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伴隨式診斷(CDx)市場 - 全球趨勢，機會，預測(第4版)
市場調查報告書
商品編碼
1852912

伴隨式診斷(CDx)市場 - 全球趨勢，機會，預測(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個工作天內

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簡介目錄

醫療保健的新時代已經來臨，伴隨診斷 (CDx) 正引領著這項變革。這些關鍵工具透過將診斷和治療決策直接連結起來，重新定義了我們檢測、監測和治療疾病的方式。 Kalorama Information 的 "伴隨診斷 (CDx) 市場——全球趨勢、機會與預測（第四版）" 報告對這一快速發展的市場進行了深入的數據驅動型分析，該市場融合了診斷、製藥和精準醫療三大領域。

精準醫療的新標準

隨著全球醫療保健系統不斷追求更高的效率和成本控制，伴隨診斷提供了至關重要的解決方案。透過識別哪些患者最能從特定療法中獲益，哪些患者不能，伴隨診斷技術可以減少不必要的治療，改善患者預後，並優化醫療保健支出。隨著新型腫瘤療法和專科療法的成本持續上漲，這一點尤其重要。本報告運用可靠的市場數據、預測模型和專家見解，探討伴隨診斷如何塑造腫瘤學及其他專科領域的個人化醫療。

加速發現與商業化的科技

基因組學、生物標記研究和診斷技術的突破正在以前所未有的速度推動伴隨診斷的發展。從基因檢測和藥物代謝檢測到治療藥物監測，本報告探討了新型生物標記如何改變我們對疾病的理解，並推動從 "一刀切" 模式轉向真正個人化醫療的轉變。這些技術正在推動製藥公司與診斷開發商之間建立新的合作關係，重塑臨床試驗和商業化格局。

2024 年至 2029 年全面市場分析

本報告基於 Kalorama Information 值得信賴的研究方法，第四版以 2024 年為基準年，預測至 2029 年，並提供基於供應商到終端用戶銷售數據的全球市場數據。本報告深入分析了收入趨勢、人口統計影響、生物標記和伴隨診斷 (CDx) 交易趨勢、監管動態以及公司績效。

報告還包含基本的競爭對手概況和成長預測（2024-2029 年複合年增長率），以指導策略決策。

診斷和製藥業利益相關者的必備資源

本報告專為診斷、生物技術和製藥行業的管理人員、策略家和創新者而設計，提供以下可操作的資訊：

  • 評估當前市場表現
  • 發掘伴隨診斷開發的新機遇
  • 協調研發、監理和商業化策略
  • 評估在快速變化的市場中的競爭地位

連結診斷與治療

隨著醫療保健產業在經濟壓力、監管變化和科學突破的推動下不斷發展，伴隨診斷為通往更具針對性、更經濟高效且以患者為中心的未來提供了一座橋樑。

"伴隨診斷（CDx）市場－全球趨勢、機會與預測（第四版）" 提供了駕馭和引領這項變革所需的清晰思路、背景資訊和策略洞察。

目錄

第1章 摘要整理

  • 概要
  • 主要調查結果
    • 三大要點
    • 面向不同群體的價值主張
    • 市場的主要驅動因素、限制因素和影響因素
  • 本報告中使用的伴隨診斷和個人化醫療的定義
    • 伴隨診斷和個人化醫療中使用的術語
  • 範圍與調查手法
  • 市場摘要
    • 伴隨式診斷市場主要的焦點

第2章 個性化醫療保健和伴隨式診斷的簡介

  • 概要
  • 法規的變更
    • FDA伴隨診斷監管變更：向藥物分類伴隨診斷標籤過渡
    • 歐盟伴隨診斷監管指南
    • EMA的作用
    • FDA與藥物基因學關聯的識別
  • 報銷方面的突破與挑戰
    • 人口與經濟壓力
    • 改善預後檢測的報銷
    • 藥物基因組學報銷的挑戰
  • 次世代定序覆蓋範圍
    • 美國醫療保險和醫療補助服務中心 (CMS) 與 NGS 應用範圍
    • 概覽確定 (LCD) 和 NGS 的擴展應用
  • CDX 批准：美國 FDA
  • 標靶治療市場：腫瘤學
  • 用於伴隨診斷 (CDX) 的 NGS 開發
  • 次世代定序 (NGS) 或大規模平行定序在癌症診斷的應用
  • 日本臨床定序與伴隨診斷 (CDX) 的發展機會
  • 伴隨診斷 (CDX) 市場疾病概況
    • 癌症
  • 心血管疾病
    • 急性心肌梗塞和急性冠狀動脈綜合徵
    • 血脂異常
    • 某些血液疾病
    • 自體免疫疾病與免疫性疾病
    • 感染疾病

    第3章 CDX市場分析

    • 市場概要
      • 伴隨式診斷市場主要的焦點
    • 治療標籤的生物標記
    • 腫瘤學的伴隨式診斷
      • 市場檢討與展望
    • 其他的疾病的伴隨式診斷
      • 概要
      • 自體免疫疾病
    • 心臟病及血液學
    • 感染疾病
      • 抗生素抗性
      • 疾病專一傳染病檢查
      • 神經學
    • 診斷技術
    • 市場概要
      • 免疫組織化學 (IHC)
      • 原位雜交
      • 核酸擴增技術
      • 定序技術
      • 次世代定序 (NGS)
      • 流式細胞儀
      • 微陣列
      • 質譜
      • 液體切片循環腫瘤細胞和循環腫瘤DNA（遊離DNA）
      • 基因表現模式（基因特徵）分析
      • 資訊技術
    • 地區市場檢討
      • 美國市場
      • 複雜的美國的償付制度
        • 分子病理學CPTcode system的摘要
      • 償付率的設定
      • 歐洲市場
      • 歐洲市場上償付
      • 日本市場
      • 日本的保險償付環境
      • 中國市場
      • 中國的保險償付環境
      • 其他的全球市場
      • 澳洲的新的CDx法規結構

    第4章 競爭情形和企業簡介

    • 簡介
    • 競爭情形
      • 策略模式
    • 企業簡介
    • ABBOTT
    • AGILENT TECHNOLOGIES/DAKO
    • GUARDANT HEALTH
    • LIFE TECHNOLOGIES (THERMO FISHER SCIENTIFIC)
    • QIAGEN
    • ROCHE
簡介目錄
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