Europe In Vitro Diagnostics Market
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
OVERVIEW
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
The Europe in vitro diagnostics market is projected to grow from USD 33.83 billion in 2026 to USD 49.49 billion by 2031, registering a CAGR of 7.9% during the forecast period. Market growth is driven by rising diagnostic test volumes across national healthcare systems, broader adoption of population-based screening programs, and increasing emphasis on standardized disease monitoring. The growing implementation of laboratory automation and advanced molecular diagnostic technologies is further improving testing efficiency while addressing workforce limitations. In addition, ongoing investments in healthcare infrastructure modernization continue to support the sustained expansion of the IVD market across the region.
KEY TAKEAWAYS
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By CountryBy country, Germany accounted for the largest share of the European in vitro diagnostics market in 2025.
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By Product & ServicesBy product & service, the reagents & kits segment is expected to register the highest CAGR of 8.4%.
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By TechnologyBy technology, the immunoassay segment accounted for the largest market share in 2025, while molecular diagnostics is expected to register the highest CAGR during the forecast period.
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By SpecimenBy specimen, the blood, serum, and plasma specimens segment is expected to dominate the market.
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By Site of TestingBy site of testing, the laboratory test segment held the largest share of the market in 2025.
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By ApplicationBy application, the infectious diseases segment is expected to dominate the market.
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By End UserBy end user, clinical laboratories segment will grow the fastest during the forecast period.
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Competitive LandscapeF. Hoffmann-La Roche Ltd., Abbott, Siemens Healthineers AG, Danaher Corporation, and Thermo Fisher Scientific Inc. were identified as some of the star players in the European in vitro diagnostics market, supported by their strong market presence and extensive product portfolios.
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Competitive LandscapeDevyser (Sweden) and Boster Biological Technology (US), among others, have distinguished themselves among startups and SMEs by securing strong footholds in specialized niche areas.
The Europe in vitro diagnostics market is experiencing strong growth due to the increasing burden of chronic and infectious diseases, an aging population requiring regular diagnostic monitoring, and expanding preventive healthcare initiatives across the region. Greater awareness of early disease detection, combined with rising participation in routine health screening programs, is improving testing uptake. In addition, government support for timely diagnosis and the growing demand for personalized medicine are encouraging wider adoption of advanced IVD solutions. These factors are driving consistent growth in diagnostic testing volumes and strengthening the overall market outlook in Europe.
TRENDS & DISRUPTIONS IMPACTING CUSTOMERS' CUSTOMERS
The Europe in vitro diagnostics market is being shaped by several key trends and disruptions, including the rapid adoption of laboratory automation and digital workflow solutions to address workforce shortages and improve testing efficiency. The growing reliance on molecular diagnostics and next-generation sequencing is expanding test capabilities, particularly in the areas of infectious diseases and oncology. Point-of-care testing is gaining momentum as healthcare providers seek faster diagnostics in decentralized settings, while the wider implementation of population-based screening programs is driving consistent demand for testing.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
MARKET DYNAMICS
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Expanding geriatric population and resulting rise in chronic disease
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Emergence of point-of-care diagnostic technologies and growing adoption of automated analyzers
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High capital investment associated with diagnostic equipment
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Stringent regulatory requirements
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Development of disease-specific biomarkers and diagnostic tests
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Growing importance and adoption of companion diagnostics
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Operational challenges
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Data privacy and cybersecurity risks
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Driver: Emergence of point-of-care diagnostic technologies and growing adoption of automated analyzers
The Europe in vitro diagnostics market is being driven by the rapid uptake of point-of-care diagnostic technologies and the growing implementation of automated laboratory analyzers. Healthcare systems across the region are focusing on faster diagnosis, reduced turnaround times, and improved efficiency, particularly in decentralized settings and high-volume laboratories. Automation helps address staffing shortages and workload pressures while ensuring consistent result quality, further supporting adoption across hospitals & clinics, and clinical laboratories, and other end users.
Restraint: High capital investment associated with diagnostic equipment
High upfront costs associated with advanced diagnostic platforms, laboratory automation systems, and molecular analyzers continue to limit adoption, especially among smaller laboratories and healthcare facilities. Additional expenses related to installation, maintenance, quality compliance, and workforce training increase the overall financial burden, which can delay equipment upgrades and restrict access to newer technologies despite strong clinical demand.
Opportunity: Growing importance and adoption of companion diagnostics
The growing focus on personalized medicine is creating significant opportunities for companion diagnostics. These tests play a key role in identifying patient populations most likely to benefit from targeted therapies, particularly in oncology and autoimmune diseases. Increasing collaboration between pharmaceutical companies and diagnostic manufacturers, along with regulatory support for precision medicine initiatives, is driving wider adoption of companion diagnostics across clinical settings.
Challenge: Operational challenges
Operational challenges such as regulatory complexity, workforce shortages, and laboratory workflow integration issues continue to affect market efficiency. Managing compliance requirements, coordinating multi-site laboratory operations, and integrating advanced platforms into existing infrastructures can delay implementation and scale-up of diagnostic solutions, adding operational pressure for healthcare providers and diagnostic service companies across the European region.
Europe IVD Market: COMMERCIAL USE CASES ACROSS INDUSTRIES
| COMPANY | USE CASE DESCRIPTION | BENEFITS |
|---|---|---|
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Employs the cobas 4800 and cobas 5800/6800/8800 molecular platforms for high-throughput viral load testing in centralized clinical laboratories. | Delivers high analytical accuracy, automated large-volume workflows, faster turnaround times, and regulatory-compliant performance for large-scale infectious disease testing. |
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Deploys Alinity m analyzers for automated molecular detection of HIV, HBV, and HCV in medium- to high-throughput diagnostic laboratories. | Enables faster sample-to-result processing, minimizes manual handling, ensures consistent assay performance, and improves overall laboratory workflow efficiency. |
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Utilizes the Atellica CI Analyzer for integrated clinical chemistry and immunoassay testing in hospital laboratory settings. | Improves operational efficiency, reduces turnaround times, streamlines sample management, and offers scalable flexibility for medium-throughput laboratory environments. |
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Provides GeneXpert systems for rapid, cartridge-based molecular testing across decentralized and point-of-care environments. | Provides quick results with minimal hands-on time, a broad infectious disease test menu, high analytical sensitivity, and suitability for low-resource or near-patient testing settings. |
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Provides molecular diagnostic platforms and integrated testing workflows. | Delivers high analytical performance, streamlined sample-to-result processing, reliable assay consistency, and scalable throughput |
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET ECOSYSTEM
The ecosystem of the Europe in vitro diagnostics market encompasses the key stakeholders and components across the value chain, including products and services, technologies, specimens, sites of testing, applications, and end users. It involves manufacturers responsible for product development and commercialization, distributors operating through third-party channels and e-commerce platforms, and research & development partners providing outsourced development and manufacturing support. End users, including hospitals, clinics, clinical laboratories, and other end users, utilize IVD solutions throughout the diagnostic process and represent the primary stakeholders within the European IVD supply chain.
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET SEGMENTS
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Europe In Vitro Diagnostics Market, By Product & Service
By product and service, the Europe in vitro diagnostics market is segmented into reagents and kits, instruments, and data management software and services. Among these, the reagents and kits segment accounted for the largest market share in 2025, driven by their recurring consumption, high testing volumes in routine diagnostics, and essential use across molecular diagnostics, immunoassays, clinical chemistry, and other workflows.
Europe In Vitro Diagnostics Market, By Technology
By technology, the Europe in vitro diagnostics market is segmented into immunoassay, clinical chemistry, molecular diagnostics, glucose monitoring, hematology, microbiology, coagulation & hemostasis, blood gas analyzers, urinalysis, and chromatography & mass spectrometry. The immunoassay segment held the largest market share in 2025, supported by broad clinical application, high testing frequency, and strong compatibility with automated high-throughput laboratory platforms.
Europe In Vitro Diagnostics Market, By Specimen
By specimen, the Europe in vitro diagnostics market is segmented into blood, serum, and plasma, saliva, urine, and other specimens. Among these, the blood, serum, and plasma segment dominated in 2025 due to wide clinical applicability, standardized collection processes, and compatibility with multiple diagnostic modalities.
Europe In Vitro Diagnostics Market, By Site of Testing
By site of testing, the Europe IVD market is segmented into laboratory tests and point-of-care tests. The laboratory tests segment accounted for the largest market share in 2025, driven by established centralized diagnostic infrastructure, reliance on automated testing systems, and high volumes of routine and specialized diagnostic testing.
Europe In Vitro Diagnostics Market, By Application
By application, the Europe in vitro diagnostics market is segmented into infectious diseases, oncology, endocrinology, cardiology, blood screening, genetic testing, autoimmune diseases, allergy diagnostics, drug monitoring and testing, bone and mineral disorders, coagulation testing, blood group typing, and other applications. Among these, the infectious diseases segment accounted for the largest market share, driven by sustained demand for testing in large-scale screening, routine diagnosis, and ongoing patient monitoring across hospital and laboratory settings.
