Immunoassay Market to Reach USD 60.18 Bn by 2035, Driven by Diagnostic Advancements and Rising Chronic Disease Burden

Key companies include F. Hoffmann-La Roche Ltd., Danaher Corporation, Abbott Laboratories, Siemens Healthineers (Siemens AG), DiaSorin S.p.A., Sysmex

ROCKVILLE, MD, UNITED STATES, October 31, 2025 /EINPresswire.com/ -- The global immunoassay market is experiencing robust growth, fueled by the increasing demand for accurate, rapid, and high-throughput diagnostic testing across healthcare and life sciences sectors. According to a recent study by Fact.MR, the market is valued at USD 32,740.6 million in 2025 and is projected to reach USD 60,177.9 million by 2035, registering a steady CAGR of 6.3% during the forecast period.

Immunoassays are essential analytical tools in clinical diagnostics, biotechnology, and pharmaceutical research, enabling the detection and quantification of specific proteins, hormones, and biomarkers. Their expanding applications in infectious disease testing, oncology, endocrinology, and drug monitoring are propelling global adoption.

Market Drivers: Accuracy, Automation, and Expanding Diagnostic Applications

Rising Prevalence of Infectious and Chronic Diseases

The growing incidence of infectious diseases such as COVID-19, HIV, and hepatitis, coupled with the global rise in chronic conditions like cancer and cardiovascular disorders, has significantly increased the need for precise diagnostic technologies. Immunoassays, known for their high sensitivity and specificity, have become vital in early disease detection and patient monitoring, enhancing treatment outcomes and public health responses.

Technological Innovation and Automation in Testing Platforms

The market is witnessing major innovations in automated immunoassay analyzers and multiplex testing platforms that enable simultaneous detection of multiple analytes. These advancements reduce testing time, minimize human error, and improve throughput — making immunoassays indispensable in clinical laboratories and point-of-care settings.
Integration with AI-driven diagnostic software and digital health platforms is further enhancing test interpretation and workflow efficiency, paving the way for next-generation precision diagnostics.

Rising Adoption in Pharmaceutical and Biotechnology Research

Beyond clinical diagnostics, immunoassays play a pivotal role in drug discovery, vaccine development, and clinical trials. Their ability to quantify immune responses and therapeutic efficacy supports accelerated R&D processes. Pharmaceutical companies and CROs are increasingly investing in advanced assay technologies to ensure regulatory compliance and data reliability.

Shift Toward Personalized and Preventive Healthcare

With the global healthcare landscape transitioning toward personalized medicine, immunoassays are becoming central to tailored diagnostic and treatment strategies. Their use in identifying patient-specific biomarkers enables precision therapeutics, particularly in oncology and autoimmune diseases.
Moreover, preventive healthcare initiatives and government-backed screening programs are expanding immunoassay adoption in both developed and emerging markets.

Competitive Landscape:

The global immunoassay market is highly competitive, with major players focusing on technological advancements, product portfolio expansion, and strategic collaborations to strengthen their market presence.

Key Players Include:

F. Hoffmann-La Roche Ltd.
Danaher Corporation
Abbott Laboratories
Siemens Healthineers (Siemens AG)
DiaSorin S.p.A.
Sysmex Corporation
bioMérieux SA
Ortho Clinical Diagnostics (a part of Carlyle Group)
Thermo Fisher Scientific, Inc.
Becton, Dickinson and Company
Merck KGaA

These companies are continuously investing in R&D to develop high-throughput immunoassay systems, expand test menus, and secure regulatory approvals for innovative diagnostic kits. Mergers, acquisitions, and partnerships with diagnostic laboratories and research organizations are further shaping the competitive dynamics.

Recent Developments:

July 2025 – Siemens Healthineers announced the global rollout of its next-generation Atellica^® CI Analyzer, offering faster immunoassay testing for mid-volume laboratories.

March 2025 – Abbott introduced a high-sensitivity cardiac troponin I assay to improve early detection of myocardial infarction.

December 2024 – Roche Diagnostics expanded its infectious disease testing portfolio with new immunoassays targeting emerging viral pathogens.

Market Segmentation

The immunoassay market is segmented across multiple parameters to capture its broad application base and technology diversity.

By Product Type:

Reagents & Kits
Analyzers
Software & Services

By Technology:

Enzyme-linked Immunosorbent Assay (ELISA)
Chemiluminescent Immunoassay (CLIA)
Radioimmunoassay (RIA)
Fluorescent Immunoassay (FIA)
Rapid Test Formats

By Application:

Infectious Diseases
Oncology
Endocrinology
Cardiology
Autoimmune Diseases
Drug Monitoring
Others

By End User:

Hospitals & Clinics
Diagnostic Laboratories
Research Institutes
Pharmaceutical & Biotechnology Companies

By Region:

North America: Leads global revenue share due to advanced healthcare infrastructure and strong presence of top-tier diagnostic companies.
Europe: Witnessing expansion supported by favorable reimbursement frameworks and widespread screening programs.
Asia-Pacific: Poised for the fastest growth, driven by increasing healthcare investments, growing awareness, and expanding diagnostic capacity in India and China.

Future Outlook: AI Integration and Next-Gen Diagnostics

The next decade of immunoassay innovation will be defined by:

AI-Powered Diagnostic Platforms – Enabling real-time data interpretation and predictive insights.
Miniaturized Point-of-Care Devices – Expanding access to rapid testing in low-resource settings.
Multiplex and Digital Immunoassays – Allowing simultaneous biomarker analysis for comprehensive disease profiling.
Sustainable Manufacturing – Emphasis on eco-friendly assay components and energy-efficient analyzers.

By 2035, the immunoassay market will stand as a cornerstone of precision diagnostics, shaping the future of preventive and personalized medicine across the globe.

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Related Studies Published by Fact.MR Research

Immunoassay Interference Blocker Market - https://www.factmr.com/report/immunoassay-interference-blocker-market

Particle-Enhanced Turbidimetric Immunoassay Market - https://www.factmr.com/report/particle-enhanced-turbidimetric-immunoassays-market

Chemiluminescence Immunoassay (CLIA) Analyzers Market - https://www.factmr.com/report/4734/chemiluminescence-immunoassay-clia-analyzers-market

Radioimmunoassays Market - https://www.factmr.com/report/radioimmunoassays-market

Editor’s Note:
Fact.MR is a global market research and consulting firm, renowned for delivering actionable insights across healthcare, medical devices, and biotechnology industries. Our research on the Immunoassay Market is built upon comprehensive primary interviews, advanced analytical models, and regional market intelligence empowering businesses to navigate growth opportunities and competitive challenges in this evolving sector.

S. N. Jha
Fact.MR
+1 628-251-1583
email us here

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