United States Immunoassay Market to Reach USD 15.3 Billion by 2033, Growing at 8% CAGR

Base Year: 2024

Market Size in 2024: USD 7.7 Billion

Market Forecast in 2033: USD 15.3 Billion

Market Growth Rate (2025-2033): 8%

United States immunoassay market size reached USD 7.7 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 15.3 Billion by 2033, exhibiting a growth rate (CAGR) of 8% during 2025-2033. The growing need to detect contaminants, allergens, and pathogens and ensure the safety and quality of food products, rising focus on personalized medicines, and increasing prevalence of chronic and infectious diseases represent some of the key factors driving the market.

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United States Immunoassay Market Industry Trends and Drivers:

The U.S. immunoassay market is tremendously growing, enabled by a plethora of new diagnostic technology advancements, higher chronic and infectious disease prevalence, and increased demand for rapid and accurate testing solutions. Immunoassays are commonly used for the detection of biomarkers in clinical diagnostic labs and are witnessing innovations in automation and high-throughput screening methods for increased efficiency and reliability. On the other hand, the rising acceptance of point-of-care (POC) testing solutions offered sharp backup to the growth of the market in decentralized health care settings. Also, diverse strategic collaborations between companies specializing in diagnostics and research institutions are paving the way for the development of next-gen immunoassays that can better respond to the needs of healthcare providers and laboratories for improved sensitivity and specificity.

The widening applications of immunoassays in sectors such as clinical diagnostics, pharmaceuticals, and biotechnology, as well as food safety, continue to stimulate market demand in the United States. These assays find increasing applications in oncology and infectious disease detection and drug-monitoring therapies, thereby driving the market forward. Furthermore, the infusion of artificial intelligence (AI) and machine learning (ML) in immunoassay analysis is ensuring greater data accuracy and optimally enhancing workflow productivity for timely patient-management decisions. These developments have seen a subsequent rise in research and development (R&D) investments by leading players, aimed at the introduction of new immunoassay platforms, thereby intensifying the competition in the market. The support extended by governments for early disease detection and personalized medicine is also equally important to developing the right market dynamics to boost the growth and commercialization of advanced immunodiagnostic solutions.

Growing personalized medicine has fueled market growth, as this serves the need for biomarker-based immunoassays tailored to profiles of individual patients. The large-scale adoption of multiplex immunoassays for the simultaneous detection of multiple biomarkers is optimizing diagnostic workflows and decreasing operational costs in clinical laboratories. In addition, increased availability of automated immunoassay analyzers is enhancing throughput capabilities to meet the growing demand for high-volume diagnostic testing. The evolution of regulatory systems that provide for assay standardization and quality control will promote confidence and speed up penetration in the market. Following the advancement of healthcare dynamics in the United States, the immunoassay market would therefore sustain growth, thus availing more lucrative opportunities for industry stakeholders alongside contributing to the eventuality of precision diagnostics.

United States Immunoassay Market Industry Segmentation:

The report has segmented the market into the following categories:

Technology Insights:

Radioimmunoassay
Enzyme Immunoassay
Rapid Test
Others

Product Insights:

Reagents and Kits
Analyzers/Instruments
Software and Services

Application Insights:

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

End Use Insights:

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

Breakup by Region:

Northeast
Midwest
South
West

Competitive Landscape:

The competitive landscape of the industry has also been examined along with the profiles of the key players.

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Key highlights of the Report:

Market Performance (2019-2024)
Market Outlook (2025-2033)
COVID-19 Impact on the Market
Porter's Five Forces Analysis
Strategic Recommendations
Historical, Current and Future Market Trends
Market Drivers and Success Factors
SWOT Analysis
Structure of the Market
Value Chain Analysis
Comprehensive Mapping of the Competitive Landscape

Note: If you need specific information that is not currently within the scope of the report, we can provide it to you as a part of the customization.

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About Us:

IMARC Group is a global management consulting firm that helps the world's most ambitious changemakers to create a lasting impact. They provide a comprehensive suite of market entry and expansion services. IMARC offerings include thorough market assessment, feasibility studies, incorporation assistance, factory setup support, regulatory approvals and licensing navigation, branding, marketing and sales strategies, competitive landscape and benchmarking analyses, pricing and cost research, and procurement research.

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