醫療設備測試服務市場規模、佔有率、成長分析、按服務類型、按設備類別、按測試類型、按設備類型、按最終用戶、按地區 - 行業預測，2025-2032 年

2023年醫療設備測試服務市場規模將為88.3億美元，預測期間（2025-2032年）複合年成長率為9.0%，從2024年的96.2億美元增加到2032年的191.8億美元，預計還會成長。

醫療設備測試服務市場對於確保醫療設備在推出前的安全性和監管合規性至關重要。隨著設備變得更加複雜和法規收緊，對綜合測試服務的需求正在迅速增加。這些服務範圍從性能測試和生物相容性評估到滅菌驗證和可用性評估。這些服務在識別風險和確保遵守 ISO 13485 和 FDA 指南等標準方面發揮關鍵作用。市場成長是由技術進步、對病人安全的日益關注以及製造商應對複雜法律規範的需求所推動的。此外，製造商和監管機構對這些服務重要性的日益認知也推動了市場擴張，主要企業為各種醫療設備提供專門的解決方案。

目錄

介紹

• 研究目的
• 調查範圍
• 定義

調查方法

• 資訊採購
• 二手資料和主要資料方法
• 市場規模預測
• 市場假設與限制

執行摘要

• 全球市場展望
• 供需趨勢分析
• 按細分市場的機會分析

市場動態及展望

• 市場概況
• 市場規模
• 市場動態
  • 促進因素和機遇
  • 限制因素和挑戰
• 波特的分析

主要市場考察

• 關鍵成功因素
• 競爭程度
• 主要投資機會
• 市場生態系統
• 市場吸引力指數（2024）
• PESTEL分析
• 總體經濟指標
• 價值鏈分析
• 價格分析
• 技術進步
• 監管環境
• 專利分析
• 案例研究

醫療設備測試服務市場規模：依服務類型分類

• 市場概況
• 檢驗服務
  • 生物相容性測試
  • 化學測試
  • 微生物學和無菌測試
  • 電氣安全測試
  • 電磁相容性 (EMC) 測試
  • 其他
• 檢驗服務
  • 目視檢查
  • 尺寸檢驗
  • 無損檢測（NDT）
• 認證服務
  • ISO認證
  • CE標誌
  • FDA核准

醫療設備測試服務市場規模：依設備類別

• 市場概況
• I類設備
  • 非侵入性設備
  • 可重複使用的手術器械
• II 類設備
  • 診斷設備
  • 治療設備
• III 類設備
  • 植入式裝置
  • 維生設備

醫療設備測試服務市場規模：依測試類型

• 市場概況
• 內部測試
• 外包測試

按設備類型分類的醫療設備測試服務市場規模

• 市場概況
• 主動醫療設備
  • 心律調節器
  • 心臟去顫器
• 被動醫療設備
  • 手術器械
  • 病床
• 體外診斷設備
  • 試劑
  • 檢測套組

醫療設備測試服務市場規模：依最終用戶分類

• 市場概況
• 醫院
• 臨床實驗室
• 調查機構
• 製造商

醫療設備檢測服務市場規模

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲國家地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 其他亞太地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地區
• 中東/非洲
  • 海灣合作理事會國家
  • 南非
  • 其他中東/非洲

競爭資訊

• 前5名企業對比
• 主要企業市場定位（2024年）
• 主要市場參與者所採取的策略
• 近期市場趨勢
• 公司市場佔有率分析（2024年）
• 主要企業簡介
  • 公司簡介
  • 產品系列分析
  • 按細分市場分類的佔有率分析
  • 收益與前一年同期比較（2022-2024）

主要企業簡介

• 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）

結論和建議

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