The in vitro diagnostics market in Europe is likely to grow from USD 33.83 billion in 2026 to USD 49.49 billion by 2031, at an expected CAGR of about 7.9% over the forecast period. The increased volume of diagnostic tests performed for chronic disease management and infectious disease surveillance supports this growth. There has been a rapid uptake of molecular testing platforms and expansions in laboratory automation, with an increasing number of point-of-care diagnostics being implemented across healthcare settings. The continued modernization of laboratory infrastructure and access to innovative diagnostic technologies across European healthcare systems will further enhance market growth.
In December 2025, F. Hoffmann-La Roche Ltd (Switzerland) received the CE Mark approval for its cobas BV/CV (Bacterial Vaginosis/Candida Vaginitis) assay. This allows for accurate identification of the bacteria and yeast responsible for BV and CV in vaginal specimens.
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In February 2024, HemoCue AB (Sweden), a subsidiary of Danaher Corporation (US), partnered with Novo Nordisk A/S (Denmark) to improve access to point-of-care diagnostic testing for children with type 1 diabetes in low- and middle-income countries.
The companies listed below are some of the largest providers of IVD products in Europe. F. Hoffmann-La Roche Ltd. (Switzerland), Abbott (US), Siemens Healthineers AG (Germany), Danaher Corporation (US), Thermo Fisher Scientific Inc. (US), bioMerieux (France), Sysmex Corporation (Japan), Becton Dickinson and Company (US), Werfen (Spain) and Illumina Inc. (US) have used many methods to achieve growth by expanding their product offerings and increasing their market share through collaboration on projects, buying other companies or forming partnerships with them, launching new products or services, signing contracts with other companies, etc.
F. Hoffmann-La Roche Ltd (Switzerland) is a leading player in the European in vitro diagnostics market by consistently investing in diagnostic innovation and adding advanced testing platforms. The company has a diversified portfolio in infectious diseases, tissue diagnostics, oncology, and diabetes care, with test volumes spread across the various clinical testing needs of patients in Europe. Roche is advancing its strategic initiatives, including product innovation and technological advancements, to consolidate its market position. For example, in February 2025, the company launched the SBX platform (Sequencing by Expansion). This next-generation sequencing solution enhances sequencing accuracy, operational efficiency, and the scalability of clinical laboratory applications.
Siemens Healthineers AG (Germany) is a key player in the European IVD market, supported by strong growth in diagnostic testing volumes. The company continues to prioritize innovation through substantial investment in research and development to advance its diagnostic portfolio. In 2024, Siemens Healthineers allocated approximately USD 2,107.7 million to R&D activities to support the development of next-generation diagnostic technologies.
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F. Hoffmann-La Roche Ltd (Switzerland), Abbott (US), Siemens Healthineers AG (Germany), Danaher Corporation (US), and Thermo Fisher Scientific Inc. (US) are some of the key players in the in vitro diagnostics market across Europe because of their wide diagnostic portfolios and continuous technological improvements. Roche offers innovative molecular diagnostics, laboratory automation, and personalized healthcare solutions to help diagnose diseases related to oncology and diabetes. Abbott has established a strong market presence for immunoassays, point-of-care diagnostics, and clinical chemistry testing platforms. Siemens Healthineers manufactures cutting-edge diagnostic innovations across immunoassay, hematology, and automated laboratory workflows, facilitating streamlined operations. Danaher is a major provider of a broad range of diagnostic instruments, reagents, and workflow solutions, all supported by a large global manufacturing and distribution network. Thermo Fisher Scientific offers in vitro assay solutions and molecular diagnostics systems that are widely used in healthcare settings for clinical diagnostics and testing related to infectious diseases, genetic screening, and other regulated clinical diagnostic procedures.
Related Reports:
Europe In Vitro Diagnostics Market by Product & Service (Kits, Instruments), Technology (Immunoassay, Hematology, Glucose Monitoring), Specimen (Blood), Site of Testing, Application (Endocrinology, Cardiology, Infectious Diseases) - Forecast to 2031
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