유럽의 체외진단 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the Europe in-Vitro diagnostics market size is projected to be USD 29.06 billion in 2025, USD 30.58 billion in 2026, and reach USD 39.44 billion by 2031, growing at a CAGR of 5.22% from 2026 to 2031.

This report is Segmented by Test Type (Clinical Chemistry, and More), Product & Service (Reagents & Consumables, and More), Usability (Disposable and Reusable), Specimen Type (Blood/Serum, and More), Application (Infectious Diseases, and More), End User (Academic & Research Institutes, and More), and Geography (Germany, and More). Market Forecasts are Provided in Terms of Value (USD).

Europe In-Vitro Diagnostics Market Trends and Insights

Growing Prevalence of Chronic and Infectious Diseases

Multimorbidity now impacts 50% of Europeans aged 65-74, rising from 44% in 2011, further widening the gap between life expectancy and healthy life years. The European Commission's Safe Hearts Plan, targeting universal annual measurements of blood pressure, cholesterol, and blood sugar by 2035, is driving increased per-capita test volumes for HbA1c, lipid panels, cardiac biomarkers, and oncology markers. Infectious-disease surveillance remains a critical focus, with integrated molecular panels for HIV, hepatitis, respiratory viruses, and antimicrobial resistance profiling forming the backbone of routine hospital and public health operations. The launch of bioMerieux and Oxford Nanopore's AmPORE-TB marks a strategic shift toward rapid sequencing for the characterization of drug-resistant tuberculosis. Sustained demand across chronic and infectious disease segments is expected to contribute an estimated 1.2-percentage-point increase to the CAGR of the Europe in-vitro diagnostics market.

Increasing Adoption of Point-of-Care Testing

With the expansion of hospital-at-home programs, point-of-care formats now contribute to over 30% of the in-vitro diagnostics market in Europe. England's virtual ward initiative, supported by a GBP 450 million investment through 2024, leverages near-patient testing to reduce emergency admissions. The FDA-cleared QIAstat-Dx mini panels, which deliver gastrointestinal reports within one hour, exemplify the adoption of user-friendly cartridges in primary care and pharmacy settings. Additionally, pharmacist-led testing, now authorized in 18 OECD countries, and nurse-managed remote-monitoring protocols are driving the decentralization of sample collection. Accelerating reimbursement frameworks are further fueling market growth, contributing to a 0.9-percentage-point CAGR increase in Europe's in-vitro diagnostics market.

Stringent and Lengthy Regulatory Approval Processes Under EU IVDR

Two-thirds of IVDs still awaited certification under the 2022 EU IVDR as of 2024, straining notified-body capacity and elongating time-to-market. SMEs shoulder disproportionate documentation and clinical-evidence costs, risking market exits. A December 2025 European Commission proposal outlines accelerated pathways for breakthrough devices, yet relief will not materialize before 2027. The resulting bottleneck trims 0.8 percentage points from the Europe in-vitro diagnostics market CAGR in the short term.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of National Genomic Medicine Programs
2. Digital Health Integration: Enhancing Remote Sample Collection and Result Delivery
3. Laboratory Workforce Shortages and Operational Constraints

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Clinical chemistry retained 32.12% of 2025 revenue, yet molecular diagnostics is forecast to expand fastest at 7.43% CAGR, lifting the Europe in-vitro diagnostics market size for sequencing consumables and bioinformatics. Companion diagnostic approvals for EGFR, RET, and NTRK mutations, combined with national sequencing subsidies, drive recurring demand for reagents. Rapid multiplex platforms such as QIAstat-Dx Rise, capable of 160 molecular tests daily, exemplify throughput gains needed to meet decentralized acute-care volumes. Routine biochemistry remains indispensable for chronic-disease management, anchoring base load in hospital labs.

Beyond infectious-disease panels, molecular assays are penetrating oncology, minimal residual disease monitoring, hereditary cancer screening, and pharmacogenomics. Illumina's CMS-reimbursed TruSight Oncology Comprehensive workflow underscores payer confidence, smoothing adoption in regional centers. Genotype-guided drug dosing in cardiology and psychiatry is on reimbursement agendas in Germany and the Netherlands, setting the stage for further Europe in-vitro diagnostics market expansion.

Reagents and consumables captured 54.65% of 2025 revenue thanks to recurring kits for chemistry, immunoassay, and PCR workflows. Instrument fleets are entering a replacement cycle as labs favor modular, energy-efficient analyzers with middleware connectivity. Software and services will rise at an 8.11% CAGR as laboratories integrate AI interpretation, quality dashboards, and cybersecurity hardening.

The Europe in-vitro diagnostics market benefits from subscription models: pay-per-genome analytics, cloud LIS modules, and remote calibration services, all generating predictable annuities. Gentian Diagnostics' 2026 partnership to co-develop a novel assay on an existing high-throughput chemistry line illustrates the asset-light route for smaller innovators to ride incumbent footprints.

Complete Report Scope:

• By Test Type
  • Clinical Chemistry
  • Immunodiagnostics
  • Molecular Diagnostics
  • Hematology
  • Microbiology & Lateral Flow
  • Coagulation
  • Point-Of-Care (Rapid) Tests
  • Other Tests
• By Product & Service
  • Reagents & Consumables
  • Instruments / Analyzers
  • Software & Services
• By Usability
  • Disposable IVD Devices
  • Reusable IVD Devices
• By Specimen Type
  • Blood / Serum
  • Urine
  • Saliva
  • Tissue / Biopsy
  • Other Specimen Types
• By Application
  • Infectious Diseases
  • Diabetes
  • Cancer / Oncology
  • Cardiology
  • Autoimmune Disorders
  • Nephrology & Renal Panels
  • Prenatal / Genetic Screening
  • Blood Screening
  • Other Applications
• By End User
  • Academic & Research Institutes
  • Diagnostic Laboratories
  • Home-Care / POC Centers
  • Hospitals & Clinics
  • Other End Users
• By Country
  • Germany
  • United Kingdom
  • France
  • Italy
  • Spain
  • Rest of Europe

List of Companies Covered in this Report:

1. Abbott Laboratories
2. Agilent Technologies
3. Beckton Dickinson
4. bioMerieux
5. Bio-Rad Laboratories
6. Danaher Corp. (Beckman Coulter & Cepheid)
7. DiaSorin
8. Diazyme Laboratories
9. Eurofins
10. EUROIMMUN Medizinische Labordiagnostika AG
11. Roche
12. Gentian Diagnostics ASA
13. Grifols
14. Hologic
15. Illumina
16. Mindray Bio-Medical
17. QIAGEN
18. QuidelOrtho Corp.
19. Randox Laboratories
20. Siemens Healthineers
21. Sysmex Corp.
22. Thermo Fisher Scientific
23. Werfen

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope Of The Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Growing Prevalence of Chronic and Infectious Diseases
  • 4.2.2 Increasing Adoption of Point-of-Care Testing
  • 4.2.3 Rising Geriatric Population and Preventive Screening Initiatives
  • 4.2.4 Expansion of National Genomic Medicine Programs
  • 4.2.5 Digital Health Integration Enhancing Remote Sample Collection And Result Delivery
  • 4.2.6 Sustainability Mandates Driving Eco-Friendly IVD Consumables
• 4.3 Market Restraints
  • 4.3.1 Stringent And Lengthy Regulatory Approval Processes Under EU IVDR
  • 4.3.2 Reimbursement Uncertainty for High-Cost Molecular Diagnostics
  • 4.3.3 Laboratory Workforce Shortages and Operational Constraints
  • 4.3.4 Data Security and Privacy Concerns with Cloud-Connected Analyzers
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Outlook
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat Of New Entrants
  • 4.7.2 Bargaining Power Of Buyers
  • 4.7.3 Bargaining Power Of Suppliers
  • 4.7.4 Threat Of Substitutes
  • 4.7.5 Intensity Of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Test Type
  • 5.1.1 Clinical Chemistry
  • 5.1.2 Immunodiagnostics
  • 5.1.3 Molecular Diagnostics
  • 5.1.4 Hematology
  • 5.1.5 Microbiology & Lateral Flow
  • 5.1.6 Coagulation
  • 5.1.7 Point-Of-Care (Rapid) Tests
  • 5.1.8 Other Tests
• 5.2 By Product & Service
  • 5.2.1 Reagents & Consumables
  • 5.2.2 Instruments / Analyzers
  • 5.2.3 Software & Services
• 5.3 By Usability
  • 5.3.1 Disposable IVD Devices
  • 5.3.2 Reusable IVD Devices
• 5.4 By Specimen Type
  • 5.4.1 Blood / Serum
  • 5.4.2 Urine
  • 5.4.3 Saliva
  • 5.4.4 Tissue / Biopsy
  • 5.4.5 Other Specimen Types
• 5.5 By Application
  • 5.5.1 Infectious Diseases
  • 5.5.2 Diabetes
  • 5.5.3 Cancer / Oncology
  • 5.5.4 Cardiology
  • 5.5.5 Autoimmune Disorders
  • 5.5.6 Nephrology & Renal Panels
  • 5.5.7 Prenatal / Genetic Screening
  • 5.5.8 Blood Screening
  • 5.5.9 Other Applications
• 5.6 By End User
  • 5.6.1 Academic & Research Institutes
  • 5.6.2 Diagnostic Laboratories
  • 5.6.3 Home-Care / POC Centers
  • 5.6.4 Hospitals & Clinics
  • 5.6.5 Other End Users
• 5.7 By Country
  • 5.7.1 Germany
  • 5.7.2 United Kingdom
  • 5.7.3 France
  • 5.7.4 Italy
  • 5.7.5 Spain
  • 5.7.6 Rest of Europe

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(Includes Global Level Overview, Market Level Overview, Core Segments, Financials as Available, Strategic Information, Market Rank/Share for Key Companies, Products & Services, and Recent Developments)}
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Agilent Technologies Inc.
  • 6.3.3 Becton, Dickinson & Co.
  • 6.3.4 bioMerieux SA
  • 6.3.5 Bio-Rad Laboratories Inc.
  • 6.3.6 Danaher Corp. (Beckman Coulter & Cepheid)
  • 6.3.7 DiaSorin SpA
  • 6.3.8 Diazyme Laboratories
  • 6.3.9 Eurofins Scientific SE
  • 6.3.10 EUROIMMUN Medizinische Labordiagnostika AG
  • 6.3.11 F. Hoffmann-La Roche AG
  • 6.3.12 Gentian Diagnostics ASA
  • 6.3.13 Grifols S.A.
  • 6.3.14 Hologic Inc.
  • 6.3.15 Illumina Inc.
  • 6.3.16 Mindray Bio-Medical
  • 6.3.17 QIAGEN N.V.
  • 6.3.18 QuidelOrtho Corp.
  • 6.3.19 Randox Laboratories Ltd.
  • 6.3.20 Siemens Healthineers AG
  • 6.3.21 Sysmex Corp.
  • 6.3.22 Thermo Fisher Scientific Inc.
  • 6.3.23 Werfen

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment