만성질환 관리용 SaMD(Software-as-a-Medical Device) 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the software as a medical device for chronic disease management market size is expected to grow from USD 27.55 billion in 2025 to USD 32.91 billion in 2026 and is forecast to reach USD 83.03 billion by 2031 at 19.45% CAGR over 2026-2031.

This report is Segmented by Application (Diabetes Management, Cardiovascular Disease Management, and More), Deployment (Cloud-Based, On-Premise, Hybrid), End User (Healthcare Providers, Payers, Patients and Home Care Settings, Employers), Risk Class (Class I, Class II, Class III), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Software As A Medical Device (SaMD) For Chronic Disease Management Market Trends and Insights

Rising Chronic Disease Burden Amplified by Multi-Morbidity

Chronic disease remains the core demand driver for the Software as a Medical Device (SaMD) for Chronic Disease Management Market, as treatment increasingly requires long-duration monitoring, repeated intervention, and stronger patient follow-up. In the United States, chronic and mental health conditions account for 90% of annual healthcare spending, while more than 40.1 million Americans live with diabetes. Cardiovascular disease and stroke caused more than 850,000 deaths in 2024, and noncommunicable diseases cause more than 40 million deaths globally each year. This demand favors software that tracks linked conditions across care settings, as patients often move across diabetes, cardiovascular, and metabolic pathways simultaneously.

AI-Enabled Continuous Risk Stratification and Personalization

AI is changing how the Software as a Medical Device (SaMD) for Chronic Disease Management Market creates value, as care teams can monitor risk continuously instead of relying on periodic readings. The FDA's 2025 guidance work for AI and machine learning in medical software centered attention on life cycle management, post-clearance change control, and safer algorithm updates. Vendors with stronger change management plans can improve software faster without disrupting the regulatory pathway each time they refine a model. As a result, the market is moving toward platforms that combine algorithm performance with disciplined governance, larger data pools, stronger quality systems, and continuous validation.

Clinical Validation and Evidence Generation Bottlenecks

Clinical validation remains a significant restraint in the Software as a Medical Device (SaMD) for Chronic Disease Management Market, as evidence generation is slower and more expensive than standard software release cycles. The FDA's AI-related SaMD work shows that developers must support safe change management and ongoing validation, not just initial clearance. Review timelines vary by device complexity, while quality systems, documentation controls, and software life cycle processes add fixed costs before companies can scale revenue. A 2026 framework called for good digital medicine practices and more consistent validation standards; however, until harmonization improves, evidence requirements will continue to favor better-funded companies.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Value-Based Care and Outcome-Linked Reimbursement
2. Remote Patient Monitoring Integration With Connected Devices
3. Reimbursement Variability Across Therapies and Geographies

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

Segment Analysis

Diabetes Management held 39.55% of the application base in 2025, giving it the largest position within the Software as a Medical Device (SaMD) for Chronic Disease Management market share. The segment benefited from a mature connected care stack covering continuous glucose monitoring, dose support, and automated insulin delivery. Dexcom's G7 15-Day Continuous Glucose Monitoring System received FDA clearance on February 3, 2026, underscoring continued product refinement.

The diabetes application continued to expand as developers targeted more complex user groups beyond the broad insulin-treated population. WellDoc registered its Rx App for Diabetes in Pregnancy and Insulin Pump Users with the FDA in March 2026, indicating deeper specialization within the segment. Cardiovascular Disease Management is projected to record the fastest CAGR of 21.93% from 2026 to 2031, increasing the Software as a Medical Device (SaMD) for Chronic Disease Management market size as care models become more continuous and data-driven.

Cloud-Based deployment accounted for a 64.22% share in 2025, keeping it at the center of the Software as a Medical Device (SaMD) for Chronic Disease Management market size by deployment. The model supports broad patient access, large data storage requirements, and regular software improvements without site-by-site updates. Cloud architecture also aligns with longitudinal monitoring, where repeated data capture and ongoing clinical review create value.

The Hybrid model is forecast to expand at a 22.67% CAGR through 2031 as buyers seek cloud analytics with local control over sensitive health data. Hospitals and health systems want scalability, but they also need stronger control over patient data storage and movement. On-Premise setups remain relevant in high-security environments, public health systems, and facilities with slower cloud migration timelines. As a result, deployment strategy is becoming part of the clinical and operational buying decision, not only an IT choice.

