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세계의 의료기기 시험, 검사 및 인증 시장 보고서(2025년)
Medical Device Testing, Inspection, And Certification Global Market Report 2025
상품코드 : 1877816
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

의료기기 시험, 검사 및 인증 시장 규모는 최근 현저한 성장을 이루고 있습니다. 2024년 79억 7,000만 달러로 평가되었고, 2025년에는 86억 4,000만 달러, CAGR 8.4%로 성장할 것으로 전망되고 있습니다. 과거의 성장 요인으로는 신소재에 대한 생체 적합성 시험의 이용 증가, 자동 광학 검사 시스템의 도입 확대, 사이버 보안 및 소프트웨어 검증 시험 수요 증가, 멸균·오염 관리 검증에 대한 주목의 높아짐, 의료기기 제조에 있어서의 실시간의 인라인 품질 모니터링의 필요성 증대를 들 수 있습니다.

의료기기 시험, 검사 및 인증 시장 규모는 향후 수년간 강력한 성장이 예상됩니다. 2029년에는 118억 1,000만 달러에 달하고, CAGR은 8.1%를 나타낼 전망입니다. 예측기간에 있어서의 성장요인으로는 의료기기에 대한 규제 준수 요건의 강화, 고품질로 안전한 의료제품에 대한 수요 증가, 첨단적인 시험 및 검사 기술의 채택 증가, 리스크 관리와 환자 안전에의 중시의 높아짐, 의료기기의 연구개발에 대한 투자 증가 등을 들 수 있습니다. 이 기간에 예상되는 주요 동향으로는 자동화 및 로봇 기반 검사 시스템의 진보, 예측 품질 분석을 위한 인공지능(AI)의 활용, 비파괴 검사 기술의 혁신, 기기 성능 검증을 위한 디지털 트윈의 통합, 인증 기준의 세계 조화의 진전 등이 있습니다.

의료비 지출 증가는 향후 몇 년간의 의료기기 시험, 검사 및 인증 시장의 성장을 견인할 것으로 예측됩니다. 의료비는 정부, 민간 조직 또는 개인이 의료 서비스, 치료 및 관련 활동에 할당하는 재정 자원을 의미합니다. 이러한 지출은 장기적이고 비용이 많이 드는 의료를 필요로 하는 만성 질환 증가에 따라 상승하고 있습니다. 의료비 증가는 안전하고 효과적인 의료 기술 개발, 품질 보증, 규제 준수에 대한 자금 제공을 통해 의료기기의 시험, 검사 및 인증을 지원합니다. 예를 들어, 2024년 5월에 영국 정부 기관인 국가 통계국이 발표한 바에 의하면, 2022년부터 2023년에 걸친 의료 총 지출은 명목 기준으로 5.6% 증가해, 2022년의 0.9% 증가로부터 대폭적인 가속을 나타냈습니다. 따라서 의료 지출 증가는 의료기기 시험, 검사 및 인증 시장의 확대에 기여하고 있습니다.

의료기기 시험, 검사 및 인증 시장의 주요 기업은 신뢰성 강화와 컴플라이언스 확보를 목적으로 하여 고급 제3자 검증·타당성 확인 솔루션을 통한 서비스 제공 확충에 주력하고 있습니다. 제3자의 검증 및 유효성 확인은 독립 기관이 제품, 프로세스 또는 시스템이 확립된 기준과 요구사항을 충족하는지 여부를 평가하고 확인하는 것입니다. 예를 들어, 2023년 10월 미국에 본사를 둔 시험, 검사 및 인증 서비스 제공업체인 UL Solutions는 미시간주 로체스터 힐스에 있는 연구소에서 의료기기 시험 서비스를 시작했습니다. 이 새로운 서비스는 제품의 안전성, 보안, 사용 편의성 및 상호 운용성을 향상시켜 동주에서 계속 성장하는 의료기기 산업을 지원하는 것을 목표로합니다. Rochester Hills의 시설은 제조업체를 위해 종합적인 타사 검증 및 유효성 확인, 감사, 사이버 보안 평가, 사용성 테스트 및 규정 준수 교육을 제공합니다. 또한 특정 제조업체의 요구에 맞는 가속 수명 테스트 및 환경 테스트와 같은 유연한 테스트 기능도 제공합니다. 또한 테스트의 정확성과 신뢰성을 보장하기 위해 휘발성 유기 화합물(VOC) 수준이 낮은 관리 환경을 유지하고 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

SHW
영문 목차

영문목차

Medical device testing, inspection, and certification is a comprehensive process designed to ensure that medical devices comply with safety, quality, performance, and regulatory standards. It includes functional testing, biocompatibility assessment, reliability evaluation, and certification in line with international regulations, ensuring that devices are safe, effective, and compliant before being introduced to healthcare providers or patients.

The primary device types involved in medical device testing, inspection, and certification include active medical devices, non-active medical devices, in-vitro diagnostic devices, and combination products. Active medical devices are those that require an electrical energy source or another power supply to function. These devices undergo various testing processes such as safety, performance, biocompatibility, and efficacy testing, as well as inspection procedures including component inspection, final product inspection, quality system inspection, and compliance inspection. Certification for these devices may include International Organization for Standardization (ISO) certification, Conformite Europeenne (CE) marking, Food and Drug Administration (FDA) approval, and other regulatory validations. The main end users of these processes include medical device manufacturers, regulatory authorities, healthcare institutions, and independent testing laboratories.

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

The medical device testing, inspection, and certification market size has grown strongly in recent years. It will grow from $7.97 billion in 2024 to $8.64 billion in 2025 at a compound annual growth rate (CAGR) of 8.4%. Growth during the historic period can be attributed to the increasing use of biocompatibility testing for new materials, rising adoption of automated optical inspection systems, growing demand for cybersecurity and software validation testing, greater focus on sterilization and contamination control verification, and the rising need for real-time in-line quality monitoring in medical device manufacturing.

The medical device testing, inspection, and certification market size is expected to see strong growth in the next few years. It will grow to $11.81 billion in 2029 at a compound annual growth rate (CAGR) of 8.1%. Growth in the forecast period can be attributed to increasing regulatory compliance requirements for medical devices, growing demand for high-quality and safe medical products, rising adoption of advanced testing and inspection technologies, greater emphasis on risk management and patient safety, and increasing investment in medical device research and development. Key trends expected during this period include advancements in automated and robotics-based inspection systems, the use of artificial intelligence for predictive quality analysis, innovation in non-destructive testing techniques, integration of digital twins for device performance validation, and progress in the global harmonization of certification standards.

The increasing healthcare expenditures are expected to drive the growth of the medical device testing, inspection, and certification market in the coming years. Healthcare expenditures refer to the financial resources allocated by governments, private organizations, or individuals for healthcare services, treatments, and related activities. These expenditures are rising due to the growing prevalence of chronic diseases that require prolonged and costly medical care. Increased healthcare spending supports medical device testing, inspection, and certification by funding the development, quality assurance, and regulatory compliance of safe and effective medical technologies. For example, in May 2024, the Office for National Statistics, a UK-based government department, reported that total healthcare expenditure grew by 5.6% in nominal terms from 2022 to 2023, marking a significant acceleration compared with the 0.9% growth recorded in 2022. Therefore, the rise in healthcare expenditures is contributing to the expansion of the medical device testing, inspection, and certification market.

Major players in the medical device testing, inspection, and certification market are focusing on enhancing their service offerings through advanced third-party verification and validation solutions to strengthen trust and ensure compliance. Third-party verification and validation involve an independent organization assessing and confirming that a product, process, or system meets established standards or requirements. For instance, in October 2023, UL Solutions, a US-based provider of testing, inspection, and certification services, launched medical device testing services at its laboratory in Rochester Hills, Michigan. These new services aim to support the state's growing medical device industry by improving product safety, security, usability, and interoperability. The Rochester Hills facility provides comprehensive third-party verification and validation, auditing, cybersecurity evaluation, usability testing, and compliance training for manufacturers. It also offers flexible testing capabilities, including accelerated lifespan and environmental testing, tailored to specific manufacturer needs. Additionally, the facility maintains a controlled environment with low volatile organic compound (VOC) levels to ensure testing precision and reliability.

In November 2024, Applus+, a Spain-based provider of testing, inspection, and certification services, acquired Keystone Compliance for an undisclosed amount. This acquisition aims to enhance Applus+'s presence in the North American market by expanding its local testing capabilities and providing comprehensive product testing and certification services across multiple industries. Keystone Compliance is a US-based company specializing in electromagnetic compatibility (EMC/EMI), environmental, and packaging testing services for clients in the electronics, medical device, aerospace, defense, and energy sectors.

Major players in the medical device testing, inspection, and certification market are Societe Generale de Surveillance S.A., Eurofins Scientific S.E., Bureau Veritas S.A., Intertek Group plc, Charles River Laboratories International Inc., TUV SUD Aktiengesellschaft, UL Solutions Inc., Element Materials Technology Limited, QIMA Limited, Cotecna Inspection SA, North American Science Associates LLC, TUV Rheinland AG, Freyr Solutions Pvt. Ltd., Nelson Laboratories LLC, MED Institute Inc., Auriga Research Limited, DDL Inc., F2 Labs LLC, DeviceLab LLC, and EdgeOne Medical Inc.

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

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

The medical device testing, inspection, and certification market includes revenues earned by entities by providing services such as risk assessment services, sterilization validation, software validation, packaging integrity evaluation, and environmental simulation testing. 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 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, Inspection, And Certification 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, inspection, and certification 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, inspection, and certification ? 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, inspection, and certification 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, Inspection, And Certification Market Characteristics

3. Medical Device Testing, Inspection, And Certification Market Trends And Strategies

4. Medical Device Testing, Inspection, And Certification 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, Inspection, And Certification Growth Analysis And Strategic Analysis Framework

6. Medical Device Testing, Inspection, And Certification Market Segmentation

7. Medical Device Testing, Inspection, And Certification Market Regional And Country Analysis

8. Asia-Pacific Medical Device Testing, Inspection, And Certification Market

9. China Medical Device Testing, Inspection, And Certification Market

10. India Medical Device Testing, Inspection, And Certification Market

11. Japan Medical Device Testing, Inspection, And Certification Market

12. Australia Medical Device Testing, Inspection, And Certification Market

13. Indonesia Medical Device Testing, Inspection, And Certification Market

14. South Korea Medical Device Testing, Inspection, And Certification Market

15. Western Europe Medical Device Testing, Inspection, And Certification Market

16. UK Medical Device Testing, Inspection, And Certification Market

17. Germany Medical Device Testing, Inspection, And Certification Market

18. France Medical Device Testing, Inspection, And Certification Market

19. Italy Medical Device Testing, Inspection, And Certification Market

20. Spain Medical Device Testing, Inspection, And Certification Market

21. Eastern Europe Medical Device Testing, Inspection, And Certification Market

22. Russia Medical Device Testing, Inspection, And Certification Market

23. North America Medical Device Testing, Inspection, And Certification Market

24. USA Medical Device Testing, Inspection, And Certification Market

25. Canada Medical Device Testing, Inspection, And Certification Market

26. South America Medical Device Testing, Inspection, And Certification Market

27. Brazil Medical Device Testing, Inspection, And Certification Market

28. Middle East Medical Device Testing, Inspection, And Certification Market

29. Africa Medical Device Testing, Inspection, And Certification Market

30. Medical Device Testing, Inspection, And Certification Market Competitive Landscape And Company Profiles

31. Medical Device Testing, Inspection, And Certification Market Other Major And Innovative Companies

32. Global Medical Device Testing, Inspection, And Certification Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Medical Device Testing, Inspection, And Certification Market

34. Recent Developments In The Medical Device Testing, Inspection, And Certification Market

35. Medical Device Testing, Inspection, And Certification Market High Potential Countries, Segments and Strategies

36. Appendix

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