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1842077

美國醫療設備檢測服務市場：市場規模、佔有率、趨勢分析（按服務和階段分類）、細分市場預測（2025-2033 年）

U.S. Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service, By Phase, And Segment Forecasts, 2025 - 2033
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

價格

美國醫療設備檢測服務市場摘要

預計到 2024 年，美國醫療設備測試服務市場規模將達到 22.3 億美元，預計從 2025 年到 2033 年將達到 50.9 億美元，複合年成長率為 9.66%。

市場發展受到強力的法律規範、快速的技術創新以及進入市場的設備日益複雜化的驅動。

其他推動市場成長的因素包括人口老化、慢性病發病率上升以及源源不絕的技術創新。製造商擴大將測試活動外包，以降低合規成本、應對複雜的法規並加快產品上市速度。此外，美國食品藥物管理局(FDA) 制定的嚴格安全和性能標準以及 ISO 和 IEC 標準等國際合規要求，也推動了對專業第三方測試服務的需求。這些服務對於確保合規性、降低風險以及縮短時間至關重要，尤其是在微創手術器材、植入式醫療器材、診斷影像系統和穿戴式技術等高成長領域。

此外，由於先進材料、小型化、人工智慧 (AI)、物聯網 (IoT) 和無線技術的整合，設備設計的複雜性日益增加，這也擴大了測試要求，包括網路安全檢驗、軟體效能測試、可用性工程和互通性評估。此外，新一代和下一代設備的臨床試驗數量迅速成長，也提高了對電氣安全、電磁相容性 (EMC)、機械耐久性、微生物安全性和生物相容性評估等方面的能力需求。此外，目前的測試流程涵蓋多個階段，包括可行性研究、性能檢驗和上市後監測，以確保產品有效性和患者安全。

目錄

第1章 分析方法和範圍

第2章執行摘要

第3章醫療設備檢測服務市場：影響因素、趨勢與範圍

  • 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
    • 市場限制因素分析
    • 市場挑戰
    • 市場機遇
  • 科技情勢
  • 定價模式分析
  • 關稅影響分析
  • 價值鏈分析
    • 供應趨勢
    • 需求趨勢
  • 市場分析工具
    • 波特五力分析
    • PESTEL分析與SWOT分析
    • 新冠疫情影響分析

第4章：美國醫療設備測試服務市場：按服務類型分類的估算與趨勢分析

  • 美國醫療設備測試服務市場：概覽（按服務分類）
  • 美國醫療設備檢測服務市場：按服務類型分類的變化分析
  • 依服務年資（2021-2033）
  • 生物相容性測試
    • 心血管器械生物相容性測試
    • 整形外科器械生物相容性測試
    • 人工植牙裝置的生物相容性測試
    • 皮膚填充劑的生物相容性測試
    • 一般外科植入裝置生物相容性測試
    • 神經外科植入裝置的生物相容性測試
    • 眼科植入裝置的生物相容性測試
    • 其他
  • 化學測試
    • 化學表徵（E&L）
    • 分析方法開發與檢驗
    • 毒理學風險評估與諮詢
  • 微生物學和無菌性檢測
    • 微生物附著量測量
    • 熱原和內毒素檢測
    • 無菌檢測和檢驗
    • 抗菌測試
    • 其他
  • 軟體包檢驗

第5章：美國醫療設備測試服務市場：按階段分類的估算與趨勢分析

  • 美國醫療設備測試服務市場：按階段分類的概覽
  • 美國醫療設備檢測服務市場：按階段分類的變化分析
  • 依階段分類（2021-2033 年）
  • 臨床前
    • 小動物
    • 大型動物
    • 其他
  • 臨床

第6章 競爭情勢

  • 參與企業
  • 市場分析（熱力圖分析，2024 年）
  • 公司簡介
    • SGS SA
    • Laboratory Corporation of America Holdings
    • Nelson Laboratories, LLC
    • TUV SUD
    • Charles River Laboratories
    • Element Minnetonka
    • Eurofins Scientific
    • Pace Analytical Services LLC
    • Intertek Group Plc
    • North America Science Associates Inc.（NAMSA）
Product Code: GVR-4-68040-727-9

U.S. Medical Device Testing Services Market Summary

The U.S. medical device testing services market size was estimated at USD 2.23 billion in 2024 and is projected to reach USD 5.09 billion, growing at a CAGR of 9.66% from 2025 to 2033. The market is driven by a strong regulatory framework, rapid technological innovations, and the increasing complexity of devices entering the market.

Other factors contributing to market growth are an aging population, a rise in chronic diseases, and a robust innovation pipeline. Manufacturers are increasingly outsourcing testing functions to reduce compliance costs, navigate regulatory complexities, and accelerate product launches. Besides, the stringent safety and performance standards set by the U.S. Food and Drug Administration (FDA) and international compliance requirements such as ISO and IEC standards fuel demand for specialized third-party testing services. These services are essential for ensuring regulatory compliance, mitigating risks, and accelerating the time-to-market for manufacturers, particularly in high-growth sectors like minimally invasive surgical tools, implantable devices, diagnostic imaging systems, and wearable technologies.

In addition, the rising complexity in device design due to advanced materials, miniaturization, and the integration of artificial intelligence (AI), Internet of Things (IoT), and wireless technologies has expanded testing requirements to encompass cybersecurity validation, software performance testing, usability engineering, and interoperability assessments. Besides, the surge in clinical trials for both novel and next-generation devices has increased the demand for capabilities in electrical safety, electromagnetic compatibility (EMC), mechanical durability, microbiological safety, and biocompatibility evaluation. Also, the current testing processes cover multiple stages, including feasibility studies, performance verification, and post-market surveillance, ensuring product efficacy and patient safety.

U.S. Medical Device Testing Services 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 2021 to 2033. For this study, Grand View Research has segmented the U.S. medical device testing services market report based onservice and phase:

  • ServiceOutlook (Revenue, USD Million, 2021 - 2033)
  • Biocompatibility Tests
  • Cardiovascular Device's Biocompatibility Tests
  • Orthopedic Device's Biocompatibility Tests
  • Dental Implant Devices' Biocompatibility Tests
  • Dermal Filler's Biocompatibility Tests
  • General Surgery Implantation Devices Biocompatibility Tests
  • Neurosurgical Implantation Devices Biocompatibility Tests
  • Ophthalmic Implantation Device's Biocompatibility Tests
  • Others
  • Chemistry Test
  • Chemical characterization (E&L)
  • Analytical method development and validation
  • Toxicological Risk Assessment and consulting
  • Microbiology & Sterility Test
  • Bioburden Determination
  • Pyrogen & Endotoxin Testing
  • Sterility Test & Validation
  • Antimicrobial Testing
  • Others
  • Package Validation
  • Phase Outlook (Revenue, USD Million, 2021 - 2033)
  • Preclinical
  • Large animal research
    • Biocompatibility Tests
    • Chemistry Test
    • Microbiology & Sterility Test
  • Small animal research
    • Biocompatibility Tests
    • Chemistry Test
    • Microbiology & Sterility Test
  • Clinical

Table of Contents

Chapter 1. Research Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Service
    • 1.2.2. Phase
  • 1.3. Research Methodology
  • 1.4. Information Procurement
    • 1.4.1. Purchased Database
    • 1.4.2. GVR's Internal Database
    • 1.4.3. Secondary Sources
    • 1.4.4. Primary Research
  • 1.5. Information Or Data Analysis
    • 1.5.1. Data Analysis Models
  • 1.6. Market Formulation & Validation
  • 1.7. Model Details
    • 1.7.1. Commodity Flow Analysis
    • 1.7.2. Parent Market Analysis
  • 1.8. List Of Secondary Sources
  • 1.9. List Of Abbreviations
  • 1.10. Objectives

Chapter 2. Executive Summary

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

Chapter 3. U.S. Medical Device Testing Services 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
      • 3.2.1.1. Complexity in Product Design Of Medical Device Testing Services
      • 3.2.1.2. Intense Competition in Medical Device Industry
      • 3.2.1.3. Increasing number of smaller Players lacking in-house testing capabilities
      • 3.2.1.4. Strict Approval Norms
    • 3.2.2. Market Restraint Analysis
      • 3.2.2.1. Legal and Regulatory Issues
      • 3.2.2.2. Delays in contractual obligations
    • 3.2.3. Market Challenges
    • 3.2.4. Market Opportunities
  • 3.3. Technology Landscape
  • 3.4. Pricing Model Analysis
  • 3.5. Tariff Impact Analysis
  • 3.6. Value Chain Analysis
    • 3.6.1. Supply Trends
    • 3.6.2. Demand Trends
  • 3.7. Market Analysis Tools
    • 3.7.1. Porter's Five Force Analysis
    • 3.7.2. PESTEL by SWOT Analysis
    • 3.7.3. COVID-19 Impact Analysis

Chapter 4. U.S. Medical Device Testing Services Market: Service Estimates & Trend Analysis

  • 4.1. U.S. Medical Device Testing Services Market, By Service: Segment Dashboard
  • 4.2. U.S. Medical Device Testing Services Market, By Service: Movement Analysis
  • 4.3. U.S. Medical Device Testing Services Market Estimates & Forecasts, By Service, 2021 - 2033
  • 4.4. Biocompatibility Tests
    • 4.4.1. Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.4.2. Cardiovascular Device's Biocompatibility Tests
      • 4.4.2.1. Cardiovascular Device's Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.4.3. Orthopedic Device's Biocompatibility Tests
      • 4.4.3.1. Orthopedic Device's Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.4.4. Dental Implant Devices' Biocompatibility Tests
      • 4.4.4.1. Dental Implant Devices' Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.4.5. Dermal Filler's Biocompatibility Tests
      • 4.4.5.1. Dermal Filler's Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.4.6. General Surgery Implantation Devices Biocompatibility Tests
      • 4.4.6.1. General Surgery Implantation Devices Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.4.7. Neurosurgical Implantation Devices Biocompatibility Tests
      • 4.4.7.1. Neurosurgical Implantation Devices Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.4.8. Ophthalmic Implantation Device's Biocompatibility Tests
      • 4.4.8.1. Ophthalmic Implantation Device's Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.4.9. Others
      • 4.4.9.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5. Chemistry Test
    • 4.5.1. Chemistry Test Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.5.2. Chemical characterization (E&L)
      • 4.5.2.1. Chemical Characterization (E&L) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.5.3. Analytical method development and validation
      • 4.5.3.1. Analytical Method Development and Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.5.4. Toxicological Risk Assessment and consulting
      • 4.5.4.1. Toxicological Risk Assessment and Consulting Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6. Microbiology & Sterility Testing
    • 4.6.1. Microbiology & Sterility Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.6.2. Bioburden Determination
      • 4.6.2.1. Bioburden Determination Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.6.3. Pyrogen & Endotoxin Testing
      • 4.6.3.1. Pyrogen & Endotoxin Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.6.4. Sterility Test & Validation
      • 4.6.4.1. Sterility Test & Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.6.5. Antimicrobial Testing
      • 4.6.5.1. Antimicrobial Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.6.6. Others
      • 4.6.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.7. Package Validation
    • 4.7.1. Package Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Medical Device Testing Services Market: Phase Estimates & Trend Analysis

  • 5.1. U.S. Medical Device Testing Services Market, By Phase: Segment Dashboard
  • 5.2. U.S. Medical Device Testing Services Market, By Phase: Movement Analysis
  • 5.3. U.S. Medical Device Testing Services Market Estimates & Forecasts, By Phase, 2021 - 2033
  • 5.4. Preclinical
    • 5.4.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.2. Small Animals
      • 5.4.2.1. Small Animals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 5.4.2.2. Biocompatibility Tests
        • 5.4.2.2.1. Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 5.4.2.3. Chemistry Tests
        • 5.4.2.3.1. Chemistry Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 5.4.2.4. Microbiology & Sterility Tests
        • 5.4.2.4.1. Microbiology & Sterility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.3. Large Animals
      • 5.4.3.1. Large Animals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 5.4.3.2. Biocompatibility Tests
        • 5.4.3.2.1. Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 5.4.3.3. Chemistry Tests
        • 5.4.3.3.1. Chemistry Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 5.4.3.4. Microbiology & Sterility Tests
        • 5.4.3.4.1. Microbiology & Sterility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.4. Others
      • 5.4.4.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5. Clinical
    • 5.5.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Competitive Landscape

  • 6.1. Participant Categorization
  • 6.2. Market Position Analysis, 2024 (Heat Map Analysis)
  • 6.3. Company Profiles
    • 6.3.1. SGS SA
      • 6.3.1.1. Company Overview
      • 6.3.1.2. Financial Performance
      • 6.3.1.3. Service Benchmarking
      • 6.3.1.4. Strategic Initiatives
    • 6.3.2. Laboratory Corporation of America Holdings
      • 6.3.2.1. Company Overview
      • 6.3.2.2. Financial Performance
      • 6.3.2.3. Service Benchmarking
      • 6.3.2.4. Strategic Initiatives
    • 6.3.3. Nelson Laboratories, LLC
      • 6.3.3.1. Company Overview
      • 6.3.3.2. Financial Performance
      • 6.3.3.3. Service Benchmarking
      • 6.3.3.4. Strategic Initiatives
    • 6.3.4. TUV SUD
      • 6.3.4.1. Company Overview
      • 6.3.4.2. Financial Performance
      • 6.3.4.3. Service Benchmarking
      • 6.3.4.4. Strategic Initiatives
    • 6.3.5. Charles River Laboratories
      • 6.3.5.1. Company Overview
      • 6.3.5.2. Financial Performance
      • 6.3.5.3. Service Benchmarking
      • 6.3.5.4. Strategic Initiatives
    • 6.3.6. Element Minnetonka
      • 6.3.6.1. Company Overview
      • 6.3.6.2. Financial Performance
      • 6.3.6.3. Service Benchmarking
      • 6.3.6.4. Strategic Initiatives
    • 6.3.7. Eurofins Scientific
      • 6.3.7.1. Company Overview
      • 6.3.7.2. Financial Performance
      • 6.3.7.3. Service Benchmarking
      • 6.3.7.4. Strategic Initiatives
    • 6.3.8. Pace Analytical Services LLC
      • 6.3.8.1. Company Overview
      • 6.3.8.2. Financial Performance
      • 6.3.8.3. Service Benchmarking
      • 6.3.8.4. Strategic Initiatives
    • 6.3.9. Intertek Group Plc
      • 6.3.9.1. Company Overview
      • 6.3.9.2. Financial Performance
      • 6.3.9.3. Service Benchmarking
      • 6.3.9.4. Strategic Initiatives
    • 6.3.10. North America Science Associates Inc. (NAMSA)
      • 6.3.10.1. Company Overview
      • 6.3.10.2. Financial Performance
      • 6.3.10.3. Service Benchmarking
      • 6.3.10.4. Strategic Initiatives

List of Tables

  • Table 1 List of Secondary Sources
  • Table 2 List of Abbreviations
  • Table 3 U.S. Medical Device Testing Services Market Estimates and Forecasts, by Service, 2021 - 2033 (USD Million)
  • Table 4 U.S. Medical Device Testing Services Market Estimates and Forecasts, by Phase, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information procurement
  • Fig. 3 Primary research pattern
  • Fig. 4 Market research approaches
  • Fig. 5 Market formulation & validation
  • Fig. 6 Commodity flow analysis
  • Fig. 7 Value-chain-based sizing & forecasting
  • Fig. 8 QFD model sizing & forecasting
  • Fig. 9 Bottom-up approach
  • Fig. 10 Market snapshot
  • Fig. 11 Segment snapshot 1
  • Fig. 12 Segment snapshot 2
  • Fig. 13 Competitive landscape snapshot
  • Fig. 14 Parent market outlook, 2024 (USD Billion)
  • Fig. 15 Ancillary market outlook, 2024 (USD Billion)
  • Fig. 16 U.S. Medical Device Testing Services Market Dynamics
  • Fig. 17 Porter's five forces analysis
  • Fig. 18 PESTEL analysis
  • Fig. 19 U.S. Medical Device Testing Services Market: Service Outlook and Key Takeaways
  • Fig. 20 U.S. Medical Device Testing Services Market: Service Movement Analysis
  • Fig. 21 Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 22 Cardiovascular Device's Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 23 Orthopedic Device's Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 24 Dental Implant Devices' Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 25 Dermal Filler's Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 26 General Surgery Implantation Devices Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 Neurosurgical Implantation Devices Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 Ophthalmic Implantation Device's Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 29 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 30 Chemistry Test Market Estimates and Forecasts, 2021 - 2033 (USD Million) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 Chemical Characterization (E&L) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 32 Analytical Method Development and Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 33 Toxicological Risk Assessment and Consulting Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 34 Microbiology & Sterility Test Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Bioburden Determination Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 Pyrogen & Endotoxin Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 37 Sterility Test & Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 38 Antimicrobial Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 39 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 40 Package Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 41 U.S. Medical Device Testing Services Market: Phase Outlook and Key Takeaways
  • Fig. 42 U.S. Medical Device Testing Services Market: Phase Movement Analysis
  • Fig. 43 Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 44 Large Animal Research Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 45 Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 46 Chemistry Test Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 47 Microbiology & Sterility Test Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 48 Small Animal Research Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 49 Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 50 Chemistry Test Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 51 Microbiology & Sterility Test Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 52 Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 53 Key company categorization
  • Fig. 54 Service heat map analysis
  • Fig. 55 Strategic framework