당뇨병 관리용 의료기기 소프트웨어(SaMD) 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the software as a Medical Device for Diabetes Management Market size was valued at USD 15.99 million in 2025 and is estimated to grow from USD 18.04 million in 2026 to reach USD 32.97 million by 2031, at a CAGR of 12.82% during the forecast period (2026-2031).

This report is Segmented by Component (Software Platforms, Services), Product Type (Mobile Apps, Closed-Loop/AID, and More), Clinical Use Case (Type 1, Type 2, Gestational), Deployment Mode (Cloud-Based, On-Premises, Hybrid), End User (Patients, Hospitals, Ambulatory, and More), and Geography (North America, Europe, Asia-Pacific, and More). Forecasts in Value (USD).

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

Rising Adoption of CGM-Connected Software and Automated Insulin Delivery

CGM-connected software is becoming a core part of diabetes care, pushing the SaMD for diabetes management market toward higher-value regulated tools. In January 2026, Diabeloop received FDA 510(k) clearance for DBLG2, adding another automated insulin delivery algorithm to DIABELOOP's cleared product base. Medtronic also announced FDA clearance for the MiniMed Go Smart MDI system in January 2026, indicating broader clinical adoption of software-guided dosing support. A May 2026 study on the MiniMed 780G system showed similar glycemic outcomes across two integrated sensor brands, highlighting the growing value of algorithm performance and interoperability. These developments expand opportunities for software-led vendors that can work across devices and demonstrate consistent real-world outcomes, while broadening the addressable base beyond type 1 diabetes into larger insulin-managed populations.

Expansion of Remote Patient Monitoring and Chronic Care Management

Remote monitoring is changing how providers, employers, and health plans use the SaMD for diabetes management market in routine care. Buyers now seek ongoing support for titration, adherence, symptom tracking, and escalation between visits, rather than only post-visit glucose review. This demand is also increasing with wider metabolic therapy use, especially when patients need closer follow-up during dose adjustments and tolerability changes. In 2026, Twin Health introduced a precision GLP-1 stewardship model combining CGM data, quarterly labs, a smart scale, and activity tracking in one continuously learning system. This shift supports demand beyond glucose logging and favors vendors that combine software, review tools, and managed support in a single offering.

Regulatory Uncertainty Across Device, CDS, and Wellness Classifications

Regulatory boundaries remain a key operating constraint for the SaMD for diabetes management market. Companies face different requirements across medical device software, clinical decision support (CDS), and wellness applications, even when buyers view these products as similar at the point of use. The challenge increases when vendors seek access across the United States and Europe, as they must manage clearance requirements, technical documentation, post-market follow-up, and clinical evidence across multiple regulatory systems. Smaller developers face higher exposure because quality systems, audit readiness, evidence generation, data residency rules, and cybersecurity reviews can increase costs and delay cloud and hybrid products that handle sensitive patient information across borders.

Other drivers and restraints analyzed in the detailed report include:

1. Payer Preference for HbA1c Improvement and Utilization
2. AI-Enabled Personalization for Dose Support and Behavioral Change
3. Patient Drop-Off, Low App Engagement, and Long-Term Adherence

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

Segment Analysis

Software platforms accounted for 70.65% of the SaMD for diabetes management market size in 2025, reflecting the established role of apps, dashboards, viewers, and dose support tools. This base grew from products focused on CGM viewing, insulin guidance, and population management workflows. Services are projected to grow at a 15.93% CAGR through 2031, well above the overall market rate, as buyers place greater value on managed outcomes than on software access alone.

This shift shows that buyers no longer view the SaMD for diabetes management industry only as a software category. DarioHealth's 2025 results highlighted this change, as the company linked new commercial growth to integrated service delivery along with its platform. Platforms remain the core layer because they organize device data, reporting, and care workflows across users and providers. Vendors that do not integrate services into their offer may face pricing pressure as payer contracts become more outcome focused.

Diabetes management mobile applications held the largest share at 38.23% in 2025, showing the scale of the installed base for guidance, logging, and coaching tools. Closed-loop and automated insulin dosing software is the fastest-growing product type, with a 14.67% CAGR through 2031. Diabeloop received FDA clearance for DBLG2 in January 2026, and Medtronic announced a new FDA-cleared dosing support system in the same month. Product leadership is shifting toward automation quality, real-time performance, and broad device compatibility.

The SaMD for diabetes management industry is also expanding across adjacent product categories. At the ADA 86th Scientific Sessions in June 2026, Insulet reported that its next-generation Omnipod 6 algorithm outperformed Omnipod 5 across all efficacy endpoints, including a 5.2% increase in time in tight range. Decision support and coaching software is gaining traction as employers and health plans seek tools covering diabetes, hypertension, and weight management. Glooko's expanded partnership with mylife Diabetes Care in May 2026 made Glooko the primary platform for all mylife products, including mylife Loop powered by CamAPS FX.

Complete Report Scope:

• By Component
  • Software Platforms
  • Services
• By Product Type
  • Diabetes Management Mobile Applications
  • Closed-Loop and Automated Insulin Dosing Software
  • Decision Support and Coaching Software
  • Data Integration and Analytics Platforms
• By Clinical Use Case
  • Type 1 Diabetes Management
  • Type 2 Diabetes Management
  • Gestational Diabetes Management
• By Deployment Mode
  • Cloud-Based
  • On-Premises
  • Hybrid
• By End User
  • Patients and Caregivers
  • Hospitals and Clinics
  • Ambulatory Care Centers
  • Payers and Pharmacy Benefit Managers
  • Employers and Wellness Programs
• 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 39.56% of the SaMD for diabetes management market share in 2025, maintaining its leading regional position. The United States remained the key demand center, supported by a large base of FDA-cleared products, a mature employer-sponsored benefits structure, and stronger payer engagement. The region favored vendors that demonstrated post-market outcomes, managed reporting, and supported broad commercial rollouts. Canada remained a smaller but meaningful growth pocket, and One Drop expanded its digital coaching program there in February 2025. Mexico remained at an earlier adoption stage, with demand concentrated in private insurance and employer wellness programs across major urban markets.

Europe held the second-largest position in the SaMD for diabetes management market. Germany led regional adoption, as its reimbursement framework supported regulated digital therapeutics and connected care tools. In July 2026, Diabeloop and ViCentra launched DBLG2 for prescription use in Germany, with Dexcom G7 and Kaleido integration, and the product was set to reach the Netherlands later in 2026. The United Kingdom, France, Italy, Spain, and the Nordic countries remained important markets, but documentation requirements and Notified Body costs favored vendors that could distribute compliance work across several countries.

Asia-Pacific was the fastest-growing regional segment, with a 14.56% CAGR through 2031. China and India accounted for much of this momentum, driven by large diabetes populations and expanding digital health investment. Japan and South Korea added demand from connected care users comfortable with CGM-supported monitoring and premium device-linked services. The Middle East and Africa remained a smaller part of the global base, while GCC digital transformation programs supported gradual adoption of structured chronic care tools. South America remained relevant, with Brazil standing out as the largest country opportunity due to rising private insurance and employer investment in metabolic care.

1. Abbott Laboratories
2. Ascensia Diabetes Care Holdings AG
3. Beta Bionics
4. Biolinq, Inc.
5. DarioHealth Corp.
6. Dexcom
7. Glooko, Inc.
8. Insulet
9. I-Sens
10. Medtronic
11. MicroPort
12. OneDrop, Inc.
13. PHC Holdings
14. Roche
15. Senseonics
16. Tandem Diabetes Care
17. Terumo
18. Virta Health Corp.
19. Welldoc, Inc.
20. Ypsomed

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 Adoption of CGM-Connected Software and Automated Insulin Guidance
  • 4.2.2 Expansion of Remote Patient Monitoring and Chronic Care Virtualization
  • 4.2.3 Payer Preference for HbA1c Improvement and Utilization Reduction Evidence
  • 4.2.4 Interoperability With CGM, Pumps, Connected Pens, and EHR Workflows
  • 4.2.5 AI-Enabled Personalization for Dose Support and Behavioral Nudging
  • 4.2.6 Shift Toward Subscription-Based Diabetes Care Platforms and Outcomes Contracts
• 4.3 Market Restraints
  • 4.3.1 Regulatory Uncertainty Across Device, CDS, and Wellness Classifications
  • 4.3.2 Clinical Validation Burden for SaMD Claims and Real-World Evidence Expectations
  • 4.3.3 Patient Drop-Off, Low App Engagement, and Long-Term Adherence Challenges
  • 4.3.4 Data Privacy, Cybersecurity, and Cross-Border Health Data Transfer Constraints
• 4.4 Value/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 Industry Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Component
  • 5.1.1 Software Platforms
  • 5.1.2 Services
• 5.2 By Product Type
  • 5.2.1 Diabetes Management Mobile Applications
  • 5.2.2 Closed-Loop and Automated Insulin Dosing Software
  • 5.2.3 Decision Support and Coaching Software
  • 5.2.4 Data Integration and Analytics Platforms
• 5.3 By Clinical Use Case
  • 5.3.1 Type 1 Diabetes Management
  • 5.3.2 Type 2 Diabetes Management
  • 5.3.3 Gestational Diabetes Management
• 5.4 By Deployment Mode
  • 5.4.1 Cloud-Based
  • 5.4.2 On-Premises
  • 5.4.3 Hybrid
• 5.5 By End User
  • 5.5.1 Patients and Caregivers
  • 5.5.2 Hospitals and Clinics
  • 5.5.3 Ambulatory Care Centers
  • 5.5.4 Payers and Pharmacy Benefit Managers
  • 5.5.5 Employers and Wellness Programs
• 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 Ascensia Diabetes Care Holdings AG
  • 6.3.3 Beta Bionics, Inc.
  • 6.3.4 Biolinq, Inc.
  • 6.3.5 DarioHealth Corp.
  • 6.3.6 DexCom, Inc.
  • 6.3.7 Glooko, Inc.
  • 6.3.8 Insulet Corporation
  • 6.3.9 i-SENS, Inc.
  • 6.3.10 Medtronic plc
  • 6.3.11 MicroPort Scientific Corporation
  • 6.3.12 OneDrop, Inc.
  • 6.3.13 PHC Holdings Corporation
  • 6.3.14 Roche Holding AG
  • 6.3.15 Senseonics Holdings, Inc.
  • 6.3.16 Tandem Diabetes Care, Inc.
  • 6.3.17 Terumo Corporation
  • 6.3.18 Virta Health Corp.
  • 6.3.19 Welldoc, Inc.
  • 6.3.20 Ypsomed Holding AG

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment