Immunoassay Market Size To Reach $35.10 Billion By 2030

Immunoassay Market Growth & Trends 

The global immunoassay market size is expected to reach USD 35.10 billion by 2030, registering a CAGR of 4.59% from 2025 to 2030, 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

• In 2024, kits and reagents led the market with a 66.10% share, driven by increasing demand for personalized medicine and targeted therapies for diseases. However, the software and services of the immunoassays segment is projected to grow at the fastest CAGR during the forecast period and are delivering testing services for clinical and research uses.

• The infectious disease application in the immunoassay industry led the market with a 66.10% share and is expected to grow at a CAGR of 5.43% over the forecast period. Oncology and autoimmune diseases are projected to grow at a significant growth during the forecast period.

• Enzyme immunoassays secured the dominant market share in 2024 of 63.90% focusing on personalized medicine, cancer diagnostics, cardiovascular disease testing, and infectious disease detection. However, the others segment is projected to grow at the fastest CAGR during the forecast period.

• Blood held the largest market share of 41.54% in 2024, being the largest specimen used for performing immunoassays. Urine is expected to be the fastest-growing segment over the forecast period, driven by its non-invasive nature, ease of collection, and widespread application in disease diagnostics.

• In 2024, the hospitals in the immunoassay industry held a 32.54% share. Others are projected to grow at a CAGR of 5.45% during the forecast period.

• North America immunoassay market held the largest revenue share at 47.43% in 2024, primarily supported by robust healthcare systems, a high incidence of chronic illnesses, and a growing awareness of new diagnostic technologies. Asia Pacific is set to record the fastest CAGR, propelled by healthcare reforms, infrastructure enhancements, and a large patient pool.

Immunoassay Market Segmentation

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

Immunoassay Product Outlook (Revenue, USD Million; 2018 - 2030)

• 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; 2018 - 2030)

• Therapeutic Drug Monitoring

• Oncology

• Cardiology

• Endocrinology

• Infectious Disease Testing

• Autoimmune Diseases

• Others

Immunoassay Technology Outlook (Revenue, USD Million; 2018 - 2030)

• Radioimmunoassay (RIA)

• Enzyme Immunoassays (EIA)

  • Chemiluminescence Immunoassays (CLIA)

  • Fluorescence Immunoassays (FIA)

• Rapid Test

• Others

Immunoassay Specimen Outlook (Revenue, USD Million; 2018 - 2030)

• Blood

• Saliva

• Urine

• Others

Immunoassay End-use Outlook (Revenue, USD Million; 2018 - 2030)

• Hospitals

• Blood Banks

• Clinical Laboratories

• Pharmaceutical and Biotech Companies

• Academic Research Centers

• Others

Immunoassay Regional Outlook (Revenue, USD Million; 2018 - 2030)

• 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.