시장보고서
상품코드
2070355

동반진단 시장 : 제품별(어세이, 키트 및 시약, 기기, 소프트웨어), 기술별(PCR, NGS, ISH, IHC), 적응증별(유방암, 폐암, 대장암, 심혈관질환, 감염증), 약물 유형별(MAB, 세포 및 유전자 치료) - 세계 예측(-2031년)

Companion Diagnostics Market by Product (Assays, Kits, & Reagents, Instruments, Software), Technology (PCR, NGS, ISH, IHC), Indication (Breast, Lung, Colorectal Cancer, CVD, Infectious), Drug Class (MAB, Cell & Gene Therapy) - Global Forecast to 2031

발행일: | 리서치사: 구분자 MarketsandMarkets | 페이지 정보: 영문 427 Pages | 배송안내 : 즉시배송

    
    
    




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한글목차
영문목차
※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.

동반진단 시장 규모는 2026년 63억 1,000만 달러에서 2031년에는 115억 7,000만 달러에 달할 것으로 예측되며, CAGR은 12.9%를 기록할 전망입니다.

이러한 성장은 주로 종양 분야에서의 바이오마커 검사 증가, 표적 치료 및 면역 치료의 승인 확대, 제약·진단 분야에서의 공동 개발 활동 활성화에 힘입어 이루어지고 있습니다.

조사 범위
조사 대상 기간 2026-2031년
기준 연도 2025년
예측 기간 2026-2031년
단위 금액(달러)
부문 제품 및 서비스, 기술, 적응증, 검체, 최종사용자, 약물 유형, 용도
대상 지역 북미, 유럽, 아시아태평양, 라틴아메리카, 중동 및 아프리카

시장의 성장은 중합효소 연쇄 반응(PCR), 차세대 염기서열 분석(NGS), 면역조직화학, 인 시투 하이브리다이제이션과 같은 분자진단 기술의 발전은 물론, 맞춤형 치료 선택에 대한 수요 증가에 힘입어 더욱 가속화되고 있습니다. 그러나 한편으로는 높은 개발 및 검증 비용, 복잡한 규제 절차, 보험 급여 제한, 지역별 바이오마커 검사 인프라의 편차가 시장 성장을 어느 정도 저해할 것으로 예상됩니다.

Companion Diagnostics Market-IMG1

“제품·서비스별로는 분석법, 키트, 시약이 2025년 시장에서 가장 큰 점유율을 차지했습니다.”

이는 바이오마커 검출, 변이 분석, 치료법 선택, 일상적인 분자 검사 워크플로우에서 널리 활용되고 있기 때문입니다. 지속적인 수요, 고처리량 검사 플랫폼과의 호환성, 종양에 초점을 맞춘 정밀 의학 분야에서의 채택 확대가 이 부문의 성장을 지속적으로 뒷받침하고 있습니다. 또한, 표적 치료 및 면역 치료와 관련된 동반진단 분석법의 승인 건수가 증가하고 있는 점도 이 부문의 우위를 더욱 공고히 하고 있습니다.

“기술별로는 PCR이 2025년에 큰 점유율을 차지했습니다.”

높은 분석 감도, 짧은 소요 시간, 임상 현장에서의 폭넓은 채택, 바이오마커 기반 검사에서 규제 당국의 강력한 지지에 힘입어 PCR은 2025년에 주요 시장 점유율을 차지했습니다. PCR 기술은 여러 종양 적응증에서 돌연변이 검출 및 표적 치료법 선정에 널리 활용되고 있습니다. 또한, 다중 PCR 분석법의 활용 확대와 신속한 분자 검사 수요의 증가가 전 세계적으로 이 부문의 선도적 지위를 지속적으로 뒷받침하고 있습니다.

“아시아태평양은 예측 기간 동안 가장 빠른 성장을 이룰 시장으로 예상됩니다.”

암 발병률 증가, 의료 인프라 확충, 분자진단에 대한 투자 확대, 정밀 의료 접근법의 보급 확대에 힘입어 아시아태평양은 예측 기간 동안 가장 높은 연평균 성장률(CAGR)을 기록할 것으로 전망됩니다. 또한, 첨단 암 치료에 대한 접근성 개선, 제약 기업의 임상시험 확대, 중국, 일본, 인도, 한국, 동남아시아 지역의 기업 및 세계 진단 기업의 입지 강화도 이 지역의 성장을 더욱 뒷받침하고 있습니다.

본 보고서에서는 전 세계 동반진단 시장을 조사하여, 시장 개요, 시장 성장에 영향을 미치는 다양한 요인에 대한 분석, 기술 및 특허 동향, 법규제 환경, 사례 연구, 시장 규모 추정 및 전망, 각종 분류·지역/주요 국가별 상세 분석, 경쟁 현황, 주요 기업 개요 등을 정리하고 있습니다.

자주 묻는 질문

  • 동반진단 시장 규모는 어떻게 예측되나요?
  • 동반진단 시장의 성장은 어떤 요인에 의해 이루어지나요?
  • 어떤 기술이 동반진단 시장에서 큰 점유율을 차지하나요?
  • 아시아태평양 지역의 동반진단 시장 성장 전망은 어떤가요?
  • 동반진단 시장에서 제품 및 서비스별로 어떤 것이 가장 큰 점유율을 차지하나요?

목차

제1장 소개

제2장 주요 요약

제3장 주요 인사이트

제4장 시장 개요

제5장 업계 동향

제6장 기술의 진보, AI의 영향, 특허, 혁신, 향후 응용

제7장 규제 상황과 지속가능성에 대한 대처

제8장 고객 상황과 구매 행동

제9장 동반진단 시장 : 제품 및 서비스별

제10장 동반진단 시장 : 검체 유형별

제11장 동반진단 시장 : 기술별

제12장 동반진단 시장 : 적응증별

제13장 암 동반진단 시장 : 지역별(수량 분석·검사 건수)

제14장 동반진단 시장 : 용도별

제15장 동반진단 시장 : 최종사용자별

제16장 동반진단 시장 : CDx 관련 약물 계열별

제17장 동반진단 시장 : 지역별

제18장 경쟁 구도

제19장 기업 개요

제20장 조사 방법

제21장 부록

KSM 26.07.02

The companion diagnostics market is projected to reach USD 11.57 billion by 2031, from USD 6.31 billion in 2026, with a CAGR of 12.9%. This growth is primarily driven by increasing oncology biomarker testing, expanding approvals of targeted therapies and immunotherapies, and rising pharmaceutical-diagnostic co-development activities.

Scope of the Report
Years Considered for the Study2026-2031
Base Year2025
Forecast Period2026-2031
Units ConsideredValue (USD billion)
SegmentsProduct & Service, Technology, Indication, Sample, End User, Drug Class, Application
Regions coveredNorth America, Europe, Asia Pacific, Latin America, Middle East, Africa

Market growth is further supported by advancements in molecular diagnostics technologies, such as polymerase chain reaction (PCR), next-generation sequencing (NGS), immunohistochemistry, and in situ hybridization, along with increased demand for personalized treatment selection. However, high development and validation costs, complex regulatory pathways, reimbursement limitations, and variability in biomarker testing infrastructure across regions are expected to restrain market growth to a certain extent.

Companion Diagnostics Market - IMG1

"Assays, kits & reagents accounted for the largest share of the companion diagnostics market, by product & service, in 2025."

In 2025, assays, kits & reagents accounted for the largest share due to their extensive use in biomarker detection, mutation analysis, therapy selection, and routine molecular testing workflows. Their recurring demand, compatibility with high-throughput testing platforms, and increasing adoption in oncology-focused precision medicine applications continue to support segment growth. Additionally, rising approvals of companion diagnostic assays linked to targeted therapies and immunotherapies are further strengthening the dominance of this segment.

"PCR accounted for a major share of the companion diagnostics market, by technology, in 2025."

In 2025, PCR accounted for a major share due to its high analytical sensitivity, shorter turnaround time, broad clinical adoption, and strong regulatory acceptance in biomarker-driven testing. PCR technologies are widely used for mutation detection and targeted therapy selection across multiple oncology indications. Additionally, growing use of multiplex PCR assays and increasing demand for rapid molecular testing continue to support the segment's leading market position globally.

"Asia Pacific is expected to be the fastest-growing market for companion diagnostics during the forecast period."

During the forecast period, the Asia Pacific region is projected to register the highest CAGR due to increasing cancer incidence, expanding healthcare infrastructure, rising investments in molecular diagnostics, and growing adoption of precision medicine approaches. Growth is further supported by improving access to advanced oncology care, expansion of pharmaceutical clinical trials, and increasing presence of regional and global diagnostic companies across China, Japan, India, South Korea, and Southeast Asia.

Companies Profiled

  • F. Hoffmann-La Roche AG
  • Agilent Technologies, Inc
  • Qiagen N.V.
  • Thermo Fisher Scientific, Inc.
  • Abbott Laboratories
  • Almac Group
  • Danaher Corporation
  • Illumina Inc
  • Biomerieux Sa
  • Myriad Genetics, Inc
  • Sysmex Corporation
  • Guardant Health, Inc.
  • Icon Plc
  • Quest Diagnostics
  • Amoy Diagnostics Co., Ltd
  • Tempus Ai, Inc
  • Caris Life Sciences, Inc.

Research Coverage

This research report categorizes the companion diagnostics market by product & service, technology, indication, sample, end user, drug class, application, and region. The scope of the report covers detailed information regarding the major factors, such as drivers, challenges, opportunities, and restraints, influencing the growth of the protein expression market. A detailed analysis of the key industry players has been done to provide insights into their business overview, product portfolio, key strategies such as product and service approvals and launches, collaborations, partnerships, expansions, agreements, and recent developments associated with the protein expression market. This report covers competitive analysis of top players and upcoming startups in the protein expression market ecosystem.

Key Benefits of Buying this Report

The report will help market leaders and new entrants by providing the closest approximations of revenue numbers for the overall companion diagnostics market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to position their businesses effectively and develop suitable go-to-market strategies. The report will enable stakeholders to understand the market pulse and provide information on key market drivers, restraints, opportunities, and challenges.

The report provides insights into the following points:

  • Analysis of key drivers, including increasing adoption of precision medicine, expanding targeted therapy pipelines, rising oncology biomarker testing volumes, growing pharmaceutical-diagnostic partnerships, and increasing demand for personalized treatment approaches; restraints including high assay development costs, reimbursement limitations, and regulatory complexities; and challenges including standardization issues, biomarker validation complexities, and limited molecular testing infrastructure in emerging regions.
  • Product Development/Innovation: Detailed insights on newly launched companion diagnostic assays, biomarker testing technologies, liquid biopsy platforms, NGS solutions, and therapy-linked molecular testing workflows.
  • Market Development: Comprehensive information about lucrative markets - the report analyzes the companion diagnostics market across various regions.
  • Market Diversification: Exhaustive information about product portfolios, technology developments, regulatory approvals, collaborations, partnerships, acquisitions, and investments in the companion diagnostics market.
  • Competitive Assessment: In-depth assessment of market shares, growth strategies, technology capabilities, and service offerings of leading players such as F. Hoffmann-La Roche AG, Agilent Technologies, Inc., QIAGEN N.V., Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Illumina Inc., bioMerieux SA, Sysmex Corporation, and Guardant Health, Inc.

TABLE OF CONTENTS

1 INTRODUCTION

  • 1.1 STUDY OBJECTIVES
  • 1.2 MARKET DEFINITION
  • 1.3 STUDY SCOPE
    • 1.3.1 MARKETS COVERED & REGIONAL SCOPE
    • 1.3.2 INCLUSIONS & EXCLUSIONS
    • 1.3.3 YEARS CONSIDERED
    • 1.3.4 CURRENCY CONSIDERED
  • 1.4 STAKEHOLDERS
  • 1.5 SUMMARY OF CHANGES

2 EXECUTIVE SUMMARY

  • 2.1 KEY INSIGHTS & MARKET HIGHLIGHTS
  • 2.2 KEY MARKET PARTICIPANTS: INSIGHTS & STRATEGIC DEVELOPMENTS
  • 2.3 DISRUPTIVE TRENDS SHAPING MARKET GROWTH
  • 2.4 HIGH-GROWTH SEGMENTS & EMERGING FRONTIERS
  • 2.5 SNAPSHOT: GLOBAL MARKET SIZE, GROWTH RATE, AND FORECAST

3 PREMIUM INSIGHTS

  • 3.1 COMPANION DIAGNOSTICS MARKET OVERVIEW
  • 3.2 COMPANION DIAGNOSTICS MARKET, BY PRODUCT & SERVICE, 2026 VS. 2031
  • 3.3 COMPANION DIAGNOSTICS MARKET, BY TECHNOLOGY, 2026 VS. 2031
  • 3.4 COMPANION DIAGNOSTICS MARKET, BY INDICATION, 2026 VS. 2031
  • 3.5 COMPANION DIAGNOSTICS MARKET, BY SAMPLE TYPE, 2026 VS. 2031
  • 3.6 COMPANION DIAGNOSTICS MARKET, BY DRUG ASSOCIATED WITH CDX, 2026 VS. 2031
  • 3.7 COMPANION DIAGNOSTICS MARKET, BY APPLICATION, 2026 VS. 2031
  • 3.8 COMPANION DIAGNOSTICS MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES

4 MARKET OVERVIEW

  • 4.1 INTRODUCTION
  • 4.2 MARKET DYNAMICS
    • 4.2.1 DRIVERS
      • 4.2.1.1 Increasing adoption of precision medicine and targeted therapies
      • 4.2.1.2 Growing investments in genomics, molecular diagnostics, and biomarker discovery
      • 4.2.1.3 Expanding pharmaceutical-diagnostic co-development partnerships
    • 4.2.2 RESTRAINTS
      • 4.2.2.1 High development, clinical validation, and regulatory approval costs
    • 4.2.3 OPPORTUNITIES
      • 4.2.3.1 Expansion of liquid biopsy and non-invasive companion diagnostics
      • 4.2.3.2 AI-driven biomarker interpretation and digital pathology integration
    • 4.2.4 CHALLENGES
      • 4.2.4.1 Regulatory complexity associated with simultaneous drug-diagnostic approvals
  • 4.3 UNMET NEEDS & WHITE SPACES
    • 4.3.1 UNMET NEEDS IN COMPANION DIAGNOSTICS MARKET
    • 4.3.2 WHITE SPACE OPPORTUNITIES
  • 4.4 INTERCONNECTED MARKETS & CROSS-SECTOR OPPORTUNITIES
    • 4.4.1 INTERCONNECTED MARKETS
    • 4.4.2 CROSS-SECTOR OPPORTUNITIES
  • 4.5 STRATEGIC MOVES BY TIER 1/2/3 PLAYERS
    • 4.5.1 KEY MOVES & STRATEGIC FOCUS

5 INDUSTRY TRENDS

  • 5.1 PORTER'S FIVE FORCES ANALYSIS
    • 5.1.1 BARGAINING POWER OF SUPPLIERS
    • 5.1.2 BARGAINING POWER OF BUYERS
    • 5.1.3 THREAT OF NEW ENTRANTS
    • 5.1.4 THREAT OF SUBSTITUTES
    • 5.1.5 INTENSITY OF COMPETITIVE RIVALRY
  • 5.2 MACROECONOMIC OUTLOOK
    • 5.2.1 INTRODUCTION
    • 5.2.2 GDP TRENDS & FORECAST
    • 5.2.3 TRENDS IN GLOBAL COMPANION DIAGNOSTICS INDUSTRY
  • 5.3 SUPPLY CHAIN ANALYSIS
  • 5.4 VALUE CHAIN ANALYSIS
  • 5.5 ECOSYSTEM ANALYSIS
  • 5.6 PRICING ANALYSIS
    • 5.6.1 AVERAGE SELLING PRICE TREND, BY KEY PLAYER, 2024-2026
    • 5.6.2 AVERAGE SELLING PRICE TREND, BY REGION, 2024-2026
    • 5.6.3 AVERAGE SELLING PRICE TREND, BY TECHNOLOGY TYPE, 2024-2026
  • 5.7 TRADE ANALYSIS
    • 5.7.1 IMPORT SCENARIO (HS CODE 3822)
    • 5.7.2 EXPORT SCENARIO (HS CODE 3822)
  • 5.8 KEY CONFERENCES & EVENTS, 2026-2027
  • 5.9 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS' BUSINESSES
  • 5.10 INVESTMENT & FUNDING SCENARIO
  • 5.11 IMPACT OF US TARIFFS-COMPANION DIAGNOSTICS MARKET
    • 5.11.1 INTRODUCTION
    • 5.11.2 KEY TARIFF RATES
    • 5.11.3 PRICE IMPACT ANALYSIS
    • 5.11.4 IMPACT ON COUNTRIES/REGIONS
      • 5.11.4.1 North America
      • 5.11.4.2 Europe
      • 5.11.4.3 Asia Pacific
    • 5.11.5 IMPACT ON END-USE INDUSTRIES
      • 5.11.5.1 Hospital and cancer centers
      • 5.11.5.2 Pharmaceutical and biopharmaceutical companies
      • 5.11.5.3 Other end users

6 TECHNOLOGICAL ADVANCEMENTS, AI-DRIVEN IMPACT, PATENTS, INNOVATIONS, AND FUTURE APPLICATIONS

  • 6.1 KEY EMERGING TECHNOLOGIES
    • 6.1.1 NEXT-GENERATION SEQUENCING (NGS)-BASED COMPREHENSIVE GENOMIC PROFILING
    • 6.1.2 LIQUID BIOPSY (CFDNA/CTDNA TESTING)
  • 6.2 COMPLEMENTARY TECHNOLOGIES
    • 6.2.1 BIOINFORMATICS & AI-DRIVEN CLINICAL INTERPRETATION
    • 6.2.2 MULTIPLEX PCR/QPCR PLATFORMS
  • 6.3 ADJACENT TECHNOLOGIES
    • 6.3.1 DIGITAL PATHOLOGY & AI-BASED IMAGING
  • 6.4 TECHNOLOGY/PRODUCT ROADMAP
  • 6.5 PATENT ANALYSIS
    • 6.5.1 LIST OF MAJOR PATENTS
  • 6.6 FUTURE APPLICATIONS
  • 6.7 IMPACT OF AI/GENERATIVE AI ON COMPANION DIAGNOSTICS MARKET
    • 6.7.1 INTRODUCTION
    • 6.7.2 TOP USE CASES & MARKET POTENTIAL
    • 6.7.3 KEY COMPANIES IMPLEMENTING AI
    • 6.7.4 FUTURE OF AI

7 REGULATORY LANDSCAPE AND SUSTAINABILITY INITIATIVES

  • 7.1 REGIONAL REGULATIONS & COMPLIANCE
    • 7.1.1 REGULATORY ANALYSIS
      • 7.1.1.1 North America
        • 7.1.1.1.1 US
        • 7.1.1.1.2 Canada
      • 7.1.1.2 Europe
        • 7.1.1.2.1 Germany
        • 7.1.1.2.2 UK
        • 7.1.1.2.3 France
        • 7.1.1.2.4 Italy
      • 7.1.1.3 Asia Pacific
        • 7.1.1.3.1 China
        • 7.1.1.3.2 Japan
        • 7.1.1.3.3 India
        • 7.1.1.3.4 Australia
      • 7.1.1.4 Latin America
        • 7.1.1.4.1 Brazil
        • 7.1.1.4.2 Mexico
      • 7.1.1.5 Middle East
        • 7.1.1.5.1 Africa
    • 7.1.2 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS
  • 7.2 SUSTAINABILITY INITIATIVES
    • 7.2.1 ENVIRONMENTAL IMPACT & ECO-FRIENDLY INITIATIVES
      • 7.2.1.1 Eco-friendly initiatives
    • 7.2.2 SUSTAINABILITY IMPACT & REGULATORY POLICY INITIATIVES

