IVD 시약 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the IVD reagents market size is expected to grow from USD 48.95 billion in 2025 to USD 52.79 billion in 2026 and is forecast to reach USD 76.99 billion by 2031 at 7.84% CAGR over 2026-2031.

Global IVD Reagents Market Trends and Insights

Aging Population and Chronic Disease Testing Demand

The IVD reagents market draws steady volume from older patients who need regular screening and disease monitoring. The World Health Organization expects 1 in 6 people worldwide to be aged 60 years or older by 2030. It also expects the population aged 80 years and over to reach 426 million by 2050, or 3 times its 2020 level. These patients often require recurring hematology, immunoassay, and biomarker testing for diabetes, cardiovascular conditions, and cancer. A 2025 study reported 34.68 million deaths among older people from noncommunicable diseases in 2021 and projected elderly noncommunicable disease prevalence of 100,026 cases per 100,000 people by 2050. Japan, South Korea, and Western Europe face especially strong demand because their older populations are expanding quickly. Suppliers can respond with testing bundles that suit primary care pathways and recurring disease management.

Expansion of Molecular Diagnostics

Molecular diagnostic reagents now serve oncology profiling, sepsis detection, and antimicrobial resistance surveillance beyond respiratory testing. This broadens the IVD reagents market beyond the temporary demand pattern seen during the pandemic. The U.S. Food and Drug Administration issued a final rule in 2024 that treats in vitro diagnostic tests offered as laboratory-developed tests as devices, with the first stage of enforcement beginning in May 2025. Laboratories using cleared commercial kits may therefore face a clearer compliance path than laboratories relying on in-house formulations. Once a laboratory adopts a validated kit, it often standardizes the associated instrument platform. This can support repeat reagent purchases over the life of the installed base. Molecular suppliers in the IVD reagents market with strong clinical evidence and regulatory support are therefore better placed to serve oncology and infectious disease testing programs.

IVDR, FDA, and Clinical-Validation Burden

Europe's In Vitro Diagnostic Regulation requires suppliers to provide scientific validity and analytical performance evidence for most marketed products. Regulation EU 2024/1860 extended transition periods for some classes until 2027 to 2029, but technical documentation and notified body review remain demanding. Spain published Real Decreto 942/2025 in October 2025 to apply the regulation nationally, with provisions on notified body engagement, post-market surveillance, and registries. The IVD reagents market must also respond to the FDA's phased laboratory-developed test rule in the United States. Smaller companies can face longer development schedules and greater spending before commercialization. ISO 13485 and ISO 15189 practices now act as baseline expectations in many procurement and laboratory settings. These demands can favor suppliers that already maintain regulatory, quality, and clinical support capabilities.

Other drivers and restraints analyzed in the detailed report include:

1. Decentralization of Testing Through Point-of-Care Platforms
2. Core-Laboratory Automation and Network Consolidation
3. Reimbursement and Tender-Driven Price Compression

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

Segment Analysis

Antibodies held 36.51% of IVD reagents market share in 2025. They are used across immunoassays, lateral flow point-of-care tests, and immunohistochemistry companion diagnostic panels. Their target specificity makes substitution difficult in many validated workflows. Purified proteins and peptides provide reference materials, calibrators, quality controls, and functional reagents for clinical chemistry and immunoassay procedures. Their role is supported by laboratories seeking consistent measurement across sites. Antigens remain important in infectious disease serology and autoimmune testing. Pathogen surveillance programs continue to support this requirement after the pandemic period. The IVD reagents industry depends on these materials because reliable routine testing requires closely controlled assay inputs.

Oligonucleotides and nucleic acid probes are projected to grow at an 8.23% CAGR through 2031. They support PCR panels, next-generation sequencing library preparation, and emerging CRISPR-based detection systems. Their demand is closely linked to infectious disease testing, cancer profiling, and companion diagnostic development. Local synthesis and fill-finish capacity are becoming more important for supply security. European and U.S. policy discussions have identified nucleic acid synthesis as an important healthcare input. This supports interest in regional production partnerships. Enzymes, buffers, and proprietary reagent cocktails also support automated high-throughput systems. These products form the working basis for many laboratories even when they receive less attention than antibodies or probes.

Immunoassay and immunochemistry held 32.48% of revenue in 2026. The segment covers autoimmune, hormone, cardiac, and infectious disease testing in both central laboratories and decentralized settings. The IVD reagents market size for immunoassay is sustained by the wide range of conditions that require repeated monitoring. Integrated chemistry and immunoassay platforms remain central to laboratory capital spending. Roche received FDA 510(k) clearance in March 2026 for the cobas c703 and cobas ISE neo units. Roche stated that the cobas ISE neo can complete up to 1,800 tests per hour and includes automated maintenance functions intended to reduce hands-on work and reagent waste. Hematology and clinical chemistry remain established foundations of core laboratory testing. Their recurring use makes them important to reagent rental and total automation contracts.

Molecular diagnostics is forecast to grow at an 8.91% CAGR through 2031. Oncology profiling, syndromic infectious disease panels, and pharmacogenomic companion assays each add a durable source of demand. These use cases require both specialized chemistry and sustained clinical validation. A possible change in U.S. classification for some oncology companion diagnostics could reduce the burden of certain premarket submissions if finalized. That could widen access for smaller molecular assay developers. Flow cytometry and coagulation reagents remain important for specialized hematology-oncology and hemostasis work. Their clinical specificity can help sustain pricing. The IVD reagents market is moving toward technologies that combine high clinical value with clear laboratory workflow benefits.

Complete Report Scope:

• By Type of Reagent
  • Antibodies
  • Purified Proteins and Peptides
  • Antigens
  • Oligonucleotides and Nucleic Acid Probes
  • Others
• By Technology
  • Hematology
  • Clinical Chemistry
  • Molecular Diagnostics
  • Immunoassay and Immunochemistry
  • Others
• By Application
  • Infectious Diseases
  • Oncology
  • Cardiology
  • Endocrinology and Diabetes
  • Autoimmune Diseases and Inflammation
  • Others
• By End User
  • Hospitals & Clinics
  • Clinical Laboratories
  • Blood Banks
  • Home Care Settings
  • Pharmaceutical & Biotechnology
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 38.15% of the IVD reagents market share in 2025. The IVD reagents market in the region has a strong base in molecular testing and companion diagnostics. The FDA laboratory developed test rule is encouraging laboratories to assess validated commercial products for workflows that have used in-house assays. Abbott Laboratories completed the Exact Sciences acquisition in March 2026 at an enterprise value of USD 23 billion. Roche received FDA approval in June 2026 for the VENTANA PTEN SP218 RxDx assay for identifying PTEN protein loss in prostate adenocarcinoma.

Europe is the second-largest regional grouping, with national differences operating under the IVDR framework. Germany recorded EUR 2.38 billion in IVD revenue in 2025, equal to USD 2.6 billion using the supplied average conversion, and reagents and test kits represented 82% of that value. The country's revenue declined 0.8% from the prior year as compliance costs and reimbursement conditions affected growth. Spain adopted its national IVDR rules in October 2025. The IVD reagents market in Europe also benefits from bioMerieux's planned BIOFIRE PCR facility in France, supported by an investment exceeding EUR 250 million, equal to USD 270 million, using the supplied conversion.

Asia-Pacific is forecast to grow at a 10.57% CAGR through 2031. The IVD reagents market is supported by volume-based procurement, expanding laboratory networks, and growing digital health use across the region. India's private laboratory chains and government health programs support demand for standardized immunoassay and molecular products. Thermo Fisher opened a Barueri manufacturing facility in Brazil in 2026 to expand molecular reagent production for Latin American customers.

1. Abbott Laboratories
2. Agilent Technologies
3. Beckton Dickinson
4. bioMerieux
5. Bio-Rad Laboratories
6. Danaher
7. DiaSorin
8. DiaSys Diagnostic Systems
9. Roche
10. Grifols
11. Hologic
12. Illumina
13. QIAGEN
14. QuidelOrtho
15. Randox Laboratories
16. Revvity, Inc.
17. Siemens Healthineers
18. Sysmex
19. Thermo Fisher Scientific
20. Werfen, S.A.

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 Aging Population and Chronic Disease Testing Demand
  • 4.2.2 Expansion of Molecular Diagnostics
  • 4.2.3 Decentralization of Testing Through Point-of-Care Platforms
  • 4.2.4 Core-Laboratory Automation and Network Consolidation
  • 4.2.5 Personalized Medicine and Companion-Diagnostic Adoption
  • 4.2.6 Ambient-Stable Reagents and Local Fill-Finish Capacity
• 4.3 Market Restraints
  • 4.3.1 IVDR, FDA, and Clinical-Validation Burden
  • 4.3.2 Reimbursement and Tender-Driven Price Compression
  • 4.3.3 Lot-to-Lot Variability and Cold-Chain Dependence
  • 4.3.4 Skilled Workforce and Assay-Interpretation Bottlenecks
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Type of Reagent
  • 5.1.1 Antibodies
  • 5.1.2 Purified Proteins and Peptides
  • 5.1.3 Antigens
  • 5.1.4 Oligonucleotides and Nucleic Acid Probes
  • 5.1.5 Others
• 5.2 By Technology
  • 5.2.1 Hematology
  • 5.2.2 Clinical Chemistry
  • 5.2.3 Molecular Diagnostics
  • 5.2.4 Immunoassay and Immunochemistry
  • 5.2.5 Others
• 5.3 By Application
  • 5.3.1 Infectious Diseases
  • 5.3.2 Oncology
  • 5.3.3 Cardiology
  • 5.3.4 Endocrinology and Diabetes
  • 5.3.5 Autoimmune Diseases and Inflammation
  • 5.3.6 Others
• 5.4 By End User
  • 5.4.1 Hospitals & Clinics
  • 5.4.2 Clinical Laboratories
  • 5.4.3 Blood Banks
  • 5.4.4 Home Care Settings
  • 5.4.5 Pharmaceutical & Biotechnology
  • 5.4.6 Others
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

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, Products & Services, and Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Agilent Technologies, Inc.
  • 6.3.3 Becton, Dickinson and Company
  • 6.3.4 bioMerieux SA
  • 6.3.5 Bio-Rad Laboratories, Inc.
  • 6.3.6 Danaher Corporation
  • 6.3.7 DiaSorin S.p.A.
  • 6.3.8 DiaSys Diagnostic Systems GmbH
  • 6.3.9 F. Hoffmann-La Roche Ltd
  • 6.3.10 Grifols, S.A.
  • 6.3.11 Hologic, Inc.
  • 6.3.12 Illumina, Inc.
  • 6.3.13 QIAGEN N.V.
  • 6.3.14 QuidelOrtho Corporation
  • 6.3.15 Randox Laboratories Ltd
  • 6.3.16 Revvity, Inc.
  • 6.3.17 Siemens Healthineers AG
  • 6.3.18 Sysmex Corporation
  • 6.3.19 Thermo Fisher Scientific Inc.
  • 6.3.20 Werfen, S.A.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment