시장보고서 | 연간정보서비스 | 맞춤형시장조사 | 메일링 | 비교리스트
세계의 의료기기 감시 시장 보고서(2025년)
Medical Devices Vigilance Global Market Report 2025
상품코드 : 1693252
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 200 Pages
 라이선스 & 가격 (부가세 별도)
US $ 4,490 ￦ 6,496,000
PDF (Single User License) help
PDF 보고서를 1명만 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 6,490 ￦ 9,390,000
PDF (Site License) help
PDF 보고서를 동일 사업장의 모든 분이 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 8,490 ￦ 12,284,000
PDF (Enterprise License) help
PDF 보고서를 동일 기업의 모든 분이 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.


ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
ㅁ 보고서에 따라 최신 정보로 업데이트하여 보내드립니다. 배송기일은 문의해 주시기 바랍니다.

한글목차

의료기기 감시 시장 규모는 향후 몇 년 동안 강력한 성장세를 보일 것으로 예상되며, 2029년까지 8.9%의 CAGR로 1,376억 1,000만 달러 규모로 성장할 것으로 예상됩니다. 예측 기간 동안의 성장은 의료기기 리콜 시스템 출시 증가, 의료기기 시판 후 조사 프로그램 증가, 부작용 보고 증가, 치료제 및 수술에 대한 수요 증가, 환자 안전 규제와 관련된 복잡성 증가 등에 기인합니다. 예측 기간의 주요 동향으로는 기술 발전, 국제의료기기규제포럼(IMDRF) 프레임워크, 국경을 초월한 안전성 정보 교환 강화, 원격 환자 모니터링 기기, 3D 프린팅, 맞춤형 기기 등을 들 수 있습니다.

의료 리콜 건수의 증가는 향후 의료기기 모니터링 시장의 성장을 촉진할 것으로 예상됩니다. 의료 리콜은 규제 당국, 제조업체 또는 유통업체가 공중 보건에 위험을 초래하거나 규제 기준을 준수하지 않는 의료 제품을 제거하거나 수정하기 위해 취하는 조치를 말합니다. 의료기기 모니터링은 시중에 유통되는 의료기기를 지속적으로 모니터링하여 부작용, 결함, 안전성 문제를 확인하고, 이를 규제 당국에 보고하여 추가 조사 및 정당한 사유가 있는 경우 제품 회수로 이어질 수 있습니다. 예를 들어, 2022년 12월 미국 연방정부 기관인 식품의약국(FDA)은 의료기기 리콜이 증가하여 2022년에는 442건의 리콜이 기록되어 2021년 331건보다 약 10% 증가했다고 밝혔습니다. 따라서 의료 리콜 건수의 증가는 의료기기 경보 시장의 성장을 촉진하고 있습니다.

의료기기 감시 시장에서 활동하는 주요 기업들은 고객 만족도를 높이기 위해 품질 관리 소프트웨어와 같은 혁신적인 제품을 개발하고 있습니다. 품질 관리 소프트웨어(QMS)는 품질 정책과 목표를 달성하기 위한 프로세스, 절차, 책임을 문서화한 공식적인 시스템입니다. 예를 들어, 2022년 12월, 미국에 본사를 둔 의료기기 기업에 시스템 및 소프트웨어를 제공하는 Greenlight Guru사는 의료기기 기업의 프로세스 현대화, 임상시험 시간 단축, 보다 안전한 제품의 빠른 시장 출시를 돕기 위해 설계된 QMS 소프트웨어를 발표했습니다. Greenlight Guru의 소프트웨어는 FDA 및 ISO 모범 사례에 따라 사전 검증되었으며, 기업이 끊임없이 변화하는 표준을 준수할 수 있도록 돕습니다. 또한, 제품 개발, 품질, 규제 보증 분야의 경력을 쌓을 수 있도록 교육 및 인증도 제공하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 - 금리, 인플레이션, 지정학, 코로나, 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 개요

제31장 기타 주요 기업과 혁신적 기업

제32장 세계의 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병

제34장 최근의 시장 동향

제35장 시장 잠재력이 높은 국가, 부문, 전략

제36장 부록

ksm
영문 목차

영문목차

Medical device vigilance refers to monitoring and reporting adverse events or incidents related to the use of medical devices. It is a critical component of post-market surveillance to ensure the safety and effectiveness of medical devices throughout their lifecycle. It identifies and addresses potential risks associated with medical devices, ensures patient safety, and maintains public trust in the healthcare system.

The main delivery modes of medical devices vigilance are on-demand and on-premise. On-demand medical device vigilance delivery mode refers to a system or approach where medical device vigilance services, such as monitoring, reporting, risk assessment, and communication related to adverse events or incidents with medical devices, are provided as needed or requested by healthcare providers, manufacturers, or regulatory authorities. It is used for therapeutics, diagnostics, surgical, research, and other applications by end-users such as original equipment manufacturers (OEMs), clinical research organizations (CROs), and business process outsourcing (BPO) firms.

The main delivery modes of medical devices vigilance are on-demand and on-premise. On-demand medical device vigilance delivery mode refers to a system or approach where medical device vigilance services, such as monitoring, reporting, risk assessment, and communication related to adverse events or incidents with medical devices, are provided as needed or requested by healthcare providers, manufacturers, or regulatory authorities. It is used for therapeutics, diagnostics, surgical, research, and other applications by end-users such as original equipment manufacturers (OEMs), clinical research organizations (CROs), and business process outsourcing (BPO) firms.

The medical devices vigilance market size has grown strongly in recent years. It will grow from $90.26 billion in 2024 to $97.94 billion in 2025 at a compound annual growth rate (CAGR) of 8.5%. The growth in the historic period can be attributed to growing awareness regarding medical device vigilance, growing awareness among the physicians and patients regarding the benefits of medical devices vigilance, rising pressure on medical devices manufacturers, increasing number of government initiative, and rising medical device usage.

The medical devices vigilance market size is expected to see strong growth in the next few years. It will grow to $137.61 billion in 2029 at a compound annual growth rate (CAGR) of 8.9%. The growth in the forecast period can be attributed to increasing launches of recall systems for medical devices, increasing number of post market surveillance programs for medical devices, increasing number of adverse events reported, increasing need for therapeutics and surgical procedures, and growing complexity related to patient safety regulations. Major trends in the forecast period include technological advancements, international medical device regulators forum (IMDRF) framework, enhances the exchange of safety information across borders, remote patient monitoring devices, 3D printing and personalized devices.

The increasing number of medical recalls is expected to propel the growth of the medical device vigilance market going forward. Medical recalls refer to the action taken by regulatory authorities, manufacturers, or distributors to remove or correct medical products that pose a risk to public health or do not comply with regulatory standards. Medical device vigilance entails continuous monitoring of medical devices in the market to identify adverse events, malfunctions, or safety concerns that, upon identification, are reported to regulatory authorities, potentially leading to further investigation and, if warranted, a product recall. For instance, in December 2022, the Food and Drug Administration (FDA), a US-based federal agency, observed a rise in medical device recalls, with 442 recalls documented in 2022, up from 331 in 2021, an almost 10% increase from 2021. Therefore, the increasing number of medical recalls is driving the growth of the medical device vigilance market.

Major companies operating in the medical device devices vigilance market are developing innovative products, such as quality management software, to improve customer satisfaction. Quality management software (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. For instance, in December 2022, Greenlight Guru, a US-based company providing systems and software to medical device companies, launched QMS software designed to help medical device companies modernize their processes, cut time from clinical testing, and bring safer products to market faster. Greenlight Guru's software is pre-validated per FDA and ISO best practices, aiming to help companies comply with the ever-changing standards. The company also offers training and certifications to help advance careers in product development, quality, and regulatory assurance.

In January 2024, GE Healthcare, a US-based medical technology company that offers a diverse portfolio of products, solutions, and services, acquired MIM Software Inc. for an undisclosed amount. The acquisition aims to reinforce GE HealthCare's digital strategy and enhance its imaging portfolio, particularly in medical device vigilance. MIM Software Inc. is a US-based company that provides services related to medical device surveillance through its specialization in medical imaging analysis and artificial intelligence (AI) solutions.

Major companies operating in the medical devices vigilance market are Johnson & Johnson, Intel Corporation, Oracle Corporation, Medtronic, Siemens Healthineers, RELX Group plc, MasterControl Inc., Laerdal Medical, Numerix, Smithers, Omnify Software Inc., Freyr, Sparta Systems, MDI Consultants Inc., Greenlight Guru, Jama Software, Sarjen Systems Pvt. Ltd, Arena Solutions Inc., Xybion Corporation, ZEINCRO Group, Extedo Gmbh, AssurX Inc., AB-Cube, Panacea Pharma Projects Limited, Qvigilance, General Electric (GE) Healthcare, Philips Healthcare, Baxter International, Stryker Corporation, Boston Scientific

North America was the largest region in the medical devices vigilance market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the medical devices vigilance market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the medical devices vigilance market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The medical device vigilance market consists of revenues earned by entities by providing services such as adverse event reporting, post-market surveillance, risk management, quality management systems, and regulatory compliance. The market value includes the value of related goods sold by the service provider or included within the service offering. The medical device vigilance market also includes sales of data collection devices, communication devices, data storage and processing devices, medical imaging equipment, and wearable devices. 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.

Medical Devices Vigilance 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 medical devices vigilance 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 medical devices vigilance ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The medical devices vigilance 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 Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.

Scope

Table of Contents

1. Executive Summary

2. Medical Devices Vigilance Market Characteristics

3. Medical Devices Vigilance Market Trends And Strategies

4. Medical Devices Vigilance Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Covid And Recovery On The Market

5. Global Medical Devices Vigilance Growth Analysis And Strategic Analysis Framework

6. Medical Devices Vigilance Market Segmentation

7. Medical Devices Vigilance Market Regional And Country Analysis

8. Asia-Pacific Medical Devices Vigilance Market

9. China Medical Devices Vigilance Market

10. India Medical Devices Vigilance Market

11. Japan Medical Devices Vigilance Market

12. Australia Medical Devices Vigilance Market

13. Indonesia Medical Devices Vigilance Market

14. South Korea Medical Devices Vigilance Market

15. Western Europe Medical Devices Vigilance Market

16. UK Medical Devices Vigilance Market

17. Germany Medical Devices Vigilance Market

18. France Medical Devices Vigilance Market

19. Italy Medical Devices Vigilance Market

20. Spain Medical Devices Vigilance Market

21. Eastern Europe Medical Devices Vigilance Market

22. Russia Medical Devices Vigilance Market

23. North America Medical Devices Vigilance Market

24. USA Medical Devices Vigilance Market

25. Canada Medical Devices Vigilance Market

26. South America Medical Devices Vigilance Market

27. Brazil Medical Devices Vigilance Market

28. Middle East Medical Devices Vigilance Market

29. Africa Medical Devices Vigilance Market

30. Medical Devices Vigilance Market Competitive Landscape And Company Profiles

31. Medical Devices Vigilance Market Other Major And Innovative Companies

32. Global Medical Devices Vigilance Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Medical Devices Vigilance Market

34. Recent Developments In The Medical Devices Vigilance Market

35. Medical Devices Vigilance Market High Potential Countries, Segments and Strategies

36. Appendix

(주)글로벌인포메이션 02-2025-2992 kr-info@giikorea.co.kr
ⓒ Copyright Global Information, Inc. All rights reserved.
PC버전 보기