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세계의 의료기기 안전성 시험 시장 보고서(2025년)
Medical Device Safety Testing Global Market Report 2025
상품코드 : 1760610
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 175 Pages
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한글목차

의료기기 안전성 시험 시장 규모는 향후 몇 년 동안 강력한 성장을 보일 것으로 예상됩니다. 예측 기간 동안의 성장은 웨어러블 및 이식형 기기의 부상, 국제 규제 조화의 강화, 지속 가능성 및 환경 규제, 원격 테스트 및 가상 시뮬레이션의 증가, 규제 컨설팅 서비스의 성장에 기인할 수 있습니다. 이 기간 동안 예상되는 주요 동향으로는 AI 기반 예측 테스트, 디지털 트윈 기술, 사이버 보안 및 임베디드 소프트웨어 테스트, 웨어러블 기기 테스트 프레임워크, 5세대(5G) 및 무선 신호 간섭 테스트 등이 있습니다.

생활습관 관련 질환의 확산은 향후 몇 년간 의료기기 안전성 시험 시장 성장을 촉진할 것으로 예상됩니다. 생활습관 관련 질환은 개인의 일상적인 습관과 선택으로 인해 주로 발생하는 건강 상태로, 심장병, 제2형 당뇨병, 비만, 고혈압, 특정 암, 정신 건강 문제 등이 포함됩니다. 이러한 질환의 증가세는 주로 신체 활동 부족으로 인해 체중 증가, 심혈관 건강 악화, 인슐린 민감도 감소 등이 발생하며, 이는 만성 질환 위험을 높입니다. 의료기기 안전성 시험는 진단 및 치료 기기의 신뢰성과 성능을 확보함으로써 이러한 질환 관리에 중요한 역할을 합니다. 규제 기준 충족 여부를 검증함으로써 환자 안전을 강화하고 치료 결과를 개선하며, 의료 시스템의 신뢰성과 효율성을 높입니다. 예를 들어, 2024년 6월 영국 정부 부처인 국립보건서비스(NHS)는 2023년 일반의사(GP)에 등록된 361만 5,330명으로 2022년 306만 5,825명에서 18% 증가했다고 보고했습니다.

의료기기 안전성 시험 시장의 선도 기업들은 기기의 정확성을 개선하고, 출시 시간을 단축하며, 진화하는 세계의 규제 기준을 준수하기 위해 첨단 테스트 시설을 통해 역량을 확대하는 데 주력하고 있습니다. 이러한 최첨단 테스트 시설은 최신 기술을 활용하여 의료기기를 종합적으로 평가합니다. 예를 들어, 2023년 12월, 인도에 본사를 둔 기술 기업 Impelsys는 인도 망갈로르에 첨단 의료기기 테스트 연구소를 설립했습니다. 이 연구소는 AI 기반 분석 및 클라우드 기반 플랫폼을 사용하여 첨단 테스트, 시뮬레이션 및 규제 지원을 제공함으로써 진단 및 치료 기기의 개발을 가속화합니다. 이 움직임은 의료 분야에서 데이터 기반 혁신에 대한 이 회사의 의지를 잘 보여줍니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 - 금리, 인플레이션, 지정학, 무역전쟁과 관세, 코로나 19 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

HBR
영문 목차

영문목차

Medical device safety testing involves evaluating a medical device to ensure its safety for use by patients, healthcare professionals, and others in its intended environment. This process identifies and mitigates potential risks related to electrical, mechanical, thermal, biological, and radiation hazards. Medical device safety testing ensures compliance with regulatory standards and verifies that the device performs as intended without causing harm.

The primary services in medical device safety testing include testing, inspection, and certification. Testing is a systematic process used to evaluate medical devices to ensure they meet safety requirements. This testing is applied to various types of medical devices, including active medical devices, passive medical devices, in vitro diagnostic devices, implantable devices, and surgical instruments. The technologies involved include active implantable devices, in vitro diagnostic devices, diagnostic imaging devices, and ophthalmic devices. Key application areas include cardiovascular devices, orthopedic devices, neurological devices, ophthalmic devices, and dental devices. These services are used by various end users such as hospitals, clinics, research laboratories, medical device manufacturers, and regulatory bodies.

The medical device safety testing market research report is one of a series of new reports from The Business Research Company that provides medical device safety testing market statistics, including medical device safety testing industry global market size, regional shares, competitors with a medical device safety testing market share, detailed medical device safety testing market segments, market trends and opportunities, and any further data you may need to thrive in the medical device safety testing industry. This medical device safety testing 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 medical device safety testing market size has grown strongly in recent years. It will grow from $8.55 billion in 2024 to $9.31 billion in 2025 at a compound annual growth rate (CAGR) of 8.9%. The growth during the historic period can be attributed to the increasing complexity of medical devices, a rise in product recalls, more stringent regulatory requirements, the globalization of medical device manufacturing, and a higher frequency of regulatory inspections.

The medical device safety testing market size is expected to see strong growth in the next few years. It will grow to $13.04 billion in 2029 at a compound annual growth rate (CAGR) of 8.8%. The growth during the forecast period can be attributed to the rise of wearable and implantable devices, stricter international regulatory harmonization, sustainability and environmental regulations, an increase in remote testing and virtual simulations, and the growth of regulatory consulting services. Major trends expected during this period include AI-powered predictive testing, digital twin technology, cybersecurity and embedded software testing, wearable device testing frameworks, and testing for fifth generation (5G) and wireless signal interference.

The growing prevalence of lifestyle-related diseases is expected to fuel the growth of the medical device safety testing market in the coming years. Lifestyle-related diseases include health conditions primarily caused by an individual's daily habits and choices, such as heart disease, type 2 diabetes, obesity, hypertension, certain cancers, and mental health issues. The rise in these diseases is largely attributed to physical inactivity, leading to weight gain, poor cardiovascular health, and decreased insulin sensitivity, all of which increase the risk of chronic conditions. Medical device safety testing plays a crucial role in managing these diseases by ensuring the reliability and performance of diagnostic and therapeutic devices. By verifying that devices meet regulatory standards, it enhances patient safety, improves treatment outcomes, and fosters greater trust and efficiency in healthcare systems. For example, in June 2024, the National Health Service (NHS), a UK-based government department, reported that 3,615,330 individuals registered with a general practitioner (GP) were diagnosed with non-diabetic hyperglycemia or pre-diabetes in 2023, marking an 18% increase from 3,065,825 cases in 2022. This rise in lifestyle-related diseases underscores the growing demand for medical device safety testing.

Leading companies in the medical device safety testing market are focusing on expanding their capabilities with advanced testing facilities to improve device accuracy, reduce time-to-market, and ensure compliance with evolving global regulatory standards. These state-of-the-art testing facilities leverage cutting-edge technology to conduct comprehensive evaluations of medical devices. For instance, in December 2023, Impelsys, an India-based technology company, launched an advanced medical device testing laboratory in Mangalore, India. The facility uses AI-driven analytics and cloud-based platforms to accelerate the development of diagnostic and therapeutic devices by offering advanced testing, simulations, and regulatory support. This move highlights the company's commitment to data-driven innovation in healthcare.

In January 2025, Applus+ Laboratories, a Spain-based provider of testing, inspection, and certification services, acquired De.Testing for an undisclosed amount. This acquisition enables Applus+ to enhance its position in the rapidly growing Chinese medical device market, expand its global testing capabilities, and provide more comprehensive and innovative solutions in the healthcare sector. De.Testing, based in China, specializes in medical device safety testing, making it a strategic addition to Applus+ Laboratories' portfolio.

Major players in the medical device safety testing market are Thermo Fisher Scientific, Medtronic plc, Baxter International, SGS SA, Eurofins Scientific SE, Bureau Veritas SA, Bausch & Lomb, Intertek Group plc, TUV SUD AG, Underwriters Laboratories LLC, Applus+ Group, BSI Group, NSF International, NEMKO AS, Smithers Group Inc., Laboratory Testing Inc., JPen Medical Inc., ArchiMed, F2 Labs Inc., Medistri SA.

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

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

The medical device safety testing market consists of revenues earned by entities by providing services such as product safety assessments, regulatory compliance testing, risk management analysis, performance validation, clinical trials support, environmental stress testing, material characterization, and software performance evaluations. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

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 and 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 Device Safety Testing 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 device safety testing 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 device safety testing ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The medical device safety testing 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 Device Safety Testing Market Characteristics

3. Medical Device Safety Testing Market Trends And Strategies

4. Medical Device Safety Testing 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 Medical Device Safety Testing Growth Analysis And Strategic Analysis Framework

6. Medical Device Safety Testing Market Segmentation

7. Medical Device Safety Testing Market Regional And Country Analysis

8. Asia-Pacific Medical Device Safety Testing Market

9. China Medical Device Safety Testing Market

10. India Medical Device Safety Testing Market

11. Japan Medical Device Safety Testing Market

12. Australia Medical Device Safety Testing Market

13. Indonesia Medical Device Safety Testing Market

14. South Korea Medical Device Safety Testing Market

15. Western Europe Medical Device Safety Testing Market

16. UK Medical Device Safety Testing Market

17. Germany Medical Device Safety Testing Market

18. France Medical Device Safety Testing Market

19. Italy Medical Device Safety Testing Market

20. Spain Medical Device Safety Testing Market

21. Eastern Europe Medical Device Safety Testing Market

22. Russia Medical Device Safety Testing Market

23. North America Medical Device Safety Testing Market

24. USA Medical Device Safety Testing Market

25. Canada Medical Device Safety Testing Market

26. South America Medical Device Safety Testing Market

27. Brazil Medical Device Safety Testing Market

28. Middle East Medical Device Safety Testing Market

29. Africa Medical Device Safety Testing Market

30. Medical Device Safety Testing Market Competitive Landscape And Company Profiles

31. Medical Device Safety Testing Market Other Major And Innovative Companies

32. Global Medical Device Safety Testing Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Medical Device Safety Testing Market

34. Recent Developments In The Medical Device Safety Testing Market

35. Medical Device Safety Testing Market High Potential Countries, Segments and Strategies

36. Appendix

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