Immunoassay Market Size To Reach $40.25 Billion By 2033

May 2026 | Report Format: Electronic (PDF)

Immunoassay Market Growth & Trends

The global immunoassay market size is estimated to reach USD 40.25 billion by 2033, registering a CAGR of 4.63% from 2026 to 2033, according to a new report by Grand View Research, Inc. The introduction of PoC rapid tests and automated immunoassay analyzers is boosting market growth. In addition, the rising number of chronic and infectious diseases is leading to high market growth.

According to the American Cancer Society, there were an estimated 16.9 million cancer patients/survivors in 2020. Around 1.8 million cancer cases were diagnosed in the U.S., according to the National Cancer Institute 2019 data. According to the American Cancer Society, nearly 606,880 deaths occurred due to cancer in the U.S. in 2019. Thus, the rise in the number of cancer cases being diagnosed is driving the demand for immunoassays. This is expected to boost the market growth in the coming years.

Furthermore, growing awareness regarding infectious diseases and preventive measures has led to a high demand for rapid diagnostic test products, thereby increasing sales. Based on a survey by the WHO on the World malaria report 2018, manufacturers reported sales of 276 million for lateral flow assays in 2017. It also reported that around 75.0% of malaria cases were diagnosed using lateral flow assays in sub-Saharan Africa in 2017.

Several smartphone-based devices and associated tools have emerged as next-generation point-of-care diagnostics or testing devices, thereby boosting the market growth. For instance, a smartphone application combined with the autonomous capillary microfluidic chip is used for the rapid testing of cardiac troponin I in myocardial infarction. This platform can be easily used in resource-limited settings, providing test results within 12 minutes. Thus, novel technological advancements are anticipated to further drive the market over the forecast period.

The first implementation of the Atellica immunoassay solutions with Aptio automation in the United States was announced by Siemens Healthcare GmbH in April 2018. The objective of this product was designed to promote advanced technological products in the U.S. In December 2020, Beckman Coulter, a Danaher business, introduced its first high-quality as well as throughput assay for the COVID-19 antigen detection, officially named Access SARS-CoV-2 Antigen assay. In July 2018, Cygnus Technologies and Gyros Protein Technologies collaborated to produce immunoassay to identify biotherapeutic toxins. The two companies' strategic alliance will primarily focus on offering bioanalytical solutions and increasing biotherapeutics manufacturing efficiencies.


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Immunoassay Market Report Highlights

  • By product, the kits and reagents accounted for the largest share in the market, driven by rising demand for rapid, high-throughput, and disease-specific diagnostic testing across oncology, infectious disease, cardiology, and neurology applications.

  • By application, the infectious disease application segment led the market with a 30.07% revenue share in 2025, driven by the increasing prevalence of tuberculosis, HIV, hepatitis, influenza, and other infectious diseases globally.

  • By technology, the enzyme immunoassays dominated the market with a 64.10% revenue share in 2025, driven by increasing adoption across personalized medicine, cancer diagnostics, cardiovascular disease testing, and infectious disease detection.

  • By specimen, the blood segment held the largest share of the market, accounting for 41.45% of revenue in 2025, as blood-based specimens remain the most widely used sample type for immunoassay testing across oncology, infectious disease, cardiology, and endocrinology applications.

  • By end-use, the hospitals accounted for the largest revenue share of 32.37% in the market, driven by increasing adoption of advanced diagnostic technologies for oncology, infectious disease, cardiology, and chronic disease testing.

  • North America immunoassay market dominated the global industry for immunoassays, accounting for 47.27% of revenue in 2025, driven by advanced healthcare infrastructure, the high prevalence of chronic and infectious diseases, and the growing adoption of innovative diagnostic technologies across hospitals and clinical laboratories.

Immunoassay Market Segmentation

Grand View Research has segmented the global immunoassay market based on product, specimen, technology, application, end-use, and region:

Immunoassay Product Outlook (Revenue, USD Million, 2021 - 2033)

  • Reagents & Kits

    • ELISA Reagents & Kits

    • Rapid Tests Reagents & Kits

    • ELISPOT Reagents & Kits

    • Western Blot Reagents & Kits

    • Other Reagents & Kits 

  • Analyzers/Instruments

    • Open-Ended Systems

    • Closed-Ended Systems

  • Software & Services

Immunoassay Application Outlook (Revenue, USD Million, 2021 - 2033)

  • Therapeutic Drug Monitoring

  • Oncology

  • Cardiology

  • Endocrinology

  • Infectious Disease Testing

  • Autoimmune Diseases

  • Others

Immunoassay Technology Outlook (Revenue, USD Million, 2021 - 2033)

  • Radioimmunoassay (RIA)

  • Enzyme Immunoassays (EIA)

    • Chemiluminescence Immunoassays (CLIA)

    • Fluorescence Immunoassays (FIA)

  • Rapid Test

  • Others

Immunoassay Specimen Outlook (Revenue, USD Million, 2021 - 2033)

  • Blood

  • Saliva

  • Urine

  • Others

Immunoassay End-use Outlook (Revenue, USD Million, 2021 - 2033)

  • Hospitals

  • Blood Banks

  • Clinical Laboratories

  • Pharmaceutical and Biotech Companies

  • Academic Research Centers

  • Others

Immunoassay Regional Outlook (Revenue, USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait

List of Key Players in the Immunoassay Market

  • Abbott

  • Siemens Healthineers

  • Danaher Corporation (Beckman Coulter)

  • bioMérieux SA

  • Quidel Corporation

  • Sysmex Corporation

  • Ortho Clinical Diagnostics

  • Bio-Rad Laboratories, Inc.

  • F. Hoffmann-La Roche AG

  • Becton, Dickinson, and Company

  • Thermo Fisher Scientific, Inc.

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