규제 대상 AI 의료 소프트웨어 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the regulated AI medical software market size was valued at USD 2.51 billion in 2025 and is estimated to grow from USD 2.96 billion in 2026 to reach USD 6.74 billion by 2031, at a CAGR of 17.90% during the forecast period (2026-2031).

This report is Segmented by Product Type (AI-Enabled Diagnostic Software, and More), Deployment Model (On-Premise, and More), Clinical Function (Screening, Triage, Diagnosis and Classification, and More), End User (Hospitals and IDNs, Ambulatory Surgery Centers, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Regulated AI Medical Software Market Trends and Insights

Shortage of Specialist Clinicians and Diagnostic Capacity

The regulated AI medical software market benefits from clinician shortages, which have become an operating constraint for many providers. The World Health Organization projects a global shortfall of 11 million health workers by 2030, with shortages concentrated in diagnosis and specialized care roles. Radiology, pathology, and cardiology face rising pressure as specialist review volumes increase. In the United States, HRSA projected a shortfall of 81,180 full-time equivalent physicians by 2035 across 26 of 36 specialty categories.

Regulatory Pathway Maturation for AI-Enabled Devices

Regulatory clarity is making the regulated AI medical software market more accessible for developers with robust quality systems. The FDA's 2025 lifecycle guidance established a clearer approach to iterative updates for AI-enabled devices, while Predetermined Change Control Plans gave manufacturers a structured way to manage certain model changes after authorization. GE HealthCare received FDA 510(k) clearance for MIM Contour ProtegeAI+ 2.0 in June 2026, including a PCCP for expanded clinical capabilities. Germany's Federal Network Agency also issued guidance in May 2026 on AI medical device regulatory questions.

Prospective Clinical Evidence and Generalizability Gaps

Prospective evidence remains a restraint for the regulated AI medical software market, as decision-makers need confidence that performance will transfer across care settings. Retrospective testing can establish technical performance, but it may not show how clinicians use a tool under normal time and workflow pressures. A prospective study in 2026 found that an AI admission-prediction tool reduced median emergency department length of stay by 12 minutes while physician volume remained constant. Health systems and payers still evaluate whether outcomes will remain consistent across community hospitals, specialist centers, and different patient populations, making local validation plans and clear evidence packages critical for broad adoption.

Other drivers and restraints analyzed in the detailed report include:

1. Hospital Demand for Productivity and Throughput Improvement
2. Public Investment in Interoperable Health Data Infrastructure
3. Cybersecurity, Privacy, and Third-Party Model Dependency

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

Segment Analysis

AI-enabled diagnostic software held 33.22% of the regulated AI medical software market size in 2025. This leadership reflected early adoption in radiology and cardiac imaging, where providers used these tools for image interpretation, quantification, and case prioritization. The software fit into established reading workflows without requiring major care pathway redesign, while radiologists' familiarity with software-assisted imaging supported broader use across diagnostic departments.

AI-enabled digital pathology and in vitro diagnostic software is forecast to grow at a CAGR of 21.93% through 2031. Digitized slide libraries, whole-slide imaging systems, and high-volume review algorithms support expansion across laboratories. Tempus reported that Articulate Pro changed the initial diagnosis or grade group in 5% of prostate biopsy cases, while 1.3% of changes affected clinical management. The study also reported a turnaround-time reduction of nearly one day, strengthening laboratory interest in standardized review workflows.

Cloud-based deployment accounted for 36.23% of the regulated AI medical software market size in 2025. Early adopters favored cloud systems for scalable computing capacity and continuous updates without local hardware management. The model remained relevant for imaging centers and laboratories with limited on-premise infrastructure, while vendors used it to manage consistent software versions across distributed provider locations.

Hybrid deployment is forecast to grow at a CAGR of 19.67% through 2031. It keeps identifiable patient data within hospital or national boundaries while allowing suitable non-sensitive workloads to use cloud resources. This approach addressed data residency expectations in Germany, India, and GCC countries and gave institutions stronger control over access and retention. Edge and embedded deployment remained important for imaging hardware and interventional systems that require low latency or operate with limited connectivity.

Complete Report Scope:

• By Product Type
  • AI-Enabled Diagnostic Software
  • AI-Enabled Monitoring and Predictive Analytics Software
  • AI-Enabled Clinical Decision Support Software
  • AI-Enabled Treatment Planning and Procedural Guidance Software
  • AI-Enabled Digital Pathology and In Vitro Diagnostic Software
  • AI-Enabled Therapeutic and Rehabilitation Software
  • AI-Enabled Surgical and Robotic Software
  • Others
• By Deployment Model
  • On-Premise Deployment
  • Cloud-Based Deployment
  • Edge and Embedded Deployment
  • Hybrid Deployment
• By Clinical Function
  • Screening and Early Detection
  • Triage and Prioritization
  • Diagnosis and Classification
  • Quantification and Measurement
  • Prognosis and Risk Prediction
  • Treatment Selection and Recommendation
  • Treatment Planning and Navigation
  • Monitoring and Recurrence Detection
  • Others
• By End User
  • Hospitals and Integrated Delivery Networks
  • Ambulatory Surgery Centers
  • Diagnostic Imaging Centers and Laboratories
  • Physician Practices and Specialty Clinics
  • Academic and Research Institutions
  • Public Health and Government Providers
  • Pharmaceutical and Biotechnology Companies
• 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 39.76% of the regulated AI medical software market share in 2025. The region benefited from a large installed base of advanced provider systems, strong clinical software procurement, and mature regulatory processes. HHS reported in June 2026 that TEFCA had surpassed 1 billion exchanged health records, strengthening connected clinical data exchange and reducing information gaps across care settings. Canada and Mexico also supported regional adoption through academic health centers and large hospital networks linked to United States technology ecosystems.

Europe is the second-largest regional market for regulated AI medical software. Germany, the United Kingdom, and France are key adopters, supported by advanced care delivery and active medical technology regulation. Vendors in the region must manage medical device requirements alongside AI and data governance obligations. Germany's May 2026 orientation guide clarified issues at the intersection of AI and medical devices.

Asia-Pacific is forecast to expand at a CAGR of 19.56% through 2031. Growth is supported by domestic software development in China, device regulation in South Korea, and health data reforms in Japan. Japan's reforms between December 2025 and April 2026 addressed health data, AI, and clinical research, while the Japanese Federation of Medical Devices Associations examined review approaches for AI-enabled program medical devices in August 2025. India offers strong potential for diagnostic and decision support software as digital health infrastructure develops, while South America, the Middle East, and Africa remain earlier-stage markets.

1. Abbott Laboratories
2. Aidoc Medical Ltd.
3. Butterfly Network, Inc.
4. Canon
5. Cleerly, Inc.
6. GE HealthCare Technologies Inc.
7. Intuitive Surgical, Inc.
8. iRhythm Technologies
9. Koninklijke Philips
10. Medtronic
11. NVIDIA
12. Owkin, Inc.
13. Paige.AI, Inc.
14. Shanghai United Imaging Healthcare Co., Ltd.
15. Siemens Healthineers
16. SOPHiA GENETICS SA
17. Stryker
18. Subtle Medical, Inc.
19. Tempus AI, Inc.
20. Viz.ai, 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 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 Shortage of Specialist Clinicians and Diagnostic Capacity
  • 4.2.2 Expansion of Multimodal Clinical Data and Precision Medicine
  • 4.2.3 Hospital Demand for Productivity and Throughput Improvement
  • 4.2.4 Public Investment in Interoperable Health Data Infrastructure
  • 4.2.5 Regulatory Pathway Maturation for AI-Enabled Devices
  • 4.2.6 Local Validation and Monitoring Requirements Creating Compliance Moats
• 4.3 Market Restraints
  • 4.3.1 Prospective Clinical Evidence and Generalizability Gaps
  • 4.3.2 Cybersecurity, Privacy and Third-Party Model Dependency
  • 4.3.3 Workflow Integration and Reimbursement Friction
  • 4.3.4 Model Drift, Change-Control and Post-Market Surveillance Burden
• 4.4 Value/Supply-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 AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Product Type
  • 5.1.1 AI-Enabled Diagnostic Software
  • 5.1.2 AI-Enabled Monitoring and Predictive Analytics Software
  • 5.1.3 AI-Enabled Clinical Decision Support Software
  • 5.1.4 AI-Enabled Treatment Planning and Procedural Guidance Software
  • 5.1.5 AI-Enabled Digital Pathology and In Vitro Diagnostic Software
  • 5.1.6 AI-Enabled Therapeutic and Rehabilitation Software
  • 5.1.7 AI-Enabled Surgical and Robotic Software
  • 5.1.8 Others
• 5.2 By Deployment Model
  • 5.2.1 On-Premise Deployment
  • 5.2.2 Cloud-Based Deployment
  • 5.2.3 Edge and Embedded Deployment
  • 5.2.4 Hybrid Deployment
• 5.3 By Clinical Function
  • 5.3.1 Screening and Early Detection
  • 5.3.2 Triage and Prioritization
  • 5.3.3 Diagnosis and Classification
  • 5.3.4 Quantification and Measurement
  • 5.3.5 Prognosis and Risk Prediction
  • 5.3.6 Treatment Selection and Recommendation
  • 5.3.7 Treatment Planning and Navigation
  • 5.3.8 Monitoring and Recurrence Detection
  • 5.3.9 Others
• 5.4 By End User
  • 5.4.1 Hospitals and Integrated Delivery Networks
  • 5.4.2 Ambulatory Surgery Centers
  • 5.4.3 Diagnostic Imaging Centers and Laboratories
  • 5.4.4 Physician Practices and Specialty Clinics
  • 5.4.5 Academic and Research Institutions
  • 5.4.6 Public Health and Government Providers
  • 5.4.7 Pharmaceutical and Biotechnology Companies
• 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 India
    • 5.5.3.3 Japan
    • 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, Products and Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Aidoc Medical Ltd.
  • 6.3.3 Butterfly Network, Inc.
  • 6.3.4 Canon Medical Systems Corporation
  • 6.3.5 Cleerly, Inc.
  • 6.3.6 GE HealthCare Technologies Inc.
  • 6.3.7 Intuitive Surgical, Inc.
  • 6.3.8 iRhythm Technologies, Inc.
  • 6.3.9 Koninklijke Philips N.V.
  • 6.3.10 Medtronic plc
  • 6.3.11 NVIDIA Corporation
  • 6.3.12 Owkin, Inc.
  • 6.3.13 Paige.AI, Inc.
  • 6.3.14 Shanghai United Imaging Healthcare Co., Ltd.
  • 6.3.15 Siemens Healthineers AG
  • 6.3.16 SOPHiA GENETICS SA
  • 6.3.17 Stryker Corporation
  • 6.3.18 Subtle Medical, Inc.
  • 6.3.19 Tempus AI, Inc.
  • 6.3.20 Viz.ai, Inc.

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment