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2103138

胃癌診斷市場：策略性洞察與預測（2026-2035）

Diagnostics for Gastric Cancer Market - Strategic Insights and Forecasts (2026-2035)
出版日期: | 出版商: Knowledge Sourcing Intelligence | 英文 180 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

預計胃癌診斷市場將從 2026 年的 44.9 億美元成長到 2035 年的 102.1 億美元，複合年成長率為 9.6%。

胃癌診斷市場正經歷一場重大變革，其驅動力在於向生物標記驅動療法和精準腫瘤學的模式轉移。這一市場演變的特點是，人們日益認知到治療結果不僅取決於組織學分類，而且高度依賴準確的分子特徵分析。這種認知的提高催生了對能夠識別關鍵生物標記（例如 HER2、PD-L1、MSI 和 Claudin 18.2）的先進診斷解決方案的顯著需求。內視鏡診斷、組織病理學、分子檢測和液態生物檢體技術的整合，能夠實現更全面的疾病特徵分析和治療分層。由於治療選擇依賴分子層面的證據，醫療系統正擴大將生物標記評估納入診斷流程的早期階段。標靶治療和免疫療法的出現正在擴大臨床適用生物標記的範圍，從而催生對更廣泛診斷策略的需求。監管機構也認知到伴隨診斷在實現胃癌個人化治療中的關鍵作用，並正在加強監管。診斷設備製造商正在擴展其配套診斷產品線，並加強循證實踐，以支持臨床應用和醫療覆蓋範圍。市場正在對數位病理學、次世代定序和液態生物檢體技術進行大量投資，先進的診斷技術正成為胃癌治療的基石。

市場促進因素

基於生物標記的療法種類不斷擴展，是胃癌診斷市場的主要驅動力。分子標靶癌症療法需要進行分子層面的檢驗，因為治療效果取決於生物標記的狀態。隨著醫生需要在開始治療前識別合格的患者，對HER2、PD-L1、MSI和Claudin 18.2檢測的需求日益成長。這項需求推動了病理檢查室檢測數量的增加。醫療機構正在將生物標記評估更早納入診斷流程，從而增加了對胃癌診斷服務的需求。精準腫瘤學的日益普及進一步加速了市場成長。精準腫瘤學依賴全面的疾病表徵，因為腫瘤異質性會影響治療反應。隨著臨床醫生尋求更深入了解胃癌的生物學特徵，對分子診斷的需求不斷成長。這種期望推動了對先進檢測技術的更大需求。為了滿足這些需求，實驗室正在擴展其基因組分析能力，從而增加了分子診斷平台的使用。對疾病早期檢測的日益重視正在推動對先進診斷路徑的投資。胃癌的早期檢測能夠提供更廣泛的早期治療選擇，從而改善臨床療效。醫療系統致力於降低晚期患者就診率，促使醫療機構加強對先進內視鏡和病理技術的投資。醫療服務提供者正在實施更最佳化的診斷流程以提高檢出率，從而推動整個診斷生態系統的需求成長。伴隨診斷的發展正在促進標靶治療的應用。法規核准越來越重視治療和生物標記檢測的相關性，為診斷和治療藥物研發人員之間的合作創造了機會。診斷試劑生產商正在擴展其伴隨診斷產品組合以支持商業化進程，從而推動市場持續成長。

市場限制因素

分子檢測的高成本限制了其普及，因為其需要先進的技術、專門的基礎設施和專業知識。購買先進診斷設備和熟練人員所需的大量投資，對小規模檢查室和醫療機構而言是一大障礙。由於不同醫療系統和地區的支付方覆蓋範圍不同，報銷政策的差異也限制了檢測的可及性。不一致的報銷框架為診斷服務提供者帶來了不確定性，並限制了患者獲得先進檢測方案的機會。由於訓練有素的人員和先進的檢測設施集中在特定地區，專業病理服務的匱乏也限制了檢測的可及性。許多醫療系統缺乏分子病理學的專業知識，限制了生物標記檢測計畫的擴充性。複雜且區域差異顯著的監管環境，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。不斷變化的監管環境需要持續調整，導致營運成本增加，新產品上市時間延長。

目錄

第1章：執行摘要

  • 市場概述
  • 主要發現
  • 分析師意見
  • 策略建議

第2章：調查方法

  • 調查設計
  • 資料收集和調查方法
  • 市場規模估算
  • 預測模型
  • 先決條件和限制

第3章 胃癌診斷市場：概述、市場規模與預測

  • 市場定義和範圍
  • 胃癌診斷行業概覽
  • 產業變化
  • 主要市場趨勢
  • 市場規模表現分析
  • 市場預測分析
  • 胃癌症疾病負擔分析
  • 胃癌盛行率分析
  • 已確診患者族群的分析
  • 胃癌篩檢數量分析
  • 胃癌診斷中的病人歷程分析
  • 胃癌生物標記檢測的發展趨勢
  • HER2、PD-L1、MSI 和 Claudine 18.2 檢測趨勢

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

  • 胃癌診斷領域的新興技術
  • 產品創新
  • 臨床試驗分析
  • 管道分析
  • 技術藍圖
  • 人工智慧在胃癌診斷的應用
  • 數位病理學的整合

第7章 監理情勢

  • 法律規範
  • 核准流程
  • 合規要求

第8章：胃癌診斷市場：展望分析

  • 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：透過臨床應用
  • 分析：透過調查方法

第9章 胃癌診斷市場：細分市場分析

  • 按診斷類型
    • 內視鏡診斷
    • 組織病理學診斷
    • 分子診斷
    • 基於免疫組織化學（IHC）的診斷方法
    • 基於原位雜合反應（ISH）的診斷方法
    • 液態生物檢體診斷
  • 依生物標誌類型
    • HER2生物標記檢測
    • PD-L1生物標記檢測
    • 微衛星不穩定性（MSI）測試
    • Claudin 18.2 測試
    • EB病毒（EBV）檢測
    • 其他生物標記檢測
  • 透過技術
    • 免疫組織化學（IHC）
    • 螢光原位雜合反應（FISH）
    • 聚合酵素鏈鎖反應（PCR）
    • 次世代定序（NGS）
    • 數位病理學
    • 液態生物檢體技術
  • 依樣本類型
    • 組織切片檢查
    • 血液檢體
    • 胃液檢體
    • 其他生物檢體
  • 最終用戶
    • 醫院
    • 診斷檢查室
    • 癌症中心
    • 學術研究機構

第10章 胃癌診斷市場：區域分析

  • 北美洲
  • 歐洲
  • 亞太地區
  • 南美洲
  • 中東和非洲

第11章：胃癌診斷市場：國別分析

  • 美國
  • 加拿大
  • 德國
  • 英國
  • 法國
  • 義大利
  • 西班牙
  • 日本
  • 中國
  • 韓國
  • 印度
  • 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
  • 併購、合作與聯盟
  • 新產品發布

第13章：公司簡介

  • F. Hoffmann-La Roche
  • Agilent Technologies
  • QIAGEN
  • Abbott Laboratories
  • Thermo Fisher Scientific
  • Illumina
  • Sysmex Corporation
  • Danaher Corporation
  • Guardant Health
  • Foundation Medicine
  • Exact Sciences
  • NeoGenomics
  • Bio-Rad Laboratories
  • Leica Biosystems
  • Tempus AI

第14章：胃癌診斷市場：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-009028

The Diagnostics for Gastric Cancer Market is anticipated to grow at a CAGR of 9.6% from USD 4.49 billion in 2026 to USD 10.21 billion in 2035.

The diagnostics for gastric cancer market is experiencing significant transformation driven by the paradigm shift toward biomarker-directed therapies and precision oncology. The market's evolution is characterized by the growing recognition that treatment outcomes depend heavily on accurate molecular characterization rather than histological classification alone. This realization is creating substantial demand for advanced diagnostic solutions capable of identifying key biomarkers including HER2, PD-L1, MSI, and Claudin 18.2. The convergence of endoscopic diagnostics, histopathology, molecular testing, and liquid biopsy technologies is enabling more comprehensive disease characterization and treatment stratification. Healthcare systems are increasingly integrating biomarker evaluation earlier in diagnostic workflows because therapeutic selection depends on molecular evidence. The emergence of targeted therapies and immunotherapies is expanding the range of clinically actionable biomarkers, creating demand for broader testing strategies. Regulatory agencies are strengthening oversight of companion diagnostics, recognizing their critical role in enabling personalized gastric cancer treatment. Diagnostic manufacturers are expanding companion testing portfolios and strengthening evidence-generation activities to support clinical adoption and reimbursement. The market is witnessing significant investment in digital pathology, next-generation sequencing, and liquid biopsy technologies, positioning advanced diagnostics as a cornerstone of gastric cancer management.

Market Drivers

The expansion of biomarker-driven therapy selection represents the primary driver for the gastric cancer diagnostics market. Targeted oncology treatment requires molecular validation because therapeutic efficacy depends on biomarker status. Demand is increasing for HER2, PD-L1, MSI, and Claudin 18.2 testing because physicians must identify eligible patients before treatment initiation. This requirement expands testing volumes across pathology laboratories. Healthcare providers are integrating biomarker evaluation earlier in diagnostic workflows, resulting in stronger demand for gastric cancer diagnostic services. The increasing adoption of precision oncology is further accelerating market growth. Precision oncology depends on comprehensive disease characterization because tumor heterogeneity influences treatment response. Demand is increasing for molecular diagnostics because clinicians seek greater insight into gastric cancer biology. This expectation raises the need for advanced testing technologies. Laboratories are expanding genomic profiling capabilities to support these requirements, resulting in growing utilization of molecular diagnostic platforms. The rising focus on earlier disease detection is driving investment in advanced diagnostic pathways. Clinical outcomes improve when gastric cancer is identified earlier because therapeutic options remain broader during initial stages. Healthcare systems aim to reduce advanced-stage presentation rates, encouraging investment in advanced endoscopic and pathology technologies. Providers are adopting enhanced diagnostic workflows to improve detection rates, increasing demand across the diagnostic ecosystem. The growth of companion diagnostics is supporting targeted treatment utilization. Regulatory approvals increasingly link therapies to biomarker testing, creating collaboration opportunities between diagnostics and therapeutics developers. Diagnostic manufacturers are expanding companion testing portfolios to support commercialization efforts, resulting in sustained market growth.

Market Restraints

High costs associated with molecular testing limit adoption because advanced technologies require specialized infrastructure and expertise. The significant investment needed for sophisticated diagnostic equipment and skilled personnel creates barriers for smaller laboratories and healthcare facilities. Variability in reimbursement policies constrains utilization because payer coverage differs across healthcare systems and geographic regions. Inconsistent coverage frameworks create uncertainty for diagnostic providers and limit patient access to advanced testing options. Limited access to specialized pathology services restricts testing availability because trained personnel and advanced laboratories remain concentrated in selected regions. The shortage of molecular pathology expertise in many healthcare systems limits the scalability of biomarker testing programs. 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 integrated diagnostic platforms. Demand is shifting toward broader testing strategies because multiple biomarkers now influence treatment pathways. This expansion increases laboratory complexity and data interpretation requirements. IHC and FISH technologies remain fundamental because established biomarkers continue guiding treatment decisions. PCR and NGS platforms are expanding for broader molecular assessment because clinicians seek comprehensive genomic characterization. Digital pathology adoption is expanding because laboratories require scalable interpretation workflows. Liquid biopsy technologies are gaining attention because clinicians seek minimally invasive monitoring approaches. The segment analysis reveals that molecular diagnostics represent a major growth area because biomarker-directed therapies require more than conventional histopathological evaluation. HER2 testing demand is increasing because HER2-targeted therapies require validated biomarker identification. PD-L1 and MSI testing utilization is expanding as immunotherapy adoption grows. Claudin 18.2 testing is gaining relevance because emerging targeted therapies depend on patient stratification. Endoscopic diagnostics remain essential for initial disease detection and tissue acquisition. Histopathology diagnostics provide the foundational tissue evaluation that supports biomarker testing. Diagnostic laboratories and cancer centers represent key end-user segments, with hospitals playing a central role in integrated diagnostic workflows. The integration of artificial intelligence is becoming increasingly important because diagnostic workloads and molecular complexity continue expanding simultaneously. AI-enabled pathology and biomarker interpretation tools are improving efficiency and consistency in diagnostic workflows.

Competitive and Strategic Outlook

The competitive landscape features established diagnostic companies with broad oncology portfolios alongside specialized molecular testing providers. F. Hoffmann-La Roche maintains a strong position because it combines a leading oncology therapeutics portfolio with one of the most established companion diagnostics businesses. The company's integration of diagnostic and therapeutic capabilities creates a competitive advantage in biomarker-guided treatment selection. Agilent Technologies remains strategically distinct because its Dako pathology portfolio supports many biomarker testing workflows used in precision oncology, with strong positioning within tissue-based gastric cancer diagnostics. QIAGEN combines molecular testing expertise with extensive experience in companion diagnostic development, expanding partnerships with pharmaceutical developers. Abbott Laboratories possesses broad diagnostic capabilities spanning molecular testing, laboratory systems, and clinical diagnostics, with sustained participation in cancer diagnostics markets. Thermo Fisher Scientific provides a comprehensive portfolio of sequencing platforms, molecular diagnostic technologies, reagents, and laboratory workflow solutions, with strong positioning across multiple layers of the gastric cancer diagnostics value chain. Illumina's sequencing technologies serve as a foundation for many genomic profiling applications, with continued influence over the expansion of molecular diagnostics. Companies are pursuing product portfolio expansion through innovation in molecular assays, digital pathology solutions, and liquid biopsy technologies. Strategic collaborations between diagnostic manufacturers and pharmaceutical companies are increasing, driven by the need for companion diagnostic development alongside targeted therapies. Geographic expansion remains a key strategic priority, with companies targeting rapidly growing emerging markets, particularly in Asia Pacific where gastric cancer incidence remains high. Mergers and acquisitions are occurring as larger players seek to expand market presence and technology portfolios. Diagnostic companies are investing in clinical validation programs and real-world evidence generation to support reimbursement and adoption.

Short Conclusion

The diagnostics for gastric cancer market is positioned for sustained growth driven by the convergence of biomarker-driven therapy, precision oncology, and expanding healthcare infrastructure. The transition toward integrated diagnostic platforms that combine histopathology, molecular testing, and digital solutions represents a fundamental shift in gastric cancer management. While challenges related to high costs, reimbursement variability, and limited specialized expertise 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 gastric cancer diagnostics evolving into foundational tools that determine therapeutic access, treatment response, and long-term patient outcomes across the continuum of 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.

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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

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. Diagnostics for Gastric Cancer Market Overview, Size & Forecast

  • 3.1 Market Definition & Scope
  • 3.2 Gastric Cancer Diagnostics 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 Gastric Cancer Disease Burden Analysis
  • 3.8 Gastric Cancer Prevalence Analysis
  • 3.9 Diagnosed Patient Population Analysis
  • 3.10 Gastric Cancer Testing Volume Analysis
  • 3.11 Patient Journey Analysis in Gastric Cancer Diagnosis
  • 3.12 Biomarker Testing Trends in Gastric Cancer
  • 3.13 HER2, PD-L1, MSI, and Claudin 18.2 Testing 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 Technologies in Gastric Cancer Diagnostics
  • 6.2 Product Innovation
  • 6.3 Clinical Trial Analysis
  • 6.4 Pipeline Analysis
  • 6.5 Technology Roadmap
  • 6.6 AI Integration in Gastric Cancer Diagnostics
  • 6.7 Digital Pathology Integration

7. Regulatory Landscape

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

8. Diagnostics for Gastric Cancer 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

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

  • 9.1 By Diagnostic Type
    • 9.1.1 Endoscopic Diagnostics
    • 9.1.2 Histopathology Diagnostics
    • 9.1.3 Molecular Diagnostics
    • 9.1.4 Immunohistochemistry (IHC)-Based Diagnostics
    • 9.1.5 In Situ Hybridization (ISH)-Based Diagnostics
    • 9.1.6 Liquid Biopsy Diagnostics
  • 9.2 By Biomarker Type
    • 9.2.1 HER2 Biomarker Testing
    • 9.2.2 PD-L1 Biomarker Testing
    • 9.2.3 Microsatellite Instability (MSI) Testing
    • 9.2.4 Claudin 18.2 Testing
    • 9.2.5 Epstein-Barr Virus (EBV) Testing
    • 9.2.6 Other Biomarker Testing
  • 9.3 By Technology
    • 9.3.1 Immunohistochemistry (IHC)
    • 9.3.2 Fluorescence In Situ Hybridization (FISH)
    • 9.3.3 Polymerase Chain Reaction (PCR)
    • 9.3.4 Next-Generation Sequencing (NGS)
    • 9.3.5 Digital Pathology
    • 9.3.6 Liquid Biopsy Technologies
  • 9.4 By Sample Type
    • 9.4.1 Tissue Biopsy
    • 9.4.2 Blood Samples
    • 9.4.3 Gastric Fluid Samples
    • 9.4.4 Other Biological Samples
  • 9.5 By End User
    • 9.5.1 Hospitals
    • 9.5.2 Diagnostic Laboratories
    • 9.5.3 Cancer Centers
    • 9.5.4 Academic and Research Institutes

10. Diagnostics for Gastric Cancer 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. Diagnostics for Gastric Cancer 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 South Korea
  • 11.11 India
  • 11.12 Australia
  • 11.13 Brazil
  • 11.14 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
  • 13.2 Agilent Technologies
  • 13.3 QIAGEN
  • 13.4 Abbott Laboratories
  • 13.5 Thermo Fisher Scientific
  • 13.6 Illumina
  • 13.7 Sysmex Corporation
  • 13.8 Danaher Corporation
  • 13.9 Guardant Health
  • 13.10 Foundation Medicine
  • 13.11 Exact Sciences
  • 13.12 NeoGenomics
  • 13.13 Bio-Rad Laboratories
  • 13.14 Leica Biosystems
  • 13.15 Tempus AI

14. Diagnostics for Gastric Cancer Market Commercial Forecast Analysis

  • 14.1 HER2 Diagnostic Testing Forecast
  • 14.2 PD-L1 Diagnostic Testing Forecast
  • 14.3 MSI Diagnostic Testing Forecast
  • 14.4 Endoscopic Diagnostic Procedures Forecast
  • 14.5 Histopathology Diagnostic Testing Forecast
  • 14.6 Molecular Diagnostic Testing Forecast
  • 14.7 Liquid Biopsy Diagnostic Testing Forecast

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