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. Immunoassays are bioanalytical methods that detect or quantify specific proteins, hormones, or pathogens using antibody-antigen reactions. These assays are widely used in clinical diagnostics, drug development, infectious disease testing, and therapeutic monitoring.

Market Overview
The U.S. market is driven by rising incidences of chronic diseases such as cancer, cardiovascular disorders, and diabetes, which demand accurate and early diagnostic tools. Additionally, the increase in infectious disease testing, especially post-COVID-19, has significantly boosted the adoption of immunoassay-based diagnostic systems in hospitals, clinical laboratories, and research centers.

Key Growth Drivers
Key drivers of growth include technological advancements in immunoassay platforms such as chemiluminescence and multiplex assays, which offer greater sensitivity, specificity, and faster turnaround times. The expansion of point-of-care testing and home diagnostics, particularly for conditions like pregnancy, thyroid disorders, and viral infections, has further accelerated market penetration. Increased government spending on healthcare infrastructure and the ongoing shift toward personalized medicine also contribute to the robust demand for immunoassay products.

Market Challenges
Despite growth opportunities, the market faces challenges such as high costs of advanced immunoassay systems and reagents, along with regulatory complexities associated with diagnostic approvals. In addition, technical issues like cross-reactivity and false positives/negatives may impact test reliability in certain conditions.

Market Segmentation
By Product: Reagents & Kits, Analyzers, Software & Services
By Technology: ELISA, Rapid Tests, Western Blotting, Radioimmunoassay (RIA), Others
By Application: Infectious Diseases, Oncology, Endocrinology, Cardiology, Autoimmune Disorders, Others
By End-User: Hospitals, Clinical Laboratories, Academic Research Institutions, Point-of-Care Settings

Key Companies in the U.S. Immunoassay Market

• 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.

Outlook
The U.S. immunoassay  market is expected to see consistent growth driven by demand for early disease detection, adoption of high-throughput testing platforms, and expanding healthcare access. As innovations in automation and digital health integration continue, immunoassay technologies are likely to remain essential tools in clinical diagnostics and disease management.

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