세계의 유전체 바이오마커 시장(2025-2035년)

Genomic Biomarker Market Size, Share & Trends Analysis Report by Type (Predictive Biomarkers, and Prognostic Biomarkers) by Disease Indication (Oncology, Cardiovascular Diseases, Neurological Diseases, Renal Disorders, and Others), and by End-User (Diagnostic and Research Laboratories, Hospitals, and Others) Forecast Period (2025-2035)

Industry Overview

Genomic biomarker market was valued at $8.4 billion in 2024 and is projected to reach $41.7 billion by 2035, growing at a CAGR of 15.8% during the forecast period (2025-2035). Genomic biomarkers are DNA and RNA traits used as diagnostic indicators, disease characterization, and therapy selection tools. The body's response to treatment, as well as pathological and physiological processes, is represented by genomic biomarkers. Testing for genomic biomarkers can find molecular changes in a single gene, a group of genes, or a whole genome. A relationship between a genetic biomarker and the likelihood of developing a disease may or may not have strong supporting data. Functional laboratory evaluations and genetic epidemiology evidence are two variables that contribute to the clinical validity and usability of genomic biomarkers. The growing innovation in the healthcare industry by using novel medicines, increasing research & development programs to diagnose chronic diseases, and growing proliferation of minimally invasive procedures are positively influencing the genomic biomarkers market. In addition, the rising focus on the availability of personalized medicines for enabling better patient care, along with favorable government initiatives relating to genomic research, is additionally augmenting the growth of the global market.

Market Dynamics

Clinical Demand from Precision Oncology and Targeted Therapies

The largest immediate growth engine is oncology: as more targeted drugs and immunotherapies require genomic stratification, both predictive and prognostic biomarkers are embedded into standard-of-care pathways and clinical trials. Companion diagnostic requirements and payer-backed indications for molecular tests push hospitals and reference labs to adopt standardized genomic panels and reporting workflows, increasing test volumes and market revenues.

Technology Advances That Lower Cost and Expand Utility (NGS, CTDNA, Single-Cell, Bioinformatics)

Ongoing declines in sequencing costs, improvements in throughput (NGS platforms), and maturation of liquid-biopsy assays (ctDNA) reduce per-patient testing cost and make broader screening, monitoring, and minimal residual disease (MRD) applications commercially feasible. Better bioinformatics, variant interpretation platforms, and cloud-based reporting tools also raise the clinical utility of genomic biomarkers, accelerating uptake across hospitals and labs.

Regulatory, Reimbursement, and Pharma Partnerships Enabling Commercialization

Regulatory clarity for companion diagnostics, growing reimbursement coverage for high-value genomic tests, and strategic co-development deals between diagnostics firms and pharma (to support targeted therapy launches) materially improve commercial viability. These structural enables reduce payer uncertainty and create predictable revenue paths for both assay providers and profiling labs - while M&A accelerates capability scale.

Market Segmentation

• Based on the type, the market is segmented into predictive biomarkers and prognostic biomarkers.
• Based on the disease indication, the market is segmented into oncology, cardiovascular diseases, neurological diseases, renal disorders, and others.
• Based on the end-user, the market is segmented into diagnostic and research laboratories, hospitals, and others.

Oncology Largest Segment in the Global Genomic Biomarker Market

Oncology under the disease indication segment leads with the largest share. Cancer remains the single biggest therapeutic area where genomic biomarkers are integrated into clinical care, research, and drug development pipelines. Precision oncology relies extensively on genomic insights, with predictive and prognostic biomarkers guiding not only diagnosis but also therapeutic selection, risk assessment, and disease monitoring. The need to match patients with targeted therapies or immunotherapies has made oncology biomarker testing indispensable in both developed and emerging healthcare systems.

Predictive Biomarkers: A Key Segment in Market Growth

The predictive biomarkers segment by type is emerging as the fastest-growing area within the global genomic biomarker market. Predictive biomarkers are critical because they directly inform treatment response and therapeutic decision-making, making them indispensable for precision medicine. The rapid expansion of companion diagnostics, especially in oncology, neurology, and cardiovascular diseases, has created a strong pipeline for predictive biomarker adoption.

