According to Precedence Research, the global Immunoassay market size was evaluated at USD 35.57 billion in 2024 and is expected to hit over USD 56.2 billion by 2034 with a CAGR of 4.68 % from 2025 to 2034.
In terms of revenue, the worldwide market of immunoassay is worth around $37.23 billion in 2025, and it is projected to reach USD 53.69 billion by 2033. The increasing incidence of chronic and infectious diseases, rapid technology innovation, growing demand for point-of-care testing, growing awareness for early diagnosis, and rising geriatric population are expected to propel the growth of the immunoassay market.
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Immunoassay Market Key Takeaways
• North America contributed the highest market share of 36% in 2024.
• Asia Pacific is expected to grow at a notable CAGR during the forecast period.
• The kit and reagent segment dominated the market and generated more than 61% of the total market share in 2024.
• The software and services segment is expected to grow at a CAGR of 5.68% from 2025 to 2034.
• The ELISA segment dominated the market and capture more than 61% of the revenue share in 2024.
• The infectious disease segment dominated the market and generated more than 31% of the market share in 2024.
• The hospital & clinical segment will dominate the market and contribute more than 31% market share in 2024.
• The blood banks are expected to grow at a healthy CAGR from 2025 to 2034.
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Market Overview and Industry Potential
Immunoassays are bioanalytical methods that widely utilize the specificity of an antigen-antibody reaction to detect and quantify target molecules in biological samples. These methods have widespread adoption in clinical diagnostics, drug monitoring, drug discovery, and food testing. Immunoassays are rapid and accurate tests that can be extensively used on-site and in the laboratory to detect specific molecules.
Immunoassay can be classified into the following types Radioimmunoassay (RIA), Enzyme Immunoassay (EIA), Fluoroimmunoassay (FIA), Chemiluminescence Immunoassay (CLIA), and Immunochromatograohic Assay (ICA). Researchers and healthcare professionals widely use immunoassay testing to detect different kinds of antibodies. The rising technological advancements in immunoassay instruments and expanding applications of immunoassay-based diagnostics are projected to offer lucrative growth opportunities to the immunoassay market during the forecast period.
Role of Artificial Intelligence in the Immunoassay Market
As the technology continues to evolve, the integration of artificial intelligence has significantly revolutionized the immunoassay market. By leveraging the power of artificial intelligence (AI) and machine learning assisting in improving diagnostic accuracy and automating data interpretation.
AI-powered algorithms can analyze complex immunoassay data, identify trends, and precisely predict patient outcomes based on test results, facilitating proactive and personalized medical interventions. Automation accelerates testing processes, streamlines workflows, enhances laboratory productivity, and minimizes human error.
Major Trends in the Immunoassay Market
Rising demand from medical diagnostics
The growing demand for medical diagnostics is expected to drive the growth of the immunoassay market during the forecast period. Immunoassays have a wide range of applications in medical diagnostics due to the rising prevalence of chronic and infectious diseases. The prevalence of these diseases is majorly attributed to numerous factors, including alcohol abuse, smoking, antimicrobial resistance, unhealthy food habits, and sedentary lifestyles.
The surge in chronic conditions such as cardiovascular diseases (CVDs), cancer, gastrointestinal diseases, diabetes, and contagious outbreaks has led to increasing demand for rapid and reliable diagnostic tests that can detect specific biomarkers or pathogens.
Immunoassays offer high sensitivity and specificity which makes them the most popular and valuable tools for accurate disease detection and effective monitoring. Additionally, the market has witnessed a higher demand for rapid diagnostic test kits owing to the rising awareness of infectious diseases and preventive measures, which further boosted sales.
Rising popularity of automated immunoassay
The rising popularity of automated immunoassay is projected to offer lucrative growth opportunities in the coming years. Automated immunoassay offers various benefits, including less time-consuming, reduced reagent consumption, greater sensitivity, and improved performance.
The clinical interpretation of diagnostic testing depends on assay analyzers and a skilled technical workforce. The time it takes to interpret assays affects the results. The rapid technological innovation in automation for immunoassays in labs and clinics provides precise and accurate test results. This automated platform eliminates the need for any operator intervention during the analysis of each sample. Such technological advancements are expected to create opportunities for market growth.
🔸In July 2024, Roche Diagnostics India announced the launch of the Elecsys HCV Duo which is India’s first commercially available fully automated immunoassay that allows simultaneous and independent determination of the hepatitis C virus (HCV) antigen and antibody status from a single human plasma or serum sample.
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Immunoassay Market Report Coverage
|
Report Attributes |
Key Statistics |
|
Market Size in 2024 |
USD 35.57 Billion |
|
Market Size in 2025 |
USD 37.23 Billion |
|
Market Size by 2034 |
USD 56.2 Billion |
|
CAGR 2025 to 2034 |
4.68% |
|
Leading Region |
North America |
|
Fastest Growing Market |
Asia Pacific |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Segments Covered |
Product, Technology, Specimen, Application, End User, and Region |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America and Middle East & Africa |
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Immunoassay Market Key Regional Outlook
U.S. Immunoassay Market Size to Hit USD 14.46 billion by 2034
The U.S. immunoassay market size was valued at USD 8.96 billion in 2024 and is expected to be hit around USD 14.46 billion by 2034, growing at a CAGR of 4.90% from 2025 to 2034.
North America holds the dominating share in the immunoassay market. The growth of the region is attributed to the presence of sophisticated healthcare infrastructure, rising prevalence of cancer, CVDs, HIV, and tuberculosis cases, rising healthcare expenditure, increasing demand for rapid diagnostic techniques, and rapid technological innovations.
🔸According to the CDC data published in May 2024, every year in the United States, 1.7 million people are diagnosed with cancer, and more than 600,000 die from it, making it the second leading cause of death.
Asia Pacific is expected to be the fastest-growing region owing to the rising prevalence of chronic and infectious diseases, the rising aging population, rising demand for point-of-care diagnostics, improved healthcare regulatory environment in developing nations, and rising awareness regarding infectious diseases and preventive measures.
Several private and public programs are propelling collaborative efforts to spread scientific awareness and boost innovations in this domain. In addition, innovative laboratory procedures and techniques for rapid diagnosis and investigation of infectious and chronic diseases are anticipated to contribute to the overall growth of the market.
• In October 2024, Roche Diagnostics Korea announced that its Elecsys Total-Tau CSF (t-Tau) test, a cerebrospinal fluid (CSF) test method for Alzheimer’s disease, has received approval from the Ministry of Food and Drug Safety (MFDS).
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Immunoassay Market Segmentation:
The ELISA segment held the largest segment of the immunoassay market in 2024. The growth of the segment is driven by the rising benefits of this method over immunoelectrophoretic & immunodiffusion including shorter assay times, qualitative & qualitative results, and the use of antiserum for analysis.
On the other hand, the rapid tests segment is expected to grow significantly during the forecast period. Rapid tests are extensively utilized to detect target analytes without specialized equipment. The rapid test technique is widely utilized for a wide range of applications such as in dengue and infections caused by Salmonella, Legionella, Zika, Campylobacter, and Listeria. In addition, the approval of numerous home-based immunoassays is anticipated to fuel the segment's growth.
Product Insights:
On the other hand, the software and services segment accounted for considerable growth in the global immunoassay market over the forecast period owing to the rising availability and demand for low-cost immunoassay services in developing nations.
Application Insights
The infectious disease segment is expected to hold the dominating share of the market during the forecast period. The surge in the incidence of infectious diseases around the world such as HIV/AIDS, malaria, tuberculosis, and SARS-COVID-19 is likely to boost the segment’s growth. Additionally, the launch and approval of novel products by prominent market leaders in the field of infectious disease testing are further accelerating the segment’s growth in the coming years.
On the other hand, the oncology segment is expected to grow at a notable rate owing to the rising prevalence of cancer incidence globally. As a result, a surge in cancer cases is anticipated to spur the demand for immunoassays. Efficient and accurate diagnostic tests are necessary for early detection and treatment of cancer.
End-user Insights
The hospital segment held the largest share of the market in 2024. The surge in the number of hospitals and the availability of rapid and reliable diagnostics facilities has propelled the growth of the hospital segment during the forecast period.
On the other hand, the clinical laboratory segment is expected to grow fastest during the forecast period. The growth of the segment is driven by the rising inclination toward diagnostic laboratories for rapid and cost-effective testing services. In addition, the rising demand for point-of-care testing owing to the increasing incidence of chronic & infectious diseases around the world is expected to fuel the segment’s growth.
Browse More Insights:
• Chemiluminescence Immunoassay Market - https://www.precedenceresearch.com/chemiluminescence-immunoassay-market
• Automated Immunoassay Analyzers Market - https://www.precedenceresearch.com/automated-immunoassay-analyzers-market
• Lateral Flow Assay Market - https://www.precedenceresearch.com/lateral-flow-assay-market
• Multiplex Assays Market - https://www.precedenceresearch.com/multiplex-assays-market
• Automated Analyzers Market - https://www.precedenceresearch.com/automated-analyzers-market
• Enzyme-Linked Immunosorbent Assay Testing Market - https://www.precedenceresearch.com/enzyme-linked-immunosorbent-assay-testing-market
• Cystatin C assay Market - https://www.precedenceresearch.com/cystatin-c-assay-market
• Cell-based Assays Market - https://www.precedenceresearch.com/cell-based-assays-market
• Research Antibodies Market - https://www.precedenceresearch.com/research-antibodies-market
• In Vitro Diagnostics Market - https://www.precedenceresearch.com/in-vitro-diagnostics-market
• Toxicology Testing Services Market - https://www.precedenceresearch.com/toxicology-testing-services-market
Immunoassay market Companies
• Becton, Dickinson, and Company
• Bio-Rad Laboratories, Inc.
• Danaher Corporation (Beckman Coulter)
• F. Hoffmann-La Roche AG
• Ortho Clinical Diagnostics
• Quidel Corporation
• Siemens Healthinners
• Sysmex Corporation
• Thermo Fisher Scientific, Inc.
What is Going Around the Globe?
In March 2024, Sysmex Corp. launched six testing parameters, including, HISCL LH Assay Kit, HISCL FSH Assay Kit, HISCL Prolactin Assay Kit, HISCL Estradiol Assay Kit, HISCL Progesterone Assay Kit, and HISCL Testosterone Assay Kit. The parameters will be applied to gynecological and gonadal hormone immunoassay panels in Japan. The testing parameters are applicable for Automated Immunoassay System HISCL-5000/HISCL-800 (HISCL-Series) and will address a wide range of laboratory needs.
In January 2025, Beckman Coulter Diagnostics, a global leader in advanced diagnostics, today announced the availability of new Research Use Only (RUO) blood-based biomarker immunoassays designed to advance neurodegenerative disease research. These assays are intended to assess p-Tau217, GFAP, NfL, and APOE ε4 biomarkers, which are emerging as the most important biomarkers in neurodegenerative disease research, including interventional clinical trials.
In January 2024, Fujirebio Holdings, Inc. and Agappe Diagnostics Ltd announced that they have agreed to a Contract Development and Manufacturing Organization (CDMO) partnership for Cartridge based CLIA system reagents manufacturing project for the immunology equipment Mispa i60 and Mispa i121. Notably, the analyzers and reagents will be sold under Agappe’s brand, making Agappe the first Indian local company with a complete Chemiluminescence Solution comprising locally manufactured reagents.
Segments Covered in the Report
By Product Type
• Monoclonal Antibodies
• Polyclonal Antibodies
• Recombinant Proteins
• Proteins Vaccines
• Cell-Based Immunotherapy Products
• Gene Therapy Products
• Cell Therapy Products
• Stem Cells
• Tissue-Engineered Products
• Cell Culture
• Viral Vector
• Enzymes
• Animal models
• Molecular diagnostics
• Kits and Reagents
• Others
By Application
• Pharmacogenomics
• Biopharmaceutical Production
• Gene Therapy
• Genetic Testing
By End-user
• CMOs & CROs
• Research Institutes
• Biopharmaceutical Industries
• Others
By Geography
• North America
• Europe
• Asia Pacific
• Middle East & Africa
• Latin America
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