동반진단(CDx) 시장 - 세계의 동향, 기회, 예측(제4판)

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