Medical Device Security Market

Market Definition

The market encompasses solutions designed to protect medical devices from cybersecurity threats and vulnerabilities. It includes hardware, software, and services such as encryption, access control, threat detection, and risk management. This market covers medical imaging systems, implantable devices, monitoring equipment, and hospital networks. 

The report outlines the primary drivers of market growth, along with an in-depth analysis of emerging trends and evolving regulatory frameworks shaping the industry in the forecast period.

Medical Device Security Market Overview

The global medical device security market size was valued at USD 8.44 billion in 2024 and is projected to grow from USD 9.11 billion in 2025 to USD 16.52 billion by 2032, exhibiting a CAGR of 8.60% during the forecast period. 

The increasing digitization of healthcare and the rise of connected medical technologies are driving the demand for advanced cybersecurity solutions. Healthcare organizations are actively investing in threat detection and protection systems to comply with regulatory requirements and safeguard devices against evolving cyber threats.

Major companies operating in the medical device security industry are Medcrypt., Cisco Systems, Inc, GE HealthCare., Koninklijke Philips N.V., Armis Inc., Kudelski Group., Forescout, SGS Société Générale de Surveillance SA., Cybellum, KPMG LLP, IBM, Palo Alto Networks., Zscaler, Inc., Sophos Ltd., and Imperva.

The rising frequency of cyberattacks targeting healthcare infrastructure is increasing the demand for advanced medical device security solutions. Moreover, regulatory mandates enforcing stringent data protection and patient safety protocols are further driving the adoption of robust cybersecurity measures. 

Integration of connected medical devices within healthcare ecosystems is increasing vulnerability, prompting healthcare providers to prioritize comprehensive security frameworks, thereby accelerating market expansion.

Key Highlights:

1. The medical device security market size was recorded at USD 8.44 billion in 2024.
2. The market is projected to grow at a CAGR of 8.60% from 2025 to 2032.
3. North America held a market share of 34.07% in 2024, with a valuation of USD 2.88 billion.
4. The solution segment garnered USD 5.21 billion in revenue in 2024.
5. The hospital-based segment is expected to reach USD 6.89 billion by 2032.
6. The on-premise segment secured the largest revenue share of 59.81% in 2024.
7. The endpoint security is poised for a robust CAGR of 9.08% through the forecast period.
8. The medical device manufacturers segment is expected to reach USD 6.17 billion by 2032.
9. Asia Pacific is anticipated to grow at a CAGR of 9.51% during the forecast period.

Market Driver

Rising Healthcare Expenditure and Digital Transformation

The global market is driven by increasing healthcare spending and the rapid digitalization of medical infrastructure. The widespread deployment of connected technologies and integration of IoT and AI into medical devices are expanding the attack surface, making devices more susceptible to cybersecurity threats. 

This shift has prompted healthcare providers, manufacturers, and regulatory bodies to adopt more robust security frameworks. As a result, there is a growing focus on implementing advanced cybersecurity protocols to ensure data integrity, device functionality, and patient safety, thereby driving the growth of the market.

• In April 2025, the American Medical Association reported that U.S. health spending rose by 7.5% in 2023, reaching USD 4.9 trillion, or USD 14,570 per person. Overall, healthcare expenditures accounted for 17.6% of the nation’s GDP in 2023.

Market Challenge

Securing Legacy Medical Devices Amid Complex IT Integration

 The global medical device security market is increasingly challenged by the complexities of integrating legacy systems with contemporary IT infrastructures. Many healthcare providers continue to operate outdated medical devices that lack fundamental security capabilities, posing significant risks to patient safety and data integrity. 

In response, manufacturers are advancing retrofit solutions and secure communication protocols to improve interoperability without compromising device performance. Additionally, they are prioritizing scalable software updates and modular architectures to enhance long-term adaptability. 

These initiatives are focused on enabling seamless system integration, minimizing operational vulnerabilities, and ensuring compliance with stringent regulatory standards, thereby supporting the adoption of secure and resilient medical technologies.

Market Trend

Enhanced Threat Detection Integration

 A key trend in the market is the increased implementation of advanced threat detection technologies designed to identify and neutralize cyber risks in real time. These solutions support a shift from reactive to proactive cybersecurity, aligning with evolving regulatory demands and addressing the growing complexity of cyber threats targeting healthcare systems.

• In March 2024, Claroty announced the Advanced Anomaly Threat Detection (ATD) Module within its Medigate Platform at HIMSS24. It aims to provide healthcare organizations with clinical context to identify and prioritize threats to connected medical devices, IoT, and building systems through agentless detection, deep network visibility, and continuous compliance monitoring.

Medical Device Security Market Report Snapshot

Segmentation	Details
By Component	Solution (Identity & access management (IAM), Antivirus/Antimalware, Encryption, Distributed denial of service (DDoS), Intrusion detection system/Intrusion prevention system (IDS/IPS), Data loss prevention (DLP), Risk & compliance management, Disaster recovery), Services
By Device	Hospital-based, Internally embedded, Wearable & external
By Deployment	Cloud-based, On-premise
By Type	Network Security, Endpoint Security, Application Security, Cloud Security
By End Use	Healthcare providers, Medical device manufacturers, Healthcare payers
By Region	North America: U.S., Canada, Mexico
	Europe: France, UK, Spain, Germany, Italy, Russia, Rest of Europe
	Asia-Pacific: China, Japan, India, Australia, ASEAN, South Korea, Rest of Asia-Pacific
	Middle East & Africa: Turkey, U.A.E., Saudi Arabia, South Africa, Rest of Middle East & Africa
	South America: Brazil, Argentina, Rest of South America

Market Segmentation:

• By Component (Solution, Services): The solution segment earned USD 5.21 billion in 2024 due to the growing demand for advanced cybersecurity solutions that can proactively protect connected medical devices from increasingly sophisticated cyber threats.
• By Device (Hospital-based, Internally embedded, Wearable & external): The hospital-based segment held 42.13% of the market in 2024, due to the rising adoption of connected medical devices, which require tailored security measures to address device-specific vulnerabilities and ensure patient safety.
• By Deployment (Cloud-based, On-premise): The on-premise segment is projected to reach USD 71 billion by 2032, owing to the preference of healthcare organizations for greater control, data privacy, and customized security infrastructure within their own facilities.
• By Type (Network Security, Endpoint Security, Application Security, Cloud Security): The network security segment earned USD 2.37 billion in 2024 due to the increasing need to protect interconnected medical devices and systems from unauthorized access, data breaches, and network-based cyber threats.
• By End Use (Healthcare Providers, Medical Device Manufacturers, Healthcare Payers): The medical device manufacturers segment held 37.70% of the market in 2024, due to the growing responsibility to embed robust cybersecurity features during the design and development phase to comply with regulatory standards and ensure device integrity.

Medical Device Security Market Regional Analysis

Based on region, the global market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and South America.

The North America medical device security market share stood around 34.07% in 2024 in the global market, with a valuation of USD 2.88 billion. This dominance is attributed to the extensive adoption of advanced healthcare technologies and robust digital infrastructure across North America. 

The region’s well-established healthcare ecosystem prioritizes patient safety and regulatory compliance, driving demand for sophisticated security solutions. Additionally, significant investments in healthcare IT and increasing cyber threats drive healthcare providers to implement comprehensive medical device security measures. These factors are driving the market in this region.

Asia Pacific is poised for significant growth at a CAGR of 9.51% over the forecast period. The growth is  propelled by the swift development and modernization of healthcare infrastructure, which includes the establishment of new hospitals, clinics, and diagnostic centers equipped with advanced medical technologies. 

This expansion increases the volume and complexity of connected devices, thereby intensifying the need for robust security measures. Coupled with stringent regulatory frameworks and a rising incidence of cyber-attacks, this growth is further supported by accelerated digitization and government initiatives aimed at enhancing patient data protection. 

Moreover, the widespread adoption of mobile health applications and telemedicine platforms has heightened vulnerability concerns, prompting healthcare providers to implement advanced encryption, authentication, and comprehensive risk management strategies to secure their operations.

Regulatory Frameworks

• In the U.S., the Food and Drug Administration (FDA) mandates cybersecurity integration in medical devices through its 2023 guidance and QSR (21 CFR 820), requiring SBOMs, threat modeling, and update plans.
• In China, the NMPA regulates medical device cybersecurity through 2021 guidelines outlining premarket and postmarket requirements, including SBOM, risk assessment, and update plans. MLPS 2.0 mandates cybersecurity controls for networked devices, requiring data protection, encryption, and continuous threat monitoring across healthcare systems and medical technologies.

Competitive Landscape

The competitive landscape of the medical device security market features key players actively expanding their product portfolios and incorporating advanced threat detection solutions to tackle cyber risks in connected medical environments. 

Market participants are engaging in collaborations, mergers, and innovations as strategic approaches to enhance their offerings and solidify market presence. These efforts contribute to heightened competition and support wider availability of secure healthcare systems across diverse regions globally.

• In March 2024, Cynerio expanded its Healthcare Cybersecurity Platform to protect patient data and fight rising cyber threats. The expansion includes enhanced Patient Data Security solutions designed to safeguard electronic Protected Health Information (ePHI) across hospital networks. Additionally, the platform now offers Complete Asset Visibility, which automates the identification and tracking of all connected medical devices in real-time.

List of Key Companies in Medical Device Security Market:

• Medcrypt.
• Cisco Systems, Inc
• GE HealthCare.
• Koninklijke Philips N.V.
• Armis Inc.
• Kudelski Group.
• Forescout
• SGS Société Générale de Surveillance SA.
• Cybellum
• KPMG LLP
• IBM
• Palo Alto Networks.
• Zscaler, Inc.
• Sophos Ltd.
• Imperva.

Recent Developments (Product Launch)

•  In June 2024, Ascensia achieved a significant milestone by having its medical devices certified under the IEEE Medical Device Cybersecurity Certification Program. This certification, based on the rigorous international IEEE 2621 standard, was awarded following thorough evaluations conducted by authorized third-party laboratories, including atsec’s recognized test facilities in Sweden, Germany, and the United States. By securing this certification, Ascensia demonstrates its commitment to ensuring the highest standards of cybersecurity in its medical devices.
• In January 2024, Document Storage Systems, Inc. (DSS) announced the integration of cybersecurity solutions from PFP Cybersecurity (PFP) into its product portfolio. Through this integration, DSS aims to enhance the security of connected devices within healthcare environments. The company will provide PFP’s device credentialing tools to federal healthcare clients, including the Department of Veterans Affairs (VA) and Defense Health.