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癌症生物標記

市場調查報告書

商品編碼

2103140

癌症生物標記檢測市場：策略性洞察與預測（2026-2035）

Cancer Biomarker Testing Market - Strategic Insights and Forecasts (2026-2035)

出版日期: 2026年07月09日 | 出版商:

Knowledge Sourcing Intelligence | 英文 170 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄

預計癌症生物標記檢測市場將從 2026 年的 279 億美元成長到 2035 年的 609 億美元，複合年成長率為 9.1%。

癌症生物標記檢測市場正經歷根本性的變革，其驅動力是精準腫瘤學和生物標記主導醫療保健的模式轉移。這一市場演變的特點是，人們日益認知到分子譜分析是腫瘤學實踐中不可或缺的要素，因為標靶治療需要在治療開始前精確識別基因組突變。先進的定序技術、液態生物檢體平台和人工智慧的融合，使得疾病特徵分析和治療選擇更加全面。單基因檢測的順序進行會導致診斷延遲並消耗寶貴的組織樣本，因此，醫療系統正日益將全面的基因組譜分析整合到常規臨床工作流程中。生物標記標靶療法的不斷普及，推動了對多種固體癌和骨髓惡性腫瘤檢測的需求。製藥公司正在藥物發現和開發早期階段引入生物標記策略，因為透過縮小臨床試驗族群，可以提高治療反應率和試驗效率。監管機構認知到治療效果取決於精準的患者選擇，因此正在加強對伴隨診斷的核准，與標靶治療的核准同步進行。隨著對多組體學平台、微量殘存疾病(MRD) 監測和人工智慧分析工具的大量投資，生物標記檢測正成為現代腫瘤學的基石。

市場促進因素

精準腫瘤學的蓬勃發展是癌症生物標記檢測市場的主要驅動力。精準腫瘤學依賴在選擇標靶治療之前進行精確的分子表徵。隨著生物標記導向療法的日益普及，對多種固體癌和骨髓惡性腫瘤進行全面基因組分析的需求也日益成長。逐個基因進行檢測會導致診斷延遲、治療啟動延遲以及寶貴組織樣本的浪費。因此，臨床檢查室正在採用能夠同時評估多種有用生物標記的多定序平台，從而持續擴大生物標記檢測的應用。此外，伴隨診斷在癌症藥物研發的應用也加速了市場成長。伴隨診斷透過識別最有可能從治療中獲益的患者，使生物標記特異性療法能夠獲得監管部門的批准。製藥公司正在藥物研發的早期階段引入生物標記策略，因為縮小臨床試驗的目標族群可以提高治療反應率。診斷試劑開發商正拓展與製藥公司的合作，透過與在臨床實驗藥物同步開發檢驗的檢測方法，加強診斷與治療的整合。由於整體組織切片檢查難以重複進行分子層面的評估，液態生物檢體切片在癌症治療中的應用日益廣泛。液態生物檢體技術能夠利用血液進行生物標記分析，以實現連續的基因組監測。腫瘤內科醫生擴大利用循環腫瘤DNA來檢測新的抗藥性突變、評估治療反應並監測疾病復發。監管機構對基於生物標記的醫學的日益重視正在加速市場成長。監管機構越來越認知到分子生物標記是癌症個人化治療的關鍵要素。由於治療效果取決於精準的患者選擇，伴隨診斷的核准仍然與標靶治療的核准密切相關。診斷試劑生產商正在加大對分析驗證、品質保證和法規遵循的投入，以滿足不斷變化的核准要求。

市場限制因素

儘管綜合基因組分析的臨床應用價值日益成長，但由於不同醫療體系的報銷標準缺乏一致性，限制了其常規效用。地區性和保險公司特定的福利政策為診斷服務提供者帶來不確定性，並限制了患者獲得先進檢測方案的機會。檢體品質和檢測前實驗室流程的差異會影響分析效能，並使標準化結果的解讀變得困難。不同檢查室之間缺乏標準化的操作規程會導致結果不一致，降低臨床可靠性。分子病理學和生物資訊學的專業知識匱乏，限制了其在一些新興醫療市場的應用。難以獲得能夠解讀複雜基因組數據的訓練有素的人員，限制了生物標記檢測服務的擴充性。複雜且因地區而異的法規給尋求將新型檢測方案商業化的診斷試劑製造商帶來了合規負擔。不斷適應不斷變化的監管環境會增加營運成本，並延長新產品的上市時間。

市場定義和範圍
癌症生物標記檢測產業概覽
產業變化
主要市場趨勢
市場規模表現分析
市場預測
癌症負擔和未滿足的需求
流行病學和癌症發生率分析
對所進行的生物標記檢測數量進行分析
伴隨診斷的現狀
詳細腫瘤檢查實施分析
分析患者檢測途徑

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

新興技術
產品創新
臨床試驗分析
管道分析
液態生物檢體技術藍圖
將人工智慧應用於生物標記檢測
數位病理學和基因組數據的整合

第7章監理情勢

法律規範
核准流程
合規要求

第8章全球癌症生物標記檢測市場：展望分析

分析：依生物標記類型
分析：按技術
分析：依樣本類型
分析：按癌症類型分類
分析：透過臨床應用
分析：按最終用戶

第9章全球癌症生物標記檢測市場：細分市場分析

依生物標誌類型
- 基因生物標記
- 蛋白質生物標記
- 其他生物標記
透過技術
- 聚合酵素鏈鎖反應（PCR）
- 次世代定序（NGS）
- 免疫組織化學（IHC）
- 螢光原位雜合反應（FISH）
- 其他技術
依樣本類型
- 組織切片檢查
- 液態生物檢體
- 尿
- 其他體液
按癌症類型
- 固體癌
  - 乳癌
  - 肺癌
  - 結腸癌
  - 攝護腺癌
  - 黑色素瘤
  - 其他
- 骨髓惡性腫瘤
臨床應用
- 風險評估
- 早期檢測和篩檢
- 診斷
- 預後
- 治療監測
- 其他
最終用戶
- 醫院和專科診所
- 臨床診斷檢測實驗室
- 製藥和生物技術公司
- 其他

第10章全球癌症生物標記檢測市場：區域分析

北美洲
歐洲
亞太地區
南美洲
中東和非洲

第11章全球癌症生物標記檢測市場：國別分析

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

第12章競爭格局

市佔率分析
策略趨勢
併購、合作與聯盟
新產品發布

第13章：公司簡介

F. Hoffmann-La Roche Ltd.
QIAGEN NV
Illumina, Inc.
Thermo Fisher Scientific Inc.
Abbott Laboratories
Danaher Corporation
Qiagen
Guardant Health, Inc.
Siemens AG
Natera

第14章：全球癌症生物標記檢測市場：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-009031

The Cancer Biomarker Testing Market is expected to grow at a CAGR of 9.1% from a market value of USD 27.9 billion in 2026 to USD 60.9 billion in 2035.

The cancer biomarker testing market is undergoing fundamental transformation driven by the paradigm shift toward precision oncology and biomarker-driven healthcare. The market's evolution is characterized by the growing recognition that molecular profiling is an indispensable component of oncology practice because targeted therapies require accurate identification of genomic alterations before treatment initiation. The convergence of advanced sequencing technologies, liquid biopsy platforms, and artificial intelligence is enabling more comprehensive disease characterization and treatment selection. Healthcare systems are increasingly integrating comprehensive genomic profiling into routine clinical workflows because sequential single-gene testing creates diagnostic delays and consumes valuable tissue samples. The expanding availability of biomarker-directed therapeutics is increasing demand for testing across multiple solid tumors and hematologic malignancies. Pharmaceutical companies are incorporating biomarker strategies earlier in drug development because enriched clinical trial populations improve therapeutic response rates and trial efficiency. Regulatory agencies are strengthening companion diagnostic approvals alongside targeted therapeutic approvals, recognizing that treatment effectiveness depends on accurate patient selection. The market is witnessing significant investment in multi-omics platforms, minimal residual disease monitoring, and AI-enabled interpretation tools, positioning biomarker testing as a cornerstone of modern oncology care.

Market Drivers

The expanding precision oncology therapeutics landscape represents the primary driver for the cancer biomarker testing market. Precision oncology depends on accurate molecular characterization before targeted therapy selection. The expanding availability of biomarker-directed therapeutics is increasing demand for comprehensive genomic profiling across multiple solid tumors and hematologic malignancies. Sequential single-gene testing creates diagnostic delays that limit treatment initiation and consume valuable tissue samples. Clinical laboratories are therefore adopting multiplex sequencing platforms that simultaneously evaluate numerous actionable biomarkers, resulting in sustained growth in biomarker testing utilization. The integration of companion diagnostics into oncology drug development is further accelerating market growth. Companion diagnostics enable regulatory approval of biomarker-specific therapeutics by identifying patients most likely to benefit from treatment. Pharmaceutical companies are incorporating biomarker strategies earlier in drug development because enriched clinical trial populations improve therapeutic response rates. Diagnostic developers are expanding partnerships with drug manufacturers to co-develop validated assays alongside investigational therapies, strengthening alignment between diagnostics and therapeutics. Liquid biopsy adoption is expanding across cancer management because traditional tissue biopsy limits repeated molecular assessment. Liquid biopsy technologies are enabling serial genomic monitoring through blood-based biomarker analysis. Oncologists are increasingly using circulating tumor DNA to detect emerging resistance mutations, evaluate treatment response, and monitor disease recurrence. Regulatory recognition of biomarker-based medicine is accelerating market growth. Regulatory agencies increasingly recognize molecular biomarkers as essential components of individualized oncology treatment. Companion diagnostic approvals continue to align with targeted therapeutic approvals because treatment effectiveness depends on accurate patient selection. Diagnostic manufacturers are investing in analytical validation, quality assurance, and regulatory compliance to satisfy evolving approval requirements.

Market Restraints

Limited reimbursement consistency across healthcare systems restricts routine adoption of comprehensive genomic profiling despite expanding clinical utility. Coverage policies differ across regions and payers, creating uncertainty for diagnostic providers and limiting patient access to advanced testing options. Variability in specimen quality and pre-analytical laboratory processes affects analytical performance, creating challenges for standardized interpretation. The lack of standardized protocols across different laboratories can lead to inconsistent results and reduced clinical confidence. Shortages of molecular pathology expertise and bioinformatics capabilities constrain implementation in several emerging healthcare markets. The limited availability of trained personnel capable of interpreting complex genomic data reduces the scalability of biomarker testing services. Regulatory complexities across different jurisdictions create compliance burdens for diagnostic manufacturers seeking to commercialize new testing solutions. The evolving regulatory landscape requires continuous adaptation, increasing operational costs and time-to-market for new products.

Technology and Segment Insights

The technology landscape is characterized by the growing importance of comprehensive genomic profiling platforms. Demand is shifting from single-gene assays to multiplex sequencing technologies because targeted therapies continue expanding across multiple tumor types. Clinical laboratories are adopting NGS platforms that simultaneously evaluate numerous actionable biomarkers, strengthening utilization of comprehensive genomic profiling. PCR technologies remain widely utilized for focused biomarker detection where rapid turnaround and cost-effectiveness are priorities. IHC and FISH technologies continue supporting established protein and chromosomal biomarker assessment. Liquid biopsy technologies are reshaping testing paradigms by enabling minimally invasive genomic assessment through circulating tumor DNA and circulating tumor cells. The segment analysis reveals that genetic biomarkers constitute the largest demand segment because precision oncology increasingly depends on identifying actionable genomic alterations before therapy selection. Solid tumors, including breast, lung, colorectal, prostate, and melanoma, represent major testing opportunities due to the expanding availability of targeted therapeutics. Hematological malignancies also generate substantial demand because genetic profiling supports diagnosis and treatment planning. Tissue biopsy remains the diagnostic reference standard because histopathological confirmation and molecular characterization originate from tumor specimens. Liquid biopsy adoption is expanding for longitudinal disease monitoring where repeated tissue biopsies remain clinically challenging. Clinical diagnostic laboratories and hospitals represent key end-user segments, with pharmaceutical and biotechnology companies playing an increasingly important role in companion diagnostic development. The integration of artificial intelligence is becoming increasingly important because large genomic datasets require sophisticated analytical interpretation. AI is supporting automated variant prioritization, evidence synthesis, and treatment recommendation workflows, reducing interpretation time while improving reporting consistency.

Competitive and Strategic Outlook

The competitive landscape features established diagnostic companies with broad oncology portfolios alongside specialized molecular testing and liquid biopsy providers. F. Hoffmann-La Roche maintains a leading position through its integrated pharmaceuticals and diagnostics business, enabling simultaneous development of targeted therapies and companion diagnostics. QIAGEN specializes in molecular diagnostics and sample preparation technologies, with a strong focus on companion diagnostics and biomarker discovery. Illumina remains a global leader in NGS platforms that support comprehensive genomic profiling across clinical oncology. Thermo Fisher Scientific offers an extensive portfolio of sequencing instruments, PCR technologies, and clinical diagnostic solutions for oncology applications. Abbott strengthens its oncology diagnostics portfolio through molecular testing platforms and automated laboratory solutions that improve diagnostic efficiency. Danaher leverages its diagnostics subsidiaries and life science technologies to deliver advanced molecular testing solutions. Guardant Health differentiates itself through liquid biopsy expertise and extensive oncology-focused assay development. Natera emphasizes personalized molecular monitoring and recurrence detection through MRD testing. Companies are pursuing product portfolio expansion through innovation in multi-omics platforms, liquid biopsy technologies, and AI-enabled interpretation tools. Strategic collaborations between diagnostic manufacturers and pharmaceutical companies are increasing, driven by the need for companion diagnostic development alongside targeted therapies. Recent key developments include Foundation Medicine announcing plans to launch advanced digital solutions to support patient care management throughout the cancer treatment continuum. Myriad Genetics received FDA approval of the MyChoice CDx Test as the companion diagnostic for Zejula in ovarian cancer and commercially launched the Precise MRD test for breast cancer. Exact Sciences launched Cancerguard, a multi-cancer early detection blood test scanning for 50 different cancers. Geographic expansion remains a key strategic priority, with companies targeting rapidly growing emerging markets. Mergers and acquisitions are occurring as larger players seek to expand market presence and technology capabilities.

Short Conclusion

The cancer biomarker testing market is positioned for sustained growth driven by the convergence of precision oncology, technological innovation, and expanding healthcare investment. The transition from single-gene assays to comprehensive genomic profiling and integrated multi-omics platforms represents a fundamental shift in cancer management. While challenges related to reimbursement consistency, specimen quality variability, and expertise shortages persist, strategic investments in technology, evidence generation, and regulatory compliance are creating durable competitive advantages for market leaders. The long-term market outlook remains positive, with cancer biomarker testing evolving into an essential enabler of personalized treatment, improved clinical outcomes, and future oncology innovation across the entire continuum of cancer care.

Key Benefits of this Report

Insightful Analysis: Detailed market insights across regions, customer segments, policies, socio-economic factors, consumer preferences, and industry verticals.
Competitive Landscape: Understand strategic moves by key players to identify optimal market entry approaches.
Market Drivers and Future Trends: Assess major growth forces and emerging developments shaping the market.
Actionable Recommendations: Support strategic decisions to unlock new revenue streams.
Caters to a Wide Audience: Suitable for startups, research institutions, consultants, SMEs, and large enterprises.

What Businesses Use Our Reports For

Industry and market insights, opportunity assessment, product demand forecasting, market entry strategy, geographical expansion, capital investment decisions, regulatory analysis, new product development, and competitive intelligence.

Report Coverage

Historical data from 2021 to 2024, Base year 2025, and Forecast years from 2026 to 2035
Growth opportunities, challenges, supply chain outlook, regulatory framework, and trend analysis
Competitive positioning, strategies, and market share evaluation, and trade analysis
Revenue growth and forecast assessment across segments and regions
Company profiling including strategies, products, financials, and key developments

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 Biomarker Testing Market Overview, Size & Forecast

3.1 Market Definition & Scope
3.2 Cancer Biomarker Testing 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 Cancer Burden & Unmet Clinical Needs
3.8 Epidemiology & Cancer Incidence Analysis
3.9 Biomarker Testing Volume Analysis
3.10 Companion Diagnostics Landscape
3.11 Precision Oncology Testing Adoption Analysis
3.12 Patient Testing Pathway Analysis

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 Technologies
6.2 Product Innovation
6.3 Clinical Trial Analysis
6.4 Pipeline Analysis
6.5 Liquid Biopsy Technology Roadmap
6.6 Artificial Intelligence Integration in Biomarker Testing
6.7 Digital Pathology & Genomic Data Integration

7. Regulatory Landscape

7.1 Regulatory Framework
7.2 Approval Pathways
7.3 Compliance Requirements

8. Global Cancer Biomarker Testing Market Landscape Analysis

8.1 Analysis by Biomarker Type
8.2 Analysis by Technology
8.3 Analysis by Sample Type
8.4 Analysis by Cancer Type
8.5 Analysis by Clinical Application
8.6 Analysis by End User

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

9.1 By Biomarker Type
- 9.1.1 Genetic Biomarkers
- 9.1.2 Protein Biomarkers
- 9.1.3 Other Biomarkers
9.2 By Technology
- 9.2.1 Polymerase Chain Reaction (PCR)
- 9.2.2 Next-Generation Sequencing (NGS)
- 9.2.3 Immunohistochemistry (IHC)
- 9.2.4 Fluorescence In Situ Hybridization (FISH)
- 9.2.5 Other Technologies
9.3 By Sample Type
- 9.3.1 Tissue Biopsy
- 9.3.2 Liquid Biopsy
- 9.3.3 Urine
- 9.3.4 Other Body Fluids
9.4 By Cancer Type
- 9.4.1 Solid Tumor
  - 9.4.1.1 Breast Cancer
  - 9.4.1.2 Lung Cancer
  - 9.4.1.3 Colorectal Cancer
  - 9.4.1.4 Prostate Cancer
  - 9.4.1.5 Melanoma
  - 9.4.1.6 Others
- 9.4.2 Hematological Malignancies
9.5 By Clinical Application
- 9.5.1 Risk Assessment
- 9.5.2 Early Detection & Screening
- 9.5.3 Diagnosis
- 9.5.4 Prognosis
- 9.5.5 Treatment Monitoring
- 9.5.7 Others
9.6 By End User
- 9.6.1 Hospitals & Specialty Clinics
- 9.6.2 Clinical Diagnostic Laboratories
- 9.6.3 Pharmaceutical & Biotechnology Companies
- 9.6.4 Others

10. Global Cancer Biomarker Testing 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 Biomarker Testing 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 Japan
11.9 China
11.10 India
11.11 South Korea
11.12 Australia
11.13 Brazil
11.14 Saudi Arabia
11.15 South Africa

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 QIAGEN N.V.
13.3 Illumina, Inc.
13.4 Thermo Fisher Scientific Inc.
13.5 Abbott Laboratories
13.6 Danaher Corporation
13.7 Qiagen
13.8 Guardant Health, Inc.
13.9 Siemens AG
13.10 Natera