According to the latest report, the global Immunoassay market size was USD 28.19 billion in 2023, calculated at USD 29.26 billion in 2024 and is expected to reach around USD 40.93 billion by 2033, expanding at a CAGR of 3.80% from 2024 to 2033. North America dominate the Immunoassay market with a revenue share of 41.08% in 2023.
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Immunoassay Market, a Hemp for Clinical Trials
The worldwide market for goods and techniques associated with immunoassay testing is referred to as the “immunoassay market.” Specific chemicals, such as hormones, proteins, medications, or infectious agents, can be found and measured in a patient’s blood, serum, urine, or other body fluids using immunoassays, a type of biochemical test. Due to its high throughput, high sensitivity, and intrinsic specificity for the analysis of a wide range of analytes in biological samples, immunoassay methods are widely used in pharmaceutical analysis and have become important.
The immunoassay market is growing due to the growing population, especially the geriatric population, which is increasing the prevalence of chronic conditions. The continuous growth in healthcare, pharmaceuticals, biotechnology, and clinical trials is increasing the demand for immunoassays.
Immunoassay Market Key Takeaways
- The enzyme immunoassays (EIA) segment held the largest market share of 64.11% in 2023, owing to their repeated usage in the detection of infectious and chronic diseases, food allergies, and drug abuse, among other applications.
- The reagents and kits segment contributed to the largest share of 66.96% in 2023. A significant market share can be attributed to the increased demand for immunoassay reagents and diagnostic kits, owing to the rising prevalence of infectious and autoimmune diseases.
- Based on application, the infectious diseases testing segment held the largest market share of 36.89% in 2023 and is anticipated to grow at the fastest CAGR over the forecast period.
- The blood specimen segment held the largest share of 44.11% in 2023 attributed to an increase in disease occurrence, which drives demand for different blood testing procedures, supporting segment growth.
- Based on end-use, the hospitals segment dominated the market in 2023 with a revenue share of 33.11%. Hospitals and clinics are primary care settings for the diagnosis and treatment of medical conditions.
- North America generated the highest revenue in 2023 with a 41.08% revenue share. The rise in demand for diagnostics related to chronic diseases and the increase in availability of technologically advanced diagnostic techniques are expected to propel market growth over the forecast period.
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U.S. Immunoassay Market Size, Industry Report, 2033
The U.S. Immunoassay market size was estimated at USD 10.65 billion in 2023 and is projected to hit around USD 14.17 billion by 2033, growing at a CAGR of 2.90% during the forecast period from 2024 to 2033.
North America generated the highest revenue in 2023 with a 41.08% revenue share. The rise in demand for diagnostics related to chronic diseases and the increase in availability of technologically advanced diagnostic techniques are expected to propel market growth over the forecast period. Furthermore, in the U.S., there were 55.7 million people aged over 65 years in 2022 (~17% of the population in the country). Nearly 25% of this geriatric population suffers from cancer of which 30% are obese, creating an opportunity for local market players to boost their sales of diagnostic products for cancer, cardiology, endocrinology, infectious diseases, and other tests.
The Asia Pacific region is projected to witness the fastest CAGR over the forecast period. Unmet medical needs, positive economic growth, and increasing scientific research efforts are some of the primary growth drivers of the market. In addition, an improved healthcare regulatory environment in high-growth nations is anticipated to draw in more foreign investors and encourage them to take the opportunities. Positive developments, such as government healthcare benefits, raised public knowledge, and a willingness to pay for advanced medical care, are anticipated to further fuel the market growth.
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Rising Prevalence of Chronic Diseases: A Major Driver
The increasing prevalence of chronic diseases such as diabetes, cancer, and cardiovascular conditions is a significant driver for the immunoassay market. These diseases necessitate precise and early diagnostic tools, and immunoassays are known for their accuracy and sensitivity in detecting biomarkers associated with various conditions. As healthcare providers prioritize early detection and personalized treatment plans, the demand for immunoassay technologies continues to rise. This trend is further supported by advancements in biotechnology and an aging global population, which collectively propel the growth of the immunoassay market.
Personalized Medicine: Expanding Opportunity for the Market
The rise of personalized medicine presents a significant opportunity for the immunoassay market. Personalized medicine tailors’ medical treatment to the individual characteristics of each patient, and immunoassays are crucial in this approach. These diagnostic tests, known for their high specificity and sensitivity, can identify biomarkers that indicate how a patient might respond to specific therapies, enabling more effective and targeted treatments.
One key opportunity lies in the oncology field, where immunoassays can detect cancer biomarkers, allowing for early diagnosis and personalized treatment plans. With cancer treatments increasingly moving towards targeted therapies, the demand for precise diagnostic tools like immunoassays is set to rise. Additionally, the growing prevalence of chronic diseases such as diabetes and cardiovascular disorders further fuels the need for personalized diagnostic solutions.
Immunoassay Market Segmental Insights
- In 2023, the kit and reagent segment emerged as the dominant force in the immunoassay market, commanding the largest of the total market share. This substantial share underscores the critical role that these components play in the immunoassay ecosystem. Kits and reagents are fundamental to immunoassay testing, providing the necessary tools and substances required to perform various diagnostic assays.
- In 2023, the enzyme-linked immunosorbent assay (ELISA) segment dominated the immunoassay market. This prominence can be attributed to several key factors that underscore ELISA’s widespread adoption and continued relevance in diagnostic testing. ELISA is a well-established technique known for its reliability, sensitivity, and versatility in detecting and quantifying specific antigens or antibodies in a sample.
Recent Breakthroughs in the Immunoassay Market:
- In June 2024, the Indian Institute of Technique Kanpur (IIT-K) introduced an innovative technique called the “Lateral Flow Immunoassay Strip and Method for Detection of Mastitis in Bovines” with the goal of reducing the financial losses in the dairy industry caused by the disease. Indian Patent Office No. 455232 has been awarded to the technology.
- In March 2024, Enzo Life Sciences introduced the most sensitive IL-6 ELISA available on the market, the IL-6 (human) high-sensitivity ELISA kit, as its newest immunoassay. With Enzo’s new kit, IL-6 levels can be as low as 0.057 pg/mL. Furthermore, the kit provides a three-hour detection time with liquid, color-coded reagents that minimize error chances. Enzo has been producing immunoassays for 40 years, and they have excellent sensitivity, specificity, accuracy, and precision.
- In November 2023, Roche introduced the automated Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for the detection of hepatitis E virus (HEV) infections in nations that recognize the CE mark, including those in the European Union.
Top Companies in the Immunoassay Market and Recent Innovation
The global immunoassay market is fragmented with multiple small scale and large scale companies such as, Abbott Laboratories, Danaher Corporation (Beckman Coulter), Quidel Corporation, Ortho Clinical Diagnostics, Sysmex Corporation, Bio-Rad Laboratories, Inc., Becton,
diseases, cancer, cardiovascular diseases, and metabolic disorders. The system’s high throughput and precision have made it a preferred choice for clinical laboratories globally. Abbott’s continuous improvements to this platform ensure that it meets the evolving needs of healthcare providers and patients.
Recently, Bio-Rad has focused on expanding their portfolio of immunoassay products, addressing the growing need for accurate and reliable diagnostic tools. Their new offerings include advanced Dickinson, and Company, F. Hoffmann-La Roche AG, Thermo Fisher Scientific, Inc. and Siemens Healthinners.
One of Abbott’s flagship contributions is the ARCHITECT immunoassay system, which offers a comprehensive menu of tests that cover a wide range of medical conditions, including infectious assays for the detection of infectious diseases, cancer biomarkers, and autoimmune disorders. These assays leverage the latest in biomarker discovery and assay development, ensuring high sensitivity and specificity, which are crucial for early and accurate diagnosis.
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Immunoassay Market Top Key Companies:
- Abbott
- Siemens Healthineers
- Danaher Corporation (Beckman Coulter)
- bioMérieux SA
- Quidel Corporation
- Sysmex Corporation
- Ortho Clinical Diagnostics
- Bio-Rad Laboratories, Inc.
- F. Hoffmann-La Roche AG
- Becton, Dickinson, and Company
- Thermo Fisher Scientific, Inc.
Immunoassay Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Immunoassay market.
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
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
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