U.S. Immunoassay Market Size Worth USD 18.49 Billion by 2034 | CAGR: 4.6%

The U.S. Immunoassay Market size is expected to reach USD 18.49 billion by 2034, according to a new study by Polaris Market Research. The report “U.S. Immunoassay Market Share, Size, Trends, Industry Analysis Report By Product (Reagents & Kits, Analyzers/Instruments), By Technology, By Specimen, By Application, By End Use; Market Forecast, 2025–2034” gives a detailed insight into current market dynamics and provides analysis on future market growth.

Immunology is the branch of biomedical science concerned with the study of the immune system’s structure, function, and disorders. The U.S. immunology market is increasingly influenced by the rising burden of autoimmune and chronic inflammatory diseases, which has elevated the need for targeted immunotherapy drugs and biologics. This trend aligns with the broader healthcare focus on personalized medicine, as immunological insights enable more precise and individualized treatment strategies. Pharmaceutical and biotechnology companies are boosting their efforts to develop novel therapies that effectively modulate immune responses, driven by the growing scientific understanding of immune-related pathways, thereby fueling advancements across the market.

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The continuous evolution of therapeutic monoclonal antibodies and biologics drives the U.S. immunology market growth. These biologics are rapidly becoming the standard of care for various immune-mediated conditions due to their high specificity and ability to target major immune regulators. Ongoing innovation in antibody engineering, including bispecific and antibody-drug conjugates, is expanding the scope of immunological treatments beyond traditional indications. Additionally, the development of next-generation immunotherapies is boosting strong interest in both academic and commercial research sectors, reinforcing the momentum of the immunology market.

Top of FormU.S. Immunoassay Market Report Highlights

• In terms of product, the reagents & kits segment accounted for USD 7.46 billion in 2024, fueled by consistent demand across clinical diagnostics and research labs due to their essential role in immunoassay workflows.
• Based on technology, the rapid test segment is expected to register a CAGR of 4.2% during the forecast period, driven by the rising adoption of point-of-care testing for faster clinical decisions in emergency and primary care environment.
• In terms of specimen, the blood specimen segment dominated with USD 6.76 billion in 2024, owing to its versatility in detecting diverse biomarkers and its status as the gold-standard sample for diagnostics.
• Based on application, the cardiology segment is anticipated to expand rapidly during the forecast period due to the growing burden of cardiovascular diseases and increasing focus on preventive cardiac risk screening.
• A few key players in the U.S. immunoassay market include Abbott; Agilent Technologies, Inc.; BD; Beckman Coulter, Inc.; Bio-Rad Laboratories, Inc.; DH Life Sciences, LLC.; Dynex Technologies, Inc.; Quanterix; QuidelOrtho Corporation; and Thermo Fisher Scientific Inc.

Polaris Market Research has segmented the U.S. immunoassay market report on the basis of product, technology, specimen, application, and end use:

By Product Outlook (Revenue, USD Billion, 2020–2034)

• Reagents & Kits
  • ELISA Reagents & Kits
  • Rapid Test Reagents & Kits
  • Western Blot Reagents & Kits
  • ELISPOT Reagents & Kits
  • Other Reagents & Kits
• Analyzers/Instruments
  • Open Ended Systems
  • Closed Ended Systems
• Software & Services

By Technology Outlook (Revenue, USD Billion, 2020–2034)

• Enzyme Immunoassays (EIA)
  • Chemiluminescence Immunoassays (CLIA)
  • Fluorescence Immunoassays (FIA)
• Rapid Test
• Radioimmunoassay (RIA)
• Others

By Specimen Outlook (Revenue, USD Billion, 2020–2034)

• Blood
• Urine
• Saliva
• Others

By Application Outlook (Revenue, USD Billion, 2020–2034)

• Infectious Disease Testing
• Cardiology
• Oncology
• Endocrinology
• Autoimmune Diseases
• Therapeutic Drug Monitoring
• Others

By End Use Outlook (Revenue, USD Billion, 2020–2034)

• Hospitals
• Laboratories
• Others