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市場調查報告書

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2126334

伴隨診斷市場：策略洞察與預測（2026-2035 年）

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

出版日期: 2026年08月03日 | 出版商:

Knowledge Sourcing Intelligence | 英文 174 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄

伴隨診斷市場預計將從 2026 年的 81 億美元成長到 2035 年的 209.3 億美元，複合年成長率為 11.1%。

伴隨診斷市場正經歷重大變革，其驅動力是精準醫療和基於生物標記的治療選擇模式轉移。這一市場演變的特點是，人們日益認知到，準確的生物標記識別對於確定患者合格治療條件以及最佳化標靶治療的療效至關重要。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，使得基因組分析更全面且有效率。製藥公司正在加強與診斷試劑生產商的合作開發夥伴關係，加速臨床開發並與監管申報同步進行。監管機構不斷提高對治療產品和伴隨診斷試劑的檢驗、臨床和協作檢驗的要求，這增加了開發的複雜性，但也增強了人們對臨床效用價值的信心。隨著對液態生物檢體技術、人工智慧驅動的數據解讀以及不斷擴展的生物標記組合的大量投資，伴隨診斷正在成為個人化醫療的基礎工具。隨著精準醫療的普及，伴隨診斷正從支持標靶治療轉變為腫瘤學和新興治療領域臨床決策的重要組成部分。

市場促進因素

精準腫瘤藥物研發的拓展是伴隨診斷市場的主要動力。精準腫瘤學是需求的主要促進因素，因為標靶治療需要在治療開始前識別檢驗的生物標記。腫瘤藥物研發管線擴大納入分子層面的選擇標準，以在臨床開發階段確定患者的合格。這種發展趨勢促使整個藥物商業化過程中對精準診斷檢測的依賴性不斷增強，從而推動伴隨診斷應用的持續成長。次世代定序次世代定序(NGS) 的日益普及透過實現全面的生物標記分析，進一步加速了市場成長。 NGS 允許透過單一工作流程同時分析多種臨床相關的生物標記。多重分析提高了診斷效率，同時減少了切片檢查組織量有限的患者的組織消耗。這項能力支持了精準腫瘤學中日益複雜的治療流程，從而增強了對基於 NGS 的伴隨診斷的需求。製藥公司和診斷開發公司之間日益增多的合作開發夥伴關係正在推動研發和商業化的同步進行。伴隨診斷需要同步的臨床證據來證明其治療效果和診斷效能。製藥公司在藥物發現、臨床試驗和監管申報的整個過程中都與診斷開發商密切合作。這種合作降低了研發過程中的不確定性，並有助於與監管機構協調。液態生物檢體的應用範圍不斷擴大，增強了疾病的長期管理能力。液態生物檢體是傳統組織切片檢查的補充，它能夠以微創的方式檢測循環腫瘤DNA和其他分子生物標記。這種方法允許在整個治療期間重複採集檢體，從而可以動態評估疾病進展和治療反應。伴隨診斷的作用範圍正在從初始治療方案的選擇擴展到疾病的長期管理。

市場限制因素

伴隨診斷和治療通常需要經過協調一致的審查流程，由於監管檢驗要求，導致研發週期延長。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。即使臨床效用得到證實，不同醫療體系報銷標準的不統一性也限制了全面分子檢測的常規應用。保險覆蓋政策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。先進的定序基礎設施、專業的檢查室人員和生物資訊學能力增加了許多醫療機構的實施成本。先進技術所需的大量投資對資源有限的小規模機構和環境構成了障礙。不同司法管轄區法規的複雜性也給尋求將新型伴隨診斷解決方案商業化的製造商帶來了合規負擔。

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）
- 原位雜合反應（ISH）
- 其他
依生物標誌類型
- 基因生物標記
- 蛋白質體學生物標記
- 基因表現標記
- 表觀遺傳生物標記
- 其他
適應症
- 非小細胞肺癌（NSCLC）
- 乳癌
- 結腸癌
- 黑色素瘤
- 卵巢癌
- 骨髓惡性腫瘤
- 其他
依樣本類型
- 組織切片檢查
- 液態生物檢體
- 其他生物檢體
最終用戶
- 醫院
- 診斷檢查室
- 學術研究機構
- 其他

第10章：全球伴隨診斷市場：區域分析

北美洲
歐洲
亞太地區
南美洲
中東和非洲

第11章全球伴隨診斷市場：國家分析

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
墨西哥
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

Abbott
Agilent Technologies, Inc.
QIAGEN NV
F. Hoffmann-La Roche Ltd
Thermo Fisher Scientific Inc.
Illumina, Inc.
Siemens AG
bioMerieux SA
Myriad Genetics, Inc.
Guardant Health, Inc.

第14章全球伴隨診斷市場：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-009046

The Companion Diagnostics Market is expected to grow at a CAGR of 11.1% from a market value of USD 8.10 billion in 2026 to USD 20.93 billion in 2035.

The companion diagnostics market is undergoing significant transformation driven by the paradigm shift toward precision medicine and biomarker-guided therapeutic selection. The market's evolution is characterized by the growing recognition that targeted therapies depend on accurate biomarker identification to determine patient eligibility and optimize treatment outcomes. The convergence of advanced molecular technologies, including next-generation sequencing, polymerase chain reaction, and immunohistochemistry, is enabling more comprehensive and efficient genomic analysis. Pharmaceutical companies are strengthening co-development partnerships with diagnostic manufacturers, accelerating synchronized clinical development and regulatory submissions. Regulatory agencies continue strengthening expectations for analytical validation, clinical validation, and coordinated review of therapeutic products and companion diagnostics, increasing development complexity but also improving confidence in clinical utility. The market is witnessing significant investment in liquid biopsy technologies, AI-enabled data interpretation, and expanded biomarker panels, positioning companion diagnostics as foundational tools within personalized healthcare. As precision medicine adoption expands, companion diagnostics are transitioning from supporting targeted therapies to becoming essential components of clinical decision-making across oncology and emerging therapeutic areas.

Market Drivers

The expansion of precision oncology drug development represents the primary driver for the companion diagnostics market. Precision oncology represents the primary demand driver because targeted therapies require validated biomarker identification before treatment initiation. Oncology pipelines are increasingly incorporating molecular selection criteria that define patient eligibility during clinical development. This evolution increases dependence on accurate diagnostic testing throughout drug commercialization, resulting in sustained growth in companion diagnostic utilization. The increasing adoption of next-generation sequencing is further accelerating market growth by enabling comprehensive biomarker analysis. NGS enables simultaneous analysis of numerous clinically relevant biomarkers through a single workflow. Multiplex testing improves diagnostic efficiency while reducing tissue consumption in patients with limited biopsy material. This capability supports increasingly complex precision oncology treatment algorithms, strengthening demand for NGS-based companion diagnostics. Rising pharmaceutical-diagnostic co-development partnerships are driving synchronized development and commercialization. Companion diagnostics require synchronized clinical evidence demonstrating both therapeutic efficacy and diagnostic performance. Pharmaceutical companies collaborate with diagnostic developers throughout drug discovery, clinical trials, and regulatory submission processes. These partnerships reduce development uncertainty while improving regulatory coordination. The expansion of liquid biopsy applications is strengthening longitudinal disease management capabilities. Liquid biopsy complements traditional tissue biopsy by enabling minimally invasive detection of circulating tumor DNA and other molecular biomarkers. This approach supports repeated sampling throughout treatment, providing a dynamic assessment of disease progression and therapeutic response. Companion diagnostics extend beyond initial treatment selection into longitudinal disease management.

Market Restraints

Regulatory validation requirements increase development timelines because companion diagnostics and therapeutics frequently undergo coordinated review processes. The rigorous evidence requirements create significant time and cost burdens for developers. Limited reimbursement consistency across healthcare systems restricts routine adoption of comprehensive molecular testing despite demonstrated clinical utility. Inconsistent coverage policies across regions create uncertainty for diagnostic providers and limit patient access. Advanced sequencing infrastructure, specialized laboratory personnel, and bioinformatics capabilities increase implementation costs for many healthcare providers. The significant investment required for advanced technologies creates barriers for smaller facilities and resource-constrained settings. Regulatory complexities across different jurisdictions create compliance burdens for manufacturers seeking to commercialize new companion diagnostic solutions.

Technology and Segment Insights

The technology landscape is characterized by the growing importance of comprehensive genomic profiling platforms. Demand is shifting from sequential single-gene testing toward NGS-based companion diagnostics that simultaneously evaluate numerous clinically relevant variants. NGS platforms are replacing single-gene testing, reducing diagnostic turnaround time while improving biomarker coverage. PCR remains important for focused biomarker detection where rapid turnaround and cost-effectiveness are priorities. IHC and ISH technologies continue supporting established protein and gene expression biomarker assessment. Liquid biopsy is becoming an increasingly important sample type because minimally invasive blood collection supports repeated molecular assessment throughout treatment. The segment analysis reveals that genomic biomarkers represent the largest segment because most targeted oncology therapies rely on identifying actionable DNA alterations that predict therapeutic response. Demand is increasing as NGS replaces sequential single-gene testing across multiple cancer indications. Non-Small Cell Lung Cancer remains one of the largest companion diagnostic markets because actionable biomarkers, including EGFR, ALK, ROS1, BRAF, MET, RET, KRAS, HER2, and NTRK, influence therapeutic eligibility. Breast cancer increasingly relies on HER2, BRCA1/2, PIK3CA, ESR1, and additional genomic biomarkers for treatment optimization. Diagnostic laboratories represent the leading end-user segment because advanced molecular testing requires specialized sequencing platforms, bioinformatics infrastructure, and quality-controlled analytical workflows. Hospitals and academic research institutes are expanding testing capabilities. The integration of AI is becoming increasingly important because genomic testing generates complex datasets requiring efficient interpretation. AI supports automated variant classification, workflow optimization, and clinical reporting, improving consistency while reducing analytical turnaround time.

Competitive and Strategic Outlook

The competitive landscape features established diagnostic and life science companies alongside specialized molecular testing and liquid biopsy providers. Abbott strengthens its position through a diversified molecular diagnostics portfolio and global laboratory presence supporting precision medicine, continuing to expand companion diagnostic collaborations with pharmaceutical developers. Agilent differentiates itself through its expertise in pathology, genomics, and companion diagnostic assay development, strengthening strategic partnerships with biopharmaceutical sponsors to co-develop biomarker-driven diagnostic solutions. QIAGEN is a leading provider of molecular testing technologies with a broad portfolio of PCR and NGS-based companion diagnostics, continuing to expand pharmaceutical collaborations to support biomarker identification and regulatory-approved precision therapies. Roche maintains one of the strongest integrated pharmaceutical and diagnostics ecosystems, continuously co-developing companion diagnostics alongside targeted oncology drugs, enabling synchronized regulatory approvals. Thermo Fisher Scientific leverages its comprehensive molecular diagnostics, sequencing, and laboratory solutions to support precision oncology, expanding its companion diagnostic portfolio through strategic collaborations. Illumina leads the market in NGS platforms that underpin comprehensive genomic profiling for companion diagnostics, continuing to advance regulatory-approved NGS-based assays. 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 Leica Biosystems and CellCarta expanding their collaborative companion diagnostic development model to accelerate commercialization globally, introducing a flexible global framework for CDx development. Lunit Oncology and CellCarta announced a strategic collaboration to accelerate AI-enabled digital pathology for companion diagnostic programs. Geographic expansion remains a key strategic priority, with companies targeting rapidly growing Asia Pacific and emerging markets where healthcare infrastructure is expanding. Mergers and acquisitions are occurring as larger players seek to expand market presence and technology capabilities.

Short Conclusion

The companion diagnostics market is positioned for sustained growth driven by the convergence of precision oncology, pharmaceutical co-development, and technological innovation. The transition from supporting targeted therapies to becoming foundational tools within personalized healthcare represents a fundamental shift in clinical decision-making. While challenges related to regulatory complexity, reimbursement variability, and high implementation costs persist, strategic investments in technology, partnerships, and evidence generation 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 medicine across oncology and emerging therapeutic areas, supporting improved patient outcomes through biomarker-guided treatment selection.

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 Market Overview, Size & Forecast

3.1 Market Definition & Scope
3.2 Industry Overview
3.3 Industry Evolution
3.4 Key Market Trends
3.5 Historical Market Size Analysis (2021-2025)
3.6 Market Forecast Analysis (2026-2035)
3.7 Oncology Biomarker Landscape
3.8 Companion Diagnostics Development Ecosystem
3.9 Disease Burden and Precision Medicine Trends
3.10 Patient Testing and Adoption Analysis
3.11 Treatment Selection and Clinical Decision-Making Landscape

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
6.4 Companion Diagnostics Pipeline Analysis
6.5 Biomarker Discovery Trends
6.6 AI Integration in Companion Diagnostics
6.7 Digital Pathology and Next-Generation Sequencing Integration

7. Regulatory Landscape

7.1 Regulatory Framework
7.2 Approval Pathways
7.3 Compliance Requirements

8. Global Companion Diagnostics Market Landscape Analysis

8.1 Analysis by Technology Platform
8.2 Analysis by Biomarker Type
8.3 Analysis by Sample Type
8.4 Analysis by Clinical Application
8.5 Analysis by Testing Methodology
8.6 Analysis by End-use Setting

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

9.1 By Technology
- 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 Proteomic Biomarkers
- 9.2.3 Gene Expression Biomarkers
- 9.2.4 Epigenetic Biomarkers
- 9.2.5 Others
9.3 By Indication
- 9.3.1 Non-Small Cell Lung Cancer (NSCLC)
- 9.3.2 Breast Cancer
- 9.3.3 Colorectal Cancer
- 9.3.4 Melanoma
- 9.3.5 Ovarian Cancer
- 9.3.6 Hematological Malignancies
- 9.3.7 Others
9.4 By Sample Type
- 9.4.1 Tissue Biopsy
- 9.4.2 Liquid Biopsy
- 9.4.3 Other Biological Samples
9.5 By End User
- 9.5.1 Hospitals
- 9.5.2 Diagnostic Laboratories
- 9.5.3 Academic & Research Institutes
- 9.5.4 Others

10. Global Companion 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 Companion 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 Japan
11.9 China
11.10 India
11.11 South Korea
11.12 Australia
11.13 Brazil
11.14 Mexico
11.15 Saudi Arabia
11.16 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 Abbott
- 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 F. Hoffmann-La Roche Ltd
13.5 Thermo Fisher Scientific Inc.
13.6 Illumina, Inc.
13.7 Siemens AG
13.8 bioMerieux SA
13.9 Myriad Genetics, Inc.
13.10 Guardant Health, Inc.