Europe In Vitro Diagnostics Market Size, Share, Trends and Forecast by Test Type, Product, Usability, Application, End User, and Country, 2026-2034

Europe In Vitro Diagnostics Market Summary: 

The Europe in vitro diagnostics market size was valued at USD 28.69 Billion in 2025 and is projected to reach USD 44.12 Billion by 2034, growing at a compound annual growth rate of 4.90% from 2026-2034.   

The Europe in vitro diagnostics market is driven by the increasing focus on improving healthcare infrastructure across the region, rising investments from public and private sectors, and the growing incidence of chronic diseases requiring early and accurate diagnosis. The expanding geriatric population combined with the adoption of advanced technologies including artificial intelligence and machine learning in diagnostics is accelerating demand for sophisticated IVD solutions. Furthermore, the shift towards personalized medicine and the rapid proliferation of private laboratories offering specialized testing services are strengthening the Europe in vitro diagnostics market share. 

Key Takeaways and Insights: 

• By Test Type: Clinical chemistry dominates the market with a share of 32% in 2025, driven by widespread application in routine diagnostic testing for metabolic and organ function assessments across hospital and clinical laboratories. 

• By Product: Reagents and kits lead the market with a share of 68% in 2025, owing to their recurring consumption patterns and essential role across molecular diagnostics, immunoassays, and clinical chemistry workflows. 

• By Usability: Disposable IVD devices dominate the market with a share of 62% in 2025, attributed to enhanced infection control measures, reduced cross-contamination risks, and growing preference for single-use diagnostic products. 

• By Application: Infectious disease leads the market with a share of 28% in 2025, supported by the widespread adoption of IVD solutions for detecting respiratory infections, viral diseases, and hospital-acquired infections. 

• By End User: Hospitals laboratories dominate with a share of 44% in 2025, driven by high patient inflow, comprehensive in-house testing capabilities, and increasing integration of automated diagnostic systems. 

• By Country: Germany leads the market with a share of 18% in 2025, attributed to the country's robust healthcare infrastructure, advanced diagnostic technology adoption, and strong presence of leading IVD manufacturers. 

• Key Players: The Europe in vitro diagnostics market exhibits a moderately consolidated competitive landscape with multinational diagnostics corporations and specialized regional players competing across product segments. Major industry participants are focusing on technological innovation, strategic partnerships, and expanding product portfolios. Some of the key players operating in the market include F. Hoffmann-La Roche Ltd., Siemens Healthineers AG, Abbott Laboratories, Danaher Corporation, BioMérieux SA, QIAGEN N.V., SYNLAB Group, DiaSorin S.p.A., Tecan Group Ltd., and Leica Biosystems. 

The Europe in vitro diagnostics market is evolving rapidly, driven by healthcare infrastructure modernization and enhanced diagnostic capabilities. In November 2025, Urteste S.A. launched a European multicenter clinical study of its Panuri diagnostic test across multiple countries, underscoring growing regional collaboration to validate new IVD solutions for broader clinical use. There is an increasing focus on early disease detection and preventive healthcare, fueling demand for advanced IVD solutions. Stricter regulations have elevated quality standards, ensuring safety, efficacy, and fostering innovation in diagnostic products. Growing emphasis on personalized medicine is boosting adoption of molecular diagnostics and genetic testing, enabling tailored treatment strategies. These advancements support more precise, patient-specific care and contribute to improved clinical outcomes across European healthcare systems. 

Europe In Vitro Diagnostics Market Trends: 

Integration of Artificial Intelligence and Machine Learning in Diagnostics  

AI and machine learning technologies are revolutionizing Europe's in vitro diagnostics landscape by enhancing accuracy and workflow efficiency. In February 2025, Aiforia Technologies secured IVDR certification and launched three new CE‑IVD‑marked AI models for breast and prostate cancer diagnostics, enabling wider clinical adoption of AI‑assisted pathology tools across Europe. Healthcare providers increasingly adopt AI-powered platforms that analyze complex datasets, detect patterns, and provide clinical decision support. These systems reduce manual interpretation time while minimizing human errors. AI in molecular diagnostics enables precise detection and personalized patient stratification. 

Expansion of Point-of-Care Testing Solutions  

Point-of-care testing is accelerating across Europe as healthcare systems prioritize faster diagnostic results and improved patient outcomes. For example, Sysmex Europe introduced a point‑of‑care antimicrobial susceptibility testing system capable of detecting resistant pathogens in about 30 minutes, enabling emergency departments and clinics to speed up treatment decisions and reduce reliance on centralized laboratories. Portable diagnostic devices deliver rapid, accurate results outside traditional laboratories, with emergency departments, primary care clinics, and ambulatory centers implementing POC solutions for immediate clinical decision-making. Decentralized testing enhances chronic disease management, drug monitoring, and patient care accessibility. 

Growing Adoption of Molecular Diagnostics for Personalized Medicine  

Personalized medicine is driving substantial molecular diagnostics growth across European healthcare systems. Next-generation sequencing and advanced PCR platforms enable comprehensive genetic profiling for disease risk assessment, treatment selection, and therapeutic monitoring. For example, Biocartis NV launched its new Idylla™ POLE‑POLD1 Mutation Assay in April 2025, a fully automated PCR test that detects key hypermutated phenotypes associated with cancer, expanding rapid molecular profiling capabilities for personalized therapy choice in clinical labs across Europe. Healthcare providers utilize molecular tools to identify genetic markers for cancer, cardiovascular diseases, and hereditary disorders.  

Market Outlook 2026-2034: 

The Europe in vitro diagnostics market is poised for sustained growth during the forecast period, driven by continuous technological advancements, expanding healthcare infrastructure, and increasing disease burden across the region. The rising prevalence of chronic conditions including diabetes, cardiovascular diseases, and cancer is creating substantial demand for diagnostic solutions enabling early detection and disease monitoring. Government initiatives supporting preventive healthcare programs and laboratory modernization are further accelerating market expansion. The market generated a revenue of USD 28.69 Billion in 2025 and is projected to reach a revenue of USD 44.12 Billion by 2034, growing at a compound annual growth rate of 4.90% from 2026-2034. 

Europe In Vitro Diagnostics Market Report Segmentation: 

Test Type Insights:

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• Clinical Chemistry 
• Molecular Diagnostics 
• Immunodiagnostics 
• Hematology 
• Others 

The clinical chemistry dominates with a market share of 32% of the total Europe in vitro diagnostics market in 2025.  

Clinical chemistry testing represents the cornerstone of laboratory diagnostics, providing essential information for assessing organ function, metabolic status, and overall patient health. The segment's dominance is attributed to the widespread utilization of biochemical tests for routine health screenings, disease diagnosis, and therapeutic monitoring across healthcare facilities. European hospitals and clinical laboratories rely extensively on clinical chemistry analyzers for measuring glucose, cholesterol, electrolytes, enzymes, and other biomarkers critical for patient management. 

The growing prevalence of metabolic disorders and chronic conditions requiring regular biochemical monitoring is sustaining demand for clinical chemistry testing solutions. Advanced automated analyzers with high throughput capabilities are increasingly deployed in centralized laboratories, enabling efficient processing of large sample volumes while maintaining accuracy and reliability. The integration of clinical chemistry platforms with laboratory information systems is enhancing workflow efficiency and supporting evidence-based clinical decision-making. 

Product Insights: 

• Reagent and Kits 
• Instruments 

The reagents and kits leads with a share of 68% of the total Europe in vitro diagnostics market in 2025.  

The reagents and kits segment commands the largest market share due to their consumable nature and recurring demand driven by continuous diagnostic testing activities. For instance, Sysmex Europe SE and Sysmex Inostics GmbH introduced CE‑IVD‑certified Plasma‑SeqSensei™ liquid biopsy reagent kits for solid and breast cancer detection in Europe, expanding the availability of advanced diagnostic kits that support high‑sensitivity mutation analysis in clinical workflows. These products form essential components across all diagnostic modalities including molecular diagnostics, immunoassays, clinical chemistry, and hematology testing.  

Diagnostic reagent manufacturers are continuously innovating to develop high-quality products with improved sensitivity, specificity, and stability. The expansion of infectious disease testing, oncology diagnostics, and autoimmune disease screening is driving sustained demand for specialized reagent kits. Additionally, the implementation of quality assurance standards and regulatory requirements is ensuring product reliability while fostering market growth through enhanced healthcare provider confidence. 

Usability Insights: 

• Disposable IVD Devices 
• ​​​​​​​Reusable IVD Devices 

The disposable IVD devices dominates with a market share of 62% of the total Europe in vitro diagnostics market in 2025.  

Disposable IVD devices have emerged as the preferred choice across European healthcare settings due to their ability to minimize cross-contamination risks and enhance infection control protocols. For example, 2cureX received CE‑IVDR marking for its single‑use IndiTreat® Specimen Collection Kit and Shipping Container, enabling ready‑to‑use, disposable sample handling solutions that support safer transport and handling of diagnostic specimens across 20 countries. The growing emphasis on patient safety and stringent regulatory requirements for infection prevention are driving widespread adoption of disposable diagnostic products. 

The segment's growth is further supported by the expanding point-of-care testing market where disposable devices enable rapid diagnostic testing in diverse healthcare environments. Healthcare facilities are increasingly prioritizing disposable consumables to reduce healthcare-associated infections and ensure consistent diagnostic quality. The development of cost-effective disposable solutions is making these products accessible across different healthcare tiers while maintaining diagnostic accuracy. 

Application Insights: 

• Infectious Disease 
• Diabetes 
• Cancer/Oncology 
• Cardiology 
• Autoimmune Disease 
• Nephrology 
• ​​​​​​​Others 

The infectious disease leads with a share of 28% of the total Europe in vitro diagnostics market in 2025.  

The infectious disease segment maintains its leading position driven by the essential role of IVD solutions in detecting, diagnosing, and monitoring various pathogens including bacteria, viruses, and fungi. European healthcare systems rely extensively on diagnostic testing for managing respiratory infections, sexually transmitted diseases, hospital-acquired infections, and emerging infectious threats. The segment benefits from established testing protocols and continuous demand for both routine and specialized pathogen detection. 

Advancements in molecular diagnostics have significantly enhanced the sensitivity and speed of infectious disease detection, enabling rapid identification of causative agents and antimicrobial resistance patterns. For example, in September 2024, QIAGEN received IVDR certification for its QIAstat‑Dx syndromic testing instruments and associated assays in Europe, enabling rapid, multiplex real‑time PCR detection of gastrointestinal and respiratory pathogens on a single platform that supports faster clinical decision‑making and antimicrobial stewardship efforts. The growing focus on infection surveillance programs and antimicrobial stewardship initiatives is sustaining demand for advanced diagnostic solutions.  

End User Insights: 

• Hospitals Laboratories 
• Clinical Laboratories 
• Point-of-care Testing Centers 
• Academic Institutes 
• Patients 
• ​​​​​​​Others 

The hospitals laboratories dominate with a market share of 44% of the total Europe in vitro diagnostics market in 2025.  

Hospital laboratories represent the primary end-user segment due to the comprehensive diagnostic testing requirements of inpatient and outpatient populations. These facilities offer extensive testing menus covering clinical chemistry, hematology, microbiology, immunology, and molecular diagnostics. The high patient volumes and diverse testing needs in hospital settings drive substantial demand for advanced diagnostic equipment and consumables, supporting faster turnaround times and improved patient care outcomes. 

European hospitals are increasingly investing in laboratory automation and integrated diagnostic platforms to enhance operational efficiency and turnaround times. The consolidation of diagnostic services within hospital laboratories enables economies of scale while ensuring quality control and regulatory compliance. The growing complexity of patient care and the need for rapid diagnostic results to guide treatment decisions are reinforcing the central role of hospital laboratories in the healthcare delivery system. 

Country Insights: 

• Germany 
• France 
• United Kingdom 
• Italy 
• Spain 
• Others 

Germany exhibits a clear dominance with a 18% share of the total Europe in vitro diagnostics market in 2025.  

Germany maintains its leadership position in the European IVD market owing to its well-developed healthcare infrastructure, strong emphasis on preventive healthcare, and the presence of leading diagnostic manufacturers. The country's healthcare system demonstrates high adoption rates for advanced diagnostic technologies, supported by favorable reimbursement policies and substantial healthcare expenditure. German hospitals and laboratories are at the forefront of implementing innovative diagnostic solutions and automation technologies. 

The German market benefits from a robust research and development ecosystem fostering continuous innovation in diagnostic technologies. The country's aging population and high prevalence of chronic diseases including diabetes and cardiovascular conditions are driving sustained demand for diagnostic testing. Government support for digital health transformation and personalized medicine initiatives is further strengthening Germany's position as a key growth engine within the European IVD landscape. 

Market Dynamics: 

Growth Drivers: 

Why is the Europe In Vitro Diagnostics Market Growing? 

Rising Prevalence of Chronic and Infectious Diseases 

The increasing burden of chronic diseases including diabetes, cardiovascular disorders, and cancer across Europe is a primary driver propelling the in vitro diagnostics market. According to a 2025 WHO analysis, chronic noncommunicable diseases like heart disease, cancer, diabetes and respiratory conditions still cause a significant share of premature deaths in the European Region, with at least 1 in 6 people dying before age 70 from these conditions, underlining the urgent need for early detection and monitoring through diagnostics. Healthcare systems see rising patient demand for regular diagnostic monitoring. Europe’s aging population and infectious threats highlight the need for rapid, accurate, and continuous diagnostic care. 

Technological Advancements and Innovation in Diagnostic Platforms 

Continuous technological innovation is transforming the diagnostic landscape across Europe, with advanced platforms offering enhanced sensitivity, specificity, and speed of detection. At SLAS Europe 2025 in Hamburg, MGI Tech unveiled its next-generation automation portfolio, featuring the compact PrepALL system and AI-optimized Smart8 platform to streamline sample preparation and molecular diagnostics in clinical and research labs. The integration of artificial intelligence, machine learning, and automation in diagnostic systems is improving workflow efficiency and diagnostic accuracy while reducing human error. Next-generation sequencing technologies, advanced immunoassay platforms, and multiplex testing solutions are enabling comprehensive disease profiling and personalized treatment approaches.  

Government Initiatives and Healthcare Infrastructure Development 

European governments are actively investing in healthcare infrastructure enhancement and diagnostic capabilities expansion to improve population health outcomes. For example, in December 2025 the European Health and Digital Executive Agency (HaDEA) announced new EU4Health projects, including cross‑border laboratory result exchange services and initiatives to advance digital healthcare and data sharing infrastructure, strengthening diagnostics accessibility and interoperability across EU healthcare systems. National screening programs for cancer, infectious diseases, and genetic conditions are driving substantial demand for diagnostic testing across the region. The implementation of supportive regulatory frameworks and reimbursement policies is facilitating access to advanced diagnostic technologies.  

Market Restraints: 

What Challenges the Europe In Vitro Diagnostics Market is Facing? 

Stringent Regulatory Requirements and Compliance Challenges 

The implementation of the EU In Vitro Diagnostic Regulation has introduced more rigorous requirements for clinical evidence, conformity assessment, and post-market surveillance, creating significant compliance challenges for manufacturers. The transition from previous directives has resulted in delays in product approvals and market access for some diagnostic devices, particularly affecting smaller companies with limited resources. 

High Costs of Advanced Diagnostic Technologies 

Advanced diagnostic equipment, reagents, and infrastructure require substantial investment, posing financial challenges for healthcare facilities, particularly in budget-limited settings. Additional expenses from research and development, regulatory approvals, and technology implementation further restrict adoption. These high costs act as significant barriers, slowing the widespread integration of innovative diagnostic solutions across different tiers of healthcare services. 

Supply Chain Vulnerabilities and Material Availability 

The European IVD market faces challenges from supply chain disruptions and heavy reliance on imported raw materials and specialized components. Dependence on critical inputs like enzymes and specialized reagents makes the sector vulnerable to geopolitical tensions and trade restrictions, potentially disrupting production schedules, limiting manufacturing capacity, and affecting the consistent availability of diagnostic products across the region. 

Competitive Landscape: 

The Europe in vitro diagnostics market exhibits a moderately consolidated competitive structure characterized by the presence of established multinational corporations alongside specialized regional players. Leading companies are focusing on technological innovation, product portfolio expansion, and strategic collaborations to strengthen their market positioning. The competitive landscape is shaped by continuous investment in research and development activities, with manufacturers emphasizing the development of advanced molecular diagnostics, point-of-care testing solutions, and integrated diagnostic platforms. Market participants are increasingly pursuing partnerships and acquisitions to enhance their technological capabilities and expand geographic reach. The implementation of stringent regulatory standards is influencing competitive dynamics by raising entry barriers while driving quality improvements across the industry. 

Some of the key players include: 

• F. Hoffmann-La Roche Ltd. 
• Siemens Healthineers AG 
• Abbott Laboratories 
• Danaher Corporation 
• BioMérieux SA 
• QIAGEN N.V. 
• SYNLAB Group 
• DiaSorin S.p.A. 
• Tecan Group Ltd. 
• ​​​​​​​Leica Biosystems 

Recent Developments: 

• In December 2025, BD (Becton, Dickinson and Company) expanded its BD MAX™ System menu with new IVDRcertified VIASURE assays in collaboration with Certest Biotec, enhancing respiratory and STI testing under the EU In Vitro Diagnostic Regulation. This launch strengthens compliance with stricter IVDR requirements and expands diagnostic capabilities across European healthcare facilities.  

Europe In Vitro Diagnostics Market Report Coverage: