세계의 인공지능(AI) 구동형 의료기기 감시 플랫폼 시장 보고서(2025년)
Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Global Market Report 2025
상품코드 : 1877498
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

인공지능(AI) 구동형 의료기기 감시 플랫폼 시장 규모는 최근 급격히 확대되고 있습니다. 2024년의 16억 4,000만 달러에서 2025년에는 20억 2,000만 달러로 성장하고, CAGR23.1%를 나타낼 것으로 전망되고 있습니다. 이러한 성장은 첨단 모니터링을 필요로 하는 복잡한 의료기기의 보급 확대, 신속한 규제 보고 및 컴플라이언스에 대한 수요 증가, 장비 모니터링에서 빅 데이터와 실세계 데이터 활용 확대, 상호 운용 가능한 모니터링 시스템에 대한 요구 증가, 환자 중심 모니터링 모델에 대한 중시 강화 등의 요인에 기인하고 있습니다.

인공지능(AI) 구동형 의료기기 감시 플랫폼 시장 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년에는 45억 8,000만 달러에 달하며 CAGR은 22.7%로 예측됩니다. 예측 기간 성장 촉진요인으로는 상호 운용 가능한 감시 플랫폼 개발을 목적으로 한 제휴 관계 증가, 신속하고 정확한 의료기기 성능 평가에 대한 수요 증가, 부작용 보고에 있어서의 인적 미스 최소화에 대한 주목의 높아짐, 비용 효율적으로 뛰어난 확장성이 있는 AI 구동형 감시 시스템의 필요성 증대, AI 기반 지식에 의한 환자 결과 개선에 중점 강화 예측 기간 동안 예상되는 주요 동향으로는 의료기기의 안전 모니터링에 있어서 실시간 데이터 분석의 진보, 예측 리스크 평가를 위한 AI 알고리즘의 통합 강화, 유해 이벤트 검출을 위한 생성형 AI 용도의 혁신, 자동화된 보고 분석을 위한 자연 언어 처리의 채용, 원격 모니터링을 위한 클라우드 기반의 안전 감시 플랫폼의 진보 등이 있습니다.

의료비 증가는 향후 수년간 인공지능(AI) 구동형 의료기기 감시 플랫폼 시장의 성장을 가속할 것으로 예측됩니다. 의료 지출이란, 건강의 유지·향상을 목적으로 한 서비스나 시책에 대한 개인, 조직, 정부에 의한 총 지출을 가리킵니다. 만성 질환이 증가함에 따라 지속적인 치료, 장기 치료 및 고급 관리 자원이 필요하기 때문에 이 지출은 증가하는 경향이 있습니다. 의료비 증가는 병원과 의료 제공업체에게 종합적인 안전 감시 시스템을 도입하는 재정적 여유를 가져오고, 규제 준수와 환자 보호 강화를 실현함으로써 AI 구동형 의료기기 감시 플랫폼을 지원하고 있습니다. 예를 들어 영국 정부 기관인 국가 통계국(ONS)에 따르면 2025년 4월 시점에서 정부 자금에 의한 의료가 의료 지출의 대부분을 차지하고, 2024년에는 3,440억 달러(2,580억 파운드)에 이르렀으며, 2023년 대비 실질 2.5% 증가했습니다. 따라서 의료 지출 증가는 인공지능(AI) 구동형 의료기기 감시 플랫폼 시장의 성장에 기여하고 있습니다.

또한 예측 기간 동안 인공지능(AI) 구동형 의료기기 감시 플랫폼 시장의 성장을 뒷받침할 것으로 전망되는 것이 임상조사 확대입니다. 임상 연구의 확대는 의학 지식의 발전과 환자 결과 개선을 목적으로 임상시험, 연구시설 및 전용 자원 증가를 의미합니다. 이 성장은 공공·민간 투자 증가에 의해 추진되고 있으며, 보다 많은 연구의 실시 능력 강화, 조사 방법의 효율화, 혁신적 치료에의 액세스 확대로 이어지고 있습니다. 임상조사 확대는 의료기관과 연구기관에 견고한 감시 시스템 구축, 규제 준수 확보, 환자 안전 향상에 필요한 인프라와 자금을 제공함으로써 AI 구동형 의료기기 감시 플랫폼을 지원합니다. 예를 들어, 2024년 12월 영국 정부는 영국, 스코틀랜드, 웨일즈, 북아일랜드에 20개의 새로운 상업 조사 실시 센터를 설립하기 위해 1억 3,400만 달러(1억 파운드)의 투자를 발표했습니다. 이 노력은 환자의 임상시험에 대한 접근성을 개선하고 연구 승인을 가속화하기 위한 것입니다. 따라서 임상연구의 확대는 인공지능(AI) 구동형 의료기기 감시 플랫폼 시장의 성장을 가속하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁과 관세, 그리고 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별/국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

KTH
영문 목차

영문목차

An artificial intelligence-driven medical device vigilance platform is a technology-based system that utilizes AI tools to monitor and assess the safety performance of medical devices. It employs machine learning and data analytics to process large volumes of information, identify potential safety issues, and detect early indicators of device-related risks.

The primary components of artificial intelligence-driven medical device vigilance platforms include software, hardware, and services. Software consists of programs and applications that enable computers and devices to execute specific functions. These platforms can be deployed on-premises or through cloud-based systems and are used for applications such as adverse event detection, regulatory compliance, risk management, data analytics, and others. They serve various end-users, including hospitals, medical device manufacturers, regulatory authorities, contract research organizations, and others.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

The artificial intelligence (AI)-driven medical device vigilance platform market research report is one of a series of new reports from The Business Research Company that provides artificial intelligence (AI)-driven medical device vigilance platform market statistics, including artificial intelligence (AI)-driven medical device vigilance platform industry global market size, regional shares, competitors with a artificial intelligence (AI)-driven medical device vigilance platform market share, detailed artificial intelligence (AI)-driven medical device vigilance platform market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence (AI)-driven medical device vigilance platform industry. This artificial intelligence (AI)-driven medical device vigilance platform market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The artificial intelligence (AI)-driven medical device vigilance platform market size has grown exponentially in recent years. It will grow from $1.64 billion in 2024 to $2.02 billion in 2025 at a compound annual growth rate (CAGR) of 23.1%. The growth during the historic period can be attributed to the increasing prevalence of complex medical devices requiring advanced vigilance, rising demand for faster regulatory reporting and compliance, expanding use of big data and real-world evidence in device monitoring, growing need for interoperable vigilance systems, and the increasing emphasis on patient-centric surveillance models.

The artificial intelligence (AI)-driven medical device vigilance platform market size is expected to see exponential growth in the next few years. It will grow to $4.58 billion in 2029 at a compound annual growth rate (CAGR) of 22.7%. The growth in the forecast period can be attributed to the rising number of partnerships aimed at developing interoperable vigilance platforms, increasing demand for faster and more accurate device performance evaluation, growing focus on minimizing manual errors in adverse event reporting, increasing need for cost-effective and scalable AI-driven vigilance systems, and greater emphasis on improving patient outcomes through AI-based insights. Major trends expected during the forecast period include advancements in real-time data analytics for device safety monitoring, enhanced integration of AI algorithms for predictive risk assessment, innovation in generative AI applications for adverse event detection, adoption of natural language processing for automated report analysis, and the advancement of cloud-based vigilance platforms for remote monitoring.

The rising healthcare expenditure is anticipated to drive the growth of the artificial intelligence-driven medical device vigilance platform market in the coming years. Healthcare expenditure represents the total spending by individuals, organizations, and governments on services and initiatives aimed at maintaining or improving health. This expenditure is increasing due to the growing prevalence of chronic diseases, which demand continuous care, long-term treatment, and advanced management resources. Rising healthcare spending supports AI-driven medical device vigilance platforms by providing hospitals and healthcare providers with the financial capacity to adopt comprehensive safety and monitoring systems, ensuring regulatory compliance and enhanced patient protection. For instance, in April 2025, according to the Office for National Statistics, a government agency based in the United Kingdom, government-funded healthcare accounted for the majority of healthcare expenditure, reaching $344 billion (£258 billion) in 2024, an increase of 2.5% in real terms compared to 2023. Therefore, the increase in healthcare expenditure is contributing to the growth of the artificial intelligence-driven medical device vigilance platform market.

The expansion of clinical research is also expected to support the growth of the artificial intelligence-driven medical device vigilance platform market during the forecast period. Clinical research expansion refers to the growing number of clinical trials, research facilities, and resources dedicated to advancing medical knowledge and improving patient outcomes. This growth is driven by increased public and private investments, which strengthen the ability to conduct more studies, streamline research processes, and expand access to innovative treatments. The expansion of clinical research supports AI-driven medical device vigilance platforms by providing healthcare organizations and research institutions with the infrastructure and funding needed to establish robust monitoring systems, ensure compliance with regulations, and enhance patient safety. For example, in December 2024, the United Kingdom government announced a $134 million (£100 million) investment to create 20 new commercial research delivery centers across England, Scotland, Wales, and Northern Ireland. This initiative aims to improve patient access to clinical trials and accelerate research approvals. Therefore, the expansion of clinical research is driving the growth of the artificial intelligence-driven medical device vigilance platform market.

Leading companies in the artificial intelligence-driven medical device vigilance platform market are focusing on developing advanced solutions such as post-market device surveillance platforms to provide actionable insights that improve patient safety and optimize device performance. Post-market device surveillance platforms are designed to monitor and evaluate the safety and performance of medical devices after they are deployed in healthcare environments. For example, in October 2025, Basil Systems, a US-based company specializing in AI-powered platforms, introduced the MedTech Safety Signaling platform. This platform utilizes artificial intelligence to detect potential safety risks early, shifting post-market surveillance toward a proactive safety management approach. It processes regulatory filings, inspection reports, and adverse event narratives using large language models trained on comprehensive industry datasets to uncover patterns that are difficult to identify manually. The system organizes and interprets this data by linking related events to their original sources with confidence levels, enabling manufacturers to identify safety trends, strengthen preventive measures, anticipate regulatory scrutiny, and guide product development decisions.

Major players in the artificial intelligence (AI)-driven medical device vigilance platform market are Amazon Web Services Inc., Johnson & Johnson Services Inc., International Business Machines Corporation, Oracle Corporation, Abbott Laboratories, Medtronic Plc, Siemens Healthineers AG, Stryker Corporation, Koninklijke Philips N.V., GE HealthCare Technologies Inc., Cognizant Technology Solutions Corporation, Boston Scientific Corporation, DXC TECHNOLOGY COMPANY, Baxter International Inc., Wipro Limited, Zimmer Biomet Holdings Inc., Veeva Systems Inc., Medidata Solutions Inc., Tata Consultancy Services Limited, and AssurX Inc.

North America was the largest region in the artificial intelligence (AI)-driven medical device vigilance platform market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in artificial intelligence (AI)-driven medical device vigilance platform report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the artificial intelligence (AI)-driven medical device vigilance platform market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The artificial intelligence (AI)-driven medical device vigilance platform market consists of revenues earned by entities by providing services such as post-market surveillance management, real-world data integration, data cleaning and normalization, safety signal prioritization, and compliance monitoring. The market value includes the value of related goods sold by the service provider or included within the service offering. The artificial intelligence (AI)-driven medical device vigilance platform market also includes sales of data storage appliances, secure enclosures, portable monitoring units, and redundant power systems. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on artificial intelligence (ai)-driven medical device vigilance platform market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for artificial intelligence (ai)-driven medical device vigilance platform ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The artificial intelligence (ai)-driven medical device vigilance platform market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market Characteristics

3. Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market Trends And Strategies

4. Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Growth Analysis And Strategic Analysis Framework

6. Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market Segmentation

7. Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market Regional And Country Analysis

8. Asia-Pacific Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

9. China Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

10. India Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

11. Japan Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

12. Australia Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

13. Indonesia Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

14. South Korea Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

15. Western Europe Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

16. UK Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

17. Germany Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

18. France Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

19. Italy Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

20. Spain Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

21. Eastern Europe Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

22. Russia Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

23. North America Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

24. USA Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

25. Canada Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

26. South America Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

27. Brazil Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

28. Middle East Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

29. Africa Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

30. Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market Competitive Landscape And Company Profiles

31. Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market Other Major And Innovative Companies

32. Global Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

34. Recent Developments In The Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market

35. Artificial Intelligence (AI)-Driven Medical Device Vigilance Platform Market High Potential Countries, Segments and Strategies

36. Appendix

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