동반진단약 시장 규모, 점유율, 성장 분석 : 제품별, 기술별, 적응증별, 샘플 유형별, 최종사용자별, 지역별 - 산업 예측(2025-2032년)

Companion Diagnostics Market size was valued at USD 6.9 billion in 2023 and is poised to grow from USD 7.76 billion in 2024 to USD 19.92 billion by 2032, growing at a CAGR of 12.5% during the forecast period (2025-2032).

The companion diagnostic market is experiencing significant growth, driven by the rising incidence of cancer and the increasing demand for precision medicine. These tests are critical for determining the safe and effective administration of related biological treatments, particularly in oncology. As genomic, proteomic, and metabolomic profiling continues to evolve, the need for companion diagnostics to identify appropriate therapies and predict positive outcomes is surging. Furthermore, the advent of personalized medication highlights the essential role of these diagnostics in individualized treatment approaches. Support from government initiatives and favorable regulatory guidance, particularly from entities like the FDA and EMA, is accelerating market momentum. Streamlined approval processes enhance the availability of companion diagnostics, promoting improved treatment efficacy and timely patient care.

Top-down and bottom-up approaches were used to estimate and validate the size of the Companion Diagnostics market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Companion Diagnostics Market Segments Analysis

Global Companion Diagnostics Market is segmented by Product, Technology, Indication, Sample Type, End User and region. Based on Product, the market is segmented into Assays, Kits, And Reagents, Instruments & Systems and Software & Services. Based on Technology, the market is segmented into Polymerase Chain Reaction, In Situ Hybridization, Next-Generation Sequencing, Immunohistochemistry and Other Technologies. Based on Indication, the market is segmented into Cancer, Neurological Diseases, Cardiovascular Diseases, Infectious Diseases and Other Indications. Based on Sample Type, the market is segmented into Tissue Samples, Blood Samples and Other Sample Types. Based on End User, the market is segmented into Pharmaceutical & Biotechnology Companies, Reference Laboratories, Contract Research Organizations and Other End Users. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Companion Diagnostics Market

In recent years, there has been a significant rise in cancer cases, which has intensified the demand for effective companion diagnostics (CDx) assays. This increasing incidence heightens the necessity for genetic testing, which equips healthcare professionals with critical insights to tailor treatment plans specifically for their patients' unique cancer profiles. Consequently, the surging prevalence of cancer is driving the market for CDx products, as these assays are essential in delivering precise and personalized therapeutic approaches. Thus, the urgent need for innovative and efficient CDx solutions has become a prominent market driver in the face of escalating cancer diagnoses.

Restraints in the Companion Diagnostics Market

The Companion Diagnostics market faces significant restraints due to the considerable financial investment required for regulatory compliance, validation, and clinical trials. These high expenses can pose a significant challenge for smaller companies, potentially hindering their ability to enter and compete in the market. Furthermore, ambiguous and varied reimbursement policies surrounding companion diagnostics further complicate market expansion. The complexity of navigating these policies can deter new entrants, creating additional barriers for growth and limiting access to advancements in personalized medicine. As a result, these factors collectively contribute to a restrained landscape within the Companion Diagnostics sector.

Market Trends of the Companion Diagnostics Market

The Companion Diagnostics market is poised for significant growth driven by innovations in Next-Generation Sequencing (NGS) technology. NGS enables comprehensive gene profiling in surgically removed tumors, facilitating the identification of cancer-associated genes and enhancing personalized treatment strategies. The transition of NGS from research to clinical applications, as highlighted by a recent CDC report, underscores its increasing importance in precision medicine. As its technological capabilities expand and adoption in clinical settings accelerates, NGS is expected to play a pivotal role in improving patient outcomes, ultimately fueling market growth and solidifying its place in oncological diagnostics and treatment planning.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Regulatory Analysis
• Technology Analysis
• Case Studies
• Customer And Buying Criteria Analysis

Global Companion Diagnostics Market Size by Product & Service & CAGR (2025-2032)

• Market Overview
• Assays, Kits, And Reagents
• Instruments & Systems
• Software & Services

Global Companion Diagnostics Market Size by Technology & CAGR (2025-2032)

• Market Overview
• Polymerase Chain Reaction
• In Situ Hybridization
• Next-Generation Sequencing
• Immunohistochemistry
• Other Technologies

Global Companion Diagnostics Market Size by Indication & CAGR (2025-2032)

• Market Overview
• Cancer
  • Lung Cancer
  • Breast Cancer
  • Blood Cancer
  • Colorectal Cancer
  • Other Cancers
• Neurological Diseases
• Cardiovascular Diseases
• Infectious Diseases
• Other Indications

Global Companion Diagnostics Market Size by Sample Type & CAGR (2025-2032)

• Market Overview
• Tissue Samples
• Blood Samples
• Other Sample Types

Global Companion Diagnostics Market Size by End User & CAGR (2025-2032)

• Market Overview
• Pharmaceutical & Biotechnology Companies
• Reference Laboratories
• Contract Research Organizations
• Other End Users

Global Companion Diagnostics Market Size & CAGR (2025-2032)

• North America (Product & Service, Technology, Indication, Sample Type, End User)
  • US
  • Canada
• Europe (Product & Service, Technology, Indication, Sample Type, End User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Product & Service, Technology, Indication, Sample Type, End User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Product & Service, Technology, Indication, Sample Type, End User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Product & Service, Technology, Indication, Sample Type, End User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Abbott (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• IDVet (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• F. Hoffmann-La Roche Ltd. (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Agilent Technologies, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AniCell Biotech (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Illumina, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Guardant Health (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BIOMERIEUX (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• NEOGEN Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Zoetis Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Myriad Genetics, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Virbac SA (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations