伴随诊断市场机会、成长驱动因素、产业趋势分析及预测（2025-2034年）

2024 年全球伴随诊断市场价值为 72 亿美元，预计到 2034 年将以 11.5% 的复合年增长率增长至 211 亿美元。

伴随诊断市场成长的驱动因素包括癌症发生率上升、药物不良反应发生率增加、精准医疗的快速普及。伴随诊断是一种专门的医学检测，有助于识别最有可能对特定疗法产生积极反应的患者。透过检测影响药物反应的特定生物标记或基因变异，这些诊断方法能够实现更精准、更个人化的治疗决策。伴随诊断的使用可以降低副作用风险，提高治疗效果，并符合全球向个人化医疗转变的趋势。伴随诊断在临床方案中的应用日益广泛，尤其是在肿瘤学、免疫学和慢性病管理领域，这反映了其在优化治疗效果方面日益重要的作用。由于药物不良反应持续对现代医疗保健构成重大挑战，监管机构和医疗服务提供者都在强调采用能够最大限度降低患者风险并提高药物安全性的诊断方法。这种日益增强的意识，加上技术进步和生物标记研究的拓展，持续推动全球伴随诊断市场的发展。

2024年，耗材市占率占比达65.3%。此类别包括一次性产品，例如试剂盒、检测试剂、测试试剂盒和样本製备材料，这些产品对于进行诊断检测至关重要。临床实验室对耗材的持续需求推动了稳定的收入来源，因为每项检测都需要耗材。与一次性资本支出的诊断仪器不同，耗材确保了持续的产品需求，使其成为整个行业供应商和製造商的关键成长驱动力。

2024年，乳癌市场规模预计将达23亿美元。乳癌的高发生率催生了对能够识别特定分子标记以指导治疗方案选择的诊断工具的迫切需求。针对HER2阳性和荷尔蒙受体阳性等亚型乳癌的个人化治疗方案的兴起，导致检测量不断增长。此外，製药公司和诊断公司之间的合作正在推动生物标记驱动型解决方案的发展，促进肿瘤诊断市场的扩张和创新。

受癌症负担日益加重和标靶治疗日益普及的推动，美国伴随诊断市场预计将在2024年达到27亿美元。随着全美癌症发生率持续上升，精准高效诊断平台的需求也日益增长。伴随诊断正快速融入精准肿瘤学，帮助医师根据肿瘤基因和患者个别情况制定个人化的治疗方案。这种方法能够提高治疗成功率并最大限度地减少不良反应，使诊断指导治疗成为美国现代癌症治疗的核心组成部分。

全球伴随诊断市场的主要参与者包括辉瑞、默克、阿斯特捷利康、赛默飞世尔科技、罗氏、雅培、安进、强生、百时美施贵宝、礼来、Myriad Genetics、Guardant Health、Foundation Medicine、百健和贝克顿迪金森公司。伴随诊断市场的关键参与者正采取一系列策略来巩固其竞争地位。许多公司正与製药公司建立长期合作关係，共同开发与新药上市相配合的标靶疗法和伴随检测。此外，各公司在生物标记发现和新一代定序技术方面投入巨资，以提高诊断检测的准确性和预测能力。策略性併购正在拓展其全球业务范围并丰富其产品组合。

目录

第一章：方法论与范围

第二章：执行概要

第三章：行业洞察

• 产业生态系分析
• 产业影响因素
  • 成长驱动因素
    • 发展中国家疾病盛行率呈上升趋势
    • 北美配备先进诊断设备的病理实验室和服务机构数量激增
    • 技术进步
    • 增加研发投资
  • 产业陷阱与挑战
    • 严格的监管框架
    • 产品开发成本高
  • 市场机会
    • 偏远和农村地区的需求不断增长
    • 与数位健康平台集成
• 成长潜力分析
• 监管环境
• 技术格局
  • 目前技术
  • 新兴技术
• 未来市场趋势
• 专利分析
• 差距分析
• 波特的分析
• PESTEL 分析

第四章：竞争格局

• 介绍
• 公司市占率分析
  • 北美洲
  • 欧洲
  • 亚太地区
• 公司矩阵分析
• 主要市场参与者的竞争分析
• 竞争定位矩阵
• 关键进展
  • 併购
  • 伙伴关係与合作
  • 新产品发布
  • 扩张计划

第五章：市场估算与预测：依产品划分，2021-2034年

• 主要趋势
• 仪器
• 消耗品
• 服务

第六章：市场估计与预测：依疾病适应症划分，2021-2034年

• 主要趋势
• 乳癌
• 肺癌
• 大肠直肠癌
• 皮肤癌
• 其他疾病适应症

第七章：市场估计与预测：依技术划分，2021-2034年

• 主要趋势
• 免疫组织化学
• 原位杂交
• 聚合酶炼式反应
• 基因定序
• 其他技术

第八章：市场估算与预测：依最终用途划分，2021-2034年

• 主要趋势
• 医院
• 诊断实验室
• 其他最终用途

第九章：市场估计与预测：依地区划分，2021-2034年

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 荷兰
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 澳洲
  • 韩国
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中东和非洲
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第十章：公司简介

• Abbott Laboratories
• Amgen
• AstraZeneca
• Becton, Dickinson and Company
• Biogen
• Bristol Myers Squibb
• Eli Lilly and Company
• F. Hoffmann-La Roche
• Foundation Medicine
• Guardant Health
• Johnson & Johnson
• Merck
• Myriad Genetics
• Pfizer
• Thermo Fisher Scientific

The Global Companion Diagnostics Market was valued at USD 7.2 billion in 2024 and is estimated to grow at a CAGR of 11.5% to reach USD 21.1 billion by 2034.

Market growth is driven by the rising prevalence of cancer, the growing incidence of adverse drug reactions, and the rapid adoption of precision medicine. Companion diagnostics are specialized medical tests that help identify patients who are most likely to respond positively to a particular therapy. By detecting specific biomarkers or genetic variations that influence drug response, these diagnostics enable more accurate, personalized treatment decisions. The use of companion diagnostics reduces the risk of side effects, enhances therapeutic efficacy, and aligns with the global shift toward individualized healthcare. Their increasing integration into clinical protocols, especially in oncology, immunology, and chronic disease management, reflects their growing role in optimizing treatment outcomes. As adverse drug reactions continue to pose major challenges in modern healthcare, both regulatory agencies and healthcare providers are emphasizing the adoption of diagnostics that minimize patient risk and improve drug safety. This growing awareness, combined with technological progress and the expansion of biomarker research, continues to strengthen the companion diagnostics market worldwide.

The consumables segment accounted for a 65.3% share in 2024. This category includes single-use products such as cartridges, assay reagents, test kits, and sample preparation materials that are vital for conducting diagnostic assays. The continuous demand for consumables in clinical laboratories drives consistent revenue streams, as they are required for every test performed. Unlike diagnostic instruments, which represent a one-time capital expense, consumables ensure ongoing product demand, making them a crucial growth driver for suppliers and manufacturers across the sector.

The breast cancer segment was valued at USD 2.3 billion in 2024. The widespread incidence of breast cancer has created a strong need for diagnostic tools capable of identifying specific molecular markers that guide therapy selection. The move toward personalized treatment approaches for subtypes such as HER2-positive and hormone receptor-positive breast cancers has resulted in increasing testing volumes. Additionally, collaborations between pharmaceutical and diagnostic companies are advancing biomarker-driven solutions, boosting market expansion and innovation in oncology diagnostics.

U.S. Companion Diagnostics Market reached USD 2.7 billion in 2024, supported by the rising cancer burden and increasing focus on targeted medicine. With cancer rates continuing to rise across the nation, the demand for accurate and efficient diagnostic platforms is intensifying. Companion diagnostics are being rapidly integrated into precision oncology, helping physicians customize treatment strategies based on tumor genetics and individual patient profiles. This approach enhances therapy success rates and minimizes adverse effects, making diagnostic-guided treatment a central part of modern cancer care in the United States.

Leading companies operating within the Global Companion Diagnostics Market include Pfizer, Merck, AstraZeneca, Thermo Fisher Scientific, F. Hoffmann-La Roche, Abbott Laboratories, Amgen, Johnson & Johnson, Bristol Myers Squibb, Eli Lilly and Company, Myriad Genetics, Guardant Health, Foundation Medicine, Biogen, and Becton, Dickinson and Company. Key players in the Companion Diagnostics Market are employing a range of strategies to strengthen their competitive positions. Many are forming long-term collaborations with pharmaceutical firms to co-develop targeted therapies and companion tests that align with new drug launches. Companies are also investing heavily in biomarker discovery and next-generation sequencing technologies to enhance the accuracy and predictive power of diagnostic assays. Strategic mergers and acquisitions are expanding their global reach and diversifying product portfolios.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Data mining sources
  • 1.3.1 Global
  • 1.3.2 Regional/Country
• 1.4 Base estimates and calculations
  • 1.4.1 Base year calculation
  • 1.4.2 Key trends for market estimation
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
• 1.6 Forecast model
• 1.7 Research assumptions and limitations

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis
• 2.2 Key market trends
  • 2.2.1 Regional trends
  • 2.2.2 Products trends
  • 2.2.3 Disease indication trends
  • 2.2.4 Technology trends
  • 2.2.5 End Use trends
• 2.3 CXO perspectives: Strategic imperatives
  • 2.3.1 Key decision points for industry executives
  • 2.3.2 Critical success factors for market players
• 2.4 Future outlook and strategic recommendations

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Upward trend in disease prevalence among developing countries
    • 3.2.1.2 Surging number of pathology labs and services equipped with advanced diagnostic equipment in North America
    • 3.2.1.3 Technological advancements
    • 3.2.1.4 Increasing R&D investment
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Stringent regulatory framework
    • 3.2.2.2 High cost of product development
  • 3.2.3 Market opportunities
    • 3.2.3.1 Growing demand in remote and rural areas
    • 3.2.3.2 Integration with digital health platforms
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
  • 3.4.1 North America
  • 3.4.2 Europe
  • 3.4.3 Asia Pacific
  • 3.4.4 Latin America
  • 3.4.5 Middle East and Africa
• 3.5 Technology landscape
  • 3.5.1 Current technologies
  • 3.5.2 Emerging technologies
• 3.6 Future market trends
• 3.7 Patent analysis
• 3.8 Gap analysis
• 3.9 Porter's analysis
• 3.10 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company market share analysis
  • 4.2.1 North America
  • 4.2.2 Europe
  • 4.2.3 Asia Pacific
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Key developments
  • 4.6.1 Mergers and acquisitions
  • 4.6.2 Partnerships and collaborations
  • 4.6.3 New product launches
  • 4.6.4 Expansion plans

Chapter 5 Market Estimates and Forecast, By Product, 2021 - 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Instruments
• 5.3 Consumables
• 5.4 Services

Chapter 6 Market Estimates and Forecast, By Disease Indication, 2021 - 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Breast cancer
• 6.3 Lung cancer
• 6.4 Colorectal cancer
• 6.5 Skin cancer
• 6.6 Other diseases indications

Chapter 7 Market Estimates and Forecast, By Technology, 2021 - 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Immunohistochemistry
• 7.3 In situ hybridization
• 7.4 Polymerase chain reaction
• 7.5 Genetic sequencing
• 7.6 Other technologies

Chapter 8 Market Estimates and Forecast, By End Use, 2021 - 2034 ($ Mn)

• 8.1 Key trends
• 8.2 Hospitals
• 8.3 Diagnostic laboratories
• 8.4 Other End Use

Chapter 9 Market Estimates and Forecast, By Region, 2021 - 2034 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Netherlands
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 South Korea
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 UAE

Chapter 10 Company Profiles

• 10.1 Abbott Laboratories
• 10.2 Amgen
• 10.3 AstraZeneca
• 10.4 Becton, Dickinson and Company
• 10.5 Biogen
• 10.6 Bristol Myers Squibb
• 10.7 Eli Lilly and Company
• 10.8 F. Hoffmann-La Roche
• 10.9 Foundation Medicine
• 10.10 Guardant Health
• 10.11 Johnson & Johnson
• 10.12 Merck
• 10.13 Myriad Genetics
• 10.14 Pfizer
• 10.15 Thermo Fisher Scientific