Europe In Vitro Diagnostics Market, By End User
By end user, the Europe IVD market is segmented into hospitals & clinics, clinical laboratories, blood banks, home care settings, pharmaceutical & biotechnology companies, and academic institutes. Among these, hospitals & clinics accounted for the largest market share in 2025, driven by high patient inflow, broad in-house testing requirements, and increasing adoption of automated diagnostic systems within clinical workflows.
REGION
UK to be fastest-growing country in European in vitro diagnostics market during forecast period
The UK is expected to register the highest CAGR in the Europe in vitro diagnostics market due to increasing demand for diagnostic testing driven by an aging population, rising prevalence of chronic and infectious diseases, and expanding national screening programs. Substantial investments in laboratory modernization, the growing adoption of laboratory automation and molecular diagnostics, and the rapid uptake of point-of-care testing are accelerating market growth.
Europe IVD Market: COMPANY EVALUATION MATRIX
F. Hoffmann-La Roche Ltd. (Start) is a leading player in the Europe in vitro diagnostics market due to its strong innovation capabilities, integrated diagnostics and automation platforms, and expanding expertise in personalized healthcare. The company’s broad portfolio, spanning infectious diseases, tissue diagnostics, oncology, and diabetes management, supports widespread adoption across European healthcare systems.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
KEY MARKET PLAYERS
MARKET SCOPE
| REPORT METRIC | DETAILS |
|---|---|
| Market Size in 2025 (Value) | USD 31.43 Billion |
| Market Forecast in 2031 (Value) | USD 49.49 Billion |
| Growth Rate | CAGR of 7.9% from 2026-2031 |
| Years Considered | 2024-2031 |
| Base Year | 2024 |
| Forecast Period | 2026-2031 |
| Units Considered | Value (USD Million) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Segments Covered |
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WHAT IS IN IT FOR YOU: Europe IVD Market REPORT CONTENT GUIDE
DELIVERED CUSTOMIZATIONS
We have successfully delivered the following deep-dive customizations:
| CLIENT REQUEST | CUSTOMIZATION DELIVERED | VALUE ADDS |
|---|---|---|
| Product Analysis | Product matrix, which provides a detailed comparison of the product portfolio of each company in the Europe In Vitro Diagnostics market | Enables easy comparison of competitors’ offerings, helping identify gaps, overlaps, and differentiation opportunities. |
| Company Information | Additional five company profiles of players operating in the Europe In Vitro Diagnostics market | Provides insights into competitors’ strategies, innovation focus, and partnerships, supporting strategic planning. |
| Geographic Analysis | Additional country-level analysis of the Europe In Vitro Diagnostics market | Guides market entry, localization, and targeted launch strategies by highlighting regional demand and opportunities. |
RECENT DEVELOPMENTS
- December 2025 : F. Hoffmann-La Roche Ltd (Switzerland) received CE Mark approval for its cobas BV/CV (Bacterial Vaginosis/Candida Vaginitis) assay, enabling accurate identification of the bacteria and yeast responsible for BV and CV.
- February 2024 : HemoCue AB (Sweden), a subsidiary of Danaher, partnered with Novo Nordisk A/S (Denmark) to enhance access to point-of-care diagnostic testing for children with type 1 diabetes in low- and middle-income countries.
- May 2023 : Abbott (US) collaborated with Real Madrid and the Real Madrid Foundation (Spain) under the “Beat Malnutrition” campaign to provide malnutrition screening tools to local communities and fund nutrition programs at Real Madrid Foundation Social Sports Schools.
- May 2023 : Siemens Healthineers AG (Germany) launched the Atellica HEMA 570 and 580 Hematology Analyzers. These systems feature intuitive user interfaces and multi-analyzer automation connectivity designed to streamline laboratory workflows and support the high-throughput demands of large-volume clinical laboratories.
Table of Contents
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Methodology
This study involved the extensive use of primary and secondary sources. A comprehensive study was conducted using secondary research methods to gather data about the market, its parent market, and its peer markets. The next stage involved conducting primary research to confirm these conclusions and assumptions and sizing with industry experts throughout the value chain. A combination of top-down and bottom-up methods was used to assess the overall market size. The market sizes of segments and subsegments were then estimated using data triangulation techniques and market breakdown.
Secondary Research
The secondary research process involves the widespread use of secondary sources, directories, databases (such as Bloomberg Businessweek, Factiva, and D&B Hoovers), white papers, annual reports, investor presentations, SEC filings of companies and publications from government sources [such as National Institutes of Health (NIH), US FDA, US Census Bureau, World Health Organization (WHO), International Trade Administration (ITA), American Association for Clinical Chemistry (AACC), American Diabetes Association (ADA), Association for Molecular Pathology (AMP) and Centers for Medicare and Medicaid Services (CMS) were referred to identify and collect information for the global Europe IVD Market study. It was also used to obtain important information about the key players and market classification & segmentation according to industry trends to the bottom-most level and key developments related to market and technology perspectives. A database of the key industry leaders was also prepared using secondary research.
Primary Research
In the primary research process, various sources from the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include industry experts such as CEOs, vice presidents, marketing and sales directors, technology & innovation directors, and related key executives from various key companies and organizations in the Europe IVD Market. The primary sources from the demand side include hospitals & clinics, clinical laboratories, blood banks, pharmaceutical and biotechnology companies, and academic institutes. Primary research was conducted to validate the market segmentation, identify key players, and gather insights on key industry trends & key market dynamics.
Market Size Estimation
For the global market value, annual revenues were calculated based on the revenue mapping of major product manufacturers and OEMs active in the global Europe IVD Market. All the major product manufacturers were identified at the global and/or country/regional level. Revenue mapping for the respective business segments/subsegments was done for the major players. The global Europe IVD Market was split into various segments and sub-segments based on:
- List of major players operating in the products market at the regional and/or country level.
- Product mapping of various in vitro diagnostics manufacturers at the regional and/or country level.
- Mapping of annual revenue generated by listed major players from in vitro diagnostics (or the nearest reported business unit/product category).
- Extrapolation of the revenue mapping of the listed major players to derive the global market value of the respective segments/subsegments.
- Summation of the market value of all segments/subsegments to arrive at the global Europe IVD Market.
The above-mentioned data was consolidated and added with detailed inputs and analysis from MarketsandMarkets and presented in this report.
Data Triangulation
After arriving at the overall size of the global Europe IVD Market through the above-mentioned methodology, this market was split into several segments and subsegments. Where applicable, the data triangulation and market breakdown procedures were employed to complete the overall market engineering process and arrive at the exact market value data for the key segments and subsegments. Examining several macro variables and regional trends from demand- and supply-side players helped triangulate the extrapolated market data.
Market Definition
IVD tests are non-invasive tests performed to diagnose, monitor, screen, and assess diseases and health conditions. The term "in vitro," which refers to "in glass," signifies that test tubes or petri dishes are typically used in these tests. These tests are performed artificially on biological samples (blood, urine, and tissues). IVD has a broad scope ranging from sophisticated technologies performed in clinical laboratories to simple and easy-to-use rapid testing kits.
IVD is used to assess a person's health. This technique is used in precision medicine to determine the suitable course of treatment for particular patients and diagnose and prevent diseases and other medical disorders.
Stakeholders
- Transfection products manufacturing companies
- Pharmaceutical & Biopharmaceutical Companies
- Chemical Companies
- Biopharmaceutical Companies
- Contract Research Organizations (CROs)
- Contract Development and Manufacturing Organizations (CDMOs)
- Research Institutes and Universities
- Venture Capitalists & Investors
- Government Associations
Report Objectives
- To define, describe, and forecast the in vitro diagnostics (IVD) market based on product & service, technology, specimen, site of testing, application, end user, and region.
- To provide detailed information regarding the major factors influencing the market growth (such as drivers, restraints, opportunities, and industry-specific challenges).
- To assess the Europe IVD Market with respect to Porter’s Five Forces, regulatory landscape, the value chain, the supply chain, ecosystem analysis, patent protection, pricing assessment, key stakeholders, and buying criteria.
- To strategically analyze micromarkets with respect to individual growth trends, prospects, and contributions to the overall market.
- To analyze the opportunities in the IVD market for stakeholders and provide details of the competitive landscape for market leaders.
- To forecast the size of the IVD market in six primary regions (along with countries)—North America, Europe, the Asia Pacific, Latin America, the Middle East & Africa, and the GCC Countries.
- To profile the key players operating in the IVD market and comprehensively analyze their core competencies and market shares.
- To track and analyze competitive developments such as partnerships, agreements, collaborations, acquisitions, expansions, product/technology developments, and product approvals.
- To benchmark players within the IVD market using the Company Evaluation Quadrant framework, which analyzes market players on various parameters within categories of business strategies, market share, and product offerings.
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Growth opportunities and latent adjacency in Europe In Vitro Diagnostics Market