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市场调查报告书
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1842077

美国医疗设备检测服务市场：市场规模、份额、趋势分析（按服务和阶段划分）、细分市场预测（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个工作天内

价格

美国医疗设备检测服务市场摘要

预计到 2024 年，美国医疗设备测试服务市场规模将达到 22.3 亿美元，预计从 2025 年到 2033 年将达到 50.9 亿美元，复合年增长率为 9.66%。

市场发展受到强有力的法律规范、快速的技术创新以及进入市场的设备日益复杂化的驱动。

其他推动市场成长的因素包括人口老化、慢性病发病率上升以及源源不绝的技术创新。製造商越来越多地将测试活动外包，以降低合规成本、应对复杂的法规并加快产品上市速度。此外，美国食品药物管理局(FDA) 制定的严格安全和性能标准以及 ISO 和 IEC 标准等国际合规要求，也推动了对专业第三方测试服务的需求。这些服务对于确保合规性、降低风险以及缩短时间至关重要，尤其是在微创手术器材、植入式医疗器材、诊断影像系统和穿戴式技术等高成长领域。

此外，由于先进材料、小型化、人工智慧 (AI)、物联网 (IoT) 和无线技术的集成，设备设计的复杂性日益增加，这也扩大了测试要求，包括网路安全检验、软体效能测试、可用性工程和互通性评估。此外，新一代和下一代设备的临床试验数量迅速增长，也提高了对电气安全、电磁相容性 (EMC)、机械耐久性、微生物安全性和生物相容性评估等方面的能力需求。此外，目前的测试流程涵盖多个阶段，包括可行性研究、性能检验和上市后监测，以确保产品有效性和患者安全。

目录

第一章 分析方法和范围

第二章执行摘要

第三章医疗设备检测服务市场：影响因素、趋势与范围

  • 市场联动展望
    • 母市场展望
    • 相关/附随市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
    • 市场挑战
    • 市场机会
  • 科技情势
  • 定价模式分析
  • 关税影响分析
  • 价值链分析
    • 供应趋势
    • 需求趋势
  • 市场分析工具
    • 波特五力分析
    • PESTEL分析与SWOT分析
    • 新冠疫情影响分析

第四章：美国医疗设备测试服务市场：按服务类型分類的估算与趋势分析

  • 美国医疗设备测试服务市场：概览（按服务分类）
  • 美国医疗设备检测服务市场：按服务类型分類的变化分析
  • 依服务年资（2021-2033）
  • 生物相容性测试
    • 心血管器械生物相容性测试
    • 整形外科器械生物相容性测试
    • 人工植牙装置的生物相容性测试
    • 皮肤填充剂的生物相容性测试
    • 一般外科植入装置生物相容性测试
    • 神经外科植入装置的生物相容性测试
    • 眼科植入装置的生物相容性测试
    • 其他的
  • 化学测试
    • 化学表征（E&L）
    • 分析方法开发与检验
    • 毒理学风险评估与咨询
  • 微生物学和无菌性检测
    • 微生物附着量测量
    • 热原和内毒素检测
    • 无菌检测和检验
    • 抗菌测试
    • 其他的
  • 软体包检验

第五章：美国医疗设备测试服务市场：按阶段分類的估算与趋势分析

  • 美国医疗设备测试服务市场：按阶段分類的概览
  • 美国医疗设备检测服务市场：按阶段分類的变化分析
  • 依阶段划分（2021-2033 年）
  • 临床前
    • 小动物
    • 大型动物
    • 其他的
  • 临床

第六章 竞争情势

  • 参与企业
  • 市场分析（热力图分析，2024 年）
  • 公司简介
    • 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