암 및 종양 바이오마커 어세이 시장 규모, 점유율과 동향 분석 리포트 : 암 유형별, 바이오마커 유형별, 최종 용도별, 지역별, 부문 예측(2025-2033년)

Cancer And Tumor Biomarker-based Assay Market Summary

The global cancer and tumor biomarker-based assay market size was estimated at USD 10.97 billion in 2024 and is projected to reach USD 26.81 billion by 2033, growing at a CAGR of 10.50% from 2025 to 2033, driven by the growing demand for early diagnosis, personalized treatment, and precision oncology. Biomarker assays-covering genomic, proteomic, and metabolomic markers-enable clinicians to detect cancers earlier, predict disease progression, and guide therapy selection with higher accuracy.

Advances in technologies such as next-generation sequencing (NGS), liquid biopsy, and multiplex immunoassays are enhancing assay sensitivity and throughput while reducing turnaround times. Pharmaceutical companies increasingly collaborate with diagnostic developers to create companion diagnostics for targeted therapies, further fueling market growth.

Rapid advances in analytic platforms are transforming biomarker testing. Next-generation sequencing (NGS) platforms have become faster, cheaper and more flexible, enabling broad genomic panels, tumor profiling and discovery of rare variants at scale - which drives demand for assay development and clinical adoption. Meanwhile, liquid biopsy (cfDNA, CTCs, exosomes) allows minimally invasive serial monitoring, early detection and therapy resistance tracking; its convenience expands testing volumes beyond tissue-only workflows. Multiplex PCR/immunoassay platforms and digital pathology/imaging biomarkers further enable simultaneous measurement of multiple markers from limited samples, improving diagnostic yield and cost per actionable result. Together these technologies lower per-test costs, shorten time-to-result for certain workflows, and unlock new clinical use cases (screening, MRD, monitoring), all of which expand total addressable market and invite investment from diagnostics firms and pharma co-development partners.

The shift to targeted oncology therapeutics has created a tight coupling between drugs and the biomarker tests that identify eligible patients. As more targeted therapies and immunotherapies receive approvals tied to specific genomic, proteomic or immunologic signatures, pharma companies increasingly require validated companion diagnostics for clinical trials and regulatory approval. This raises demand for clinically validated biomarker assays across indications and supports higher price-per-test economics when tests are linked directly to expensive therapies. Furthermore, broader adoption of comprehensive genomic profiling and tumor-agnostic approvals increases use of multiplex assays and panel testing, concentrating spend on assays that can guide multiple treatment decisions. These dynamics fuel M&A and partnerships between diagnostic companies and drug developers, accelerating commercial rollouts of biomarker assays globally.

Biomarker assays used for treatment selection-especially companion diagnostics-face stringent regulatory pathways that affect time-to-market and commercialization costs. Regulatory agencies require rigorous analytical validation, clinical validation, and often co-submission or alignment with therapeutic approvals; novel biomarkers or rare variants complicate sample accrual for validation studies. Varying regional frameworks (e.g., FDA, EMA, and evolving IVD rules) create complexity for global launches and can force iterative studies or label differences across geographies. Additionally, regulators increasingly scrutinize clinical utility and real-world performance, pushing manufacturers to generate post-market evidence and to adopt quality systems (IVDR compliance, clinical evidence generation), which raises development timelines and CAPEX but ultimately improves clinical confidence and payer acceptance.

Global Cancer And Tumor Biomarker-based Assay Market Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global cancer and tumor biomarker-based assay market based on cancer type, biomarker type, end use, and region:

• Cancer Type Outlook (Revenue, USD Million, 2021 - 2033)
• Breast Cancer
• Lung Cancer
• Colorectal Cancer
• Prostate Cancer
• Ovarian Cancer
• Others
• Biomarker Type Outlook (Revenue, USD Million, 2021 - 2033)
• Genetic / Genomic biomarkers
• Protein biomarkers
• Epigenetic biomarkers
• Others
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Hospitals and Cancer Centers
• Diagnostic Laboratories
• Others
• Regional Outlook (USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Table of Contents

