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시장보고서
상품코드
2050648
의료기기 시험 및 인증 시장 : 서비스 유형별, 조달 형태별, 기기 분류별, 기술별 및 지역별Medical Device Testing and Certification Market, By Service Type, By Sourcing Type, By Device Class, By Technology, and By Geography |
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가격
※ 부가세 별도
한글목차
영문목차
※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.
의료기기 시험·인증 시장은 2026년에 114억 5,100만 달러로 추계되고 있으며, 2033년까지 155억 8,320만 달러에 달할 것으로 예상되고 있습니다. 2026-2033년에 CAGR 4.5%로 성장하며, 155억 8,320만 달러에 달할 전망입니다.
| 리포트 범위 | 리포트 상세 | ||
|---|---|---|---|
| 기준연도 : | 2025년 | 2026년 시장 규모 : | 114억 5,100만 달러 |
| 과거 데이터 기간 : | 2020-2024년 | 예측 기간 : | 2026-2033년 |
| 2026-2033년 예측 기간의 CAGR : | 4.50% | 2033년 시장 규모 예측 : | 155억 8,320만 달러 |
의료기기의 안전성과 유효성을 보장하기 위해서는 의료기기의 시험 및 인증이 필요합니다. 미국에서는 식품의약국(FDA)의 가이드라인에 따라 캐나다에서는 캐나다 보건부의 등록이 필요하고, 유럽에서는 유럽 적합성(CE) 마크의 승인을 받아야 하며, 인도에서는 중앙의약품표준관리기구(CDSCO)의 승인을 받아야 합니다.
시장 역학:
의료기기 시험 및 인증에 대한 관심 증가, 엄격한 정부 규제, 인공지능(AI) 및 사물인터넷(IoT)의 의료기기 통합 발전, COVID-19 확산은 예측 기간 중 글로벌 의료기기 시험 및 인증 시장의 성장을 촉진할 것으로 예상되는 주요 요인으로 꼽힙니다.
예를 들어2022년 1월,TAceV SAD는 미네소타주 뉴 브라이튼에 위치한 의료기기 시험 연구소를 확장했습니다. 이 최첨단 연구소는 모든 의료기기에 대한 엔드-투-엔드 테스트 솔루션을 제공할 뿐만 아니라, TAceV SAceD가 현재 보유하고 있는 의료기기 테스트 역량을 보완하는 광범위한 생물학적 및 화학적 테스트도 제공합니다.
본 조사의 주요 특징:
- 이 보고서는 다양한 부문의 잠재적 매출 창출 기회를 밝히고, 이 시장의 매력적인 투자 제안 매트릭스를 설명합니다.
- 또한 시장 촉진요인, 억제요인, 기회, 신제품 출시 및 승인, 시장 동향, 지역별 전망, 주요 기업이 채택한 경쟁 전략에 대한 중요 인사이트를 제공합니다.
- 이 보고서는 기업의 주요 특징, 제품 포트폴리오, 주요 특징, 재무 실적, 전략 등의 매개변수를 기반으로 세계의 의료기기 시험 및 인증 시장의 주요 기업 개요을 작성했습니다.
- 이 보고서의 내용을 통해 기업의 마케팅 담당자와 경영진은 향후 제품 출시, 모델 업그레이드, 시장 확대 및 마케팅 전략에 대한 정보에 입각한 의사결정을 내릴 수 있을 것입니다.
- 이 세계의 의료기기 테스트 및 인증 시장 보고서는 투자자, 공급업체, 제품 제조업체, 유통업체, 신규 진입자, 재무 분석가 등 업계의 다양한 이해관계자를 대상으로 합니다.
- 이해관계자들은 글로벌 의료기기 시험 및 인증 시장 분석에 사용되는 다양한 전략 매트릭스를 통해 쉽게 의사결정을 내릴 수 있을 것입니다.
목차
제1장 조사 목적과 전제조건
제2장 시장 전망
제3장 시장 역학·규제·동향 분석
제4장 세계의 의료기기 시험·인증 시장 : 서비스 유형별, 2021-2033년
제5장 세계의 의료기기 시험·인증 시장 : 조달 유형별, 2021-2033년
제6장 세계의 의료기기 시험·인증 시장 : 의료기기의 분류별, 2021-2033년
제7장 세계의 의료기기 시험·인증 시장 : 기술별, 2021-2033년
제8장 세계의 의료기기 시험·인증 시장 : 지역별, 2021-2033년
제9장 경쟁 구도
제10장 섹션
KSA 26.06.10Medical Device Testing And Certification Market is estimated to be valued at USD 11,451.0 Mn in 2026 and is expected to reach USD 15,583.2 Mn by 2033, growing at a compound annual growth rate (CAGR) of 4.5%USD 15,583.2 Mn from 2026 to 2033.
| Report Coverage | Report Details | ||
|---|---|---|---|
| Base Year: | 2025 | Market Size in 2026: | USD 11,451 Mn |
| Historical Data for: | 2020 To 2024 | Forecast Period: | 2026 To 2033 |
| Forecast Period 2026 to 2033 CAGR: | 4.50% | 2033 Value Projection: | USD 15,583.2 Mn |
Medical device testing and certification is necessary to ensure safety and effectiveness of medical devices. The U.S. follows the Food and Drug Administration (FDA) guidelines, Canada needs the Health Canada Registration, Europe considers Conformite Europeenne (CE) approval, and India need approval from the Central Drugs Standard Control Organisation (CDSCO).
Market Dynamics:
Rise in focus on the medical device testing and certification, stringent government regulations, rise in integration of Artificial Intelligence (AI) and Internet of Things (IoT) in medical devices, and the outbreak of COVID-19 are major factors expected to drive growth of the global medical device testing and certification market during the forecast period.
