병리학 분야 인공지능(AI) : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the aI in Pathology market size was USD 145.39 million in 2025 and is projected to reach USD 633.69 million by 2031 at a 28.16% CAGR during 2026-2031.

This report is Segmented by Component (Software, Services, Hardware), Function (Image Analysis & Pattern Recognition, and Others), Use Case (Drug Discovery & Translational Research, and Others), End User (Hospitals, Diagnostic Laboratories, and Others), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global AI In Pathology Market Trends and Insights

Clinical Approvals Enabling Adoption (FDA/CE-IVDR Progress)

Regulatory milestones between 2025 and 2026 lowered adoption risk by enabling clinical-grade platforms and targeted computational diagnostics. In June 2025, PathAI's AISight Dx became the first FDA-cleared digital pathology image management system that included a Predetermined Change Control Plan, setting a practical precedent for iterative software improvements within regulated practice.In April 2025, the FDA granted Breakthrough Device Designation to Roche's VENTANA TROP2 RxDx Device, marking the first computational pathology companion diagnostic to receive this recognition and evidencing that AI-derived scoring can guide therapy selection in non-small cell lung cancer. The intent of such decisions is to align clinical validation, analytical performance, and postmarket oversight with the realities of learning systems. The effect for the AI in Pathology market is a tangible reduction in perceived regulatory risk as digital platforms become the operating system for enterprise workflows while AI modules connect to well-defined clinical tasks. In parallel, EU IVDR certifications across digital pathology are expanding, with vendors demonstrating quality management systems, multi-site validation, and technical documentation that support long-term compliance. This momentum collectively signals maturing oversight that aligns with software-based innovation cycles and accelerates enterprise procurement in the AI in Pathology market.

Oncology Biomarker Surge and Need for Standardized IHC Quantification

Therapy access increasingly hinges on precise biomarker thresholds, which magnifies the need to standardize immunohistochemistry scoring. A January 2026 multi-model evaluation of AI methods for HER2 scoring highlighted variability across independently developed algorithms, reinforcing the value of consistent quantitative methods when treatment eligibility depends on cutoffs like HER2-low. At the same time, clinical-grade tools like Lunit's PD-L1 scoring suite seek to reduce reading time and improve reproducibility, addressing pressure points in immuno-oncology workflows. The American Medical Association's Appendix S taxonomy update clarifies how to categorize AI-enabled clinical services across assistive, augmentative, and autonomous functions, which informs how these tools are positioned in care pathways and how coverage determinations may evolve. Together, these advances support the ongoing transition from manual visual estimation toward standardized quantitative scoring. This transition fosters a clearer role for decision support in pathology practice, improving clinical confidence and accelerating trials and treatment selection in the AI in Pathology market.

Unclear Reimbursement and ROI Pathways for AI Pathology

Coverage and coding policies shape how quickly hospitals can justify investment in AI. CMS payment integrity and anti-duplication rules restrict separate payment for multiple methods that assess the same analyte, which creates ambiguity about whether an algorithmic pathology service is distinct or bundled into an existing code. Category III CPT codes for digital pathology slide digitization provide tracking but do not carry assigned RVUs, requiring payer-by-payer engagement that delays predictable reimbursement. AMA's Appendix S taxonomy creates a framework to classify AI-enabled services as assistive, augmentative, or autonomous, which informs how these tools are documented and billed within care pathways. In the near term this limits the speed at which providers can reclaim direct revenue for AI-supported tasks, shifting the justification toward productivity, turnaround time, and quality gains. Operational complexity is a material concern as well, since Medicare's fee-for-service improper payment estimates show coding errors are a persistent source of risk for health systems. Until clearer payment pathways mature, adoption in the AI in Pathology market will skew toward large systems and labs that can fund AI as infrastructure and recoup value through scale.

