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體外診斷癌症癌症診斷

市場調查報告書

商品編碼

2103007

癌症診斷市場－策略分析與預測（2026-2035）

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

出版日期: 2026年07月07日 | 出版商:

Knowledge Sourcing Intelligence | 英文 186 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄

預計癌症診斷市場將從 2026 年的 1,418 億美元成長到 2035 年的 2,347 億美元，複合年成長率為 5.8%。

癌症診斷涵蓋了用於癌症檢測、腫瘤亞型鑑定、分子突變識別、治療方案選擇指南、療效監測和復發檢測的檢查室診斷、影像診斷、分子診斷和病理診斷技術。該市場包括診斷設備、耗材、試劑、軟體平台、成像系統、定序技術、生物標記檢測和伴隨病人歷程，這些產品和服務貫穿腫瘤患者的整個治療過程。隨著腫瘤治療向精準醫療轉型，醫療服務提供者正擴大將基因組分析、分子診斷和人工智慧驅動的分析技術融入日常臨床實踐，以提高診斷準確性並改善患者預後。

市場促進因素

精準腫瘤學的廣泛應用

精準腫瘤學正在變革癌症治療，它不僅基於腫瘤的位置，還基於分子和基因組特徵來制定治療決策。基因組分析、伴隨診斷和生物標記檢測的日益普及，推動了對先進癌症診斷技術的需求。

液態生物檢體的廣泛應用

液態生物檢體技術因其能夠以微創方式檢測循環腫瘤DNA（ctDNA）、循環性腫瘤細胞和其他生物標記物，在臨床實務上正廣泛應用。這些技術有助於疾病監測、治療最佳化和復發檢測，同時減少了重複組織切片檢查的需求。

對伴隨診斷的需求日益成長

伴隨診斷已成為標靶治療和免疫療法的關鍵組成部分。隨著越來越多的法規核准要求在治療開始前識別出檢驗的生物標記物，製藥公司和診斷設備製造商正在加速合作開發治療方法和診斷方法。

人工智慧（AI）的整合

人工智慧 (AI) 透過影像解讀、工作流程自動化、模式識別和臨床決策支持，提高了病理學、放射學和分子診斷領域的診斷準確性，幫助檢查室應對日益成長的工作量。

市場限制因素

高昂的實施成本

先進的分子診斷平台、基因測序技術、數位病理基礎設施和人工智慧系統需要大量的資金投入，這阻礙了資源有限的醫療機構採用這些技術。

與還款相關的挑戰

由於不同醫療保健系統的報銷政策不一致，儘管基因組學和液態生物檢體測試已被證明具有臨床效用，但其常規應用仍然緩慢。

與標準化相關的挑戰

檢測程序、方法協調、生物標記解釋和品管方面的差異，仍然是確保不同醫療機構獲得可重複診斷結果的挑戰。

市場定義和範圍
癌症診斷產業概覽
產業變化
主要市場趨勢
市場規模分析（實際成果值）
市場預測
全球癌症負擔和未滿足的診斷需求
流行病學和盛行率分析
- 全球癌症盛行率
- 全球癌症發生率
- 確診患者人數
癌症篩檢和早期檢測的現狀
對所進行的診斷測試數量進行分析
分析病人歷程

第4章市場動態

市場促進因素
市場限制因素
市場機遇
市場挑戰

第5章行業情勢

產業價值鏈分析
定價分析
還款狀態

第6章：創新趨勢

新型診斷技術
產品創新分析
對與癌症診斷相關的臨床試驗進行分析
新興癌症診斷技術的管道分析
人工智慧在癌症診斷的應用
數位病理學的整合
多體學和精準腫瘤診斷
液態生物檢體創新藍圖

第7章監理情勢

法律規範
核准流程
合規要求

第8章：全球癌症診斷市場：展望分析

分析：依產品類型
分析：按診斷測試類型
分析：依樣本類型
分析：透過應用
分析：按最終用戶

第9章全球癌症診斷市場：細分市場分析

依產品類型
- 裝置
- 耗材和試劑
- 軟體與資訊科學
按診斷測試類型
- 體外診斷試劑（IVD）
- 診斷影像
- 分子診斷
- 其他
依樣本類型
- 血
- 組織切片檢查
- 尿
- 唾液
- 其他體液
透過使用
- 乳癌
- 肺癌
- 結腸癌
- 攝護腺癌
- 子宮頸癌
- 皮膚癌
- 血癌
- 其他
最終用戶
- 醫院和診斷中心
- 診斷檢查室
- 癌症研究機構
- 其他

第10章：全球癌症診斷市場：區域分析

北美洲
歐洲
亞太地區
南美洲
中東和非洲

第11章全球癌症診斷市場：國別分析

美國
加拿大
德國
英國
法國
義大利
西班牙
荷蘭
瑞士
日本
中國
印度
韓國
澳洲
巴西
沙烏地阿拉伯

第12章競爭格局

市佔率分析
策略趨勢
企業合併、合作與聯盟
新產品發布

第13章：公司簡介

F. Hoffmann-La Roche Ltd.
Illumina, Inc.
Thermo Fisher Scientific Inc.
QIAGEN NV
Agilent Technologies, Inc.
Bio-Rad Laboratories, Inc.
Siemens AG
Abbott Laboratories
Becton, Dickinson and Company
Myriad Genetics, Inc.

第14章全球癌症診斷市場：商業預測分析

第15章：投資與資金籌措分析

創業投資趨勢
政府資金
研發投資

第16章：未來展望

主要成長機遇
未來產業趨勢

簡介目錄

Product Code: KSI-009011

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.

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.