Companion Diagnostics Market Analysis & Forecast: 2025-2032

Companion Diagnostics Market Size and Forecast – 2025 to 2032

Companion Diagnostics Market is estimated to be valued at USD 8.76 Bn in 2025 and is expected to reach USD 19.73 Bn in 2032, exhibiting a compound annual growth rate (CAGR) of 12.3% from 2025 to 2032.

Key Takeaways

• By Technology Type, Real Time-Polymerase Chain Reactions (PCR) hold the largest market share of 42.2% in 2025 owing to the rising adoption of precision & personalized medicine.
• By Application, Infectious Disease expected to hold largest market share in 2025 owing to its rising prevalence and impact of infectious diseases.
• By End User, Hospitals acquired the prominent market share in 2025 owing to the central role in clinical decision-making & patient management.
• By Region, North America dominates the overall market with an estimated share of 36.8% in 2025 owing to the advanced healthcare infrastructure.

Market Overview

The companion diagnostics market plays a vital role in precision medicine by helping healthcare providers identify patients who are most likely to benefit from targeted therapies. It improves treatment effectiveness, enhances safety, and supports better clinical outcomes, especially in oncology, infectious diseases, and chronic conditions. Advances in molecular diagnostics, growing biomarker discovery, strong collaboration between pharmaceutical and diagnostic companies, and wider adoption of personalized healthcare across hospitals and laboratories worldwide continue to drive the market forward.

Current Events and Its Impact on the Companion Diagnostics Market

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Role of AI (Artificial Intelligence) in Companion Diagnostics

Artificial intelligence plays a critical role in companion diagnostics by enabling precise, data-driven identification of patients most likely to benefit from specific therapies. AI algorithms analyze complex biomedical data—such as digital pathology images, genomic profiles, and biomarker patterns—to improve diagnostic accuracy, consistency, and speed. In oncology, AI enhances tissue-based assays by detecting subtle features beyond human interpretation, supporting treatment selection and clinical trial stratification.

In September 2025, Lunit, a provider of AI solutions for cancer diagnostics and therapeutics, and Agilent Technologies Inc., a global life sciences and diagnostics company, announced a nonexclusive collaboration to develop AI-based companion diagnostics. The partnership combines Lunit’s AI capabilities with Agilent’s expertise in tissue-based companion diagnostic development to address the growing need for advanced biomarker assays in drug development.

Segmental Insights

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Companion Diagnostics Market Insights, By Technology Type - Real Time-Polymerase Chain Reactions (PCR) contribute the highest share of the market owing to its high sensitivity & specificity for biomarker detection

Real Time-Polymerase Chain Reactions (PCR) hold the largest market share of 42.2% in 2025. Real-time polymerase chain reaction (PCR) strengthens the companion diagnostics market by enabling rapid and highly precise detection of genetic mutations and clinically relevant biomarkers used in therapy selection. It delivers quantitative results quickly, allowing clinicians to make timely treatment decisions, especially in oncology and infectious disease care. The growing adoption of targeted therapies, rising demand for dependable molecular testing in hospitals, ongoing assay advancements, and seamless integration of PCR systems into routine clinical workflows further reinforce its importance in companion diagnostics. For instance, in December 2025, Roche Diagnostics China launches its first locally developed quantitative polymerase chain reaction (PCR) system for the Chinese market.

Companion Diagnostics Market Insights, By Application - Infectious Disease contribute the highest share of the market owing to its precision medicine and personalized treatment strategies.

Infectious diseases fuel growth in the companion diagnostics market as clinicians depend more on accurate tests to select targeted antiviral and antimicrobial treatments. Rapid identification of pathogens, resistance indicators, and disease variants increases the demand for advanced diagnostic technologies. Rising awareness of emerging infections, ongoing improvements in molecular testing, and the use of diagnostics in infectious disease drug development further support adoption. Hospitals and laboratories increasingly implement companion diagnostics to enable faster treatment decisions and enhance overall patient care.

Companion Diagnostics Market Insights, By End User - Hospitals contribute the highest share of the market owing to its integration with precision & personalized medicine initiatives

Hospitals propel the companion diagnostics market by acting as key hubs for patient diagnosis, treatment planning, and therapy monitoring. Their broad and varied patient populations generate steady demand for biomarker-based tests, while equipped laboratories and skilled staff facilitate advanced molecular diagnostics. Hospitals actively implement personalized medicine programs, partner with pharmaceutical and diagnostic firms, and invest in innovative diagnostic technologies. By embedding companion diagnostics into clinical workflows, they improve treatment accuracy, enhance patient outcomes, and boost the use of targeted therapies across diverse medical areas. For instance, in December 2025, Guardant Health, Inc. launched FPG 360, its in-house liquid biopsy testing service, at Policlinico Gemelli in Rome, Italy.

Regional Insights

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North America Companion Diagnostics Market Trends

North America dominates the overall market with an estimated share of 36.8% in 2025. Advancements in precision medicine and molecular diagnostics are shaping key trends in the North America companion diagnostics market. Healthcare providers increasingly use biomarker-based tests to select targeted therapies, especially in oncology and infectious disease care. Pharmaceutical companies and diagnostic developers actively collaborate to launch innovative assays, while hospitals and laboratories invest in advanced diagnostic technologies. Supportive regulatory frameworks and reimbursement policies further encourage adoption. Together, these trends enable personalized treatment strategies and integrate companion diagnostics more fully into routine clinical practice across the region. For instance, in May 2025, NeoGenomics, Inc., a leading oncology testing provider, launched c-MET CDx, its companion diagnostic IHC assay for NSCLC.

Europe Companion Diagnostics Market Trends

The Europe companion diagnostics market is advancing with a strong emphasis on personalized medicine and sophisticated molecular testing. Healthcare providers increasingly apply biomarker-based diagnostics to select targeted therapies in oncology, cardiovascular, and infectious disease care. Pharmaceutical companies, diagnostic developers, and research institutions actively collaborate to drive innovation and launch new assays. Hospitals and specialized laboratories invest in state-of-the-art technologies, while supportive regulations and rising awareness among clinicians and patients promote wider adoption, further integrating companion diagnostics into routine clinical practice across Europe. For instance, in November 2024, Roche received CE Mark for VENTANA® FOLR1 RxDx Assay, the first widely available IHC companion diagnostic in Europe to identify EOC patients eligible for ELAHERE® treatment.

United States Companion Diagnostics Market Trends

The United States companion diagnostics market is growing quickly as healthcare providers increasingly adopt precision medicine and molecular diagnostic technologies. Clinicians actively use biomarker-based tests to select targeted therapies, especially in oncology and infectious disease care. Pharmaceutical and diagnostic companies collaborate to develop and launch innovative assays, while hospitals and clinical laboratories invest in advanced diagnostic platforms. Supportive regulatory frameworks and reimbursement policies encourage wider implementation, collectively promoting personalized treatment approaches and integrating companion diagnostics more fully into U.S. healthcare practice. For instance, in September 2025, the FDA approved Guardant360 CDx as a companion diagnostic to identify ESR1-mutated advanced breast cancer patients eligible for imlunestrant (Inluriyo).

United Kingdom Companion Diagnostics Market Trends

The United Kingdom companion diagnostics market is expanding with a strong focus on personalized medicine and advanced molecular testing. Healthcare providers actively use biomarker-based diagnostics to select targeted therapies, especially in oncology and rare diseases. Pharmaceutical companies, diagnostic developers, and research institutions collaborate to develop and launch innovative assays. Hospitals and specialized laboratories invest in state-of-the-art technologies, while supportive healthcare policies and increasing clinician awareness drive adoption. Together, these trends promote patient-specific treatment strategies and integrate companion diagnostics into routine clinical practice across the UK. For instance, in March 2025, Abingdon Health extended its distribution agreement with Salignostics to launch an own-brand Salistick and leverages its CDMO division to take lateral flow projects from concept to large-scale manufacturing.

End-user Feedback and Unmet Needs in the Companion Diagnostics Market

• Need for Faster Turnaround Times: End-users often highlight delays in receiving companion diagnostic results, which can slow treatment initiation. Clinicians and hospitals require rapid, reliable tests that integrate seamlessly into clinical workflows. Faster assay processing and real-time reporting would improve patient outcomes and enhance confidence in using diagnostics for timely therapy decisions.
• Desire for Broader Test Accessibility: Many healthcare providers report limited access to advanced companion diagnostic tests, especially in smaller hospitals or regional clinics. Expanding test availability and simplifying sample logistics can address disparities. End-users seek solutions that are widely deployable, cost-effective, and adaptable to various laboratory settings without compromising accuracy.
• Integration with Clinical Decision Support: Clinicians express the need for companion diagnostics to link directly with electronic medical records and clinical decision support systems. Enhanced integration can streamline data interpretation, reduce errors, and assist in selecting the most appropriate therapies. End-users value actionable insights that facilitate personalized patient care efficiently.

Companion Diagnostics Market Trend

Growth of Precision and Personalized Medicine

The companion diagnostics market is increasingly driven by the global shift toward precision and personalized medicine. Clinicians rely on biomarker-based tests to identify patients who will benefit most from targeted therapies, improving treatment efficacy and reducing adverse effects. This trend encourages pharmaceutical companies to co-develop drugs and companion diagnostics, while hospitals and laboratories invest in advanced molecular testing platforms, integrating diagnostics directly into clinical decision-making to support individualized patient care.

Companion Diagnostics Market Opportunity

Integration with Drug Development and Clinical Trials

Pharmaceutical companies increasingly require companion diagnostics to support targeted therapies during clinical trials. Developing co-branded diagnostic assays presents opportunities for companies to partner with drug developers, enhancing patient stratification, trial efficiency, and regulatory compliance. Hospitals and research institutions benefit from early access to validated tests, enabling better monitoring of therapeutic responses. This integration strengthens the value proposition of companion diagnostics, creates revenue opportunities, and accelerates the approval and adoption of novel precision therapies.

Market Report Scope

Companion Diagnostics Market News

• In September 2025, Predicine, Inc. submits a premarket approval (PMA) application to the FDA for PredicineCARE, its urine cfDNA NGS assay, as a companion diagnostic for bladder cancer.
• In July 2024, BD and Quest Diagnostics formed a global collaboration to develop, manufacture, and commercialize flow cytometry-based companion diagnostics for cancer and other diseases.

Analyst Opinion (Expert Opinion)

• The companion diagnostics market is increasingly defined by strategic scientific and regulatory inflection points rather than general adoption. The surge in FDA‑cleared assays—expanding from roughly 9 in 2010 to over 56 by 2023—illustrates how drug–diagnostic co‑development has become central to therapeutic frameworks, particularly in oncology where targeted drugs like osimertinib and pembrolizumab now require linked diagnostics for appropriate patient selection.
• Clinical and commercial dynamics also reveal that assays, kits, and reagents accounted for nearly 60 % of companion diagnostics spend in 2024, underscoring how traditional diagnostic cores remain foundational even as next‑generation sequencing and AI‑driven interpretation emerge. This tension highlights a market where technological depth and interpretive sophistication must balance operational realities in hospital and lab settings.
• The prominence of molecular methods such as PCR—holding a dominant share due to specificity and sensitivity in mutation detection—reflects entrenched clinical trust, yet it coexists with rapid NGS expansion, which is reshaping how multi‑gene profiles drive therapy decisions.
• Supporting these scientific drivers are evolving payer landscapes and regulatory clarity, such as state‑led biomarker coverage mandates in the U.S., which materially influence adoption curves by addressing longstanding reimbursement barriers. Without these systemic shifts, the potential of precision diagnostics to deliver on personalized treatment logic would remain constrained to select centers rather than becoming integrated into mainstream care.

Market Segmentation

• By Technology Type
• • Real Time-Polymerase Chain Reactions (PCR)
  • Gene Sequencing
  • Fluorescence in situ Hybridization
  • Others
• By Application
  • Oncology
  • Cardiovascular Diseases
  • Infectious Diseases
  • Neurological Diseases
  • Others
• By End User
  • Hospitals
  • Research Laboratories
  • Biopharmaceutical companies
  • Others
• Regional Insights (Revenue, USD Bn, 2020 - 2032)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • F. Hoffmann-La Roche AG
  • Agilent Technologies, Inc
  • QIAGEN N.V
  • Abbott Laboratories, Inc.
  • Almac Group
  • Danaher Corporation
  • Illumina, Inc.
  • bioMerieux SA
  • Myriad Genetics, Inc.
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • Abnova Corporation
  • Guardant Health, Inc.
  • Icon Plc.,
  • Biogenex Laboratories, Inc.

Sources

Primary Research interviews

• Oncologists, molecular pathologists, and clinical laboratory directors
• Hospital procurement and diagnostics managers
• Pharmaceutical and biotechnology R&D executives
• Regulatory affairs specialists in companion diagnostics

Databases

• PubMed
• ClinicalTrials.gov
• NIH Genetic Testing Registry
• WHO Global Health Observatory

Magazines

• Nature Biotechnology Magazine
• The Scientist
• Genetic Engineering & Biotechnology News (GEN)
• Clinical Laboratory News

Journals

• Journal of Molecular Diagnostics
• The Lancet Oncology
• Nature Medicine
• Clinical Chemistry
• Journal of Personalized Medicine

Newspapers

• The New York Times – Health Section
• The Guardian – Science & Health
• Financial Times – Healthcare Section
• The Wall Street Journal – Health & Biotech

Associations

• American Society of Clinical Oncology (ASCO)
• College of American Pathologists (CAP)
• European Society for Medical Oncology (ESMO)
• International Association for the Study of Lung Cancer (IASLC)

Public Domain sources

• FDA – Center for Devices and Radiological Health (CDRH) approvals
• CDC – Disease and Laboratory Data
• European Medicines Agency (EMA) – Public Assessment Reports
• WHO – Global Health Data and Guidelines

Proprietary Elements

• CMI Data Analytics Tool
• Proprietary CMI Existing Repository of information for last 8 years