Pharmaceutical companies are increasingly integrating predictive biomarkers early in clinical development to improve the success rates of drug candidates and to design adaptive trials. Additionally, the growing acceptance of genomic testing by healthcare providers and patients, coupled with reimbursement improvements, is accelerating the adoption of predictive biomarkers globally. As new targeted drugs enter the market, predictive biomarker demand will likely outpace prognostic and other biomarker categories, making it the key driver of growth over the coming decade.

Regional Outlook

The global genomic biomarker industry is further divided by region, including North America (the US and Canada), Europe (the UK, Germany, France, Italy, Spain, Russia, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, Australia and New Zealand, ASEAN Countries, and the Rest of Asia-Pacific), and the Rest of the World (the Middle East & Africa, and Latin America).

North America Maintains Strong Market Position

North America holds a significant share of the global genomic biomarker market. The US dominates the global genomic biomarker market with the largest share, driven by its advanced healthcare infrastructure, strong presence of leading biotechnology and pharmaceutical companies, and high investment in precision medicine. The US benefits from being home to major industry leaders such as Illumina, Thermo Fisher Scientific, Roche's Foundation Medicine, Guardant Health, Myriad Genetics, and Tempus, which spearhead biomarker research, clinical diagnostics, and commercialization of genomic tests. Extensive adoption of genomic biomarkers in oncology, particularly in companion diagnostics for targeted therapies and immunotherapies, has cemented the country's leadership position.

Market Players Outlook

The major companies operating in the global genomic biomarker market include Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd., Illumina, QIAGEN, Thermo Fisher Scientific, among others. Market players are leveraging partnerships, collaborations, mergers, and acquisition strategies for business expansion and innovative product development to maintain their market positioning.

Recent Developments

• In March 2025, LuNGS Alliance launched free lung NGS biomarker testing for lung cancer patients in India, backed by AstraZeneca, Pfizer, and Roche. The initiative, backed by 4baseCare, aims to promote precision oncology as an accessible and affordable treatment plan. The test analyzes 72 mutated genes, identifying actionable biomarkers for personalized treatment plans.
• In August 2024, the FDA approved the TruSight Oncology TruSight Comprehensive test, which uses over 500 genes to profile solid tumors. This test can identify immuno-oncology biomarkers or clinically actionable biomarkers, enabling targeted therapy options or clinical trial enrollment. It is also approved for adult patients with solid tumors positive for NTRK gene fusions and NSCLC fusion-positive NSCLC.

The Report Covers:

• Market value data analysis of 2024 and forecast to 2035.
• Annualized market revenues ($ million) for each market segment.
• Country-wise analysis of major geographical regions.
• Key companies operating in the global genomic biomarker market. Based on the availability of data, information related to new products and relevant news is also available in the report.
• Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
• Analysis of market-entry and market expansion strategies.
• Competitive strategies by identifying 'who-stands-where' in the market.

Table of Contents

1. Report Summary

• Current Industry Analysis and Growth Potential Outlook
• Global Genomic Biomarker Market Sales Analysis - Type | Disease Indication | End-User ($ Million)
• Genomic Biomarker Market Sales Performance of Top Countries
• 1.1. Research Methodology
• Primary Research Approach
• Secondary Research Approach
• 1.2. Market Snapshot

2. Market Overview and Insights

• 2.1. Scope of the Study
• 2.2. Analyst Insight & Current Market Trends
  • 2.2.1. Key Genomic Biomarker Industry Trends
  • 2.2.2. Market Recommendations

3. Market Determinants

• 3.1. Market Drivers
  • 3.1.1. Drivers For Global Genomic Biomarker Market: Impact Analysis
• 3.2. Market Pain Points and Challenges
  • 3.2.1. Restraints For Global Genomic Biomarker Market: Impact Analysis
• 3.3. Market Opportunities
  • 3.3.1. Opportunities For Global Genomic Biomarker Market: Impact Analysis

4. Competitive Landscape

• 4.1. Competitive Dashboard - Genomic Biomarker Market Revenue and Share by Manufacturers
• Genomic Biomarker Product Comparison Analysis
• Top Market Player Ranking Matrix
• 4.2. Key Company Analysis
  • 4.2.1. Bio-Rad Laboratories, Inc.
    • 4.2.1.1. Overview
    • 4.2.1.2. Product Portfolio
    • 4.2.1.3. Financial Analysis (Subject to Data Availability)
    • 4.2.1.4. SWOT Analysis
    • 4.2.1.5. Business Strategy
  • 4.2.2. F. Hoffmann-La Roche Ltd.
    • 4.2.2.1. Overview
    • 4.2.2.2. Product Portfolio
    • 4.2.2.3. Financial Analysis (Subject to Data Availability)
    • 4.2.2.4. SWOT Analysis
    • 4.2.2.5. Business Strategy
  • 4.2.3. Illumina
    • 4.2.3.1. Overview
    • 4.2.3.2. Product Portfolio
    • 4.2.3.3. Financial Analysis (Subject to Data Availability)
    • 4.2.3.4. SWOT Analysis
    • 4.2.3.5. Business Strategy
  • 4.2.4. QIAGEN
    • 4.2.4.1. Overview
    • 4.2.4.2. Product Portfolio
    • 4.2.4.3. Financial Analysis (Subject to Data Availability)
    • 4.2.4.4. SWOT Analysis
    • 4.2.4.5. Business Strategy
  • 4.2.5. Thermo Fisher Scientific
    • 4.2.5.1. Overview
    • 4.2.5.2. Product Portfolio
    • 4.2.5.3. Financial Analysis (Subject to Data Availability)
    • 4.2.5.4. SWOT Analysis
    • 4.2.5.5. Business Strategy
• 4.3. Top Winning Strategies by Market Players
  • 4.3.1. Merger and Acquisition
  • 4.3.2. Product Launch
  • 4.3.3. Partnership And Collaboration

5. Global Genomic Biomarker Market Sales Analysis By Type ($ Million)

• 5.1. Predictive Biomarkers
• 5.2. Prognostic Biomarkers

6. Global Genomic Biomarker Market Sales Analysis By Disease Indication ($ Million)

• 6.1. Oncology
• 6.2. Cardiovascular Diseases
• 6.3. Neurological Diseases
• 6.4. Renal Disorders
• 6.5. Others

7. Global Genomic Biomarker Market Sales Analysis By End-User ($ Million)

• 7.1. Diagnostic and Research Laboratories
• 7.2. Hospitals
• 7.3. Others

8. Regional Analysis

• 8.1. North American Genomic Biomarker Market Sales Analysis - Type | Disease Indication| Disease Indication| Technology | End-User ($ Million)
• Macroeconomic Factors for North America
  • 8.1.1. United States
  • 8.1.2. Canada
• 8.2. European Genomic Biomarker Market Sales Analysis - Type | Disease Indication| Disease Indication| Technology | End-User ($ Million)
• Macroeconomic Factors for Europe
  • 8.2.1. UK
  • 8.2.2. Germany
  • 8.2.3. Italy
  • 8.2.4. Spain
  • 8.2.5. France
  • 8.2.6. Russia
  • 8.2.7. Rest of Europe
• 8.3. Asia-Pacific Genomic Biomarker Market Sales Analysis - Type | Disease Indication | End-User ($ Million)
• Macroeconomic Factors for Asia-Pacific
  • 8.3.1. China
  • 8.3.2. Japan
  • 8.3.3. South Korea
  • 8.3.4. India
  • 8.3.5. Australia & New Zealand
  • 8.3.6. ASEAN Countries (Thailand, Indonesia, Vietnam, Singapore, And Other)
  • 8.3.7. Rest of Asia-Pacific
• 8.4. Rest of the World Genomic Biomarker Market Sales Analysis - Type | Disease Indication| Organization Size | Disease Indication | Technology | End-User ($ Million)
• Macroeconomic Factors for the Rest of the World
  • 8.4.1. Latin America
  • 8.4.2. Middle East and Africa

9. Company Profiles

• 9.1. Agilent Technologies
  • 9.1.1. Quick Facts
  • 9.1.2. Company Overview
  • 9.1.3. Product Portfolio
  • 9.1.4. Business Strategies
• 9.2. Almac Group
  • 9.2.1. Quick Facts
  • 9.2.2. Company Overview
  • 9.2.3. Product Portfolio
  • 9.2.4. Business Strategies
• 9.3. BGI Genomics
  • 9.3.1. Quick Facts
  • 9.3.2. Company Overview
  • 9.3.3. Product Portfolio
  • 9.3.4. Business Strategies
• 9.4. Bio-Rad Laboratories
  • 9.4.1. Quick Facts
  • 9.4.2. Company Overview
  • 9.4.3. Product Portfolio
  • 9.4.4. Business Strategies
• 9.5. Cancer Genetics, Inc. (CGI)
  • 9.5.1. Quick Facts
  • 9.5.2. Company Overview
  • 9.5.3. Product Portfolio
  • 9.5.4. Business Strategies
• 9.6. Caris Life Sciences
  • 9.6.1. Quick Facts
  • 9.6.2. Company Overview
  • 9.6.3. Product Portfolio
  • 9.6.4. Business Strategies
• 9.7. Danaher Corp.
  • 9.7.1. Quick Facts
  • 9.7.2. Company Overview
  • 9.7.3. Product Portfolio
  • 9.7.4. Business Strategies
• 9.8. Epigenomics AG
  • 9.8.1. Quick Facts
  • 9.8.2. Company Overview
  • 9.8.3. Product Portfolio
  • 9.8.4. Business Strategies
• 9.9. Eurofins Scientific
  • 9.9.1. Quick Facts
  • 9.9.2. Company Overview
  • 9.9.3. Product Portfolio
  • 9.9.4. Business Strategies
• 9.10. Exact Sciences
  • 9.10.1. Quick Facts
  • 9.10.2. Company Overview
  • 9.10.3. Product Portfolio
  • 9.10.4. Business Strategies
• 9.11. F. Hoffmann-La Roche
  • 9.11.1. Quick Facts
  • 9.11.2. Company Overview
  • 9.11.3. Product Portfolio
  • 9.11.4. Business Strategies
• 9.12. Guardant Health
  • 9.12.1. Quick Facts
  • 9.12.2. Company Overview
  • 9.12.3. Product Portfolio
  • 9.12.4. Business Strategies
• 9.13. Illumina
  • 9.13.1. Quick Facts
  • 9.13.2. Company Overview
  • 9.13.3. Product Portfolio
  • 9.13.4. Business Strategies
• 9.14. LabCorp
  • 9.14.1. Quick Facts
  • 9.14.2. Company Overview
  • 9.14.3. Product Portfolio
  • 9.14.4. Business Strategies
• 9.15. Myriad Genetics
  • 9.15.1. Quick Facts
  • 9.15.2. Company Overview
  • 9.15.3. Product Portfolio
  • 9.15.4. Business Strategies
• 9.16. PerkinElmer
  • 9.16.1. Quick Facts
  • 9.16.2. Company Overview
  • 9.16.3. Product Portfolio
  • 9.16.4. Business Strategies
• 9.17. Qiagen
  • 9.17.1. Quick Facts
  • 9.17.2. Company Overview
  • 9.17.3. Product Portfolio
  • 9.17.4. Business Strategies
• 9.18. Tempus
  • 9.18.1. Quick Facts
  • 9.18.2. Company Overview
  • 9.18.3. Product Portfolio
  • 9.18.4. Business Strategies
• 9.19. Thermo Fisher Scientific
• 9.20. Quick Facts
• 9.21. Company Overview
• 9.22. Product Portfolio
• 9.23. Business Strategies