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伴随式诊断(CDx)市场 - 全球趋势，机会，预测(第4版)
市场调查报告书
商品编码
1852912

伴随式诊断(CDx)市场 - 全球趋势，机会，预测(第4版)

Companion Diagnostics (CDx) Markets: Global Trends, Opportunities, and Forecasts, 4th Edition
出版日期: | 出版商: Kalorama Information | 英文 140 Pages | 商品交期: 最快1-2个工作天内

价格
简介目录

医疗保健的新时代已经来临，伴随诊断 (CDx) 正引领着这项变革。这些关键工具透过将诊断和治疗决策直接连结起来，重新定义了我们检测、监测和治疗疾病的方式。 Kalorama Information 的 "伴随诊断 (CDx) 市场——全球趋势、机会与预测（第四版）" 报告对这一快速发展的市场进行了深入的数据驱动型分析，该市场融合了诊断、製药和精准医疗三大领域。

精准医疗的新标准

随着全球医疗保健系统不断追求更高的效率和成本控制，伴随诊断提供了至关重要的解决方案。透过识别哪些患者最能从特定疗法中获益，哪些患者不能，伴随诊断技术可以减少不必要的治疗，改善患者预后，并优化医疗保健支出。随着新型肿瘤疗法和专科疗法的成本持续上涨，这一点尤其重要。本报告运用可靠的市场数据、预测模型和专家见解，探讨伴随诊断如何塑造肿瘤学及其他专科领域的个人化医疗。

加速发现与商业化的科技

基因组学、生物标记研究和诊断技术的突破正在以前所未有的速度推动伴随诊断的发展。从基因检测和药物代谢检测到治疗药物监测，本报告探讨了新型生物标记如何改变我们对疾病的理解，并推动从 "一刀切" 模式转向真正个人化医疗的转变。这些技术正在推动製药公司与诊断开发商之间建立新的合作关係，重塑临床试验和商业化格局。

2024 年至 2029 年全面市场分析

本报告基于 Kalorama Information 值得信赖的研究方法，第四版以 2024 年为基准年，预测至 2029 年，并提供基于供应商到终端用户销售数据的全球市场数据。本报告深入分析了收入趋势、人口统计影响、生物标记和伴随诊断 (CDx) 交易趋势、监管动态以及公司绩效。

报告还包含基本的竞争对手概况和成长预测（2024-2029 年复合年增长率），以指导策略决策。

诊断和製药业利益相关者的必备资源

本报告专为诊断、生物技术和製药行业的管理人员、策略家和创新者而设计，提供以下可操作的资讯：

  • 评估当前市场表现
  • 发掘伴随诊断开发的新机遇
  • 协调研发、监理和商业化策略
  • 评估在快速变化的市场中的竞争地位

连结诊断与治疗

随着医疗保健产业在经济压力、监管变化和科学突破的推动下不断发展，伴随诊断为通往更具针对性、更经济高效且以患者为中心的未来提供了一座桥樑。

"伴随诊断（CDx）市场－全球趋势、机会与预测（第四版）" 提供了驾驭和引领这项变革所需的清晰思路、背景资讯和策略洞察。

目录

第1章 摘要整理

  • 概要
  • 主要调查结果
    • 三大要点
    • 面向不同群体的价值主张
    • 市场的主要驱动因素、限制因素和影响因素
  • 本报告中使用的伴随诊断和个人化医疗的定义
    • 伴随诊断和个人化医疗中使用的术语
  • 范围与调查手法
  • 市场摘要
    • 伴随式诊断市场主要的焦点

第2章 个性化医疗保健和伴随式诊断的简介

  • 概要
  • 法规的变更
    • FDA伴随诊断监管变更：向药物分类伴随诊断标籤过渡
    • 欧盟伴随诊断监管指南
    • EMA的作用
    • FDA与药物基因学关联的识别
  • 报销方面的突破与挑战
    • 人口与经济压力
    • 改善预后检测的报销
    • 药物基因组学报销的挑战
  • 次世代定序覆盖范围
    • 美国医疗保险和医疗补助服务中心 (CMS) 与 NGS 应用范围
    • 概览确定 (LCD) 和 NGS 的扩展应用
  • CDX 批准：美国 FDA
  • 标靶治疗市场：肿瘤学
  • 用于伴随诊断 (CDX) 的 NGS 开发
  • 次世代定序 (NGS) 或大规模平行定序在癌症诊断的应用
  • 日本临床定序与伴随诊断 (CDX) 的发展机会
  • 伴随诊断 (CDX) 市场疾病概况
    • 癌症
  • 心血管疾病
    • 急性心肌梗塞和急性冠状动脉综合征
    • 血脂异常
    • 某些血液疾病
    • 自体免疫疾病与免疫性疾病
    • 感染疾病

    第3章 CDX市场分析

    • 市场概要
      • 伴随式诊断市场主要的焦点
    • 治疗标籤的生物标记
    • 肿瘤学的伴随式诊断
      • 市场检讨与展望
    • 其他的疾病的伴随式诊断
      • 概要
      • 自体免疫疾病
    • 心臟病及血液学
    • 感染疾病
      • 抗生素抗性
      • 疾病专一传染病检查
      • 神经学
    • 诊断技术
    • 市场概要
      • 免疫组织化学 (IHC)
      • 原位杂交
      • 核酸扩增技术
      • 定序技术
      • 次世代定序 (NGS)
      • 流式细胞仪
      • 微阵列
      • 质谱
      • 液体切片循环肿瘤细胞和循环肿瘤DNA（游离DNA）
      • 基因表现模式（基因特征）分析
      • 资讯技术
    • 地区市场检讨
      • 美国市场
      • 复杂的美国的偿付制度
        • 分子病理学CPTcode system的摘要
      • 偿付率的设定
      • 欧洲市场
      • 欧洲市场上偿付
      • 日本市场
      • 日本的保险偿付环境
      • 中国市场
      • 中国的保险偿付环境
      • 其他的全球市场
      • 澳洲的新的CDx法规结构

    第4章 竞争情形和企业简介

    • 简介
    • 竞争情形
      • 策略模式
    • 企业简介
    • ABBOTT
    • AGILENT TECHNOLOGIES/DAKO
    • GUARDANT HEALTH
    • LIFE TECHNOLOGIES (THERMO FISHER SCIENTIFIC)
    • QIAGEN
    • ROCHE
简介目录
Product Code: 25-075KA

The next era of healthcare is here-and it's powered by companion diagnostics (CDx). These essential tools are redefining how diseases are detected, monitored, and treated by aligning diagnostics directly with therapeutic decision-making. Kalorama Information's "Companion Diagnostics (CDx) Markets: Global Trends, Opportunities, and Forecasts, 4th Edition" provides an in-depth, data-driven analysis of this rapidly evolving market-one that sits at the intersection of diagnostics, pharmaceuticals, and precision medicine.

A New Standard for Precision Healthcare

As healthcare systems worldwide seek greater efficiency and cost control, companion diagnostics offer a critical solution. By identifying which patients are most likely to benefit from specific therapies-and which are not-these technologies reduce unnecessary treatments, improve patient outcomes, and optimize healthcare spending. This is especially vital as the cost of new oncology and specialty therapeutics continues to rise. The report examines how companion diagnostics are shaping personalized care across oncology and other medical specialties, supported by robust market data, forecast models, and expert insights.

Technology Driving Discovery and Commercialization

Breakthroughs in genomics, biomarker research, and diagnostic technologies are fueling an unprecedented expansion of CDx development. From genetic panels and drug metabolism tests to therapeutic drug monitoring, the report explores how novel biomarkers are transforming disease understanding and enabling a transition from a one-size-fits-all model to truly personalized medicine. These technologies are driving new partnerships between pharmaceutical and diagnostic developers and reshaping the clinical trial and commercialization landscape.

Comprehensive Market Analysis from 2024-2029

Built on Kalorama Information's trusted methodologies, this fourth edition presents global market data based on supplier sales to end users, with 2024 as the base year and forecasts through 2029. The report provides insights incorporating revenue trends, demographic influences, biomarker and CDx deal activity, regulatory developments, and company performance analysis. Basic competitor summaries and growth projections (CAGRs, 2024-2029) are included to guide strategic decision-making.

An Essential Resource for Diagnostics and Pharma Stakeholders

Designed for executives, strategists, and innovators across diagnostics, biotechnology, and pharmaceutical sectors, this report offers actionable intelligence to:

  • Benchmark current market performance
  • Identify emerging opportunities in companion diagnostics development
  • Align R&D, regulatory, and commercialization strategies
  • Evaluate competitive positioning in a rapidly evolving marketplace

The Bridge Between Diagnostics and Therapeutics

As the healthcare industry continues to evolve under economic pressures, regulatory shifts, and scientific breakthroughs, companion diagnostics stand as the bridge to a more targeted, cost-effective, and patient-centered future.

"Companion Diagnostics (CDx) Markets: Global Trends, Opportunities, and Forecasts, 4th Edition" delivers the clarity, context, and strategic insight needed to navigate this transformation-and lead it.

