시장보고서
상품코드
2103007

암 진단 시장 : 전략적 인사이트와 예측(2026-2035년)

Cancer Diagnostics Market - Strategic Insights and Forecasts (2026-2035)

발행일: | 리서치사: 구분자 Knowledge Sourcing Intelligence | 페이지 정보: 영문 186 Pages | 배송안내 : 1-2일 (영업일 기준)

    
    
    



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한글목차
영문목차
※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.

암 진단 시장은 2026년 시장 규모 1,418억 달러에서 2035년에는 2,347억 달러로, CAGR 5.8%로 확대될 것으로 예상됩니다.

암 진단에는 암 검출, 종양의 아형 특정, 분자 변이 확인, 치료법 선택 지침, 치료 효과 모니터링 및 재발 검출에 사용되는 실험실 기반, 영상 진단 기반, 분자진단, 병리 진단 기술이 포함됩니다. 이 시장에는 진단 기기, 소모품, 시약, 소프트웨어 플랫폼, 영상 진단 시스템, 시퀀싱 기술, 바이오마커 분석법, 그리고 환자 여정 전반에 걸쳐 종양 치료를 지원하는 동반진단이 포함됩니다. 종양 치료가 정밀 의학으로 전환됨에 따라, 의료 제공자들은 진단 정확도와 환자 예후를 개선하기 위해 유전체 프로파일링, 분자진단, AI를 활용한 분석을 일상적인 임상 진료에 도입하는 것을 추진하고 있습니다.

시장 촉진요인

정밀 종양학의 확산

정밀 종양학은 종양의 부위뿐만 아니라 분자적·유전체적 특성에 기반한 치료 결정을 가능하게함으로써 암 관리를 혁신하고 있습니다. 유전체 프로파일링, 동반진단, 바이오마커 검사의 활용 확대가 첨단 암 진단 기술에 대한 수요를 견인하고 있습니다.

액체 생검의 보급 확대

액체 생검 기술은 순환 종양 DNA(ctDNA), 순환종양세포 및 기타 바이오마커를 비침습적으로 검출할 수 있어 임상 현장에서 널리 받아들여지고 있습니다. 이러한 기술은 질환 모니터링, 치료 최적화, 재발 감지를 지원하는 동시에 반복적인 조직 생검의 필요성을 줄여줍니다.

동반진단에 대한 수요 증가

동반진단은 표적 치료나 면역 치료에서 필수적인 요소가 되고 있습니다. 규제 당국의 승인 과정에서 치료 시작 전에 검증된 바이오마커를 특정해야 하는 사례가 늘어나고 있어, 제약 회사와 진단 기기 제조사가 치료법과 진단법을 공동 개발하는 움직임이 촉진되고 있습니다.

인공지능(AI)의 통합

인공지능(AI)은 영상 해석, 워크플로우 자동화, 패턴 인식, 임상 의사결정 지원을 통해 병리학, 방사선학, 분자진단 각 분야의 진단 정확도를 향상시키고 있으며, 검사실이 증가하는 검사량을 관리할 수 있도록 지원하고 있습니다.

시장 억제요인

높은 도입 비용

고도의 분자진단 플랫폼, 유전체 시퀀싱 기술, 디지털 병리학 인프라, AI 탑재 시스템에는 막대한 설비 투자가 필요하며, 이는 자원이 제한된 의료 기관에서의 도입을 저해하고 있습니다.

보험 급여 관련 과제

의료 제도마다 보험 급여 방침에 차이가 있어, 임상적 유용성이 입증되었음에도 불구하고 일부 유전체 검사 및 체액 생검 검사의 일상적인 도입이 여전히 지연되고 있습니다.

표준화와 관련된 과제

검사 절차, 검사법의 조화, 바이오마커 해석, 품질 관리에 있어 의료기관 간 차이가 존재하여, 재현성 있는 진단 결과를 보장하는 데 여전히 과제로 남아 있습니다.

목차

제1장 주요 요약

제2장 분석 방법

제3장 세계의 암 진단 시장 : 개요, 시장 규모, 향후 예측

제4장 시장 역학

제5장 업계 상황

제6장 혁신 동향

제7장 규제 상황

제8장 세계의 암 진단 시장 : 전망 분석

제9장 세계의 암 진단 시장 : 부문 분석

제10장 세계의 암 진단 시장 : 지역별 분석

제11장 세계의 암 진단 시장 : 국가별 분석

제12장 경쟁 구도

제13장 기업 개요

제14장 세계의 암 진단 시장 : 상업 예측 분석

제15장 투자·자금 조달 분석

제16장 향후 전망

KSM

The Cancer Diagnostics Market is expected to grow at a CAGR of 5.8% from a market value of USD 141.8 billion in 2026 to USD 234.7 billion in 2035.

Cancer diagnostics encompasses laboratory-based, imaging-based, molecular, and pathology technologies used to detect cancer, determine tumor subtype, identify molecular alterations, guide treatment selection, monitor therapeutic response, and detect disease recurrence. The market includes diagnostic instruments, consumables, reagents, software platforms, imaging systems, sequencing technologies, biomarker assays, and companion diagnostics that support oncology care throughout the patient journey. As oncology shifts toward precision medicine, healthcare providers are increasingly integrating genomic profiling, molecular diagnostics, and AI-assisted analysis into routine clinical practice to improve diagnostic accuracy and patient outcomes.

Market Drivers

Expanding Precision Oncology Adoption

Precision oncology is transforming cancer management by enabling treatment decisions based on molecular and genomic characteristics rather than tumor location alone. Growing use of genomic profiling, companion diagnostics, and biomarker testing is driving demand for advanced cancer diagnostic technologies.

Growing Adoption of Liquid Biopsy

Liquid biopsy technologies are gaining widespread clinical acceptance because they enable minimally invasive detection of circulating tumor DNA (ctDNA), circulating tumor cells, and other biomarkers. These technologies support disease monitoring, treatment optimization, and recurrence detection while reducing the need for repeated tissue biopsies.

Rising Demand for Companion Diagnostics

Companion diagnostics have become essential for targeted therapies and immunotherapies. Regulatory approvals increasingly require validated biomarker identification before treatment initiation, encouraging pharmaceutical and diagnostic companies to co-develop therapeutic and diagnostic solutions.

Integration of Artificial Intelligence

Artificial intelligence is improving diagnostic accuracy across pathology, radiology, and molecular diagnostics by supporting image interpretation, workflow automation, pattern recognition, and clinical decision support, helping laboratories manage increasing testing volumes.

Market Restraints

High Implementation Costs

Advanced molecular diagnostic platforms, genomic sequencing technologies, digital pathology infrastructure, and AI-enabled systems require significant capital investment, limiting adoption among resource-constrained healthcare facilities.

Reimbursement Challenges

Variability in reimbursement policies across healthcare systems continues to slow the routine adoption of several genomic and liquid biopsy assays despite demonstrated clinical utility.

Standardization Issues

Differences in laboratory procedures, assay harmonization, biomarker interpretation, and quality control continue to create challenges in ensuring reproducible diagnostic results across institutions.

Market and Technology Insights

The global cancer diagnostics market can be segmented by product type, diagnostic test type, sample type, application, end user, and geography.

By product type, the market includes:

  • Instruments
  • Consumables & Reagents
  • Software & Informatics

Consumables and reagents account for a substantial share due to recurring demand across diagnostic workflows, while software and informatics solutions are expanding rapidly with the increasing adoption of digital pathology, AI, and integrated laboratory management systems.

By diagnostic test type, the market comprises:

  • In Vitro Diagnostics (IVD)
  • Imaging Diagnostics
  • Molecular Diagnostics
  • Other Diagnostic Technologies

Molecular diagnostics continue to experience strong growth due to increasing implementation of genomic profiling, companion diagnostics, and biomarker-based testing in precision oncology.

By sample type, the market includes:

  • Blood
  • Tissue Biopsy
  • Urine
  • Saliva
  • Other Body Fluids

Blood-based testing is expanding rapidly with the growing clinical adoption of liquid biopsy technologies for cancer detection and disease monitoring.

By application, the market serves:

  • Breast Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Cervical Cancer
  • Skin Cancer
  • Blood Cancer
  • Other Cancer Types

Oncology diagnostics continue expanding across virtually all major cancer indications as personalized treatment strategies become standard clinical practice.

By end user, the market includes:

  • Hospitals & Diagnostic Centers
  • Diagnostic Laboratories
  • Cancer Research Institutes
  • Other End Users

Hospitals and diagnostic centers represent the largest end-user segment because comprehensive cancer diagnosis increasingly requires integrated pathology, imaging, and molecular diagnostic capabilities.

Market Trends

Several technological innovations continue reshaping the cancer diagnostics landscape.

Key trends include:

  • Expansion of liquid biopsy technologies.
  • Increasing adoption of comprehensive genomic profiling.
  • Growing use of AI-assisted pathology and imaging.
  • Rising development of companion diagnostics.
  • Integration of digital pathology platforms.
  • Expansion of multi-omics diagnostics.
  • Greater use of precision oncology decision-support systems.

Regional Insights

North America remains the leading regional market because of advanced healthcare infrastructure, strong precision medicine initiatives, extensive adoption of genomic testing, and significant investment in oncology research. The region also benefits from close collaboration between pharmaceutical companies and diagnostic manufacturers in companion diagnostic development.

Europe continues to demonstrate strong market growth through expanding cancer screening programs, increasing adoption of molecular diagnostics, supportive regulatory frameworks, and growing implementation of personalized oncology across healthcare systems.

Asia-Pacific is expected to register the fastest growth owing to rising cancer incidence, expanding healthcare infrastructure, increasing government investment in oncology care, improving access to molecular diagnostics, and rapid adoption of precision medicine technologies across countries including China, Japan, India, South Korea, and Australia.

Latin America and the Middle East & Africa continue strengthening diagnostic capabilities through healthcare modernization, improved laboratory infrastructure, and increasing awareness of early cancer detection.

Competitive Landscape

The cancer diagnostics market is highly competitive, with companies continuously investing in molecular diagnostics, digital pathology, AI-enabled imaging, liquid biopsy, and companion diagnostics.

Major companies include Roche Diagnostics, Thermo Fisher Scientific, Abbott Laboratories, QIAGEN, Agilent Technologies, Illumina, Danaher Corporation, Bio-Rad Laboratories, Siemens Healthineers, Becton Dickinson (BD), Guardant Health, Exact Sciences, Natera, NeoGenomics Laboratories, and Foundation Medicine. Companies continue strengthening their portfolios through technological innovation, strategic partnerships, acquisitions, and pharmaceutical collaborations supporting precision oncology.

Future Outlook

The future of the cancer diagnostics market will be increasingly driven by precision oncology, comprehensive genomic profiling, AI-assisted diagnostics, and liquid biopsy technologies. Healthcare providers are moving toward integrated diagnostic ecosystems where pathology, imaging, molecular testing, bioinformatics, and clinical decision support work together to improve early detection, personalized treatment selection, therapeutic monitoring, and long-term patient management. Continued advances in companion diagnostics and multi-omics technologies are expected to further accelerate market growth.

Conclusion

The Global Cancer Diagnostics Market is expected to witness sustained growth through 2035, supported by expanding precision medicine initiatives, increasing adoption of molecular diagnostics, broader implementation of AI, and continuous innovation in liquid biopsy and genomic technologies. While challenges related to implementation costs, reimbursement, and laboratory standardization remain, advances in precision oncology and integrated diagnostic platforms are expected to create significant opportunities for diagnostic manufacturers, healthcare providers, pharmaceutical companies, researchers, and investors.

Key Benefits of this Report

  • Comprehensive assessment of the global cancer diagnostics market.
  • Detailed evaluation of diagnostic technologies and emerging innovations.
  • Analysis of market dynamics, competitive strategies, and future opportunities.
  • Insights into precision oncology, liquid biopsy, AI, companion diagnostics, and multi-omics technologies.
  • Valuable resource for healthcare providers, diagnostic manufacturers, pharmaceutical companies, researchers, investors, and policymakers.

What Businesses Use Our Reports For

Market opportunity assessment, competitive benchmarking, product portfolio planning, precision oncology strategy, companion diagnostic development, partnership evaluation, commercialization planning, investment analysis, regulatory planning, and long-term strategic decision-making.

Report Coverage

  • Historical data from 2021 to 2025, Base Year 2026, and Forecast Period 2026 to 2035
  • Comprehensive analysis by Product Type, Diagnostic Test Type, Sample Type, Application, End User, and Geography
  • Evaluation of in vitro diagnostics, imaging diagnostics, molecular diagnostics, liquid biopsy, digital pathology, AI-enabled diagnostics, genomic profiling, companion diagnostics, and precision oncology technologies
  • Analysis of market dynamics, competitive landscape, regulatory environment, innovation trends, and future growth opportunities through 2035.

TABLE OF CONTENTS

1. Executive Summary

  • 1.1 Market Snapshot
  • 1.2 Key Findings
  • 1.3 Analyst Insights
  • 1.4 Strategic Recommendations

2. Research Methodology

  • 2.1 Research Design
  • 2.2 Data Collection Methodology
  • 2.3 Market Size Estimation
  • 2.4 Forecasting Model
  • 2.5 Assumptions & Limitations

3. Global Cancer Diagnostics Market Overview, Size & Forecast

  • 3.1 Market Definition & Scope
  • 3.2 Oncology Diagnostics Industry Overview
  • 3.3 Industry Evolution
  • 3.4 Key Market Trends
  • 3.5 Historical Market Size Analysis (2021-2025)
  • 3.6 Market Forecast (2026-2035)
  • 3.7 Global Cancer Burden & Unmet Diagnostic Needs
  • 3.8 Epidemiology and Prevalence Analysis
    • 3.8.1 Global Cancer Prevalence
    • 3.8.2 Global Cancer Incidence
    • 3.8.3 Diagnosed Patient Population
  • 3.9 Cancer Screening and Early Detection Landscape
  • 3.10 Diagnostic Testing Volume Analysis
  • 3.11 Patient Journey Analysis Across the Cancer Care Continuum

4. Market Dynamics

  • 4.1 Market Drivers
  • 4.2 Market Restraints
  • 4.3 Market Opportunities
  • 4.4 Market Challenges

5. Industry Landscape

  • 5.1 Industry Value Chain Analysis
  • 5.2 Pricing Analysis
  • 5.3 Reimbursement Landscape

6. Innovation Landscape

  • 6.1 Emerging Diagnostic Technologies
  • 6.2 Product Innovation Analysis
  • 6.3 Clinical Trial Analysis for Cancer Diagnostics
  • 6.4 Pipeline Analysis of Emerging Cancer Diagnostic Technologies
  • 6.5 Artificial Intelligence in Cancer Diagnostics
  • 6.6 Digital Pathology Integration
  • 6.7 Multi-Omics and Precision Oncology Diagnostics
  • 6.8 Liquid Biopsy Innovation Roadmap

7. Regulatory Landscape

  • 7.1 Regulatory Framework
  • 7.2 Approval Pathways
  • 7.3 Compliance Requirements

8. Global Cancer Diagnostics Market Landscape Analysis

  • 8.1 Analysis by Product Type
  • 8.2 Analysis by Diagnostic Test Type
  • 8.3 Analysis by Sample Type
  • 8.4 Analysis by Application
  • 8.5 Analysis by End User

9. Global Cancer Diagnostics Market Segment Analysis (2021-2035)

  • 9.1 By Product Type
    • 9.1.1 Instruments
    • 9.1.2 Consumables & Reagents
    • 9.1.3 Software & Informatics
  • 9.2 By Diagnostic Test Type
    • 9.2.1 In Vitro Diagnostics (IVD)
    • 9.2.2 Imaging Diagnostics
    • 9.2.3 Molecular Diagnostics
    • 9.2.4 Others
  • 9.3 By Sample Type
    • 9.3.1 Blood
    • 9.3.2 Tissue Biopsy
    • 9.3.3 Urine
    • 9.3.4 Saliva
    • 9.3.5 Other Body Fluids
  • 9.4 By Application
    • 9.4.1 Breast Cancer
    • 9.4.2 Lung Cancer
    • 9.4.3 Colorectal Cancer
    • 9.4.4 Prostate Cancer
    • 9.4.5 Cervical Cancer
    • 9.4.6 Skin Cancer
    • 9.4.7 Blood Cancer
    • 9.4.8 Others
  • 9.5 By End User
    • 9.5.1 Hospitals & Diagnostic Centers
    • 9.5.2 Diagnostic Laboratories
    • 9.5.3 Cancer Research Institutes
    • 9.5.4 Others

10. Global Cancer Diagnostics Market Geographical Analysis (2021-2035)

  • 10.1 North America
  • 10.2 Europe
  • 10.3 Asia-Pacific
  • 10.4 South America
  • 10.5 Middle East & Africa

11. Global Cancer Diagnostics Market Country Analysis (2021-2035)

  • 11.1 United States
  • 11.2 Canada
  • 11.3 Germany
  • 11.4 United Kingdom
  • 11.5 France
  • 11.6 Italy
  • 11.7 Spain
  • 11.8 Netherlands
  • 11.9 Switzerland
  • 11.10 Japan
  • 11.11 China
  • 11.12 India
  • 11.13 South Korea
  • 11.14 Australia
  • 11.15 Brazil
  • 11.16 Saudi Arabia

12. Competitive Landscape

  • 12.1 Market Share Analysis
  • 12.2 Strategic Developments
  • 12.3 Mergers & Acquisitions, Partnerships & Collaborations
  • 12.4 Product Launches

13. Company Profiles

  • 13.1 F. Hoffmann-La Roche Ltd.
    • 13.1.1 Company Overview
    • 13.1.2 Financials
    • 13.1.3 Product Portfolio
    • 13.1.4 Recent Developments
  • 13.2 Illumina, Inc.
  • 13.3 Thermo Fisher Scientific Inc.
  • 13.4 QIAGEN N.V.
  • 13.5 Agilent Technologies, Inc.
  • 13.6 Bio-Rad Laboratories, Inc.
  • 13.7 Siemens AG
  • 13.8 Abbott Laboratories
  • 13.9 Becton, Dickinson and Company
  • 13.10 Myriad Genetics, Inc.

14. Global Cancer Diagnostics Market Commercial Forecast Analysis

  • 14.1 Commercial Forecast by Technology Platform
  • 14.2 Commercial Forecast by Diagnostic Purpose
  • 14.3 Commercial Forecast by Cancer Type
  • 14.4 Commercial Forecast by Biomarker Category
  • 14.5 Commercial Forecast by End User

15. Investment & Funding Analysis

  • 15.1 Venture Capital Trends
  • 15.2 Government Funding
  • 15.3 R&D Investments

16. Future Outlook

  • 16.1 Key Growth Opportunities
  • 16.2 Future Industry Trends
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