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U.S. Immunoassay Market Size, Share & Trends Analysis Report by Product (Reagent & Kits, Analyzers/Instruments), Technology (RIA, ELISA), Application, Specimen, End-use, Region, and Segment Forecasts, 2024-2030

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    Report

  • 70 Pages
  • May 2024
  • Region: United States
  • Grand View Research
  • ID: 5976460
Description Jump to:
The U.S. immunoassay market is anticipated to reach USD 12.25 billion by 2030 and is projected to grow at a CAGR of 2.8% from 2024 to 2030. The increasing incidence of chronic and infectious diseases and rising demand for early detection of diseases are the major factors contributing to the market growth. According to the International Agency for Research on Cancer, 19,292,789 cancer cases were reported in 2020 and are expected to reach 50,550,287 by 2025. Breast, lung, colorectum, prostate, and stomach are the most common cancers reported.

The rising geriatric population is a significant factor driving the market growth in the U.S. As more individuals reach retirement age and require medical care, the demand for diagnostic tests such as immunoassays is expected to rise. Furthermore, technological advancements such as automation, miniaturization, point-of-care testing devices, and advanced detection technologies are key drivers of the immunoassay market. These innovations have revolutionized immunoassay techniques, making them more efficient, reliable, and accessible for a wide range of applications in healthcare and research.

The growing adoption of immunoassay tests in clinical diagnostics and research laboratories has positively impacted the U.S. market by driving market expansion, fostering innovation in assay development, and improving patient outcomes through early and accurate diagnosis.

U.S. Immunoassay Market Report Highlights

  • Reagents & kits led the market with the largest revenue share of 65.82% in 2023 and are expected to grow at the fastest CAGR over the forecast period, owing to the increasing introduction and approval of innovative immunoassay kits
  • Based on application, the infectious diseases testing segment led the market with the largest revenue share of 29.55% in 2023, due to increasing demand for immunoassays for early detection of infectious diseases such as HIV, hepatitis, COVID-19, and others
  • Based on end-use, the hospital segments held the market with the largest revenue share of 33.01% in 2023. Hospitals are considered primary care facilities for the diagnosis of various diseases, which is driving segment growth
  • Based on specimen, the blood segment led the market with the largest revenue share of 43.19% in 2023, owing to the increasing incidence of diseases requiring these blood testing procedures and technological advancements in the segment
  • In July 2023, SEKISUI Diagnostics introduced the OSOM COVID-19 Antigen Home Test, made in the U.S. The test can be performed at home and is likely to help detect nucleocapsid protein antigen that results from the SARS-CoV-2 virus

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Segment Definitions
1.2.1. Product
1.2.2. Technology
1.2.3. Application
1.2.4. End-use
1.2.5. Specimen
1.2.6. Estimates and Forecasts Timeline
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased Database
1.4.2. Internal Database
1.4.3. Secondary Sources
1.4.4. Primary Research
1.5. Information or Data Analysis
1.5.1. Data Analysis Models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity Flow Analysis (Model 1)
1.7.2. Volume Price Analysis (Model 2)
1.8. List of Secondary Sources
1.9. List of Primary Sources
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.2.1. Product Outlook
2.2.2. Technology Outlook
2.2.3. Application Outlook
2.2.4. End-use Outlook
2.2.5. Specimen Outlook
2.3. Competitive Insights
Chapter 3. U.S. Immunoassay Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Related/ancillary Market Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.2. Market Restraint Analysis
3.3. U.S. Immunoassay Market Analysis Tools
3.3.1. Industry Analysis - Porter’s
3.3.1.1. Supplier Power
3.3.1.2. Buyer Power
3.3.1.3. Substitution Threat
3.3.1.4. Threat of New Entrant
3.3.1.5. Competitive Rivalry
3.3.2. PESTEL Analysis
3.3.2.1. Political Landscape
3.3.2.2. Economic Landscape
3.3.2.3. Social Landscape
3.3.2.4. Technological Landscape
3.3.2.5. Legal Landscape
3.3.2.6. Environmental Landscape
Chapter 4. U.S. Immunoassay Market: Product Estimates & Trend Analysis
4.1. Product Market Share, 2023 & 2030
4.2. Segment Dashboard
4.3. U.S. Immunoassay Market by Product Outlook
4.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the Following
4.4.1. Reagents & Kits
4.4.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
4.4.1.2. ELISA Reagents & Kits
4.4.1.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
4.4.1.3. Rapid Test Reagents & Kits
4.4.1.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
4.4.1.4. ELISPOT Reagents & Kits
4.4.1.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
4.4.1.5. Western Blot Reagents & Kits
4.4.1.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
4.4.1.6. Other Reagents & Kits
4.4.1.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
4.4.2. Analyzers/instruments
4.4.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
4.4.2.2. Open Ended Systems
4.4.2.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
4.4.2.3. Closed Ended Systems
4.4.2.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
4.4.3. Software & Services
4.4.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
Chapter 5. U.S. Immunoassay Market: Technology Estimates & Trend Analysis
5.1. Technology Market Share, 2023 & 2030
5.2. Segment Dashboard
5.3. U.S. Immunoassay Market by Technology Outlook
5.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the Following
5.4.1. Radioimmunoassay (RIA)
5.4.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
5.4.2. Enzyme Immunoassays (EIA)
5.4.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
5.4.2.2. Chemiluminescence Immunoassays (CLIA)
5.4.2.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
5.4.2.3. Fluorescence Immunoassays (FIA)
5.4.2.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
5.4.3. Rapid Test
5.4.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
5.4.4. Others
5.4.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
Chapter 6. U.S. Immunoassay Market: Application Estimates & Trend Analysis
6.1. Application Market Share, 2023 & 2030
6.2. Segment Dashboard
6.3. U.S. Immunoassay Market by Application Outlook
6.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the Following
6.4.1. Therapeutic Drug Monitoring
6.4.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
6.4.2. Oncology
6.4.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
6.4.3. Cardiology
6.4.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
6.4.4. Endocrinology
6.4.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
6.4.5. Infectious Disease Testing
6.4.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
6.4.6. Autoimmune Diseases
6.4.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
6.4.7. Others
6.4.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
Chapter 7. U.S. Immunoassay Market: End-use Estimates & Trend Analysis
7.1. End-use Market Share, 2023 & 2030
7.2. Segment Dashboard
7.3. U.S. Immunoassay Market by End-use Outlook
7.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the Following
7.4.1. Hospitals
7.4.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
7.4.2. Blood Banks
7.4.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
7.4.3. Clinical Laboratories
7.4.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
7.4.4. Pharmaceutical and Biotech Companies
7.4.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
7.4.5. Academic Research Centers
7.4.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
7.4.6. Others
7.4.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
Chapter 8. U.S. Immunoassay Market: Specimen Estimates & Trend Analysis
8.1. Specimen Market Share, 2023 & 2030
8.2. Segment Dashboard
8.3. U.S. Immunoassay Market by Specimen Outlook
8.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the Following
8.4.1. Blood
8.4.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
8.4.2. Saliva
8.4.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
8.4.3. Urine
8.4.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
8.4.4. Other Specimens
8.4.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
Chapter 9. U.S. Immunoassay Market: Region Estimates & Trend Analysis
9.1. Regional Market Share, 2023 & 2030
9.2. U.S. Immunoassay Market by Region Outlook
9.3. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the Following
9.3.1. West
9.3.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
9.3.2. Midwest
9.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
9.3.3. Northeast
9.3.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
9.3.4. Southwest
9.3.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
9.3.5. Southeast
9.3.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
Chapter 10. Competitive Landscape
10.1. Recent Developments & Impact Analysis, by Key Market Participants
10.2. Company/Competition Categorization
10.3. Vendor Landscape
10.3.1. List of Key Distributors and Channel Partners
10.3.2. Key Customers
10.3.3. Key Company Heat Map Analysis, 2023
10.4. Company Profiles
10.4.1. F. Hoffmann-La Roche AG
10.4.1.1. Company Overview
10.4.1.2. Financial Performance
10.4.1.3. Product Benchmarking
10.4.1.4. Strategic Initiatives
10.4.2. Abbott Laboratories
10.4.2.1. Company Overview
10.4.2.2. Financial Performance
10.4.2.3. Product Benchmarking
10.4.2.4. Strategic Initiatives
10.4.3. Siemens Healthineers
10.4.3.1. Company Overview
10.4.3.2. Financial Performance
10.4.3.3. Product Benchmarking
10.4.3.4. Strategic Initiatives
10.4.4. Danaher Corporation
10.4.4.1. Company Overview
10.4.4.2. Financial Performance
10.4.4.3. Product Benchmarking
10.4.4.4. Strategic Initiatives
10.4.5. Thermo Fisher Scientific
10.4.5.1. Company Overview
10.4.5.2. Financial Performance
10.4.5.3. Product Benchmarking
10.4.5.4. Strategic Initiatives
10.4.6. Bio-Rad Laboratories
10.4.6.1. Company Overview
10.4.6.2. Financial Performance
10.4.6.3. Product Benchmarking
10.4.6.4. Strategic Initiatives
10.4.7. Beckman Coulter (a Subsidiary of Danaher)
10.4.7.1. Company Overview
10.4.7.2. Financial Performance
10.4.7.3. Product Benchmarking
10.4.7.4. Strategic Initiatives
10.4.8. Sysmex Corporation
10.4.8.1. Company Overview
10.4.8.2. Financial Performance
10.4.8.3. Product Benchmarking
10.4.8.4. Strategic Initiatives
10.4.9. DiaSorin
10.4.9.1. Company Overview
10.4.9.2. Financial Performance
10.4.9.3. Product Benchmarking
10.4.9.4. Strategic Initiatives
10.4.10. Agilent Technologies
10.4.10.1. Company Overview
10.4.10.2. Financial Performance
10.4.10.3. Product Benchmarking
10.4.10.4. Strategic Initiatives
List of Tables
Table 1 List of Abbreviations
Table 2 U.S. Immunoassay Market, by Product, 2018-2030 (USD Million)
Table 3 U.S. Immunoassay Market, by Technology, 2018-2030 (USD Million)
Table 4 U.S. Immunoassay Market, by Application, 2018-2030 (USD Million)
Table 5 U.S. Immunoassay Market, by End Use, 2018-2030 (USD Million)
Table 6 U.S. Immunoassay Market, by Specimen, 2018-2030 (USD Million)
Table 7 U.S. Immunoassay Market, by Region, 2018-2030 (USD Million)
List of Figures
Figure 1 Market Research Process
Figure 2 Data Triangulation Techniques
Figure 3 Primary Research Pattern
Figure 4 Market Research Approaches
Figure 5 Value-chain-based Sizing & Forecasting
Figure 6 QFD Modeling for Market Share Assessment
Figure 7 Market Formulation & Validation
Figure 8 U.S. Immunoassay Market: Market Outlook
Figure 9 U.S. Immunoassay Competitive Insights
Figure 10 Parent Market Outlook
Figure 11 Related/ancillary Market Outlook
Figure 12 Penetration and Growth Prospect Mapping
Figure 13 U.S. Immunoassay Market Driver Impact
Figure 14 U.S. Immunoassay Market Restraint Impact
Figure 15 U.S. Immunoassay Market: Product Movement Analysis
Figure 16 U.S. Immunoassay Market: Product Outlook and Key Takeaways
Figure 17 Reagents & Kits Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 18 Elisa Reagents & Kits Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 19 Rapid Test Reagents & Kits Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 20 Elispot Reagents & Kits Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 21 Western Blot Reagents & Kits Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 22 Other Reagents & Kits Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 23 Analyzers/Instruments Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 24 Open Ended Systems Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 25 Closed Ended Systems Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 26 Software & Services Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 27 U.S. Immunoassay Market: Technology Movement Analysis
Figure 28 U.S. Immunoassay Market: Technology Outlook and Key Takeaways
Figure 29 Radioimmunoassay (RIA) Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 30 Enzyme Immunoassays (EIA) Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 31 Chemiluminescence Immunoassays (CLIA) Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 32 Fluorescence Immunoassays (FIA) Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 33 Rapid Test Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 34 Others Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 35 U.S. Immunoassay Market: Application Movement Analysis
Figure 36 U.S. Immunoassay Market: Application Outlook and Key Takeaways
Figure 37 Therapeutic Drug Monitoring Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 38 Oncology Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 39 Cardiology Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 40 Endocrinology Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 41 Infectious Disease Testing Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 42 Autoimmune Diseases Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 43 Others Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 44 U.S. Immunoassay Market: End-use Movement Analysis
Figure 45 U.S. Immunoassay Market: End-use Outlook and Key Takeaways
Figure 46 Hospitals Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 47 Blood Banks Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 48 Clinical Laboratories Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 49 Pharmaceutical and Biotech Companies Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 50 Academic Research Centers Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 51 Others Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 52 U.S. Immunoassay Market: Specimen Movement Analysis
Figure 53 U.S. Immunoassay Market: Specimen Outlook and Key Takeaways
Figure 54 Blood Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 55 Saliva Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 56 Urine Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 57 Other Specimens Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 58 U.S. Immunoassay Market: Regional Movement Analysis
Figure 59 U.S. Immunoassay Market: Regional Outlook and Key Takeaways
Figure 60 West Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 61 Midwest Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 62 Northeast Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 63 Southwest Market Estimates and Forecasts, 2018-2030 (USD Million)
Figure 64 Southeast Market Estimates and Forecasts, 2018-2030 (USD Million)

Companies Mentioned

  • F. Hoffmann-La Roche AG
  • Abbott Laboratories
  • Siemens Healthineers
  • Danaher Corporation
  • Thermo Fisher Scientific
  • Bio-Rad Laboratories
  • Beckman Coulter (a subsidiary of Danaher)
  • Sysmex Corporation
  • DiaSorin
  • Agilent Technologies

Methodology

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Table Information

Report AttributeDetails
No. of Pages70
PublishedMay 2024
Forecast Period2023 - 2030
Estimated Market Value ( USD ) in 2023 $ 10.31 Billion
Forecasted Market Value ( USD ) by 2030 $ 12.25 Billion
Compound Annual Growth Rate2.8%
Regions CoveredUnited States
No. of Companies Mentioned10

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About the Market

The Immunoassay market is a segment of the In Vitro Diagnostics (IVD) industry. Immunoassays are laboratory tests used to detect and measure the presence of antigens or antibodies in a sample. These tests are used to diagnose and monitor a variety of diseases, including cancer, autoimmune diseases, and infectious diseases. Immunoassays are also used to detect and measure hormones, drugs, and other substances in the body. Immunoassays are typically performed in a laboratory setting, but some tests are now available for use in point-of-care settings. Immunoassays are often used in combination with other tests to provide a more comprehensive diagnosis. The Immunoassay market is highly competitive, with a number of companies offering a wide range of products. Some of the major players in the market include Abbott Laboratories, Roche Diagnostics, Siemens Healthineers, Ortho Clinical Diagnostics, and bioMérieux. Show Less Read more

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