For instance, in January 2022, TAceV SAceD expanded its medical device testing laboratory in New Brighton, Minnesota. The state-of-the-art laboratory will offer an end-to-end testing solution for all medical devices and will also provide a wide range of biological and chemical testing of medical devices that complements TAceV SAceD's current active medical device testing capabilities.
Key features of the study:
- It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market.
- This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players.
- It profiles key players in the global medical device testing and certification market based on the following parameters such as company highlights, products portfolio, key highlights, financial performance, and strategies.
- Key companies covered as a part of this study include Medistri SA, BSI Group, GMED, IMQ Group SRL, TOXIKON, TAceV SAceD, WuXi AppTec, Pace Analytical Services LLC, Gateway Analytical LLC, Boston Analytical, Bureau Veritas, UL LLC, TUV Rheinland, SGS SA, Intertek Group PLC, Eurofins Scientific, Element Materials Technology, Dekra Testing and Certification GmbH, Ente Certificazione Macchine, and Institute for testing and Certification Inc., among others.
- Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics.
- The global medical device testing and certification market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.
- Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global medical device testing and certification market.
Detailed Segmentation:
- Global Medical Device Testing and Certification Market, By Service Type (Revenue, USD Mn, 2021 - 2033)
- Testing Services
- Inspection Services
- Certification Services
- Global Medical Device Testing and Certification Market, By Sourcing Type (Revenue, USD Mn, 2021 - 2033)
- In-house
- Outsourced
- Global Medical Device Testing and Certification Market, By Device Class (Revenue, USD Mn, 2021 - 2033)
- Class I
- Class II
- Class III
- Global Medical Device Testing and Certification Market, By Technology (Revenue, USD Mn, 2021 - 2033)
- Active Implant Medical Device
- Active Medical Device
- Non-Active Medical Device
- In-Vitro Diagnostic Medical Device
- Ophthalmic Medical Device
- Orthopedic and Dental Medical Device
- Vascular Medical Device
- Other Technologies
- Regional Insights (Revenue, USD Mn, 2021 - 2033)
- North America
- U.S.
- Canada
- Latin America
- Brazil
- Argentina
- Mexico
- Rest of Latin America
- Europe
- Germany
- U.K.
- Spain
- France
- Italy
- Russia
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East
- GCC Countries
- Israel
- Rest of Middle East
- Africa
- South Africa
- North Africa
- Central Africa
- Company Profiles
- Medistri SA
- BSI Group
- Ente Certificazione Macchine
- GMED
- IMQ Group SRL
- TOXIKON
- TAceV SAceD
- WuXi AppTec
- Pace Analytical Services LLC
- Gateway Analytical LLC
- Boston Analytical
- Bureau Veritas
- UL LLC
- TUV Rheinland
- SGS SA
- Intertek Group PLC
- Eurofins Scientific
- Element Materials Technology
- Dekra Testing and Certification GmbH
- Institute for testing and Certification Inc.
Table of Contents:
1. Research Objectives and Assumptions
- Research Objectives
- Assumptions
- Abbreviations
2. Market Purview
- Report Description
- Market Definition and Scope
- Executive Summary
- Market Snapshot, By Services Type
- Market Snapshot, By Sourcing Type
- Market Snapshot, By Device Class
- Market Snapshot, By Technology
- Market Snapshot, By Geography
- Coherent Opportunity Map (COM)
3. Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Stringent rules and regulations
- Diversity in regulations
- Impact Analysis
- Key Highlights
- Regulatory Scenario
- Product launch/Approvals
- PEST Analysis
- PORTER's Analysis
- Merger and Acquisition Scenario
4. Global Medical Device Testing and Certification Market, By Service Type, 2021 - 2033, (US$ Mn)
- Introduction
- Market Share Analysis, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
- Testing Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
- Inspection Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
- Certification Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
5. Global Medical Device Testing and Certification Market, By Sourcing Type, 2021 - 2033, (US$ Mn)
- Introduction
- Market Share Analysis, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
- In-house
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
- Outsourced
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
6. Global Medical Device Testing and Certification Market, By Device Class, 2021 - 2033, (US$ Mn)
- Introduction
- Market Share Analysis, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
- Class I
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
- Class II
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
- Class III
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
7. Global Medical Device Testing and Certification Market, By Technology, 2021 - 2033, (US$ Mn)
- Introduction
- Market Share Analysis, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
- Active Implant Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
- Active Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
- Non-Active Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
- In-Vitro Diagnostic Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
- Ophthalmic Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
- Orthopedic and Dental Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
- Vascular Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
- Other Technologies
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021 - 2033,(US$ Mn)
8. Global Medical Device Testing and Certification Market, By Geography, 2021 - 2033, (US$ Mn)
- Introduction
- Market Share Analysis, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
- North America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2021 - 2033,(US$ Mn)
- Europe
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2021 - 2033,(US$ Mn)
- Asia Pacific
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2021 - 2033,(US$ Mn)
- Latin America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2021 - 2033,(US$ Mn)
- Middle East & Africa
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2021 - 2033,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2021 - 2033,(US$ Mn)
9. Competitive Landscape
- Medistri SA
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- BSI Group
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Ente Certificazione Macchine
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- GMED
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- IMQ Group SRL
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- TOXIKON
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- TUV SUD
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- WuXi AppTec
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Pace Analytical Services LLC
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Gateway Analytical LLC
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Boston Analytical
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Bureau Veritas
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- UL LLC
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- TUV Rheinland
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- SGS SA
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Intertek Group PLC
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Eurofins Scientific
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Element Materials Technology
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Dekra Testing and Certification GmbH
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Institute for testing and Certification Inc.
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Analyst Views
10. Section
- Research Methodology
- About us