Complete Report Scope:

• By Application
  • Diabetes Management
  • Cardiovascular Disease Management
  • Respiratory Disease Management
  • Obesity and Metabolic Disease Management
  • Other Chronic Disease Management
• By Deployment
  • Cloud-Based
  • On-Premise
  • Hybrid
• By End User
  • Healthcare Providers
  • Payers
  • Patients and Home Care Settings
  • Employers
• By Risk Class
  • Class I
  • Class II
  • Class III
• 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 is expected to hold 42.25% of the Software as a Medical Device (SaMD) for Chronic Disease Management market share in 2025, maintaining its lead among regional markets. The region benefits from stronger reimbursement channels, deeper insurance penetration, and a larger base of digital health developers than most other geographies. The CMS ACCESS model, scheduled to launch on July 5, 2026, is expected to create a direct policy signal that measurable improvements in chronic care can support payment. The FDA's TEMPO pilot also adds momentum by outlining a pathway for technology-enabled patient outcomes in chronic conditions. Canada is also gaining relevance, as Huma Therapeutics received a Health Canada Class II Medical Device Licence for its cloud-based digital health platform in April 2025.

Europe remains the second-largest region in the user-supplied draft, supported by a regulated healthcare base and growing interest in reimbursable digital therapeutics. Germany stands out because it offers a clearer route for digital health reimbursement than most other European markets. This framework gives developers a more practical entry point for software commercialization in chronic care. However, the region continues to progress unevenly because payment conditions and adoption rates vary widely across national healthcare systems.

Asia-Pacific is projected to grow at a CAGR of 23.95% through 2031, making it the fastest-expanding regional opportunity and increasing the Software as a Medical Device (SaMD) for Chronic Disease Management market size during the forecast period. Large chronic disease populations, rising healthcare expenditure, and increasing digital health adoption across major economies support this growth. China and India offer the largest patient pools, especially across diabetes, cardiovascular disease, and respiratory conditions. Japan serves as an important near-term commercial marker, as iRhythm launched its Zio ECG Recording and Analysis System in the country in May 2025 through Senko Medical Instrument.

1. Abbott Laboratories
2. Akili
3. AliveCor
4. Boston Scientific
5. Dexcom
6. GE HealthCare Technologies Inc.
7. Hinge Health, Inc.
8. Huma Therapeutics Limited
9. Insulet
10. iRhythm Technologies
11. Koninklijke Philips
12. Masimo
13. Medtronic
14. Noom, Inc.
15. Omada Health
16. Resmed
17. Siemens Healthineers
18. Tandem Diabetes Care
19. Teladoc Health
20. WellDoc, 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 Rising Burden of Diabetes, Cardiovascular Disease, and COPD
  • 4.2.2 Expansion of Value-Based Care and Outcome-Linked Reimbursement
  • 4.2.3 AI-Enabled Continuous Risk Stratification and Personalized Interventions
  • 4.2.4 Remote Patient Monitoring Integration With Connected Devices
  • 4.2.5 Regulatory Clarification for AI-Enabled Medical Software
  • 4.2.6 Employer and Payer Demand for Lower Total Cost of Care
• 4.3 Market Restraints
  • 4.3.1 Clinical Validation and Evidence Generation Bottlenecks
  • 4.3.2 Reimbursement Variability Across Therapies and Geographies
  • 4.3.3 Interoperability Gaps With EHR and Device Ecosystems
  • 4.3.4 Data Privacy, Cybersecurity, and AI Liability Exposure
• 4.4 Supply/Value 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 Intensity of Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Application
  • 5.1.1 Diabetes Management
  • 5.1.2 Cardiovascular Disease Management
  • 5.1.3 Respiratory Disease Management
  • 5.1.4 Obesity and Metabolic Disease Management
  • 5.1.5 Other Chronic Disease Management
• 5.2 By Deployment
  • 5.2.1 Cloud-Based
  • 5.2.2 On-Premise
  • 5.2.3 Hybrid
• 5.3 By End User
  • 5.3.1 Healthcare Providers
  • 5.3.2 Payers
  • 5.3.3 Patients and Home Care Settings
  • 5.3.4 Employers
• 5.4 By Risk Class
  • 5.4.1 Class I
  • 5.4.2 Class II
  • 5.4.3 Class III
• 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 Akili, Inc.
  • 6.3.3 AliveCor, Inc.
  • 6.3.4 Boston Scientific Corporation
  • 6.3.5 Dexcom, Inc.
  • 6.3.6 GE HealthCare Technologies Inc.
  • 6.3.7 Hinge Health, Inc.
  • 6.3.8 Huma Therapeutics Limited
  • 6.3.9 Insulet Corporation
  • 6.3.10 iRhythm Technologies, Inc.
  • 6.3.11 Koninklijke Philips N.V.
  • 6.3.12 Masimo Corporation
  • 6.3.13 Medtronic plc
  • 6.3.14 Noom, Inc.
  • 6.3.15 Omada Health, Inc.
  • 6.3.16 ResMed Inc.
  • 6.3.17 Siemens Healthineers AG
  • 6.3.18 Tandem Diabetes Care, Inc.
  • 6.3.19 Teladoc Health, Inc.
  • 6.3.20 WellDoc, Inc.

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment