The Global Immunoassay Market was valued at USD 30.02 billion in 2022 that is expected to reach a value of USD 27.5 billion by 2030, with a compound annual growth rate (CAGR) of 6.3% during the forecast period of 2020 to 2030.

Immunoassays are a class of analytical techniques used in medical diagnosis, food testing, and environmental monitoring.

The growth of the immunoassay market is driven by factors such as the increasing prevalence of chronic and infectious diseases, the rising demand for point-of-care testing, and the development of high-sensitivity immunoassay technologies. The COVID-19 pandemic has also contributed to the growth of the market, as immunoassays are widely used for the diagnosis and monitoring of the disease.

Based on technology, the immunoassay market is segmented into enzyme-linked immunosorbent assay (ELISA), chemiluminescence immunoassay (CLIA), fluorescence immunoassay (FIA), and others. ELISA is the largest segment of the market, accounting for more than 50% of the market share.

Geographically, North America is the largest market for immunoassays, followed by Europe and Asia-Pacific. The key players in the global immunoassay market include Abbott Laboratories, Bio-Rad Laboratories, Inc., Becton, Dickinson and Company, F. Hoffmann-La Roche Ltd, Siemens Healthineers, and Thermo Fisher Scientific, Inc.

Market Dynamics

Driving Factors

The global immunoassay market is being driven by several factors, including:

Increasing adoption of immunoassays in research: Immunoassays are widely used in biomedical research to measure the levels of biomarkers in biological samples. The increasing adoption of immunoassays in research is driving the growth of the market.

Technological advancements in the field of immunoassays: The immunoassay market is constantly evolving, with new technologies and platforms being developed. These advancements are improving the accuracy, sensitivity, and specificity of immunoassays, which is driving the growth of the market.

Restraining Factors

There are several factors that may restrain the growth of the global immunoassay market, including:

Stringent regulatory requirements: Immunoassay tests are subject to regulatory approval in many countries, which can result in delays and increased costs.

Interference and cross-reactivity: Immunoassays may produce false-positive or false-negative results due to interference or cross-reactivity with other substances in the sample.

Limited sensitivity and specificity: While immunoassays have improved in terms of sensitivity and specificity, there may still be limitations in their ability to accurately detect certain biomarkers.

Challenges

The global immunoassay market faces several challenges, including:

Cross-reactivity and interference: Immunoassays can be subject to interference and cross-reactivity from other substances in the sample, which can result in false-positive or false-negative results.

Limited dynamic range: Immunoassays have a limited dynamic range, which can make it difficult to accurately quantify biomarkers that are present in low or high concentrations.

Need for specialized equipment: Immunoassays require specialized equipment, which can be expensive and may require dedicated space and infrastructure.

Data analysis and interpretation: The analysis and interpretation of immunoassay results can be complex, requiring skilled professionals and specialized software tools.

Ethical and legal considerations: The use of immunoassays in research and clinical practice raises ethical and legal considerations related to privacy, informed consent, and the ownership and sharing of data.

Opportunity Factors

The global immunoassay market presents several opportunities for growth and expansion, including:

Personalized medicine: Immunoassays have significant potential in personalized medicine, as they can be used to identify biomarkers that are associated with specific diseases or patient populations. This can help to guide treatment decisions and improve patient outcomes.

Companion diagnostics: The development of companion diagnostics presents a significant opportunity for the immunoassay market. Companion diagnostics are tests that are developed in conjunction with a specific drug therapy and are used to identify patients who are most likely to benefit from the therapy.

Biomarker discovery: Advances in immunoassay technology are enabling the discovery of new biomarkers that can be used in the diagnosis and monitoring of diseases. This presents significant opportunities for the development of new diagnostic tests and therapies.

Technological advancements: Advances in immunoassay technology, including improvements in sensitivity, specificity, and multiplexing capabilities, are driving the development of new immunoassay platforms and applications. This presents significant opportunities for the growth of the market.

Segmentation Analysis

Product Outlook

ELISA is a widely used immunoassay technique that uses an enzyme-labeled antibody or antigen to detect and quantify specific biomolecules. ELISA is used in a variety of applications, including diagnostic testing and drug discovery.

CLIA is an immunoassay technique that uses a chemiluminescent label to detect and quantify specific biomolecules. CLIA is highly sensitive and can be used to detect very low levels of analytes.

RIA is an immunoassay technique that uses a radioactive label to detect and quantify specific biomolecules. RIA has been largely replaced by other immunoassay techniques due to concerns about radiation exposure.

FIA is an immunoassay technique that uses a fluorescent label to detect and quantify specific biomolecules. FIA is highly sensitive and can be used to detect very low levels of analytes.

Multiplexed immunoassays allow for the simultaneous detection and quantification of multiple analytes in a single sample. This technique is used in a variety of applications, including biomarker discovery, drug discovery, and diagnostic testing.

Other immunoassay techniques include turbidimetric immunoassay, immunofluorescence assay, and lateral flow assay.

Each of these product segments has its own advantages and disadvantages, and their use depends on the specific application and analytical requirements. For example, ELISA is often used in diagnostic testing due to its ease of use and cost-effectiveness, while CLIA is preferred for applications that require high sensitivity and accuracy. Multiplexed immunoassays are increasingly being used in research and clinical settings due to their ability to detect multiple biomarkers in a single sample.

Application Outlook

Infectious Disease Testing the detection and diagnosis of infectious diseases such as HIV, hepatitis, tuberculosis, and others. Infectious disease testing is a major application area for immunoassays, accounting for a significant portion of the overall market.

Oncology to diagnose and monitor various types of cancer, including breast cancer, prostate cancer, and others. The use of immunoassays in oncology is growing rapidly due to their high sensitivity and specificity.

Endocrinology for the measurement of hormones and other biomarkers. This application segment includes the diagnosis and monitoring of conditions such as diabetes, thyroid disorders, and others.

Regional Analysis

North America is the largest market for immunoassays, primarily due to the high prevalence of chronic diseases such as cancer and cardiovascular diseases. The region is also home to several leading immunoassay manufacturers, which has helped to boost market growth.

Europe is the second-largest market for immunoassays, driven by the increasing demand for early and accurate diagnosis of diseases such as cancer, infectious diseases, and autoimmune diseases. The region is also home to several leading healthcare organizations, which has helped to drive market growth.

The Asia-Pacific region is expected to witness significant growth in the immunoassay market due to the increasing prevalence of chronic diseases, rising healthcare expenditure, and the growing demand for point-of-care testing. The region is also home to several emerging economies such as China and India, which are expected to drive market growth.

Scope Of Report:

The Global Immunoassay Market has been segmented into:

By Product

• Reagents & Kits
• ELISA Reagents & Kits    
• Rapid Test Reagents & Kits          
• ELISPOT Reagents & Kits              
• Western Blot Reagents & Kits    
• Other Reagents & Kits  

Analyzers/Instruments

• Open Ended Systems
• Closed Ended Systems
• Software & Services

By Specimen

• Blood  
• Saliva    
• Urine    
• Other Specimens      

By Technology

• Radioimmunoassay (RIA)
• Enzyme Immunoassays (EIA)Rapid Test
• Chemiluminescence Immunoassays (CLIA)
• Fluorescence Immunoassays (FIA)
• Others

By Application

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

By End-use

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

By Region

• North America
• US
• Canada
• Mexico
• Rest of North America
• Europe
  • Germany
  • France
  • Italy
  • Spain
  • UK
  • Nordic Countries
    • Denmark
    • Finland
    • Iceland
    • Sweden
    • Norway
  • Benelux Union
    • Belgium
    • The Netherlands
    • Luxembourg
  • Rest of Europe
• Asia-Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Southeast Asia
    • Indonesia
    • Thailand
    • Malaysia
    • Singapore
    • Rest of Southeast Asia
• Rest of Asia-Pacific
• The Middle East & Africa
• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest of the Middle East & Africa
• Latin America
• Brazil
• Argentina
• Rest of Latin America

Market Players 

The global immunoassay market is highly competitive and fragmented, with numerous players vying for market share. Some of the key companies in the market are:

• Siemens Healthineers
• bioMérieux SA
• 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.

Roche Diagnostics is a leading player in the immunoassay market, offering a wide range of products and services for the diagnosis and monitoring of various diseases. The company's product portfolio includes Elecsys immunoassay systems, cobas immunoassay systems, and others.

bioMérieux SA is a leading player in the immunoassay market, offering a wide range of products and services for the diagnosis and monitoring of infectious diseases, cancer, and other conditions. The company's product portfolio includes VIDAS immunoassay systems, VITEK immunoassay systems, and others.

Other notable players in the immunoassay market include Ortho Clinical Diagnostics, DiaSorin S.p.A., Becton, Dickinson and Company, Thermo Fisher Scientific, and Sysmex Corporation. These players are focusing on developing innovative products and services, expanding their geographic presence, and collaborating with other companies to enhance their market position.

Strategic Developments

In January 2022, Roche Diagnostics announced its acquisition of long-read sequencing company Stratos Genomics, which will enhance Roche's diagnostic capabilities in the field of precision medicine.

In December 2021, Siemens Healthineers completed its acquisition of Varian Medical Systems, a leading provider of cancer care solutions, which will enable Siemens Healthineers to expand its offerings in oncology diagnostics and therapy.

In November 2021, bioMérieux SA completed its acquisition of BBI Group, a leading provider of diagnostic tests and reagents, which will enable bioMérieux to expand its product portfolio and geographic presence.

In August 2021, Danaher Corporation announced its acquisition of Aldevron, a leading provider of plasmid DNA, mRNA, and proteins for the biotech industry, which will strengthen Danaher's position in the life sciences market.

In May 2021, Abbott Laboratories completed its acquisition of Veritor, a provider of rapid diagnostic tests, which will enable Abbott to expand its offerings in point-of-care testing and increase its global footprint.