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.
Furthermore, it is difficult to foresee how the COVID-19 virus will manifest in an individual as the symptoms of the virus range from mild fever and cough to acute respiratory distress syndrome (ARDS) and death, and the virus has an impulsive course. This variability has prompted an urgent pursuit for serology testing to detect SARS-CoV-2 antibodies in serum or plasma components of blood.
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.
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 Americaaccounts 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.
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.
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.
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 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.
Furthermore, it is difficult to foresee how the COVID-19 virus will manifest in an individual as the symptoms of the virus range from mild fever and cough to acute respiratory distress syndrome (ARDS) and death, and the virus has an impulsive course. This variability has prompted an urgent pursuit for serology testing to detect SARS-CoV-2 antibodies in serum or plasma components of blood.
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.
Scope of the Report
The Immunoassays Market 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.By Type:
- Reagents & Kits
- Analyzers/Instruments
- Software & Services
By Application:
- Cardiology
- Oncology
- Autoimmune Diseases
- Infectious Diseases
- Others
By Technology:
- Radio immunoassay (RIA)
- Enzyme Immunoassays (EIA) or Enzyme-linked immunosorbent assays (ELISA)
- Fluoro Immunoassay (FIA)
- Chemiluminescence Immunoassay (CLIA)
- Others
By End User:
- Hospital & Clinics
- Clinical Laboratories
- Pharmaceuticals & Biotech Companies
- Blood Banks
- Academic Research Centers
- Others
By Geography:
- 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
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
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 Americaaccounts 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.
Competitive Landscape
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 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.
Conclusion
The Global Immunoassays Market 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.
Key Topics Covered in the Report
- Snapshot of Global Immunoassays Market
- Industry Value Chain and Ecosystem Analysis
- Market size and Segmentation of Global Immunoassays Market
- Historic Growth of Overall Global Immunoassays Market and Segments
- Competition Scenario of the Market and Key Developments of Competitors
- Porter’s 5 Forces Analysis of Global Immunoassays Industry
- Overview, Product Offerings, and Strength & Weakness of Key Competitors
- Covid-19 Impact on the Overall Global Immunoassays Market
- Future Market Forecast and Growth Rates of the Total Global Immunoassays Market and by Segments
- Market Size of Product Type, Application, Technology, and End User Segments with Historical CAGR and Future Forecasts
- Analysis of Global Immunoassays Market
- Major Production/Supply and Consumption/Demand Hubs within Each Region
- Major Country-wise Historic and Future Market Growth Rates of the Total Market and Segments
- Overview of Notable Emerging Competitor Companies within Each Region
Companies Mentioned in the Report
- 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
- DiaSorin S.p.A
- Sysmex Corporation
- Cellabs
- Agilent Technologies
- Qiagen
- Meridian Bioscience Inc
- bioMerieux SA
- Merck KGaA
- Enzo Life Sciences, Inc
- Bio-Techne
Period Captured in the Report
- Historical Period: 2017-2021
- Forecast Period: 2022-2028F
Key Target Audience - Organizations and Entities Who Can Benefit by Subscribing This Report
- Biotechnology Companies
- Pharmaceutical Companies
- Manufacturer of Diagnostic Reagents/Kits and Instruments
- International Agency for Research on Cancer (IARC)
- Multidisciplinary Digital Publishing Institute (MDPI)
- Research Drug Monitoring Kits
- AI Solution Providers for Antibody/Antigen Testing
- Laboratory Reagents Manufacturers and Suppliers
- Specimen Collection Devices Manufacturer and Suppliers
Frequently Asked Questions
What is the Study Period of this Market Report?
- The Global Immunoassays Market is covered from 2017-2028 in this report, which includes a forecast for the period 2022-2028
What is the Future Growth Rate of the Global Immunoassays Market?
- The Global Immunoassays Market is expected to witness a CAGR of about 6% over the next 6 years
What are the Key Factors Driving the Global Immunoassays Market?
- The increasing prevalence of chronic diseases and infectious diseases along with the outbreak of the COVID-19 pandemic
Which is the Largest Application Segment within the Global Immunoassays Market?
- The infectious diseases segment holds the largest share of the Global Immunoassays Market
Who are the Key Players in Global Immunoassays Market?
- 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 other are the major companies operating in Global Immunoassays Market.
Additional benefits of purchasing an enterprise license:
- TAM/SAM/SOM Analysis
- Customer Cohort Analysis
- Marketing Initiatives
- White Space Opportunity Analysis
- Interactive Data Visualizations
- Customization: 20 Analyst Hours
- 3 Months Post Sales Analyst Support
- Complimentary Update Next Year
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Table of Contents
1. Executive Summary
2. Market Overview and Key Trends Impacting Growth
3. Global - Market Segmentation by Product Type, Historic Growth, Outlook & Forecasts
4. Global - Market Segmentation by Application, Historic Growth, Outlook & Forecasts
5. Global - Market Segmentation by Technology, Historic Growth, Outlook & Forecasts
6. Global - Market Segmentation by End User, Historic Growth, Outlook & Forecasts
7. Industry/Competition Analysis - Competitive Landscape
8. Key Competitor Profiles (Company Overview, Product Offerings, SWOT Analysis)
9. Geographic Analysis & Major Countries Market Historic Growth, Outlook, and Forecasts
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- 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
- DiaSorin S.p.A.
- Sysmex Corporation
- Cellabs
- Agilent Technologies
- Qiagen
- Meridian Bioscience Inc.
- bioMerieux SA
- Merck KGaA
- Enzo Life Sciences, Inc.
- Bio-Techne