Chapter 1. Cancer and Tumor Biomarker-based Assay Market: Methodology and Scope

• 1.1. Market Segmentation and Scope
  • 1.1.1. Segment Definitions
    • 1.1.1.1. Cancer Type Segment
    • 1.1.1.2. Biomarker Type Segment
    • 1.1.1.3. End Use Segment
• 1.2. Regional Scope
• 1.3. Estimates and Forecast Timeline
• 1.4. Objectives
  • 1.4.1. Objective - 1
  • 1.4.2. Objective - 2
  • 1.4.3. Objective - 3
• 1.5. Research Methodology
• 1.6. Information Procurement
  • 1.6.1. Purchased Database
  • 1.6.2. GVR's Internal Database
  • 1.6.3. Secondary Sources
  • 1.6.4. Primary Research
• 1.7. Information or Data Analysis
  • 1.7.1. Data Analysis Models
• 1.8. Market Formulation & Validation
• 1.9. Model Details
  • 1.9.1. Commodity Flow Analysis
• 1.10. List of Secondary Sources
• 1.11. List of Abbreviations

Chapter 2. Cancer and Tumor Biomarker-based Assay Market: Executive Summary

• 2.1. Market Snapshot
• 2.2. Cancer Type and Biomarker Type Snapshot
• 2.3. End Use Snapshot
• 2.4. Competitive Landscape Snapshot

Chapter 3. Cancer and Tumor Biomarker-based Assay Market Variables, Trends, & Scope

• 3.1. Market Segmentation and Scope
• 3.2. Market Lineage Outlook
  • 3.2.1. Parent Market Outlook
  • 3.2.2. Related/Ancillary Market Outlook
• 3.3. Market Dynamics
• 3.4. Market Drivers Analysis
  • 3.4.1. Growing demand for early cancer detection
  • 3.4.2. Advancements in molecular diagnostics and biomarker discovery
  • 3.4.3. Rising cancer prevalence and personalized medicine adoption
• 3.5. Market Restraint Analysis
  • 3.5.1. High cost of biomarker assays
  • 3.5.2. Regulatory and reimbursement challenges
• 3.6. Porter's Five Forces Analysis
• 3.7. PESTLE Analysis

Chapter 4. Cancer and Tumor Biomarker-based Assay Market: Cancer Type Estimates & Trend Analysis

• 4.1. Cancer and Tumor Biomarker-based Assay Market: Cancer Type Movement Analysis
• 4.2. Breast Cancer
  • 4.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.3. Lung Cancer
  • 4.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.4. Colorectal Cancer
  • 4.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Prostate Cancer
  • 4.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.6. Ovarian Cancer
  • 4.6.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.7. Others
  • 4.7.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. Cancer and Tumor Biomarker-based Assay Market: Biomarker Type Estimates & Trend Analysis

• 5.1. Cancer and Tumor Biomarker-based Assay Market: Biomarker Type Movement Analysis
• 5.2. Genetic / Genomic biomarkers
  • 5.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.3. Protein biomarkers
  • 5.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.4. Epigenetic biomarkers
  • 5.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Others
  • 5.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Cancer and Tumor Biomarker-based Assay Market: End Use Estimates & Trend Analysis

• 6.1. Cancer and Tumor Biomarker-based Assay Market: End Use Movement Analysis
• 6.2. Hospitals and Cancer Centers
  • 6.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.3. Diagnostic Laboratories
  • 6.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.4. Others
  • 6.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Cancer and Tumor Biomarker-based Assay Market: Regional Business Analysis

• 7.1. Regional Market Snapshot
• 7.2. North America
  • 7.2.1. North America Cancer and Tumor Biomarker-based Assay Market Estimates And Forecast, 2021 - 2033 (USD Million)
  • 7.2.2. U.S.
    • 7.2.2.1. U.S. Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.2.2.2. Key Country Dynamics
    • 7.2.2.3. Regulatory Framework
    • 7.2.2.4. Reimbursement Scenario
    • 7.2.2.5. Competitive Scenario
  • 7.2.3. Canada
    • 7.2.3.1. Canada Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.2.3.2. Key Country Dynamics
    • 7.2.3.3. Regulatory Framework
    • 7.2.3.4. Reimbursement Scenario
    • 7.2.3.5. Competitive Scenario
  • 7.2.4. Mexico
    • 7.2.4.1. Mexico Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.2.4.2. Key Country Dynamics
    • 7.2.4.3. Regulatory Framework
    • 7.2.4.4. Reimbursement Scenario
    • 7.2.4.5. Competitive Scenario
• 7.3. Europe
  • 7.3.1. Europe Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
  • 7.3.2. UK
    • 7.3.2.1. UK Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.3.2.2. Key Country Dynamics
    • 7.3.2.3. Regulatory Framework
    • 7.3.2.4. Reimbursement Scenario
    • 7.3.2.5. Competitive Scenario
  • 7.3.3. Germany
    • 7.3.3.1. Germany Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.3.3.2. Key Country Dynamics
    • 7.3.3.3. Regulatory Framework
    • 7.3.3.4. Reimbursement Scenario
    • 7.3.3.5. Competitive Scenario
  • 7.3.4. Spain
    • 7.3.4.1. Spain Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.3.4.2. Key Country Dynamics
    • 7.3.4.3. Regulatory Framework
    • 7.3.4.4. Reimbursement Scenario
    • 7.3.4.5. Competitive Scenario
  • 7.3.5. France
    • 7.3.5.1. France Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.3.5.2. Key Country Dynamics
    • 7.3.5.3. Regulatory Framework
    • 7.3.5.4. Reimbursement Scenario
    • 7.3.5.5. Competitive Scenario
  • 7.3.6. Italy
    • 7.3.6.1. Italy Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.3.6.2. Key Country Dynamics
    • 7.3.6.3. Regulatory Framework
    • 7.3.6.4. Reimbursement Scenario
    • 7.3.6.5. Competitive Scenario
  • 7.3.7. Denmark
    • 7.3.7.1. Denmark Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.3.7.2. Key Country Dynamics
    • 7.3.7.3. Regulatory Framework
    • 7.3.7.4. Reimbursement Scenario
    • 7.3.7.5. Competitive Scenario
  • 7.3.8. Sweden
    • 7.3.8.1. Sweden Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.3.8.2. Key Country Dynamics
    • 7.3.8.3. Regulatory Framework
    • 7.3.8.4. Reimbursement Scenario
    • 7.3.8.5. Competitive Scenario
  • 7.3.9. Norway
    • 7.3.9.1. Norway Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.3.9.2. Key Country Dynamics
    • 7.3.9.3. Regulatory Framework
    • 7.3.9.4. Reimbursement Scenario
    • 7.3.9.5. Competitive Scenario
• 7.4. Asia Pacific
  • 7.4.1. Asia-Pacific Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
  • 7.4.2. Japan
    • 7.4.2.1. Japan Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.4.2.2. Key Country Dynamics
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. Reimbursement Scenario
    • 7.4.2.5. Competitive Scenario
  • 7.4.3. China
    • 7.4.3.1. China Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.4.3.2. Key Country Dynamics
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Reimbursement Scenario
    • 7.4.3.5. Competitive Scenario
  • 7.4.4. India
    • 7.4.4.1. India Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.4.4.2. Key Country Dynamics
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Reimbursement Scenario
    • 7.4.4.5. Competitive Scenario
  • 7.4.5. South Korea
    • 7.4.5.1. South Korea Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.4.5.2. Key Country Dynamics
    • 7.4.5.3. Regulatory Framework
    • 7.4.5.4. Reimbursement Scenario
    • 7.4.5.5. Competitive Scenario
  • 7.4.6. Thailand
    • 7.4.6.1. Thailand Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.4.6.2. Key Country Dynamics
    • 7.4.6.3. Regulatory Framework
    • 7.4.6.4. Reimbursement Scenario
    • 7.4.6.5. Competitive Scenario
  • 7.4.7. Australia
    • 7.4.7.1. Australia Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.4.7.2. Key Country Dynamics
    • 7.4.7.3. Regulatory Framework
    • 7.4.7.4. Reimbursement Scenario
    • 7.4.7.5. Competitive Scenario
• 7.5. Latin America
  • 7.5.1. Latin America Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
  • 7.5.2. Brazil
    • 7.5.2.1. Brazil Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.5.2.2. Key Country Dynamics
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Reimbursement Scenario
    • 7.5.2.5. Competitive Scenario
  • 7.5.3. Argentina
    • 7.5.3.1. Argentina Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.5.3.2. Key Country Dynamics
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Reimbursement Scenario
    • 7.5.3.5. Competitive Scenario
• 7.6. MEA
  • 7.6.1. MEA Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
  • 7.6.2. South Africa
    • 7.6.2.1. South Africa Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.6.2.2. Key Country Dynamics
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Reimbursement Scenario
    • 7.6.2.5. Competitive Scenario
  • 7.6.3. Saudi Arabia
    • 7.6.3.1. Saudi Arabia Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.6.3.2. Key Country Dynamics
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. Reimbursement Scenario
    • 7.6.3.5. Competitive Scenario
  • 7.6.4. UAE
    • 7.6.4.1. UAE Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.6.4.2. Key Country Dynamics
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. Reimbursement Scenario
    • 7.6.4.5. Competitive Scenario
  • 7.6.5. Kuwait
    • 7.6.5.1. Kuwait Cancer and Tumor Biomarker-based Assay Market, 2021 - 2033 (USD Million)
    • 7.6.5.2. Key Country Dynamics
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Reimbursement Scenario
    • 7.6.5.5. Competitive Scenario

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
• 8.2. Strategy Mapping
  • 8.2.1. New product launch
  • 8.2.2. Partnerships
  • 8.2.3. Acquisition
  • 8.2.4. Collaboration
  • 8.2.5. Funding
• 8.3. Key Company Market Share Analysis, 2024
• 8.4. Company Heat Map Analysis
• 8.5. Company Profiles
  • 8.5.1. F. Hoffmann-La Roche Ltd,
    • 8.5.1.1. Company Overview
    • 8.5.1.2. Financial Performance
    • 8.5.1.3. Product Benchmarking
    • 8.5.1.4. Strategic Initiatives
  • 8.5.2. Thermo Fisher Scientific, Inc.,
    • 8.5.2.1. Company Overview
    • 8.5.2.2. Financial Performance
    • 8.5.2.3. Product Benchmarking
    • 8.5.2.4. Strategic Initiatives
  • 8.5.3. Illumina, Inc.
    • 8.5.3.1. Company Overview
    • 8.5.3.2. Financial Performance
    • 8.5.3.3. Product Benchmarking
    • 8.5.3.4. Strategic Initiatives
  • 8.5.4. QIAGEN
    • 8.5.4.1. Company Overview
    • 8.5.4.2. Financial Performance
    • 8.5.4.3. Product Benchmarking
    • 8.5.4.4. Strategic Initiatives
  • 8.5.5. Guardant Health
    • 8.5.5.1. Company Overview
    • 8.5.5.2. Financial Performance
    • 8.5.5.3. Product Benchmarking
    • 8.5.5.4. Strategic Initiatives
  • 8.5.6. Exact Sciences Corporation
    • 8.5.6.1. Company Overview
    • 8.5.6.2. Financial Performance
    • 8.5.6.3. Product Benchmarking
    • 8.5.6.4. Strategic Initiatives
  • 8.5.7. Bio-Rad Laboratories, Inc.
    • 8.5.7.1. Company Overview
    • 8.5.7.2. Financial Performance
    • 8.5.7.3. Product Benchmarking
    • 8.5.7.4. Strategic Initiatives
  • 8.5.8. Agilent Technologies, Inc.
    • 8.5.8.1. Company Overview
    • 8.5.8.2. Financial Performance
    • 8.5.8.3. Product Benchmarking
    • 8.5.8.4. Strategic Initiatives
  • 8.5.9. Sysmex Corporation
    • 8.5.9.1. Company Overview
    • 8.5.9.2. Financial Performance
    • 8.5.9.3. Product Benchmarking
    • 8.5.9.4. Strategic Initiatives
  • 8.5.10. Abbott
    • 8.5.10.1. Company Overview
    • 8.5.10.2. Financial Performance
    • 8.5.10.3. Product Benchmarking
    • 8.5.10.4. Strategic Initiatives
  • 8.5.11. bioMerieux
    • 8.5.11.1. Company Overview
    • 8.5.11.2. Financial Performance
    • 8.5.11.3. Product Benchmarking
    • 8.5.11.4. Strategic Initiatives
  • 8.5.12. Myriad Genetics, Inc.
    • 8.5.12.1. Company Overview
    • 8.5.12.2. Financial Performance
    • 8.5.12.3. Product Benchmarking
    • 8.5.12.4. Strategic Initiatives
  • 8.5.13. Hologic, Inc.
    • 8.5.13.1. Company Overview
    • 8.5.13.2. Financial Performance
    • 8.5.13.3. Product Benchmarking
    • 8.5.13.4. Strategic Initiatives
  • 8.5.14. Quest Diagnostics Incorporated
    • 8.5.14.1. Company Overview
    • 8.5.14.2. Financial Performance
    • 8.5.14.3. Product Benchmarking
    • 8.5.14.4. Strategic Initiatives