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세계의 의료기기 검사 서비스 시장 보고서(2025년)
Medical Device Testing Services Global Market Report 2025
상품코드 : 1825447
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

의료기기 검사 서비스 시장의 규모는 향후 수년간 강력한 성장이 예상됩니다. 2029년에는 CAGR 8.6%로 141억 5,000만 달러로 성장할 전망입니다. 예측기간의 성장은 의료기기 산업의 급성장, 신흥 시장과 규제의 변화, 맞춤의료에 대한 주력, 사이버 보안에 대한 우려, 가치기반의 헬스케어로의 시프트 등에 기인할 것으로 전망됩니다. 예측기간의 주요 동향으로는 지속 가능한 검사 실무, 규제 컨설팅 서비스의 통합, 개별화 의료와 검사, 검사기기와 기술의 진보, 체외진단(IVD) 검사 서비스의 확대 등이 있습니다.

향후 5년간의 예측 성장률 8.6%는 과거 예측에서 0.1% 소폭 감소한 수치입니다. 이러한 성장세 둔화는 주로 미국과 다른 국가 간의 관세의 영향 때문입니다. 무역 마찰은 영국과 덴마크의 제3자 ISO 13485 인증 서비스와 휴먼 팩터 엔지니어링 지원의 가격을 인상시켜 시장 진입 지연과 컴플라이언스 비용 상승을 초래하여 미국의 디바이스 혁신을 저해할 수 있습니다. 또한 상호관세와 무역의 긴장과 한계 증가로 인한 세계 경제와 무역에 대한 악영향으로 인해 그 영향이 더욱 광범위해질 것으로 예상됩니다.

만성질환 증가는 의료기기 검사 서비스 시장의 향후 성장을 가속할 것으로 예측됩니다. 만성질환은 장기간 지속되는 건강 상태를 말하며, 일반적으로 1년 이상 지속됩니다. 이 질환은 노화, 건강에 해로운 라이프스타일 선택, 환경 요인 등으로 인해 발생합니다. 의료기기 검사 서비스는 만성질환 관리에서 원격 환자 모니터링(RPM) 및 건강 상태 변화의 실시간 검출을 지원하는 데 사용되며, 이러한 서비스는 장비의 안전성, 효능, 신뢰성, 품질을 보장하고 궁극적으로 환자의 결과와 삶의 질을 향상시킵니다. 예를 들어, 미국의 의학 도서관인 국립 의학 도서관에 따르면 2023년 1월에는 적어도 하나의 만성질환을 앓고 있는 사람의 추정 수가 거의 배로 증가하였으며, 2020년의 7,152만 2,000명에서 2050년에는 1억 4,266만명으로 예측되고 있습니다. 따라서 만성질환의 유병률 증가는 의료기기 검사 서비스 시장의 성장을 이끌고 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

CSM
영문 목차

영문목차

Medical device testing services refer to the processes and procedures conducted to evaluate the safety, efficacy, reliability, and quality of medical devices. These services are crucial in ensuring that medical devices meet regulatory standards and requirements before they can be marketed and used for clinical purposes.

The main types of products in medical device testing services are active implant medical devices, active medical devices, non-active medical devices, in-vitro diagnostic medical devices, ophthalmic medical devices, orthopedic and dental medical devices, vascular medical devices, and others. An active implantable medical device (AIMD) is a type of medical device that is designed to be implanted into the body to provide therapy or monitoring. It provides various services, such as biocompatibility tests, chemistry tests, microbiology and sterility tests, and package validation and it included both preclinical and clinical phases.

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 sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.

The main types of products in medical device testing services are active implant medical devices, active medical devices, non-active medical devices, in-vitro diagnostic medical devices, ophthalmic medical devices, orthopedic and dental medical devices, vascular medical devices, and others. An active implantable medical device (AIMD) is a type of medical device that is designed to be implanted into the body to provide therapy or monitoring. It provides various services, such as biocompatibility tests, chemistry tests, microbiology and sterility tests, and package validation and it included both preclinical and clinical phases.

The medical device testing services market size has grown rapidly in recent years. It will grow from $9.25 billion in 2024 to $10.18 billion in 2025 at a compound annual growth rate (CAGR) of 10.1%. The growth in the historic period can be attributed to industry consolidation, quality assurance requirements, focus on patient safety, globalization of medical device, increasing complexity of medical devices.

The medical device testing services market size is expected to see strong growth in the next few years. It will grow to $14.15 billion in 2029 at a compound annual growth rate (CAGR) of 8.6%. The growth in the forecast period can be attributed to rapid growth in the medical device industry, emerging markets and regulatory changes, focus on personalized medicine, cybersecurity concerns, shift towards value-based healthcare. Major trends in the forecast period include sustainable testing practices, integration of regulatory consulting services, personalized medicine and testing, advancements in testing equipment and technologies, expansion of in vitro diagnostic (IVD) testing services.

