세계의 의료기기 검사 시장 보고서(2025년)
Medical Device Testing Global Market Report 2025
상품코드 : 1821685
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
 라이선스 & 가격 (부가세 별도)
US $ 4,490 ₩ 6,487,000
PDF (Single User License) help
PDF 보고서를 1명만 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 6,490 ₩ 9,376,000
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 ₩ 12,266,000
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 검사 시장 규모는 향후 수년간 강력한 성장이 예상됩니다. 2029년 연평균 성장률(CAGR)은 6.2%를 나타낼 것으로 예측되고 133억 3,000만 달러로 성장할 전망입니다. 예측 기간 동안의 성장은 의료 기술 발전, 검사 서비스 아웃소싱 증가, 맞춤형 의약품의 급속한 성장, 확대되는 규제 환경, 의료기기의 사이버 보안에 주력하는 등에 기인할 수 있습니다. 예측 기간의 주요 동향에는 향상된 규제 준수 검사, 생체 적합성 시험 방법의 확대, 시뮬레이션 및 모델링 기술 용도, 무균 검사 수요 증가, 연결 기기용 검사 서비스 도입 등이 포함됩니다.

향후 5년간 6.2% 성장 전망은 이전 예측 대비 0.2% 소폭 하락한 수치입니다. 이 하락은 주로 미국과 타국 간 관세 영향 때문입니다. 관세 장벽은 독일 및 이탈리아에서 원하여 조달하는 가속 노화 챔버와 피로 검사 시스템의 비용을 증가시켜 미국 시장에 부정적 영향을 미칠 것으로 예상됩니다. 이는 제품 개발 기간을 연장하고 품질 보증(QA) 비용을 증가시킬 것입니다. 또한 상호 관세 부과와 무역 긴장 및 제한 강화로 인한 전 세계 경제 및 무역에 대한 부정적 영향으로 그 효과가 더 광범위하게 나타날 것입니다.

의료기기 리콜 증가가 의료기기 검사 시장을 견인하고 있습니다. 기기 리콜은 의료기기의 문제점을 해결하기 위해 제조사나 유통사가 취하는 시정 조치를 의미합니다. 의료기기 검사는 제조사가 기기와 관련된 잠재적 안전 문제를 식별하는 데 활용됩니다. 이는 환자 안전 보장, 기기 효과적인 확보, 리콜 방지를 위한 제품 품질 개선을 위해 의료 리콜의 필요성을 판단하는 데 도움을 줍니다. 예를 들어, 세드윅(Sedgwick)은 2022년 2분기 의료기기 리콜 건수가 1분기 대비 11% 증가한 총 719건을 기록했다고 보고했습니다. 따라서 의료기기 리콜 건수의 증가는 의료기기 검사 시장의 주요 촉진요인입니다.

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 및 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 testing is the process of assessing and validating the safety, effectiveness, and quality of medical devices. This crucial evaluation ensures that these products are safe for use in patient care and comply with the standards and regulations established by relevant authorities.

The primary types of medical device testing include physical testing, chemical or biological testing, cybersecurity testing, microbiology and sterility testing, and other related evaluations. Physical testing involves subjecting medical devices to a series of tests to assess their performance, durability, and safety, aiding manufacturers in ensuring the safety, effectiveness, and reliability of their products. The device classes include class I, class II, and class III, and testing services can be conducted both in-house and outsourced. Services offered encompass testing, inspection, and certification. Medical device testing is utilized by various end-users, including hospitals, research centers, homecare clinics, 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 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 medical device testing market research report is one of a series of new reports from The Business Research Company that provides medical device testing market statistics, including the medical device testing industry global market size, regional shares, competitors with a medical device testing market share, detailed medical device testing market segments, market trends and opportunities, and any further data you may need to thrive in the medical device testing industry. This medical device 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 testing market size has grown strongly in recent years. It will grow from $9.89 billion in 2024 to $10.46 billion in 2025 at a compound annual growth rate (CAGR) of 5.7%. The growth in the historic period can be attributed to stringent regulatory requirements, increasing complexity of medical devices, globalization of medical device industry, rise in chronic diseases, focus on patient safety.

The medical device testing market size is expected to see strong growth in the next few years. It will grow to $13.33 billion in 2029 at a compound annual growth rate (CAGR) of 6.2%. The growth in the forecast period can be attributed to advancements in medical technology, increased outsourcing of testing services, rapid growth of personalized medicine, expanding regulatory landscape, focus on cybersecurity for medical devices. Major trends in the forecast period include enhanced regulatory compliance testing, expansion of biocompatibility testing methods, application of simulation and modeling techniques, and increased demand for sterility testing, introduction of testing services for connected devices.

The forecast of 6.2% growth over the next five years reflects a slight reduction of 0.2% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Tariff barriers are expected to hamper the U.S. by increasing the cost of accelerated aging chambers and fatigue testing systems sourced from Germany and Italy, thereby prolonging product development timelines and elevating QA expenditures. 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 medical device testing market is being propelled forward by an increase in medical device recalls. Device recalls involve corrective actions taken by manufacturers or distributors to address issues with medical devices. Medical device testing is utilized by manufacturers to identify potential safety concerns associated with devices. It helps determine the necessity of medical recalls to ensure patient safety, device effectiveness, and product quality improvement to avoid recalls. For instance, Sedgwick reported a 11% increase in medical recalls in Q2 2022 compared to Q1 2022, with a total of 719 recalls. Therefore, the growing number of medical device recalls is a key driver for the medical device testing market.

The expansion of the medical device testing market in the future is expected to be driven by the rising healthcare expenditure. Healthcare expenditure encompasses spending on healthcare-related goods and services within a healthcare system or economy. It plays a crucial role in supporting the development and accessibility of medical device testing. In November 2022, the Canadian Institute for Health Information reported a 0.8% rise in healthcare expenditure to $331 billion in 2022, following a 7.6% increase in 2021. Thus, the increasing healthcare expenditure is fueling the growth of the medical device testing market.

A prominent trend in the medical device testing market is the introduction of product innovations by major companies to maintain their market position. For instance, Nelson Labs launched the Nelson Labs Mark in February 2022, a product testing verification program that provides authentication of test reports and reliable data on product performance. This program, initially intended for masks and respirator devices, includes two-factor authentication for consumers to confirm the legitimacy of tests.

Major companies in the medical device testing market are focusing on developing innovative services to drive revenues. UL Solutions, a safety science company, launched new medical device testing services in October 2023 at its laboratory in Michigan, USA. These services aim to help manufacturers address potential risks such as quality, safety, and cybersecurity issues while supporting innovation and protecting medical device users.

In November 2022, Millstone Medical Outsourcing LLC acquired MycoScience Inc. for an undisclosed amount. This strategic acquisition is geared towards expanding Millstone Medical Outsourcing LLC's laboratory and environmental testing services in the medical device testing market. MycoScience Inc. is a provider of medical device and pharmaceutical laboratory testing services.

Major companies operating in the medical device testing market include Intertek Group plc., SGS SA, Bureau Veritas Group, TUV SUD AG, TUV Rheinland Group, Pace Analytical Services LLC., Charles River Laboratories Inc., UL Solutions, North American Science Associates LLC, Medistri SA, WuXi AppTec Inc., Cordant Health Solutions, GE Healthcare Technologies Inc., Thermo Fisher Scientific Inc., Biomedical Device Labs, NSF International, Analytical Lab Group LLC, Boston Analytical, DDL Inc., Element Materials Technology, Empirical Testing Corp., Eurofins Scientific, Gateway Analytical LLC, iuvo BioScience, Laboratory Corporation of America Holdings, Microtest Laboratories Inc., Nelson Laboratories LLC, National Technical Systems Inc., Pacific Biolabs Inc., Sterigenics International LLC, Toxikon Corporation, WCG Imaging, Westpak Inc.

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

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

The medical devices testing market includes revenues earned by entities by providing services such as biocompatibility testing services, bio-burden determination services, and quality assurance testing services. 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 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 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 ? 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 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 Market Characteristics

3. Medical Device Testing Market Trends And Strategies

4. Medical Device 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 Testing Growth Analysis And Strategic Analysis Framework

6. Medical Device Testing Market Segmentation

7. Medical Device Testing Market Regional And Country Analysis

8. Asia-Pacific Medical Device Testing Market

9. China Medical Device Testing Market

10. India Medical Device Testing Market

11. Japan Medical Device Testing Market

12. Australia Medical Device Testing Market

13. Indonesia Medical Device Testing Market

14. South Korea Medical Device Testing Market

15. Western Europe Medical Device Testing Market

16. UK Medical Device Testing Market

17. Germany Medical Device Testing Market

18. France Medical Device Testing Market

19. Italy Medical Device Testing Market

20. Spain Medical Device Testing Market

21. Eastern Europe Medical Device Testing Market

22. Russia Medical Device Testing Market

23. North America Medical Device Testing Market

24. USA Medical Device Testing Market

25. Canada Medical Device Testing Market

26. South America Medical Device Testing Market

27. Brazil Medical Device Testing Market

28. Middle East Medical Device Testing Market

29. Africa Medical Device Testing Market

30. Medical Device Testing Market Competitive Landscape And Company Profiles

31. Medical Device Testing Market Other Major And Innovative Companies

32. Global Medical Device Testing Market Competitive Benchmarking And Dashboard

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

34. Recent Developments In The Medical Device Testing Market

35. Medical Device Testing 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