U.S. Immunoassay Market Size, Share, Trends, Industry Analysis Report, By Product (Reagents & Kits, Analyzers/Instruments, Software & Services); By Technology; By Specimen; By Application; By End User; By Country, Segment Forecast, 2024 - 2032

U.S. Immunoassay Market Size, Share, Trends, Industry Analysis Report, By Product (Reagents & Kits, Analyzers/Instruments, Software & Services); By Technology; By Specimen; By Application; By End User; By Country, Segment Forecast, 2024 - 2032



The U.S. immunoassay market size is expected to reach USD 12.53 billion by 2032, 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, Software & Services); By Technology; By Specimen; By Application; By End User; By Country, Segment Forecast, 2024-2032” gives a detailed insight into current market dynamics and provides analysis on future market growth.

The growing adoption of advanced technologies and the presence of cutting-edge healthcare infrastructure in the United States are significantly driving the development of immunoassays with advanced features. For instance, in May 2024, researchers at the University of Florida unveiled the development of a new method using CRISPR gene-editing technology to identify HPV in saliva or blood samples that can enhance earlier cervical cancer diagnosis.

The rising incidence of several diseases, primarily infectious diseases, including COVID-19, is driving the use of immunoassays to monitor macro-molecule concentrations and detect disease presence accurately. For instance, in April 2024, Beckman Coulter Diagnostics, a California-based manufacturing company, announced that it had expanded its DxI 9000 Immunoassay Analyzer product line and received a CE mark for hepatitis C and B virus tests, such as anti-HCV, Access HBsAg, and Access HBsAg confirmatory assays.

Furthermore, the increasing development of new immunoassays by the major players and rising investments in research activities are creating a favorable environment for the U.S. immunoassay market. For instance, in April 2024, Labcorp, a life science company, announced the launch of an initial commercially available blood biomarker test, glial fibrillary acidic protein, in the United States to detect neuro-degenerative health problems along with brain injuries.

The rising number of people suffering from chronic health conditions, particularly heart attacks, is prompting the government to enhance healthcare infrastructure availability and equip the required number of biomarkers in public healthcare settings. According to the Harris poll survey conducted on behalf of the American Heart Association in 2023, over 51% of the respondents in the United States are unaware of heart disease as a major cause of death.

This is encouraging firms to innovate effective disease diagnostic tests in the United States. For instance, in February 2023, Cardio Diagnostics, a US-based biotechnology company, unveiled an artificial intelligence-based blood test for the rapid detection of coronary artery disease.

U.S. Immunoassay Market Report Highlights

The reagents & kits segment is anticipated to witness the highest growth during the forecast period due to its convenience and the development of ready-to-use kits.

The enzyme immunoassays segment held the largest share in 2023, owing to its potential applications in clinical trials and healthcare settings.

Massachusetts will grow at a rapid pace over the study period, attributable to the increasing incidence of chronic health problems.

The global players include Abbott, Agilent Technologies, Becton, Dickinson and Company, Beckman Coulter, Bio-Rad Laboratories, DiaSorin, Ortho Clinical Diagnostics, Quidel Corporation, Sysmex America, Inc., and Thermo Fisher Scientific, Inc.

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

U.S. Immunoassay, Product Outlook (Revenue - USD Billion, 2019 - 2032)

Reagents & Kits

- ELISA Reagents & Kits

- Rapid Test Reagents & Kits

- ELISPOT Reagents & Kits

- Western Blot Reagents & Kits

- Other Reagents & Kits

Analyzers/Instruments

- Open Ended Systems

- Closed Ended Systems

Software & Services

U.S. Immunoassay, Technology Outlook (Revenue - USD Billion, 2019 - 2032)

Radioimmunoassay (RIA)

Enzyme Immunoassays (EIA)

- Chemiluminescence Immunoassays (CLIA)

- Fluorescence Immunoassays (FIA)

Rapid Test

Others

U.S. Immunoassay, Specimen Outlook (Revenue - USD Billion, 2019 - 2032)

Blood

Saliva

Urine

Other Specimens

U.S. Immunoassay, Application Outlook (Revenue - USD Billion, 2019 - 2032)

Therapeutic Drug Monitoring

Oncology

Cardiology

Endocrinology

Infectious Disease Testing

Autoimmune Diseases

Others

U.S. Immunoassay, End User Outlook (Revenue - USD Billion, 2019 - 2032)

Hospitals

Blood Banks

Clinical Laboratories

Pharmaceutical and Biotech Companies

Academic Research Centers

Others


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 Mining
3.2. Data Sources
3.2.1. Primary Sources
3.2.2. Secondary Sources
4. U.S. Immunoassay Insights
4.1. U.S. Immunoassay – Application Snapshot
4.2. U.S. Immunoassay Dynamics
4.2.1. Drivers and Opportunities
4.2.1.1. The Rising Prevalence of Chronic Health Conditions
4.2.1.2. Increasing Healthcare Expenditure in the United States
4.2.2. Restraints and Challenges
4.2.2.1. High Costs of Investment are Likely to Impede Market Growth
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 Application Trends
4.6. Value Chain Analysis
4.7. COVID-19 Impact Analysis
5. U.S. Immunoassay, by Product
5.1. Key Findings
5.2. Introduction
5.2.1. U.S. Immunoassay, by Product, 2019-2032 (USD Billion)
5.3. Reagents & Kits
5.3.1. U.S. Immunoassay, by Reagents & Kits, 2019-2032 (USD Billion)
5.3.2. ELISA Reagents & Kits
5.3.2.1. U.S. Immunoassay, by ELISA Reagents & Kits, 2019-2032 (USD Billion)
5.3.3. Rapid Test Reagents & Kits
5.3.3.1. U.S. Immunoassay, by Rapid Test Reagents & Kits, 2019-2032 (USD Billion)
5.3.4. ELISPOT Reagents & Kits
5.3.4.1. U.S. Immunoassay, by ELISPOT Reagents & Kits, 2019-2032 (USD Billion)
5.3.5. Western Blot Reagents & Kits
5.3.5.1. U.S. Immunoassay, by Western Blot Reagents & Kits, 2019-2032 (USD Billion)
5.3.6. Other Reagents & Kits
5.3.6.1. U.S. Immunoassay, by Other Reagents & Kits, 2019-2032 (USD Billion)
5.4. Analyzers/Instruments
5.4.1. U.S. Immunoassay, by Analyzers/Instruments, 2019-2032 (USD Billion)
5.4.2. Open Ended Systems
5.4.2.1. U.S. Immunoassay, by Open Ended Systems, 2019-2032 (USD Billion)
5.4.3. Closed Ended Systems
5.4.3.1. U.S. Immunoassay, by Closed Ended Systems, 2019-2032 (USD Billion)
5.5. Software & Services
5.5.1. U.S. Immunoassay, by Software & Services, 2019-2032 (USD Billion)
6. U.S. Immunoassay, by Technology
6.1. Key Findings
6.2. Introduction
6.2.1. U.S. Immunoassay, by Technology, 2019-2032 (USD Billion)
6.3. Radioimmunoassay (RIA)
6.3.1. U.S. Immunoassay, by Radioimmunoassay (RIA), 2019-2032 (USD Billion)
6.4. Enzyme Immunoassays (EIA)
6.4.1. U.S. Immunoassay, by Enzyme Immunoassays (EIA), 2019-2032 (USD Billion)
6.4.2. Chemiluminescence Immunoassays (CLIA)
6.4.2.1. U.S. Immunoassay, by Chemiluminescence Immunoassays (CLIA), 2019-2032 (USD Billion)
6.4.3. Fluorescence Immunoassays (FIA)
6.4.3.1. U.S. Immunoassay, by Fluorescence Immunoassays (FIA), 2019-2032 (USD Billion)
6.5. Rapid Test
6.5.1. U.S. Immunoassay, by Rapid Test, 2019-2032 (USD Billion)
6.6. Others
