U.S. Immunoassay Market Size Worth $12.53 Billion By 2032 | CAGR: 2.3%

The U.S. immunoassay market size is expected to reach USD 12.53 billion by 2032, 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, Software & Services); By Technology; By Specimen; By Application; By End User; By Country, Segment Forecast, 2024-2032” gives a detailed insight into current market dynamics and provides analysis on future market growth.

The growing adoption of advanced technologies and the presence of cutting-edge healthcare infrastructure in the United States are significantly driving the development of immunoassays with advanced features. For instance, in May 2024, researchers at the University of Florida unveiled the development of a new method using CRISPR gene-editing technology to identify HPV in saliva or blood samples that can enhance earlier cervical cancer diagnosis.

The rising incidence of several diseases, primarily infectious diseases, including COVID-19, is driving the use of immunoassays to monitor macro-molecule concentrations and detect disease presence accurately. For instance, in April 2024, Beckman Coulter Diagnostics, a California-based manufacturing company, announced that it had expanded its DxI 9000 Immunoassay Analyzer product line and received a CE mark for hepatitis C and B virus tests, such as anti-HCV, Access HBsAg, and Access HBsAg confirmatory assays.

Furthermore, the increasing development of new immunoassays by the major players and rising investments in research activities are creating a favorable environment for the U.S. immunoassay market. For instance, in April 2024, Labcorp, a life science company, announced the launch of an initial commercially available blood biomarker test, glial fibrillary acidic protein, in the United States to detect neuro-degenerative health problems along with brain injuries.

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The rising number of people suffering from chronic health conditions, particularly heart attacks, is prompting the government to enhance healthcare infrastructure availability and equip the required number of biomarkers in public healthcare settings. According to the Harris poll survey conducted on behalf of the American Heart Association in 2023, over 51% of the respondents in the United States are unaware of heart disease as a major cause of death.

This is encouraging firms to innovate effective disease diagnostic tests in the United States. For instance, in February 2023, Cardio Diagnostics, a US-based biotechnology company, unveiled an artificial intelligence-based blood test for the rapid detection of coronary artery disease.

U.S. Immunoassay Market Report Highlights

• The reagents & kits segment is anticipated to witness the highest growth during the forecast period due to its convenience and the development of ready-to-use kits.
• The enzyme immunoassays segment held the largest share in 2023, owing to its potential applications in clinical trials and healthcare settings.
• Massachusetts will grow at a rapid pace over the study period, attributable to the increasing incidence of chronic health problems.
• The global players include Abbott, Agilent Technologies, Becton, Dickinson and Company, Beckman Coulter, Bio-Rad Laboratories, DiaSorin, Ortho Clinical Diagnostics, Quidel Corporation, Sysmex America, Inc., and Thermo Fisher Scientific, Inc.

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

U.S. Immunoassay, Product Outlook (Revenue - USD Billion, 2019 - 2032)

• Reagents & Kits
  • ELISA Reagents & Kits
  • Rapid Test Reagents & Kits
  • ELISPOT Reagents & Kits
  • Western Blot Reagents & Kits
  • Other Reagents & Kits

• Analyzers/Instruments
  • Open Ended Systems
  • Closed Ended Systems

• Software & Services

U.S. Immunoassay, Technology Outlook (Revenue - USD Billion, 2019 - 2032)

• Radioimmunoassay (RIA)

• Enzyme Immunoassays (EIA)
  • Chemiluminescence Immunoassays (CLIA)
  • Fluorescence Immunoassays (FIA)

• Rapid Test
• Others

U.S. Immunoassay, Specimen Outlook (Revenue - USD Billion, 2019 - 2032)

• Blood
• Saliva
• Urine
• Other Specimens

      U.S. Immunoassay, Application Outlook (Revenue - USD Billion, 2019 - 2032)

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

      U.S. Immunoassay, End User Outlook (Revenue - USD Billion, 2019 - 2032)

• Hospitals
• Blood Banks
• Clinical Laboratories
• Pharmaceutical and Biotech Companies
• Academic Research Centers
• Others

U.S. Immunoassay Market Report Scope