U.S. Immunoassay Market Poised to Capitalize on Rising Demand and Innovation

U.S. Immunoassay Market
The U.S. immunoassay market size was valued at USD 10.27 billion in 2023. The U.S. immunoassay industry is anticipated to grow from USD 10.44 billion in 2024 to USD 12.53 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 2.3% during the forecast period. The market growth is driven by rising demand for early and accurate disease diagnosis, technological advancements in assay techniques, and an increase in the prevalence of chronic and infectious diseases.

Market Overview
Immunoassays are biochemical tests that measure the presence or concentration of a substance in a solution through the use of an antibody or antigen. They are essential in clinical diagnostics, particularly for detecting infections, hormones, cancer markers, and autoimmune diseases. In the U.S., the market is supported by a highly developed healthcare system, increasing awareness of preventive healthcare, and continued investment in diagnostic innovation. The post-pandemic focus on preparedness and disease surveillance has also reinforced the demand for high-sensitivity immunoassay systems.

Market Segmentation
By Product:

Reagents & Kits
Instruments
Software & Services

By Technology:

Enzyme-Linked Immunosorbent Assay (ELISA)
Chemiluminescence Immunoassays (CLIA)
Fluorescence Immunoassays (FIA)
Radioimmunoassays (RIA)
Rapid Tests
Others

By Application:

Infectious Diseases
Oncology
Endocrinology
Cardiology
Autoimmune Diseases
Others

By End-User:

Hospitals & Clinics
Diagnostic Laboratories
Academic & Research Institutions
Biopharmaceutical Companies

Regional Insight
The U.S. dominates the North American immunoassay market due to strong R&D capabilities, high healthcare spending, and early adoption of innovative technologies. States with leading biotech clusters—such as California, Massachusetts, and New Jersey—contribute significantly to market advancements. Government support for precision medicine and growing investment in laboratory automation further bolster the sector’s prospects.

Key Companies
Abbott
Agilent Technologies
Becton, Dickinson, and Company
Beckman Coulter
Bio-Rad Laboratories, Inc.
DiaSorin S.p.A.
Ortho Clinical Diagnostics
Quidel Corporation
Sysmex America, Inc.
Thermo Fisher Scientific, Inc.

Market Trends

Increasing integration of artificial intelligence and automation in immunoassay platforms
Rising use of multiplex assays for simultaneous detection of multiple analytes
Shift toward point-of-care immunoassay testing for faster diagnostics
Growing demand for personalized medicine and companion diagnostics
Expansion of home-based and at-home testing kits for chronic disease monitoring

Future Outlook
The U.S. immunoassay market is expected to see stable growth as diagnostic needs evolve, particularly in the areas of oncology, infectious diseases, and hormone monitoring. Companies are investing in next-generation immunoassay technologies to improve test accuracy, speed, and patient convenience. With the growing emphasis on preventive care and precision diagnostics, the market is poised to benefit from both clinical and consumer-driven innovations.

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