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市場調查報告書
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1771489

美國醫療設備測試、檢驗和認證外包市場：市場規模、佔有率、趨勢分析（按服務、設備類別和最終用途）、細分預測（2025-2030 年）

U.S. Medical Device Testing, Inspection & Certification Outsourcing Market Size, Share & Trends Analysis Report By Service, By Device Class, By End Use, And Segment Forecasts, 2025 - 2030
出版日期: | 出版商: Grand View Research | 英文 120 Pages | 商品交期: 2-10個工作天內

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市場規模與趨勢：

美國醫療設備測試、檢驗和認證外包市場規模預計在2024年達到5.525億美元，預計2025年至2030年期間的複合年成長率為9.0%。推動這一成長的因素包括：法規合規性要求日益提高、醫療設備（尤其是具備數位醫療功能的設備）的技術複雜性日益提升，以及對縮短時間的需求日益成長。這些全球趨勢促使設備製造商與經驗豐富的測試、檢驗和認證 (TIC) 供應商合作，以滿足安全和品質標準，最佳化開發週期，並確保全球市場的監管一致性。

美國醫療設備業產業日益複雜的監管環境正推動測試、檢驗和認證服務向外包方向的顯著轉變。製造商正在應對由更嚴格的 FDA 指南所塑造的市場環境，這些指南涵蓋資源彙整通訊協定、可用性工程、生物相容性測試等。這些要求使得內部監管合規工作越來越耗費資源，尤其對於規模較小的公司。因此，醫療設備公司正在轉向擁有深厚監管知識和認證基礎設施的專業 TIC 提供者。這些公司不僅幫助企業完成 510(k) 和 PMA 核准流程，還提供提交監管文件所需的文件和資料。這種夥伴關係減輕了內部業務負擔，並提高了測試結果的準確性和完整性。

醫療設備日益複雜，尤其是數位技術和互聯技術的整合，推動了對專門驗證和效能測試的需求。現代醫療設備包括嵌入式軟體、無線模組、人工智慧診斷和感測器技術，這些都需要先進的測試環境和模擬工具。內部團隊通常缺乏根據實際條件和新安全標準檢驗這些功能的能力。 TIC 供應商提供客製化服務，例如軟體生命週期測試、電磁相容性 (EMC) 評估、無線訊號可靠性測試和雲端平台安全性評估。隨著市場轉向穿戴式健康監測器、遠距離診斷工具和機器人輔助手術系統，這些服務變得至關重要。臨床和家庭環境中對此類設備的依賴性日益增加，需要更全面的測試，許多公司正在外包以加速開發。隨著設備功能不斷發展以滿足新的臨床需求，外包使製造商能夠跟上技術創新，同時保持強大的安全檢驗。

目錄

第1章 分析方法與範圍

第2章執行摘要

第3章美國醫療設備測試、檢驗和認證外包市場：促進因素、趨勢和範圍

  • 市場聯動展望
    • 母市場展望
    • 相關/附隨市場展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制分析
  • 技術狀況
  • 定價模式分析
  • 產業和市場分析工具
    • 產業分析：波特五力分析
    • PESTEL分析
    • COVID-19影響分析

第4章美國醫療設備測試、檢驗和認證外包市場：按服務分類的估計和趨勢分析

  • 細分儀表板
  • 美國醫療設備測試、檢驗和認證外包市場：按服務分類的趨勢分析
  • 美國醫療設備測試、檢驗和認證外包市場規模和趨勢分析（按服務分類）（2018-2030 年）
  • 測試
  • 檢查
  • 認證

第5章美國醫療設備測試、檢驗和認證外包市場：按設備類別的估計和趨勢分析

  • 細分儀表板
  • 美國醫療設備測試、檢驗和認證外包市場：按設備類別進行趨勢分析
  • 美國醫療設備測試、檢驗及認證外包市場規模及趨勢分析（按設備類別）（2018-2030）
  • I類
  • II 類
  • III 類

第6章：美國醫療設備測試、檢驗和認證外包市場：依最終用途的估計和趨勢分析

  • 細分儀表板
  • 美國醫療設備測試、檢驗和認證外包市場：按最終用途進行趨勢分析
  • 美國醫療設備測試、檢驗和認證外包市場規模和趨勢分析（按最終用途）（2018-2030 年）
  • 醫療設備公司
  • 製藥和生物技術公司
  • 其他

第7章 競爭態勢

  • 競爭性分類
  • 公司市場佔有率/估值分析（2024年）
  • 公司簡介
    • SGS SA
    • Intertek Group plc
    • Eurofins Scientific SE
    • DEKRA CERTIFICATION BV
    • UL Solutions Inc.
    • TUV SUD
    • ALS Limited
    • Bureau Veritas SA
    • Element Materials Technology
    • Nelson Labs
Product Code: GVR-4-68040-612-2

Market Size & Trends:

The U.S. medical device testing, inspection & certification outsourcing market size was estimated at USD 552.5 million in 2024 and is projected to grow at a CAGR of 9.0% from 2025 to 2030. The growth is driven by the increasing demand for regulatory compliance, the increasing technological complexity of medical devices, especially those with digital health features, and the growing need for faster time-to-market. These trends are driving device manufacturers to partner with experienced TIC providers to meet safety and quality standards, optimize development cycles, and ensure regulatory alignment across global markets.

Rising regulatory complexity in the U.S. medical device industry is prompting a notable shift toward outsourcing of testing, inspection, and certification services. Manufacturers are navigating a landscape shaped by more rigorous FDA guidelines covering cybersecurity protocols, usability engineering, and biocompatibility testing. These demands have made in-house regulatory compliance increasingly resource-intensive, especially for small and mid-sized firms. As a result, medical device companies are turning to specialized TIC providers with deep regulatory knowledge and accredited infrastructure. These firms not only help navigate 510(k) and PMA pathways but also provide documentation and data needed for regulatory submissions. The partnership reduces internal operational burden and improves the accuracy and completeness of testing outputs.

The increasing complexity of medical devices, particularly with the integration of digital and connected technologies, is intensifying demand for specialized validation and performance testing. Several modern devices now include embedded software, wireless modules, AI-powered diagnostics, and sensor technologies that require advanced testing environments and simulation tools. In-house teams often lack the capabilities to validate these features against real-world conditions or emerging safety standards. TIC providers offer tailored services such as software lifecycle testing, electromagnetic compatibility (EMC) assessments, wireless signal reliability testing, and cloud platform security evaluations. These services are becoming essential as the market shifts toward wearable health monitors, remote diagnostic tools, and robotic-assisted surgical systems. The growing reliance on such devices in both clinical and home settings necessitates more comprehensive testing, which many companies are outsourcing to accelerate development. As device functionalities evolve to meet new clinical demands, outsourcing allows manufacturers to keep pace with innovation while maintaining robust safety validation.

U.S. Medical Device Testing, Inspection & Certification Outsourcing Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. medical device testing, inspection, and certification outsourcing market report based on service, device class, and end use.

  • Service Outlook (Revenue, USD Million, 2018 - 2030)
  • Testing
  • Inspection
  • Certification
  • Device Class Outlook (Revenue, USD Million, 2018 - 2030)
  • Class I
  • Class II
  • Class III
  • End Use Outlook (Revenue, USD Million, 2018 - 2030)
  • Medical Device Companies
  • Pharmaceutical and Biotech Companies
  • Others

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
    • 1.1.1. Regional Scope
    • 1.1.2. Estimates and Forecast Timeline
  • 1.2. Market Definitions
  • 1.3. Research Methodology
    • 1.3.1. Information Procurement
    • 1.3.2. Purchased Database
    • 1.3.3. GVR's Internal Database
    • 1.3.4. Secondary Sources
    • 1.3.5. Primary Research
  • 1.4. Information or Data Analysis
    • 1.4.1. Information Analysis
    • 1.4.2. Market Formulation & Data Visualization
    • 1.4.3. Data Validation & Publishing
  • 1.5. Model Details
    • 1.5.1. Commodity Flow Analysis (Model 1)
    • 1.5.2. Top Down Market Estimation (Model 2)
    • 1.5.3. Value-Chain-Based Sizing & Forecasting (Model 3)
    • 1.5.4. Multivariate Analysis (Model 4)
  • 1.6. List of Secondary Sources
  • 1.7. List of Abbreviations
  • 1.8. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Snapshot
  • 2.3. Competitive Insights Landscape

Chapter 3. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market Variables, Trends & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent market outlook
    • 3.1.2. Related/ancillary market outlook.
  • 3.2. Market Dynamics
    • 3.2.1. Market Driver Analysis
    • 3.2.2. Market Restraint Analysis
  • 3.3. Technology Landscape
  • 3.4. Pricing Model Analysis
  • 3.5. Industry Market Analysis Tools
    • 3.5.1. Industry Analysis - Porter's
    • 3.5.2. PESTEL Analysis
    • 3.5.3. COVID-19 Impact Analysis

Chapter 4. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market: Service Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market Service Movement Analysis
  • 4.3. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
  • 4.4. Testing
    • 4.4.1. Testing market estimates and forecasts, 2018 - 2030 (USD Million)
  • 4.5. Inspection
    • 4.5.1. Inspection market estimates and forecasts, 2018 - 2030 (USD Million)
  • 4.6. Certification
    • 4.6.1. Certification market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 5. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market: Device Class Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market Device Class Movement Analysis
  • 5.3. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market Size & Trend Analysis, by Device Class, 2018 to 2030 (USD Million)
  • 5.4. Class I
    • 5.4.1. Class I market estimates and forecasts, 2018 - 2030 (USD Million)
  • 5.5. Class II
    • 5.5.1. Class II market estimates and forecasts, 2018 - 2030 (USD Million)
  • 5.6. Class III
    • 5.6.1. Class III market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 6. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market: End Use Estimates & Trend Analysis

  • 6.1. Segment Dashboard
  • 6.2. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market End Use Movement Analysis
  • 6.3. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market Size & Trend Analysis, by End Use, 2018 to 2030 (USD Million)
  • 6.4. Medical Device Companies
    • 6.4.1. Medical device companies market estimates and forecasts, 2018 - 2030 (USD Million)
  • 6.5. Pharmaceutical and Biotech Companies
    • 6.5.1. Pharmaceutical and biotech companies market estimates and forecasts, 2018 - 2030 (USD Million)
  • 6.6. Others
    • 6.6.1. Others market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 7. Competitive Landscape

  • 7.1. Competition Categorization
  • 7.2. Company Market Share/Assessment Analysis, 2024
  • 7.3. Company Profiles
    • 7.3.1. SGS SA
      • 7.3.1.1. Company overview
      • 7.3.1.2. Financial performance
      • 7.3.1.3. Service benchmarking
      • 7.3.1.4. Strategic initiatives
    • 7.3.2. Intertek Group plc
      • 7.3.2.1. Company overview
      • 7.3.2.2. Financial performance
      • 7.3.2.3. Service benchmarking
      • 7.3.2.4. Strategic initiatives
    • 7.3.3. Eurofins Scientific SE
      • 7.3.3.1. Company overview
      • 7.3.3.2. Financial performance
      • 7.3.3.3. Service benchmarking
      • 7.3.3.4. Strategic initiatives
    • 7.3.4. DEKRA CERTIFICATION B.V.
      • 7.3.4.1. Company overview
      • 7.3.4.2. Financial performance
      • 7.3.4.3. Service benchmarking
      • 7.3.4.4. Strategic initiatives
    • 7.3.5. UL Solutions Inc.
      • 7.3.5.1. Company overview
      • 7.3.5.2. Financial performance
      • 7.3.5.3. Service benchmarking
      • 7.3.5.4. Strategic initiatives
    • 7.3.6. TUV SUD
      • 7.3.6.1. Company overview
      • 7.3.6.2. Financial performance
      • 7.3.6.3. Service benchmarking
      • 7.3.6.4. Strategic initiatives
    • 7.3.7. ALS Limited
      • 7.3.7.1. Company overview
      • 7.3.7.2. Financial performance
      • 7.3.7.3. Service benchmarking
      • 7.3.7.4. Strategic initiatives
    • 7.3.8. Bureau Veritas SA
      • 7.3.8.1. Company overview
      • 7.3.8.2. Financial performance
      • 7.3.8.3. Service benchmarking
      • 7.3.8.4. Strategic initiatives
    • 7.3.9. Element Materials Technology
      • 7.3.9.1. Company overview
      • 7.3.9.2. Financial performance
      • 7.3.9.3. Service benchmarking
      • 7.3.9.4. Strategic initiatives
    • 7.3.10. Nelson Labs
      • 7.3.10.1. Company overview
      • 7.3.10.2. Financial performance
      • 7.3.10.3. Service benchmarking
      • 7.3.10.4. Strategic initiatives

List of Tables

  • Table 1 List of Secondary Sources
  • Table 2 List of Abbreviations
  • Table 3 U.S. Medical Device Testing, Inspection & Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
  • Table 4 U.S. Medical Device Testing, Inspection & Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
  • Table 5 U.S. Medical Device Testing, Inspection & Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)

List of Figures

  • Fig. 1 Medical Device Testing, Inspection and Certification Outsourcing, Market Segmentation
  • Fig. 2 Market research process
  • Fig. 3 Information Procurement
  • Fig. 4 Primary Research Pattern
  • Fig. 5 Market Research Approaches
  • Fig. 6 Value Chain-Based Sizing & Forecasting
  • Fig. 7 Market Formulation & Validation
  • Fig. 8 Market Dynamics
  • Fig. 9 Market Driver Relevance Analysis (Current & Future Impact)
  • Fig. 10 Market Restraint Relevance Analysis (Current & Future Impact)
  • Fig. 11 Porter's Five Forces Analysis
  • Fig. 12 PESTEL by SWOT Analysis
  • Fig. 13 Country Marketplace: Key Takeaways
  • Fig. 14 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Testing, 2018 - 2030 (USD Million)
  • Fig. 15 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Inspection, 2018 - 2030 (USD Million)
  • Fig. 16 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Certification, 2018 - 2030 (USD Million)
  • Fig. 17 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Class I, 2018 - 2030 (USD Million)
  • Fig. 18 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Class II, 2018 - 2030 (USD Million)
  • Fig. 19 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Class III, 2018 - 2030 (USD Million)
  • Fig. 20 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Medical Device Companies, 2018 - 2030 (USD Million)
  • Fig. 21 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Pharmaceutical and Biotech Companies, 2018 - 2030 (USD Million)
  • Fig. 22 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Others, 2018 - 2030 (USD Million)