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U.S. Medical Device Testing Services Market Size, Share & Trends Analysis Report by Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Testing, Package Validation), Phase (Preclinical, Clinical), and Growth Forecasts, 2025-2033

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    Report

  • 120 Pages
  • September 2025
  • Region: United States
  • Grand View Research
  • ID: 6176819
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Description Jump to:
The U.S. medical device testing services market size was estimated at USD 2.43 Billion in 2025 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, the analyst 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
  • Small animal research
  • Clinical

Why should you buy this report?

  • Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
  • Competitive Landscape: Explore the market presence of key players.
  • Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
  • Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.

This report addresses:

  • Market intelligence to enable effective decision-making
  • Market estimates and forecasts from 2018 to 2030
  • Growth opportunities and trend analyses
  • Segmental and regional revenue forecasts for market assessment
  • Competition strategy and market share analysis
  • Product innovation listings for you to stay ahead of the curve

This product will be delivered within 2 business days.

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

Companies Mentioned

The leading players profiled in this U.S. Medical Device Testing Services market report include:
  • GS SA
  • aboratory Corporation of America Holdings
  • elson Laboratories, LLC
  • ÜV SÜD
  • harles River Laboratories
  • lement Minnetonka
  • urofins Scientific
  • ace Analytical Services LLC
  • ntertek Group Plc
  • orth America Science Associates Inc. (NAMSA)

Table Information

Report AttributeDetails
No. of Pages120
PublishedSeptember 2025
Forecast Period2025 - 2033
Estimated Market Value ( USD ) in 2025 $ 2.43 Billion
Forecasted Market Value ( USD ) by 2033 $ 5.09 Billion
Compound Annual Growth Rate9.6%
Regions CoveredUnited States
No. of Companies Mentioned11

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