북미와 유럽의 전임상 의료기기 시험 서비스 시장 : 시장 규모, 점유율, 동향 분석 보고서-서비스별, 지역별, 부문별 예측(2025-2030년)

North America And Europe Preclinical Medical Device Testing Service Market Growth & Trends:

The North America and Europe preclinical medical device testing services market size is expected to reach USD 3.14 billion by 2030, expanding at a CAGR of 9.3% from 2025 to 2030, according to a new report by Grand View Research, Inc. The increase in the number of small medical devices lacking in-house testing capabilities and complexity in product design are the major factors driving the growth of the market.

There has been an increase in the number of players operating in the market over the last decade. Due to this large number, it has witnessed fierce competition. To sustain the market, a mix of defensive and offensive marketing strategies is used. For instance, extensive R&D, competitive pricing, new product launches, collaborative development, regional expansion, and mergers and acquisitions.

The COVID-19 pandemic has created a huge demand for these services. The rise was not significant in the first half, but it became more significant in the second as the industry adapted to operating during the pandemic. There has been an increase in the production and testing of personal protective equipment, and several projects that were put on hold because of COVID have resumed personal protective equipment. The epidemic has increased demand for a wide range of medical gadgets, diverting attention from those needed for surgery. COVID-19 vaccinations, ventilators, and pulse oximeters are the main goods seeing an increase in demand.

North America And Europe Preclinical Medical Device Testing Services Market Highlights

• In 2024, the biocompatibility tests segment dominated the market, accounting for a revenue share of 44.7%. Manufacturing safe and effective goods is a top priority for medical device manufacturers, and quality assurance is crucial in accomplishing this aim.
• The chemistry test segment is expected to rise with the fastest CAGR of 9.6% in the forecast period. Chemistry tests support the medical device industry across the value chain.
• North America preclinical medical device testing services market dominated in 2024 with a larger share of 55.0%.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Market Definitions
• 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. Market Formulation & Validation
• 1.6. Model Details
  • 1.6.1. Commodity Flow Analysis
  • 1.6.2. Bottom-up Approach
• 1.7. List of Secondary Sources
• 1.8. List of Abbreviations
• 1.9. Objectives

Chapter 2. Executive Summary

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

Chapter 3. North America and Europe Preclinical 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
    • 3.2.1.2. Strict approval norms
    • 3.2.1.3. Increase in number of small medical device lacking in-house testing capabilities
    • 3.2.1.4. Intense competition in medical device industry
  • 3.2.2. Market restraint analysis
    • 3.2.2.1. Legal and Regulatory Issues
• 3.3. Market Analysis Tools
  • 3.3.1. Porter's Five Forces Analysis
  • 3.3.2. PESTEL Analysis
  • 3.3.3. COVID-19 Impact Analysis

Chapter 4. North America and Europe Preclinical Medical Device Testing Services Market: Service Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. North America and Europe Preclinical Medical Device Testing Services Market; Method Movement Analysis
• 4.3. North America and Europe Preclinical Medical Device Testing Services Size & Trend Analysis, by Method, 2018 to 2030 (USD Million)
• 4.4. Biocompatibility Tests
  • 4.4.1. Biocompatibility tests market estimates and forecasts 2018 to 2030 (USD Million)
• 4.5. Chemistry Test
  • 4.5.1. Chemistry test market estimates and forecasts 2018 to 2030 (USD Million)
• 4.6. Microbiology & Sterility Testing
  • 4.6.1. Microbiology & sterility testing market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.6.2. Bioburden Determination
    • 4.6.2.1. Bioburden determination market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.6.3. Pyrogen & Endotoxin Testing
    • 4.6.3.1. Pyrogen & endotoxin testing market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.6.4. Sterility Test and Validation
    • 4.6.4.1. Sterility test and validation market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.6.4.2. Ethylene Oxide (EO) gas sterilization
      • 4.6.4.2.1. Ethylene oxide (EO) gas sterilization market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.6.4.3. Gamma-irradiation
      • 4.6.4.3.1. Gamma-irradiation market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.6.4.4. E-beam sterilization
      • 4.6.4.4.1. E-beam sterilization market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.6.4.5. X-ray sterilization
      • 4.6.4.5.1. X-ray sterilization market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.6.5. Antimicrobial Activity Testing
    • 4.6.5.1. Antimicrobial activity testing market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.6.6. Others
    • 4.6.6.1. Others market estimates and forecasts 2018 to 2030 (USD Million)
• 4.7. Package Validation
  • 4.7.1. Package validation market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 5. North America and Europe Preclinical Medical Device Testing Services Market: Regional Estimates & Trend Analysis

• 5.1. Regional Market Share Analysis, 2024 & 2030
• 5.2. Regional Market Dashboard
• 5.3. North America
  • 5.3.1. North America Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 5.3.2. U.S.
    • 5.3.2.1. Key country dynamics
    • 5.3.2.2. Competitive scenario
    • 5.3.2.3. Regulatory framework
    • 5.3.2.4. U.S. market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.3.3. Canada
    • 5.3.3.1. Key country dynamics
    • 5.3.3.2. Competitive scenario
    • 5.3.3.3. Regulatory framework
    • 5.3.3.4. Canada market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.3.4. Mexico
    • 5.3.4.1. Key country dynamics
    • 5.3.4.2. Competitive scenario
    • 5.3.4.3. Regulatory framework
    • 5.3.4.4. Mexico market estimates and forecasts 2018 to 2030 (USD Million)
• 5.4. Europe
  • 5.4.1. Europe Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 5.4.2. UK
    • 5.4.2.1. Key country dynamics
    • 5.4.2.2. Competitive scenario
    • 5.4.2.3. Regulatory framework
    • 5.4.2.4. UK market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.3. Germany
    • 5.4.3.1. Key country dynamics
    • 5.4.3.2. Competitive scenario
    • 5.4.3.3. Regulatory framework
    • 5.4.3.4. Germany market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.4. France
    • 5.4.4.1. Key country dynamics
    • 5.4.4.2. Competitive scenario
    • 5.4.4.3. Regulatory framework
    • 5.4.4.4. France market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.5. Italy
    • 5.4.5.1. Key country dynamics
    • 5.4.5.2. Competitive scenario
    • 5.4.5.3. Regulatory framework
    • 5.4.5.4. Italy market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.6. Spain
    • 5.4.6.1. Key country dynamics
    • 5.4.6.2. Competitive scenario
    • 5.4.6.3. Regulatory framework
    • 5.4.6.4. Spain market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.7. Denmark
    • 5.4.7.1. Key country dynamics
    • 5.4.7.2. Competitive scenario
    • 5.4.7.3. Regulatory framework
    • 5.4.7.4. Denmark market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.8. Sweden
    • 5.4.8.1. Key country dynamics
    • 5.4.8.2. Competitive scenario
    • 5.4.8.3. Regulatory framework
    • 5.4.8.4. Sweden market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.9. Norway
    • 5.4.9.1. Key country dynamics
    • 5.4.9.2. Competitive scenario
    • 5.4.9.3. Regulatory framework
    • 5.4.9.4. Norway market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 6. Competitive Landscape

• 6.1. Company Categorization
• 6.2. Company Market Position Analysis, 2023
• 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. Toxikon, Inc.
    • 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. Eurofins Scientific
    • 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. Pace Analytical Services LLC
    • 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. Intertek Group Plc
    • 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. WUXI APPTEC
    • 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. TUV SUD AG
    • 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. Sterigenics International 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. Nelson Labs
    • 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 American Science Associates, Inc.
    • 6.3.10.1. Company overview
    • 6.3.10.2. Financial performance
    • 6.3.10.3. Service benchmarking
    • 6.3.10.4. Strategic initiatives
  • 6.3.11. American Preclinical Services
    • 6.3.11.1. Company overview
    • 6.3.11.2. Financial performance
    • 6.3.11.3. Service benchmarking
    • 6.3.11.4. Strategic initiatives
  • 6.3.12. Charles River Laboratories International, Inc.
    • 6.3.12.1. Company overview
    • 6.3.12.2. Financial performance
    • 6.3.12.3. Service benchmarking
    • 6.3.12.4. Strategic initiatives