8 CUSTOMER LANDSCAPE & BUYER BEHAVIOR

  • 8.1 DECISION-MAKING PROCESS
  • 8.2 BUYER STAKEHOLDERS & BUYING EVALUATION CRITERIA
    • 8.2.1 KEY STAKEHOLDERS IN BUYING PROCESS
    • 8.2.2 BUYING CRITERIA
  • 8.3 ADOPTION BARRIERS & INTERNAL CHALLENGES
  • 8.4 UNMET NEEDS IN VARIOUS END-USE INDUSTRIES
  • 8.5 MARKET PROFITABILITY
    • 8.5.1 REVENUE POTENTIAL
    • 8.5.2 COST DYNAMICS

9 COMPANION DIAGNOSTICS MARKET, BY PRODUCT & SERVICE

  • 9.1 INTRODUCTION
  • 9.2 ASSAYS, KITS, AND REAGENTS
    • 9.2.1 INCREASING ROUTINE USE OF BIOMARKER-BASED TESTING FOR TARGETED THERAPY AND IMMUNOTHERAPY SELECTION
  • 9.3 INSTRUMENTS/SYSTEMS
    • 9.3.1 RISING ADOPTION OF AUTOMATED MOLECULAR, PATHOLOGY, AND NGS PLATFORMS TO SUPPORT STANDARDIZED AND SCALABLE CDX TESTING
  • 9.4 SOFTWARE & SERVICES
    • 9.4.1 INCREASING DEMAND FOR HIGH-VALUE NGS INTERPRETATION, LIQUID BIOPSY SERVICES, PHARMA CDX CO-DEVELOPMENT, AND CLINICALLY ACTIONABLE REPORTING

10 COMPANION DIAGNOSTICS MARKET, BY SAMPLE TYPE

  • 10.1 INTRODUCTION
  • 10.2 TISSUE SAMPLES
    • 10.2.1 CONTINUED DOMINANCE OF TISSUE-BASED BIOMARKER TESTING IN ONCOLOGY TREATMENT SELECTION
  • 10.3 BLOOD SAMPLES
    • 10.3.1 RAPID ADOPTION OF LIQUID BIOPSY AND CIRCULATING TUMOR DNA-BASED COMPANION DIAGNOSTICS TO DRIVE MARKET
  • 10.4 OTHER SAMPLE TYPES

11 COMPANION DIAGNOSTICS MARKET, BY TECHNOLOGY

  • 11.1 INTRODUCTION
  • 11.2 POLYMERASE CHAIN REACTION
    • 11.2.1 PREFERENCE FOR COST-EFFECTIVE, CLINICALLY ESTABLISHED SINGLE-GENE/HOTSPOT MUTATION TESTING DRIVES MARKET
  • 11.3 IN SITU HYBRIDIZATION
    • 11.3.1 NEED FOR TISSUE-BASED DETECTION OF GENE AMPLIFICATION, REARRANGEMENTS, AND EXPRESSION-LINKED THERAPY SELECTION DRIVE MARKET
  • 11.4 NEXT-GENERATION SEQUENCING
    • 11.4.1 GROWING APPLICATIONS IN DIAGNOSING BACTERIAL, VIRAL, FUNGAL, AND PARASITIC INFECTIONS TO DRIVE MARKET
  • 11.5 IMMUNOHISTOCHEMISTRY
    • 11.5.1 STRONG USE OF TISSUE-BASED PROTEIN-EXPRESSION TESTING FOR IMMUNO-ONCOLOGY AND TARGETED THERAPY SELECTION
  • 11.6 OTHER TECHNOLOGIES

12 COMPANION DIAGNOSTICS MARKET, BY INDICATION

  • 12.1 INTRODUCTION
  • 12.2 CANCER
    • 12.2.1 LUNG CANCER
      • 12.2.1.1 Growing demand for effective therapeutic drugs to increase CDx adoption
    • 12.2.2 BREAST CANCER
      • 12.2.2.1 Wide prevalence of breast cancer among women contributes to the large market size of the segment
    • 12.2.3 LEUKEMIA & LYMPHOMA
      • 12.2.3.1 Precision profiling of targeted alterations in hematologic malignancies
    • 12.2.4 COLORECTAL CANCER
      • 12.2.4.1 Integration of biomarker testing for targeted and immunotherapy selection
    • 12.2.5 MELANOMA
      • 12.2.5.1 High immunotherapy and targeted therapy use based on molecular status
    • 12.2.6 OTHER CANCERS
  • 12.3 NEUROLOGICAL DISEASES
    • 12.3.1 RISING BURDEN OF NEURODEGENERATIVE DISEASES TO DRIVE MARKET
  • 12.4 CARDIOVASCULAR DISEASES
    • 12.4.1 RISING GLOBAL INCIDENCE OF CARDIOVASCULAR PATIENTS TO EXPEDITE GROWTH
  • 12.5 INFECTIOUS DISEASES
    • 12.5.1 INCREASING AWARENESS OF TARGETED THERAPIES TO PROPEL SEGMENT GROWTH
  • 12.6 OTHER INDICATIONS

13 COMPANION DIAGNOSTICS MARKET VOLUME ANALYSIS FOR CANCER, BY REGION (NUMBER OF TESTS)

14 COMPANION DIAGNOSTICS MARKET, BY APPLICATION

  • 14.1 INTRODUCTION
  • 14.2 CLINICAL DIAGNOSTICS
    • 14.2.1 INCREASING USE OF CDX TESTING FOR REAL-TIME THERAPY SELECTION IN ONCOLOGY AND PRECISION MEDICINE
  • 14.3 RESEARCH USE
    • 14.3.1 RISING BIOMARKER DISCOVERY AND PHARMA-LED DRUG-DIAGNOSTIC CO-DEVELOPMENT PROGRAMS

15 COMPANION DIAGNOSTICS MARKET, BY END USER

  • 15.1 INTRODUCTION
  • 15.2 PHARMACEUTICAL & BIOPHARMACEUTICAL COMPANIES
    • 15.2.1 RISING PHARMA-LED DRUG-DIAGNOSTIC CO-DEVELOPMENT FOR TARGETED THERAPIES AND IMMUNOTHERAPIES DRIVES MARKET
  • 15.3 REFERENCE LABORATORIES
    • 15.3.1 INCREASING DEMAND FOR OUTSOURCED HIGH-COMPLEXITY MOLECULAR AND GENOMIC CDX TESTING
  • 15.4 CONTRACT RESEARCH ORGANIZATIONS
    • 15.4.1 INCREASING USE OF BIOMARKER-DRIVEN CLINICAL TRIALS AND CDX-ENABLED DRUG DEVELOPMENT PROGRAMS
  • 15.5 OTHER END USERS

16 COMPANION DIAGNOSTICS MARKET, BY DRUG CLASS ASSOCIATED WITH CDX

  • 16.1 INTRODUCTION
  • 16.2 MONOCLONAL ANTIBODIES
    • 16.2.1 RISING USE OF BIOMARKER-GUIDED MONOCLONAL ANTIBODY THERAPIES IN ONCOLOGY AND IMMUNO-ONCOLOGY
  • 16.3 CELL & GENE THERAPY
    • 16.3.1 INCREASING NEED FOR GENETIC, ANTIGEN, AND PATIENT-ELIGIBILITY TESTING IN ADVANCED PERSONALIZED THERAPIES

17 COMPANION DIAGNOSTICS MARKET, BY REGION

  • 17.1 INTRODUCTION
  • 17.2 NORTH AMERICA
    • 17.2.1 US
      • 17.2.1.1 Presence of advanced healthcare infrastructure to augment growth
    • 17.2.2 CANADA
      • 17.2.2.1 Expanding public oncology testing infrastructure and growing biomarker-based cancer care
  • 17.3 EUROPE
    • 17.3.1 GERMANY
      • 17.3.1.1 Advanced molecular pathology infrastructure and strong oncology testing adoption
    • 17.3.2 UK
      • 17.3.2.1 NHS-led genomic medicine infrastructure and national test directory-based access
    • 17.3.3 FRANCE
      • 17.3.3.1 National cancer programs and structured molecular oncology networks
    • 17.3.4 ITALY
      • 17.3.4.1 Expanding molecular oncology adoption across regional cancer centers
    • 17.3.5 SWITZERLAND
      • 17.3.5.1 High-value precision medicine environment and strong pharma-diagnostics presence
    • 17.3.6 SPAIN
      • 17.3.6.1 Increasing adoption of biomarker-guided oncology across public hospital networks
    • 17.3.7 REST OF EUROPE
  • 17.4 ASIA PACIFIC
    • 17.4.1 CHINA
      • 17.4.1.1 Large oncology patient pool and rapid expansion of domestic precision medicine infrastructure
    • 17.4.2 JAPAN
      • 17.4.2.1 Universal healthcare reimbursement policy to foster growth
    • 17.4.3 INDIA
      • 17.4.3.1 Increased private and public investments to bolster growth
    • 17.4.4 SOUTH KOREA
      • 17.4.4.1 Advanced healthcare infrastructure and strong adoption of precision oncology technologies
    • 17.4.5 AUSTRALIA
      • 17.4.5.1 Strong oncology care infrastructure and high biomarker testing need in melanoma and solid tumors
    • 17.4.6 REST OF ASIA PACIFIC
  • 17.5 LATIN AMERICA
    • 17.5.1 BRAZIL
      • 17.5.1.1 Largest oncology patient pool in Latin America and growing adoption of precision oncology in private healthcare
    • 17.5.2 MEXICO
      • 17.5.2.1 Expanding oncology care networks and increasing use of biomarker testing in urban cancer centers
    • 17.5.3 REST OF LATIN AMERICA
  • 17.6 MIDDLE EAST & AFRICA
    • 17.6.1 GCC COUNTRIES
      • 17.6.1.1 Growing public healthcare funding to drive market
    • 17.6.2 REST OF MIDDLE EAST & AFRICA

