Market Overview
The United States immunoassay market size was valued at USD 7.7 Billion in 2024. It is expected to grow at a CAGR of 8% to reach USD 15.3 Billion by 2033. Factors driving this growth include the rising need to detect contaminants, allergens, and pathogens in food products, increased focus on personalized medicine, and the growing prevalence of chronic and infectious diseases. The market covers technologies such as radioimmunoassay, enzyme immunoassay, and rapid tests, with applications across therapeutic drug monitoring, oncology, and infectious disease testing.
Study Assumption Years
● Base Year: 2024
● Historical Year/Period: 2019-2024
● Forecast Year/Period: 2025-2033
United States Immunoassay Market Key Takeaways
● Current Market Size: USD 7.7 Billion (2024)
● CAGR: 8% (2025-2033)
● Forecast Period: 2025-2033
● The escalating demand for immunoassays in the food and beverage industry to detect contaminants, allergens, and pathogens ensures food safety and quality.
● Growing use in pharmaceutical industry for pharmacokinetics and pharmacodynamics evaluation of new drugs boosts market growth.
● Increasing need to detect target molecules at very low concentrations and discover new biomarkers supports positive outlook.
● Advancements in immunoassay technologies such as automation and multiplexing enhance performance and efficiency.
● Rising prevalence of chronic and infectious diseases propels market growth.
● Development of portable and easy-to-use immunoassay devices and focus on personalized medicine offer lucrative growth opportunities.
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Market Growth Factors
The expanding demand to test for contaminants, allergens, and pathogens in the food and beverage industry is a major driver for the US immunoassay market share. Given growing concerns for food safety and quality, the food and beverage industry is increasingly relying upon immunoassay techniques in testing various components. Immunoassays detect allergens and pathogens in food items or packaging. These substances could harm consumers.
Furthermore, the rapid adoption of immunoassays within the pharmaceutical industry to evaluate pharmacokinetics and pharmacodynamics of new drugs before their commercial launch is anticipated to drive the growth of the overall market. Immunoassays are used more to evaluate drugs during the drug development and regulatory approval process.
Further growth has been driven by being able to detect target molecules in low concentrations, using immunoassays for identifying novel biomarkers and conducting protein analysis, and applying more in the fields of health care and research. The continuing development in technology, including automation, miniaturization, multiplexing, and other improvements, is expected to drive future growth.
Chronic and infectious diseases increasingly prevail in the United States so this will increase demand for immunoassay technology, which provides quantitative information to diagnose disease early and to modify existing treatment. Portable and easy-to-use immunoassay devices see growing use, and access expands to different locations.
Immunoassays play an important role in the detection of biomarkers and the progress of personalized treatments as opportunities emerge for personalized medicine. Treatments are tailored based on a person's biomarker profile.
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Market Segmentation
Breakup by Technology:
● Radioimmunoassay: Includes methods using radioactive isotopes for detecting antigens and antibodies, offering high sensitivity and specificity.
● Enzyme Immunoassay: Utilizes enzyme-linked reactions to quantify target molecules, commonly applied in diagnostic labs.
● Rapid Test: Comprises quick, easy-to-use immunoassay formats suitable for point-of-care testing.
● Others: Encompasses other immunoassay technologies such as chemiluminescent, fluorescent, and lateral flow assays.
Breakup by Product:
● Reagents and Kits: Consists of chemical substances and assembled kits required to perform immunoassays.
● Analyzers/Instruments: Includes the hardware devices used for conducting immunoassays in clinical and research settings.
● Software and Services: Encompasses digital tools and support services facilitating immunoassay operation and data analysis.
Breakup by Application:
● Therapeutic Drug Monitoring: Use of immunoassays to track drug levels in patients to ensure optimal dosing.
● Oncology: Detection and monitoring of cancer biomarkers using immunoassay techniques.
● Cardiology: Application in identifying cardiovascular disease markers.
● Endocrinology: Use in measuring hormones related to endocrine disorders.
● Infectious Disease Testing: Detection of pathogens and infection markers.
● Autoimmune Diseases: Identification of antibodies related to autoimmune conditions.
● Others: Additional miscellaneous applications of immunoassay testing.
Breakup by End Use:
● Hospitals: Use of immunoassays for diagnostics and patient management in hospital settings.
● Blood Banks: Application in screening donated blood for pathogens and contaminants.
● Clinical Laboratories: Utilization in centralized labs for diverse diagnostic testing.
● Pharmaceutical and Biotech Companies: Use in drug research, development, and quality control.
● Academic Research Centers: Application in scientific research for biomarker discovery and validation.
● Others
Regional Insights
The report analyzes major US regional markets, including Northeast, Midwest, South, and West. Specific market shares or CAGR by region are not provided. The market encompasses these four regions comprehensively, reflecting widespread application and adoption across the United States.
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Key Players
Competitive Landscape
The competitive landscape of the industry has also been examined along with the profiles of the key players.
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