Press release
Europe In Vitro Diagnostics (IVD) Market to Reach USD 43.6 Billion by 2034
Europe In Vitro Diagnostics (IVD)
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Europe has long been a global leader in IVD due to its strong regulatory environment, advanced healthcare infrastructure, and early adoption of precision medicine. The market is witnessing robust expansion as point-of-care testing, molecular diagnostics, and digital platforms transform diagnostics accessibility and efficiency.
Market Overview
• Market Size (2024): USD 27.5 billion
• Forecast (2034): USD 43.6 billion
• CAGR (2025-2034): 4.7%
Growth is driven by aging population, rising burden of chronic and infectious diseases, adoption of molecular and companion diagnostics, and EU regulatory transitions under IVDR.
Key Highlights:
• Europe accounts for ~30% of the global IVD market.
• Strong adoption of PCR and next-generation sequencing (NGS) in infectious diseases and oncology.
• Rising use of point-of-care devices in decentralized healthcare settings.
• Digital diagnostics and AI enhancing efficiency in laboratory medicine.
Segmentation Analysis
By Product Type:
• Reagents & Kits (largest revenue contributor)
• Instruments & Systems
• Software & Services
By Technology:
• Immunoassays
• Molecular Diagnostics (PCR, NGS, LAMP)
• Clinical Chemistry
• Hematology
• Microbiology
• Coagulation & Hemostasis
• Others (urinalysis, histology)
By Application:
• Infectious Diseases (COVID-19, HIV, tuberculosis, hepatitis)
• Oncology (biomarker testing, companion diagnostics)
• Cardiology
• Diabetes Management
• Autoimmune Disorders
• Others (nephrology, rare diseases)
By End Use:
• Hospital Laboratories
• Independent Diagnostic Laboratories
• Point-of-Care Testing Centers
• Academic & Research Institutes
Segmentation Summary:
Reagents and kits remain the largest revenue contributor, but molecular diagnostics and point-of-care testing are the fastest-growing areas due to their role in personalized medicine and decentralized healthcare.
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Regional Analysis (Europe Focus)
Germany
• Largest market in Europe.
• Strong emphasis on oncology diagnostics and precision medicine.
• Well-established lab networks and diagnostic infrastructure.
United Kingdom
• Rapid adoption of molecular and point-of-care diagnostics.
• NHS integrating digital platforms for real-time patient management.
France
• Rising oncology testing adoption with strong government support.
• Growing use of AI-based pathology and digital diagnostics.
Italy & Spain
• Increasing investment in molecular testing and infectious disease diagnostics.
• Expansion of private diagnostic laboratory chains.
Nordic Countries
• High adoption of advanced genetic and rare disease testing.
• Integration of IVD into public health systems.
Eastern Europe
• Smaller share but rapidly growing adoption of affordable point-of-care testing.
• Infrastructure expansion in Poland, Hungary, and Czech Republic.
Regional Summary:
Germany, UK, and France lead in innovation and adoption, while Eastern Europe represents high-growth opportunities due to healthcare modernization and decentralized testing.
Market Dynamics
Key Growth Drivers:
• Growing prevalence of chronic diseases (cancer, diabetes, cardiovascular diseases).
• Increasing adoption of molecular diagnostics and companion diagnostics.
• Regulatory transition to EU In Vitro Diagnostic Regulation (IVDR) driving innovation and compliance.
• Demand for point-of-care and home-based testing solutions.
Key Challenges:
• High cost of advanced molecular diagnostic platforms.
• Complex regulatory approval process under IVDR.
• Reimbursement constraints across different EU nations.
• Data privacy and interoperability challenges in digital diagnostics.
Latest Trends:
• Rise of liquid biopsy and NGS-based cancer diagnostics.
• Expansion of AI-driven image analysis in pathology.
• Growth of self-testing devices for chronic conditions.
• Integration of telemedicine with rapid diagnostic devices.
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Competitor Analysis
Major Players in the Europe IVD Market:
• Roche Diagnostics (Switzerland)
• Siemens Healthineers (Germany)
• bioMérieux SA (France)
• Qiagen N.V. (Netherlands/Germany)
• Abbott Laboratories (US - strong EU presence)
• Danaher Corporation (Cepheid, Beckman Coulter)
• Thermo Fisher Scientific Inc.
• Becton, Dickinson and Company (BD)
• Grifols, S.A. (Spain - transfusion diagnostics leader)
• Werfen (Spain - hemostasis diagnostics)
Competitive Summary:
Roche and Siemens dominate Europe's IVD market, while bioMérieux leads microbiology. Qiagen and Thermo Fisher specialize in molecular diagnostics. Abbott and Danaher drive innovation in point-of-care. Grifols and Werfen focus on transfusion and hemostasis. Competition centers on molecular platforms, AI-driven diagnostics, and IVDR compliance.
Conclusion
The Europe In Vitro Diagnostics Market, valued at USD 27.5 billion in 2024, is projected to reach USD 43.6 billion by 2034, growing at a CAGR of 4.7%.
Key Takeaways:
• Molecular and point-of-care diagnostics are the fastest-growing segments.
• Germany, UK, and France dominate, while Eastern Europe presents emerging opportunities.
• EU IVDR regulations reshaping the competitive and compliance landscape.
• AI, digital pathology, and self-testing driving the future of diagnostics.
The next decade will see Europe's IVD market evolve from traditional laboratory testing to AI-powered, decentralized, and patient-centric diagnostics, creating major opportunities for diagnostic companies, digital health innovators, and healthcare providers.
This report is also available in the following languages : Japanese (欧州の体外診断市場), Korean (유럽 체외진단 시장), Chinese (欧洲体外诊断市场), French (Marché européen du diagnostic in vitro), German (Europäischer Markt für In-vitro-Diagnostika), and Italian (Mercato europeo della diagnostica in vitro), etc.
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