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U.S. Immunoassay Market Size, Share, Trends, & Industry Analysis Report By Product (Reagents & Kits, Analyzers/Instruments), By Technology, By Specimen, By Application, By End Use – Market Forecast, 2025–2034

Publisher Polaris Market Research & Consulting LLP
Published Aug 01, 2025
Length 129 Pages
SKU # PLRS20381474

Description

The U.S. Immunoassay Market size is expected to reach USD 18.49 billion by 2034, according to a new study by Polaris Market Research. The report “U.S. Immunoassay Market Share, Size, Trends, Industry Analysis Report By Product (Reagents & Kits, Analyzers/Instruments), By Technology, By Specimen, By Application, By End Use; Market Forecast, 2025–2034” gives a detailed insight into current market dynamics and provides analysis on future market growth.

Immunology is the branch of biomedical science concerned with the study of the immune system’s structure, function, and disorders. The U.S. immunology market is increasingly influenced by the rising burden of autoimmune and chronic inflammatory diseases, which has elevated the need for targeted immunotherapy drugs and biologics. This trend aligns with the broader healthcare focus on personalized medicine, as immunological insights enable more precise and individualized treatment strategies. Pharmaceutical and biotechnology companies are boosting their efforts to develop novel therapies that effectively modulate immune responses, driven by the growing scientific understanding of immune-related pathways, thereby fueling advancements across the market.

The continuous evolution of therapeutic monoclonal antibodies and biologics drives the U.S. immunology market growth. These biologics are rapidly becoming the standard of care for various immune-mediated conditions due to their high specificity and ability to target major immune regulators. Ongoing innovation in antibody engineering, including bispecific and antibody-drug conjugates, is expanding the scope of immunological treatments beyond traditional indications. Additionally, the development of next-generation immunotherapies is boosting strong interest in both academic and commercial research sectors, reinforcing the momentum of the immunology market.

U.S. Immunoassay Market Report Highlights

In terms of product, the reagents & kits segment accounted for USD 7.46 billion in 2024, fueled by consistent demand across clinical diagnostics and research labs due to their essential role in immunoassay workflows.

Based on technology, the rapid test segment is expected to register a CAGR of 4.2% during the forecast period, driven by the rising adoption of point-of-care testing for faster clinical decisions in emergency and primary care environment.

In terms of specimen, the blood specimen segment dominated with USD 6.76 billion in 2024, owing to its versatility in detecting diverse biomarkers and its status as the gold-standard sample for diagnostics.

Based on application, the cardiology segment is anticipated to expand rapidly during the forecast period due to the growing burden of cardiovascular diseases and increasing focus on preventive cardiac risk screening.

A few key players in the U.S. immunoassay market include Abbott; Agilent Technologies, Inc.; BD; Beckman Coulter, Inc.; Bio-Rad Laboratories, Inc.; DH Life Sciences, LLC.; Dynex Technologies, Inc.; Quanterix; QuidelOrtho Corporation; and Thermo Fisher Scientific Inc.

Polaris Market Research has segmented the U.S. immunoassay market report on the basis of product, technology, specimen, application, and end use:

By Product Outlook (Revenue, USD Billion, 2020–2034)

Reagents & Kits

ELISA Reagents & Kits

Rapid Test Reagents & Kits

Western Blot Reagents & Kits

ELISPOT Reagents & Kits

Other Reagents & Kits

Analyzers/Instruments

Open Ended Systems

Closed Ended Systems

Software & Services

By Technology Outlook (Revenue, USD Billion, 2020–2034)

Enzyme Immunoassays (EIA)

Chemiluminescence Immunoassays (CLIA)

Fluorescence Immunoassays (FIA)

Rapid Test

Radioimmunoassay (RIA)

Others

By Specimen Outlook (Revenue, USD Billion, 2020–2034)

Blood

Urine

Saliva

Others

By Application Outlook (Revenue, USD Billion, 2020–2034)

Infectious Disease Testing

Cardiology

Oncology

Endocrinology

Autoimmune Diseases

Therapeutic Drug Monitoring

Others

By End Use Outlook (Revenue, USD Billion, 2020–2034)

Hospitals

Laboratories

Others

Table of Contents

129 Pages
1. Introduction
1.1. Report Description
1.1.1. Objectives of the Study
1.1.2. Market Scope
1.1.3. Assumptions
1.2. Stakeholders
2. Executive Summary
2.1. Market Highlights
3. Research Methodology
3.1. Overview
3.1.1. Data Retail and E-Commerce
3.2. Data Sources
3.2.1. Primary Sources
3.2.2. Secondary Sources
4. U.S. Immunoassay Market Insights
4.1. U.S. Immunoassay Market – Material Snapshot
4.2. U.S. Immunoassay Market Dynamics
4.2.1. Drivers and Opportunities
4.2.1.1. Increasing Prevalence of Chronic and Infectious Diseases
4.2.1.2. Technological Advancements in Immunoassay Methods
4.2.2. Restraints and Challenges
4.2.2.1. Regulatory Challenges and Market Fragmentation
4.3. Porter’s Five Forces Analysis
4.3.1. Bargaining Power of Suppliers (Moderate)
4.3.2. Threats of New Entrants: (Low)
4.3.3. Bargaining Power of Buyers (Moderate)
4.3.4. Threat of Substitute (Moderate)
4.3.5. Rivalry among existing firms (High)
4.4. PESTEL Analysis
4.5. U.S. Immunoassay Market Material Trends
4.6. Value Chain Analysis
5. U.S. Immunoassay Market, by Product
5.1. Key Findings
5.2. Introduction
5.2.1. U.S. Immunoassay Market, by Product, 2020-2034 (USD Billion)
5.3. Reagents & Kits
5.3.1. U.S. Immunoassay Market, by Reagents & Kits, 2020–2034 (USD Billion)
5.3.2. ELISA Reagents & Kits
5.3.2.1. U.S. Immunoassay Market, by ELISA Reagents & Kits, 2020–2034 (USD Billion)
5.3.3. Rapid Test Reagents & Kits
5.3.3.1. U.S. Immunoassay Market, by Rapid Test Reagents & Kits, 2020–2034 (USD Billion)
5.3.4. Western Blot Reagents & Kits
5.3.5. U.S. Immunoassay Market, by Western Blot Reagents & Kits, 2020–2034 (USD Billion)
5.3.6. ELISPOT Reagents & Kits
5.3.6.1. U.S. Immunoassay Market, by ELISPOT Reagents & Kits, 2020–2034 (USD Billion)
5.3.7. Other Reagents & Kits
5.3.7.1. U.S. Immunoassay Market, by Other Reagents & Kits, 2020–2034 (USD Billion)
5.4. Analyzers/Instruments
5.4.1. U.S. Immunoassay Market, by Analyzers/ Instruments, 2020–2034 (USD Billion)
5.4.2. Open Ended Systems
5.4.2.1. U.S. Immunoassay Market, by Open Ended Systems, 2020–2034 (USD Billion)
5.4.3. Closed Ended Systems
5.4.3.1. U.S. Immunoassay Market, by Closed Ended Systems, 2020–2034 (USD Billion)
5.5. Software & Services
5.5.1. U.S. Immunoassay Market, by Software & Services, 2020–2034 (USD Billion)
6. U.S. Immunoassay Market, Technology
6.1. Key Findings
6.2. Introduction
6.2.1. U.S. Immunoassay Market, Technology, 2020-2034 (USD Billion)
6.3. Enzyme Immunoassays (EIA)
6.3.1. U.S. Immunoassay Market, by Enzyme Immunoassays (EIA), 2020–2034 (USD Billion)
6.3.2. Chemiluminescence Immunoassays (CLIA)
6.3.2.1. U.S. Immunoassay Market, by Chemiluminescence Immunoassays (CLIA), 2020–2034 (USD Billion)
6.3.3. Fluorescence Immunoassays (FIA)
6.3.3.1. U.S. Immunoassay Market, by Fluorescence Immunoassays (FIA), 2020–2034 (USD Billion)
6.4. Rapid Test
6.4.1. U.S. Immunoassay Market, by Rapid Test, 2020–2034 (USD Billion)
6.5. Radioimmunoassay (RIA)
6.5.1. U.S. Immunoassay Market, by Radioimmunoassay (RIA), 2020–2034 (USD Billion)
6.6. Others
6.6.1. U.S. Immunoassay Market, by Others, 2020–2034 (USD Billion)
7. U.S. Immunoassay Market, by Specimen
7.1. Key Findings
7.2. Introduction
7.2.1. U.S. Immunoassay Market, by Specimen, 2020-2034 (USD Billion)
7.3. Blood
7.3.1. U.S. Immunoassay Market, by Blood, 2020–2034 (USD Billion)
7.4. Urine
7.4.1. U.S. Immunoassay Market, by Urine, 2020–2034 (USD Billion)
7.5. Saliva
7.5.1. U.S. Immunoassay Market, by Saliva, 2020–2034 (USD Billion)
7.6. Others
7.6.1. U.S. Immunoassay Market, by Others, 2020–2034 (USD Billion)
8. U.S. Immunoassay Market, by Application
8.1. Key Findings
8.2. Introduction
8.2.1. U.S. Immunoassay Market, by Application, 2020-2034 (USD Billion)
8.3. Infectious Disease Testing
8.3.1. U.S. Immunoassay Market, by Infectious Disease Testing, 2020–2034 (USD Billion)
8.4. Cardiology
8.4.1. U.S. Immunoassay Market, by Cardiology, 2020–2034 (USD Billion)
8.5. Oncology
8.5.1. U.S. Immunoassay Market, by Oncology, 2020–2034 (USD Billion)
8.6. Endocrinology
8.6.1. U.S. Immunoassay Market, by Endocrinology, 2020–2034 (USD Billion)
8.7. Autoimmune Diseases
8.7.1. U.S. Immunoassay Market, by Autoimmune Diseases, 2020–2034 (USD Billion)
8.8. Therapeutic Drug Monitoring
8.8.1. U.S. Immunoassay Market, by Therapeutic Drug Monitoring, 2020–2034 (USD Billion)
8.9. Others
8.9.1. U.S. Immunoassay Market, by Others, 2020–2034 (USD Billion)
9. U.S. Immunoassay Market, by End Use
9.1. Key Findings
9.2. Introduction
9.2.1. U.S. Immunoassay Market, by End Use, 2020-2034 (USD Billion)
9.3. Hospitals
9.3.1. U.S. Immunoassay Market, by Hospitals, 2020-2034 (USD Billion)
9.4. Laboratories
9.4.1. U.S. Immunoassay Market, by Laboratories, 2020-2034 (USD Billion)
9.5. Others
9.5.1. U.S. Immunoassay Market, by Others, 2020-2034 (USD Billion)
10. Competitive Landscape
10.1. Expansion and Acquisition Analysis
10.1.1. Expansion
10.1.2. Acquisitions
10.2. Partnerships/Collaborations/Agreements/Exhibitions
11. Company Profiles
11.1. Abbott
11.1.1. Company Overview
11.1.2. Financial Performance
11.1.3. Product Benchmarking
11.1.4. Recent Development
11.2. Agilent Technologies, Inc.
11.2.1. Company Overview
11.2.2. Financial Performance
11.2.3. Product Benchmarking
11.2.4. Recent Development
11.3. BD
11.3.1. Company Overview
11.3.2. Financial Performance
11.3.3. Product Benchmarking
11.3.4. Recent Development
11.4. Beckman Coulter, Inc.
11.4.1. Company Overview
11.4.2. Financial Performance
11.4.3. Product Benchmarking
11.4.4. Recent Development
11.5. Bio-Rad Laboratories, Inc.
11.5.1. Company Overview
11.5.2. Financial Performance
11.5.3. Product Benchmarking
11.5.4. Recent Development
11.6. DH Life Sciences, LLC.
11.6.1. Company Overview
11.6.2. Financial Performance
11.6.3. Product Benchmarking
11.6.4. Recent Development
11.7. Dynex Technologies, Inc.
11.7.1. Company Overview
11.7.2. Financial Performance
11.7.3. Product Benchmarking
11.7.4. Recent Development
11.8. Quanterix
11.8.1. Company Overview
11.8.2. Financial Performance
11.8.3. Product Benchmarking
11.8.4. Recent Development
11.9. QuidelOrtho Corporation
11.9.1. Company Overview
11.9.2. Financial Performance
11.9.3. Product Benchmarking
11.9.4. Recent Development
11.10. Thermo Fisher Scientific Inc.
11.10.1. Company Overview
11.10.2. Financial Performance
11.10.3. Product Benchmarking
11.10.4. Recent Development

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