디지털 병리학 : 시장 점유율 분석, 산업 동향 및 통계 데이터, 성장 예측(2026-2031년)

According to Mordor Intelligence, the digital pathology market size is expected to increase from USD 1.83 billion in 2025 to USD 2.01 billion in 2026 and reach USD 3.21 billion by 2031, growing at a CAGR of 9.90% over 2026-2031.

This report is Segmented by Product (Whole Slide Imaging Scanners, Image Analysis & AI Software, and More), Imaging Technique (Brightfield, Fluorescence), Application (Disease Diagnosis, Education & Training, and More), End User (Hospitals, and More), Deployment (On-Premise, Cloud/SaaS), and Geography (North America, Europe, and More). The Market Sizes and Forecasts are Provided in Terms of Value (USD).

Global Digital Pathology Market Trends and Insights

Pathologist Workforce Shortages Accelerate Automation-Enabled Digital Workflows

Workforce models published in 2024 predicted the United States will be short 5,900 pathologists by 2030, equal to 18% of present capacity . Forty percent of consultant positions in the United Kingdom stayed vacant for more than six months in 2025. Digital platforms let one specialist review cases from several hospitals without shipping glass slides, effectively multiplying throughput. A 2025 College of American Pathologists study confirmed that AI-guided prescreening shortened routine biopsy turnaround time significantly with high diagnostic concordance. Hospitals are therefore redirecting capital from new hires to scanners and algorithm subscriptions that cost less than annual physician salaries.

Large Oncology/Immunotherapy Trials Mandate Image-Based Biomarker Assessment

Investigational new drug filings in immuno-oncology climbed to 1,847 in 2025, and 68% required digital quantification of PD-L1, tumor mutational burden, or immune-cell density. Manual scoring shows inter-observer variability exceeding 20% for PD-L1, whereas validated AI algorithms push variability below 5%, satisfying regulatory precision thresholds. Roche revealed that 82% of its late-stage oncology studies centralized slide review on digital platforms in 2025. Contract research organizations have mirrored this shift, installing scanners at regional hubs so international sites upload images to a single repository, insulating demand from hospital budget cycles.

High Scanner, Storage & IT Costs for Mid-Tier/Public Labs

A 40X WSI scanner costs USD 150,000-400,000 and generates roughly 50 terabytes per 10,000 slides, demanding enterprise storage of another USD 100,000-200,000 plus recurring cloud fees. Community hospitals operate on thin margins and cannot recoup capital through the USD 45 CPT 88360 reimbursement, prolonging payback periods. District hospitals in India budgeted only INR 5 million (USD 60,000) for all diagnostics in fiscal 2024-25, making WSI unattainable without grant support. Vendors now offer leasing and pay-per-slide pricing, but take-up remains slow where upfront cash constraints dominate purchasing.

Other drivers and restraints analyzed in the detailed report include:

1. Government Healthcare-Digitization & National AI Grants/Fast-Tracks
2. Growth of Companion Diagnostics Needs Quantitative Tissue-Image Analytics
3. Lack of Universal Interoperability Across Scanners, LIS & AI Ecosystems

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

Segment Analysis

Whole Slide Imaging Scanners generated 43.5% of 2025 revenue, reflecting the prerequisite hardware investment before any digitized workflow begins. Image Analysis & AI Software is expected to grow at a 10.21% CAGR, the fastest among products, as laboratories recognize that raw images have limited clinical value without automated quantification tools. Philips shifted to a subscription model in 2025, bundling its IntelliSite scanner and algorithms for USD 8,000 per month, lowering upfront costs that previously exceeded USD 350,000. Communication & Storage Systems also expand steadily because the College of American Pathologists mandates 10-year retention of diagnostic images, prompting multi-petabyte archives.

Slide Management Systems & Accessories, including barcode labelers and robotic loaders, reduce technician touch-time. Leica reports its GT 450 DX paired with a 400-slide loader drops handling from 45 seconds to 8 seconds per slide. AI firms increasingly embed algorithms directly into scanner firmware, blurring hardware and software revenue streams. This convergence complicates vendor positioning but enhances user experience, strengthening the digital pathology market value proposition.