TABLE OF CONTENTS

CHAPTER 1: EXECUTIVE SUMMARY

  • OVERVIEW
  • KEY FINDINGS
    • Three Key Takeaways
    • Value Propositions for Different Groups
    • Key Drivers, Restraints, and Influencing Factors in the Market
  • DEFINITIONS OF COMPANION DIAGNOSTICS AND PERSONALIZED MEDICINE USED IN THIS REPORT
    • Terms Used in Companion Diagnostics and Personalized Medicine
      • Table 1-1: Industry Recognized Terms for Companion Diagnostics and Personalized Medicine, 2025
  • SCOPE AND METHODOLOGY
  • MARKET SUMMARY
    • Key Highlights of the Companion Diagnostics Market
      • Table 1-2: Global In Vitro Companion Diagnostic (CDx) Market, 2024-2029 ($ million)
      • Figure 1-1: Global In Vitro Companion Diagnostic (CDx) Market, 2024-2029 ($ million)

CHAPTER 2: INTRODUCTION TO PERSONALIZED HEALTHCARE AND COMPANION DIAGNOSTICS

  • OVERVIEW
  • REGULATORY CHANGES
    • FDA Changes in CDx Regulation: Shift to Drug Classification CDx Labeling
      • Table 2-1: FDA Approved Companion Diagnostics Labeled for Identifying Patients with NSCLC whose Tumors have EGFR Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations and the Associated Therapeutic Products Listed on the Companion Diagnostic Labels
    • EU Companion Diagnostic Regulation Guidance
    • Role of the EMA
    • The FDA and Identifying Pharmacogenetic Associations
      • Table 2-2: FDA Pharmacogenetic Associations for Which Data Support Therapeutic Management Recommendations
      • Table 2-3: Pharmacogenetic Associations for Which the Data Indicate a Potential Impact on Safety or Response
      • Table 2-4: Pharmacogenetic Associations for Which the Data Demonstrate a Potential Impact on Pharmacokinetic Properties Only (the impact of these genetic variants or genetic variant inferred phenotypes on the safety or response of the corresponding drug has not been established)
      • Table 2-5: Biomarkers and Associated FDA Approved Therapies
  • REIMBURSEMENT BREAKTHROUGHS AND CHALLENGES
    • Demographic and Economic Pressures
    • Improving Reimbursement for Prognostic Assays
    • Reimbursement Challenges in Pharmacogenomics
  • NEXT GENERATION SEQUENCING COVERAGE
    • Centers for Medicare & Medicaid Services (CMS) and NGS Coverage
    • Local Coverage Determinations (LCDs) and Expanded NGS Access
  • CDX APPROVALS: UNITED STATES FDA
    • Figure 2-1: Personalized Medicines' Share of Newly Approved Drugs, 2015-2024
    • Figure 2-2: Number of FDA Cleared/Approved Companion Diagnostic and Therapeutic Application Approvals per Year, 1997-2024
  • THE MARKET FOR TARGETED THERAPIES: ONCOLOGY
    • Table 2-6: Top Performing Targeted Therapies in Oncology with CDx Component, 2024 Sales ($ million)
    • Figure 2-3: Distribution of Commercialized Targeted Therapies Revenues, Using CDx by Drug Class (%) [ADC, Apoptosis Inducer, Kinase Inhibitor, Monoclonal Antibody (mAb), Poly ADP Ribose Polymerase Inhibitor (PARPi), Other]
    • Figure 2-4: Market Value of Commercialized Targeted Therapies Compared to Companion Diagnostic Market Value, 2020-2024 ($ million)
  • DEVELOPMENT IN NGS FOR CDX
    • Figure 2-5: CDx Approval Events (Test-Therapy-Indication) by Technique, Through February 2025 [Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Other]
  • NEXT-GENERATION SEQUENCING (NGS) OR MASSIVELY PARALLEL SEQUENCING IN CANCER DIAGNOSTICS
  • THE EVOLVING OPPORTUNITY FOR CLINICAL SEQUENCING AND CDX IN JAPAN
  • DISEASE PROFILES IN CDX MARKETS
    • Cancer
      • Table 2-7: Incidence of Cancer by Type, 2022 [Bladder, Breast (female), Cervix/ uterus, Colorectum, Esophagus, Liver, Lung, Non-Hodgkin lymphoma, Pancreas, Prostate, Stomach, Thyroid]
      • Figure 2-6: Incidence of Cancer by Type, 2022 [Bladder, Breast (female), Cervix/Uterus, Colorectum, Esophagus, Liver, Lung, Non-Hodgkin lymphoma, Pancreas, Prostate, Stomach, Thyroid]
      • Figure 2-7: Incidence of Cancer by Type, 2022 [Bladder, Breast (female), Cervix/Uterus, Colorectum, Esophagus, Liver, Lung, Non-Hodgkin lymphoma, Pancreas, Prostate, Stomach, Thyroid]
  • CARDIOVASCULAR DISEASE
    • Acute Myocardial Infarction and Acute Coronary Syndrome
    • Lipid Disorders
    • Selected Blood Disorders
    • Autoimmune and Immunological Diseases
  • INFECTIOUS DISEASES

CHAPTER 3: CDX MARKET ANALYSIS

  • MARKET OVERVIEW
    • Key Highlights of the Companion Diagnostics Market
      • Table 3-1: Global In Vitro Companion Diagnostic (CDx) Market, 2024-2029 ($ million)
      • Figure 3-1: Global In Vitro Companion Diagnostic (CDx) Market, 2024-2029 ($ million)
  • BIOMARKERS IN THERAPEUTIC LABELING
    • Table 3-2: Pharmacogenomic Biomarkers in Drug Labeling, FDA
  • COMPANION DIAGNOSTICS IN ONCOLOGY
    • Market Review and Outlook
      • Figure 3-2: CDx Approvals (PMAs) by Cancer Type, 1997-Feb 2025 [Breast cancer, Colorectal cancer, Endometrial carcinoma (EC), Gastric, Leukemia, Melanoma, NSCLC, Ovarian cancer, Prostate, Other]
      • Table 3-3: Selected FDA Approved or Cleared Companion Diagnostic (CDx) Tests and Corresponding Therapies, Oncology
      • Table 3-4: Selected Major Biomarkers in Oncology Personalized Medicine Tests
      • Table 3-5: Selected Companies with Oncology Personalized Medicine Tests Offered as a Service
  • COMPANION DIAGNOSTICS IN OTHER DISEASES
    • Overview
      • Table 3-6: Selected Major Biomarkers in Other Personalized Medicine Tests
    • Autoimmune Disorders
  • CARDIOLOGY AND HEMATOLOGY
  • INFECTIOUS DISEASE
    • Antibiotic Resistance
    • Disease-Specific Infectious Disease Tests
    • Neurology
  • DIAGNOSTIC TECHNIQUES
    • Figure 3-3: FDA Approved Companion Dx by Technique and Year, 2010-2024 [Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR)]
  • MARKET OVERVIEW
    • Table 3-7: Global CDx Market by Technology Method, 2024 and 2029 ($ million) [Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR)]
    • Figure 3-4: Global CDx Market Share Distribution by Technology Method, 2024 (%) [Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR)]
    • Immunohistochemistry (IHC)
      • Table 3-8: Examples of Commercially Available IHC Companion Diagnostics
    • In Situ Hybridization
      • Table 3-9: Examples of Commercially Available ISH Companion Diagnostics
    • Nucleic Acid Amplification Technologies
      • Table 3-10: Examples of Commercially Available PCR Companion Diagnostics
    • Sequencing Technologies
    • Next-Generation Sequencing (NGS)
      • Table 3-11: Examples of Commercially Available NGS Companion Diagnostics
    • Flow Cytometry
    • Microarrays
    • Mass Spectrometry
    • Liquid Biopsies - Circulating Tumor Cells and Circulating Tumor DNA (Cell-Free DNA)
    • Analysis of Gene Expression Patterns (Gene Signatures)
    • Information Technology
  • REGIONAL MARKET REVIEW
    • Table 3-12: Global CDx Market by Region, 2024-2029 ($ million) [APAC, Europe, United Staes, Rest of World]
    • Figure 3-5: Global CDx Market by Region, 2024 (%) [APAC, Europe, United Staes, Rest of World]
    • Figure 3-6: Global CDx Market by Region, 2029 (%) [APAC, Europe, United Staes, Rest of World]
    • U.S. Market
      • Table 3-13: Main Reasons for Gaps in CDx Usage, and Numbers of Patients Affected
    • The Complex U.S. Reimbursement System
      • Summary of Molecular Pathology CPT Coding System
    • Establishing Reimbursement Rates
    • European Market
    • Reimbursement in European Markets
    • Japanese Market
    • Reimbursement Environment in Japan
    • Chinese Market
    • Reimbursement Environment in China
    • Rest of World Market
    • Australia's New CDx Regulatory Framework

CHAPTER 4: COMPETITIVE LANDSCAPE AND CORPORATE PROFILES

  • INTRODUCTION
  • COMPETITIVE LANDSCAPE
    • Strategic Models
      • Table 4-1: Deals in the CDx Market, 2024-2025
      • Table 4-2: CDx Regulatory Approvals, 2024-2025
  • COMPANY PROFILES
  • ABBOTT
  • AGILENT TECHNOLOGIES/DAKO
  • GUARDANT HEALTH
  • LIFE TECHNOLOGIES (THERMO FISHER SCIENTIFIC)
  • QIAGEN
  • ROCHE