查看購物車
  • English
  • Japanese
  • Korean
封面
市場調查報告書
商品編碼
1961043

全球腫瘤伴隨診斷市場：市場規模、產業趨勢、機會分析及預測（2026-2035 年），依產品/服務、技術、疾病類型、最終用途及地區劃分

Global Oncology Companion Diagnostic Market: Analysis By Product & Services, Technology, Disease Type, End-use, Region - Market Size, Industry Dynamics, Opportunity Analysis and Forecast for 2026-2035
出版日期: | 出版商: Astute Analytica | 英文 240 Pages | 商品交期: 最快1-2個工作天內

價格
簡介目錄

全球腫瘤伴隨診斷市場正經歷顯著成長，預計到 2025 年將達到 56.8 億美元。這一成長趨勢預計將在未來十年持續強勁，到 2035 年市場規模將成長近一倍，達到約 128.4 億美元。這一增長反映了 2026 年至 2035 年預測期內 8.50% 的複合年增長率，顯示腫瘤伴隨診斷技術的需求和應用正在快速增長。

推動這令人矚目的市場成長的因素有很多。其中一個關鍵因素是放鬆管制，這使得新的診斷測試更容易進入市場，並能更快地惠及患者。 簡化監管流程降低了將創新伴隨診斷引入臨床實踐的時間和成本，鼓勵更多公司開發和商業化這些檢測方法。此外，液體活檢技術的日益普及在加速市場擴張方面發揮著重要作用。

市場趨勢

腫瘤伴隨診斷市場的競爭格局呈現出動態且不斷發展的生態系統，其中，成熟的診斷領導者與敏捷創新的基因組學公司並存競爭。該市場融合了傳統與尖端技術，主要參與者利用其豐富的資源和專業知識保持領先地位，同時適應基因組學的快速發展。

羅氏診斷建構了一個全面整合的生態系統，涵蓋癌症診斷的多個方面，使其成為該領域無可爭議的領導者。該公司的產品組合包括透過其Ventana平台提供的基於組織的免疫組化（IHC）解決方案，該平台以其準確性和可靠性而廣受認可。 此外，羅氏旗下子公司 Foundation Medicine 在提供高品質的綜合基因組分析 (CGP) 方面享有盛譽。

腫瘤伴隨診斷市場的另一個主要參與者是安捷倫科技，該公司在 "藥物診斷 (PharmDx)" 領域擁有強大的市場地位。透過與各大製藥公司緊密合作，該公司已建立起一套策略模式，專門針對重磅免疫療法共同開發伴隨診斷測試。這種合作不僅提高了治療選擇的準確性，還確保了診斷工具與製藥業湧現的治療創新緊密結合。

核心成長驅動因子

醫院和癌症中心正逐漸拋棄將樣本送往中心實驗室的傳統方法。取而代之的是，他們正在加速採用“試劑盒式下一代定序 (NGS) 解決方案”，從而實現院內檢測。這種轉變的驅動力在於提高效率和加快檢測速度的需求，而與外包相比，院內檢測流程更有效率且可控。 這些試劑盒式NGS解決方案的引入顯著縮短了檢測結果的周轉時間，從數週縮短至數天。

新機遇

人工智慧 (AI) 在病理領域的應用是腫瘤伴隨診斷市場的關鍵顛覆性趨勢。傳統上，病理學家需要手動檢查組織樣本，以識別和評估對癌症診斷和治療決策至關重要的生物標記。然而，這個過程具有主觀性，且容易受到人為因素的影響，例如疲勞以及專家之間解讀的差異。人工智慧演算法的出現正在徹底改變這一現狀，為病理學家提供強大的工具，以提高生物標記評估的準確性和可重複性。

優化障礙

由於區域分散以及嚴格且不統一的監管審批流程，腫瘤伴隨診斷市場面臨許多挑戰。 美國食品藥物管理局 (FDA) 和歐洲藥品管理局 (EMA) 等監管機構對診斷產品的評估和批准都有各自的要求、指南和時間表。這種缺乏協調性的做法造成了複雜的監管環境，延緩了新型伴隨診斷技術進入市場的速度。開發這些診斷產品的公司必須應對多個往往相互矛盾的批准途徑，這會導致更長的審批時間和更高的成本。

目錄

第一章：摘要整理：全球腫瘤伴隨診斷市場

第二章：報告概述

  • 研究框架
    • 研究目標
    • 市場定義
    • 市場區隔
  • 研究方法
    • 市場規模估算
    • 質性研究
    • 量化研究
    • 依地區劃分的原始調查受訪者細分
    • 資料三角驗證
    • 研究假設

第三章：全球腫瘤伴隨診斷市場概述

  • 產業價值鏈分析
    • 生物標記發現與檢測開發
    • 診斷測試製造和試劑盒生產
    • 監管審批和藥物診斷合作開發
    • 分銷和實驗室實施
    • 終端用戶
  • 行業展望
    • 精準醫療的日益普及
    • 全球癌症負擔日益加重
    • 標靶療法的快速發展
    • 分子診斷技術的進步
    • 伴隨診斷獲得強而有力的監管支持
  • PESTLE 分析
  • 波特五力分析
    • 供應商議價能力
    • 買方議價能力
    • 替代品威脅
    • 新進入者威脅
    • 競爭強度
  • 市場成長與展望
    • 市場收入預測及預測（2020-2035）
    • 依產品/服務劃分的價格分析
  • 市場吸引力分析
    • 依產品/服務劃分
  • 實務見解（分析師建議）

第四章 競爭格局概覽

  • 市場集中度
  • 公司佔有率分析（基於價值，2025）
  • 競爭格局分析與基準分析

第五章：全球腫瘤伴隨診斷市場分析

  • 市場動態與趨勢
    • 成長驅動因素
    • 限制因素
    • 機遇
    • 關鍵趨勢
  • 市場規模及預測（2020-2035）
    • 主要發現
    • 依技術分類
    • 依疾病類型分類
    • 依最終用途分類
    • 依地區分類

第六章：北美腫瘤伴隨診斷市場分析

第七章：歐洲腫瘤伴隨診斷市場分析

第八章：亞太地區腫瘤伴隨診斷市場分析

第九章：中東和非洲腫瘤伴隨診斷市場分析

第十章：南美洲腫瘤伴隨診斷市場分析

第11章 企業簡介

  • Abbott Laboratories
  • Agilent Technologies
  • Bio-Rad Laboratories
  • Biocartis
  • Exact Sciences
  • Genedrive
  • Genomic Health
  • Guardant Health
  • Illumina
  • Invivoscribe
  • Myriad Genetics
  • QIAGEN
  • Roche Diagnostics
  • Sysmex Corporation
  • Thermo Fisher Scientific
  • Other Prominent Players

第12章 附錄

簡介目錄
Product Code: AA01261643

The global oncology companion diagnostic market is experiencing significant growth, with its valuation estimated to reach USD 5.68 billion by 2025. This upward trajectory is expected to continue robustly over the next decade, with projections indicating that the market will nearly double, reaching approximately USD 12.84 billion by 2035. This expansion reflects a compound annual growth rate (CAGR) of 8.50% during the forecast period from 2026 to 2035, underscoring the rapidly increasing demand and adoption of companion diagnostic technologies in oncology.

Several key factors are driving this impressive market growth. One critical element is the trend toward regulatory deregulation, which has made it easier for new diagnostic tests to enter the market and reach patients more quickly. Streamlined regulatory pathways reduce the time and cost associated with bringing innovative companion diagnostics to clinical practice, encouraging more companies to develop and commercialize these tests. Additionally, the growing adoption of liquid biopsy technologies is playing a major role in accelerating market expansion.

Noteworthy Market Developments

The competitive landscape of the oncology companion diagnostic market is characterized by a dynamic and evolving ecosystem where well-established diagnostic giants coexist and compete alongside nimble and innovative genomic companies. This market is shaped by a blend of tradition and cutting-edge technology, with major players leveraging their extensive resources and expertise to maintain leadership while also adapting to the fast pace of advancements in genomic science.

Roche Diagnostics stands out as a formidable leader within this space, having built a comprehensive and integrated ecosystem that addresses multiple facets of oncology diagnostics. Their portfolio includes tissue-based immunohistochemistry (IHC) solutions through the Ventana platform, which is widely recognized for its precision and reliability. Additionally, Roche's subsidiary, Foundation Medicine, has carved out a distinguished reputation for delivering high-quality comprehensive genomic profiling (CGP).

Another major player in the oncology companion diagnostic arena is Agilent Technologies, which holds a particularly strong presence in the "PharmDx" segment. Agilent has developed a strategic model that involves close partnerships with leading pharmaceutical companies to co-develop companion diagnostic tests tailored specifically for blockbuster immunotherapy drugs. This collaboration not only enhances the precision of treatment selection but also ensures that diagnostic tools are closely aligned with the therapeutic innovations emerging from the pharma industry.

Core Growth Drivers

Hospitals and cancer centers are progressively shifting away from the traditional practice of sending samples to central reference laboratories for testing. Instead, they are increasingly adopting "kitted" next-generation sequencing (NGS) solutions that enable them to perform testing in-house. This transition is driven by the need for greater efficiency and faster results, as in-house testing offers a more streamlined and controlled process compared to outsourcing. The adoption of these kitted NGS solutions significantly shortens the turnaround time for test results, reducing it from several weeks to just a few days.

Emerging Opportunity Trends

A significant and transformative trend within the oncology companion diagnostic market is the increasing integration of Artificial Intelligence (AI) into the field of pathology. Traditionally, pathologists have relied on manual examination of tissue samples to identify and score biomarkers critical for cancer diagnosis and treatment decisions. However, this process can be subjective and prone to variability due to human factors such as fatigue or differing interpretations among experts. The advent of AI algorithms is revolutionizing this landscape by providing pathologists with powerful tools that enhance both the accuracy and reproducibility of biomarker assessments.

Barriers to Optimization

The oncology companion diagnostic market faces significant challenges due to fragmented, strict, and varying regulatory approval processes across different regions. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) each have their own distinct sets of requirements, guidelines, and timelines for evaluating and approving diagnostic products. This lack of harmonization creates a complex regulatory landscape that can delay the market entry of new companion diagnostic technologies. Companies developing these diagnostics must navigate multiple, often disparate approval pathways, which can result in prolonged review periods and increased costs.

Detailed Market Segmentation

Considering disease type, Non-small cell lung cancer (NSCLC) stands out as the dominant disease segment within the oncology companion diagnostic market, largely due to its overwhelming prevalence, accounting for approximately 87% of all lung cancer cases worldwide. This significant share highlights the critical importance of NSCLC in shaping diagnostic and therapeutic approaches in oncology. However, the segment's growth is not merely quantitative; it is marked by increasing complexity and sophistication. NSCLC has evolved into a multifaceted ecosystem characterized by a rapidly expanding portfolio of targeted therapies, each designed to address specific genetic mutations that drive the disease.

By end-use, the hospitals segment holds a leading position in the oncology companion diagnostic market, and this dominance is the result of several strategic and practical factors. Central to this leadership is the ongoing shift in healthcare toward a "patient-centric" model of care, which emphasizes delivering diagnostics and treatment within a single, coordinated setting. By housing both diagnostic and therapeutic services under one roof, hospitals provide a streamlined and efficient environment that enhances patient experience and improves clinical outcomes.

By Technology, Next-Generation Sequencing (NGS) has firmly established itself as the leading technology in the field of precision oncology, commanding a substantial 38% share of the companion cancer diagnostics market revenue as of 2025. This prominent position reflects a significant evolution in diagnostic approaches, marking a decisive shift away from traditional single-biomarker Polymerase Chain Reaction (PCR) tests toward more comprehensive and sophisticated methods. The growing preference for NGS stems from its ability to provide Comprehensive Genomic Profiling (CGP), which offers a far more detailed and expansive view of a patient's genetic makeup compared to legacy diagnostic techniques.

Segment Breakdown

By Product & Services

  • Product
  • Instrument
  • Consumables
  • Software
  • Services

By Technology

  • Polymerase Chain Reaction (PCR)
  • Next-generation Sequencing (NGS)
  • Immunohistochemistry (IHC)
  • In Situ Hybridization (ISH)/Fluorescence In Situ Hybridization (FISH)
  • Other Technologies

By Disease Type

  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Leukemia
  • Melanoma
  • Prostate Cancer
  • Others

By End-use

  • Hospital
  • Pathology/Diagnostic Laboratory
  • Academic Medical Center

By Region

  • North America
  • Europe
  • Asia Pacific
  • Middle East and Africa
  • South America

Geography Breakdown

  • The Asia-Pacific (APAC) region has rapidly established itself as the most dynamic and fastest-growing segment within the oncology companion diagnostic market. Forecasts indicate a remarkable Compound Annual Growth Rate (CAGR) ranging between 13.3% and 13.55% through 2030, significantly outpacing the global average growth rates in this sector. This robust expansion is fueled by a convergence of several critical factors that together create a "perfect storm" for market growth. One of the primary drivers is the vast patient population in the region, which inherently increases demand for advanced diagnostic solutions.
  • Government intervention further accelerates this growth trajectory, with many APAC countries implementing strong policies and funding initiatives aimed at combating the cancer burden. China, in particular, stands out as a major contributor to this market surge. The country's ambitious "Healthy China 2030" plan underscores a national commitment to improving healthcare outcomes, especially in oncology. Under this initiative, domestic companies are rapidly advancing the development of proprietary next-generation sequencing (NGS) technologies and artificial intelligence (AI)-driven diagnostic platforms.

Leading Market Participants

  • Abbott Laboratories
  • Agilent Technologies
  • Bio-Rad Laboratories
  • Biocartis
  • Exact Sciences
  • Genedrive
  • Genomic Health
  • Guardant Health
  • Illumina
  • Invivoscribe
  • Myriad Genetics
  • QIAGEN
  • Roche Diagnostics
  • Sysmex Corporation
  • Thermo Fisher Scientific
  • Other Prominent Players

Table of Content

Chapter 1. Executive Summary: Global Oncology Companion Diagnostic Market

Chapter 2. Report Description

  • 2.1. Research Framework
    • 2.1.1. Research Objective
    • 2.1.2. Market Definitions
    • 2.1.3. Market Segmentation
  • 2.2. Research Methodology
    • 2.2.1. Market Size Estimation
    • 2.2.2. Qualitative Research
      • 2.2.2.1. Primary & Secondary Sources
    • 2.2.3. Quantitative Research
      • 2.2.3.1. Primary & Secondary Sources
    • 2.2.4. Breakdown of Primary Research Respondents, By Region
    • 2.2.5. Data Triangulation
    • 2.2.6. Assumption for Study

Chapter 3. Global Oncology Companion Diagnostic Market Overview

  • 3.1. Industry Value Chain Analysis
    • 3.1.1. Biomarker Discovery & Assay Development
    • 3.1.2. Diagnostic Test Manufacturing & Kit Production
    • 3.1.3. Regulatory Approval & Drug-Diagnostic Co-Development
    • 3.1.4. Distribution & Laboratory Implementation
    • 3.1.5. End Users
  • 3.2. Industry Outlook
    • 3.2.1. Growing Adoption of Precision Medicine
    • 3.2.2. Increasing Global Cancer Burden
    • 3.2.3. Increasing Targeted Therapy Development
    • 3.2.4. Advancements in Molecular Diagnostics Technologies
    • 3.2.5. Strong Regulatory Support for Companion Diagnostics
  • 3.3. PESTLE Analysis
  • 3.4. Porter's Five Forces Analysis
    • 3.4.1. Bargaining Power of Suppliers
    • 3.4.2. Bargaining Power of Buyers
    • 3.4.3. Threat of Substitutes
    • 3.4.4. Threat of New Entrants
    • 3.4.5. Degree of Competition
  • 3.5. Market Growth and Outlook
    • 3.5.1. Market Revenue Estimates and Forecast (US$ Mn), 2020-2035
    • 3.5.2. Pricing Analysis, By Product & Services
  • 3.6. Market Attractiveness Analysis
    • 3.6.1. By Product & Services
  • 3.7. Actionable Insights (Analyst's Recommendations)

Chapter 4. Competition Dashboard

  • 4.1. Market Concentration Rate
  • 4.2. Company Market Share Analysis (Value %), 2025
  • 4.3. Competitor Mapping & Benchmarking

Chapter 5. Global Oncology Companion Diagnostic Market Analysis

  • 5.1. Market Dynamics and Trends
    • 5.1.1. Growth Drivers
    • 5.1.2. Restraints
    • 5.1.3. Opportunity
    • 5.1.4. Key Trends
  • 5.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 5.2.1. Key Insights
      • 5.2.1.1. Product & Services
        • 5.2.1.1.1. Product
          • 5.2.1.1.1.1. Instrument
          • 5.2.1.1.1.2. Consumables
        • 5.2.1.1.2. Software
          • 5.2.1.1.2.1. Services
    • 5.2.2. By Technology
      • 5.2.2.1. Key Insights
        • 5.2.2.1.1. Polymerase Chain Reaction (PCR)
        • 5.2.2.1.2. Next-generation Sequencing (NGS)
        • 5.2.2.1.3. Immunohistochemistry (IHC)
        • 5.2.2.1.4. In Situ Hybridization (ISH)/Fluorescence In Situ Hybridization (FISH)
        • 5.2.2.1.5. Other Technologies
    • 5.2.3. By Disease Type
      • 5.2.3.1. Key Insights
        • 5.2.3.1.1. Breast Cancer
        • 5.2.3.1.2. Non-small Cell Lung Cancer
        • 5.2.3.1.3. Colorectal Cancer
        • 5.2.3.1.4. Leukemia
        • 5.2.3.1.5. Melanoma
        • 5.2.3.1.6. Prostate Cancer
        • 5.2.3.1.7. Others
    • 5.2.4. By End Use
      • 5.2.4.1. Key Insights
        • 5.2.4.1.1. Hospital
        • 5.2.4.1.2. Pathology/Diagnostic Laboratory
        • 5.2.4.1.3. Academic Medical Center
    • 5.2.5. By Region
      • 5.2.5.1. Key Insights
        • 5.2.5.1.1. North America
          • 5.2.5.1.1.1. The U.S.
          • 5.2.5.1.1.2. Canada
          • 5.2.5.1.1.3. Mexico
        • 5.2.5.1.2. Europe
          • 5.2.5.1.2.1. Western Europe
            • 5.2.5.1.2.1.1. The UK
            • 5.2.5.1.2.1.2. Germany
            • 5.2.5.1.2.1.3. France
            • 5.2.5.1.2.1.4. Italy
            • 5.2.5.1.2.1.5. Spain
            • 5.2.5.1.2.1.6. Rest of Western Europe
          • 5.2.5.1.2.2. Eastern Europe
            • 5.2.5.1.2.2.1. Poland
            • 5.2.5.1.2.2.2. Russia
            • 5.2.5.1.2.2.3. Rest of Eastern Europe
        • 5.2.5.1.3. Asia Pacific
          • 5.2.5.1.3.1. China
          • 5.2.5.1.3.2. India
          • 5.2.5.1.3.3. Japan
          • 5.2.5.1.3.4. South Korea
          • 5.2.5.1.3.5. Australia & New Zealand
          • 5.2.5.1.3.6. ASEAN
            • 5.2.5.1.3.6.1. Indonesia
            • 5.2.5.1.3.6.2. Malaysia
            • 5.2.5.1.3.6.3. Thailand
            • 5.2.5.1.3.6.4. Singapore
            • 5.2.5.1.3.6.5. Rest of ASEAN
          • 5.2.5.1.3.7. Rest of Asia Pacific
        • 5.2.5.1.4. Middle East & Africa
          • 5.2.5.1.4.1. UAE
          • 5.2.5.1.4.2. Saudi Arabia
          • 5.2.5.1.4.3. South Africa
          • 5.2.5.1.4.4. Rest of MEA
        • 5.2.5.1.5. South America
          • 5.2.5.1.5.1. Argentina
          • 5.2.5.1.5.2. Brazil
          • 5.2.5.1.5.3. Rest of South America

Chapter 6. North America Oncology Companion Diagnostic Market Analysis

  • 6.1. Market Dynamics and Trends
    • 6.1.1. Growth Drivers
    • 6.1.2. Restraints
    • 6.1.3. Opportunity
    • 6.1.4. Key Trends
  • 6.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 6.2.1. By Product & Services
    • 6.2.2. By Technology
    • 6.2.3. By Disease Type
    • 6.2.4. By End Use
    • 6.2.5. By Country

Chapter 7. Europe Oncology Companion Diagnostic Market Analysis

  • 7.1. Market Dynamics and Trends
    • 7.1.1. Growth Drivers
    • 7.1.2. Restraints
    • 7.1.3. Opportunity
    • 7.1.4. Key Trends
  • 7.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 7.2.1. By Product & Services
    • 7.2.2. By Technology
    • 7.2.3. By Disease Type
    • 7.2.4. By End Use
    • 7.2.5. By Country

Chapter 8. Asia Pacific Oncology Companion Diagnostic Market Analysis

  • 8.1. Market Dynamics and Trends
    • 8.1.1. Growth Drivers
    • 8.1.2. Restraints
    • 8.1.3. Opportunity
    • 8.1.4. Key Trends
  • 8.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 8.2.1. By Product & Services
    • 8.2.2. By Technology
    • 8.2.3. By Disease Type
    • 8.2.4. By End Use
    • 8.2.5. By Country

Chapter 9. Middle East & Africa Oncology Companion Diagnostic Market Analysis

  • 9.1. Market Dynamics and Trends
    • 9.1.1. Growth Drivers
    • 9.1.2. Restraints
    • 9.1.3. Opportunity
    • 9.1.4. Key Trends
  • 9.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 9.2.1. By Product & Services
    • 9.2.2. By Technology
    • 9.2.3. By Disease Type
    • 9.2.4. By End Use
    • 9.2.5. By Country

Chapter 10. South America Oncology Companion Diagnostic Market Analysis

  • 10.1. Market Dynamics and Trends
    • 10.1.1. Growth Drivers
    • 10.1.2. Restraints
    • 10.1.3. Opportunity
    • 10.1.4. Key Trends
  • 10.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 10.2.1. By Product & Services
    • 10.2.2. By Technology
    • 10.2.3. By Disease Type
    • 10.2.4. By End Use
    • 10.2.5. By Country

Chapter 11. Company Profile (Company Overview, Company Timeline, Organization Structure, Key Product landscape, Financial Matrix, Key Customers/Sectors, Key Competitors, SWOT Analysis, Contact Address, and Business Strategy Outlook)

  • 11.1. Abbott Laboratories
  • 11.2. Agilent Technologies
  • 11.3. Bio-Rad Laboratories
  • 11.4. Biocartis
  • 11.5. Exact Sciences
  • 11.6. Genedrive
  • 11.7. Genomic Health
  • 11.8. Guardant Health
  • 11.9. Illumina
  • 11.10. Invivoscribe
  • 11.11. Myriad Genetics
  • 11.12. QIAGEN
  • 11.13. Roche Diagnostics
  • 11.14. Sysmex Corporation
  • 11.15. Thermo Fisher Scientific
  • 11.16. Other Prominent Players

Chapter 12. Annexure

  • 12.1. List of Secondary Sources
  • 12.2. Key Country Markets- Macro Economic Outlook/Indicators