디지털 동반진단 소프트웨어 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the digital companion diagnostics software market size is projected to grow from USD 2.54 billion in 2025 and USD 3.00 billion in 2026 to USD 6.97 billion by 2031, registering a CAGR of 18.35% during the forecast period 2026-2031.

This report is Segmented by Product Type (Software Platforms, Digital Pathology, Others), Deployment (Cloud-Based, On-Premise, Hybrid), Technology (NGS, Digital PCR, Digital Pathology, Liquid Biopsy, Others), Application (Oncology, Neurology, Others), End User (Pharma, Hospitals, Cros, Others), and Geography (North America, Europe, Asia-Pacific, MEA, South America). Forecasts in Value (USD).

Global Digital Companion Diagnostics Software Market Trends and Insights

Precision Oncology and Biomarker-Guided Therapy Expansion

Each new oncology label requiring biomarker stratification can create sustained software demand across co-development and patient-selection workflows. This trend makes companion diagnostic development a key source of recurring licenses and subscriptions for the digital companion diagnostics software market. Tempus received FDA approval in May 2026 for a tumor-only indication for its xT CDx platform, becoming the first laboratory with companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling. Roche received FDA approval in June 2026 for the VENTANA PTEN assay, the first IHC companion diagnostic for PTEN-deficient prostate adenocarcinoma. The approval supported patients eligible for AstraZeneca's TRUQAP and addressed a population in which 25% of metastatic hormone-sensitive cases carried PTEN deficiency. Broader use of antibody-drug conjugates and multi-target therapies supports demand for multi-panel software, as single-gene PCR tests cannot manage the required biomarker combinations.

Rising Adoption of Next-Generation Sequencing-Based Therapy Selection

NGS-based workflows in the digital companion diagnostics software market are expanding beyond tertiary cancer centers into community oncology settings. Thermo Fisher received FDA approval in July 2025 for the Oncomine Dx Express Test on its Ion Torrent Genexus Dx Integrated Sequencer, which can deliver results for EGFR exon 20 insertion mutations in as few as 24 hours from decentralized laboratories. Illumina launched DRAGEN v4.4 in May 2025 with configured applications for heme WGS, solid WGS tumor-normal, and MRD pipelines, and reported a 30% improvement in germline structural variant calling accuracy, validated in a Nature Biotechnology study. SOPHiA GENETICS introduced MSK-IMPACT Flex in September 2025, combining DNA and RNA biomarker analysis, including TMB, MSI, HRD, and CNV detection, in one modular workflow. Higher testing volumes can strain older laboratory information systems, increasing demand for middleware and interpretation tools that connect sequencing output with clinical decision support.

Regulatory Complexity for Continuously Updated Diagnostic Algorithms

Machine-learning software in the digital companion diagnostics software market must balance continuous refinement with stable, validated diagnostic outputs. When a retrained model changes an output, developers may need to revalidate it against clinical specimen sets that took years to assemble. European platforms also face Class C and D re-certification requirements under the EU IVDR in 2027 and 2028, which may require prospective clinical evidence for tools that previously relied on CE marking. This workload favors companies with dedicated regulatory teams and may delay performance-enhancing updates, while dataset bias can require additional validation before international label expansion.

Other drivers and restraints analyzed in the detailed report include:

1. Mainstreaming of AI-Assisted Digital Pathology
2. Decentralized Companion Diagnostic Deployment and Trial Matching
3. Uneven Reimbursement and System Interoperability

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Software platforms held 34.55% of product revenue in 2025. Hospital networks and pharmaceutical research organizations used these licensed environments to integrate biomarker analytics, NGS interpretation, and regulatory documentation. Multi-application suites strengthened the digital companion diagnostics software market, as each added module increased switching complexity for institutions. Interpretation tools, clinical decision support, patient-matching applications, real-world evidence analytics, and development software supported sponsors and contract research organizations seeking verified biomarker outputs and automated bioinformatics documentation.

Digital pathology and image-analysis software was the fastest-growing product type, registering an 18.93% CAGR through 2031. Proscia launched the fifth generation of Concentriq in June 2026 as an AI-native platform used by 16 of the top 20 pharmaceutical companies. The platform supported drug discovery, clinical development, and diagnostic review within related workflows. Validation and regulatory services remained the smallest product category, but demand increased as regulated algorithms required structured evidence, IEC 62304 lifecycle compliance, and ISO 13485 quality management alignment.

Cloud-based deployment accounted for 63.56% of the digital companion diagnostics software market size in 2025. NGS secondary analysis, whole-slide image management, and multi-site real-world evidence aggregation required scalable computing capacity without fixed local hardware. SOPHiA GENETICS connected more than 800 institutions across more than 70 countries through its cloud-native DDM platform. This architecture supported geographically dispersed pharmaceutical trial networks more effectively than isolated on-premise installations.

Hybrid deployment is forecast to register a 19.67% CAGR through 2031. Hospital security teams may require raw patient genomic data to remain behind institutional firewalls, even when analytics and reporting use cloud resources. Vendors offering containerized deployments can run a common codebase inside a hospital or on a cloud cluster, improving competitiveness in enterprise tenders. On-premise systems retained relevance in European and Middle Eastern settings where data-sovereignty requirements restricted cross-border patient data transfers.

Complete Report Scope:

• Product Type
  • Software Platforms
  • Interpretation and Decision-Support Software
  • Clinical Trial and Patient-Matching Software
  • Digital Pathology and Image-Analysis Software
  • Real-World Evidence and Data-Analytics Software
  • Companion Diagnostic Development Software
  • Software-Related Validation and Regulatory Services
• By Deployment
  • Cloud-Based
  • On-Premise
  • Hybrid
• By Technology
  • Next-Generation Sequencing
  • Polymerase Chain Reaction
  • Digital Polymerase Chain Reaction
  • Immunohistochemistry
  • In-Situ Hybridization
  • Digital Pathology
  • Liquid Biopsy
  • Circulating Tumor DNA
  • Multi-Omics
• By Application
  • Oncology
  • Rare and Genetic Diseases
  • Neurology
  • Cardiovascular Diseases
  • Infectious Diseases
  • Immunology and Autoimmune Diseases
• By End User
  • Pharmaceutical Companies
  • Biotechnology Companies
  • Contract Research Organizations
  • Clinical Reference Laboratories
  • Hospitals and Comprehensive Cancer Centers
  • Academic and Research Institutes
  • Payers and Health Technology Assessment Organizations
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 41.45% of the digital companion diagnostics software market size in 2025. The region had a strong base of FDA-approved companion diagnostic drug labels, an established CMS Advanced Diagnostic Laboratory Test reimbursement mechanism, and a large AI diagnostics ecosystem. Guardant Health received FDA approval in 2025 for Guardant360 CDx in HER2-mutant non-small cell lung cancer, its 25th companion diagnostic indication. Canada's health technology assessment process and Mexico's lower investment in molecular diagnostics concentrated regional revenue in the United States.

Europe was the second-largest geography in the digital companion diagnostics software market in 2025. EU IVDR Class C and D requirements raised compliance standards for digital pathology platforms and favored clinically validated systems over research tools. Ibex achieved CE-IVDR certification for breast IHC AI algorithms in July 2026, while Tribun Health announced CaloPix 6 as its first IVDR-certified version for routine diagnostic use in June 2026. Tyrolpath adopted SOPHiA GENETICS' MSK-IMPACT Flex as Austria's first modular comprehensive genomic profiling laboratory, and the UK NHS deployment of the Paige Prostate AI Suite provided clinical evidence for procurement decisions across European health systems.

Asia-Pacific is forecast to grow at a 20.56% CAGR through 2031, the fastest regional rate in the digital companion diagnostics software market. China's Healthy China 2030 program, Japan's expedited pathways for AI-integrated IVD devices, South Korea's precision medicine programs, and India's pharmaceutical outsourcing base support demand. CancerVision's deployment at 10 South Korean hospitals showed that institutional-scale adoption can advance quickly with reimbursement support. Middle East and Africa and South America remain smaller markets, although national genomics programs in GCC countries and Brazil's SUS health system are creating early demand, while interoperability constraints and limited bioinformatics workforces limit near-term adoption.

1. Abbott Laboratories
2. Agilent Technologies
3. Amoy Diagnostics Co., Ltd.
4. Arterys, Inc.
5. Burning Rock Biotech Limited
6. Caris Life Sciences, Inc.
7. Danaher
8. Exact Sciences
9. Roche
10. Foundation Medicine, Inc.
11. Geneseeq Technology Inc.
12. Genomenon, Inc.
13. Guardant Health, Inc.
14. Illumina
15. LabCorp
16. Myriad Genetics
17. Natera, Inc.
18. NeoGenomics, Inc.
19. Paige.AI, Inc.
20. PathAI, Inc.
21. Personalis, Inc.
22. Quest Diagnostics
23. SOPHiA GENETICS SA
24. Tempus AI, Inc.
25. Thermo Fisher Scientific

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET LANDSCAPE

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Precision Oncology and Biomarker-Guided Therapy Expansion
  • 4.2.2 Rising Adoption of Next-Generation Sequencing-Based Therapy Selection
  • 4.2.3 Mainstreaming of Artificial Intelligence-Assisted Digital Pathology
  • 4.2.4 Decentralized Companion Diagnostic Deployment
  • 4.2.5 Pharmaceutical Demand for Real-World Evidence and Biomarker-Defined Trial Matching
  • 4.2.6 Companion Diagnostic Expansion Beyond Oncology
• 4.3 Market Restraints
  • 4.3.1 Regulatory Complexity for Continuously Updated Diagnostic Algorithms
  • 4.3.2 Uneven Reimbursement for Software-Enabled Interpretation
  • 4.3.3 Interoperability Gaps Across Laboratory and Clinical Systems
  • 4.3.4 Dataset Bias and Limited Representation of Under-Studied Populations
• 4.4 Value and Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 Product Type
  • 5.1.1 Software Platforms
  • 5.1.2 Interpretation and Decision-Support Software
  • 5.1.3 Clinical Trial and Patient-Matching Software
  • 5.1.4 Digital Pathology and Image-Analysis Software
  • 5.1.5 Real-World Evidence and Data-Analytics Software
  • 5.1.6 Companion Diagnostic Development Software
  • 5.1.7 Software-Related Validation and Regulatory Services
• 5.2 By Deployment
  • 5.2.1 Cloud-Based
  • 5.2.2 On-Premise
  • 5.2.3 Hybrid
• 5.3 By Technology
  • 5.3.1 Next-Generation Sequencing
  • 5.3.2 Polymerase Chain Reaction
  • 5.3.3 Digital Polymerase Chain Reaction
  • 5.3.4 Immunohistochemistry
  • 5.3.5 In-Situ Hybridization
  • 5.3.6 Digital Pathology
  • 5.3.7 Liquid Biopsy
  • 5.3.8 Circulating Tumor DNA
  • 5.3.9 Multi-Omics
• 5.4 By Application
  • 5.4.1 Oncology
  • 5.4.2 Rare and Genetic Diseases
  • 5.4.3 Neurology
  • 5.4.4 Cardiovascular Diseases
  • 5.4.5 Infectious Diseases
  • 5.4.6 Immunology and Autoimmune Diseases
• 5.5 By End User
  • 5.5.1 Pharmaceutical Companies
  • 5.5.2 Biotechnology Companies
  • 5.5.3 Contract Research Organizations
  • 5.5.4 Clinical Reference Laboratories
  • 5.5.5 Hospitals and Comprehensive Cancer Centers
  • 5.5.6 Academic and Research Institutes
  • 5.5.7 Payers and Health Technology Assessment Organizations
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 India
    • 5.6.3.3 Japan
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Agilent Technologies, Inc.
  • 6.3.3 Amoy Diagnostics Co., Ltd.
  • 6.3.4 Arterys, Inc.
  • 6.3.5 Burning Rock Biotech Limited
  • 6.3.6 Caris Life Sciences, Inc.
  • 6.3.7 Danaher Corporation
  • 6.3.8 Exact Sciences Corporation
  • 6.3.9 F. Hoffmann-La Roche Ltd
  • 6.3.10 Foundation Medicine, Inc.
  • 6.3.11 Geneseeq Technology Inc.
  • 6.3.12 Genomenon, Inc.
  • 6.3.13 Guardant Health, Inc.
  • 6.3.14 Illumina, Inc.
  • 6.3.15 Laboratory Corporation of America Holdings
  • 6.3.16 Myriad Genetics, Inc.
  • 6.3.17 Natera, Inc.
  • 6.3.18 NeoGenomics, Inc.
  • 6.3.19 Paige.AI, Inc.
  • 6.3.20 PathAI, Inc.
  • 6.3.21 Personalis, Inc.
  • 6.3.22 Quest Diagnostics Incorporated
  • 6.3.23 SOPHiA GENETICS SA
  • 6.3.24 Tempus AI, Inc.
  • 6.3.25 Thermo Fisher Scientific Inc.

7 Market Opportunities and Future Outlook

• 7.1 White-Space and Unmet-Need Assessment