United States Immunoassay Market Size, Share, and COVID-19 Impact Analysis, By Product (Reagents & Kits, Analyzers/Instruments, and Software & Services), By Technology (RIA, EIA, Rapid Test, and Others), and United States Immunoassay Market Insights, Industry Trend, Forecasts to 2035

United States Immunoassay Market Insights Forecasts to 2035

• The US Immunoassay Market Size Was Estimated at USD 1237.7 Million in 2024
• The Market Size is Expected to Grow at a CAGR of around 4.69% from 2025 to 2035
• The US Immunoassay Market Size is Expected to Reach USD 2048.1 Million by 2035

According to a research report published by Spherical Insights & Consulting, the United States Immunoassay Market is anticipated to reach USD 2048.1 million by 2035, growing at a CAGR of 4.69% from 2025 to 2035. The expansion of the United States immunoassay market is propelled by technological developments in immunoassay methods, a growing geriatric population, increased prevalence of infectious and chronic diseases, growing demand for early disease detection and diagnosis, and expanding use of immunoassay tests in clinical diagnostics and research labs.

Market Overview

An immunoassay is an analytical technique that uses the specific binding between antibodies and antigens to identify or quantify target substances. Continuous advancements in immunoassay technology have significantly enhanced their multiplexing capabilities, speed, and overall performance. By making immunoassays more effective and affordable, innovations such as automated platforms, high-throughput systems, and improved assay sensitivity are driving market growth. The increasing demand for immunoassays in the US healthcare sector is largely fueled by the rising rates of chronic diseases and a deeper understanding of the importance of early disease detection and diagnosis. Another key factor contributing to the market's growth is the increasing elderly population. Older adults are more likely to suffer from chronic conditions like diabetes, heart disease, and cancer, leading to a heightened need for early diagnosis and detection. Additionally, due to their complex medical histories and multiple comorbidities, older individuals may require more frequent diagnostic tests. Consequently, hospitals and long-term care facilities are experiencing a greater demand for immunoassays.

The U.S. government actively supports the immunoassay diagnostic sector through coordinated funding, development, and regulatory initiatives involving agencies such as the FDA, NIH, and BARDA. The FDA offers thorough guidance that outlines the analytical validation, flex studies, design control, and labelling criteria required for immunoassay device clearance under both standard Class II device paths and CLIA-waived pathways through 510(k)/PMA submissions.

Report Coverage

This research report categorizes the market for the United States immunoassay market based on various segments and regions and forecasts revenue growth and analyses trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the United States immunoassay market. Recent market developments and competitive strategies such as expansion, product launch, development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the United States immunoassay market.

Driving Factors

The growth of the United States Immunoassay market is boosted by the rising number of chronic diseases like diabetes, heart disease, and cancer. Immunoassays play a crucial role in early diagnosis and monitoring, which is becoming increasingly important as the patient population grows. With strong support from organizations for better screening and diagnostic tests, the immunoassay market is set for significant growth.

Restraining Factors

The United States Immunoassay market faces obstacles, like the smaller labs and clinics are finding it tough to adopt these technologies due to the hefty investment needed for advanced immunoassay analyzers and reagentss, especially those that are automated, multiplex, or high-sensitivity.

Market Segmentation

The United States immunoassay market share is classified into product and technology.

• The reagents & kits segment held the largest market share in 2024 and is expected to grow at a remarkable CAGR during the forecast period.

The United States immunoassay market is segmented by product into reagents & kits, analyzers/instruments, and software & services. Among these, the reagents & kits segment held the largest market share in 2024 and is expected to grow at a remarkable CAGR during the forecast period. The segment is driven by the rising number of autoimmune and infectious diseases. Additionally, the introduction and approval of new immunoassay kits are expected to further boost this market.

• The EIA segment held the highest revenue share in 2024 and is expected to grow at a significant CAGR during the forecast period.

Based on the technology, the United States immunoassay market is segmented into RIA, EIA, rapid test, and others. Among these, the EIA segment held the highest revenue share in 2024 and is expected to grow at a significant CAGR during the forecast period. The segmental growth is propelled because this method is often utilized to diagnose food sensitivities, drug addiction, as well as infectious and chronic diseases. When compared to immunoelectrophoresis and immunodiffusion, it offers several benefits, such as a quicker experimental timeframe, quantifiable results, and a smaller number of antisera required for analysis.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the United States immunoassay market, along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborate analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Becton, Dickinson & Company
• Quidel Corporation
• Abbott
• Bio-Rad Laboratories, Inc.
• Danaher Corporation
• Thermo Fisher Scientific, Inc.
• Ortho-Clinical Diagnostics
• Siemens Healthineers
• Others

Recent Development

• In May 2023, Beckman Coulter Diagnostics announced the global launch of the DxI 9000 Access Immunoassay Analyzer, designed to address demands for quality, reliability, speed, reproducibility, and menu expansion.

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Market Segment

This study forecasts revenue at the United States, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the United States immunoassay market based on the following segments:

United States Immunoassay Market, By Product

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

United States Immunoassay Market, By Technology

• RIA
• EIA
• Rapid Test
• Others