PUBLISHER: Polaris Market Research | PRODUCT CODE: 1807494
PUBLISHER: Polaris Market Research | PRODUCT CODE: 1807494
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
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
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
- 4.2.1. Drivers and Opportunities
- 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
List of Tables:
- Table 1 US: U.S. Immunoassay Market, By Product, 2020-2034 (USD Billion)
- Table 2 US: U.S. Immunoassay Market, Technology, 2020-2034 (USD Billion)
- Table 3 US: U.S. Immunoassay Market, By Specimen, 2020-2034 (USD Billion)
- Table 4 US: U.S. Immunoassay Market, By Application, 2020-2034 (USD Billion)
- Table 5 US: U.S. Immunoassay Market, by End Use, 2020-2034 (USD Billion)
List of Figures:
- Figure 1. U.S. Immunoassay Market, 2020-2034 (USD Billion)
- Figure 2. Integrated Ecosystem
- Figure 3. Research Methodology: Top-Down & Bottom-Up Price
- Figure 4. Porter's Five Forces
- Figure 5. Market By Product
- Figure 6. U.S. Immunoassay Market, By Product, 2024 & 2034 (USD Billion)
- Figure 7. Market Technology
- Figure 8. U.S. Immunoassay Market, Technology, 2024 & 2034 (USD Billion)
- Figure 9. Market By Specimen
- Figure 10. U.S. Immunoassay Market, By Specimen, 2024 & 2034 (USD Billion)
- Figure 11. Market By Application
- Figure 12. U.S. Immunoassay Market, By Application, 2024 & 2034 (USD Billion)
- Figure 13. Market by End Use
- Figure 14. U.S. Immunoassay Market, by End Use, 2024 & 2034 (USD Billion)
