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

According to Mordor Intelligence, the medical device cybersecurity market is projected to expand from USD 7.87 billion in 2025 and USD 8.99 billion in 2026 to USD 18.28 billion by 2031, registering a CAGR of 15.24% between 2026 to 2031.

This report is Segmented by Component (Solutions, Services), Deployment Mode (On-Premises, Cloud-Based, Hybrid), Security Type (Network and IoMT, Endpoint Security, and Others), Device Type (Hospital Medical Devices, and Others), End-User (Hospitals and Health Systems, and Others), and Geography (North America, Europe, and Others). The Market Forecasts are Provided in Terms of Value (USD).

Global Medical Device Cybersecurity Market Trends and Insights

Rising Connected Device Attack Surface

The medical device cybersecurity market is drawing stronger demand because the FBI Cyber Division found that 53% of networked medical devices contain at least 1 critical known vulnerability, which places device risk in a separate category from general hospital IT exposure. RunSafe Security reported in 2025 that 22% of healthcare organizations faced cyberattacks that directly affected medical devices, and 75% of those incidents disrupted patient care, with 24% requiring patient transfers, which linked device compromise to care continuity rather than only data loss. The same body of evidence showed that malware infections affected 51% of impacted organizations and that ransomware targeted device operations in more than 1/3 of organizations in 2025, which confirmed that attackers were moving deeper into device-layer disruption. This pattern is pushing the medical device cybersecurity market toward behavioral anomaly detection, firmware attestation, and segmentation orchestration, because healthcare buyers now need controls that stay effective even when devices cannot be patched quickly.

FDA 524B and Premarket Cybersecurity Readiness Pressure

The medical device cybersecurity market is receiving a direct regulatory lift from the FDA's February 2026 final guidance, which integrates cybersecurity expectations into the Quality Management System Regulation and requires manufacturers to submit SBOMs, threat models, secure development evidence, and postmarket vulnerability management plans. This change matters because cybersecurity evidence is no longer treated as a supporting document for selected products and is instead tied to the full device lifecycle and to the way manufacturers govern software components before and after launch. The pressure grows further because IEC 81001-5-1 alignment in Japan and under the EU framework is extending 524B-style expectations beyond the United States, which shortens the period during which manufacturers could treat cybersecurity as a country-specific issue. That combination is helping the medical device cybersecurity market shift toward recurring compliance support and managed advisory work, which supports the faster expansion rate seen in services.

Legacy Device Replacement Cycles

The medical device cybersecurity market still faces a structural slowdown because device hardware often stays in service for 10 to 30 years, while embedded software reaches end-of-life much earlier and leaves hospitals with unsupported systems that no longer receive practical patch coverage. This gap is not only financial, because high-capital systems such as MRI and CT equipment are deeply tied to daily patient throughput and cannot be removed from service without affecting clinical schedules and diagnostic access. Rural and critical-access hospitals face the strongest constraint because the combination of cybersecurity and biomedical engineering expertise needed to manage legacy device risk safely remains limited even when the need for compensating controls is well understood. As a result, the medical device cybersecurity market continues to rely on network isolation, monitoring, and virtual patching in environments where direct hardware replacement remains too slow and too disruptive.

Other drivers and restraints analyzed in the detailed report include:

1. Hospital Zero Trust Modernization Programs
2. AI-Enabled Threat Detection Demand in Clinical Environments
3. Limited Cybersecurity Budgets in Mid-Tier Care Settings

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

Segment Analysis

Solutions accounted for 67.83% share of the medical device cybersecurity market size in 2025, which reflected strong hospital demand for asset discovery, network segmentation, endpoint protection, and visibility tools needed to establish a basic control layer across connected devices. The segment led because many health systems had already been buying discrete products to address immediate compliance and monitoring gaps, which made software platforms the most direct way to improve visibility without changing core clinical workflows. The medical device cybersecurity market therefore showed a strong installed base of point tools in 2025, especially in hospitals that first focused on discovery, scanning, and segmentation before trying to integrate those functions into broader security operations. That pattern explains why solutions still lead revenue today, even as buyer attention shifts toward lifecycle accountability and continuous program support.

Services are forecasted to expand at a 15.64% CAGR through 2031 in the medical device cybersecurity market, which shows that many buyers now want ongoing support instead of treating cybersecurity as a one-time implementation exercise. The medical device cybersecurity market is therefore shifting from stand-alone product deployment toward operating models where software, response services, advisory work, and audit support are purchased together as part of a longer customer relationship.

Cloud-based deployment held 56.47% of the medical device cybersecurity market in 2025, and this lead reflected the cost, scalability, and centralized management advantages that SaaS models offer to health systems overseeing large device estates across multiple sites. The segment benefited from easier policy updates, shared threat intelligence, and lower onsite infrastructure needs, which made cloud deployment the practical default for providers that needed faster rollout and consistent visibility across distributed campuses. That mix of lower operating complexity and broader remote oversight helped cloud deployments secure the largest installed base in the medical device cybersecurity market during 2025. It also made cloud platforms the starting point for many mid-tier hospitals and for providers in cost-sensitive environments that needed immediate visibility without major hardware investment.

Hybrid deployment is projected to grow at a 16.28% CAGR through 2031, which shows that buyers are now balancing cloud efficiency with the clinical need for local resilience and tighter control over sensitive telemetry. On-premises models still hold a meaningful place in government systems, research hospitals, and markets with stricter data residency rules, but the medical device cybersecurity market is increasingly settling around hybrid as the most workable enterprise standard. This is likely to remain the preferred path where providers need centralized governance, local continuity, and enough architectural flexibility to satisfy both regulators and clinical teams.

Complete Report Scope:

• By Component
  • Solutions
  • Services
• By Deployment Mode
  • On-Premises
  • Cloud-Based
  • Hybrid
• By Security Type
  • Network and IoMT Security
  • Endpoint Security
  • Application Security
  • Cloud Security
  • Firmware and Device Integrity Security
• By Device Type
  • Hospital Medical Devices
  • Internally Embedded Medical Devices
  • Wearable and External Medical Devices
• By End-User
  • Hospitals and Health Systems
  • Ambulatory Surgery Centers
  • Diagnostic and Imaging Centers
  • Other End-Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • 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 42.63% share of the medical device cybersecurity market size in 2025, which made it the leading regional revenue base during the year. The region's lead came from the high density of connected medical devices, strong specialist vendor presence, and demanding regulatory structure built around FDA Section 524B, HIPAA, and HHS cybersecurity expectations. The United States accounts for most regional spending, while Canada and Mexico are moving forward as cross-border healthcare networks absorb more U.S.-aligned security expectations. The medical device cybersecurity market in North America is also being supported by zero trust roadmaps that move security planning from optional modernization into a more structured multi-year operating priority.

Europe ranked as the second-largest region in the medical device cybersecurity market, and its demand profile is being shaped by the combined pressure of MDR cybersecurity requirements and the EU Cyber Resilience Act. Germany remains the leading market in the region because of its concentration of device manufacturers facing both MDR compliance and CRA readiness demands. The United Kingdom also moved faster in 2026 through the NHS Secure Boundary program, although that contract sits outside the most authentic citation set used below.

Asia-Pacific is forecasted to grow at a 18.38% CAGR through 2031, giving it the fastest regional expansion rate in the medical device cybersecurity market. This pace is being supported by healthcare digitization, rising IoMT deployment, and the spread of country-level cybersecurity expectations across major healthcare systems. Japan's move from April 2024 to require continuous software security improvement under amendments aligned with IEC 81001-5-1 gave the region a concrete compliance anchor that now supports wider adoption. China, India, and Australia add volume through hospital network expansion and public digital health efforts, while the Middle East and Africa and South America remain smaller but structurally growing markets where cloud-first models help providers adopt security controls despite budget pressure.

1. Armis
2. Asimily
3. Axonius
4. Broadcom Inc. (Symantec Enterprise Security)
5. Check Point Software Technologies Ltd.
6. Cisco Systems
7. Claroty
8. Cynerio
9. Forescout Technologies
10. Fortinet, Inc.
11. IBM
12. Imprivata, Inc.
13. MedCrypt
14. Medigate (Claroty)
15. Microsoft
16. Nozomi Networks Inc.
17. Ordr, Inc.
18. Palo Alto Networks
19. Trend Micro Incorporated

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 Connected Device Attack Surface
  • 4.2.2 FDA 524B and Premarket Cybersecurity Readiness Pressure
  • 4.2.3 Hospital Zero Trust Modernization Programs
  • 4.2.4 Postmarket Vulnerability Disclosure and Patch Governance Burden
  • 4.2.5 Cloud-Connected Remote Monitoring Expansion
  • 4.2.6 AI-Enabled Threat Detection Demand in Clinical Environments
• 4.3 Market Restraints
  • 4.3.1 Legacy Device Replacement Cycles
  • 4.3.2 Safety Validation Delays for Security Updates
  • 4.3.3 Fragmented Vendor Accountability Across OEMs, Providers, and IT Teams
  • 4.3.4 Limited Cybersecurity Budgets in Mid-Tier Care Settings
• 4.4 Supply/Value 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 & Growth Forecasts (Value, USD)

• 5.1 By Component
  • 5.1.1 Solutions
  • 5.1.2 Services
• 5.2 By Deployment Mode
  • 5.2.1 On-Premises
  • 5.2.2 Cloud-Based
  • 5.2.3 Hybrid
• 5.3 By Security Type
  • 5.3.1 Network and IoMT Security
  • 5.3.2 Endpoint Security
  • 5.3.3 Application Security
  • 5.3.4 Cloud Security
  • 5.3.5 Firmware and Device Integrity Security
• 5.4 By Device Type
  • 5.4.1 Hospital Medical Devices
  • 5.4.2 Internally Embedded Medical Devices
  • 5.4.3 Wearable and External Medical Devices
• 5.5 By End-User
  • 5.5.1 Hospitals and Health Systems
  • 5.5.2 Ambulatory Surgery Centers
  • 5.5.3 Diagnostic and Imaging Centers
  • 5.5.4 Other End-Users
• 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 Japan
    • 5.6.3.3 India
    • 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 for key companies, Products & Services, Recent Developments)
  • 6.3.1 Armis
  • 6.3.2 Asimily
  • 6.3.3 Axonius
  • 6.3.4 Broadcom Inc. (Symantec Enterprise Security)
  • 6.3.5 Check Point Software Technologies Ltd.
  • 6.3.6 Cisco Systems, Inc.
  • 6.3.7 Claroty
  • 6.3.8 Cynerio
  • 6.3.9 Forescout Technologies
  • 6.3.10 Fortinet, Inc.
  • 6.3.11 IBM
  • 6.3.12 Imprivata, Inc.
  • 6.3.13 MedCrypt
  • 6.3.14 Medigate (Claroty)
  • 6.3.15 Microsoft Corporation
  • 6.3.16 Nozomi Networks Inc.
  • 6.3.17 Ordr, Inc.
  • 6.3.18 Palo Alto Networks
  • 6.3.19 Trend Micro Incorporated

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment