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市场调查报告书
商品编码
1747304
医疗设备测试和认证市场（按服务类型、采购类型、设备类别、技术和地区划分）Medical Device Testing and Certification Market, By Service Type, By Sourcing Type, By Device Class, By Technology, and By Geography |
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价格
简介目录
预计医疗设备测试和认证市场在 2025 年将保持 109.579 亿美元的市场规模，到 2032 年将达到 147.136 亿美元，2025 年至 2032 年的复合年增长率为 4.3%。
| 报告范围 | 报告详细信息 | ||
|---|---|---|---|
| 基准年 | 2024 | 2025年的市场规模 | 109.579亿美元 |
| 效能数据 | 从2020年到2024年 | 预测期 | 2025年至2032年 |
| 预测期：2025-2032年复合年增长率： | 4.30% | 2032年价值预测 | 147.136亿美元 |
医疗设备测试和认证对于确保其安全性和有效性至关重要。美国遵循食品药物管理局( FDA) 的指导方针，加拿大要求在加拿大卫生署註册，欧洲考虑欧洲符合性 (CE) 认证，印度则要求获得中央药品标准控制组织 (CDSCO) 的批准。
市场动态：
对医疗设备测试和认证的关注度不断提高、政府法规越来越严格、人工智慧 (AI) 和物联网 (IoT) 在医疗设备中的日益融合以及 COVID-19 疫情是预计在预测期内推动全球医疗设备测试和认证市场成长的关键因素。
例如，2022年1月，TUV SUD扩建了位于明尼苏达州新布莱顿的医疗设备检测实验室。这座先进的检测设施将为所有医疗设备提供端到端的检测解决方案，并将对医疗设备，从而补充TUV SUD现有的主动医疗设备检测能力。
本研究的主要特点
- 本报告对全球医疗设备测试和认证市场进行了详细分析，并以 2024 年为基准年，提供了 2025 年至 2032 年预测期的市场规模和年复合成长率(CAGR)。
- 它还强调了各个领域的潜在商机，并说明了该市场的有吸引力的投资提案矩阵。
- 它还提供了有关市场驱动因素、限制因素、机会、新产品发布和核准、市场趋势、区域前景和主要企业采用的竞争策略的主要考察。
- 该报告涵盖了全球医疗设备测试和认证市场的主要企业概况，基于以下参数，例如公司亮点、产品系列、关键亮点、财务表现和策略。
- 本报告的见解将使负责人和公司经营团队能够就未来的产品发布、类型升级、市场扩张和行销策略做出明智的决策。
- 全球医疗设备测试与认证市场报告针对该行业的各个相关人员，包括投资者、供应商、产品製造商、经销商、新进业者和金融分析师。
- 相关人员可以透过用于分析全球医疗设备测试和认证市场的各种策略矩阵来促进他们的决策。
目录：
第一章 调查目的与前提条件
- 研究目标
- 先决条件
- 简称
第二章 市场展望
- 报告描述
- 市场定义和范围
- 执行摘要
- Coherent Opportunity Map（COM）
第三章市场动态、法规与趋势分析
- 市场动态
- 严格的规章制度
- 监管多样性
- COVID-19（大流行）疫情
- 影响分析
- 主要亮点
- 监管情景
- 产品发布/核准
- PEST分析
- 波特分析
- 併购场景
4. 全球医疗设备测试和认证市场-冠状病毒（COVID-19）大流行的影响
- COVID-19流行病学
- 供需侧分析
- 经济影响
5. 2020 年至 2032 年全球医疗设备测试及认证市场（按服务类型）
- 测试服务
- 检验服务
- 身份验证服务
6. 2020 年至 2032 年按采购类型分類的全球医疗设备测试和认证市场
- 内部
- 外包
7. 2020 年至 2032 年全球医疗设备测试及认证市场（按设备类别）
- I类
- II 类
- III 类
8. 全球医疗设备测试与认证市场（依技术划分），2020 年至 2032 年
- 主动植入医疗设备
- 有源医疗设备
- 被动医疗设备
- 体外诊断医疗设备
- 眼科医疗设备
- 整形外科和牙科医疗设备
- 血管医疗设备
- 其他技术
9. 2020 年至 2032 年全球医疗设备测试及认证市场（按地区）
- 北美洲
- 欧洲
- 亚太地区
- 拉丁美洲
- 中东和非洲
第十章 竞争格局
- Medistri SA
- BSI Group
- Ente Certificazione Macchine
- GMED
- IMQ Group SRL
- TOXIKON
- TUV SUD
- 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.
第 11 章 章节
- 调查方法
- 关于出版商
简介目录
Product Code: CMI5665
Medical Device Testing and Certification Market is poised to hold a valuation of USD 10,957.9 Mn in 2025 and is expected to reach USD 14,713.6 Mn in 2032. The market is expected to exhibit a CAGR of 4.3% from 2025 to 2032.
| Report Coverage | Report Details | ||
|---|---|---|---|
| Base Year: | 2024 | Market Size in 2025: | USD 10,957.9 Mn |
| Historical Data for: | 2020 To 2024 | Forecast Period: | 2025 To 2032 |
| Forecast Period 2025 to 2032 CAGR: | 4.30% | 2032 Value Projection: | USD 14,713.6 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, TUV SUD 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 TUV SUD's current active medical device testing capabilities.
Key features of the study:
- This report provides in-depth analysis of the global medical device testing and certification market, and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period 2025-2032, considering 2024 as the base year.
- 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, TUV SUD, 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
- Testing Services
- Inspection Services
- Certification Services
- Global Medical Device Testing and Certification Market, By Sourcing Type
- In-house
- Outsourced
- Global Medical Device Testing and Certification Market, By Device Class
- Class I
- Class II
- Class III
- Global Medical Device Testing and Certification Market, By Technology
- 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
- Global Medical Device Testing and Certification Market, By Geography
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
- Company Profiles
- Medistri SA
- BSI Group
- Ente Certificazione Macchine
- GMED
- IMQ Group SRL
- TOXIKON
- TUV SUD
- 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
- Outbreak of COVID-19 (pandemic)
- 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 - Impact of Coronavirus (COVID-19) Pandemic
- COVID-19 Epidemiology
- Supply Side and Demand Side Analysis
- Economic Impact
5. Global Medical Device Testing and Certification Market, By Service Type, 2020-2032, (US$ Mn)
- Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021 - 2032
- Segment Trends
- Testing Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Inspection Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Certification Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
6. Global Medical Device Testing and Certification Market, By Sourcing Type, 2020-2032, (US$ Mn)
- Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021 - 2032
- Segment Trends
- In-house
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Outsourced
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
7. Global Medical Device Testing and Certification Market, By Device Class, 2020-2032, (US$ Mn)
- Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021 - 2032
- Segment Trends
- Class I
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Class II
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Class III
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
8. Global Medical Device Testing and Certification Market, By Technology, 2020-2032, (US$ Mn)
- Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021 - 2032
- Segment Trends
- Active Implant Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Active Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Non-Active Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- In-Vitro Diagnostic Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Ophthalmic Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Orthopedic and Dental Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Vascular Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Other Technologies
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
9. Global Medical Device Testing and Certification Market, By Geography, 2020-2032, (US$ Mn)
- Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021 - 2032
- Segment Trends
- North America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
- Europe
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
- Asia Pacific
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
- Latin America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
- Middle East & Africa
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
10. 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
11. Section
- Research Methodology
- About us
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