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Immunoassay Market Size and Forecast, by Technology (ELISA, RIA, Rapid Tests); Product (Reagents & Kits, Analysis Equipment, Software & Services); Specimen (Blood, Saliva, Urine); End User (Hospitals & Clinics, Blood Bank, Research & Academic Institutes, Clinical Research Institute, Home Medical Facility, Pharmaceuticals, Biotech Companies and CROs) - Growth Trends, Key Players, Regional Analysis 2026-2035

  • Report ID: 6001
  • Published Date: Sep 17, 2025
  • Report Format: PDF, PPT

Immunoassay Market Outlook:

Immunoassay Market size was over USD 33.31 billion in 2025 and is poised to exceed USD 54.78 billion by 2035, witnessing over 5.1% CAGR during the forecast period i.e., between 2026-2035. In the year 2026, the industry size of immunoassay is estimated at USD 34.84 billion.

Immunoassay Market Size
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The growth of the market is set to be dominated by the rising prevalence of infectious diseases such as COVID-19. Across the globe, over 767 million cases of Covid-19 were recorded as of June 13, 2023. Hence, the demand for immunoassay is also predicted to rise. This is because to detect both IgM and IgG against SARS-CoV-2, the immunoassay has been significantly researched as a point-of-care (POC) test.

Moreover, the immunoassay market is also surging on account of growing demand for point-of-care diagnostics throughout the forecast period. This rise in demand for point-of-care diagnostics is primarily influenced by the escalating demand for quick and efficient solutions for diagnostics in diverse healthcare settings. Point-of-care diagnostics, distinguished by their directness and convenience, resonate with advanced healthcare dynamics, boosting a paradigm move in the management of patients. Immunoassays which are studied for their specificity and sensitivity, appear as crucial contributors to this paradigm move, aligning continuously with the need for point-of-care applications. 

Key Immunoassay Market Insights Summary:

  • Regional Highlights:

    • North America immunoassay market will secure over 41% share by 2035, driven by growing healthcare investment and advanced technologies.

  • Segment Insights:

    • The reagents & kits segment in the immunoassay market is projected to hold a 68% share by 2035, influenced by growing autoimmune disease prevalence and demand for precise testing tools.
    • The reagents & kits segment in the immunoassay market is set for substantial growth through 2035, driven by the availability of advanced, premium testing reagents and automation.

  • Key Growth Trends:

    • Growing Product Launch & Approval
    • Surging Growth in the Biotechnology & Pharmaceutical Sector

  • Major Challenges:

    • High Price of Immunoassay
    • Strict Approval for Immunoassay Instruments

  • Key Players: Abbott, Beckman Coulter, Inc., QuidelOrtho Corporation, Bio-Rad Laboratories, Inc., Becton, Dickinson, and Company, BIOMÉRIEUX, F. Hoffmann-La Roche AG, Thermo Fisher Scientific, Inc., Siemens Healthinners AG, Merck KGaA, Hologic, Inc., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., MIZUHO MEDY Co., Ltd., Immunosens Co., Ltd., Immuno-Biological Laboratories Co, Ltd., H.U. Group Holdings, Inc., Sysmex Corporation, Sumitomo Bakelite Co., Ltd.

Global Immunoassay Market Forecast and Regional Outlook:

  • Market Size & Growth Projections:

    • 2025 Market Size: USD 33.31 billion
    • 2026 Market Size: USD 34.84 billion
    • Projected Market Size: USD 54.78 billion by 2035
    • Growth Forecasts: 5.1% CAGR (2026-2035)

  • Key Regional Dynamics:

    • Largest Region: North America (41% Share by 2035)
    • Fastest Growing Region: Asia Pacific
    • Dominating Countries: United States, China, Germany, Japan, United Kingdom
    • Emerging Countries: China, India, Japan, South Korea, Singapore

    • Last updated on : 17 September, 2025

Growth Drivers

  • Growing Product Launch & Approval - Several strategic initiatives are adopted by companies including geographic expansion, product collaborations, and strategic agreements for expansion of product portfolio to boost their market share. Moreover, industry key players are focusing on collaborations, acquisitions and mergers, and product approval to sustain their existence in the market. For instance, the development of automated laboratory instruments and equipment has grown for quick testing and results. This automation guides laboratories by boosting efficiency and limiting the necessity for space and labor. Therefore, the market is growing rapidly, since a large number of players in pharmaceuticals offer compact, portable automated laboratory systems and point-of-care tests.

  • Surging Growth in the Biotechnology & Pharmaceutical Sector - There has been a surge in the biotechnology & pharmaceutical sector owing to growing investment in R&D along with the development of drugs. Additionally, there have been growing virtual trials conducted by this sector which is also boosting the growth of this sector. Furthermore, the launch of various strict regulations is also projected to influence the biotechnology & pharmaceutical growth. Hence, the factors that are boosting the growth of the biotechnology & pharmaceutical sector are also estimated to drive the market demand for immunoassay.

  • Rising Geriatric Population  - The geriatric population in the world has risen steadily in recent years. This shift in demographic is greatly owing to improved health care and living standards, leading to longer life expectancies.   According to the WHO predictions, 1 in 6 people in the globe is estimated to be aged 60 years or more by 2030. By 2050, the population aged 60 years and older is predicted to double (2.1 billion). Hence, with this, the prevalence of disease among them is also growing. This is since, the older people are greatly receptive to different age-related diseases, including cardiovascular diseases, and neurodegenerative disorders. Moreover, the recognition of the genetic risk elements for various diseases is made possible with the adoption of immunoassays, hence authorizing preventive measures and targeted screening. 

Challenges

  • Technical Issues in Immunoassay - Immunoassay kits constitute a notable threat to the growth of the global immunoassay sector owing to growing technical issues during the coming years. These challenges may be displayed in various forms, including cross-reactivity, assay variability, or interference from substances in the sample. The precision and reliability of test results are compromised owing to such issues, causing an absence of confidence among end-users, such as research facilities and clinical laboratories. Furthermore, these technical challenges translate into rising operational costs and damage to potential reputational manufacturers. Moreover, laboratories depending on immunoassay kits request compatible performance and accuracy to make certain reliable outcomes of patients and affirm regulatory compliance. Hence, the market for immunoassays is predicted to be hindered over the coming years. 

  • High Price of Immunoassay

  • Strict Approval for Immunoassay Instruments

Immunoassay Market Size and Forecast:

Report Attribute Details

Base Year

2025

Forecast Period

2026-2035

CAGR

5.1%

Base Year Market Size (2025)

USD 33.31 billion

Forecast Year Market Size (2035)

USD 54.78 billion

Regional Scope

  • North America (U.S. and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, Malaysia, Australia, South Korea, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC, North Africa, South Africa, Rest of the Middle East and Africa)
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Immunoassay Market Segmentation:

Product Segment Analysis

The reagents & kits segment in the immunoassay market is estimated to gather the highest revenue share of 68% by 2035. This growth of the segment is set to be dominated by the growing prevalence of autoimmune disease. Currently, it is predicted that there has been a growing prevalence of autoimmune diseaseS by about 2% and 9% a year in the world. Moreover, the availability of a broad range of specified and premium reagents and kits plays an important role in acknowledging precise and reproducible immunology analysis. Furthermore, the segment is characterized by continued change, such as the evolution of sensitive and specific reagents, and the integration of automation and artificial intelligence technologies. Hence, this segment is predicted to observe growth further encouraging market growth.

Specimen Segment Analysis

The blood segment is set to capture the highest revenue share of 56% in the immunoassay market by the end of 2035. Blood specimens are mostly utilized to estimate a wide range of parameters, such as antigens, antibodies, immune cell populations, cytokines, and other biomarkers. Valuable information about the functioning of the immune system, autoimmune disorders, allergies, and the reaction to therapies are provided by this estimation. Moreover, the examination of blood-derived cells has a central role in biomedical research and healthcare. Cells of interest are usually blood leucocytes, cord blood stem cells, bone marrow aspirates, tissue extracts, or cultured cells. As a result, the blood segment is predicted to gather the highest revenue which is additionally estimated to influence the market movement.

Our in-depth analysis of the global immunoassay market includes the following segments:

          Technology
  • ELISA
  • RIA
  • Rapid Tests
  • Others

          Product
  • Reagents & Kits
  • Analysis Equipment
  • Software & Services

          Specimen
  • Blood
  • Saliva
  • Urine
  • Others

          Application
  • Infection, Oncology
  • Endocrinology
  • Bone/Mineral Disease
  • Cardiology
  • Blood Screening
  • Autoimmune Disease
  • Allergy Diagnosis
  • Toxicology
  • Newborn Screening
  • Others
Vishnu Nair
Vishnu Nair
Head - Global Business Development

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Immunoassay Market Regional Analysis:

North America Market Insights

The North America immunoassay market is poised to generate the highest revenue share of 41% by the end of 2035. This growth of the market in this region is poised to be encouraged by growing healthcare investment. The health spending offered by the federal government stood at 33 percent whereas the households amounted to 28 percent.  The share of private business on health spending accounted for 18 percent of total expenditure on health care. Further, state and local governments reached 15 percent, and other private organizations accounted for 7 percent. Moreover, this region is also observing high investment in cutting-edge technology. Hence, the deployment of such technologies is predicted to rise in immunoassay in this region since it is predicted to reduce the price of the treatment.

APAC Market Insights

The Asia Pacific immunoassay market is also predicted to have notable growth over the coming years. Asia Pacific is estimated to have the quickest-growing market for Immunoassay owing to the emergence of the COVID-19 pandemic which has further led to the production of rapid diagnostic tests (RDTs) which utilize immunoassay techniques. Moreover, this region is projected to have the presence of a huge number of key players in the field of immunoassay. As a result, this factor is also estimated to dominate the market expansion in this region.

Immunoassay Market Share
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Immunoassay Market Players:

    • Abbott
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Beckman Coulter, Inc.
    • QuidelOrtho Corporation
    • Bio-Rad Laboratories, Inc.
    • Becton, Dickinson, and Company
    • BIOMÉRIEUX
    • F. Hoffmann-La Roche AG
    • Thermo Fisher Scientific, Inc.
    • Siemens Healthinners AG
    • Merck KGaA
    • Hologic, Inc.
    • Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
    • MIZUHO MEDY Co., Ltd.
    • Immunosens Co., Ltd.
    • Immuno-Biological Laboratories Co, Ltd.
    • H.U. Group Holdings, Inc.
    • Sysmex Corporation
    • Sumitomo Bakelite Co., Ltd.

Recent Developments

  • June 23, 2021: CM mark has been received by Hologic, Inc. for its novel Aptima CMV Quant assay in Europe. This assay is intended to the utilization to help in the diagnostics and management of hematopoietic stem cell transplant patients and solid-orgon transplant patients. 
  • February 7, 2021: Mindray announced the partnership with Thermo Fisher Scientific in launching efficient biochemistry solution for abuse testing and drugs. The two biochemistry analyzers of Mindray including BS-480 and BA-800M have been recognized and validated by Thermo Scientific for their ease of use, reliability and simple maintenance.
  • Report ID: 6001
  • Published Date: Sep 17, 2025
  • Report Format: PDF, PPT
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Frequently Asked Questions (FAQ)

In the year 2026, the industry size of immunoassay is estimated at USD 34.84 billion.

The global immunoassay market size was more than USD 33.31 billion in 2025 and is anticipated to witness a CAGR of over 5.1%, crossing USD 54.78 billion revenue by 2035.

North America immunoassay market will secure over 41% share by 2035, driven by growing healthcare investment and advanced technologies.

Key players in the market include Abbott, Beckman Coulter, Inc., QuidelOrtho Corporation, Bio-Rad Laboratories, Inc., Becton, Dickinson, and Company, BIOMÉRIEUX, F. Hoffmann-La Roche AG, Thermo Fisher Scientific, Inc., Siemens Healthinners AG, Merck KGaA, Hologic, Inc., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., MIZUHO MEDY Co., Ltd., Immunosens Co., Ltd., Immuno-Biological Laboratories Co, Ltd., H.U. Group Holdings, Inc., Sysmex Corporation, Sumitomo Bakelite Co., Ltd.

Immunoassay Market Report Scope

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