Companion Diagnostics (CDx) Markets: Global Trends, Opportunities, and Forecasts, 4th Edition

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