Enzyme Immunoassay Market Size, Share, Trends, Industry Analysis Report
By Product (Reagents & Kits, Analyzers/Instruments, Software & Services), By Technology, By Specimen, By Application, By End User, and By Region – Market Forecast, 2025–2034
- Published Date:Oct-2025
- Pages: 125
- Format: PDF
- Report ID: PM6503
- Base Year: 2024
- Historical Data: 2020-2023
Overview
The global enzyme immunoassay market size was valued at USD 17.68 billion in 2024, growing at a CAGR of 3.64% from 2025 to 2034. Key factors driving demand for enzyme immunoassay include the increasing R&D expenditure worldwide coupled with rising cases of cancer worldwide.
Key Insights
- The segment of reagents & kits dominated the market in 2024.
- The software & services segment is expected to expand at a fast rate in the coming years due to increasing adoption of automated analysis and data management solutions.
- North America enzyme immunoassay market held the largest share in 2024.
- The U.S. enzyme immunoassay market is fueled by increasing need for clinical diagnostics and research uses.
- Asia Pacific market is expected to grow at a rapid rate from 2025-2034, driven by growing healthcare and biotech industries.
- China and Japan drive regional growth with high investments in biotechnology research and laboratories.
Industry Dynamics
- Rising global R&D spending boosts the adoption of enzyme immunoassay in diagnostics and research.
- Increasing cancer cases increase the need for enzyme immunoassay in early detection and monitoring.
- Advancement in biomarker research is expected to create new opportunities during the forecast period.
- The expensive setup and maintenance of automated EIA analyzers is anticipated to limit market growth.
Market Statistics
- 2024 Market Size: USD 17.68 Billion
- 2034 Projected Market Size: USD 25.26 Billion
- CAGR (2025–2034): 3.64%
- North America: Largest Market Share
Enzyme immunoassay (EIA) is a technique applied to detect and measure proteins, hormones, and antibodies in biologic samples. The technique provides accurate disease diagnosis and drug testing in the research and clinical arenas. The increasing need for accurate and effective testing is driving the market forward.
The growing prevalence of chronic conditions is driving demand for enzyme immunoassay tests for disease monitoring and diagnosis. As per the U.S. Department of Health and Human Services, about 129 million Americans live with at least one major chronic condition, while Eurostat 2023 reports 50.6% in Finland and 43.2% in Germany. This rising disease burden is driving adoption of trusted diagnostic solutions.
Growing number of the elderly is pushing demand for enzyme immunoassay tests to identify and track age-related illnesses. Increasing life expectancy and aging populations are generating demand for proper diagnostics thereby propelling steady growth of the market.
Drivers & Opportunities
Growing Global R&D Expenditures: Rising investment in research around the globe is fueling innovation in enzyme immunoassay technologies to meet greater diagnostic accuracy and performance. According to the World Intellectual Property Organization, global R&D spending grew from 2.39% of GDP in 2020 to 2.75% in 2023. This steady increase in funding is stimulating innovation in assay development and boosting market growth.
Rising Global Cancer Prevalence: Climbing cancer rates globally are driving enzyme immunoassay test demand utilized for early detection and disease monitoring. According to the World Health Organization, 20 million new instances and 9.7 million fatalities were registered in 2022, with cancer cases expected to reach over 35 million by 2050, a 77% escalation from 2022. Accelerating increase in cancer burden is driving adoption of precise and effective diagnostic assays in healthcare facilities.
Segmental Insights
Product Analysis
By product, the market is divided into reagents & kits, analyzers/instruments and software & services. Reagents & kits dominated the market in 2024 due to its essential role in diagnostic accuracy and frequent use across testing workflows.
The software & services sector are anticipated to report the highest growth till 2034, boosted by the move towards autonomous data interpretation and cloud-based analytical platforms.
Technology Analysis
By technology, the market is divided into enzyme-linked immunosorbent assay (ELISA), enzyme-linked immunospot (ELISPOT) assay, chemiluminescent enzyme immunoassay (CLEIA), fluoroenzyme immunoassay (FEIA) and others. The ELISA market held the highest market share in 2024 due to its widespread usage in diagnostics and research for precision and economical testing. In September 2025, Creative Diagnostics launched new ELISA kits to provide better accuracy and consistency in the detection of inorganic pyrophosphatase.
The CLEIA segment is anticipated to develop at a fast rate by 2034 due to its sensitivity and compatibility with automated platforms. The method is accurate and efficient, which makes it perfect for use in large-scale diagnostics.
Specimen Analysis
By specimen, the market is divided into blood, saliva, urine, and other specimens. Blood specimen dominated the market in 2024 owing to their accuracy in detecting a wide range of diseases and biomarkers.
Saliva specimens are expected to grow rapidly till 2034 with growing demand for non-invasive testing. They are convenient to collect and are pushing wider clinical use.
Application Analysis
Based on application, the market is segmented into therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious disease testing and others. The infectious disease testing led in 2024, reflecting consistent demand for rapid and accurate pathogen detection.
The oncology segment projected to witness the fastest growth by 2034, driven by increasing preference for non-invasive testing and also their convenience and ease of collection drive broader clinical adoption.
End User Analysis
By end user, the market is divided into hospitals, clinical laboratories, pharmaceutical and biotech companies, academic research centers and others. The hospitals led the market in 2024 as they conduct extensive diagnostic testing for patient management and treatment decisions.
Pharmaceutical and biotechnology firms are anticipated to register rapid growth until 2034 owing to increasing R&D efforts and applications of immunoassays in drug discovery and validation procedures.
Regional Analysis
North America led the enzyme immunoassay market in 2024, with its high level of diagnostic testing volume and strong base of advanced healthcare laboratories. Increasing rate of infectious and chronic disease cases are driving demand for accurate and speedy immunoassay methods among hospitals and research institutions.
U.S. Enzyme Immunoassay Market Insights
Increasing cancer incidence throughout the U.S. is fueling demand for enzyme immunoassay tests applied in diagnosis and monitoring of treatment. Based on the American Cancer Society, Inc., in 2025 the nation is projected to register 2,041,910 new cases of cancer and 618,120 deaths, driving application of diagnostic assays, aiding market growth.
Europe Enzyme Immunoassay Market Assessments
Europe is expected to hold a large share of the market in 2034 due to established clinical diagnostics infrastructure and continuous adoption of automated testing systems. Increasing focus on early disease diagnosis and strong government initiatives towards healthcare modernization are fueling stable regional growth.
Asia Pacific Enzyme Immunoassay Market Trends
Asia Pacific is expected to show the highest growth, driven by growing healthcare access and increasing awareness of preventive diagnostics. Also, the growing research activity across biotechnology sectors are accelerating market expansion.
India Enzyme Immunoassay Market Overview
Expanding biotechnology sector is boosting adoption of enzyme immunoassay technologies for research and diagnostic applications. According to DBT-BIRAC, the biotech industry of India grew from USD 44 billion in 2017 to a projected USD 300 billion by 2030, marking a CAGR of more than 15.8%. This speedy growth of the industry is encouraging innovation and market development.
Key Players & Competitive Analysis
The enzyme immunoassay market is competitive and dominated by key players such as Thermo Fisher Scientific, Bio-Rad Laboratories, Abbott Laboratories, and F. Hoffmann-La Roche AG. Firms invest in the development of consistent diagnostic kits and broadening applications for infectious diseases and disease testing. Moreover, strategic partnerships and product innovations are increasing its global reach.
A few major companies operating in the enzyme immunoassay industry include Siemens Healthineers AG, Danaher Corporation, Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Abbott Laboratories, F. Hoffmann-La Roche AG, bioMérieux SA, QuidelOrtho Corporation, Sysmex Corporation, Becton, Dickinson and Company, Fujirebio Inc., and Revvity Inc.
Key Players
- Abbott Laboratories
- Becton, Dickinson and Company
- Bio-Rad Laboratories, Inc.
- bioMérieux SA
- Danaher Corporation
- F. Hoffmann-La Roche AG
- Fujirebio Inc.
- QuidelOrtho Corporation
- Revvity Inc.
- Siemens Healthineers AG
- Sysmex Corporation
- Thermo Fisher Scientific Inc.
Enzyme Immunoassay Industry Developments
July 2025: Fujirebio launched the Lumipulse G sTREM2 assay for use on LUMIPULSE G analyzers. The test analyzes sTREM2 in blood and cerebrospinal fluid and aids research into neuroinflammation and Alzheimer's disease.
May 2025: Revvity, Inc. launched the EUROIMMUN IDS i20, an automated system for specialty disease testing. The CE-marked and FDA-listed platform combines multiple assays to improve lab speed and accuracy.
Enzyme Immunoassay Market Segmentation
By Product Outlook (Revenue, USD Billion, 2020–2034)
- Reagents & Kits
- Analyzers/Instruments
- Software & Services
By Technology Outlook (Revenue, USD Billion, 2020–2034)
- Enzyme-Linked Immunosorbent Assay (ELISA)
- Enzyme-Linked Immunospot (ELISPOT) Assay
- Chemiluminescent Enzyme Immunoassay (CLEIA)
- Fluoroenzyme Immunoassay (FEIA)
- Others
By Specimen Outlook (Revenue, USD Billion, 2020–2034)
- Blood
- Saliva
- Urine
- Other Specimens
By Application Outlook (Revenue, USD Billion, 2020–2034)
- Therapeutic Drug Monitoring
- Oncology
- Cardiology
- Endocrinology
- Infectious Disease Testing
- Others
By End User Outlook (Revenue, USD Billion, 2020–2034)
- Hospitals
- Clinical Laboratories
- Pharmaceutical and Biotech Companies
- Academic Research Centers
- Others
By Regional Outlook (Revenue, USD Billion, 2020–2034)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Italy
- Spain
- Netherlands
- Russia
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Malaysia
- South Korea
- Indonesia
- Australia
- Vietnam
- Rest of Asia Pacific
- Middle East & Africa
- Saudi Arabia
- UAE
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Mexico
- Brazil
- Argentina
- Rest of Latin America
Enzyme Immunoassay Market Report Scope
|
Report Attributes |
Details |
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Market Size in 2024 |
USD 17.68 Billion |
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Market Size in 2025 |
USD 18.31 Billion |
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Revenue Forecast by 2034 |
USD 25.26 Billion |
|
CAGR |
3.64% from 2025 to 2034 |
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Base Year |
2024 |
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Historical Data |
2020–2023 |
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Forecast Period |
2025–2034 |
|
Quantitative Units |
Revenue in USD Billion and CAGR from 2025 to 2034 |
|
Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Industry Trends |
|
Segments Covered |
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|
Regional Scope |
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|
Competitive Landscape |
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Report Format |
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Customization |
Report customization as per your requirements with respect to countries, regions, and segmentation. |
FAQ's
The global market size was valued at USD 17.68 billion in 2024 and is projected to grow to USD 25.26 billion by 2034.
The global market is projected to register a CAGR of 3.64% during the forecast period.
North America dominated the market in 2024 driven by strong healthcare systems and high diagnostic adoption.
A few of the key players in the market are Siemens Healthineers AG, Danaher Corporation, Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Abbott Laboratories, F. Hoffmann-La Roche AG, bioMérieux SA, QuidelOrtho Corporation, Sysmex Corporation, Becton, Dickinson and Company, Fujirebio Inc., and Revvity Inc.
The infectious disease testing segment led the market in 2024 due to growing need for accurate and rapid diagnostics.
The pharmaceutical and biotech segment is projected to witness the fastest growth during the forecast period driven by rising research and drug development activities.
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