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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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.
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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