Brightfield imaging accounted for 85.1% of 2025 revenue because most primary diagnoses rely on hematoxylin-and-eosin staining, and FDA approvals still emphasize brightfield platforms. Fluorescence imaging should grow at a 10.55% CAGR through 2031 on demand from multiplex immunofluorescence and spatial-omics assays. Akoya's PhenoCycler, which profiles up to 100 proteins, expanded placements from 87 in 2024 to 142 in 2025, mostly at academic and pharma R&D sites. Fluorescence scanners command premiums of USD 250,000-600,000, yet grant funding and trial budgets often cover incremental costs, sustaining adoption.

Hybrid scanners that toggle between brightfield and fluorescence modes help laboratories consolidate equipment. Ventana's DP 200 won FDA clearance in November 2025 for dual-mode primary diagnosis, signaling regulatory endorsement of integrated workflows. Confocal and light-sheet platforms enable 3D reconstruction but remain confined to research because diagnostic pathways for volumetric imaging have not been defined.

Complete Report Scope:

• By Product
  • Whole Slide Imaging Scanners
  • Image Analysis & AI Software
  • Communication & Storage Systems
  • Slide Management Systems & Accessories
• By Imaging Technique
  • Brightfield
  • Fluorescence
• By Application
  • Disease Diagnosis
  • Drug Discovery & Companion Diagnostics
  • Telepathology & Consultation
  • Education & Training
  • Quality Assurance & Archiving
• By End User
  • Hospital & Reference Laboratories
  • Pharmaceutical & Biotechnology Companies & CROs
  • Diagnostic Centers
  • Other End Users
• By Deployment Model
  • On-premise
  • Cloud-based / SaaS
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of APAC
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America captured 47.8% of 2025 revenue and benefits from FDA clarity, CPT reimbursement, and NIH dataset funding. Clearance of Philips IntelliSite, Leica Aperio AT2, and Hamamatsu NanoZoomer between 2017 and 2024 ended compliance uncertainty, accelerating procurement. CMS introduced CPT 88360 in 2024, providing USD 45 per digital consultation, a modest but critical catalyst. The NIH Bridge2AI program invested USD 150 million in standardized datasets during 2025, fueling algorithm R&D. Canada's Ontario province linked 12 community hospitals to a central telepathology hub in 2025, cutting turnaround time by 38%.

Europe follows with strong regulatory push. The EU Medical Device Regulation requires CE-IVD certification for AI software by mid-2027, prompting hospitals to validate workflows early. The United Kingdom committed GBP 180 million in 2025 to digitize pathology across all NHS trusts by 2028. Germany's health ministry opened a EUR 50 million grant program in 2025 for university hospitals, while France's regulator approved seven AI algorithms for clinical use, the highest in Europe.

Asia-Pacific posts the fastest 11.21% CAGR. China's Healthy China 2030 plan mandates county-level telepathology links and funds scanner rollouts worth RMB 2.3 billion. India's Ayushman Bharat Digital Mission awarded INR 15 billion for 5,000 hospitals. Japan began reimbursing AI-assisted diagnosis at JPY 8,000 (USD 55) per case in April 2025, outpacing U.S. payment rates. Australia published national practice guidelines in 2025, giving hospitals a clear compliance roadmap. Middle East & Africa and South America lag due to infrastructure gaps. The UAE piloted digital pathology at eight hospitals in 2025 to test nationwide feasibility. South Africa's National Health Laboratory Service connected rural clinics via telepathology in 2024 but struggles with bandwidth. Brazil invested BRL 120 million (USD 24 million) in 2025 to equip 50 cancer centers, focusing on high-mortality regions.

1. 3DHistech
2. Aiforia Technologies Oy
3. Akoya Biosciences Inc.
4. Danaher Corp. (Leica Biosystems)
5. DeepBio Inc.
6. F. Hoffmann-La Roche Ltd (Ventana)
7. Hamamatsu Photonics
8. Huron Digital Pathology Inc.
9. Indica Labs Inc.
10. Inspirata Inc.
11. Koninklijke Philips
12. Mikroscan Technologies
13. Nikon Corp.
14. Olympus Corp.
15. OptraSCAN Inc.
16. Paige AI Inc.
17. PathAI Inc.
18. Proscia
19. Sectra
20. Visiopharm
21. XIFIN Inc.

Additional Benefits:

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

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & 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 Pathologist Workforce Shortages Accelerate Automation-Enabled Digital Workflows
  • 4.2.2 Large Oncology/Immunotherapy Trials Mandate Image-Based Biomarker Assessment
  • 4.2.3 Government Healthcare-Digitization & National AI Grants/Fast-Tracks
  • 4.2.4 Growth Of Companion Diagnostics Needs Quantitative Tissue-Image Analytics
  • 4.2.5 FDA Synthetic-Tissue Dataset Pilot Speeds Algorithm Approvals
  • 4.2.6 Spatial-Omics Integration Drives High-Plex Imaging Demand
• 4.3 Market Restraints
  • 4.3.1 High Scanner, Storage & IT Costs for Mid-Tier/Public Labs
  • 4.3.2 Lack Of Universal Interoperability Across Scanners, LIS & AI Ecosystems
  • 4.3.3 Volatile Global Glass-Slide Supply Constrained CAPEX Planning
  • 4.3.4 Data-Center Carbon-Footprint/ESG Limits Long-Term Cloud Storage
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD Million)

• 5.1 By Product
  • 5.1.1 Whole Slide Imaging Scanners
  • 5.1.2 Image Analysis & AI Software
  • 5.1.3 Communication & Storage Systems
  • 5.1.4 Slide Management Systems & Accessories
• 5.2 By Imaging Technique
  • 5.2.1 Brightfield
  • 5.2.2 Fluorescence
• 5.3 By Application
  • 5.3.1 Disease Diagnosis
  • 5.3.2 Drug Discovery & Companion Diagnostics
  • 5.3.3 Telepathology & Consultation
  • 5.3.4 Education & Training
  • 5.3.5 Quality Assurance & Archiving
• 5.4 By End User
  • 5.4.1 Hospital & Reference Laboratories
  • 5.4.2 Pharmaceutical & Biotechnology Companies & CROs
  • 5.4.3 Diagnostic Centers
  • 5.4.4 Other End Users
• 5.5 By Deployment Model
  • 5.5.1 On-premise
  • 5.5.2 Cloud-based / SaaS
• 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 Russia
    • 5.6.2.7 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 South Korea
    • 5.6.3.5 Australia
    • 5.6.3.6 Rest of APAC
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & 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 & Services, Recent Developments)}
  • 6.3.1 3DHISTECH Ltd.
  • 6.3.2 Aiforia Technologies Oy
  • 6.3.3 Akoya Biosciences Inc.
  • 6.3.4 Danaher Corp. (Leica Biosystems)
  • 6.3.5 DeepBio Inc.
  • 6.3.6 F. Hoffmann-La Roche Ltd (Ventana)
  • 6.3.7 Hamamatsu Photonics K.K.
  • 6.3.8 Huron Digital Pathology Inc.
  • 6.3.9 Indica Labs Inc.
  • 6.3.10 Inspirata Inc.
  • 6.3.11 Koninklijke Philips N.V.
  • 6.3.12 Mikroscan Technologies Inc.
  • 6.3.13 Nikon Corp.
  • 6.3.14 Olympus Corp.
  • 6.3.15 OptraSCAN Inc.
  • 6.3.16 Paige AI Inc.
  • 6.3.17 PathAI Inc.
  • 6.3.18 Proscia Inc.
  • 6.3.19 Sectra AB
  • 6.3.20 Visiopharm A/S
  • 6.3.21 XIFIN Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment