor, particularly for dexamethasone and hydrocortisone. Respondents noted that sustained price pressure may undermine the economic viability of production, with potential implications for long-term supply continuity.
Regulatory requirements. Companies pointed to increasing regulatory constraints and associated compliance costs, including requirements related to environmental risk assessments (ERA) and broader regulatory updates (e.g. revisions to technical annexes). Some respondents warned that additional requirements to segregate corticosteroid production from other products could be particularly burdensome, as current practices already rely on validated cleaning procedures and campaign-based manufacturing. Such measures were viewed as potentially reducing operational flexibility and increasing costs.
Stockpiling policies generated mixed views but were often associated with potentially negative effects if not carefully designed. Respondents emphasised that stockpiling obligations should be proportionate, based on forward-looking demand forecasts, and aligned with realistic supply capabilities. Several highlighted the need for EU-level co‑ordination of national stockpiles to improve predictability.
Financial incentives and supportive regulatory frameworks to strengthen manufacturing capacity within the EU for both finished products and active pharmaceutical ingredients were mentioned as measures that could improve long-term supply resilience.
Source: Based on responses of survey sent to manufacturers.
1.2.4. Analysis of shortages
National shortage notification registries were analysed to obtain information on the occurrence, timing and reported causes of shortages. National registries were scraped using a Python-based tool (Selenium library), which enabled systematic searches by ATC codes or product names (dexamethasone, methylprednisolone and hydrocortisone) and the construction of a consolidated database compiling all available information.
Shortage notification standards vary across countries, particularly with regard to the threshold and timing for formally declaring a shortage. In some countries, a shortage is recorded as soon as demand exceeds supply, whereas others require that the imbalance persists for a defined period before a notification is issued. These differences affect the comparability of reported shortage statistics across jurisdictions.
Reported shortages of injectable corticosteroids varied markedly across countries over 2019‑2025 as shown in Figure 1.8. Notifications were highly concentrated in a few countries. Czechia reported by far the highest number of shortages (104 notifications), accounting for well over half of all reported events in the sample. A second tier of countries reported substantially fewer cases, including Italy (25) and Sweden (20). All other countries recorded fewer than 15 notifications over the six‑year period, with very low counts in Austria (3), France (3), Spain (2) and Latvia (1). No shortages were reported in Belgium, Finland or Ireland during the period analysed.
The distribution of shortage notifications also varied across molecules. In most countries, reported shortages were dominated by methylprednisolone and dexamethasone, while hydrocortisone accounted for a smaller share of notifications. In Czechia, all three molecules contributed to the high overall number of reports, suggesting recurrent supply disruptions across the injectable corticosteroid class rather than problems confined to a single product. In contrast, countries with low overall counts typically reported shortages affecting only one molecule or a small number of isolated events. Looking ahead, the implementation of the EU pharmaceutical package is expected to strengthen existing obligations for early notification of shortages by requiring marketing authorisation holders to report supply disruptions in a more timely and harmonised manner, including in advance of anticipated shortages or market withdrawals (see Box 1.1).
Note: No shortages were reported for Belgium, Finland and Ireland.
Source: Estimations based on National registers notifications for 12 EU countries.
Figure 1.9 shows that the timing of reported shortages does not appear to be strongly correlated across countries. In most years, peaks in notifications are driven primarily by one or a small number of countries rather than occurring simultaneously across the full set of reporting countries. This pattern is observed across all three molecules, where periods of elevated notifications in one country are seldom mirrored elsewhere. Some partial overlap in reporting is visible in the later years of the period, particularly for methylprednisolone, when a broader group of countries report shortages in the same year. However, the number of shortage events remained uneven across countries. These findings suggest that, while certain supply disruptions may have had cross-border effects, many reported shortages likely reflect a combination of domestic market dynamics, product-specific issues, and differences in reporting practices rather than international supply shocks.
Efforts towards harmonisation of shortage notifications are ongoing and should facilitate in the future both the monitoring of shortages at the EU level and the cross-country comparisons of shortage occurrences (see EU Regulation 2022/123 in Box 1.1).
Note: No shortages were reported for Belgium, Finland and Ireland.
Source: Estimations based on National registers notifications for 12 EU countries.
1.3.1. Data sources for monitoring vaccine supply and production capacity
Two main sources were identified as providing useful and relevant information on volumes sold by manufacturers and supply chains and are described below. For a full list of all sources investigated refer to Annex 1.A.
IQVIA MIDAS
The IQVIA MIDAS sales database is described in Annex 1.A. QVIA notes that audit-based estimates may be biased downward where relevant market segments are not captured, and explicitly identifies “tender” among examples of “unaudited market channels” that may not be fully reflected in audited data (IQVIA, 2023[21]). For influenza vaccines, this implies that MIDAS sales data may reflect only a subset of total vaccine volumes in some countries. To assess the extent of IQVIA data coverage in the influenza vaccine market, vaccine volumes reported by IQVIA were benchmarked against figures from publicly available sources. These sources included vaccination coverage statistics and dashboards, official press releases on procurement for national seasonal influenza campaigns, and reimbursement or utilisation statistics published by public authorities. The sources and calculations behind this classification can be found in Annex 1.B. Owing to differences in data availability across countries, the time period varied depending on the most recent and reliable public information identified for each country. Based on this comparison, countries were classified according to the estimated degree of IQVIA coverage of total influenza vaccine volumes as shown in Table 1.6. Among the 25 EU/EEA countries for which IQVIA data were available, 16 were assessed as having good coverage, while eight were found to have very limited coverage. For Luxembourg, no comparison could be undertaken, as no suitable public estimates were identified against which IQVIA data could be benchmarked. This finding implies that the ranking of vaccines by sales, used to identify the top-selling egg- and cell-based vaccines for further supply chain analysis through interviews, may be subject to bias.
Source: Based on IQVIA MIDAS quarterly volume sales data for the period Q3 2024-Q1 2025, reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved. Full coverage exercise can be found in Annex 1.B.
WHO production capacity surveys
WHO monitors global vaccine production to inform pandemic preparedness by regularly surveying influenza vaccine manufacturers and to estimate both seasonal and potential pandemic vaccine production capacity overall and by region, vaccine type, and manufacturing process. These surveys have been carried out since 2006 and collect information on:
a) the types of influenza vaccines being produced (production platform, formulation, etc.)
b) country locations of vaccine licensure and production facilities
c) an estimate of maximum production capacity if operating at full scale
d) pandemic preparedness and capacity (i.e. licensed pre‑pandemic vaccines, access to dose sparing adjuvants, and expectations for adequate supplies and filling capacity to meet their maximum capacity in the event of a pandemic).
The results of this survey are made public as scientific articles, with the main limitation being they are aggregated across manufacturers and presented at the regional level (Taaffe et al., 2025[22]).
1.3.2. Identification of influenza vaccines and manufacturers selling in the EU/EEA market
Overall, across EU/EEA countries, the influenza vaccine market is characterised by limited manufacturer diversity and high concentration at the country level. In IQVIA data, five9 main manufacturers were identified as supplying influenza vaccines in EU/EEA countries, namely Sanofi, CSL Seqirus, Abbott/Viatris,10 Fluart and GSK, for the 2024/25 influenza season.
Table 1.7 provides an overview of manufacturer presence and market concentration for seasonal influenza vaccines across EU and selected European countries during the 2024/25 influenza season. Across most countries, the number of active manufacturers supplying influenza vaccines is limited, with more than half of countries (14 out of 25) depending on one or two suppliers. One country relied on a single manufacturer, while 13 countries were supplied by only two. Seven countries had three manufacturers, and six countries had four manufacturers active in their national markets.
Market concentration is high in most countries. In 24 out of 25 countries, the leading manufacturer accounts for more than 50% of total influenza vaccine volumes. In several cases, concentration is substantially higher: the top supplier exceeds 75% market share in eight countries, and in Croatia and Hungary a single manufacturer accounts for approximately 100% of reported volumes. In Croatia, this reflects the use of a national tender that selects a single supplier for vaccinating at-risk populations, while other vaccines may still be available through private channels. Only two countries (France and Portugal) had a top-supplier market share below 50%. Even in markets with multiple manufacturers, supply is often highly skewed. Countries with three or four active manufacturers frequently display pronounced asymmetries in market shares, with the top one or two suppliers accounting for bulk of the market.
Sanofi is the leading supplier in 16 of the 26 countries, while Abbott/Viatris is the top supplier in six countries. GSK and CSL Seqirus are the leading suppliers in two countries each.
Note: Covers Q3 2024 – Q1 2025 -i.e. the 2024‑2025 influenza season in Europe. Shaded rows are those countries where IQVIA data has limited coverage. Company and product names were harmonised to avoid counting importers and distributors as distinct manufacturers and to avoid double counting the same name with different spellings.
Source: Based on IQVIA MIDAS quarterly volume sales data for the period Q3 2024-Q1 2025, reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved.
1.3.3. Demand for influenza vaccines in the EU
Influenza vaccination in EU countries is predominantly organised through national or regional public health programmes. Recommendations on seasonal influenza vaccination for targeted or at-risk groups are standard in most countries, and these typically include the elderly, people with chronic medical conditions, pregnant women, healthcare workers, and residents of long-term care facilities (ECDC, 2025[23]).
Influenza vaccines are procured and distributed through different mechanisms across EU countries. A survey of 18 European countries published in 2021 identified four main procurement models for vaccines used in national influenza campaigns: a) national public tenders (Croatia, Denmark, Finland, Ireland, Lithuania, the Netherlands, Norway, Scotland, Slovenia); b) regional public tenders (Italy, Spain, Sweden); c) direct purchase by general practitioners from manufacturers (England, Wales); and d) direct purchase by pharmacies from manufacturers or wholesalers (Belgium, France, Germany, Greece) (Stuurman, Rizzo and Haag, 2021[24]).
A survey of healthcare distributors carried out by the European Healthcare Distribution Association (GIRP) on behalf of OECD confirmed that the distribution pathways through which influenza vaccines reach patients vary across countries. In some cases, vaccines are distributed primarily through dedicated state‑managed systems, with limited or no involvement of pharmaceutical wholesalers. For example, in Greece, vaccines are delivered through a central logistics system under state and military supervision, while in Denmark and Slovenia distribution is organised through public authorities or tendered logistics arrangements linked to national immunisation programmes. In other countries, vaccine distribution relies on full-line wholesalers to supply pharmacies, general practitioners or health centres, as is the case in Austria, Romania, Estonia, Latvia and Hungary. By contrast, France relies more heavily on manufacturers distributing directly to pharmacies, with wholesalers accounting for only a small share of influenza vaccine volumes. In most countries where a private market exists (vaccines which are not covered by public systems), this is typically organised through wholesalers supplying community pharmacies, resulting in multiple parallel distribution channels within the same country.
Figure 1.10 illustrates the evolution of the influenza vaccine market using IQVIA data, providing a more detailed picture of the composition of the European11 market over time. Figure 1.10 shows that across all panels, influenza vaccine sales volumes exhibit pronounced seasonality, with sharp peaks in the third and fourth quarters of each year, corresponding to pre‑season stocking and administration ahead of the winter influenza season (Stuurman, Rizzo and Haag, 2021[24]). Volumes sold outside this window are minimal, underscoring the temporal nature of influenza vaccine demand. Total sales volumes in EU/EEA countries increased markedly during the 2020/21 and 2021/22 seasons, coinciding with heightened vaccination demand during the COVID‑19 pandemic period. From 2022 onwards, total volumes declined, suggesting a reversion to earlier demand patterns.
Across all seasons shown, a small number of manufacturers account for the majority of sales. Sanofi consistently has the largest share of EU influenza vaccine sales, followed by Abbott/Viatris, with CSL Seqirus and GSK occupying smaller but stable positions.
Sales volumes are overwhelmingly concentrated in inactivated influenza vaccines with products such as Vaxigrip® (Sanofi) and Influvac® (Abbott/Viatris) consistently accounting for the largest share of volumes across seasons. Most vaccines sold in the EU market are 0.5 ml doses, corresponding to 77% of sales in 2024. High-dose vaccines (0.7 ml), more specifically Efluelda® (Sanofi), made up 23% of the market in 2024 and have increased visibly in the post-pandemic period, consistent with broader adoption for older age groups in several countries. However, as of 2024, high-dose vaccines were only sold in 14 out of the 25 countries available in IQVIA data.12 Over the whole period, Italy and Spain were the only countries purchasing 0.1 ml doses (Intanza®13) but this ceased after Q3 2023.
Note: EU market includes all Member States except Malta, Cyprus, Denmark and Slovenia. Company and product names were harmonised to avoid counting importers and distributors as distinct manufacturers and to avoid double counting the same name with different spellings.
Source: Based on IQVIA MIDAS quarterly volume sales data for the period Q4 2019-Q1 2025, reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved.
1.3.4. Analysis of influenza vaccine supply chains
Although the precise stages and inputs needed for the production of a given vaccine vary depending on the technology platform (e.g. inactivated vaccine, live attenuated vaccine, viral vector-based, recombinant protein, messenger ribonucleic acids (mRNA) etc.), vaccine supply chains can be broadly described as in Figure 1.11.
Note: The stages depicted in this schematic intend to provide a general overview of vaccine production and are not comprehensive.
Source: OECD (2024[8]), Securing Medical Supply Chains in a Post-Pandemic World, https://doi.org/10.1787/119c59d9-en.
Primary manufacturing consists of the initial production steps to create the vaccine’s active ingredient i.e. the antigen, which is responsible for inducing an immune response. The process and type of production facility needed for this vary according to the type of vaccine being produced. Typically, it includes culturing and propagating the target organism (e.g. virus or bacteria) in bioreactors, inactivating or attenuating the pathogen, and purifying the antigenic components – to create what is often known as “bulk antigen” or “bulk vaccine”.
Secondary manufacturing involves the formulation of the vaccine, by combining the vaccine’s active ingredient with all other components and mixing them uniformly in a single vessel. Here, stabilisers, adjuvants, and preservatives may be added. Additional ingredients in the production or packaging of a vaccine may require separate mini supply chains.
For packaging, vaccine formulations are transferred to a separate facility in order to “fill” (squirt doses into vials) and “finish” (cap the vials with stoppers and then label and package) the vaccine. This requires specialised assembly-line capital equipment, in addition to inputs such as glass vials and stoppers. In some cases, the formulation and fill and finish take place in the same facility. Stringent quality controls are taken at this stage.
Finally, vaccines doses must be transported at appropriate temperatures, and delivered while maintaining the cold chain. The cold chain is interconnected with refrigeration equipment; while most vaccines can be kept between 2°C and 8°C, some require temperatures as low as ‑20°C or ‑70°C.The three main manufacturing stages described above can take place in different factory buildings, as well as across several countries.
Note: The stages depicted in this schematic intend to provide a general overview of vaccine production and are not exhaustive.
Source: OECD (2024[8]), Securing Medical Supply Chains in a Post-Pandemic World, https://doi.org/10.1787/119c59d9-en.
Table 1.8 displays the results of the latest WHO global vaccine capacity survey for manufacturers of influenza vaccines in Europe, complemented and refined using insights from interviews with vaccine manufacturers and desk research to narrow down production sites supplying to the EU market. Bulk vaccine manufacturing sites are located in a limited number of countries, including the Netherlands, Hungary, Germany, France, and selected non-EU locations such as the United States and the United Kingdom.
When linking IQVIA sales data for EU/EEA countries to information on manufacturing sites, France emerges as the single largest location for bulk manufacturing, accounting for around one‑third of all influenza vaccines sold in the region (approximately 18 million standard units), as shown in Figure 1.12. The Netherlands follows with roughly one‑quarter (around 15 million standard units). Taken together, these two EU Member States account for well over half of the bulk manufacturing volume captured in the data. Outside the European Union, the United States represents the largest production hub, contributing a similar volume to the Netherlands (around 15 million standard units, or just over one‑quarter of total output). Smaller shares are observed in Germany (about 7%) and the United Kingdom (about 8%).
Source: Adapted from 2023 WHO Production Capacity survey (Taaffe et al., 2025[22]) using insights from interviews and desk research.
Share of influenza vaccines (SUs) sold in the 2024‑2025 influenza season in EU/EEA countries, by location of bulk manufacturing
Note: Covers 99.9% of the market in IQVIA data.
Source: Based on IQVIA MIDAS quarterly volume sales data, reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved; combined with 2023 WHO Production Capacity survey (Taaffe et al., 2025[22]), manufacturer interviews and desk research.
Furthermore, interviews were conducted with two influenza vaccine manufacturers to gain deeper insights into influenza vaccine supply-chain structures, namely Sanofi and CSL Seqirus. The selection was intended to reflect key features of the European market: Sanofi manufactures Vaxigrip®, the top-selling seasonal influenza vaccine, while CSL Seqirus is a major supplier of both egg-based and cell-based influenza vaccines and plays an important role in EU pandemic preparedness arrangements.
Manufacturing footprint and site specialisation
For their seasonal vaccines Fluad® and Flucelvax®, CSL Seqirus operates a multi-site manufacturing network with distinct roles across facilities.
The Liverpool (United Kingdom) site is the core egg-based manufacturing facility.
The North Carolina (United States) site focusses on the production of cell-based vaccines.
Fill-and-finish operations are also carried out in Europe (through CMO), to manage the short production window for Northern Hemisphere vaccination campaigns.
Quality control and batch release take place in the Netherlands, with support from the Liverpool site.
In the case of Sanofi, their main influenza vaccine manufacturing site is located in Val-de‑Reuil (France), where bulk production and filling of Vaxigrip® takes place, alongside filling and packaging of the high-dose vaccine Efluelda®, with bulk production in the United States.
Vulnerabilities and bottlenecks along the supply chain
Interviews with manufacturers indicated that demand uncertainty, rather than production capacity, represents the central structural challenge in seasonal influenza vaccine supply. From a supply-chain perspective, manufacturers did not identify overall antigen production capacity as the primary limitation. Instead, constraints arise from the tight and highly sequential production timeline. The period between WHO strain selection and the start of vaccination campaigns encompasses bulk production, fill-and-finish, quality control, regulatory batch testing, and distribution. Regulatory batch release was highlighted as a particular bottleneck. Regulatory batch release was highlighted as a particular bottleneck. Testing and release by Official Medicines Control Laboratories (OMCLs) occurs sequentially and can extend over several weeks as multiple manufacturers submit batches at the same time before flu season. At the same time, procurement authorities often require a large share of contracted volumes to be available at the outset of vaccination campaigns, creating pressure to front-load deliveries in late summer. This combination of very tight timelines and concentrated delivery requirements reduces operational buffers.
Seasonal production planning is typically supported by multi-year forecasting and integrated sales and operations planning processes (S&OP). However, manufacturers noted that the effectiveness of these planning tools depends on a predictable demand environment and timely procurement decisions. One of the manufacturers reported that year-to-year variability in volumes ordered by public authorities complicates production planning. Fluctuations are driven by factors such as unused doses from previous seasons, changes in vaccination eligibility or targets, and budgetary decisions. In systems relying on competitive tendering, this uncertainty is amplified; a manufacturer might supply most or all of a national market in one year and none the next. When tenders are finalised late in the production cycle, manufacturers must commit output before final demand is known, increasing the risk of both shortages and unsold doses.
Country-specific packaging and regulatory requirements further constrain the reallocation of doses between markets once production has begun. One of the manufacturers reported having to commit to language‑specific packaging several months in advance, limiting the scope to redirect doses later in the season. They also noted that during the COVID‑19 pandemic, there were temporary exemptions to labelling and packaging requirements, which facilitated the reallocation of doses across EU countries. While “standard export” presentations can provide some flexibility, their use generally requires additional national regulatory approvals, packaging/labelling exemptions and administrative steps.
Preparedness and resilience measures
Both manufacturers reported having implemented preparedness measures aimed at strengthening resilience in the event of a pandemic. These include maintaining stockpiles of critical inputs with long lead times and shelf-lives (such as glass vials, stoppers and syringes), reservation agreements with key suppliers to secure surge capacity, and arrangements with contract manufacturers to ensure access to fill-and-finish capacity.
Manufacturers also indicated that, in a declared pandemic, seasonal production lines could be reoriented toward pandemic vaccine production across their global manufacturing networks. For example, CSL Seqirus would reallocate production such that manufacturing sites for egg-based and cell-based seasonal vaccines would switch to producing pandemic vaccines, with the UK site producing egg-based and US site cell-based vaccines. Because seasonal and pandemic influenza vaccines rely on similar production platforms, many supplier relationships and material requirements are expected to remain applicable under pandemic conditions.
Neither manufacturer reported systemic seasonal supply shortages at the manufacturing level in recent years, despite periods of heightened demand during the 2020/21 season and shortages of certain packaging materials linked to Russia’s war of aggression against Ukraine.
CSL Seqirus supplies different influenza vaccines to the EU market depending on whether they are intended for routine seasonal use, pandemic preparedness, or zoonotic viruses. These vaccines are produced using both egg-based and cell-based platforms and are procured through different mechanisms, ranging from annual tenders for seasonal vaccines to bilateral or joint procurement frameworks for advance purchase agreements (reservations) or stockpile purchases for preparedness and response. Table 1.9 summarises the main features of influenza vaccines supplied or reserved for the EU market by CSL Seqirus.
Source: Based on interview with CSL Seqirus
1.3.5. Analyses of shortages
With the exception of Czechia, national registries of shortage notifications did not reveal any occurrences of shortages of influenza vaccines between Q4 2019 and Q1 2025, and none of the manufacturers interviewed reported any recent shortages.
Seasonal and pandemic influenza place a significant burden on global health systems with cyclical surges, mainly during winter months, in the demand for diagnostic testing. Each year, influenza viruses, including four main types (A, B, C, and D14) infect an estimated 1 billion people worldwide, making influenza one of the most prevalent respiratory infectious diseases. While most cases are mild, the WHO estimates that influenza causes 3 to 5 million cases of severe illness and between 290 000 to 650 000 deaths annually (WHO, 2025[26]). Pandemic influenza occurs at irregular intervals when an influenza A virus of animal origin acquires the ability to spread efficiently among humans with no pre‑existing immunity leading to a sudden increase in mortality and morbidity globally. In recent years, avian influenza viruses, particularly H5 and H7 subtypes, have caused hundreds to thousands of zoonotic infections in humans with high case‑fatality rates. The likelihood of these animal influenza viruses to evolve and acquire airborne transmission among humans represents a significant risk for future pandemics (Liang, 2023[27]). As a result, both seasonal and pandemic threats place pressures on health systems across countries, particularly regarding diagnostic testing capacity.
The PCR method used to diagnose influenza is more precisely referred to as reverse transcription polymerase chain reaction (RT-PCR). This is because influenza is an RNA virus, and its detection by PCR requires an essential preliminary step in which viral RNA is converted into complementary DNA by the enzyme reverse transcriptase, in a process known as reverse transcription. Accordingly, PCR kits used to detect influenza are referred to in this section as influenza RT-PCR kits. RT-PCR is the gold standard for influenza detection, due to its high sensitivity and specificity as well as its ability to identify specific influenza strains15 (ECDC, 2025[28]). However, where resources for PCR testing are limited, rapid influenza diagnostic tests are also used.
RT-PCR involves several analytical steps including RNA isolation, reverse transcription, PCR amplification and PCR product analysis, each requiring specific reagents (Box 1.6) that may become scarce during outbreaks.
RT-PCR consists of an initial reverse transcription step, followed by PCR amplification performed over multiple cycles, from 20 to 40 cycles. The process includes:
Reverse transcription: viral RNA is converted into complementary DNA (cDNA) by the enzyme reverse transcriptase.
Each PCR cycle includes three main steps:
Denaturation (94‑98°C): to break the hydrogen bonds between the DNA strands, resulting in single‑stranded DNA.
Annealing (50‑65°C): primers bind to their complementary sequences on the single‑stranded DNA.
Extension (72°C): DNA polymerase synthesizes new DNA strands by adding nucleotides to the primers.
RT-PCR kits for the detection of viral pathogens consist of both generic components that are common across assays and target-specific components that must be specific to the virus being detected.
Components that are common for RT-PCR kit for different viruses
Plastic consumables: collection tubes, pipette tips, plates.
Generic buffer solutions: including reaction buffers and solutions to secure enzymatic efficiency.
Nucleotides (dNTPs): pieces required for DNA synthesis during amplification process.
Enzymes: DNA polymerase for DNA amplification and reverse transcriptase for the conversion of viral RNA1 into complementary DNA.
Basic laboratory equipment, such as the PCR machines called thermal cyclers.
Components that are specific for RT-PCR kits and virus-specific
Primers: short and single‑stranded nucleotide sequences that are designed to bind to specific target sequences of the viral DNA. In influenza RT-PCR assays, primers typically target conserved regions of viral genes, such as the matrix (M) gene for influenza A detection. Primers are among the most critical components, as they must be specifically designed for each target virus and variant.
Probes: short nucleotide sequences that enable the detection of amplified genetic material.
Positive and negative controls: materials containing known target sequences and samples not containing the targeted virus, respectively, used to ensure the accuracy and reliability of the test.
Internal controls: reagents included to verify that nucleic acid extraction has been performed correctly and to reduce the risk of false‑negative results due to incidences during the extraction.
Documentation: instructions for use (IFUs) and package labelling.
1. Influenza viruses are RNA viruses, and the transcription of RNA into complementary DNA is an essential step in PCR-based detection.
Source: Interview with an IVD expert, November 2025.
The COVID‑19 pandemic exposed significant vulnerabilities in RT-PCR testing supply chains. Shortages affected multiple components of PCR kits, including nucleotides and primers. In addition, reagents used in sample preparation and nucleic acid extraction to isolate viral genetic material prior to PCR testing were also in short supply, notably RNA extraction kits and associated lysis buffers. Shortages were also observed for plastic consumables, including pipette tips, tubes and specimen collection swabs.
An interview with a supply chain expert revealed that extraction buffers were subject to the most persistent supply constraints. Specifically, in the European Union, the limited availability of lysis buffers represented a key bottleneck, mainly due to their short shelf life. In response, some laboratories adopted in-house preparation of these solutions, which in some cases negatively affected test performance. Among extraction reagents, magnetic beads were one of the molecular testing reagents with most limited availability during the COVID‑19 pandemic (HaDEA, 2024[29]) (Box 1.7).
The extraction of viral RNA is an essential upstream step in RT-PCR testing which enables the isolation and purification of the genetic material from collected samples. It involves the following steps:
1. Sample collection: using nasopharyngeal or oropharyngeal swabs. Viral RNA is placed in transport media and kept in cold temperature until the extraction is done.
2. Viral lysis: samples are treated with lysis buffers containing chemical agents that break the membranes of infected cells releasing the viral RNA into a solution while inactivating nucleases that could degrade the RNA.
3. Binding of nucleic acids: released RNA is bound to magnetic beads, spin columns or other, depending on the extraction type, enabling its separation from cellular debris This step allows selective capture of nucleic acids while other cellular components remain in solution.
4. Washing steps: the bound RNA is washed multiple times to remove proteins, lipids, and other contaminants that may interfere with downstream enzymatic reaction.
5. Elution of purified RNA: purified viral RNA is released from the solid support using an elution buffer and collected in a final solution suitable for reverse transcription and PCR amplification.
Source: Made Artika et al. (2025[30]), “Comprehensive Review on Viral RNA Extraction Strategies for Enhanced Molecular Diagnostics”, https://doi.org/10.1155/ipid/5579320.
Findings from the Laboratory Observer State of the Industry survey, which focusses on molecular diagnostics, indicate that although supply chain pressures have eased since the peak of the COVID‑19 pandemic, disruptions have not been fully resolved. Some respondents reported ongoing challenges in accessing key products, specifically pipettes, reagents, and transport media for clinical laboratories (Nadeau, 2023[31]). Moreover, performing RT-PCRs testing requires adequate laboratory infrastructure, specialised molecular instruments, and trained laboratory personnel. These requirements are increasingly constrained by persistent shortages of laboratory workers and the difficulties medical laboratories face in recruiting and retaining qualified staff (GW University, 2025[32]).
1.4.1. Mapping of influenza PCR tests sold in EU Member States
Initial investigations and interviews with experts confirmed the challenge of identifying all PCR tests commercialised in EU Member States and companies marketing them. To be sold in the EU, in vitro diagnostic (IVD) tests must obtain a certificate (known as CE marking), from one of 19 notified bodies in charge of examining compliance with regulatory requirements (European Commission, 2025[33]). To date, however, there is no central database fully capturing information on in vitro diagnostics authorised for sale in the EU. The European Database on Medical Devices (EUDAMED) is an IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on IVDs. This database is still being implemented, and the information contained is incomplete, as companies willing to sell IVDs in Europe currently only register their products on a voluntary basis (EUDAMED, n.d.[34]).
EUDAMED search for influenza PCR kits
The EUDAMED database includes six modules related to “Actor registration”, “Unique Device Identification (UDI) and device registration”, “Notified Bodies and certificates”, “Clinical investigations and performance studies”, “Vigilance and Post-market surveillance” and “Market surveillance”. Based on the Commission Decision (EU) 2025/2371 of 26 November 2025, the use of the first four modules will become mandatory from 28 May 2026.
Information in EUDAMED can be searched through three search interfaces: i) Economic Operators, ii) Devices, Systems and Procedure Packs, and iii) Certificates (issued or refused). The Devices, Systems and Procedure Packs was used to identify CE‑marked influenza PCR kits, using relevant European Medical Devices Nomenclature codes (EU Commission, 2026[35]) that may include influenza PCR kits, all under the grouping of Infectious Diseases (W0105) and filtered as “on the EU market” (Figure 1.13). The inclusion criteria required that the IVD use PCR technology and target either influenza A or B, including highly pathogenic avian influenza subtype. IVDs based on rapid antigen testing, next generation sequencing or non-PCR nucleic acid amplification methods (e.g. isothermal amplification) were excluded.
Source: Based on the influenza RT-PCR kits manufacturers listed in EUDAMED as of January 2026.
The four search queries delivered some overlapping results, with 132 different IVDs sold by 45 different manufacturers. However, the presence of these products in EUDAMED does not necessarily indicate that they are currently being marketed. In some cases, production may have stopped, and the manufacturer may not have updated their status in EUDAMED.
Interestingly, some entries in EUDAMED show different “(Master) UDI-DI / EUDAMED ID” and “Basic UDI-DI / EUDAMED DI” identifiers, despite having the same device name. These discrepancies are often due to variations in pack size or number of tests per kit. For the purpose of estimating the total number of IVDs, only entries with distinct device names were counted as separate devices.
According to survey responses, EUDAMED contains information on certified IVD tests which are no longer being produced. As a result, estimates of the number of products marketed by a given manufacturer should be interpreted with caution, as discrepancies may exist between regulatory listings and products currently available on the market. To improve the reliability of EUDAMED data, it is recommended that manufacturers update the device status to “no longer placed on the market” when devices are discontinued. Although this status field already exists, it is not consistently updated in practice. Therefore, additional compliance checks could be introduced to prevent outdated products from remaining listed as active in the EU market. This recommendation is aligned with the amended Article 29 of the European Commission’s proposal to revise Regulations (EU) 2017/745 and (EU) 2017/746, which explicitly requires manufacturers to keep the information provided to the UDI database up to date.
Most influenza IVDs identified in EUDAMED were self-certified under the IVDD and never assessed by a notified body (NB). Only fewer than 20 were marketed under the IVDR. Under Regulation (EU) 2024/1860, manufacturers may continue selling IVDs marketed under the IVDD until 31 December 2028 or 2029, provided that a confirmation letter is issued by a NB before 26 September 2026 or 2027, respectively.
Dx Connect search for influenza PCR kits
The database Dx Connect Test Directory database produced by FIND was consulted to partially address the data incompleteness from EUDAMED (FIND, 2026[36]). This non-governmental organisation aims to improve access to tests and diagnostics for infectious diseases of interest through a searchable directory called DxConnect. The database was launched during the COVID‑19 crisis as an open-source portal referencing all in vitro medical diagnostics in development or authorised for sale in the world. The constitution of this database, for a given disease, is based on an overall search in public databases, a literature review, searches in specialised diagnosis and internal databases, consultation with manufacturers, and collaboration with local consultants.
The database prioritises the identification of tests that can be performed at home, in communities, in primary care centres (True Point of Care) and in laboratories of district hospitals and small dispensaries (Near Point of Care). Specifically, PCR tests require specialised equipment and trained personnel and therefore can only be performed in a laboratory setting (Lab-based). DxConnect also notes that the location of the commercial entity listed in the database is not necessarily that of the manufacturer. For some companies, it is difficult to identify the manufacturing site or to distinguish the distributor from the manufacturer. When manufacturer information is available, it is prioritised for inclusion in the database; otherwise, the distributor is included.
Starting from this global base of several thousand products, different filters were applied to select PCR tests potentially commercialised in the EU market (Figure 1.14).
Category: the first filter selected the “Outbreak” category. This category covers the diagnosis of the following diseases: COVID‑19, Pneumonia, Mpox, Gastroenteritis, Salmonellosis, Cholera, Influenza, Yellow fever, Ebola virus disease, Bronchiolitis, Chikungunya, Dengue, Zika fever, Meningitis, Marburg virus disease, Nipah virus disease, Lassa, Typhoid fever, Enteric fever, Rubella, Paratyphoid fever, Measles, West Nile Fever. The Outbreak category includes 4 215 distinct tests.
Target pathogen: the second filter focussed on Influenza A and Influenza B, yielding 254 assays from 165 manufacturers with headquarters located in 20 countries.
Regulatory body: the third filter applied was “Regulatory body”, including CE, CE‑IVDD and CE‑IVDR markings. It should be noted that CE‑IVDD marking does not necessarily mean that the product is currently available on the European market, as it may correspond to products withdrawn from the market. This filter resulted in 134 assays from 95 manufacturers across 19 countries.
Type of technology: the fourth filter restricted the selection to molecular tests, excluding immunoassays such as rapid antigen tests. This step resulted in 47 tests from 36 manufacturers headquartered in 17 countries.
Source: Based on DxConnect database by FIND as of January 2026.
Websites search for influenza PCR kits
To complement the information obtained from EUDAMED and DxConnect, a systematic search was performed using Google with keywords including “influenza RT-PCR kit”, “influenza A/B RT-PCR”, and “influenza PCR CE-marked”. Manufacturers’ websites were consulted and only tests described as RT-PCR for influenza and CE‑marked were considered.
In parallel, an assisted web search was conducted using Perplexity to identify major manufacturers commercialising RT-PCR assays for influenza in EU Member States. Manufacturer websites were then consulted to verify the information and confirm that the products were certified for sale on the EU market.
1.4.2. Influenza PCR tests identified in the EU market
Using these three approaches, 85 manufacturers of RT-PCR kits for influenza detection were identified. The geographical location of manufacturers’ headquarters documented in the DxConnect and EUDAMED databases, complemented with the targeted website searches, was used to map the global distribution of RT-PCR influenza kits manufacturers (see Figure 1.15). Asia accounts for 48.2% of influenza RT-PCR kits manufacturers, followed by Europe (32.9%), the United States (9.4%), Australia (3.5%) and Türkiye (5.9%). China holds a substantial share of manufacturers; however, production capacity remains geographically distributed at the global level.
Geographical distribution of companies with CE‑marked influenza RT-PCR kits in 2025 (number of manufacturers)
Note: Orange colour represents Asian countries, light blue colour represents European countries.
Source: Estimations based on the databases consulted as of January 2026.
Annex Table 1.C.1 provides an overview of the 85 identified manufacturers of CE‑marked PCR kits for influenza diagnosis. It presents the manufacturer name, the country where headquarters are located, the assay name, and revenue figures as of December 2024. As the available information was not sufficiently granular to isolate revenues attributable specifically to PCR tests, the table reports, where available, revenues for the broader business segment in which PCR tests are included, typically molecular diagnostics. Note that this business segment is not exclusive to influenza PCR diagnostics and may include a wide range of other diagnostic tests, such as molecular assays for oncology used to detect cancer-related genetic mutations.
Among the 85 manufacturers, 49 companies (57.6%) primarily focussed on molecular diagnostics, although not exclusively on influenza, while the remaining 36 companies (42.4%) operate more broadly across the diagnostics and life‑science sectors, including areas such as general IVD, sequencing technologies and pharmaceuticals. From the 85 RT-PCR kits manufacturers, proxies for firm size including information on revenue, revenue specific by business segment or number of employees were available for only 41 companies. Considering the companies from which total revenue information was available, 22 companies were large,16 9 companies were medium, 9 companies were small and 1 was a micro‑enterprise.
1.4.3. Analysis of the demand for influenza RT-PCR in the EU
Five different approaches were explored to obtain useful information on volumes of RT-PCR kits for influenza sold in the EU. An information query was launched via the Pharmaceutical Pricing and Reimbursement Information (PPRI) thematic network on medical devices17 on 16 December 2025 to identify additional sources of information, but unfortunately it did not yield any new information.
Reimbursement claims for PCR influenza tests
In some EU countries, PCR tests performed in private laboratories are reimbursed on a fee‑for-service basis by national health insurance schemes. For instance, in France, information on the number of tests performed is publicly available in OpenBio, and the fee schedule for PCR tests for influenza can be found under code 5 272. Using this billing code, the number of tests performed in 2024 was estimated at 71 000.
However, this estimation approach is only feasible in countries where detailed reimbursement data are publicly available and where PCR tests are billed on a fee‑for-service basis in ambulatory or private laboratory settings. In the EU, many Member States do not publish test-level reimbursement data. As a result, these estimates would only capture a subset of total national influenza PCR testing, restricted to a small number of countries, and therefore underestimate overall demand.
Influenza PCR kits procured through public tenders
Public national procurement databases were investigated to obtain information on the quantities of PCR for influenza purchased across EU countries (Box 1.8). However, no publicly available information on influenza PCR kits procurement could be identified in EU-level databases, including the EU-wide tender awards platform (TED) and national procurement databases, where calls for tenders and contract award notices are usually published.
Due to data incompleteness, procurement data cannot be used to estimate PCR kit sales across EU countries.
Insights from an interview with a procurement expert highlighted several barriers to using tender data to estimate PCR kits purchased for influenza detection. Some of the limitations mentioned were:
Limitation of CPV codes: The Common Procurement Vocabulary (CPV) establishes a single classification system for public procurement aimed at standardising the references used by contracting authorities and entities to describe procurement contracts (European Commission, n.d.[37]). However, in practice, procurement notices frequently bundle multiple products under broad CPV codes. This insufficient granularity in CPV coding prevents the isolation of influenza PCR kits procurement.
Limited visibility of below-threshold procurements: In many Member States, procurements below a certain financial threshold are not required to be published, or their publication is voluntary, leading to substantial differences in data availability. For example, Italy maintains open data platforms were below-threshold procurements are published, whereas in Germany below-threshold procurement reporting is voluntary.
Heterogeneity and fragmentation of procurement systems: National procurement systems differ in accessibility. For instance, Portugal has one of the most accessible platforms, while France operates through multiple decentralised hospital-level procurement systems, hindering national-level data aggregation.
E‑forms to harmonise procurement data: The European Commission introduced mandatory e‑forms in October 2023 for publishing public procurement data, established under Commission Implementing Regulation (EU) 2019/1780 (European Commission, n.d.[38]). However, coverage is still uneven, and databases are not yet complete.
Source: Interview with a procurement expert, December 2025.
Estimation of demand for influenza RT-PCR tests using ECDC data
A last attempt to estimate volumes of RT-PCR influenza RT-PCR used in Europe relied on data collected by epidemiologic surveillance systems, namely the European Respiratory Virus Surveillance Summary (ERVISS), developed by the European Centre for Disease Prevention and Control (ECDC) and the WHO Regional Office for Europe. This approach is described in Annex 1.D but was not conclusive.
1.4.4. Supply chains of manufacturers of CE‑marked influenza PCR tests
Supply chain mapping for RT-PCR tests for influenza mainly relied on two sources: a survey of companies with CE‑marked PCR tests, and a survey of EU notified bodies in charge of assessing the conformity of IVD products before being placed on the market. Surveys of manufacturers and notified bodies were conducted between 1 December 2025 and 25 January 2026.
Manufacturers consultation
The first source is a survey of 66 companies identified through EUDAMED and for which contact information was available. A questionnaire was sent to these companies (see Surveys conducted as part of the study), to which 12 responded (18.2%). Among these, three indicated that their influenza RT-PCR kit is still listed in EUDAMED but no longer manufactured. Nine respondents (13.6%) completed the questionnaire, from which three reported zero sales to the EU market from 2022 to 2024, while six (9.1% of the total sample) reported the number of RT-PCR tests sold.
These six companies reported a total of about 570 900 PCR tests for influenza sold in EU in 2022, 1 426 100 in 2023 and 1 495 900 in 2024 (Figure 1.16). Given that the total volume of sales in EU is unknown, it is impossible to assess the representativeness of this sample of companies, to conclude anything about the global trend in the volumes of sales over the period, or to even explain the increased sales for one of these companies, which might be due to increased market shares.
Number of influenza RT-PCR test sold in the EU market by origin of the responding manufacturer (n=6). This cannot be considered as representative of the PCR market, but indicative of the sample of respondents
Note: These numbers should be interpreted with caution due to the small sample size (n = 6) and the fact that some of the larger influenza RT-PCR manufacturers did not respond to the questionnaire.
Source: Based on surveys sent to the manufacturers of influenza RT-PCR kits between December 2025 and January 2026.
Survey respondents indicated that they sell influenza RT-PCR kits to European and non-European countries. One manufacturer reported marketing the product in all EU Member States except Malta; another indicated sales limited to Spain and Italy, another listed all European countries; another reported to sell in Austria, Belgium, Bulgaria, Croatia, France, Germany, Greece, Hungary, Ireland, Lithuania, the Netherlands, Poland, Portugal, Romania, the Slovak Republic, Slovenia, Spain, Sweden; another indicated the product was marketed in the Slovak Republic, Hungary, Spain, Bulgaria, the United Kingdom, Italy, Malta, North Macedonia and Greece; and finally, one manufacturer reported marketing the product exclusively in Greece.
When manufacturers were asked about their ability to scale up production for influenza RT-PCR kits, most of them indicated that an increase would be feasible, although timelines would vary depending on scalability constraints. Only one manufacturer reported no capacity to increase production in either the short or medium term. For a two‑fold increase in production, one manufacturer indicated that it could scale up immediately, arguing sufficient availability of raw materials. The rest of the respondents would require between one and six weeks. For a five‑fold increase, manufacturers estimated that scaling up would take between one and six months, noting that raw material replenishment and logistics could constrain production due to the limited existing stocks and only under the assumption that supply chains would remain stable. For a ten‑fold increase in production, manufacturers answered that a minimum of 6 months would be required. One manufacturing company reported substantially longer time requirements than the others.
Considering these constraints in scaling up production of influenza RT-PCR kits, measures to improve visibility and strengthen information flows across supply chains would help anticipate and, where possible, avert potential shortages. For MCM such as influenza RT-PCR kits, closer monitoring of volumes and flows could be established in partnership with suppliers. Achieving better visibility requires the collection of more granular, real-time information on the structure, status and content of supply chains. To better anticipate the risks of discontinuation, information sharing between stakeholders would also be necessary (OECD, 2024[8]).
Regarding the number of manufacturing sites involved in producing influenza RT-PCR kits, most manufacturers reported to have one single manufacturing site located in different countries including the United States, France, India and Türkiye. Not all manufacturers shared information on the number of suppliers of raw materials such as enzymes, primers, probes, plastic consumables and packaging components. Among the respondents, the reported number of suppliers ranged from five to nine. From these suppliers, manufacturers were asked how many of them were declared as critical in the technical documentation sent to the notified body, on the grounds that they provide essential components or perform processes that are fundamental to the performance and regulatory compliance of the PCR influenza diagnostic kits. The number of critical suppliers reported ranged from two to six.
Manufacturers classified the following components as critical in their technical documentation due to their direct impact on the analytic performance and safety of the PCR kits: DNA polymerase and reverse transcriptase enzymes, reaction buffers, primers and probes for influenza A and B, buffer ion systems, positive control plasmid and negative control material.
Regarding the origin of the components used to manufacture influenza RT-PCR kits, 33% of primers, 17% of nucleotides, enzymes, and MgCl2 and 43% of probes suppliers are placed in the EU (Figure 1.17). While most other components have six suppliers, probes have seven within the EU and outside the EU.
Geographical distribution of suppliers of influenza RT-PCR kit components
Note: These numbers should be interpreted with caution due to the small sample size of respondent manufacturers (n = 5). Only 5 manufacturers responded to this question. When two or more suppliers were reported for a specific component, each supplier’s country was counted as an independent entry in the graph. This explains why, for example, seven entries are shown for probes, despite having only five respondents.
Source: Based on surveys sent to the manufacturers of influenza RT-PCR kits between December 2025 and January 2026.
Manufacturers were also asked to provide information on the manufacture of extraction buffers, which are required to isolate influenza RNA from a patient sample and represent an essential preparatory step for RT-PCR testing. These extraction buffers, specifically the magnetic beads, were among the reagents most affected by supply chain shortages during the COVID‑19 pandemic, resulting in downstream disruptions to PCR diagnostic capacity (HaDEA, 2024[29]). Four manufacturers of RT-PCR kits for influenza also produce acid nucleic extraction buffers. The geographical distribution of their suppliers can be seen in Figure 1.18.
Information regarding potential vulnerabilities in the supply chain for influenza RT-PCR components was requested from manufacturers. Potential supply chain vulnerabilities relate to the sensitivity of enzymes to transportation conditions, supplier dependency and logistics lead times for critical materials such as enzymes, primers, probes and controls. These risks were reported to be mitigated through proximity-based-sourcing, shortened transport times, safety stock maintenance, dual sourcing where feasible, validated supplier substitution plans, and ongoing risk assessments and supplier audits.
Geographical distribution of suppliers of acid nucleic extraction buffer components
Note: These numbers should be interpreted with caution due to the small sample size of respondent manufacturers (n = 4). This question was only answered by 4 of the respondent manufacturers. When two or more suppliers were reported for a specific component, each supplier’s country was counted as an independent entry in the graph.
Source: Based on surveys sent to the manufacturers of influenza RT-PCR kits between December 2025 and January 2026.
Notified bodies consultation
The Regulation (EU) 2017/746 classifies medical devices into four risk classes: Class A, B, C and D. The classification is based on the intended purpose and the risk for the patient, and it is the manufacturer’s responsibility to assign their device to a risk class (Box 1.9).
Two interviews were held with two notified bodies which confirmed that devices intended for the detection of seasonal influenza are classified as Class B while tests for highly virulent influenza virus are classified as Class D (Box 1.9). In EUDAMED, multiplex assays that include seasonal influenza as one of the targets are classified as either class B or class C, and for multiplex devices the risk class assigned corresponds to the target with the highest associated risk. The risk class of an influenza PCR kit determines the depth of post-market surveillance performed by notified bodies but does not affect the manufacturing information requirements set out under the IVDR. However, discrepancies exist in the risk classification of certain viruses (Annex 1.F).
The certification process for class B and class C devices follows a sampling approach, in accordance with MDGC 2019‑2013 Rev 01, after which a quality management system (QMS) certificate is issued. Under this approach, only 5% of the devices from a single manufacturer within a given device category are subject to assessment. Consequently, some products may not be directly assessed by a notified body. Requirements to be fulfilled regarding manufacturing, in accordance with the IVDR (Annex II), include the following section:
A description of the critical ingredients of the devices such as antibodies, antigens, enzymes and nucleic acid primers provided or recommended for use with the device;
Information to allow the manufacturing processes such as production, assembly, final product testing, and packaging of the finished device to be understood;
Identification of all sites, including suppliers and sub-contractors, where manufacturing activities are performed.
However, for influenza RT-PCR kits, the assessment of technical documentation focusses only on enzymes and nucleic acid primers. As a result, buffer, MgCl2 and nucleotides information is not included. Supply chain management falls under the QMS (IVDR, Article 10 8 (d), EN ISO13485) and is audited during regular QMS audits. Nevertheless, disclosure of raw material supply chain sites is not a requirement under the IVDR.
In summary, there are no significant differences in the technical documentation assessment requirements between class B and class C devices, whereas more substantial differences are found in the post-market surveillance obligations.
For class D devices, there is no sampling approach, and all the devices require a pre‑market review, and each batch must undergo verification testing by an EU Reference Laboratory to confirm their performance.
Source: Interview with a notified body, January 2026.
Survey to notified bodies
All the 19 IVDR notified bodies were invited to participate to a survey, to which nine responded (47.37%) (survey can be seen in Surveys conducted as part of the study). Of these, 4 reported that they had not certified any RT-PCR tests for influenza, one indicated that an RT-PCR for influenza is currently under review, and the remaining four issued a total of 20 certifications for RT-PCR products to diagnose influenza (Figure 1.19). Overall, 18 influenza RT-PCR kits were multiplex and two were singleplex.18 There is no way to assess the representativity of survey results. They should be considered as illustrative.
Note: Eighteen influenza RT-PCR products were assessed under the IVDR, and two products were assessed under the IVDD.
Source: Based on the results of the survey sent to notified bodies between December 2025 and January 2026.
Most of the 20 PCR kits certified by the responding Notified Bodies are marketed in a large set of countries, exceeding 25 (see Figure 1.20).
Note: Kits are grouped according to the number of countries in which they are marketed. For instance, the first bar shows that six different kits have the market coverage illustrated in that bar. The country codes shown within each bar indicate the countries where those kits are marketed.
Source: Based on the results of the survey sent to notified bodies between December 2025 and January 2026.
These 20 CE‑marked influenza RT-PCR products were manufactured at 21 finished product manufacturing sites, of which 13 are located in Europe (61.9%), followed by 6 in the United States (28.5%), 1 in Australia (4.8%) and 1 in China (4.8%), see Figure 1.21. Overall, finished-product manufacturing for this sample of products is concentrated in only five countries. In addition, within Spain and the United States, several PCR kits are reported as being finalised in the same regions, indicating a degree of geographical concentration at the regional level.
Source: Based on the results of the survey sent to notified bodies between December 2025 and January 2026.
Across the 18 influenza RT-PCR kits certified under the IVDR for which supply chain information is available, the number of manufacturing sites listed in the supply chain ranged from one to nine. Most kits (72.2%) reported only one manufacturing site in their supply chain. Suppliers included both external and internal suppliers of the disclosed critical material, however manufacturing sites for external suppliers were not specified. For primers, nucleotides and probes, the most frequently reported manufacturing site was the United States (40%), followed by Spain (26.7%), Germany (13.3%), the United Kingdom (6.66%) and China (6.66%). For DNA polymerase, the United States was again the most common location (43.75%), followed by Spain (33.3%), Germany (12.5%) and the United Kingdom (12.5%). A similar pattern was observed for reverse transcriptase, with the United States accounting for 50% of manufacturing reported sites, followed by Spain (31.25%), Germany (12.5%) and the United Kingdom (6.25%). Finally, for MgCl2, Spain was the most frequently reported location (50%), followed by Germany (25%), the United Kingdom (12.5%) and China (12.5%), see Figure 1.22.
Note: Values reported are the number of times a country was cited as hosting a manufacturing site for each component. Information from 18 products is shown, however, for some components the location was unknown.
Source: Based on the results of the survey sent to notified bodies between December 2025 and January 2026.
1.4.5. Final remarks
An extensive mapping of CE‑marked influenza RT-PCR kits was conducted using multiple data sources, including EUDAMED, DxConnect by FIND and systematic website searches, leading to the identification of 85 manufacturers.
Overall demand for RT-PCR tests could not be robustly estimated due to data limitations. Several approaches were explored, including analysis of reimbursement claims for influenza RT-PCR tests and a review of influenza PCR kits procured through public tenders; however, these did not yield sufficient data. As a result, the representativeness of the survey of manufacturers and NB could not be determined.
Results from a survey of influenza PCR manufacturers, to which only 6 manufacturers responded, suggests that, even when kits are produced by EU-based companies, most critical components are not supplied by EU-based companies. However, this set of information cannot be considered as representative due to the low response rate of companies and the impossibility to estimate total volumes of tests sold within the EU. Findings from a survey of IVDs notified bodies provide partial information on the market coverage of certified influenza PCR kits and indicate a high degree of concentration in finished-product manufacturing as well as in the supply of the PCR components. However, this analysis is not exhaustive as information is only available for PCR devices certified under the IVDR between 2017 and 2024 and it is based on responses from only nine of the 19 designated notified bodies.
In summary, data limitations prevent a complete assessment of supply chains of influenza PCR kits. Any further attempt to characterise supply chains for this type of in vitro diagnostic test would require both industry’s engagement to respond to a survey and more market intelligence drawn from diverse data sets.
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The following paragraphs describe the main data sources considered, their key limitations, and the rationale for their inclusion or exclusion from the analysis. One of the objectives of this study was to identify all publicly available database in priority. The timeframe of this study did not allow the aggregation/harmonisation of existing national databases based on e‑prescriptions or reimbursement claims. The Pharma 14 database has done this aggregation of publicly available information from 27 countries and is available through subscription (Pharma 14, n.d.[39]), but its main inconvenient for this study is that it most often includes medicines dispensed to outpatients for self-administration. A full overview of all data sources is provided in Annex Table 1.A.1 at the end of this section.
IQVIA data on sales by countries
IQVIA MIDAS® is an IQVIA proprietary information service which integrates IQVIA’s national audits into a globally consistent view of the pharmaceutical market, and provides estimated product volumes of registered medicines, trends and market share through retail and non-retail channels.
Data are primarily collected at the distribution stage, involving the transfer of medications from wholesalers, distributors, and manufacturers to dispensing facilities such as pharmacies, clinics, and hospitals. Retail panels cover sales in number of packs of products from wholesalers to retail pharmacies, while hospital panels measure sales from wholesalers to hospitals. On some occasions, data collection also occurs during the distribution process to patients (WTO, 2019[40]; IQVIA, 2023[21]; IQVIA, 2022[41]).
It should be noted that IQVIA data is not available for all EU countries. For this study, the OECD licensed IQVIA MIDAS quarterly sales data of injectable systemic corticosteroids and for influenza vaccines for 26 (25 in the case of influenza vaccines) countries for the period Q4 2019-Q1 2025. Sales values and volumes are available for individual products, sold to hospitals or to retail pharmacies, and for individual countries, with the exception of Malta, Cyprus and Denmark for corticosteroids and influenza vaccines, and Slovenia additionally for influenza vaccines only.
The IQVIA 2023 ACTS Annual Report notes that audit-based estimates may be biased downward where relevant market segments are not captured, and explicitly identifies “tender” among examples of “unaudited market channels” that may not be fully reflected in audited data (IQVIA, 2023[21]). For influenza vaccines, this implies that MIDAS sales data may reflect only a subset of total vaccine volumes in some countries.
National registers of shortage notifications
The list of national registers of shortage notifications published by the European Medicines Agency (EMA, 2026[42]) was used as the starting point of the scraping tool developed for the study. It lists all the links leading to public national registers of shortage notification for EU Member States.
National registers were included in the analysis where they were accessible online in a format compatible with automated extraction by the web scraping tool developed for this study and allowed for sufficiently targeted identification of relevant products, resulting in a total of 12 registers. Eight national registers (Austria, Belgium, Czechia, Denmark, Finland, Germany, Italy, Sweden) allowed searches using ATC codes. In other cases, registers were available but did not support ATC-based queries or were published in formats such as PDF (e.g. France, Ireland, Latvia, Spain). For these, identification of relevant products relied on searches by molecule or substance names. However, this approach is more complex, as corticosteroids are marketed in a wide range of pharmaceutical products with different forms, dosages and indications. In particular, isolating injectable corticosteroids – the focus of this study – from other formulations is not always possible, which contributes to variability in coverage across countries. In the case of Slovenia, the structure of the register did not allow for identification based on ATC codes or molecule names. Although an alternative database was identified, it could not be integrated into the scraping tool within the timeline of the study.
These databases present some limitations, as national shortage notification systems vary widely in terms of scope and content, and some of them were only recently implemented (European Commission, 2021[43]).In addition, data availability may not be consistent across the full period of interest.
The different registers listed were the subject of the construction of a scraping tool in Python (Selenium library) allowing to visit each of the registers, to enter therein each of the ATC codes or molecule names entering into the scope of the case study (dexamethasone, methylprednisolone and hydrocortisone) to develop a data frame bringing together each of the shortage notifications for all the countries on the exploitable list. Shortage notifications corresponding to the period Q4 2019-Q1 2025 were considered, for alignment with information on sales.
European Directorate for the Quality of Medicines and Healthcare (EDQM)
The European Directorate for the Quality of Medicines and Healthcare (EDQM) created and maintains the database of Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP) (EDQM, 2024[44]). EDQM publishes monographs describing all the tests to be carried out to control the substance or product, as well as the corresponding quality standards for Active Pharmaceutical Ingredients (APIs). A manufacturer willing to sell APIs for use in products approved in Europe can apply to obtain such a Certificate of Suitability (CEP). The EDQM checks, for each application, whether the substance produced by the manufacturer complies with the standard of the monograph. The EDQM’s CEP database covers all the certificates of suitability requested by CEP holders with a view to placing them on the European market, i.e. a volume of 6 800 CEPs. They cover a large number of the substances described in the European Pharmacopoeia but not all, as the procedure for Certification of Suitability to the Monographs of the European Pharmacopoeia (CEPs) is intended for substances for which a general or individual monograph has been adopted by the European Pharmacopoeia Commission. The procedure does not apply to gene products (e.g. proteins) or products obtained from human tissues, vaccines and blood products and preparations.
Obtaining a CEP, however, is not the only regulatory tool allowing a manufacturer to sell a product for the European market. For example, the manufacturer may wish to instead use an Active Substance Masterfile (ASMf) when filing its application for marketing authorisation to the regulatory agency. In that case, the company will not be referenced in the EDQM’s CEP database. Experts interviewed during this study estimate that when a monograph is published, CEPs represent about 85% of all manufacturers of the substance.
On the other side, the existence of a CEP does not mean that the product is actually marketed in EU or even meant to be distributed in Europe. A CEP can exist for a product not yet approved or already withdrawn. Some manufacturers may even seek to obtain a CEP to target non-European market, as the CEP is considered by others as an indicator of quality.
Moreover, although the information reported in the CEP database is useful for identifying potential sources of API, it not fully reliable for identifying the location of manufacturing sites since the location indicated in the database may correspond to the CEP holders’ headquarters instead of the place of manufacture. Finally, the monographs published in the EDQM database concern APIs and do not contain any explicit indication on the final use of this API. An API can thus be used as much for the development of an injectable corticosteroid product as a corticosteroid product for the treatment of skin or eyes, for example.
FindDx information on Diagnostic tests
The NGO Find Dx19 launched during COVID‑19 is an open-source portal to improve access to information on tests and diagnostics for infectious diseases of interest. The Dx Connect Test Directory database references all in vitro medical diagnostics. The constitution of this database is based, for a given disease, on an overall search in public databases, a literature review, a search in specialised databases on diagnosis, a search in internal databases, consultation with manufacturers and work with local consultants.
The database prioritises the identification of tests that can be performed at home, in communities, in primary care centres (True Point of Care) and in laboratories of district hospitals and small dispensaries (Near Point of Care). Regarding the scope of the case study (PCR test for infectious disease), a significant part of the tests present in the database are also kits or tests that can only be carried out in a laboratory (Lab-based).
Find Dx finally specifies that the location of the manufacturers indicated is not systematically that of the producer. For some manufacturers, it is difficult to identify the place of production or distinguish the distributor from the manufacturer. In this case, it is the information on the manufacturer that is given priority; when the information is absent, it is that of the distributor.
Clarivate data on supply chains
Clarivate Cortellis product intelligence provides information on API manufacturers, the location of production plants, as well as dates of inspections by competent authorities. This information is based on literature, public sources, interviews with manufacturers and processed by a team of analysts in charge of reviewing and validating the information collected from the different sources.
The data source, however, does not enable to retrieve information on where these APIs are shipped and for which products they are used. Cortellis is currently working on the integration of import/export data for these APIs but such information is not yet available for trade with EU Member States.
Nonetheless, this database allowed for an extraction of the following information:
A list of active pharmaceutical ingredient (API) manufacturers, including the addresses of their manufacturing sites, that hold a Certificate of Suitability to the European Pharmacopoeia (CEP);
A list of all manufacturers with capabilities for producing injectable formulations; and
Sales data (in USD) and API consumption (in kilograms) by route of administration.
Market Information for Access to Vaccines (MI4A)
A key limitation of this dataset is that volumes for individual countries are not disclosed for confidentiality reasons; instead, vaccines sales in the EU can only be approximated using data for the broader European high-income group. In addition, reporting to the Immunisation Joint Reporting Form (JRF) is voluntary and based on country self-reporting, leading to variation in data coverage across countries and years. Although the precise degree of coverage could not be established, reported volumes are substantially lower than those observed in IQVIA data and MI4A data was therefore not used for analysis. However, MI4A data did provide external validation of the ranking of top-selling products identified using IQVIA data.
IFPMA Influenza Vaccine Supply International Task Force (IVS) surveys
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Influenza Vaccine Supply International Task Force (IVS) established a dose distribution survey in 2008 to better estimate global distribution of seasonal influenza vaccines in the absence of a harmonised global coverage database. This survey has been conducted approximately every two years and data are available from 2004 to 2021. Member manufacturers report the numbers of influenza vaccine doses supplied to each WHO Member State, which are then aggregated and presented at the global and WHO region level. The main limitation of this survey is that information on the number of doses sold by a manufacturer to a given country remains confidential (Stuurman, Rizzo and Haag, 2021[24]; Palache et al., 2023[45]) and therefore it could not be used in this study.
TED procurement database
Tenders Electronic Daily (TED) is the European Union’s online journal for public procurement and serves as the open-data source for all notices published under EU procurement directives. The data are drawn directly from standardised procurement forms, completed by contracting authorities and transmitted for publication.
Contracts are classified using Common Procurement Vocabulary (CPV) codes. The specific CPV code for influenza vaccines is 33651660‑2 (Influenza vaccines), whereas there are no specific codes for injectable corticosteroids or PCR tests for influenza. TED primarily includes notices above EU public procurement thresholds, although contracting authorities may voluntarily publish below-threshold notices as a good-practice measure. The overall coverage of such voluntary notices, however, is not known.
In terms of data quality, the dataset is provided as is. Errors and omissions are relatively common, as the procurement forms are completed by contracting authorities themselves. A review of multiple procurement forms for influenza vaccines showed that, while these notices typically include information on the winning suppliers and the contract value (in euros) awarded, they do not report the quantities or doses purchased.
United Nations Commodity Trade Statistics Database (UN Comtrade)
The United Nations Commodity Trade Statistics Database (UN Comtrade) is a comprehensive repository of official international trade data compiled from national customs and statistical authorities. For EU Member States, data reported in UN Comtrade originate from Eurostat’s COMEXT database, which harmonises and transmits national trade statistics to the UN Statistics Division. This ensures consistency between EU and global trade statistics.
Reported trade data are classified according to the Harmonised Commodity Description and Coding System (HS), maintained by the World Customs Organization (WCO). HS codes are six‑digit numerical groupings that standardise the classification of traded goods. While they are useful for broad analyses of trade flows, HS codes do not distinguish specific active pharmaceutical ingredients (APIs) by molecule, nor by pharmaceutical presentation or formulation. In other words, customs data cannot be disaggregated to identify individual molecules, brands or dosage forms in trade flows. For the three injectable corticosteroids of interest in this study – dexamethasone, hydrocortisone and methylprednisolone – this lack of specificity poses a clear limitation. Although certain HS subheadings cover corticosteroids broadly, they encompass large groups of related substances or formulations and cannot be used to isolate trade in the target molecules with precision (see Annex Table 1.A.1 below). More detailed customs data (e.g. at the eight‑ or ten‑digit national level or specific tariff item level) would permit greater granularity, but such data were not available for this project and are often subject to confidentiality restrictions.
Source: WCO’s HS Nomenclature 2022 Edition.
For influenza vaccines, under the current HS system, vaccines for human medicine are grouped within heading 3002.41 (“Vaccines for human medicine”) since the introduction of the HS 2022 revision by the World Customs Organization (WCO). Prior to 2022, all such products were classified under HS 3002.20 (“Vaccines for human medicine”). These headings encompass all human vaccines, including those against influenza, without distinction by disease or strain.
In the European Union Combined Nomenclature (CN), which provides greater detail at the eight‑digit level and forms the basis of Eurostat’s Comext database, code 3002 41 is subdivided into:
3002 41 10 – Vaccines against SARS-related coronaviruses (SARS-CoV species), corresponding to COVID‑19 vaccines; and
3002 41 90 – Other vaccines for human medicine, encompassing all other human vaccines, including influenza vaccines.
In conclusion, influenza vaccines cannot be directly identified in international trade statistics because they are not assigned a unique customs classification code under the Harmonised System (HS) or the European Union’s Combined Nomenclature (CN).
For PCR tests, in previous HS (HS 2017), PCR and other in-vitro diagnostic kits were included in HS 3822.00 – “Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents, whether or not on a backing, other than those of heading 3002 or 3006; certified reference materials.” (see (WCO, 2022[46])). This is, however, a very broad heading that includes not only PCR kits but also rapid antigen tests, pregnancy tests, blood-glucose reagent strips, and other diagnostic reagents.
Following the HS 2022 revision, this heading was subdivided as follows:
3822.11 – Diagnostic reagents for malaria;
3822.12 – Diagnostic reagents for HIV;
3822.19 – Other diagnostic reagents on a backing; and
3822.90 – Other diagnostic or laboratory reagents (not on a backing).
According to World Customs Organization, PCR test kits, including those used for influenza or COVID‑19, fall under HS 3822.19 (“Other diagnostic reagents on a backing”), depending on their format (WCO, 2022[47]). Nonetheless, this subheading still aggregates a broad range of diagnostic reagents, including antigen tests, pregnancy tests, and glucose monitoring strips. Other PCR test components may also be classified under 3 822.90.
Source: Based on investigation of available data sources.
Source: Based on IQVIA sales data and publicly available information on number of vaccinations administered, procured or distributed at the country level.
Sources: EUDAMED, DxConnect, FACTSET® database and companies’ websites.
This annex describes in detail an attempt to estimate the number of RT-PCR tests for influenza sold in Europe using epidemiological surveillance data.
The European Centre for Disease Prevention and Control (ECDC) and the WHO Regional Office for Europe jointly developed the European Respiratory Virus Surveillance Summary (ERVISS). This database provides a weekly integrated epidemiological summary for influenza, respiratory syncytial virus (RSV) and severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) for the European Union/European Economic Area (EU/EEA) and the WHO European Region.
ERVISS integrates respiratory virus surveillance data from two surveillance systems:
Influenza-like illness (ILI) and/or acute respiratory infection (ARI) and/or severe acute respiratory infection (SARI) syndromic and virological surveillance: This is the preferred method in primary care and hospitals. This surveillance relies on standardised syndromic case definitions for ILI, ARI and SARI with cases coming from well-defined and representative populations to provide reliable denominators for estimating disease incidence. In most countries, this surveillance is conducted through sentinel networks of primary care practices, while in others it may be universal and cover the entire population. In the syndromic component, countries report the number of patients meeting the ILI/ ARI definitions in primary care and the SARI definition in hospitals. In the virological component, all or a subset of these patients are swabbed and laboratory-tested for respiratory viruses, including SARS‑CoV‑2, RSV and influenza, allowing the calculation of test positivity.
Non-sentinel laboratory-based surveillance: Uses data from laboratory information systems to report tests results from settings such as schools, primary care facilities, hospitals, nursing homes and other institutions or laboratories not participating in sentinel virological surveillance, regardless of whether patients meet a syndromic case definition. Tests performed and number of respiratory viruses’ detections are typically available in much higher volumes than data from sentinel surveillance. The scale, the geographical distribution, testing criteria, and volume of these data differ by country, therefore cross-country comparisons should be avoided. In addition, it should be noted that not all the test included in the ERVISS data are PCR-based, as the dataset may also include antigen rapid tests.
Source: ERVISS database (n.d.[72]), “Methods section”, https://erviss.org/.
To estimate the number of influenza RT-PCR tests performed in the EU, data from the ECDC were analysed. Following guidance provided by ECDC, the number of influenza RT-PCR tests was estimated using data from primary care sentinel virologic surveillance, SARI virologic surveillance and non-sentinel laboratory-based surveillance was used. The ECDC provided the three datasets used to conduct the following calculations for each country for 2022, 2023 and 2024 (Annex Figure 1.D.1).
Total influenza PCRs years,country = Ʃ(sentinel primary care surveillance influenza total tests) + Ʃ(SARI surveillance tests influenza total tests) + Ʃ(non-sentinel laboratory-based surveillance influenza total tests)
Estimation of the number of influenza tests performed across EU Member States
Note: Tests from sentinel, SARI and non-sentinel data.
Source: Based on ECDC ERVISS data.
In these datasets, tests for influenza diagnosis were reported without being specified as RT-PCR, implying that rapid tests could also be included. According to information provided by the European Centre for Disease Prevention and Control (ECDC), all sentinel surveillance tests are expected to be PCR-based. However, some countries may also report results from antigen-based tests, particularly where resources for PCR testing are limited or where the use of rapid tests incentivises participation by general practitioners in surveillance systems. Any antigen-based tests are expected to represent a very small proportion of total sentinel tests. On this basis, it was assumed that the reported diagnostic tests predominantly reflect RT-PCR testing. Using these data, the total number of influenza RT-PCR performed in all EU Member States was 1 713 845 in 2025, 1 737 673 in 2024, 1 743 725 in 2023 and 1 865 138 in 2022. These estimates, however, are likely to underestimate the real numbers, as not all countries report influenza testing in SARI patients, and some report only a subset of cases.
As an attempt to assess the market share covered by the six companies who responded to the OECD manufacturer’s survey, ERVISS-based estimates were benchmarked to the total number of tests sold by these respondents. The number of influenza RT-PCR kits sold reported by these six companies accounted for respectively 81.8% in 2023 and 86.1% on the 2024 of the number of tests performed according to estimates from ERVISS data. This result is considered unplausible, with two consequences: 1) ERVISS data does not seem appropriate to estimate the number of PCR tests performed (which is not ERVISS’s objective), and 2) there is no way to assess the representativeness of the information collected from six companies for the EU market.
Geographical distribution of the product in Europe
1. In how many countries does your company sell PCR kits for influenza diagnosis? Could you provide a list of these countries?
2. How many PCR kits for influenza did you sell in the past 3 years in the EU? (2022, 2023 and 2024)
Surge capacity
1. Would you be able to multiply your production by 2, by 5 y 10 and if so in how much time?
Supply chain details
1. How many suppliers and/or manufacturing sites are involved in producing your PCR kits, and where are they located?
2. How many “critical” suppliers have you declared to the EU notified body in your dossier, and what components or processes are considered “critical” in your supply chain?
3. What is the origin of the components used to manufacture PCR kits?
Country or countries | Region/s | |
|---|---|---|
Nucleotides | ||
Primers | ||
Enzymes (DNA polymerase) | ||
MgCl2 | ||
Probes | ||
Lysis buffer |
Extraction buffer production
1. In case your company also manufacture nucleic acid extraction buffers, where do the components come from?
Country or countries | Region/s | |
|---|---|---|
Lysis buffer | ||
RNA extraction buffer | ||
RNAse inhibitors | ||
Elution buffer | ||
Wash buffers |
Vulnerabilities in the supply chain
1. Are there any potential vulnerabilities in the supply chain for these components?
Notified body name (please add):
PCR section:
Anonymous PCR test device for influenza detection assessed and CE‑marked under IVDR and currently available on the European market
Single/Multiplex
EU Member States in which this test kit is marketed or expected to be marketed
Finished product manufacturing site
Total number of manufacturing sites listed for the supply chain of this test
Critical components supply chain analysis of PCR kits for influenza detection (Manufacturing sites location for Nucleotides, Primers, DNA polymerase, Reverse transcriptase, MgCl2, Probes)
Extraction buffer section:
Anonymous RNA extraction buffers CE‑marked under IVDR and currently available on the European market
EU Member States in which this product is marketed or expected to be marketed
Finished product manufacturing site
Total number of manufacturing sites listed for the supply chain of this extraction buffer
Critical components supply chain analysis of extraction buffers (Lysis buffer, Magnetic beads, RNA extraction buffer, RNAse inhibitors, Elution buffer, Wash buffer)
Questions
1. If you were to receive a questionnaire asking for information on manufacturing sites involved in the supply chains of injectable corticosteroids marketed in your country, coming from your government or from the European Commission, would you be legally able to share the information you have?
If not, do you know which piece of national legislation would prevent you from sharing such information?
2. Would you be able to retrieve this information with a straightforward or brief electronic query in your system, or would it be more complex and lengthier?
3. The New Zealand’s Medecines agency (MedSafe) publishes information on the manufacturing sites of individual products on its website, accessible to the public – see here, where you can search information. How would you evaluate such an approach in your context? (please free to select several responses):
☐ useful and quite easy to implement at national level (assuming budget could be made available).
☐ quite useful but too difficult to implement in your information system.
☐ not particularly useful.
☐ more useful at a centralised level for a selected sample of “critical products”
☐ impossible to achieve because of companies’ reluctance to make this information public.
Product and market presence in the EU
1. For which of the following products does your company currently supply one or more EU/EEA Member States?
☐ Injectable dexamethasone for intramuscular or intravenous use.
☐ Injectable methylprednisolone for intramuscular or intravenous use (ie.methylprednisolone sodium succinate).
☐ Injectable hydrocortisone for intramuscular or intravenous use (ie. hydrocortisone sodium succinate).
If you supply more than one of these products, could you please complete a questionnaire for each product?
Brand name(s) of the product(s): ________________________________________________________________
2. What proportion of the volume of your global sales does the EU/EEA market represent for this product? _________percentage
3. Over the past 36 months, has your company experienced any supply interruptions or shortages for these products in EU/EEA? Y/N
If yes, were these:
☐ Localised (limited to one Member State).
☐ Experienced in several Member States (please state how many: ____).
☐ EU-wide or near EU-wide.
Manufacturing and supply chain structure
1. For each product, how many distinct manufacturing steps are involved in its supply chain? ___________________
Table 1 – Location of manufacturing steps declared in the application for marketing authorisation.
Note: If, despite our commitment not to disclose information on specific products and companies, you are unable to share detailed information on manufacturing sites, please indicate the region: (eg. EU, other European country, Asia, Africa, North America, South America, Oceania) where possible.
Examples of steps (please adapt to your supply chain) | Is this manufacturing step fully integrated or outsourced? | What is (are) the location(s) of the manufacturing site(s) for this step? Please specify country and city |
|---|---|---|
Active Pharmaceutical Ingredient (API) manufacturing | ||
API finishing / sterilisation | ||
Finished dose manufacturing | ||
Lyophilisation | ||
Packaging / labelling | ||
Quality control/batch release | ||
Please add rows as needed |
2. Does production currently rely on single‑source or highly concentrated supply for any of the following?
☐ Key starting materials (KSM).
☐ Vials, stoppers, or other primary packaging.
Add comments if needed: ____________________
Supply chain vulnerabilities and risk factors
1. In your view, which parts of the supply chain for injectable corticosteroids are most vulnerable to disruption?
☐ Sources of KSM.
☐ API or intermediate sourcing.
☐ Sterile manufacturing.
☐ Fill-and-finish.
☐ Quality control / batch release.
☐ Packaging components.
☐ Logistics / cold chain.
2. Are any of these vulnerabilities related to:
☐ Limited supply of KSM.
☐ Limited sources of API.
☐ Limited availability of sterile excipients.
☐ Limited global manufacturing capacity.
☐ Environmental or regulatory constraints.
☐ Geopolitical or trade risks.
☐ Demand volatility or tendering practices.
Ability to respond to a surge in demand
1. In the event of a sudden increase in EU/EEA demand (e.g. epidemic or pandemic), does your company have the ability to:
☐ Increase production volumes within existing sites?
☐ Redeploy some of your manufacturing capacities towards the production of these products?
☐ Reallocate supply from non-EU markets to the EU?
2. Approximately how long would it take to:
☐ Increase output by 10%? ____________
☐ Increase output by more than 20%? ____________
☐ Increase output by more than 50%? ____________
3. What are the key constraints in scaling up production and/or supply?
☐ KSM availability.
☐ API availability.
☐ Sterile manufacturing capacity.
☐ Workforce / skills availability.
☐ Regulatory requirements.
☐ Packaging components.
☐ Transportation/distribution.
4. Would increasing manufacturing capacity for one injectable corticosteroid be likely to:
☐ Affect your ability to supply other corticosteroid products?
☐ Affect the supply of other sterile injectables produced at the same site(s)?
Impact of public policies and purchasing practices
5. From your perspective, which public policies or practices are most likely to affect supply security for injectable corticosteroids, positively or negatively? (e.g. procurement and tendering practices, stockpiling strategies, regulatory requirements, etc.)
Please explain: ____________________________________________________________________________
Class A includes products for general laboratory use accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination. Class B includes devices which are controls without a quantitative or qualitative assigned value, as well as devices that are not covered by the other classification rules. Devices are classified as class C if they are intended to be used for human testing, for detecting the presence of, or exposure to, a sexually transmitted agent, for detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested, or to the individual’s offspring, among others. Class D represents the highest risk and includes reagents intended for blood, organ, tissue and cell testing for specific transmissible pathogens, such as HIV and hepatitis B or C, as well as reagents for blood grouping (Annex Figure 1.F.1).
Note: CDx stands for companion diagnostics, NPT stands for near-patient testing.
Source: Based on Regulation (EU) 2017/746 (IVDR) and guidance from notified bodies.
Influenza PCR kits are classified as class B or D IVDs; however, discrepancies in the risk classification of certain viruses may appear between the MDCG 2020‑2016, Rev04 classification and the advice provided by the IVD Expert Panel/Influenza Sub-group from the European Commission. Two interviews were held with two notified bodies which confirmed that devices intended for the detection of seasonal influenza are classified as Class B while tests for highly virulent influenza virus are classified as Class D (Box 1.9 in the main text). Note that in EUDAMED, multiplex assays that include seasonal influenza as one of the targets are classified as either class B or class C, and for multiplex devices the risk class assigned corresponds to the target with the highest associated risk. The risk class of an influenza PCR kit determines the depth of post-market surveillance performed by notified bodies but does not affect the manufacturing information requirements set out under the IVDR. However, discrepancies exist in the risk classification of certain viruses (see Annex Table 1.F.1).
According to the interviews, these inconsistencies can create confusion among manufacturers and NBs and are typically resolved after consultation with national competent authorities. This highlights the need for further harmonisation to ensure that final decisions on risk class classification do not differ between countries based on the interpretation of each national competent authority. This is particularly relevant because the technical documentation required to the manufacturers as well as the post-market surveillance obligations vary by class risk under the IVDR.
Note: The expert panel considers that Influenza virus A(H1N1)pdm09 fulfils the criteria for Class D as showed a high fatality rate and higher incidence among younger people, a sustained global circulation and outbreaks across multiple countries with a high burden of severe cases and with only low to moderate vaccine effectiveness as reported by CDC and ECDC.
Source: Interview with a notified body, January 2026.
← 1. At the international level, the WHO’s guidelines on corticosteroids for COVID‑19 recommend dexamethasone for hospitalised cases (WHO, 2020[73]). Similarly, in France, the Haut Conseil de la santé publique (HCSP) recommends applying the RECOVERY protocol – that is, the use of dexamethasone for hospitalised COVID‑19 patients requiring oxygen therapy, including those in intensive care (HCSP, 2020[74]). In its opinion on corticosteroid use during COVID‑19, the HCSP also outlines substitution options in the event of dexamethasone shortages. Specifically, it proposes systemic replacement with methylprednisolone, hydrocortisone 160 mg/day (intravenous), or prednisone 40 mg.
Outside the context of COVID‑19, IV hydrocortisone has been recommended for sepsis and septic shock, according to the guidelines from the Surviving Sepsis 2021 Campaign (Evans et al., 2021[75]). Hydrocortisone and methylprednisolone have also been recommended in the treatment of severe community-acquired pneumonia (sCAP) (Martin-Loeches et al., 2023[76]).
From a supply chain perspective, the reality of pandemic response centres on hospital-based care for the most severely affected patients, where parenteral preparations will be the standard of care and for which ensuring resilience of the supply chain is of greatest importance. Sterile injectables present particular supply chain vulnerabilities. Unlike oral preparations, sterile injectables require specialised manufacturing facilities with stringent environmental controls, aseptic processing capability, and complex quality assurance systems that cannot be easily scaled or replicated in emergency situations. The sterile manufacturing process is also more susceptible to disruption from workforce issues, as it requires trained personnel who cannot be easily replaced, and any contamination event can shut down a production line for an extended period. Additionally, while most corticosteroid injectables are stable at room temperature, their sterile nature makes them more vulnerable to supply disruptions than oral formulations, as any breach in sterile manufacturing protocols can result in batch recalls or facility shutdowns, thus making the supply chains of injectable corticosteroid inherently more fragile than those of the oral preparations.
← 2. Other methods include use of protein-based technologies, genetic vaccines (mRNA and DNA), and viral vector vaccines. In addition, toxoid vaccines are used for some bacterial diseases.
← 3. The substances identified are dexamethasone base, dexamethasone dihydrogen phosphate disodium, dexamethasone disodium phosphate, dexamethasone phosphate, dexamethasone sodium phosphate, hydrocortisone, hydrocortisone acetate, hydrocortisone hydrogen succinate, hydrocortisone sodium phosphate, hydrocortisone sodium succinate, methylprednisolone, methylprednisolone acetate, methylprednisolone hydrogen succinate, methylprednisolone sodium hemisuccinate, and methylprednisolone sodium succinate, as well as multi‑ingredient products containing bupivacaine hydrochloride/methylprednisolone acetate, hydrocortisone acetate/lidocaine hydrochloride monohydrate, lidocaine hydrochloride monohydrate/dexamethasone acetate, and lidocaine hydrochloride monohydrate/methylprednisolone acetate.
← 4. MAHs were identified by searching each product name reported in IQVIA data in the Article 57 database and attributing the MAH for the country where sales occurred. Product names were not always specific enough, and in some cases consisted of only the international non-proprietary name (INN) (e.g. dexamethasone). In these cases, the manufacturer reported by IQVIA was cross-checked against MAHs listed for the same substance in the Article 57 database to support attribution. MAH names were subsequently harmonised where they clearly referred to the same corporate entity. For example, different country-level legal entity names associated with Pfizer were standardised under “Pfizer.” This harmonisation was applied only where entity relationships were unambiguous.
← 5. The concentration calculated using the Herfindahl – Hirschman Index (HHI) across presentations within each country and molecule. It is computed as the sum of the squared market shares of all individual presentations (based on their share of total standard units in that country). The index ranges from 0 to 1, where higher values indicate that sales are concentrated in fewer presentations and lower values indicate more even distribution across multiple presentations.
← 6. The substances identified in the IQVIA data that were also available in the EDQM database are hydrocortisone, hydrocortisone acetate, hydrocortisone hydrogen succinate, methylprednisolone, methylprednisolone acetate, methylprednisolone hydrogen succinate, dexamethasone, dexamethasone acetate and dexamethasone sodium phosphate.
← 7. In our analysis each CEP holder is only counted once regardless of how many substances they hold a certificate for.
← 8. The EDQM does offer CEP holders the possibility to claim a sterile grade for their substance based on compliance with Chapter 2.6.1. of the European Pharmacopoeia, which sets out the standard methodology for sterility testing. However, the CEPs for the selected corticosteroids do not carry such a grade and as such do not indicate whether the API is manufactured to a standard suitable for injectable use.
← 9. In the IQVIA data, BILTHOVEN BIOLOGIC appeared as supplying vaccines to the Netherlands, but sales were negligible.
← 10. Influvac originates from Abbott’s legacy vaccines business but, following portfolio divestments and corporate restructuring, marketing authorisation and commercialisation responsibilities are held by Viatris in several countries, while manufacturing remains linked to Abbott entities; it is therefore referred to here as Abbott/Viatris.
← 11. EU market includes all Member States except Malta, Cyprus, Denmark and Slovenia.
← 12. These countries are: Austria, Belgium, Czechia, Finland, France, Germany, Greece, Italy, Poland, Portugal, Romania, Spain, Sweden and Switzerland.
← 13. Itanza® is an intradermal inactivated trivalent influenza vaccine, withdrawn at Sanofi’s request in 2018, so these sales must represent remaining inventory.
← 14. Influenza A and B viruses are responsible for most seasonal epidemics in humans, with influenza A also posing the greatest pandemic risk due to its extensive genetic diversity and ability to infect multiple animal species. Influenza C typically causes mild respiratory illness and is not associated with epidemics, while influenza D primarily affects cattle and is not currently known to cause disease in humans.
← 15. RT-PCR kits in this section refer to real-time RT-PCR, which represent standard practice in hospital and public health diagnostic settings. Conventional gel-based RT-PCR is primarily used in research and academic laboratories and is therefore not considered in this analysis.
← 16. Companies with more than EUR 50 million for revenue were considered large, with medium-size companies earning between EUR15 million and EUR 50 million, small firms between EUR 2 million and EUR 15 million, and micro‑enterprises below EUR 2 million.
← 17. For general information on the PPRI network, see (Austrian National Public Health Institute (GÖG), n.d.[77]).
← 18. Singleplex PCR amplifies one viral gene target at a time in a single reaction, while multiplex PCR allow the amplification of two or more viral gene targets, enabling the detection of more than one virus per patient sample.