미국의 의료기기 검사 서비스 시장 규모, 점유율, 동향 분석 : 서비스별, 단계별, 부문별 예측(2025-2033년)

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