6.6.1. U.S. Immunoassay, by Others, 2019-2032 (USD Billion)
7. U.S. Immunoassay, by Specimen
7.1. Key Findings
7.2. Introduction
7.2.1. U.S. Immunoassay, by Specimen, 2019-2032 (USD Billion)
7.3. Blood
7.3.1. U.S. Immunoassay, by Blood, 2019-2032 (USD Billion)
7.4. Saliva
7.4.1. U.S. Immunoassay, by Saliva, 2019-2032 (USD Billion)
7.5. Urine
7.5.1. U.S. Immunoassay, by Urine, 2019-2032 (USD Billion)
7.6. Other Specimens
7.6.1. U.S. Immunoassay, by Other Specimens, 2019-2032 (USD Billion)
8. U.S. Immunoassay, by Application
8.1. Key Findings
8.2. Introduction
8.2.1. U.S. Immunoassay, by Application, 2019-2032 (USD Billion)
8.3. Therapeutic Drug
8.3.1. U.S. Immunoassay, by Therapeutic Drug, 2019-2032 (USD Billion)
8.4. Monitoring
8.4.1. U.S. Immunoassay, by Monitoring, 2019-2032 (USD Billion)
8.5. Oncology
8.5.1. U.S. Immunoassay, by Oncology, 2019-2032 (USD Billion)
8.6. Cardiology
8.6.1. U.S. Immunoassay, by Cardiology, 2019-2032 (USD Billion)
8.7. Endocrinology
8.7.1. U.S. Immunoassay, by Endocrinology, 2019-2032 (USD Billion)
8.8. Infectious Disease Testing
8.8.1. U.S. Immunoassay, by Infectious Disease Testing, 2019-2032 (USD Billion)
8.9. Autoimmune Diseases
8.9.1. U.S. Immunoassay, by Autoimmune Diseases, 2019-2032 (USD Billion)
8.10. Others
8.10.1. U.S. Immunoassay, by Others, 2019-2032 (USD Billion)
9. U.S. Immunoassay, by End-User
9.1. Key Findings
9.2. Introduction
9.2.1. U.S. Immunoassay, by End-User, 2019-2032 (USD Billion)
9.3. Hospitals
9.3.1. U.S. Immunoassay, by Hospitals, 2019-2032 (USD Billion)
9.4. Blood Banks
9.4.1. U.S. Immunoassay, by Blood Banks, 2019-2032 (USD Billion)
9.5. Clinical Laboratories
9.5.1. U.S. Immunoassay, by Clinical Laboratories, 2019-2032 (USD Billion)
9.6. Pharmaceutical and Biotech Companies
9.6.1. U.S. Immunoassay, by Pharmaceutical and Biotech Companies, 2019-2032 (USD Billion)
9.7. Academic Research Centers
9.7.1. U.S. Immunoassay, by Academic Research Centers, 2019-2032 (USD Billion)
9.8. Others
9.8.1. U.S. Immunoassay, by Others, 2019-2032 (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
11.2.1. Company Overview
11.2.2. Financial Performance
11.2.3. Product Benchmarking
11.2.4. Recent Development
11.3. Becton, Dickinson, and Company
11.3.1. Company Overview
11.3.2. Financial Performance
11.3.3. Product Benchmarking
11.3.4. Recent Development
11.4. Beckman Coulter
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. DiaSorin S.p.A.
11.6.1. Company Overview
11.6.2. Financial Performance
11.6.3. Product Benchmarking
11.6.4. Recent Development
11.7. Ortho Clinical Diagnostics
11.7.1. Company Overview
11.7.2. Financial Performance
11.7.3. Product Benchmarking
11.7.4. Recent Development
11.8. Quidel Corporation
11.8.1. Company Overview
11.8.2. Financial Performance
11.8.3. Product Benchmarking
11.8.4. Recent Development
11.9. Sysmex America, Inc
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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