Immunoassay Market Size, Share, Growth, Trends, and Global Industry Analysis: By Component (Instruments, Reagents and Kits, Software and Services), By Technology (ELISA, RIA, CLIA, FIA, Others), By Test Type (Oncology, Cardiac, Fertility, Infectious Diseases, Metabolic, Renal, Sepsis, Thyroid, Therapeutic Drug Monitoring, TBI, Others), By End-user (Public Hospitals, Private Hospitals, Home Care Settings), and Region Forecast 2020-2031

Immunoassay Market was valued at US$ 26,378.3 million in 2024 and is projected to reach US$ 38,884.1 million by 2031 at a CAGR of 5.7% from 2025-2031. The immunoassay market refers to a sector within the diagnostics and biotechnology industries that involves tests designed to detect and quantify substances such as hormones, proteins, and pathogens in biological samples. These tests use antibodies or antigens as a basis for detecting specific analytes. Immunoassays are commonly used in clinical diagnostics and drug testing. They offer high sensitivity, specificity, and speed, making them crucial tools in medical research, disease diagnosis, and therapeutic monitoring.

The market has witnessed significant growth in recent years, driven by advancements in technology and increasing demand for quick, accurate diagnostic tests. This market is primarily fuelled by the rise in chronic diseases, growing awareness of early detection, and the need for personalized medicine. Immunoassays are widely used in hospitals, laboratories, and research settings for applications such as cancer detection, cardiovascular disease monitoring, infectious disease diagnostics, and fertility testing. Additionally, the market is being shaped by the increasing adoption of point-of-care (POC) testing and the integration of automation in laboratory processes.

The global immunoassay market is highly competitive, with key players offering a broad range of products, including enzyme-linked immunosorbent assays (ELISA), radioimmunoassay’s (RIA), and chemiluminescent immunoassays (CLIA). As the demand for faster and more accurate diagnostic tools grows, the market is expected to continue expanding, with growth in emerging regions and areas like oncology, immunology, and infectious diseases.

List of Instances

• In January 2024, Fujirebio Holdings, Inc. and Agappe Diagnostics Ltd announced a CDMO partnership for the manufacturing of cartridge-based CLIA system reagents for the immunology equipment Mispa i60 and Mispa i121. Under this agreement, the analyzers and reagents will be sold under Agappe’s brand, making it the first Indian company to offer a complete locally manufactured chemiluminescence solution.
• In March 2024, Sysmex Corporation launched six new assay kits for gynecological and gonadal hormone immunoassay panels in Japan. These include the HISCL LH, FSH, Prolactin, Estradiol, Progesterone, and Testosterone Assay Kits. The expansion of testing parameters for the HISCL-Series (HISCL-5000/HISCL-800) enhances the system’s capability to meet diverse laboratory needs.

Facts and Figures

• Disease Prevalence: Over 10 million cancer-related deaths were reported globally in 2022, driving demand for oncology-related immunoassay tests.
• Diagnostic Testing Growth: More than 70% of medical decisions are influenced by laboratory test results, with immunoassays playing a crucial role in disease detection and monitoring.
• Automation Impact: Automated immunoassay systems can process up to 400- 600 tests per hour, significantly improving laboratory efficiency and reducing turnaround time.

Key Developments

• In July 2024, Beckman Coulter Diagnostics introduced the DxC 500i Clinical Analyzer, an integrated clinical chemistry and immunoassay analyzer. Designed to support networked laboratory models, it enhances efficiency for both core and satellite laboratories. Utilizing Beckman Coulter’s common reagents, it ensures commutable patient results, improving patient care and inventory management.
• In July 2024, Wondfo Biotech held a New Product Launch Event, showcasing its latest innovations, including the fully automatic chemiluminescence immunoassay analyzer FC-2100, the fluorescence immunoassay analyzers Finecare™ FIA Meter X1 and X2, and the automatic blood gas analyzer Ucare-6000.
• In August 2024, Bio-Rad Laboratories introduced Specialty Immunoassay Plus (SPIA Plus), a consolidated liquid specialty IA control. Designed to enhance the precision of specialty immunoassay testing, SPIA Plus is available in InteliQ and Liquichek configurations and includes key analytes such as Procalcitonin, IL-6, and Active Vitamin B12. It also features optimized Vitamin D ranges for VDSP-compliant assays and improved intact PTH stability to reduce QC waste.

Immunoassay Market Segmentation:

By Component: The Reagents and Kits segment is the leading driver in the immunoassay market. This segment is growing rapidly due to the critical role reagents and kits play in the effectiveness and reliability of immunoassay tests. Reagents, including antibodies and antigens, are essential for the detection and quantification of target molecules in biological samples. They are fundamental to the performance of various immunoassay techniques, such as enzyme-linked immunosorbent assays (ELISA), chemiluminescence immunoassays (CLIA), and radioimmunoassay’s (RIA). The increasing demand for these reagents and kits is primarily driven by the rising need for accurate and early diagnosis of chronic diseases such as cancer, diabetes, and cardiovascular disorders, which require frequent testing. Additionally, the growing prevalence of infectious diseases and the shift towards personalized medicine have further fuelled the demand for these products. Reagents and kits are widely used in clinical laboratories, hospitals, and research facilities, making them a cornerstone of the immunoassay market.

By Technology: Enzyme-Linked Immunosorbent Assay (ELISA) is the leading technology segment in the immunoassay market. ELISA has been the cornerstone of immunoassay testing due to its high sensitivity, versatility, and wide application across diagnostics, research, and monitoring. This technology involves using enzyme-linked antibodies to detect and quantify substances such as proteins, hormones, and pathogens in biological samples. ELISA's widespread use can be attributed to its ease of use, cost-effectiveness, and ability to handle a broad range of assays, including antigen and antibody detection.

The demand for ELISA-based tests is increasing, particularly in clinical diagnostics, where it is extensively used for disease detection, including HIV, cancer, and autoimmune disorders. Furthermore, the expansion of its applications into areas such as food safety testing, veterinary diagnostics, and environmental monitoring contributes significantly to the growth of the ELISA segment. The ability of ELISA to be adapted for high-throughput screening, coupled with advances in automation and miniaturization, is propelling its continued dominance in the market. With ongoing technological improvements aimed at enhancing assay sensitivity and reducing testing time, ELISA is expected to maintain its position as the leading technology in the immunoassay market, driving the growth of diagnostic testing worldwide.

By Test Type: Oncology is the leading test type segment in the immunoassay market. This segment has experienced significant growth due to the increasing global prevalence of cancer and the rising demand for early detection and monitoring tools. Immunoassays play a crucial role in oncology by detecting specific biomarkers related to various types of cancers, including prostate, breast, and colorectal cancers. Tests such as Free PSA (Prostate-Specific Antigen) and Total PSA are widely used for prostate cancer screening, while other cancer-related immunoassays are used for diagnostic purposes, assessing disease progression, and monitoring treatment efficacy. The demand for oncology immunoassays is driven by the increasing focus on personalized medicine, where targeted therapies are guided by the results of these biomarker-based tests.

In addition to the rise in cancer incidences, advancements in technology have improved the sensitivity and accuracy of oncology immunoassays, enabling the detection of biomarkers at earlier stages, which can significantly improve patient outcomes. This has further boosted the growth of the oncology segment in the immunoassay market. As healthcare systems around the world place greater emphasis on early diagnosis and preventative care, the oncology segment is expected to continue leading the market, with increasing investments in cancer research and diagnostic innovations.

By End-user: Private Hospitals lead the end-user segment in the immunoassay market. This segment is experiencing substantial growth due to the increasing demand for advanced diagnostic tools in private healthcare settings. Private hospitals often have access to cutting-edge technology and can invest in high-quality immunoassay systems, which are essential for the accurate and timely diagnosis of diseases such as cancer, cardiovascular conditions, and infectious diseases. The demand for immunoassays in private hospitals is driven by a higher volume of patients seeking specialized care, including personalized medicine, and the ability to perform a wide range of diagnostic tests in-house.

Moreover, private hospitals typically have faster turnaround times for test results, which enhances their ability to provide prompt treatment decisions, particularly for critically ill patients. The ability to offer a broad array of immunoassay-based diagnostic services also gives private hospitals a competitive edge, attracting more patients who seek timely and precise testing. This trend is further bolstered by the increasing focus on preventative healthcare and early disease detection, which private hospitals are well-positioned to support. As the demand for high-quality, rapid diagnostic solutions continues to rise, private hospitals are expected to maintain their dominant position in the immunoassay market, with continued investment in the latest testing technologies and expansion of services.