医疗设备测试服务市场规模、份额、成长分析、按服务类型、按设备类别、按测试类型、按设备类型、按最终用户、按地区 - 行业预测，2025-2032 年

2023年医疗设备测试服务市场规模将为88.3亿美元，预测期间（2025-2032年）复合年增长率为9.0%，从2024年的96.2亿美元增加到2032年的191.8亿美元，预计还会增长。

医疗设备测试服务市场对于确保医疗设备在推出前的安全性和监管合规性至关重要。随着设备变得更加复杂和法规收紧，对综合测试服务的需求正在迅速增加。这些服务范围从性能测试和生物相容性评估到灭菌验证和可用性评估。这些服务在识别风险和确保遵守 ISO 13485 和 FDA 指南等标准方面发挥关键作用。市场成长是由技术进步、对病人安全的日益关注以及製造商应对复杂法律规范的需求所推动的。此外，製造商和监管机构对这些服务重要性的日益认识也推动了市场扩张，主要企业为各种医疗设备提供专门的解决方案。

目录

介绍

• 研究目的
• 调查范围
• 定义

调查方法

• 资讯采购
• 二手资料和主要资料方法
• 市场规模预测
• 市场假设与限制

执行摘要

• 全球市场展望
• 供需趋势分析
• 按细分市场的机会分析

市场动态及展望

• 市场概况
• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制因素和挑战
• 波特的分析

主要市场考察

• 关键成功因素
• 竞争程度
• 主要投资机会
• 市场生态系统
• 市场吸引力指数（2024）
• PESTEL分析
• 总体经济指标
• 价值链分析
• 价格分析
• 技术进步
• 监管环境
• 专利分析
• 案例研究

医疗设备测试服务市场规模：依服务类型划分

• 市场概况
• 检验服务
  • 生物相容性测试
  • 化学测试
  • 微生物学和无菌测试
  • 电气安全测试
  • 电磁相容性 (EMC) 测试
  • 其他的
• 检验服务
  • 目视检查
  • 尺寸检验
  • 无损检测（NDT）
• 认证服务
  • ISO认证
  • CE标誌
  • FDA核准

医疗设备测试服务市场规模：依设备类别

• 市场概况
• I类设备
  • 非侵入性设备
  • 可重复使用的手术器械
• II 类设备
  • 诊断设备
  • 治疗设备
• III 类设备
  • 植入式装置
  • 维生设备

医疗设备测试服务市场规模：依测试类型

• 市场概况
• 内部测试
• 外包测试

按设备类型分類的医疗设备测试服务市场规模

• 市场概况
• 主动医疗设备
  • 心律调节器
  • 心臟去颤器
• 被动医疗设备
  • 手术器械
  • 病床
• 体外诊断设备
  • 试剂
  • 检测套组

医疗设备测试服务市场规模：依最终用户划分

• 市场概况
• 医院
• 临床实验室
• 调查机构
• 製造商

医疗设备检测服务市场规模

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲国家地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 其他亚太地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地区
• 中东/非洲
  • 海湾合作委员会国家
  • 南非
  • 其他中东/非洲

竞争资讯

• 前5名企业对比
• 主要企业市场定位（2024年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市场占有率分析（2024年）
• 主要企业简介
  • 公司简介
  • 产品系列分析
  • 按细分市场分類的份额分析
  • 收益与前一年同期比较（2022-2024）

主要企业简介

• SGS（Switzerland）
• Eurofins Scientific（UK）
• Bureau Veritas（France）
• Intertek（UK）
• TUV SUD（Germany）
• DEKRA（Germany）
• TUV Rheinland（Germany）
• UL LLC（USA）
• Element Materials Technology（UK）
• Charles River Laboratories（USA）
• Pace Analytical Services（USA）
• NSF International（USA）
• BSI Group（UK）
• LGC Group（UK）
• Medistri SA（Switzerland）
• Sterigenics International LLC（USA）
• Nelson Laboratories（USA）
• NTS（USA）
• Avomeen Analytical Services（USA）
• Accurate Chemical & Scientific Corporation（USA）

结论和建议

Medical Device Testing Services Market size was valued at USD 8.83 Billion in 2023 and is poised to grow from USD 9.62 Billion in 2024 to USD 19.18 Billion by 2032, growing at a CAGR of 9.0% during the forecast period (2025-2032).

The Medical Device Testing Services market is essential for ensuring the safety and regulatory compliance of medical devices prior to market introduction. As devices grow in complexity and regulations tighten, the demand for comprehensive testing services has skyrocketed. These services range from performance testing and biocompatibility assessments to sterilization validation and usability evaluations. They play a critical role in identifying risks and ensuring adherence to standards like ISO 13485 and FDA guidelines. Market growth is fueled by technological advancements, heightened focus on patient safety, and the necessity for manufacturers to navigate intricate regulatory frameworks. Moreover, the increasing awareness among manufacturers and regulators about the vital nature of these services further propels market expansion, with key players offering specialized solutions for diverse medical devices.

Top-down and bottom-up approaches were used to estimate and validate the size of the Medical Device Testing Services market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Medical Device Testing Services Market Segmental Analysis

Global Medical Device Testing Services Market is segmented by service type, device class, testing type, device type, end-user and region. Based on service type, the market is segmented into testing services, inspection services and certification services. Based on device class, the market is segmented into class I devices, class II devices and class III devices. Based on testing type, the market is segmented into in-house testing and outsourced testing. Based on device type, the market is segmented into active medical devices, non-active medical devices and in-vitro diagnostic devices. Based on end-user, the market is segmented into hospitals, clinical laboratories, research institutes and manufacturers. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Medical Device Testing Services Market

The Medical Device Testing Services market is significantly driven by the growing rigor of regulatory compliance and quality assurance demands. As regulatory bodies implement more stringent standards and requirements for medical devices, manufacturers are compelled to utilize extensive testing services to verify that their products fulfill the necessary safety and effectiveness benchmarks. This ensures not only regulatory approval but also enhances the likelihood of market acceptance. Consequently, the emphasis on maintaining high-quality standards and adhering to regulatory protocols is a crucial factor propelling the expansion of the Medical Device Testing Services market, as stakeholders strive to navigate the complexities of product testing and approval.

Restraints in the Medical Device Testing Services Market

The Medical Device Testing Services market faces significant constraints due to elevated testing costs. The complexity inherent in medical device evaluation, which requires detailed protocols and advanced equipment, can result in substantial financial burdens. This situation poses challenges, particularly for smaller manufacturers and startups with limited financial resources, as they may struggle to secure comprehensive testing services. Consequently, these constraints can hinder their ability to efficiently develop products and enter the market, ultimately stifling innovation and slowing down overall progress within the industry. Addressing these cost-related barriers is essential to support diverse participants in the medical device landscape.

Market Trends of the Medical Device Testing Services Market

The Medical Device Testing Services market is witnessing significant growth driven by heightened regulatory scrutiny from agencies like the FDA and European Medicines Agency. Manufacturers are increasingly prioritizing compliance with rigorous quality and safety standards, resulting in a surge in demand for comprehensive testing services. This trend has prompted service providers to enhance their offerings, addressing a broad spectrum of regulatory requirements encompassing both pre-market and post-market testing. As medical device companies seek to mitigate risks and streamline the approval process, investments in advanced testing methodologies and technologies are becoming integral, positioning the market for robust expansion in the coming years.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Technological Advancement
• Regulatory Landscape
• Patent Analysis
• Case Studies

Global Medical Device Testing Services Market Size by Service Type & CAGR (2025-2032)

• Market Overview
• Testing Services
  • Biocompatibility Testing
  • Chemistry Testing
  • Microbiology & Sterility Testing
  • Electrical Safety Testing
  • Electromagnetic Compatibility (EMC) Testing
  • Others
• Inspection Services
  • Visual Inspection
  • Dimensional Inspection
  • Non-Destructive Testing (NDT)
• Certification Services
  • ISO Certification
  • CE Marking
  • FDA Approval

Global Medical Device Testing Services Market Size by Device Class & CAGR (2025-2032)

• Market Overview
• Class I Devices
  • Non-Invasive Devices
  • Reusable Surgical Instruments
• Class II Devices
  • Diagnostic Devices
  • Therapeutic Devices
• Class III Devices
  • Implantable Devices
  • Life-Supporting Devices

Global Medical Device Testing Services Market Size by Testing Type & CAGR (2025-2032)

• Market Overview
• In-House Testing
• Outsourced Testing

Global Medical Device Testing Services Market Size by Device Type & CAGR (2025-2032)

• Market Overview
• Active Medical Devices
  • Pacemakers
  • Defibrillators
• Non-Active Medical Devices
  • Surgical Instruments
  • Hospital Beds
• In-Vitro Diagnostic Devices
  • Reagents
  • Test Kits

Global Medical Device Testing Services Market Size by End-User & CAGR (2025-2032)

• Market Overview
• Hospitals
• Clinical Laboratories
• Research Institutes
• Manufacturers

Global Medical Device Testing Services Market Size & CAGR (2025-2032)

• North America (Service Type, Device Class, Testing Type, Device Type, End-User)
  • US
  • Canada
• Europe (Service Type, Device Class, Testing Type, Device Type, End-User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Service Type, Device Class, Testing Type, Device Type, End-User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Service Type, Device Class, Testing Type, Device Type, End-User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Service Type, Device Class, Testing Type, Device Type, End-User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• SGS (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eurofins Scientific (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bureau Veritas (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Intertek (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• TUV SUD (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• DEKRA (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• TUV Rheinland (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• UL LLC (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Element Materials Technology (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pace Analytical Services (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• NSF International (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BSI Group (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• LGC Group (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Medistri SA (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sterigenics International LLC (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nelson Laboratories (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• NTS (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Avomeen Analytical Services (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Accurate Chemical & Scientific Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations