Immunoassay Market Size To Attain USD 51.33 Billion By 2032

Published Date : 02 Mar 2023

The global immunoassay market size is projected to attain around USD 51.33 billion by 2032 and poised to grow at a compound annual growth rate (CAGR) of 4.68% during the forecast period 2023 to 2032.

The rise in chronic diseases, the rise in geriatric populations globally, the expansion of the pharmaceutical and biotechnology industries, and the high degree of accuracy of immunoassays are the main factors contributing to the growth of the global immunoassay market. An increasing number of patients suffering from rare and chronic diseases has boosted the market for immunoassay. Immunoassays have been considered frontline diagnostics in several diseases that include pathophysiological conditions and pathogens.

Report Highlights

The immunoassay market was dominated by the reagents and kits segment in 2021. Owing to the increasing prevalence of autoimmune diseases and viral infections, the need for immunoassay kits and reagents will increase in the coming years. The market for immunoassays was dominated by the EIA/ELISA sector. This method has several significant advantages over immunoelectrophoresis & immunodiffusion, including faster assays, more precise results, and a need for fewer antisera for analysis. 

Additionally, the sector for testing for infectious diseases dominated the market in 2021. This segment will grow due to the growing prevalence of the diseases like malaria, HIV, COVID-19, and influenza. The immunoassay market was dominated by the hospital sector. The strong growth of this market segment is a result of the increase in hospitals. The increasing demand for innovative amenities in hospitals will provide good opportunities for the growth of the market.

Immunoassay Market Report Scope

Report Coverage Details
Market Size in 2023 USD 33.98 Billion
Projected Forecast Value in 2032 USD 51.33 Billion
Growth Rate 4.68% from 2023 to 2032
Hospital & Clinical Segment Revenue Share In 2022 31.00%
Base Year 2022
Forecast Period 2022 To 2030
Segments Covered By Product, By Technology, By Specimen, By Application and By End User
Regions Covered North America, Europe, Asia-Pacific, Latin America and Middle East & Africa

Regional Snapshots

North America accounted for the greatest revenue share in 2021 and is expected to continue to rule the market for the duration of the research. The high prevalence of infectious diseases including HIV, TB, and influenza in the area is also driving up the demand for diagnosis and treatment. Due to its huge geriatric population and high frequency of infectious diseases, the region with the fastest expected growth during the forecast period is Asia Pacific. 

The rising use of cutting-edge laboratory processes and techniques for quicker investigation and diagnosis of infectious and chronic disorders is one of the factors driving the market in this field. Major market drivers include the creation of molecular kits and the rise in demand for diagnostic reagents.

Market Dynamics


The market for immunoassays is influenced by a variety of variables. The increase in chronic diseases, diabetic disorders, and cardiovascular diseases is one of the key market drivers. In addition, the prevalence of illnesses like malaria, COVID-19, dengue, hepatitis, HIV, and other infections is driving the market for immunoassay products. The WHO reports that 19, 655, 3009 people have tested positive for the covid-19 as of yet. Because of this, the use of immunoassay has grown recently. 

The Immunoassay test is one of the main drivers in the Immunoassay sector since it is affordable, offers quick findings with detection limits, and has higher efficiency. An increasing number of cases of cancer has also emerged as a major driving force for the growth of the immunoassay market. Stages and the type of cancer can be detected with the help of the immunoassay system. The tumor antigens are determined in the tissue with the help of polyclonal and monoclonal antibodies. Epidemic diseases and infectious diseases can be controlled with the help of immunoassay by spreading awareness regarding this system of diagnosis. 


There are certain disadvantages associated with the use of immunoassay kits. The specificity and reliability are uncertain due to which the market of immunoassays will suffer to a great extent. When a patient is infected with any kind of infection detecting such infections is difficult. Inaccurate sensitivity will hamper market growth in the coming years. Diseases that produce viral RNA sequences cannot be diagnosed accurately with the help of immunoassays. Interferons, nonspecific IgM, and rheumatoid factors cannot be detected accurately with the help of the immunoassay system. 

The lack of skilled professionals has proven to be a major restraining factor for the market. The various restrictions that have been imposed by the regulatory authorities and the government regarding the commercialization of immunoassay techniques have emerged as restraining factors for the growth of the market. Design challenge has emerged as another restraining factor for the growth of the Immunoassay market. 


Numerous applications, including pharmaceutical analysis, food safety, medical diagnostics, and basic science research, make extensive use of immunoassay. The market for immunoassays will have potential as a result of the use of immunoassays in many different fields. Opportunities for the market are being created by the expanding global demand for safer medications and specialized therapies. The industry is anticipated to have significant expansion in developing regions like the Asia-Pacific. 

The growing trend of early diagnosis has emerged as a major driving force for the market as it has helped the healthcare system carry out preventive measures for patients. The rate of mortality can be controlled considerably with the help of early diagnosis using immunoassay. The constant research and development activities carried out by the key market players have emerged as opportunities for the growth of the immunoassay market.  


The immunoassay market, like other markets, faces numerous difficulties. The design problem surrounding the immunoassay is one of the main obstacles. Design flaws might lead to incorrect outcomes and interpretations. Another significant obstacle for the business is the dearth of knowledgeable specialists in the field of diagnostics. 

The major players are making every effort to overcome these obstacles and increase the demand for immunoassay products. Technical hurdles such as crossreactivity have proved to be a major challenge for the growth of the immunoassay market. The specificity and reliability of the immunoassays become questionable because of crossreactivity. The sample volume which is required for the detection is high which proves to be another restraining factor.

Recent Developments

  • In June 2022 - the FDA granted emergency use authorization to Roche for SARS CoV 2 Duo. This was granted for the application on the automated Cobas system. 
  • In July 2021 - an agreement took place between Quidel Corporation and Beckman Coulter for obtaining rights for distribution, manufacturing, and sales of BNP assay. 
  • In February 2021 - The private point-of-care molecular diagnostic business Mesa Biotech was acquired by Thermo Fisher Scientific Inc.

Key Market Players

  • Abbott Laboratories
  • Danaher Corporation (Beckman Coulter)
  • Quidel Corporation
  • Ortho Clinical Diagnostics
  • Sysmex Corporation
  • Bio-Rad Laboratories, Inc.
  • Becton, Dickinson, and Company
  • F. Hoffmann-La Roche AG
  • Thermo Fisher Scientific, Inc.
  • Siemens Healthinners

Segments Covered in the Report:

By Product

  • Reagents & Kits
  • ELISA Reagents & Kits
  • Rapid Test Reagent & Kits
  • ELISpot Reagents & Kits
  • Western Blot Reagents & Kits
  • Other Reagents & Kits
  • Analyzer

By Type

  • Open-ended System
  • Closed-Ended System

By Purchased Mode

  • Rental Purchased
  • Outright Purchased
  • Software and Services

By Technology

    • By generation
      • Third generation & Above
      • Second-generation & Below
  • Rapid Tests
  • ELISpot
  • Western Blotting
  • Radioimmunoassay
  • Other technologies

By Specimen

  • Blood
  • Saliva
  • Urine
  • Other Specimen

By Application

  • Infectious diseases
  • Endocrinology
  • Oncology
  • Bone and mineral disorders
  • Cardiology
  • Blood screening
  • Autoimmune Disorders
  • Allergy Diagnostics
  • Toxicology
  • Newborn Screening
  • Other Application

By End-User

  • Hospitals & Clinics
  • Clinical Laboratories
  • Pharmaceutical & Biotechnology Companies And Cro
  • Blood Banks
  • Research & Academic Laboratories
  • Home Care Setting

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