Other drivers and restraints analyzed in the detailed report include:

1. Pharma-CDx Partnerships Embedding AI in Assay Workflows
2. Foundation and Embedding Models Improving Scalability and Domain Robustness
3. Compute, Storage, and IT Overhead for WSI-Scale AI Inference

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

Segment Analysis

Software commanded the largest share at 50.33% in 2025 as enterprise platforms integrated image management and AI modules for validated clinical and research tasks in the AI in Pathology market. Services is projected to grow at 29.20% CAGR through 2031 as hospitals and labs require implementation support, workflow design, LIS integration, and continuous model validation to maintain regulated use. Multi-year collaborations with large health systems pair platform deployment with managed services, training, and algorithm co-development, reflecting how organizations buy solutions rather than point tools. These services often include quality assurance, policy templates, and documentation that streamline compliance for digital primary diagnosis across distributed sites. Hardware choices increasingly align with cloud-enabled workflows and next-generation file outputs that ease transmission and storage load at scale. Over time, the services mix supports repeatable outcomes by embedding governance structures, model monitoring practices, and continuous updates into routine operations for the AI in Pathology market.

Service-led growth also reflects how buyers de-risk transformation with vendor-managed deployments and lifecycle support. Platform releases increasingly enable multi-algorithm workflows, flexible slide ingestion, and collaborative review, which accelerates standardization across multi-site networks. Cloud-first deployments reduce on-premises overhead and speed adoption across labs with heterogeneous IT capabilities. Structured rollouts with executive sponsorship and governance boards create durable pathways for algorithm updates and validation cycles. Implementation partners also help facilities align SOPs with accreditation expectations for digital workflows. These operating practices strengthen the services thesis for the AI in Pathology market as organizations prioritize dependable outcomes over license-only models.

Image analysis and pattern recognition held 48.38% AI in Pathology market share in 2025, reflecting historical reliance on segmentation, detection, and classification engines that supported research and early-stage clinical tasks. Diagnostic decision support is forecast to grow at 29.46% CAGR through 2031 as clinical-grade solutions inform therapy selection and reporting with validated scoring outputs. FDA Breakthrough Device Designation for the VENTANA TROP2 RxDx Device established a precedent for AI-derived metrics to guide therapy selection in non-small cell lung cancer, signaling the rising role of decision support tools within regulated CDx frameworks. Momentum for decision support is reinforced by taxonomy updates that specify how augmentative tools fit within physician workflows, reducing adoption friction while enabling methodical evaluation of value and risk. Validated QC workflows are also gaining traction, raising the reliability of downstream decision support and limiting rescans that delay reporting.

As health systems operationalize AI, tools that connect quantitative scoring with clinical reporting pathways gain clear priority. Multi-algorithm orchestration and specimen-level reporting features streamline how case evidence is assembled for pathologists across large networks. The ability to deliver prompt, reproducible quantification for IHC targets and to integrate with LIS workflows represents a practical bridge from pattern recognition to decision support at scale. QC automation layers catch input issues before human review, preventing recuts and rescans that diminish productivity. Collectively, these shifts align with a measured but steady pivot toward tools that affect patient management, reinforcing the growth prospects for this function within the AI in Pathology market.

Geography Analysis

North America held 50.13% of AI in Pathology market share in 2025, supported by regulatory clearances that de-risked enterprise deployment and by large system rollouts that validated digital primary diagnosis at scale. FDA-cleared enterprise platforms converged with hospital and lab network deployments, which modernized workflows and created shared infrastructure for algorithmic decision support. System-wide adoption by large networks established governance baselines and reinforced purchasing confidence across additional providers. Advances in platform interoperability and scanner compatibility, together with cloud-enabled architecture, gave North American providers a practical path to scale. These elements stabilized the foundation for broader clinical AI use and underpin the region's leadership position in the AI in Pathology market.

Europe progressed under IVDR with vendors demonstrating certified quality systems, clinical performance, and postmarket surveillance plans that support sustainable clinical use. Certifications that cover both models and the supporting quality management infrastructure reflect a maturing regulatory environment that emphasizes lifecycle rigor. Labs in European health systems also benefit from cloud-enabled platform strategies that align with strict data governance, helping organizations manage deployment complexity without enlarging internal IT teams. The combination of IVDR guardrails and enterprise-grade platforms positions Europe for steady expansion across primary diagnosis, QA, and algorithmic scoring embedded in clinical reporting. As scanner vendors iterate on file formats that reduce storage overhead, European networks can scale digitization more efficiently and sustain multi-year archives that satisfy retention mandates.

Asia-Pacific is projected to record 31.24% CAGR through 2031, with demand driven by workforce capacity constraints and the need to standardize workflows across high-volume centers. In regions where the ratio of pathologists to population is low, AI-augmented processes for triage, QC, and quantitative scoring can help scale diagnostic throughput in a controlled and auditable manner. Growth in cloud-enabled platforms further expands access by reducing up-front capital requirements and by facilitating uniform deployments across multi-site systems. As foundation and embedding models improve performance for tissue-specific tasks, regional providers can adopt decision support that meets local disease burden needs, advancing the case for investment. Vendor partnerships with global diagnostics and pharma ecosystems also accelerate knowledge transfer and standard-setting, accelerating uptake across oncology programs in the AI in Pathology market.

1. Aiforia Technologies
2. Aiosyn
3. Deciphex (Patholytix)
4. DeepBio
5. 3DHISTECH / Epredia QuantCenter
6. Roche
7. Ibex Medical Analytics
8. Indica Labs
9. Lunit
10. Mindpeak
11. Nucleai
12. OptraSCAN
13. Owkin
14. Paige
15. Philips Digital & Computational Pathology
16. Proscia
17. Qritive
18. Sectra
19. Techcyte
20. Visiopharm

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 Clinical Approvals Enabling Adoption (FDA/CE/IVDR Progress)
  • 4.2.2 Oncology Biomarker Surge and Need for Standardized IHC Quantification
  • 4.2.3 AI-Ready Digital Pathology Platforms Easing Deployment
  • 4.2.4 Pharma-CDx Partnerships Embedding AI in Assay Workflows
  • 4.2.5 Foundation and Embedding Models Improving Scalability and Domain Robustness
  • 4.2.6 Automated Slide QC Reducing Rescans and Enabling Reliable AI at Scale
• 4.3 Market Restraints
  • 4.3.1 Unclear Reimbursement and ROI Pathways for AI Pathology
  • 4.3.2 Domain Shift Across Scanners/Stains/Sites Limiting Generalizability
  • 4.3.3 IVDR Notified-Body Capacity and Evidentiary Burden Raising Time-to-Market
  • 4.3.4 Compute, Storage, and IT Overhead for WSI-Scale AI Inference
• 4.4 Value-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Component
  • 5.1.1 Software
  • 5.1.2 Services
  • 5.1.3 Hardware (WSI scanners, AI-enabled microscopes)
• 5.2 By Function
  • 5.2.1 Image Analysis and Pattern Recognition
  • 5.2.2 Diagnostic Decision Support
  • 5.2.3 Workflow/Quality Control Automation
  • 5.2.4 Others
• 5.3 By Use Case
  • 5.3.1 Drug Discovery and Translational Research
  • 5.3.2 Primary Diagnosis and Quality Assurance
  • 5.3.3 Clinical Trials and Companion Diagnostics
  • 5.3.4 Others
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Diagnostic Laboratories
  • 5.4.3 Pharmaceutical and Biopharmaceutical Companies
  • 5.4.4 Others
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 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 for key companies, Products & Services, Recent Developments)
  • 6.3.1 Aiforia Technologies
  • 6.3.2 Aiosyn
  • 6.3.3 Deciphex (Patholytix)
  • 6.3.4 DeepBio
  • 6.3.5 3DHISTECH / Epredia QuantCenter
  • 6.3.6 F. Hoffmann La Roche
  • 6.3.7 Ibex Medical Analytics
  • 6.3.8 Indica Labs
  • 6.3.9 Lunit
  • 6.3.10 Mindpeak
  • 6.3.11 Nucleai
  • 6.3.12 OptraSCAN
  • 6.3.13 Owkin
  • 6.3.14 Paige
  • 6.3.15 Philips Digital & Computational Pathology
  • 6.3.16 Proscia
  • 6.3.17 Qritive
  • 6.3.18 Sectra
  • 6.3.19 Techcyte
  • 6.3.20 Visiopharm

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment