Global Immunoassay Market Size, Share, and COVID-19 Impact Analysis, By Product (Reagents & Kits, Analyzers/Instruments, and Software & Services), By Specimen (Blood, Saliva, Urine, and Others), By Technology (Radioimmunoassay, Enzyme Immunoassays Rapid Test, and Others), By Application (Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Disease Testing, Autoimmune Diseases, and Others), By End-Use (Hospitals, Blood Banks, Clinical Laboratories, Pharmaceutical & Biotech Companies, Academic Research Centers, and Others), By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2022 – 2032).

Industry: Healthcare


Global Immunoassay Market Insights Forecasts to 2032

  • The Immunoassay Market was valued at USD 32.45 Billion in 2022.
  • The Market is growing at a CAGR of 5.2% from 2022 to 2032.
  • The Global immunoassay market is expected to reach USD 53.87 Billion by 2032.
  • Asia-Pacific is expected to grow higher during the forecast period.


Global Immunoassay Market

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The Global Immunoassay Market is expected to reach USD 53.87 Billion by 2032, at a CAGR of 5.2% during the forecast period 2022 to 2032.


Market Overview

Immunoassay is a highly sensitive and specific laboratory technique used to detect and quantify various substances, such as proteins, hormones, drugs, and infectious agents, in biological samples. It relies on the binding interactions between antigens (substances of interest) and specific antibodies, leading to the formation of antigen-antibody complexes. These complexes are then measured using various detection methods, such as enzyme-linked immunosorbent assay (ELISA), radioimmunoassay (RIA), or chemiluminescence immunoassay (CLIA). Immunoassays play a crucial role in medical diagnostics, drug testing, monitoring therapeutic drug levels, and studying immune responses.


Report Coverage

This research report categorizes the market for immunoassay market based on various segments and regions and forecasts revenue growth and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the immunoassay market. Recent market developments and competitive strategies such as expansion, product launch, and development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segments of the immunoassay market.


Global Immunoassay Market Report Coverage

Report CoverageDetails
Base Year:2022
Market Size in 2022:USD 32.45 Bn
Forecast Period:2022 – 2032
Forecast Period CAGR 2022 – 2032 :5.2%
022 – 2032 Value Projection:USD 53.87 Bn
Historical Data for:2018-2021
No. of Pages:200
Tables, Charts & Figures:150
Segments covered:By Product, By Specimen, By Technology, By Application, By End-Use, By Region.
Companies covered:: Siemens Healthineers, BioMerieux SA, Abbott Laboratories, Danaher Corporation, Quidel Corporation, Ortho Clinical Diagnostics, Sysmex Corporation, Bio-Rad Laboratories, Inc., Becton, Dickinson, and Company, F. Hoffmann-La Roche AG, Thermo Fisher Scientific, Inc., and Others.
Pitfalls & Challenges:COVID-19 Empact, Challenge, Future, Growth, & Analysis

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Driving Factors

The immunoassay market is influenced by several key drivers that contribute to its growth and widespread adoption in various industries such as the increasing prevalence of chronic diseases and infectious disorders worldwide has created a growing demand for accurate and rapid diagnostic methods. Immunoassays offer high sensitivity and specificity, making them valuable tools in detecting and monitoring diseases, leading to their rising adoption. Advancements in technology and automation have improved the efficiency and throughput of immunoassay systems, reducing testing time and cost. The integration of robotics, artificial intelligence, and miniaturization of devices has further expanded the applications of immunoassays in point-of-care testing and home diagnostics, driving market expansion. Moreover, the rising geriatric population has led to a higher incidence of age-related diseases, necessitating increased diagnostic testing. Immunoassays have found significant applications in areas such as oncology, cardiac markers, and infectious diseases, catering to the healthcare needs of the elderly population. Furthermore, the pharmaceutical and biotechnology industries' growth has increased the demand for drug development and monitoring. Immunoassays play a vital role in the analysis of drug efficacy, pharmacokinetics, and pharmacodynamics, fostering market growth. Additionally, government initiatives promoting early disease diagnosis and prevention have bolstered the immunoassay market. Public health campaigns, disease surveillance programs, and reimbursement policies for diagnostic tests have further encouraged the adoption of immunoassay technologies. Overall, the increasing awareness among patients and healthcare professionals about the benefits of early diagnosis and personalized medicine has contributed to the immunoassay market's expansion. As a result, the immunoassay market is anticipated to experience continued growth as technology advancements persist and healthcare priorities prioritize disease detection, monitoring, and prevention.


Restraining Factors

The immunoassay market faces several restraints that hinder its growth and adoption, such as the high costs associated with developing and implementing sophisticated immunoassay technologies pose a barrier, particularly in low-resource settings. The potential for false-positive or false-negative results can erode trust in immunoassay tests, leading to apprehension among healthcare providers and patients. The complex regulatory landscape surrounding diagnostic assays can delay approvals and market entry. Additionally, the emergence of alternative diagnostic technologies and point-of-care testing methods presents competition for immunoassays.



Market Segmentation

  • In 2022, the reagents & kits segment accounted for around 65.4% market share

On the basis of the product, the global immunoassay market is segmented into reagents & kits, analyzers/instruments, and software & services. Reagents and kits have contributed to the largest market share in the immunoassay market due to their crucial role in facilitating accurate and reliable test results. As immunoassays heavily rely on specific antigen-antibody interactions, the quality and specificity of reagents and kits significantly impact the assay's performance. Their ease of use and ready availability make them attractive options for laboratories and healthcare facilities. Additionally, advancements in reagent technologies, such as monoclonal antibodies and enzyme labels, have further enhanced their efficiency and contributed to their dominant position in the immunoassay market.


  • The enzyme immunoassays segment held the largest market with more than 58.2% revenue share in 2022.

Based on the technology, the global immunoassay market is segmented into radioimmunoassay, enzyme immunoassays rapid test, and others. Enzyme Immunoassays (EIA) have held the largest market share in the immunoassay market due to their wide range of applications, high sensitivity, and specificity. EIA's ability to detect and quantify antigens in various biological samples has made them a preferred choice in clinical diagnostics, drug development, and research. They offer a cost-effective and efficient solution for detecting analytes, making them suitable for large-scale testing. Additionally, advancements in enzyme labels and automation technologies have further boosted the adoption of EIA, solidifying their dominant position in the immunoassay market.


  • The infectious disease testing segment is expected to grow at a CAGR of around 5.6% during the forecast period

Based on the application, the global immunoassay market is segmented into therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious disease testing, autoimmune diseases, and others. The infectious diseases testing segment is anticipated to experience the fastest growth rate over the forecast period due to the increasing global incidence of infectious diseases, such as HIV, hepatitis, and respiratory infections, has created a pressing need for efficient and accurate diagnostic tools. Immunoassays offer high sensitivity and specificity, making them indispensable in infectious disease detection. The ongoing efforts by governments and healthcare organizations to combat infectious disease outbreaks and improve public health have spurred the demand for reliable testing methods.


  • The hospitals segment held the largest market with more than 31.7% revenue share in 2022

Based on the end-use, the global immunoassay market is segmented into hospitals, blood banks, clinical laboratories, pharmaceutical & biotech companies, academic research centers, and others. The hospitals segment dominated the overall immunoassay market primarily due to its vital role as a primary healthcare provider and diagnostic hub. Hospitals have a significant patient load, necessitating a wide range of diagnostic tests, including immunoassays, to accurately diagnose and monitor various diseases. Additionally, hospitals often have advanced laboratory facilities equipped with state-of-the-art immunoassay systems, enabling them to conduct a large number of tests efficiently. The availability of skilled healthcare professionals and the capability to handle complex medical cases further contribute to the hospitals' dominance in the immunoassay market.


Regional Segment Analysis of the Immunoassay Market

  • North America (U.S., Canada, Mexico) 
  • Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
  • Asia-Pacific (China, Japan, India, Rest of APAC)
  • South America (Brazil and the Rest of South America) 
  • The Middle East and Africa (UAE, South Africa, Rest of MEA)


North America dominated the market with more than 36.2% revenue share in 2022.

Global Immunoassay Market

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Based on region, North America has emerged as the leading revenue generator in the immunoassay market due to advanced healthcare infrastructure, strong emphasis on early disease detection, and extensive research and development activities have driven the adoption of immunoassay technologies. Additionally, a high prevalence of chronic diseases, such as diabetes, cardiovascular disorders, and cancer, has fueled the demand for accurate diagnostic tools, in which immunoassays excel. Moreover, favorable government policies, supportive reimbursement frameworks, and a well-established pharmaceutical and biotechnology industry.


The Asia Pacific region is projected to experience rapid growth in the immunoassay market during the forecast period due to the large and growing population, coupled with increasing healthcare awareness and spending, which is driving the demand for advanced diagnostic technologies. Additionally, the rising prevalence of infectious diseases, chronic conditions, and lifestyle-related disorders in the region has created a significant need for accurate and efficient diagnostic tools like immunoassays.


Recent Developments

  • In November 2022, Getein debuted the MAGICL 6000 CLIA analyzer at MEDICA 2022. MAGICL 6000 is a small and innovative CLIA analyzer that is ideal for mid to high-workflow laboratories that require a one-step CLIA solution.


  • In November 2022, LumiraDx has introduced a quick microfluidic immunoassay HbA1c test throughout Europe, the Middle East, Asia, Latin America, and Africa.


Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the global immunoassay market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.


List of Companies:

  • Siemens Healthineers
  • BioMerieux SA
  • Abbott Laboratories
  • Danaher Corporation
  • Quidel Corporation
  • Ortho Clinical Diagnostics
  • Sysmex Corporation
  • Bio-Rad Laboratories, Inc.
  • Becton, Dickinson, and Company
  • F. Hoffmann-La Roche AG
  • Thermo Fisher Scientific, Inc.


Key Target Audience

  • Market Players
  • Investors
  • End-Users
  • Government Authorities 
  • Consulting and Research Firm
  • Venture Capitalists
  • Value-Added Resellers (VARs)



Market Segment

This study forecasts revenue at global, regional, and country levels from 2019 to 2032. Spherical Insights has segmented the global immunoassay market based on the below-mentioned segments:


Immunoassay Market, By Product

  • Reagents & Kits
  • Analyzers/Instruments
  • Software & Services


Immunoassay Market, By Specimen

  • Blood
  • Saliva 
  • Urine   
  • Others


Immunoassay Market, By Technology

  • Radioimmunoassay
  • Enzyme Immunoassays Rapid Test
  • Others


Immunoassay Market, By Application

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


Immunoassay Market, By End-Use

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


Immunoassay Market, Regional Analysis

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia Pacific
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Middle East & Africa
    • UAE
    • Saudi Arabia
    • Qatar
    • South Africa
    • Rest of Middle East & Africa

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