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

According to Mordor Intelligence, the connected medical device software market size was valued at USD 11.33 billion in 2025 and is estimated to grow from USD 12.95 billion in 2026 to reach USD 25.32 billion by 2031, at a CAGR of 14.34% during the forecast period (2026-2031).

This report is Segmented by Component (Cloud-Based, On-Premises, Edge-Based, Hybrid), Connectivity (Wired, Wireless, Hybrid), Device Type (Patient Monitoring, Respiratory, Infusion, Cardiac, Surgical, Wearable/Home), Application (10 Types), End User (6 Types), and Geography (North America, Europe, Asia-Pacific, MEA, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Connected Medical Device Software Market Trends and Insights

Expansion of Remote Physiologic and Therapeutic Monitoring

CMS finalized CPT codes 98975-98980 for remote therapeutic monitoring, anchoring software procurement cycles for connected device platforms and making reimbursement-driven demand a structural market feature. The FDA's December 2025 TEMPO Digital Health Devices Pilot granted enforcement discretion on premarket requirements while generating real-world evidence. Dexcom entered as its first participant in July 2026, deploying an AI-powered glucose health program that integrated G7 and Stelo CGM data with contextual nutrition, sleep, and activity signals. Edwards Lifesciences' May 2025 HePI algorithm clearance and June 2026 Respiration Rate algorithm clearance showed how vendors expanded software revenue by adding AI-enabled parameter detection to existing connected hardware.

Interoperability and Electronic Health Record Integration Requirements

EHR integration advanced from a procurement preference to a contractual mandate for hospital-grade connected device software, as ONC's FHIR interoperability rules required certified EHR technology to support standardized API interfaces across US non-federal acute care hospitals. Germany's hospital sector followed a similar path, with SAP and Fresenius announcing a January 2026 collaboration to build a sovereign European health ecosystem using HL7 FHIR interfaces and KHZG digitalization program funding. FHIR adoption weakened proprietary data moats, increasing margin pressure on vendors without cross-platform analytics differentiation. ISO/IEC 80001-1 remained the leading global compliance framework, while EU MDR Article 83 added post-market software surveillance obligations for European market access.

Fragmented Legacy Protocols and Proprietary Device Architectures

The installed device base across most large health systems includes HL7 v2, DICOM, proprietary serial protocols, and newer FHIR-enabled APIs. This architectural disparity limits the ability of vendor-neutral middleware to resolve integration challenges. Germany's DigitalRadar assessment scored hospitals on connected device integration as a discrete digitalization metric, and published interim data indicated that a material share of surveyed facilities still relied on manual data transfer between bedside devices and clinical information systems. China's NMPA released YY/T 1406-2026 in March 2026, revising software risk management requirements and requiring manufacturers with legacy validation frameworks to conduct fresh assessments before maintaining connected product market authorizations.

Other drivers and restraints analyzed in the detailed report include:

1. AI-Enabled Predictive Monitoring and Clinical Workflow Automation
2. Growth of Home-Based and Decentralized Care
3. High Integration, Validation, and Lifecycle-Maintenance Costs

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

Segment Analysis

Cloud-based software held 48.22% of the connected medical device software market in 2025. It supported multi-site deployment, centralized alarm normalization, and rolling software updates, aligning with post-market maintenance and security management needs. Persistent connectivity also supported continuous clinical data review and periodic reporting obligations in Europe. On-premises software remained relevant where data residency rules limited cross-border health-data transfers, while large health systems in Asia-Pacific favored local deployment under national privacy and data-control rules.

Hybrid software is forecast to grow at a CAGR of 17.86% from 2026 to 2031, the fastest rate among component types. It enables time-sensitive processing at the bedside or local edge while storing longitudinal information in the cloud for population-level analysis. Hospital procurement teams increasingly specify hybrid-capable platforms in requests for proposals. The connected medical device software market size for hybrid solutions is supported by the need for both rapid response and enterprise-wide data access.

Wired connectivity held 57.68% of the connected medical device software market in 2025. Intensive care units and operating rooms continued to depend on hardwired networks for continuous critical monitoring. These settings required dependable connections and limited unmanaged radio-frequency interference. The connected medical device software market continued to rely on wired networks where uninterrupted high-acuity monitoring was required.

Wireless connectivity is forecast to grow at a CAGR of 19.67% from 2026 to 2031. Wi-Fi 6E and private 5G deployments address latency and interference concerns that previously restricted wireless monitoring to lower-acuity uses. Hospitals are adopting hybrid connectivity models that retain wired backup paths for critical alerts. The connected medical device software market size for wireless connectivity grows as hospitals extend monitoring beyond fixed bedside locations.Patient monitoring devices held 36.78% of the connected medical device software market in 2025. Their position reflected widespread use in intensive care, telemetry, and general ward environments. Medtronic and GE HealthCare expanded their alliance in March 2026 to integrate Nellcor pulse oximetry, Microstream capnography, INVOS regional oximetry, and BIS brain monitoring with GE HealthCare monitoring platforms. The collaboration reduced interface complexity for health systems operating devices from both companies.

Wearable and home medical devices are forecast to grow at a CAGR of 18.35% from 2026 to 2031. Their growth follows broader clinical acceptance of ambulatory monitoring for arrhythmia, glucose management, and sleep-disordered breathing. The ZEUS Platform received FDA 510(k) clearance in May 2026 as AI- and machine-learning-enabled software that analyzes continuous ECG recordings from Zio monitors and generates arrhythmia reports with 99% physician agreement. The connected medical device software market size for wearable and home devices benefits from these expanding clinical applications.

Complete Report Scope:

• By Component
  • Cloud-Based Software
  • On-Premises Software
  • Edge-Based Software
  • Hybrid Software
• By Connectivity
  • Wired Connectivity
  • Wireless Connectivity
  • Hybrid Connectivity
• By Device Type
  • Patient Monitoring Devices
  • Respiratory Devices
  • Infusion and Drug-Delivery Devices
  • Diagnostic and Imaging Devices
  • Cardiac and Implantable Devices
  • Surgical and Perioperative Devices
  • Wearable and Home Medical Devices
  • Others
• By Application
  • Continuous Patient Monitoring
  • Remote Physiologic Monitoring
  • Remote Therapeutic Monitoring
  • Tele-ICU and Tele-Stroke
  • Chronic Disease Management
  • Medication Adherence and Optimization
  • Early Warning and Deterioration Detection
  • Predictive Maintenance and Asset Utilization
  • Clinical Research and Real-World Evidence
  • Others
• By End User
  • Hospitals and Health Systems
  • Ambulatory Surgical Centers
  • Diagnostic and Imaging Centers
  • Clinics and Physician Practices
  • Home Healthcare Providers
  • Skilled Nursing and Long-Term Care Facilities
  • Others
• 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 connected medical device software market share in 2025. The region benefited from established remote monitoring reimbursement, high hospital device density, and active FDA oversight of digital health. The TEMPO pilot supported real-world evidence collection for software-enabled connected devices. U.S. hospitals also had a growing base of FHIR-based data exchange and standardized interfaces. Europe held the second-largest regional position, with Germany influencing procurement through EU MDR requirements, hospital digitalization funding, and its digital health environment.

Asia-Pacific is forecast to grow at a CAGR of 18.56% from 2026 to 2031, making it the fastest-growing regional market. Major regional markets are advancing regulatory modernization alongside healthcare infrastructure investment. Japan's DASH for SaMD 2 program supports faster review pathways for eligible connected monitoring software. South Korea's Digital Medical Products Act is increasing the relevance of digital health support devices for hospital buyers. China's revised YY/T 1406-2026 software requirements create demand for updated validation documentation, while India's private hospital groups and Australia's hospital-at-home programs are expanding adoption.

The Middle East and Africa and South America remain earlier-stage regions in the connected medical device software market. Adoption is concentrated among private healthcare groups and major public hospital projects. In GCC countries, new hospital construction offers a simpler integration environment than legacy upgrades in North America and Europe. Saudi Arabia's Vision 2030 programs and UAE digital health mandates support connected monitoring deployments, while Brazil's digital health activity and South Africa's health system changes indicate longer-term public-sector demand.

1. Abbott Laboratories
2. Ascom
3. Baxter
4. Boston Scientific
5. Cisco Systems
6. Dexcom
7. Dragerwerk
8. Edward Lifesciences
9. GE HealthCare Technologies Inc.
10. Insulet
11. iRhythm Technologies
12. Koninklijke Philips
13. Masimo
14. Medtronic
15. Oracle
16. Resmed
17. S3 Connected Health Limited
18. Siemens Healthineers
19. Stryker
20. Tandem Diabetes Care

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 Remote Physiologic and Therapeutic Monitoring
  • 4.2.2 Interoperability and Electronic Health Record Integration Requirements
  • 4.2.3 Growth of Home-Based and Decentralized Care
  • 4.2.4 Cybersecurity-by-Design Requirements for Connected Devices
  • 4.2.5 AI-Enabled Predictive Monitoring and Clinical Workflow Automation
  • 4.2.6 Device Fleet Complexity and Demand for Vendor-Neutral Orchestration
• 4.3 Market Restraints
  • 4.3.1 Fragmented Legacy Protocols and Proprietary Device Architectures
  • 4.3.2 High Integration, Validation, and Lifecycle-Maintenance Costs
  • 4.3.3 Cybersecurity Liability and Patient-Data Privacy Exposure
  • 4.3.4 Alert Fatigue, Workflow Misalignment, and Clinician Adoption Barriers
• 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 Component
  • 5.1.1 Cloud-Based Software
  • 5.1.2 On-Premises Software
  • 5.1.3 Edge-Based Software
  • 5.1.4 Hybrid Software
• 5.2 By Connectivity
  • 5.2.1 Wired Connectivity
  • 5.2.2 Wireless Connectivity
  • 5.2.3 Hybrid Connectivity
• 5.3 By Device Type
  • 5.3.1 Patient Monitoring Devices
  • 5.3.2 Respiratory Devices
  • 5.3.3 Infusion and Drug-Delivery Devices
  • 5.3.4 Diagnostic and Imaging Devices
  • 5.3.5 Cardiac and Implantable Devices
  • 5.3.6 Surgical and Perioperative Devices
  • 5.3.7 Wearable and Home Medical Devices
  • 5.3.8 Others
• 5.4 By Application
  • 5.4.1 Continuous Patient Monitoring
  • 5.4.2 Remote Physiologic Monitoring
  • 5.4.3 Remote Therapeutic Monitoring
  • 5.4.4 Tele-ICU and Tele-Stroke
  • 5.4.5 Chronic Disease Management
  • 5.4.6 Medication Adherence and Optimization
  • 5.4.7 Early Warning and Deterioration Detection
  • 5.4.8 Predictive Maintenance and Asset Utilization
  • 5.4.9 Clinical Research and Real-World Evidence
  • 5.4.10 Others
• 5.5 By End User
  • 5.5.1 Hospitals and Health Systems
  • 5.5.2 Ambulatory Surgical Centers
  • 5.5.3 Diagnostic and Imaging Centers
  • 5.5.4 Clinics and Physician Practices
  • 5.5.5 Home Healthcare Providers
  • 5.5.6 Skilled Nursing and Long-Term Care Facilities
  • 5.5.7 Others
• 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 Ascom Holding AG
  • 6.3.3 Baxter International Inc.
  • 6.3.4 Boston Scientific Corporation
  • 6.3.5 Cisco Systems, Inc.
  • 6.3.6 Dexcom, Inc.
  • 6.3.7 Dragerwerk AG & Co. KGaA
  • 6.3.8 Edwards Lifesciences Corporation
  • 6.3.9 GE HealthCare Technologies Inc.
  • 6.3.10 Insulet Corporation
  • 6.3.11 iRhythm Technologies, Inc.
  • 6.3.12 Koninklijke Philips N.V.
  • 6.3.13 Masimo Corporation
  • 6.3.14 Medtronic plc
  • 6.3.15 Oracle Corporation
  • 6.3.16 ResMed Inc.
  • 6.3.17 S3 Connected Health Limited
  • 6.3.18 Siemens Healthineers AG
  • 6.3.19 Stryker Corporation
  • 6.3.20 Tandem Diabetes Care, Inc.

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment