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市場調査レポート
商品コード
1642553
医療機器セキュリティの市場レポート:機器タイプ別、コンポーネント別、展開モード別、エンドユーザー別、地域別、2025年~2033年Medical Device Security Market Report by Device Type, Component, Deployment Mode, End User, and Region 2025-2033 |
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医療機器セキュリティの市場レポート:機器タイプ別、コンポーネント別、展開モード別、エンドユーザー別、地域別、2025年~2033年 |
出版日: 2025年01月18日
発行: IMARC
ページ情報: 英文 142 Pages
納期: 2~3営業日
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世界の医療機器セキュリティの市場規模は、2024年に110億米ドルに達しました。今後、IMARC Groupは、同市場が2033年までに322億米ドルに達し、2025年から2033年にかけて12.7%の成長率(CAGR)を示すと予測しています。同市場は、患者データを保護し、機器の改ざんを防止するための高度なセキュリティソリューションの必要性に対する意識の高まり、先端技術の統合、コネクテッド医療機器の採用増加などを背景に、着実な成長を遂げています。
市場の成長と規模市場の成長と規模:ヘルスケア分野におけるデジタル化の進展に加え、サイバーセキュリティの脅威がもたらす影響に対する意識の高まりにより、市場は力強い成長を遂げています。
技術の進歩:高度な暗号化、認証、人工知能(AI)ベースの脅威検知セキュリティ技術の導入が市場の成長を後押ししています。また、セキュアバイデザインの原則は、リスクを先制的に軽減するために医療機器の開発に不可欠なものとなりつつあります。
産業への応用:医療機器セキュリティ・ソリューションは、病院、診療所、在宅医療、遠隔患者監視システムなど、幅広いヘルスケア環境に適用されています。これらのソリューションは、輸液ポンプや診断機器からウェアラブル医療機器まで、幅広い機器を保護します。
地域別動向:北米は高度なヘルスケア・インフラの存在により市場をリードしています。しかし、セキュリティリスクに対する意識の高まりから、アジア太平洋が急成長市場として浮上しています。
競合情勢:主要企業は、設計段階から製品にセキュリティ機能を組み込んでおり、製品の脆弱性に対処するためのセキュリティ・アップデートやパッチを定期的にリリースしています。
課題と機会:市場は、多様な医療機器のセキュリティ確保の複雑さなどの課題に直面する一方で、革新的なセキュリティ・ソリューションという機会にも遭遇しています。
将来の展望:ヘルスケアにおけるサイバーセキュリティの重要性に対する認識が高まっており、医療機器セキュリティ市場の将来は有望です。さらに、患者のセキュリティ強化への注目の高まりが市場成長を促進すると予想されます。
サイバーセキュリティへの懸念の高まり
サイバーセキュリティに対する懸念の高まりから、医療機器のセキュリティに対する需要が高まっており、市場の見通しは明るいです。これに伴い、医療記録のデジタル化が急速に進むとともに、ネットワークに接続された医療機器への依存度が高まり、サイバー脅威に対する脆弱性が高まっていることが、市場の成長に寄与しています。さらに、ヘルスケアデータは非常に貴重であるため、ハッカーの格好の標的となっています。これとは別に、医療分野におけるセキュリティ侵害の潜在的な影響は深刻で、患者データの漏洩から輸液ポンプやペースメーカーなどの重要な医療機器の操作に至るまで、人命を危険にさらします。さらに、ヘルスケア機関は、データ侵害の有害なリスクを軽減するために、暗号化、アクセス制御、侵入検知システム、定期的なセキュリティ監査などの医療機器セキュリティ・ソリューションへの投資を増やしており、これが市場の成長を後押ししています。さらに、潜在的な脅威を迅速に特定し緩和するために、脅威インテリジェンスとプロアクティブなモニタリングの採用が増加していることも、市場の成長を後押ししています。
厳しい規制コンプライアンス
ヘルスケアデータとデバイスのセキュリティを強化するための厳格な規制環境を背景に、医療機器セキュリティへの注目が高まっていることが、市場の成長を後押ししています。加えて、医療機器に保存され送信されるデータなどの患者データを保護するために、各国の行政機関が厳しい規制を実施しており、これが市場の成長を後押ししています。これに加え、これらの規制を遵守しない場合、多額の罰金を含む厳しい罰則が科される可能性があります。さらに、ヘルスケア機関はコンプライアンスを確保するため、安全なデータ保存やトランスミッション、アクセス制御、定期的なセキュリティ評価など、高度なセキュリティ対策の実施に注力しています。これに伴い、いくつかの国の規制機関は、新たな脅威に対処するための要件を継続的に更新しており、セキュリティ・ソリューションと実践への継続的な投資が必要となっています。さらに、コンプライアンスを遵守することで、法的な影響を回避できるだけでなく、機密性の高い医療情報を保護することで、患者からの信頼も得ることができます。
先端技術の統合
医療機器は、ワイヤレス接続、遠隔モニタリング、データ共有機能などの機能を組み込むことで、ますます高度化しています。技術の進歩は、患者の治療やケアに多大な恩恵をもたらしますが、同時に新たな脆弱性ももたらします。さらに、ハッカーはこうした脆弱性を悪用して医療機器に不正アクセスし、患者に危害を加える可能性もあります。これとは別に、さまざまな医療機器を保護するための高度なセキュリティ技術に対するニーズの高まりが、市場の成長に寄与しています。さらに、通信チャネルの保護や暗号化・認証方法による機器の完全性の確保など、医療機器向けに特別に設計されたセキュリティ・プロトコルの開発が進んでいることも、市場の成長を支えています。さらに、人工知能(AI)と機械学習(ML)を医療機器セキュリティ・ソリューションに統合することで、脅威のリアルタイム検知と対応が可能になります。また、進化するサイバー脅威からの医療機器の保護を強化し、市場の成長を強化しています。
The global medical device security market size reached USD 11.0 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 32.2 Billion by 2033, exhibiting a growth rate (CAGR) of 12.7% during 2025-2033. The market is experiencing steady growth driven by the increasing awareness about the need for advanced security solutions to protect patient data and prevent device tampering, integration of advanced technologies, and the rising adoption of connected medical devices.
Market Growth and Size: The market is witnessing robust growth, driven by the increasing awareness about the impacts of cybersecurity threats, along with rising digitalization in the healthcare sector.
Technological Advancements: The introduction of advanced encryption, authentication, and artificial intelligence (AI)-based threat detection security technologies is bolstering the market growth. In addition, secure-by-design principles are becoming integral to the development of medical devices to preemptively mitigate risks.
Industry Applications: Medical device security solutions are applied across a broad spectrum of healthcare settings, including hospitals, clinics, home healthcare, and remote patient monitoring systems. These solutions protect a wide range of devices, ranging from infusion pumps and diagnostic equipment to wearable health devices.
Geographical Trends: North America leads the market, driven by the presence of advanced healthcare infrastructure. However, Asia Pacific is emerging as a fast-growing market on account of the increasing awareness about security risks.
Competitive Landscape: Key players are incorporating security features into their products from the design stage and are regularly releasing security updates and patches to address vulnerabilities in their products.
Challenges and Opportunities: While the market faces challenges, such as the complexity of securing diverse medical devices, it also encounters opportunities in innovative security solutions.
Future Outlook: The future of the medical device security market looks promising, with the increasing awareness about the importance of cybersecurity in healthcare. Moreover, the rising focus on enhanced patient security is expected to propel the market growth.
Increasing cybersecurity concerns
The growing demand for medical device security on account of the increasing cybersecurity concerns is offering a positive market outlook. In line with this, rapid digitization of healthcare records, along with the rising reliance on network-connected medical devices causes more vulnerability to cyber threats, is contributing to the growth of the market. Moreover, healthcare data is highly valuable, making it a prime target for hackers. Apart from this, the potential consequences of a security breach in the medical sector are severe, ranging from the compromise of patient data to the manipulation of critical medical devices like infusion pumps and pacemakers, endangering lives. Furthermore, healthcare organizations are increasingly investing in medical device security solutions, such as encryption, access control, intrusion detection systems, and regular security audits, to mitigate the adverse risks of data breaches, which is bolstering the market growth. In addition, the increasing adoption of threat intelligence and proactive monitoring to identify and mitigate potential threats promptly is propelling the market growth.
Stringent regulatory compliance
The rising focus on medical device security on account of the stringent regulatory environment to enhance healthcare data and device security is impelling the growth of the market. In addition, governing agencies of numerous countries are implementing stringent regulations to protect patient data, such as data stored on and transmitted by medical devices, which is bolstering the market growth. Besides this, non-compliance with these regulations can result in severe penalties, including substantial fines. Additionally, healthcare organizations are focusing on implementing advanced security measures, such as secure data storage and transmission, access controls, and regular security assessments, to ensure compliance. In line with this, regulatory bodies of several countries are continuously updating their requirements to address emerging threats and necessitating ongoing investment in security solutions and practices. Furthermore, compliance not only avoids legal consequences but also encourages trust among patients by safeguarding sensitive medical information.
Integration of advanced technologies
Medical devices are becoming increasingly advanced by incorporating features like wireless connectivity, remote monitoring, and data sharing capabilities. Technological advancements offer substantial benefits in terms of patient care and treatment but also introduce new vulnerabilities. Moreover, hackers can exploit these vulnerabilities to gain unauthorized access to medical devices, potentially causing harm to patients. Apart from this, the rising need for advanced security technologies to protect various medical devices is contributing to the growth of the market. Furthermore, the increasing development of security protocols specifically designed for medical devices, such as securing communication channels and ensuring device integrity through encryption and authentication methods, is supporting the market growth. Additionally, the integration of artificial intelligence (AI) and machine learning (ML) into medical device security solutions assists in enabling real-time threat detection and response. It also enhances the protection of medical devices from evolving cyber threats, which is strengthening the market growth.
Stationery Medical Devices
Internally Embedded Medical Devices
External Medical Devices and Consumer Wearable
Stationery medical devices account for the majority of the market share
Stationery medical devices are usually non-mobile and fixed in healthcare facilities, such as hospitals and clinics. They comprise x-ray machines, magnetic resonance imaging (MRI) scanners, and laboratory equipment. In addition, security measures for stationary devices focus on access control, data encryption, and network security to prevent unauthorized access to patient data and device manipulation, which is bolstering the market growth.
Internally embedded medical devices encompass pacemakers, insulin pumps, and neurostimulators, that are implanted within the body of the patient for therapeutic or diagnostic purposes. Security for these devices is concerned, as any compromise can have life-threatening consequences. Protection often involves encryption of data communication between the device and external equipment, secure remote monitoring, and stringent authentication measures. The rising focus on securing firmware and software updates to address vulnerabilities is impelling the market growth.
External medical devices and consumer wearable involve infusion pumps, ventilators, glucose monitors, fitness trackers, and smartwatches. In addition, the rising focus on preventing tampering with device settings or unauthorized access to patient data is supporting the market growth. Security focuses on protecting personal health data from breaches and ensuring data accuracy. User authentication and data encryption are essential, as these devices often sync data to cloud services. Moreover, there is an increase in privacy concerns and adherence to data protection regulations.
Solution
Identity and Access Management Solutions
Antivirus and Antimalware Solutions
Encryption Solutions
Data Loss Prevention Solutions
Risk and Compliance Management
Intrusion Detection Systems and Intrusion Prevention Systems
Disaster Recovery Solutions
Distributed Denial of Service Solutions
Others
Services
Solution holds the largest share
Solution are software and hardware products designed to protect medical devices and the data they handle from cybersecurity threats. These solutions encompass a wide range of technologies and tools aimed at securing medical devices, networks, and data. In addition, encryption solutions secure data in transit and at rest, ensuring that patient information remains confidential. Apart from this, intrusion prevention systems assist in preventing unauthorized access to medical devices and networks by monitoring and blocking suspicious activities, which is impelling the market growth.
Services complement security solutions and provide expertise, support, and consulting to healthcare organizations. These services assist healthcare providers in implementing and maintaining effective security measures. Besides this, medical device security services are crucial for healthcare organizations to assess, implement, and maintain effective security strategies and respond effectively to evolving threats. Furthermore, the rising focus on outsourcing security monitoring and management to specialized providers is strengthening the growth of the market.
On-premises
Cloud-based
On-premises represent the leading market segment
On-premises are the installation and operation of medical device security solutions within the physical infrastructure of a healthcare facility or organization. Healthcare organizations have full control over the hardware, software, and data security within their premises. In addition, on-premises solutions often offer low-latency access to medical devices and data due to their proximity. Apart from this, sensitive patient data remains within the own data center of the organization, which assists in enhancing data privacy and compliance with regulations.
Cloud-based involves the use of remote servers and data centers provided by third-party cloud service providers to host medical device security solutions. Besides this, cloud solutions offer scalability on-demand, allowing healthcare organizations to adjust resources as needed without large upfront investments. Authorized users can access medical device security solutions and data from anywhere with an internet connection. Furthermore, cloud providers offer managed services, such as updates, maintenance, and security patches.
Healthcare Institutions
Medical Device Manufacturers
Others
Healthcare institutions exhibits a clear dominance in the market
Healthcare institutions encompass hospitals, clinics, long-term care facilities, home healthcare, and rehabilitation centers. Hospitals encompass various medical specialties, departments, and units. In addition, hospitals ensure the security of medical devices to protect patient data and deliver quality care. Moreover, clinics, including outpatient and specialized clinics, rely on medical devices for diagnostics and treatment. Secure medical device usage is essential to maintain patient trust. Furthermore, nursing homes and long-term care facilities utilize medical devices for patient monitoring and care.
Medical device manufacturers are responsible for ensuring the security of their products. They design and produce devices with built-in security features, regularly issue security updates, and collaborate with healthcare institutions to address vulnerabilities. In line with this, companies that provide software and hardware solutions for securing medical devices partner with manufacturers and healthcare institutions to offer comprehensive security solutions. They may offer services, such as threat assessments, security consulting, and ongoing monitoring.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America leads the market, accounting for the largest medical device security market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share due to the rising focus on protecting patient data and medical devices. In line with this, North America has a developed healthcare infrastructure, with a large number of hospitals, clinics, research institutions, and long-term care facilities. Moreover, the increasing awareness among healthcare facilities about the importance of medical device security is propelling the growth of the market in the region.
Asia Pacific stands as another key region in the market, driven by rapid digitalization and interconnected healthcare systems. In addition, the rising number of cybersecurity threats in medical devices is supporting the market growth. The increasing awareness about the importance of medical device security solutions to protect patient data is impelling the market growth.
Europe maintains a strong presence in the market, with the rising adoption of advanced security solutions in medical devices. In line with this, Europe has a highly developed healthcare infrastructure with advanced medical facilities and research institutions. Furthermore, the stringent regulatory framework for medical devices and data security is contributing to the growth of the market in Europe.
Latin America exhibits growing potential in the medical device security market on account of the increasing need for security solutions to prevent financial losses and enhance patient trust. Apart from this, the growing awareness of cybersecurity risks, along with the rapid digitalization of healthcare systems, is offering a positive market outlook in the region.
The Middle East and Africa region shows a developing market for medical device security, primarily driven by the rising adoption of advanced medical devices. In addition, healthcare organizations in the region are understanding the importance of securing medical devices to protect patient data and ensure the integrity of healthcare services. Some countries in the Middle East and Africa are developing and enhancing healthcare cybersecurity regulations, which is bolstering the market growth.
Key players in the market are investing in research and development (R&D) activities to develop advanced security technologies specifically tailored as per medical devices, such as encryption methods, authentication mechanisms, and intrusion detection systems. In line with this, medical device manufacturers are incorporating security features into their products from the design stage. Furthermore, companies are regularly releasing security updates and patches to address vulnerabilities in their products. This proactive approach helps in keeping medical devices secure. Besides this, manufacturers are collaborating with healthcare institutions, including hospitals, clinics, and other healthcare organizations, to understand their specific security needs and offer tailored solutions.
The market research report has provided a comprehensive analysis of the competitive landscape. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:
Check Point Software Technologies Ltd.
Cisco Systems Inc.
ClearDATA
FireEye (Symphony Technology Group)
Fortinet Inc.
General Electric Company
International Business Machines Corporation
Koninklijke Philips N.V.
McAfee Corp.
Medigate
Palo Alto Networks Inc.
Synopsys Inc.