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市场调查报告书
商品编码
1961043

全球肿瘤伴随诊断市场：市场规模、产业趋势、机会分析及预测（2026-2035 年），依产品/服务、技术、疾病类型、最终用途及地区划分

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个工作天内

价格
简介目录

全球肿瘤伴随诊断市场正经历显着成长，预计到 2025 年将达到 56.8 亿美元。这一成长趋势预计将在未来十年持续强劲，到 2035 年市场规模将成长近一倍，达到约 128.4 亿美元。这一增长反映了 2026 年至 2035 年预测期内 8.50% 的复合年增长率，显示肿瘤伴随诊断技术的需求和应用正在快速增长。

推动这令人瞩目的市场成长的因素有很多。其中一个关键因素是放鬆管制，这使得新的诊断测试更容易进入市场，并能更快地惠及患者。 简化监管流程降低了将创新伴随诊断引入临床实践的时间和成本，鼓励更多公司开发和商业化这些检测方法。此外，液体活检技术的日益普及在加速市场扩张方面发挥着重要作用。

市场趋势

肿瘤伴随诊断市场的竞争格局呈现出动态且不断发展的生态系统，其中，成熟的诊断领导者与敏捷创新的基因组学公司并存竞争。该市场融合了传统与尖端技术，主要参与者利用其丰富的资源和专业知识保持领先地位，同时适应基因组学的快速发展。

罗氏诊断建构了一个全面整合的生态系统，涵盖癌症诊断的多个方面，使其成为该领域无可争议的领导者。该公司的产品组合包括透过其Ventana平台提供的基于组织的免疫组化（IHC）解决方案，该平台以其准确性和可靠性而广受认可。 此外，罗氏旗下子公司 Foundation Medicine 在提供高品质的综合基因组分析 (CGP) 方面享有盛誉。

肿瘤伴随诊断市场的另一个主要参与者是安捷伦科技，该公司在 "药物诊断 (PharmDx)" 领域拥有强大的市场地位。透过与各大製药公司紧密合作，该公司已建立起一套策略模式，专门针对重磅免疫疗法共同开发伴随诊断测试。这种合作不仅提高了治疗选择的准确性，还确保了诊断工具与製药业涌现的治疗创新紧密结合。

核心成长驱动因子

医院和癌症中心正逐渐抛弃将样本送往中心实验室的传统方法。取而代之的是，他们正在加速采用“试剂盒式下一代定序 (NGS) 解决方案”，从而实现院内检测。这种转变的驱动力在于提高效率和加快检测速度的需求，而与外包相比，院内检测流程更有效率且可控。 这些试剂盒式NGS解决方案的引入显着缩短了检测结果的周转时间，从数週缩短至数天。

新机遇

人工智慧 (AI) 在病理领域的应用是肿瘤伴随诊断市场的关键颠覆性趋势。传统上，病理学家需要手动检查组织样本，以识别和评估对癌症诊断和治疗决策至关重要的生物标记。然而，这个过程具有主观性，且容易受到人为因素的影响，例如疲劳以及专家之间解读的差异。人工智慧演算法的出现正在彻底改变这一现状，为病理学家提供强大的工具，以提高生物标记评估的准确性和可重复性。

优化障碍

由于区域分散以及严格且不统一的监管审批流程，肿瘤伴随诊断市场面临许多挑战。 美国食品药物管理局 (FDA) 和欧洲药品管理局 (EMA) 等监管机构对诊断产品的评估和批准都有各自的要求、指南和时间表。这种缺乏协调性的做法造成了复杂的监管环境，延缓了新型伴随诊断技术进入市场的速度。开发这些诊断产品的公司必须应对多个往往相互矛盾的批准途径，这会导致更长的审批时间和更高的成本。

目录

第一章：摘要整理：全球肿瘤伴随诊断市场

第二章：报告概述

  • 研究框架
    • 研究目标
    • 市场定义
    • 市场区隔
  • 研究方法
    • 市场规模估算
    • 质性研究
    • 量化研究
    • 依地区划分的原始调查受访者细分
    • 资料三角验证
    • 研究假设

第三章：全球肿瘤伴随诊断市场概述

  • 产业价值链分析
    • 生物标记发现与检测开发
    • 诊断测试製造和试剂盒生产
    • 监管审批和药物诊断合作开发
    • 分销和实验室实施
    • 终端用户
  • 行业展望
    • 精准医疗的日益普及
    • 全球癌症负担日益加重
    • 标靶疗法的快速发展
    • 分子诊断技术的进步
    • 伴随诊断获得强而有力的监管支持
  • PESTLE 分析
  • 波特五力分析
    • 供应商议价能力
    • 买方议价能力
    • 替代品威胁
    • 新进入者威胁
    • 竞争强度
  • 市场成长与展望
    • 市场收入预测及预测（2020-2035）
    • 依产品/服务划分的价格分析
  • 市场吸引力分析
    • 依产品/服务划分
  • 实务见解（分析师建议）

第四章 竞争格局概览

  • 市场集中度
  • 公司占有率分析（基于价值，2025）
  • 竞争格局分析与基准分析

第五章：全球肿瘤伴随诊断市场分析

  • 市场动态与趋势
    • 成长驱动因素
    • 限制因素
    • 机遇
    • 关键趋势
  • 市场规模及预测（2020-2035）
    • 主要发现
    • 依技术分类
    • 依疾病类型分类
    • 依最终用途分类
    • 依地区分类

第六章：北美肿瘤伴随诊断市场分析

第七章：欧洲肿瘤伴随诊断市场分析

第八章：亚太地区肿瘤伴随诊断市场分析

第九章：中东和非洲肿瘤伴随诊断市场分析

第十章：南美洲肿瘤伴随诊断市场分析

第11章 企业简介

  • 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 附录

简介目录
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