The forecast of 8.6% growth over the next five years reflects a slight reduction of 0.1% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Trade tensions could hinder U.S. device innovation by inflating prices of third-party ISO 13485 certification services and human factors engineering support from the UK and Denmark, resulting in delayed market entry and higher compliance costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The rising prevalence of chronic diseases is expected to propel the growth of the medical device testing services market going forward. Chronic diseases refer to long-term health conditions that persist over an extended period, typically lasting for a year or more. This disease arises due to an aging population, unhealthy lifestyle choices, and environmental factors. Medical device testing services are used in the management of chronic diseases to support remote patient monitoring (RPM) and real-time detection of health changes, and these services ensures the safety, efficacy, reliability, and quality of devices, ultimately improving patient outcomes and quality of life. For instance, in January 2023, according to the National Library of Medicine, a US-based medical library, the estimated number of individuals affected by at least one chronic disease is projected to nearly double, increasing by 99.5% from 71.522 million in 2020 to 142.66 million by the year 2050. Therefore, the rising prevalence of chronic diseases is driving the growth of the medical device testing services market.

Major companies operating in the medical device testing services market are concentrating on the adoption of technological advancements, such as new medical device testing services, to provide comprehensive testing solutions. These services refer to a range of tests conducted by specialized companies to ensure the effectiveness, safety, and compliance of medical devices with national and international regulations. For instance, in October 2023, UL Solutions, a US-based provider of medical testing, inspection, and certification services, launched new medical device testing services at its laboratory in Rochester Hills. These services include medical device makers' compliance training, usability testing, and third-party verification and validation. It contributes to the state's developing medical device sector and helps manufacturers improve the safety, security, usability, and interoperability of their devices. Additionally, it also provides third-party verification and validation, cybersecurity services, auditing, usability testing, and compliance training to medical device manufacturers, as well as addressing potential risks such as quality, safety, and cybersecurity issues, all while maintaining the pace of innovation and protecting users.

In December 2022, Millstone Medical Outsourcing, a US-based provider of outsourcing solutions to the medical device industry, acquired Ethide Laboratories for an undisclosed amount. This acquisition aims to expand Millstone's internal capabilities, reinforcing its end-to-end expert sourcing, and bolstering support for medical device services. This move underscores Millstone's dedication to upholding quality standards, ensuring compliance, and driving business success within the industry. Ethide Laboratories is a US-based provider of contract medical testing services intended for the pharmaceutical industry.

Major companies operating in the medical device testing services market are Laboratory Corporation of America Holdings, Eurofins Scientific SE, SGS SA, Bureau Veritas SA, WuXiAppTec Group, Steris plc, Sartorius AG, Charles River Laboratories International Inc., Altran Corporation, TUV SUD AG, Element Minnetonka, Underwriters Laboratories LLC, Intertek Group Plc., QTS Analytical Limited, Pace Analytical Services LLC., Sterigenics International LLC, Nelson Laboratories LLC, Exova Group Limited, Merieux NutriSciences Corporation, American Preclinical Services LLC, Toxikon Corporation, North American Science Associates Inc., Avomeen Analytical Services LLC, Element Materials Technology Group Limited, Sionic Advisors LLC, Medical Engineering Technologies Ltd.

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

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

The medical device testing services market includes revenues earned by entities through services such as sterility testing, packaging testing, electrical safety testing, performance testing, usability testing, and post-market surveillance testing services. The market value includes the value of related goods sold by the service provider or included within the service offering. The medical device testing services market also includes sales of testing instruments and equipment, consumables and reagents, mechanical testing machines, electrical safety testers and sterilizers, and autoclaves. 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 Device Testing Services 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 testing services 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 testing services ? 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 medical device testing services 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. Medical Device Testing Services Market Characteristics

3. Medical Device Testing Services Market Trends And Strategies

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

6. Medical Device Testing Services Market Segmentation

7. Medical Device Testing Services Market Regional And Country Analysis

8. Asia-Pacific Medical Device Testing Services Market

9. China Medical Device Testing Services Market

10. India Medical Device Testing Services Market

11. Japan Medical Device Testing Services Market

12. Australia Medical Device Testing Services Market

13. Indonesia Medical Device Testing Services Market

14. South Korea Medical Device Testing Services Market

15. Western Europe Medical Device Testing Services Market

16. UK Medical Device Testing Services Market

17. Germany Medical Device Testing Services Market

18. France Medical Device Testing Services Market

19. Italy Medical Device Testing Services Market

20. Spain Medical Device Testing Services Market

21. Eastern Europe Medical Device Testing Services Market

22. Russia Medical Device Testing Services Market

23. North America Medical Device Testing Services Market

24. USA Medical Device Testing Services Market

25. Canada Medical Device Testing Services Market

26. South America Medical Device Testing Services Market

27. Brazil Medical Device Testing Services Market

28. Middle East Medical Device Testing Services Market

29. Africa Medical Device Testing Services Market

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

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

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

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

34. Recent Developments In The Medical Device Testing Services Market

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

36. Appendix

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