Immunoassays are bioanalytical techniques that use the precision of an antigen-antibody reaction to detect and quantify analytes in biological samples such as urine, blood, saliva, tissues, and cells. Clinical diagnostics, drug discovery, environmental monitoring, biopharmaceutical analysis, drug monitoring, and food testing are all common applications for such techniques. In addition, they generally exhibit quick and precise outcomes, allowing a clinician to diagnose a variety of diseases such as diabetes, cancer, and heart disease accurately.
The Global Immunoassays Market is expected to record a positive CAGR of ~6% during the forecast period (2022-2028) and reach a revenue of ~US$ 60 Bn by 2028, due to the rising prevalence of chronic and infectious diseases. The ongoing Covid-19 pandemic has accelerated the use of immune-diagnostics assays for correct diagnosis and containment of the Covid-19 pandemic. In addition, immunoassay tests are highlighted as an important diagnostic method as they enable reliable and affordable detection of viruses and bacteria. Such tests are used to detect both acute and chronic diseases.
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The rising prevalence of chronic, and infectious diseases, including COVID-19, HIV/AIDS, dengue, foodborne disease, and other diseases is one of the major factors propelling the immunoassays market growth.
In addition, the cost-effectiveness and higher efficiency of immunoassay tests also make a significant contribution to their growth.
For instance, the WHO Pan American Health Organization (PAHO) reported 21,41,240 dengue cases in the Americas, including 10,53,420 confirmed cases and 927 associated deaths, as of August 2022. In addition, Brazil (19,10,657), Peru (57,469), Colombia (38,844), Nicaragua (37,369), and Ecuador have reported the most cases (12,645) during the same period.
In addition, according to the study conducted in 2021 by Food Security Cluster, an Italian non-profit organization that outlines food availability, access, and utilization issues, more than 600 million individuals (one in ten) globally, become ill with the foodborne disease each year, and 420,000 die.
Technical challenges with immunoassay kits/reagents and instruments are likely to impede the market growth.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak had been proclaimed a public health emergency in late January 2020, medical professionals and scientists experienced the necessity for extensive and rapid testing of individuals to implement measures to contain the virus's spread. Additionally, real-time PCR (RTPCR) tests and antibody/antigen tests have erupted as vital tools for the global healthcare system in managing the outbreak.
Key Trends by Market Segment
By Product Type: Reagents & Kits hold the largest share of the Global Immunoassays Market in 2021.
Reagents/kits are a preferable type of product for immunoassay testing as they offer a quick, simple, and cost-effective method of detection with accuracy and specificity considerably better (in some cases) than other methods.
The global outbreak of Covid-19 has prompted governments to impose critical measures to prevent its spread, which focus primarily on accurate and prompt identification of virus-infected individuals using the most precise and sensitive method available, notably real-time reverse transcriptase PCR (RT-PCR). This has raised the global demand for detection kits.
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By Application: The infectious disease segment held the largest market share in 2021.
The rising global prevalence rate of infectious diseases such as HIV/AIDS, malaria, dengue fever, influenza, and Covid-19 is one of the major factors driving the demand for immunoassays tests for infectious diseases.
For instance, according to the world health organization (WHO), influenza leads to around 3 to 5 million serious cases and 250,000 to 500,000 deaths worldwide every year.
The growing number of cancer cases worldwide is also a significant contributor to the expansion of the immunoassay market during the forecast period.
For instance, according to the American Cancer Society, cancer continues to be the second leading cause of death in the U.S., after cardiovascular disease. In 2022, the U.S. is expected to see 1.9 million new cancer cases and 609,360 cancer deaths, for a total of 1,670 deaths per day.
By Technology: The Enzyme Immunoassays (EIA)/Enzyme-linked immunosorbent assays (ELISA) technology segment dominated the market for immunoassays in 2021.
This technology's accuracy and ability to provide quick results is a major driving factor. In addition, ELISA's simple procedure, high specificity and sensitivity, cost-effectiveness, and high efficiency are all contributing factors to its growth.
Furthermore, the use of ELISA/EIA for antigen/antibody detection is among the most commonly available diagnostic tools, and it is extensively used for diagnosing swine influenza as well.
According to the National Library of Medicine (NLM), operated by the U.S. federal government, ELISA, indirect fluorescence antibody (IFA), and virus neutralizing assays are used to detect porcine parainfluenza virus type-1 (PPIV-1) antibody in swine serum.
By End User: The Hospitals & Clinics segment account for the majority share of the Global Immunoassays Market in 2021.
The continuous development in the healthcare industry across countries has raised the requirement for hospitals with advanced techniques and facilities.
The growing number of infectious diseases tested during the assessments and processing of body fluids, particularly following the worldwide explosion of the Covid-19 pandemic, are other major factors influencing the demand for immunoassays tests in hospitals and clinics.
By Geography: North America accounts for the largest share among all Regions within the total Immunoassays market in 2021.
Increased technological adoption in diagnostic techniques, extensive research initiatives, and increasing government funding for point-of-care testing and regulatory science activities across the healthcare industry are all contributing factors to the growth of Immunoassays in North America.
For instance, in November 2021, the U.S. Department of Health and Human Services (HHS) announced a USD 650 million investment to enhance manufacturing capacity for fast, high-quality diagnostic testing via rapid point-of-care molecular tests that help in the detection of influenza, respiratory syncytial virus (RSV), and a cluster of respiratory viruses.
In October 2020, the National Institutes of Health announced the third round of contract awards for the intensity and manufacturing of new COVID-19 testing technologies in collaborative efforts with the Biomedical Advanced Research and Development Authority (BARDA), a U.S. Department of Health and Human Services.
Additionally, the six new rapid acceleration of diagnostics (RADx) initiative contracts comprise USD 98.35 million for point-of-care and other novel testing techniques that provide modes of sample collection, processing, and output. Inclusion with smart devices, digital processing that can be deployed to COVID-19 hot spots, and test results readily accessible in minutes are among the advancements in such new techniques.
The Asia Pacific region is expected to grow at the fastest CAGR during the forecasted period 2022-2028, owing to the government's increased emphasis on improving healthcare infrastructure, the adoption of innovative laboratory techniques and procedures, such as blotting technique, and gel electrophoresis for quicker and more efficient examination and diagnosis of infectious and chronic diseases, and growing preference for diagnostic reagents.
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The Global Immunoassays market is highly competitive with ~500 players which include globally diversified players, regional players as well as a large number of country-niche players each with their niche bioanalytical setting such as clinical diagnostics, biopharmaceutical analysis, environmental monitoring, security, and food testing, and others, for end-users. The immunoassays market's growth is heavily reliant on detection technologies and advancements in testing equipment and instruments.
Country-Niche players constitute about ~75% of the competitors, while regional players constitute about ~20%. Some of the major players in the market include F. Hoffmann-La Roche Ltd., Abbott Laboratories, Becton, Dickinson and Company (BD), Bio-Rad Laboratories, Inc., Siemens Healthineers, Thermo Fisher Scientific, Danaher Corporation, PerkinElmer, Quidel Corporation, Ortho Clinical Diagnostics Holdings, Sysmex Corporation, DiaSorin S.p.A. and among others.
Recent Developments Related to Major Players and Organizations
In February 2022, Siemens Healthineers, a German healthcare company, launched Enhanced Liver Fibrosis (ELF) Test in the U.S., offering broad clinical access to the nonsurgical diagnostic tool. In addition, the Food and Drug Administration (FDA) granted De Novo marketing authorization for the test.
In July 2021, Roche, a Swiss pharmaceutical company, announced the launch of its new Elecsys Epstein-Barr virus (EBV) immunoassay panel, which includes the Elecsys EBV IgM, EBV VCA IgG, and EBV EBNA IgG immunoassays and detects Epstein-Barr virus antibodies at various infection stages.
In April 2021, DiaSorin, an Italian Biotechnology company, launched its new immunodiagnostic Point-of-Care (POC) reader 'LIAISON IQ' and the 'LIAISON Quick Detect Covid TrimericS Ab' test. The LIAISON IQ's test detects specific IgG antibodies against SARS-CoV-2 Spike Protein in human blood capillaries from a throat swab in 10 minutes.
In February 2021, Thermo Fisher Scientific Inc., a U.S.-based manufacturer of analytical laboratory instruments, announced a partnership with Mindray, a Chinese medical device company, to make two clinical chemistry analyzers available to customers in the United States (U.S.) and Canada for drug of abuse testing.
In April 2020, Bio-Rad Laboratories, a U.S.-based manufacturer of specialized technological products for the life science research and clinical diagnostics markets, announced the release of a blood-based immunoassay kit to detect antibodies to the coronavirus SARS-CoV-2, the virus associated with COVID-19.
The Global Immunoassays Market (https://www.kenresearch.com/business-research/global-immunoassays-market-outlook-2028/) is forecasted to continue steady growth that is witnessed since 2017. The market is primarily driven by the rising prevalence of chronic, and infectious diseases, including COVID-19. Though the market is highly competitive with over ~500 participants, few global players control the dominant share and regional players also hold a significant share.
Note: This is an upcoming/planned report, so the figures quoted here for market size estimate, forecast, growth, segment share and competitive landscape are based on initial findings and might vary slightly in the actual report. Also, any required customizations can be covered to the best feasible extent for Pre-booking clients and report delivered within maximum 2 working weeks.
The Global Immunoassays Market (https://www.kenresearch.com/business-research/global-immunoassays-market-outlook-2028/) Size, Segments, Outlook, and Revenue Forecast 2022-2028 is segmented by Product Types, Application, Technology, and End-User. In addition, the report also covers the market size for each of the five regions' immunoassays markets. The revenue used to size and forecast the market for each segment is USD billion.
Reagents & Kits
Software & Services
Radio immunoassay (RIA)
Enzyme Immunoassays (EIA) or Enzyme-linked immunosorbent assays (ELISA)
Fluoro Immunoassay (FIA)
Chemiluminescence Immunoassay (CLIA)
By End User
Hospital & Clinics
Pharmaceuticals & Biotech Companies
Academic Research Centers
North America (U.S., Canada, Mexico)
Europe (Germany, UK, France, Italy, Spain, Rest of Europe)
Asia Pacific (China, Japan, India, Australia, South Korea, Rest of Asia Pacific)
Latin America, Middle East and Africa