18 COMPETITIVE LANDSCAPE

  • 18.1 INTRODUCTION
  • 18.2 KEY PLAYER STRATEGIES/RIGHT TO WIN
    • 18.2.1 OVERVIEW OF STRATEGIES DEPLOYED BY PLAYERS IN COMPANION DIAGNOSTICS MARKET
  • 18.3 REVENUE ANALYSIS, 2023-2025
  • 18.4 MARKET SHARE ANALYSIS, 2025
    • 18.4.1 GLOBAL MARKET SHARE ANALYSIS, 2025
  • 18.5 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2025
    • 18.5.1 STARS
    • 18.5.2 EMERGING LEADERS
    • 18.5.3 PERVASIVE PLAYERS
    • 18.5.4 PARTICIPANTS
    • 18.5.5 COMPANY FOOTPRINT: KEY PLAYERS, 2025
      • 18.5.5.1 Company footprint
      • 18.5.5.2 Region footprint
      • 18.5.5.3 Product & service footprint
      • 18.5.5.4 Indication footprint
      • 18.5.5.5 Technology footprint
  • 18.6 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2025
    • 18.6.1 PROGRESSIVE COMPANIES
    • 18.6.2 RESPONSIVE COMPANIES
    • 18.6.3 DYNAMIC COMPANIES
    • 18.6.4 STARTING BLOCKS
    • 18.6.5 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2025
      • 18.6.5.1 Detailed list of key startups/SMEs
      • 18.6.5.2 Competitive benchmarking of startups/SMEs
  • 18.7 COMPANY VALUATION & FINANCIAL METRICS
    • 18.7.1 FINANCIAL METRICS
    • 18.7.2 COMPANY VALUATION
  • 18.8 BRAND/PRODUCT COMPARISON
  • 18.9 COMPETITIVE SCENARIO
    • 18.9.1 PRODUCT LAUNCHES & APPROVALS
    • 18.9.2 DEALS
    • 18.9.3 EXPANSIONS
    • 18.9.4 OTHER DEVELOPMENTS

19 COMPANY PROFILES

  • 19.1 KEY PLAYERS
    • 19.1.1 F. HOFFMANN-LA ROCHE LTD.
      • 19.1.1.1 Business overview
      • 19.1.1.2 Products/Services/Solutions offered
      • 19.1.1.3 Recent developments
        • 19.1.1.3.1 Product launches & approvals
        • 19.1.1.3.2 Deals
        • 19.1.1.3.3 Expansions
      • 19.1.1.4 MnM view
        • 19.1.1.4.1 Key strengths
        • 19.1.1.4.2 Strategic choices
        • 19.1.1.4.3 Weaknesses & competitive threats
    • 19.1.2 AGILENT TECHNOLOGIES, INC
      • 19.1.2.1 Business overview
      • 19.1.2.2 Products/Services/Solutions offered
      • 19.1.2.3 Recent developments
        • 19.1.2.3.1 Product launches & approvals
        • 19.1.2.3.2 Deals
      • 19.1.2.4 MnM view
        • 19.1.2.4.1 Key strengths
        • 19.1.2.4.2 Strategic choices
        • 19.1.2.4.3 Weaknesses & competitive threats
    • 19.1.3 QIAGEN
      • 19.1.3.1 Business overview
      • 19.1.3.2 Products/Services/Solutions offered
      • 19.1.3.3 Recent developments
        • 19.1.3.3.1 Product launches & approvals
        • 19.1.3.3.2 Deals
        • 19.1.3.3.3 Expansions
      • 19.1.3.4 MnM view
        • 19.1.3.4.1 Key strengths
        • 19.1.3.4.2 Strategic choices
        • 19.1.3.4.3 Weaknesses & competitive threats
    • 19.1.4 THERMO FISHER SCIENTIFIC INC.
      • 19.1.4.1 Business overview
      • 19.1.4.2 Products/Services/Solutions offered
      • 19.1.4.3 Recent developments
        • 19.1.4.3.1 Product launches
        • 19.1.4.3.2 Deals
      • 19.1.4.4 MnM view
        • 19.1.4.4.1 Key strengths
        • 19.1.4.4.2 Strategic choices
        • 19.1.4.4.3 Weaknesses & competitive threats
    • 19.1.5 ABBOTT
      • 19.1.5.1 Business overview
      • 19.1.5.2 Products/Services/Solutions offered
      • 19.1.5.3 Recent developments
        • 19.1.5.3.1 Product approvals
        • 19.1.5.3.2 Deals
      • 19.1.5.4 MnM view
        • 19.1.5.4.1 Key strengths
        • 19.1.5.4.2 Strategic choices
        • 19.1.5.4.3 Weaknesses & competitive threats
    • 19.1.6 DANAHER
      • 19.1.6.1 Business overview
      • 19.1.6.2 Products/Services/Solutions offered
      • 19.1.6.3 Recent developments
        • 19.1.6.3.1 Product approvals
        • 19.1.6.3.2 Deals
      • 19.1.6.4 MnM view
        • 19.1.6.4.1 Key strengths
        • 19.1.6.4.2 Strategic choices
        • 19.1.6.4.3 Weaknesses & competitive threats
    • 19.1.7 ILLUMINA, INC.
      • 19.1.7.1 Business overview
      • 19.1.7.2 Products/Services/Solutions offered
      • 19.1.7.3 Recent developments
        • 19.1.7.3.1 Product launches & approvals
        • 19.1.7.3.2 Deals
    • 19.1.8 BIOMERIEUX
      • 19.1.8.1 Business overview
      • 19.1.8.2 Products/Services/Solutions offered
      • 19.1.8.3 Recent developments
        • 19.1.8.3.1 Deals
    • 19.1.9 MYRIAD GENETICS, INC.
      • 19.1.9.1 Business overview
      • 19.1.9.2 Products/Services/Solutions offered
      • 19.1.9.3 Recent developments
        • 19.1.9.3.1 Product launches & approvals
        • 19.1.9.3.2 Deals
    • 19.1.10 SYSMEX CORPORATION
      • 19.1.10.1 Business overview
      • 19.1.10.2 Products/Services/Solutions offered
      • 19.1.10.3 Recent developments
        • 19.1.10.3.1 Deals
    • 19.1.11 QUEST DIAGNOSTICS
      • 19.1.11.1 Business overview
      • 19.1.11.2 Products/Services/Solutions offered
      • 19.1.11.3 Recent developments
        • 19.1.11.3.1 Deals
    • 19.1.12 GUARDANT HEALTH
      • 19.1.12.1 Business overview
      • 19.1.12.2 Products/Services/Solutions offered
      • 19.1.12.3 Recent developments
        • 19.1.12.3.1 Product launches & approvals
    • 19.1.13 ICON PLC
      • 19.1.13.1 Business overview
      • 19.1.13.2 Products/Services/Solutions offered
    • 19.1.14 TEMPUS AI, INC.
      • 19.1.14.1 Business overview
      • 19.1.14.2 Products/Services/Solutions offered
      • 19.1.14.3 Recent developments
        • 19.1.14.3.1 Deals
        • 19.1.14.3.2 Other developments
    • 19.1.15 CARIS LIFE SCIENCES, INC.
      • 19.1.15.1 Business overview
      • 19.1.15.2 Products/Services/Solutions offered
      • 19.1.15.3 Recent developments
        • 19.1.15.3.1 Product launches & approvals
  • 19.2 OTHER PLAYERS
    • 19.2.1 THE ALMAC GROUP
    • 19.2.2 AMOY DIAGNOSTICS CO., LTD.
    • 19.2.3 ARUP LABORATORIES
    • 19.2.4 ABNOVA CORPORATION
    • 19.2.5 INVIVOSCRIBE, INC.
    • 19.2.6 Q2 SOLUTIONS
    • 19.2.7 CREATIVE BIOLABS
    • 19.2.8 PILLAR BIOSCIENCES
    • 19.2.9 ENTROGEN, INC.
    • 19.2.10 BIOCARTIS

20 RESEARCH METHODOLOGY

  • 20.1 RESEARCH DATA
    • 20.1.1 SECONDARY DATA
      • 20.1.1.1 List of secondary sources
      • 20.1.1.2 Key data from secondary sources
    • 20.1.2 PRIMARY DATA
      • 20.1.2.1 List of primary sources
      • 20.1.2.2 Key data from primary sources
      • 20.1.2.3 Key industry insights
      • 20.1.2.4 Breakdown of primary interviews
  • 20.2 MARKET SIZE ESTIMATION
    • 20.2.1 TOTAL MARKET SIZE: COMPANION DIAGNOSTICS MARKET
    • 20.2.2 BOTTOM-UP APPROACH
      • 20.2.2.1 Approach 1: Revenue estimation of key players
      • 20.2.2.2 Approach 2: Study of annual reports and investor presentations
      • 20.2.2.3 Approach 3: Primary interviews
      • 20.2.2.4 Growth forecast
      • 20.2.2.5 CAGR projections
    • 20.2.3 TOP-DOWN APPROACH
  • 20.3 DATA TRIANGULATION
  • 20.4 RESEARCH ASSUMPTIONS
    • 20.4.1 STUDY-RELATED ASSUMPTIONS
  • 20.5 STUDY ASSUMPTIONS
    • 20.5.1 PARAMETRIC ASSUMPTIONS
    • 20.5.2 GROWTH RATE ASSUMPTIONS
  • 20.6 RESEARCH LIMITATIONS
  • 20.7 RISK ASSESSMENT

21 APPENDIX

  • 21.1 DISCUSSION GUIDE
  • 21.2 KNOWLEDGESTORE: MARKETSANDMARKETS' SUBSCRIPTION PORTAL
  • 21.3 CUSTOMIZATION OPTIONS
  • 21.4 RELATED REPORTS
  • 21.5 AUTHOR DETAILS
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