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

According to Mordor Intelligence, the medical device companion software market size was valued at USD 3.9 billion in 2025 and is estimated to grow from USD 4.5 billion in 2026 to reach USD 9.23 billion by 2031, at a CAGR of 15.45% during the forecast period 2026-2031.

This report is Segmented by Product Type (Patient Monitoring, and More), Form Factor (Native Mobile, and More), Deployment Mode (Cloud-Based, and More), Device Category (CGM Systems, Insulin Pumps, Blood Glucose Meters, and More), Application (Chronic Disease Management, and More), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Medical Device Companion Software Market Trends and Insights

Expansion of Home-Based and Remote Care

Home-based care is expanding connected-device use in settings where clinicians rely on remote data capture. As a result, the medical device companion software market depends on applications that collect, transmit, and present data without an in-person visit. CMS introduced CPT 99445 for 2 to 15 days of transmitted data and CPT 99470 for 10 to 19 minutes of treatment management in 2026. This change removed the former 16-day threshold that excluded patients with intermittent device use. Manufacturers that record transmission compliance through their applications can help provider customers support clearer billing, while the combination of remote patient monitoring and Chronic Care Management increases the role of companion applications in value-based care agreements.

Rising Clinical Value of Continuous Device-Generated Data

Companion applications increasingly support clinical decisions rather than only displaying readings. This shift raises the value of the medical device companion software market for providers that need timely and actionable patient information. Dexcom became the first participant in the FDA Technology-Enabled Meaningful Patient Outcomes Pilot on July 22, 2026. The pilot combined G7 and Stelo data with nutrition, activity, and related inputs in an AI-powered glucose health program. It created a real-world evidence pathway that may reduce reliance on the traditional premarket authorization process for qualifying programs and encourages investment in clinical-grade analytics for treatment decisions and payer discussions.

Cybersecurity, Privacy, and Software Liability Exposure

Cybersecurity requirements continue to increase costs and operational workloads for application developers. FDA final guidance published on June 27, 2025, requires Software Bills of Materials, interface disclosures, and lifecycle malware prevention plans for applicable cyber devices under Section 524B of the FD&C Act. Companion applications may include third-party libraries, cloud services, and device interfaces that require lifecycle monitoring. This ongoing compliance burden is significant for mid-sized developers with smaller quality and cybersecurity teams and favors established suppliers with mature processes and larger support budgets.

Other drivers and restraints analyzed in the detailed report include:

1. Interoperability and Open API Adoption
2. Reimbursement for Remote Physiologic and Therapeutic Monitoring
3. Fragmented Global Regulatory and Data-Residency Requirements

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

Segment Analysis

Patient Monitoring Companion Software held 34.55% of product-type revenue in 2025. This category supports implantable cardiac monitors, ambulatory ECG patches, connected oximeters, and continuous glucose monitoring systems. These devices generate regular readings that providers must transmit, review, and act on within care plans. Established reimbursement pathways for several monitoring applications support their commercial role.

Diagnostic Device Companion Software is forecast to grow at a CAGR of 15.93% through 2031, supported by AI imaging and pathology tools that improve triage and findings correlation within clinical workflows. Drug Delivery Device Companion Software is also advancing as pharmaceutical companies integrate applications into drug-device combinations for adherence monitoring. Aptar Digital Health's connected inhaler ecosystem reflects this use of software alongside drug delivery devices. Therapeutic and Surgical Device Software occupies mid-range growth positions, while Implantable Device Companion Software grows more slowly due to longer hardware replacement cycles.

Cloud-Based Web Platforms held 33.56% of form-factor revenue in 2025. Their position reflects health system demand for multi-user tools that do not require installation on each workstation. The medical device companion software market size for this form factor benefits when EHR workflow access is built into a browser-based experience. GE HealthCare received FDA 510(k) clearance for its View diagnostic viewer in March 2026.

The browser-based design allows radiologists to access diagnostic imaging tools without local software installation. Responsive Web Applications are forecast to grow at a 17.67% CAGR through 2031. Clinicians value access across devices, while health systems can reduce app-store and desktop deployment friction. Native Mobile Applications remain important for patient-facing uses that depend on Bluetooth pairing with CGMs and cardiac monitors.

Complete Report Scope:

• By Product Type
  • Patient Monitoring Companion Software
  • Diagnostic Device Companion Software
  • Therapeutic Device Companion Software
  • Drug Delivery Device Companion Software
  • Surgical and Interventional Device Companion Software
  • Rehabilitation and Assistive Device Companion Software
  • Implantable Device Companion Software
  • Home-Use Medical Device Companion Software
• By Form Factor
  • Native Mobile Application
  • Responsive Web Application
  • Desktop Application
  • Embedded Device Software
  • Cloud-Based Web Platform
  • Hybrid Application
  • Conversational and Voice Interface
• By Deployment Mode
  • Cloud-Based
  • On-Premises
  • Hybrid
  • Edge-Based
• By Device Category
  • Continuous Glucose Monitoring Systems
  • Insulin Pumps and Automated Insulin Delivery Systems
  • Connected Blood Glucose Meters
  • Connected Blood Pressure Monitors
  • Connected Pulse Oximeters
  • Connected Weight Scales
  • Connected Spirometers and Respiratory Devices
  • Connected Inhalers
  • Sleep Apnea and Ventilation Devices
  • Ambulatory Cardiac Monitoring Devices
  • Implantable Cardiac Devices
  • Patient Monitoring Systems
  • Medical Imaging Devices
  • Surgical Robotics and Navigation Systems
  • Neurostimulation Devices
  • Orthopedic and Rehabilitation Devices
  • Home Diagnostic Devices
• By Application
  • Chronic Disease Management
  • Acute Care Monitoring
  • Post-Acute Care
  • Medication Administration and Adherence
  • Screening and Early Detection
  • Diagnosis and Clinical Assessment
  • Treatment Planning
  • Therapy Optimization
  • Recovery and Rehabilitation
  • Patient Safety and Risk Reduction
• 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 42.45% of the medical device companion software market share in 2025, supported by established RPM reimbursement infrastructure and a large installed base of connected devices. CMS added CPT 99445 and CPT 99470 in 2026 and set the conversion factor at USD 33.40 per RVU, expanding the billable patient pool by removing the 16-day minimum for data transmission. The FDA also broadened enforcement discretion for certain lower-risk clinical decision support functions in January 2026. Canada and Mexico are adopting digital health procurement approaches that increasingly align with U.S. payer models, while U.S. provider organizations are expected to make RPM and Chronic Care Management billing combinations more routine through 2027.

Europe holds the second-largest regional position in the supplied analysis. Germany's DiGA framework and the United Kingdom's NICE Evidence Standards Framework provide structured pathways for software that meets clinical evidence requirements. EU Medical Device Regulation reclassification work since 2024 created a competitive filter among developers, with validated companies gaining evidence packages for expansion and others facing pressure to consolidate or seek acquisition. Siemens Healthineers and Philips disclosed AI imaging companion investments at RSNA 2025, while the European Health Data Space targets implementation in 2027 with FHIR-based health data portability requirements.

Asia-Pacific is forecast to grow at a CAGR of 18.56% through 2031, the fastest regional rate in the medical device companion software market. Government action in Japan, hospital digitalization in China, and private hospital investment in India support demand. China published YY/T 1406-2026 in March 2026 to establish software lifecycle risk management requirements, and the Gates Foundation provided Qure.ai with a USD 8 million grant in January 2026 for AI-driven tuberculosis and pneumonia ultrasound diagnosis. Opportunities in the Middle East and Africa include Saudi Arabia's Vision 2030 digital health investments and Huma Therapeutics' cardiac health program with Bayer, while South America offers a longer-term opening as Brazil advances digital health regulation.

1. Abbott Laboratories
2. Adherium
3. Aidoc Medical Ltd.
4. AliveCor
5. Apple
6. Aptar Digital Health
7. Arterys Inc.
8. Baxter
9. Boston Scientific
10. Brainomix Limited
11. Butterfly Network, Inc.
12. Dexcom
13. GE HealthCare Technologies Inc.
14. Glooko Inc.
15. Huma Therapeutics Limited
16. Insulet
17. iRhythm Holdings, Inc.
18. Koninklijke Philips
19. Masimo
20. MedM Health
21. Medtronic
22. Resmed
23. Siemens Healthineers
24. Tandem Diabetes Care
25. Tempus 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 Expansion of Home-Based and Remote Care
  • 4.2.2 Rising Clinical Value of Continuous Device-Generated Data
  • 4.2.3 Interoperability and Open API Adoption
  • 4.2.4 Reimbursement for Remote Physiologic and Therapeutic Monitoring
  • 4.2.5 Device-Embedded Personalization and Closed-Loop Therapy
  • 4.2.6 Software-Led Differentiation of Mature Medical Device Portfolios
• 4.3 Market Restraints
  • 4.3.1 Cybersecurity, Privacy and Software Liability Exposure
  • 4.3.2 Fragmented Global Regulatory and Data-Residency Requirements
  • 4.3.3 Low Patient Engagement and Digital Health Literacy
  • 4.3.4 Device-Software Validation Burden Across Long Product Lifecycles
• 4.4 Value and 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 Intensity of Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Product Type
  • 5.1.1 Patient Monitoring Companion Software
  • 5.1.2 Diagnostic Device Companion Software
  • 5.1.3 Therapeutic Device Companion Software
  • 5.1.4 Drug Delivery Device Companion Software
  • 5.1.5 Surgical and Interventional Device Companion Software
  • 5.1.6 Rehabilitation and Assistive Device Companion Software
  • 5.1.7 Implantable Device Companion Software
  • 5.1.8 Home-Use Medical Device Companion Software
• 5.2 By Form Factor
  • 5.2.1 Native Mobile Application
  • 5.2.2 Responsive Web Application
  • 5.2.3 Desktop Application
  • 5.2.4 Embedded Device Software
  • 5.2.5 Cloud-Based Web Platform
  • 5.2.6 Hybrid Application
  • 5.2.7 Conversational and Voice Interface
• 5.3 By Deployment Mode
  • 5.3.1 Cloud-Based
  • 5.3.2 On-Premises
  • 5.3.3 Hybrid
  • 5.3.4 Edge-Based
• 5.4 By Device Category
  • 5.4.1 Continuous Glucose Monitoring Systems
  • 5.4.2 Insulin Pumps and Automated Insulin Delivery Systems
  • 5.4.3 Connected Blood Glucose Meters
  • 5.4.4 Connected Blood Pressure Monitors
  • 5.4.5 Connected Pulse Oximeters
  • 5.4.6 Connected Weight Scales
  • 5.4.7 Connected Spirometers and Respiratory Devices
  • 5.4.8 Connected Inhalers
  • 5.4.9 Sleep Apnea and Ventilation Devices
  • 5.4.10 Ambulatory Cardiac Monitoring Devices
  • 5.4.11 Implantable Cardiac Devices
  • 5.4.12 Patient Monitoring Systems
  • 5.4.13 Medical Imaging Devices
  • 5.4.14 Surgical Robotics and Navigation Systems
  • 5.4.15 Neurostimulation Devices
  • 5.4.16 Orthopedic and Rehabilitation Devices
  • 5.4.17 Home Diagnostic Devices
• 5.5 By Application
  • 5.5.1 Chronic Disease Management
  • 5.5.2 Acute Care Monitoring
  • 5.5.3 Post-Acute Care
  • 5.5.4 Medication Administration and Adherence
  • 5.5.5 Screening and Early Detection
  • 5.5.6 Diagnosis and Clinical Assessment
  • 5.5.7 Treatment Planning
  • 5.5.8 Therapy Optimization
  • 5.5.9 Recovery and Rehabilitation
  • 5.5.10 Patient Safety and Risk Reduction
• 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 Adherium Limited
  • 6.3.3 Aidoc Medical Ltd.
  • 6.3.4 AliveCor, Inc.
  • 6.3.5 Apple Inc.
  • 6.3.6 Aptar Digital Health
  • 6.3.7 Arterys Inc.
  • 6.3.8 Baxter International Inc.
  • 6.3.9 Boston Scientific Corporation
  • 6.3.10 Brainomix Limited
  • 6.3.11 Butterfly Network, Inc.
  • 6.3.12 DexCom, Inc.
  • 6.3.13 GE HealthCare Technologies Inc.
  • 6.3.14 Glooko Inc.
  • 6.3.15 Huma Therapeutics Limited
  • 6.3.16 Insulet Corporation
  • 6.3.17 iRhythm Holdings, Inc.
  • 6.3.18 Koninklijke Philips N.V.
  • 6.3.19 Masimo Corporation
  • 6.3.20 MedM Health
  • 6.3.21 Medtronic plc
  • 6.3.22 ResMed Inc.
  • 6.3.23 Siemens Healthineers AG
  • 6.3.24 Tandem Diabetes Care, Inc.
  • 6.3.25 Tempus AI, Inc.

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment