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2126412

全球伴隨診斷（CDx）市場－競爭格局分析，2026年

Global Companion Diagnostics (CDx) Market - Competitive Landscape Analysis, 2026

出版日期: 2026年08月11日 | 出版商:

Knowledge Sourcing Intelligence | 英文 185 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

由於精準腫瘤學模式轉移、基於生物標記的療法研發日益複雜以及分子診斷在常規臨床實踐中日益普及，伴隨診斷市場正經歷顯著的變革。這個市場演變的特點在於，人們逐漸認知到伴隨診斷對於基於遺傳、基因組、蛋白質組或分子生物標記識別能夠預測治療反應的患者至關重要，從而提高治療效果並最大限度地減少不必要的標靶治療。次世代定序、聚合酵素鏈鎖反應(PCR) 和免疫組織化學等先進分子技術的融合，使得生物標記的評估更加全面和標準化。製藥公司正在擴大以生物標記主導的臨床試驗，從而推動了對多重分子檢測的需求，以提高患者分層和臨床試驗效率。監管機構繼續透過協調的監管流程批准伴隨診斷及其相應的抗癌療法，同時加強對臨床性能和分析有效性的證據要求。隨著對液態生物檢體技術、人工智慧驅動的解讀平台以及製藥公司和診斷公司之間策略合作的大量投資，伴隨診斷正在成為全球醫療保健系統中實現精準醫療的關鍵要素。

市場動態

市場促進因素

精準腫瘤治療的擴展是伴隨診斷市場的主要驅動力。由於大多數標靶治療需要在治療開始前識別生物標記物，精準腫瘤仍然是關鍵的成長要素。隨著基因組研究的進展，在多種癌症類型中發現了新的可治療標靶突變，製藥公司不斷擴大基於生物標記的臨床試驗。這項進展推動了對經過驗證的伴隨檢驗的需求，這些診斷能夠在臨床開發和商業化的各個階段準確識別合格的患者。因此，標靶治療產品線的擴展增強了對先進分子檢測平台的長期需求，並推動了伴隨診斷應用的持續成長。全面基因組分析的日益普及透過提高診斷效率進一步加速了市場成長。全面基因組分析能夠同時評估單一患者檢體中的多個可治療標靶生物標記。臨床檢查室正在從順序單基因檢測轉向多重NGS工作流程。這是因為更廣泛的分子表徵可以在節省有限的組織檢體的同時提高診斷效率。這項轉變有助於加速治療決策，並推動高通量定序技術在整個癌症治療過程中的應用。液態生物檢體的廣泛應用透過微創檢測提升了診斷能力。液態生物檢體能夠以微創方式檢測循環腫瘤DNA和其他分子生物標記物，從而拓展了診斷範圍。醫療專業人員擴大使用血液檢測進行治療監測和抗藥性突變檢測。診斷公司正透過提高分析靈敏度和擴大生物標記覆蓋範圍來應對這一需求。製藥公司和診斷公司之間的策略合作對於透過整合開發拓展市場至關重要。伴隨診斷需要與標靶治療療法進行合作開發，因此策略夥伴關係是市場拓展的基礎。

市場限制因素

臨床檢驗要求依然繁瑣，增加了伴隨診斷的研發成本，並延長了法規核准時間。嚴格的證據要求給研發人員帶來了巨大的時間和經濟負擔。即使臨床效用價值得到證實，不同醫療體系的報銷政策也限制了先進分子檢測技術的普及應用。保險覆蓋範圍的區域差異給診斷服務提供者帶來了不確定性，並限制了患者的就醫途徑。在某些醫療機構，專業分子檢測設施的匱乏限制了複雜伴隨診斷技術的應用。專業檢測設施和訓練有素的人員短缺限制了先進診斷技術的擴充性。區域間法規的複雜性也給尋求將新型診斷解決方案商業化的製造商帶來了合規負擔。

市場機遇

隨著精準醫療拓展至免疫學、神經病學、感染疾病和罕見遺傳疾病等領域，腫瘤學以外的領域蘊藏著巨大的機會。製藥公司正在這些領域探索基於生物標記的治療策略，這為診斷試劑製造商創造了機會，使其能夠拓展檢測產品組合，同時降低對以腫瘤學為中心的收入來源的依賴。人工智慧 (AI) 與分子分析的融合正在改善突變分類和臨床報告。 AI 透過輔助自動突變分類和臨床報告，增強了對複雜基因組資料集的解讀。隨著生物標記複雜性的增加，對可擴展分析能力的需求日益成長，促使診斷公司採用先進的生物資訊平台。多生物標記伴隨診斷的發展使得透過單一的綜合檢測即可支持多種治療決策成為可能。標靶治療越來越依賴多種基因組突變，而非單一生物標記。診斷試劑開發商正在擴展多重檢測平台，以同時評估多種預測性生物標記。全球監管協調正在創造更廣泛的商業化機會。監管機構正持續加強體外診斷醫療器材評估和精準醫療標準的國際一致性。

市場定義和範圍
伴隨診斷行業概覽
伴隨診斷市場的演變
主要市場趨勢
市場規模表現分析
市場預測
腫瘤伴隨診斷市場趨勢
腫瘤領域以外的伴隨診斷
生物標記市場趨勢分析
按治療領域分類的已通過核准伴隨診斷
伴隨診斷和藥物協同開發的發展趨勢
伴隨診斷在臨床環境中的實施現狀

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
伴隨診斷流程分析
人工智慧在伴隨診斷的應用
數位病理學與數位健康的融合

第7章監理情勢

法律規範
核准流程
- 上市前批准（PMA）
- 510（k）
- 全新分類
- 基於體外診斷醫療器材法規 (IVDR) 的 CE 標誌
- 獲得各國監管機構的批准
- 同時批准藥品和伴隨診斷
- 後續伴隨診斷的批准
- 橋接測試
合規要求

第8章：全球伴隨診斷（CDx）競爭格局分析

分析：按技術平台
分析：依生物標記類型
分析：依樣本類型
分析：透過調查方法
分析：透過臨床應用
按監管狀態分析

第9章：全球伴隨診斷（CDx）市場的競爭格局與細分市場分析

透過技術平台
- 聚合酵素鏈鎖反應（PCR）
- 次世代定序（NGS）
- 免疫組織化學（IHC）
- 原位雜合反應（ISH）
- 其他
依生物標誌類型
- 基因生物標記
- 蛋白質生物標記
- 基因表現標記
- 其他
依樣本類型
- 組織
- 血液（液態生物檢體）
- 其他
按治療區域
- 腫瘤學適應症
  - 乳癌
  - 非小細胞肺癌
  - 結腸癌
  - 黑色素瘤
  - 卵巢癌
  - 骨髓惡性腫瘤
  - 其他
- 非腫瘤領域的適應症
最終用戶
- 醫院
- 參考實驗室
- 學術研究機構
- 其他

第10章：全球伴隨診斷（CDx）競爭格局的區域分析

北美洲
歐洲
亞太地區
南美洲
中東和非洲

第11章：伴隨診斷（CDx）全球競爭格局的國別分析

美國
加拿大
德國
英國
法國
義大利
西班牙
日本
中國
韓國
澳洲
印度
巴西

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.
Agilent Technologies, Inc.
QIAGEN NV
Thermo Fisher Scientific Inc.
Illumina, Inc.
BioMerieux
Exact Sciences
Guardant Health, Inc.
Foundation Medicine, Inc.
Abbott Laboratories

第14章：伴隨診斷（CDx）的全球競爭格局與市場預測分析

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-009123

The companion diagnostics market is undergoing significant transformation driven by the paradigm shift toward precision oncology, the increasing complexity of biomarker-guided therapeutic development, and the growing integration of molecular diagnostics into routine clinical practice. The market's evolution is characterized by the recognition that companion diagnostics are essential for identifying patients based on genetic, genomic, proteomic, or molecular biomarkers that predict treatment response, thereby improving therapeutic efficacy and minimizing unnecessary exposure to targeted drugs. The convergence of advanced molecular technologies, including next-generation sequencing, polymerase chain reaction, and immunohistochemistry, is enabling more comprehensive and standardized biomarker assessment. Pharmaceutical companies are expanding biomarker-driven clinical trials, increasing demand for multiplex molecular assays that improve patient stratification and clinical trial efficiency. Regulatory agencies continue to approve companion diagnostics alongside corresponding oncology therapeutics through coordinated regulatory pathways, while strengthening evidence requirements for clinical performance and analytical validation. The market is witnessing significant investment in liquid biopsy technologies, AI-enabled interpretation platforms, and strategic pharmaceutical-diagnostic collaborations, positioning companion diagnostics as a critical enabler of precision medicine across global healthcare systems.

Market Dynamics

Market Drivers

The expansion of precision oncology therapeutics represents the primary driver for the companion diagnostics market. Precision oncology remains the primary growth driver because most targeted therapies depend on biomarker identification before treatment initiation. Pharmaceutical companies are continuing to expand biomarker-selected clinical trials as genomic discoveries identify new actionable mutations across multiple cancer types. This progression increases demand for validated companion diagnostics capable of accurately identifying eligible patients throughout clinical development and commercial practice. The expanding pipeline of targeted therapies therefore strengthens long-term demand for advanced molecular testing platforms, resulting in sustained growth in companion diagnostic utilization. The increasing adoption of comprehensive genomic profiling is further accelerating market growth through improved diagnostic efficiency. Comprehensive genomic profiling enables simultaneous evaluation of numerous actionable biomarkers from a single patient specimen. Clinical laboratories are increasingly replacing sequential single-gene testing with multiplex NGS workflows because broader molecular characterization improves diagnostic efficiency while conserving limited tissue samples. This transition supports faster therapeutic decision-making and increases utilization of high-throughput sequencing technologies across oncology care pathways. The growth of liquid biopsy applications is expanding diagnostic capabilities through minimally invasive testing. Liquid biopsy expands diagnostic capabilities by enabling minimally invasive detection of circulating tumor DNA and other molecular biomarkers. Healthcare providers are increasingly adopting blood-based testing for treatment monitoring and resistance mutation detection because repeated tissue biopsies often present clinical limitations. Diagnostic developers are responding by improving analytical sensitivity and expanding biomarker coverage. Strategic pharmaceutical-diagnostic collaborations are fundamental to market expansion through integrated development. Companion diagnostics require coordinated development with targeted therapeutics, making strategic partnerships fundamental to market expansion.

Market Restraints

Clinical validation requirements remain extensive, increasing development costs and extending regulatory approval timelines for companion diagnostics. The rigorous evidence requirements create significant time and cost burdens for developers. Reimbursement policies differ across healthcare systems, limiting consistent adoption of advanced molecular testing despite demonstrated clinical utility. Inconsistent coverage across regions creates uncertainty for diagnostic providers and limits patient access. Limited access to specialized molecular laboratories restricts implementation of complex companion diagnostic technologies in several healthcare settings. The shortage of specialized laboratories and trained personnel limits the scalability of advanced diagnostics. Regulatory complexities across different jurisdictions create compliance burdens for manufacturers seeking to commercialize new diagnostic solutions.

Market Opportunities

The expansion beyond oncology represents a significant opportunity as precision medicine extends into immunology, neurology, infectious diseases, and rare genetic disorders. Drug developers are exploring biomarker-guided treatment strategies across these therapeutic areas, creating opportunities for diagnostic manufacturers to diversify assay portfolios while reducing dependence on oncology-focused revenues. The integration of artificial intelligence in molecular interpretation is improving variant classification and clinical reporting. AI improves interpretation of complex genomic datasets by supporting automated variant classification and clinical reporting. Diagnostic companies are integrating advanced bioinformatics platforms because increasing biomarker complexity requires scalable analytical capabilities. The growth of multi-biomarker companion diagnostics is enabling support for multiple therapeutic decisions through one comprehensive assay. Targeted therapies increasingly depend on multiple genomic alterations rather than single biomarkers. Diagnostic developers are expanding multiplex testing platforms that evaluate several predictive biomarkers simultaneously. Increasing global regulatory harmonization is enabling broader commercialization opportunities. Regulatory authorities are continuing to strengthen international alignment for in vitro diagnostic evaluation and precision medicine standards.

Technology and Product Insights

The technology landscape is characterized by the growing importance of comprehensive genomic profiling, liquid biopsy, and integrated bioinformatics platforms. NGS platforms are replacing multiple single-gene assays because comprehensive genomic profiling improves laboratory workflow efficiency while supporting a growing number of actionable biomarkers. PCR remains important for focused mutation detection where rapid turnaround is prioritized. IHC continues supporting protein biomarker assessment for biomarkers including PD-L1 and HER2. ISH remains essential for gene amplification and rearrangement detection. Liquid biopsy is gaining clinical acceptance because minimally invasive sampling supports treatment monitoring, resistance mutation detection, and longitudinal disease assessment. The segment analysis reveals that oncology represents the largest therapeutic segment because targeted cancer therapies increasingly depend on validated biomarker identification before treatment initiation. Pharmaceutical developers are expanding biomarker-enriched clinical programs as genomic discoveries continue identifying actionable mutations across multiple tumor types. Breast cancer represents one of the largest applications because HER2, PIK3CA, ESR1, BRCA1/2, and other actionable biomarkers increasingly determine treatment eligibility. NSCLC requires comprehensive molecular profiling for EGFR, ALK, ROS1, BRAF, RET, MET, KRAS, HER2, and NTRK before first-line targeted therapy. Reference laboratories occupy a central position within the companion diagnostics ecosystem because they perform high-complexity molecular testing at scale. The integration of AI is becoming increasingly important because AI improves interpretation of complex genomic datasets by supporting automated variant classification and clinical reporting.

Competitive and Strategic Outlook

The competitive landscape features established diagnostics and life science companies alongside specialized precision oncology, molecular, and liquid biopsy providers. Roche remains the global leader because it combines one of the industry's largest oncology pharmaceutical portfolios with an extensive in vitro diagnostics business, enabling simultaneous advancement of targeted therapeutics and companion diagnostic assays. Agilent Technologies has established a strong position through its pathology, genomics, and molecular diagnostics capabilities, with its Dako immunohistochemistry portfolio remaining widely adopted for biomarker testing. QIAGEN continues expanding its companion diagnostics business through expertise in molecular testing, sample preparation, PCR technologies, and NGS solutions, collaborating extensively with pharmaceutical manufacturers. Thermo Fisher Scientific occupies a significant position through its comprehensive precision medicine ecosystem encompassing sequencing instruments, PCR platforms, bioinformatics, clinical laboratory solutions, and regulatory expertise. Illumina remains a foundational technology provider because its sequencing platforms underpin comprehensive genomic profiling across research, clinical development, and commercial oncology testing. bioMerieux is strengthening its presence by leveraging its expertise in molecular diagnostics, syndromic testing, and clinical microbiology while expanding precision medicine capabilities. Companies are pursuing product portfolio expansion through innovation in NGS panels, liquid biopsy assays, 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 NeoGenomics introducing an FDA-approved PTEN IHC companion diagnostic to identify prostate cancer patients whose tumors demonstrate PTEN loss and may be eligible for TRUQAP. CellCarta and Sonic Healthcare announced a partnership to support CDx commercialization through a global lab network. Labcorp announced nationwide availability of Agilent's PD-L1 IHC 22C3 pharmDx, the FDA-approved companion diagnostic used to identify patients with platinum-resistant ovarian cancer who may be eligible for KEYTRUDA. Geographic expansion remains a key strategic priority, with companies targeting rapidly growing Asia Pacific and emerging markets where healthcare infrastructure is expanding.

Short Conclusion

The companion diagnostics market is positioned for sustained growth driven by the convergence of precision oncology, technological innovation, and regulatory support. The transition from single-analyte testing toward integrated multi-biomarker platforms represents a fundamental shift in precision medicine. While challenges related to clinical validation, reimbursement variability, and infrastructure limitations persist, strategic investments in technology, partnerships, and global capabilities are creating durable competitive advantages for market leaders. The long-term market outlook remains positive, with companion diagnostics evolving into an essential component of precision healthcare, supporting therapeutic development, patient selection, and improved clinical outcomes across global healthcare systems.

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 Companion Diagnostics (CDx) Competitive Landscape Analysis Overview, Size & Forecast

3.1 Market Definition & Scope
3.2 Companion Diagnostics Industry Overview
3.3 Evolution of the Companion Diagnostics Market
3.4 Key Market Trends
3.5 Historical Market Size Analysis (2021-2025)
3.6 Market Forecast (2026-2035)
3.7 Oncology Companion Diagnostics Landscape
3.8 Companion Diagnostics Beyond Oncology
3.9 Biomarker Landscape Analysis
3.10 Approved Companion Diagnostics by Therapeutic Area
3.11 Companion Diagnostic-Drug Co-development Landscape
3.12 Companion Diagnostic Adoption Across Clinical Practice

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 Companion Diagnostic Pipeline Analysis
6.5 AI Integration in Companion Diagnostics
6.6 Digital Pathology & Digital Health Integration

7. Regulatory Landscape

7.1 Regulatory Framework
7.2 Approval Pathways
- 7.2.1 Premarket Approval (PMA)
- 7.2.2 510(k)
- 7.2.3 De Novo Classification
- 7.2.4 CE Mark under IVDR
- 7.2.5 National Regulatory Approval
- 7.2.6 Simultaneous Drug-CDx Co-approval
- 7.2.7 Follow-on Companion Diagnostic Approval
- 7.2.8 Bridging Studies
7.3 Compliance Requirements

8. Global Companion Diagnostics (CDx) Competitive Landscape Analysis

8.1 Analysis by Technology Platform
8.2 Analysis by Biomarker Type
8.3 Analysis by Sample Type
8.4 Analysis by Testing Methodology
8.5 Analysis by Clinical Application
8.6 Analysis by Regulatory Status

9. Global Companion Diagnostics (CDx) Competitive Landscape Segment Analysis (2021-2035)

9.1 By Technology Platform
- 9.1.1 Polymerase Chain Reaction (PCR)
- 9.1.2 Next-Generation Sequencing (NGS)
- 9.1.3 Immunohistochemistry (IHC)
- 9.1.4 In Situ Hybridization (ISH)
- 9.1.5 Others
9.2 By Biomarker Type
- 9.2.1 Genomic Biomarkers
- 9.2.2 Protein Biomarkers
- 9.2.3 Gene Expression Biomarkers
- 9.2.4 Others
9.3 By Sample Type
- 9.3.1 Tissue
- 9.3.2 Blood (Liquid Biopsy)
- 9.3.3 Others
9.4 By Therapeutic Area
- 9.4.1 Oncology Indication
  - 9.4.1.1 Breast Cancer
  - 9.4.1.2 Non-Small Cell Lung Cancer
  - 9.4.1.3 Colorectal Cancer
  - 9.4.1.4 Melanoma
  - 9.4.1.5 Ovarian Cancer
  - 9.4.1.6 Hematological Malignancies
  - 9.4.1.7 Other
- 9.4.2 Non-Oncology Indications
9.5 By End User
- 9.5.1 Hospitals
- 9.5.2 Reference Laboratories
- 9.5.3 Academic & Research Institutes
- 9.5.4 Others

10. Global Companion Diagnostics (CDx) Competitive Landscape 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 Companion Diagnostics (CDx) Competitive Landscape 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 South Korea
11.11 Australia
11.12 India
11.13 Brazil

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 Agilent Technologies, Inc.
13.3 QIAGEN N.V.
13.4 Thermo Fisher Scientific Inc.
13.5 Illumina, Inc.
13.6 BioMerieux
13.7 Exact Sciences
13.8 Guardant Health, Inc.
13.9 Foundation Medicine, Inc.
13.10 Abbott Laboratories