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PUBLISHER: Polaris Market Research | PRODUCT CODE: 1786973

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PUBLISHER: Polaris Market Research | PRODUCT CODE: 1786973

US Biomarkers Market Size, Share, Trends, & Industry Analysis By Type,, By Research Area, By Technology, By Disease Indication, By Application, and By Country - Market Forecast, 2025-2034

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The U.S. biomarkers market size is expected to reach USD 106.03 Billion by 2034, according to a new study by Polaris Market Research. The report "US Biomarkers Market Size, Share, Trends, & Industry Analysis By Type, (Safety Biomarkers, Efficacy Biomarkers, and Validation Biomarkers), By Research Area, By Technology, By Disease Indication, By Application, and By Country - Market Forecast, 2025-2034" gives a detailed insight into current market dynamics and provides analysis on future market growth.

The U.S. biomarkers market continues to grow as the use expands across hospitals, laboratories, and research institutions nationwide. Biomarkers help identify and monitor a wide range of health conditions, making it easier for healthcare professionals to deliver accurate diagnoses and track treatment progress. These tools are commonly applied in areas such as cancer, cardiovascular disease, and neurological disorders.

Industry investments and broader adoption across healthcare systems made biomarker testing a regular part of clinical and research workflows. Improvements in testing technologies and greater awareness of the benefits are further accelerating the role of biomarkers in medical practice. The contribution of biomarkers to better health outcomes and informed decision-making is becoming increasingly valuable throughout the country.

U.S. Biomarkers Market Report Highlights

In terms of type, the efficacy US biomarkers segment is projected to reach at a significant share by 2034. This growth is driven by the expanded use of efficacy biomarkers to evaluate drug responses during clinical trials and track therapeutic performance in real-world applications.

Based on research area, the genomics segment held the leading market position in 2024, primarily due to its extensive application in detecting genetic variations, assessing disease susceptibility, and enabling precision medicine approaches across therapeutic areas.

In terms of technology, the next-generation sequencing technology is anticipated to experience the most rapid market expansion during the forecast period. This accelerated growth reflects NGS's unparalleled capacity for high-throughput genomic analysis, which facilitates comprehensive biomarker discovery

In terms of disease indication, the cancer segment dominated the market, in 2024. This is due to rising global cancer rates and growing reliance on biomarker-based diagnostics and targeted therapies.

In terms of application, the clinical diagnostics segment dominated the market in 2024. This is due to the growing adoption of biomarkers in routine diagnostics for cardiovascular, infectious, and oncology-related diseases.

A few global key market players include 23andMe, Inc., Abbott Laboratories, Agilent Technologies, Inc., Bio-Rad Laboratories, Inc., Charles River Laboratories International, Inc., Exact Sciences Corporation, Guardant Health, Inc., Hologic, Inc., Illumina, Inc., Johnson & Johnson Services, Inc., Laboratory Corporation of America Holdings, Meso Scale Diagnostics, LLC, PerkinElmer, Inc. (Revvity, Inc.), Quest Diagnostics Incorporated, and Thermo Fisher Scientific, Inc.

Polaris Market Research has segmented the market report on the basis of type, research area, technology, disease indication, application, and country:

By Type Outlook (Revenue, USD Billion, 2020-2034)

Safety Biomarkers

Efficacy Biomarkers

Validation Biomarkers

By Research Area Outlook (Revenue, USD Billion, 2020-2034)

Genomics

Proteomics

Metabolomics

Other Research Areas

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

Immunoassays

Next-Generation Sequencing (NGS)

Polymerase Chain Reaction (PCR)

Mass Spectrometry

Chromatography

Other Technologies

By Disease Indication Outlook (Revenue, USD Billion, 2020-2034)

Cancer

Infectious Disease

Immunological Disorders

Neurological Disorders

Cardiovascular Disorders

Other Disease Indications

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

Clinical Diagnostics

Drug Discovery & Development

Personalized Medicine

Clinical Research

Other Application

Product Code: PM5964

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 Mining
  • 3.2. Data Sources
    • 3.2.1. Primary Sources
    • 3.2.2. Secondary Sources

4. US Biomarkers Market Insights

  • 4.1. US Biomarkers Market - Market Snapshot
  • 4.2. US Biomarkers Market Dynamics
    • 4.2.1. Drivers and Opportunities
      • 4.2.1.1. Rising Cancer Incidence and Chronic Disease Burden
      • 4.2.1.2. Robust Government Support and Regulatory Framework
    • 4.2.2. Restraints and Challenges
      • 4.2.2.1. High Cost of Biomarker Validation and Development
      • 4.2.2.2. Regulatory Uncertainty and Lengthy Approval Processes
  • 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. US Biomarkers Market Trends
  • 4.6. Value Chain Analysis

5. US Biomarkers Market, by Type

  • 5.1. Key Findings
  • 5.2. Introduction
    • 5.2.1. US Biomarkers Market, by Type, 2020-2034 (USD Billion)
  • 5.3. Safety US Biomarkers
    • 5.3.1. US Biomarkers Market, by Safety US Biomarkers, by Country, 2020-2034 (USD Billion)
  • 5.4. Efficacy US Biomarkers
      • 5.4.1.1. US Biomarkers Market, by Efficacy US Biomarkers, by Country, 2020-2034 (USD Billion)
    • 5.4.2. US Biomarkers Market, by Type, 2020-2034 (USD Billion)
  • 5.5. Validation US Biomarkers
    • 5.5.1. US Biomarkers Market, by Validation US Biomarkers, by Country, 2020-2034 (USD Billion)

6. US Biomarkers Market, by Research Area

  • 6.1. Key Findings
  • 6.2. Introduction
    • 6.2.1. US Biomarkers Market, by Research Area, 2020-2034 (USD Billion)
  • 6.3. Genomics
    • 6.3.1. US Biomarkers Market, by Genomics, by Country, 2020-2034 (USD Billion)
  • 6.4. Proteomics
    • 6.4.1. US Biomarkers Market, by Proteomics, by Country, 2020-2034 (USD Billion)
  • 6.5. Metabolomics
    • 6.5.1. US Biomarkers Market, by Metabolomics, by Country, 2020-2034 (USD Billion)
  • 6.6. Other Research Areas
    • 6.6.1. US Biomarkers Market, by Other Research Areas, by Country, 2020-2034 (USD Billion)

7. US Biomarkers Market, by Technology

  • 7.1. Key Findings
  • 7.2. Introduction
    • 7.2.1. US Biomarkers Market, by Technology, 2020-2034 (USD Billion)
  • 7.3. Immunoassays
    • 7.3.1. US Biomarkers Market, by Immunoassays, by Country, 2020-2034 (USD Billion)
  • 7.4. Next-Generation Sequencing (NGS)
    • 7.4.1. US Biomarkers Market, by Next-Generation Sequencing (NGS), by Country, 2020-2034 (USD Billion)
  • 7.5. Polymerase Chain Reaction (PCR)
    • 7.5.1. US Biomarkers Market, by Polymerase Chain Reaction (PCR), by Country, 2020-2034 (USD Billion)
  • 7.6. Mass Spectrometry
    • 7.6.1. US Biomarkers Market, by Mass Spectrometry, by Country, 2020-2034 (USD Billion)
  • 7.7. Chromatography
    • 7.7.1. US Biomarkers Market, by Chromatography, by Country, 2020-2034 (USD Billion)
  • 7.8. Other Technologies
    • 7.8.1. US Biomarkers Market, by Other Technologies, by Country, 2020-2034 (USD Billion)

8. US Biomarkers Market, by Disease Indication

  • 8.1. Key Findings
  • 8.2. Introduction
    • 8.2.1. US Biomarkers Market, by Disease Indication, 2020-2034 (USD Billion)
  • 8.3. Cancer
    • 8.3.1. US Biomarkers Market, by Cancer, by Country, 2020-2034 (USD Billion)
  • 8.4. Infectious Disease
    • 8.4.1. US Biomarkers Market, by Infectious Disease, by Country, 2020-2034 (USD Billion)
  • 8.5. Immunological Disorders
    • 8.5.1. US Biomarkers Market, by Immunological Disorders, by Country, 2020-2034 (USD Billion)
  • 8.6. Government & Public Sector
    • 8.6.1. US Biomarkers Market, by Government & Public Sector, by Country, 2020-2034 (USD Billion)
  • 8.7. Neurological Disorders
    • 8.7.1. US Biomarkers Market, by Neurological Disorders, by Country, 2020-2034 (USD Billion)
  • 8.8. Cardiovascular Disorders
    • 8.8.1. US Biomarkers Market, by Cardiovascular Disorders, by Country, 2020-2034 (USD Billion)
  • 8.9. Other Disease Indications
    • 8.9.1. US Biomarkers Market, by Other Disease Indications, by Country, 2020-2034 (USD Billion)

9. US Biomarkers Market, by Application

  • 9.1. Key Findings
  • 9.2. Introduction
    • 9.2.1. US Biomarkers Market, by Application, 2020-2034 (USD Billion)
  • 9.3. Clinical Diagnostics
    • 9.3.1. US Biomarkers Market, by Clinical Diagnostics, by Country, 2020-2034 (USD Billion)
  • 9.4. Drug Discovery & Development
    • 9.4.1. US Biomarkers Market, by Drug Discovery & Development, by Country, 2020-2034 (USD Billion)
  • 9.5. Personalized Medicine
    • 9.5.1. US Biomarkers Market, by Personalized Medicine, by Country, 2020-2034 (USD Billion)
  • 9.6. Clinical Research
    • 9.6.1. US Biomarkers Market, by Clinical Research, by Country, 2020-2034 (USD Billion)
  • 9.7. Other Application
    • 9.7.1. US Biomarkers Market, by Other Application, by Country, 2020-2034 (USD Billion)

10. US Biomarkers Market, by Country

  • 10.1. Key Findings
  • 10.2. Introduction
    • 10.2.1. US Biomarkers Market Assessment, By Country, 2020-2034 (USD Billion)
  • 10.3. US Biomarkers Market
    • 10.3.1. US Biomarkers Market - US
      • 10.3.1.1. U.S.: Biomarkers Market, by Type, 2020-2034 (USD Billion)
      • 10.3.1.2. U.S.: Biomarkers Market, by Research Area, 2020-2034 (USD Billion)
      • 10.3.1.3. U.S.: Biomarkers Market, by Technology, 2020-2034 (USD Billion)
      • 10.3.1.4. U.S.: Biomarkers Market, by Disease Indication, 2020-2034 (USD Billion)
      • 10.3.1.5. U.S.: Biomarkers Market, by Application, 2020-2034 (USD Billion)

11. Competitive Landscape

  • 11.1. Expansion and Acquisition Analysis
    • 11.1.1. Expansion
    • 11.1.2. Acquisitions
  • 11.2. Partnerships/Collaborations/Agreements/Exhibitions

12. Company Profiles

  • 12.1. 23andMe, Inc.
    • 12.1.1. Company Overview
    • 12.1.2. Financial Performance
    • 12.1.3. Product Benchmarking
    • 12.1.4. Recent Development
  • 12.2. Abbott Laboratories
    • 12.2.1. Company Overview
    • 12.2.2. Financial Performance
    • 12.2.3. Product Benchmarking
    • 12.2.4. Recent Development
  • 12.3. Agilent Technologies, Inc.
    • 12.3.1. Company Overview
    • 12.3.2. Financial Performance
    • 12.3.3. Product Benchmarking
    • 12.3.4. Recent Development
  • 12.4. Bio-Rad Laboratories, Inc.
    • 12.4.1. Company Overview
    • 12.4.2. Financial Performance
    • 12.4.3. Product Benchmarking
    • 12.4.4. Recent Development
  • 12.5. Charles River Laboratories International, Inc.
    • 12.5.1. Company Overview
    • 12.5.2. Financial Performance
    • 12.5.3. Product Benchmarking
    • 12.5.4. Recent Development
  • 12.6. Exact Sciences Corporation
    • 12.6.1. Company Overview
    • 12.6.2. Financial Performance
    • 12.6.3. Product Benchmarking
    • 12.6.4. Recent Development
  • 12.7. Guardant Health, Inc.
    • 12.7.1. Company Overview
    • 12.7.2. Financial Performance
    • 12.7.3. Product Benchmarking
    • 12.7.4. Recent Development
  • 12.8. Hologic, Inc.
    • 12.8.1. Company Overview
    • 12.8.2. Financial Performance
    • 12.8.3. Product Benchmarking
    • 12.8.4. Recent Development
  • 12.9. Illumina, Inc.
    • 12.9.1. Company Overview
    • 12.9.2. Financial Performance
    • 12.9.3. Product Benchmarking
    • 12.9.4. Recent Development
  • 12.10. Johnson & Johnson Services, Inc.
    • 12.10.1. Company Overview
    • 12.10.2. Financial Performance
    • 12.10.3. Product Benchmarking
    • 12.10.4. Recent Development
  • 12.11. Laboratory Corporation of America Holdings
    • 12.11.1. Company Overview
    • 12.11.2. Financial Performance
    • 12.11.3. Product Benchmarking
    • 12.11.4. Recent Development
  • 12.12. Meso Scale Diagnostics, LLC
    • 12.12.1. Company Overview
    • 12.12.2. Financial Performance
    • 12.12.3. Product Benchmarking
    • 12.12.4. Recent Development
Product Code: PM5964

List of Tables:

  • Table 1 US Biomarkers Market, by Type, 2020-2034 (USD Billion)
  • Table 2 US Biomarkers Market, by Research Area, 2020-2034 (USD Billion)
  • Table 3 US Biomarkers Market, by Technology, 2020-2034 (USD Billion)
  • Table 4 US Biomarkers Market, by Disease Indication, 2020-2034 (USD Billion)
  • Table 5 US Biomarkers Market, by Application, 2020-2034 (USD Billion)

List of Figures:

  • Figure 1. US Biomarkers Market, 2020-2034 (USD Billion)
  • Figure 2. Integrated Ecosystem
  • Figure 3. Research Methodology: Top-Down & Bottom-Up Price
  • Figure 4. Market by Country
  • Figure 5. Porter's Five Forces
  • Figure 6. Market by Type
  • Figure 7. US Biomarkers Market, by Type, 2024 & 2034 (USD Billion)
  • Figure 8. Market by Research Area
  • Figure 9. US Biomarkers Market, by Research Area, 2024 & 2034 (USD Billion)
  • Figure 10. Market by Technology
  • Figure 11. US Biomarkers Market, by Technology, 2024 & 2034 (USD Billion)
  • Figure 12. Market by Disease Indication
  • Figure 13. US Biomarkers Market, by Disease Indication, 2024 & 2034 (USD Billion)
  • Figure 14. Market by Application
  • Figure 15. US Biomarkers Market, by Application, 2024 & 2034 (USD Billion)
Have a question?
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Jeroen Van Heghe

Manager - EMEA

+32-2-535-7543

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Christine Sirois

Manager - Americas

+1-860-674-8796

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