United States Immunoassay Market

Market Overview:

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.

Immunoassay is a highly sensitive and specific laboratory technique used to measure the concentration of specific substances, often known as analytes, within biological samples, such as blood, urine, serum, or other bodily fluids. It comprises enzyme-linked immunosorbent assay (ELISA), radioimmunoassay (RIA), chemiluminescent immunoassay (CLIA), fluorescent immunoassay, and lateral flow immunoassay. It can detect specific biomarkers, antibodies, antigens, or proteins associated with diseases, such as human immunodeficiency viruses (HIV), cancer, diabetes, autoimmune disorders, and infectious diseases. It provides quantitative data and allows healthcare professionals to track changes in biomarker levels over time, assess treatment effectiveness, and adjust therapies accordingly. It ensures that patients receive the correct dosage within the therapeutic range and minimizes the risk of side effects or treatment failures. It detects and quantifies pollutants, toxins, and chemicals in environmental samples. It also helps assess water quality, soil contamination, and air pollution, contributing to environmental protection and public health. As it aids in enabling the early detection of diseases, the demand for immunoassay is rising in the United States.

United States Immunoassay Market Trends:

The escalating demand for immunoassays in the food and beverage (F&B) industry to detect contaminants, allergens, and pathogens and ensure the safety and quality of food products currently represents one of the major factors influencing the market positively in the United States. Additionally, the increasing employment of immunoassays in the pharmaceutical industry to evaluate the pharmacokinetics and pharmacodynamics of new drugs and ensure their safety and efficacy is impelling the growth of the market in the country. Apart from this, there is a rise in the need to detect target molecules at very low concentrations. This, coupled with the growing adoption of immunoassays to discover new biomarkers, study protein interactions, and investigate various biological processes, is offering a positive market outlook in the country. Moreover, the increasing demand for immunoassays in forensic science to detect drugs, toxins, and substances in biological samples collected as evidence in criminal investigations is bolstering the growth of the market. In line with this, advancements in immunoassay technologies, including automation, miniaturization, and multiplexing, enhance their performance and efficiency, which is strengthening the market growth in the US. Furthermore, the rising prevalence of chronic and infectious diseases among the masses is propelling the market growth. In addition, the increasing development of portable and easy-to-use immunoassay devices is contributing to the market growth in the country. The rising focus on personalized medicines among individuals is also providing lucrative growth opportunities to industry investors.

United States Immunoassay Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the country level for 2025-2033. Our report has categorized the market based on technology, product, application, and end use.

Technology Insights:

• Radioimmunoassay
• Enzyme Immunoassay
• Rapid Test
• Others
   

The report has provided a detailed breakup and analysis of the market based on the technology. This includes radioimmunoassay, enzyme immunoassay, rapid test, and others.

Product Insights:

• Reagents and Kits
• Analyzers/Instruments
• Software and Services
   

A detailed breakup and analysis of the market based on the product have also been provided in the report. This includes reagents and kits, analyzers/instruments, and software and services.

Application Insights:

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

The report has provided a detailed breakup and analysis of the market based on the application. This includes therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious disease testing, autoimmune diseases, and others.

End Use Insights:

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

A detailed breakup and analysis of the market based on the end use have also been provided in the report. This includes hospitals, blood banks, clinical laboratories, pharmaceutical and biotech companies, academic research centers, and others.

Regional Insights:

• Northeast 
• Midwest 
• South 
• West
   

The report has also provided a comprehensive analysis of all the major regional markets, which include Northeast, Midwest, South, and West.

Competitive Landscape:

The market research report has also provided a comprehensive analysis of the competitive landscape. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided.

United States Immunoassay Market Report Coverage:

Key Questions Answered in This Report:

• How has the United States immunoassay market performed so far and how will it perform in the coming years?
• What has been the impact of COVID-19 on the United States immunoassay market?
• What is the breakup of the United States immunoassay market on the basis of technology?
• What is the breakup of the United States immunoassay market on the basis of product?
• What is the breakup of the United States immunoassay market on the basis of application?
• What is the breakup of the United States immunoassay market on the basis of end use?
• What are the various stages in the value chain of the United States immunoassay market? 
• What are the key driving factors and challenges in the United States immunoassay?
• What is the structure of the United States immunoassay market and who are the key players?
• What is the degree of competition in the United States immunoassay market?

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the United States immunoassay market from 2019-2033.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the United States immunoassay market.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the United States immunoassay industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.