의료기기 검사 서비스 시장 : 시장 규모, 점유율, 동향 분석 보고서 - 서비스별, 페이즈별, 지역별, 부문 예측(2025-2030년)

Medical Device Testing Services Market Growth & Trends:

The global medical device testing services market size is expected to reach USD 16.78 billion by 2030, registering a CAGR of 9.49% from 2025 to 2030, according to a new report by Grand View Research, Inc. Increasing complexity in product design and stringent government regulations are driving demand for medical device testing services.

Significant rise in preclinical spending is a recent trend among pharmaceutical and medical device companies, which is expected to significantly contribute to market growth. According to the global health center, for pharmaceuticals, supporting preclinical research required 73 months and cost USD 7 million for biologics, it took 47 months and cost USD 6.3 million.

With modern medical devices offering a host of complex functions, the need for appropriate tests to check the compliance of the device with regulatory requirements is becoming vital. In order to meet the requirement of enhanced accuracy, ease of use, and durability, medical devices need to undergo extensive tests. This is expected to deliver competitive advantage to manufacturers.

On the other hand, an increase in the need for production efficiency and safety and rising regulatory requirements for medical devices are some of the major factors driving the market growth. Regulatory bodies such as the European Medicines Agency, U.S. Food and Drug Administration, Therapeutic Goods Administration, and other country regulatory bodies require documentation and testing to certify that medical devices meet efficacy and safety standards prior they can be sold and marketed to patients and healthcare providers.

The COVID-19 pandemic has created an unprecedented demand for medical device testing services. This is largely due to the increasing demand for COVID-10 related products such as masks, PPE, & respiratory equipments. Besides, countries such as Mexico, Spain, and France have published pertinent specifications and standards, namely the UNE 0064-1, UNE 0064-2, AFNOR-SPEC-S76 & UNE 0065, which must be met until a mask can be sold.

Medical Device Testing Services Market Report Highlights:

• On the basis of service segment, the market is classified into biocompatibility testing, chemistry testing, microbiology & sterility testing, and package validation.
• On the basis of phase segment, the market is segregated into preclinical and clinical. The clinical segment accounted for the largest market share in 2024.
• The North America Medical Device Testing Services market is projected to grow at the fastest CAGR over the forecast period.
• Asia Pacific accounted for the largest market share of 41.18% in 2024. The evolving medical device testing services are expected to increase the market demand in the region, owing to established healthcare infrastructure with government initiatives.

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. 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
• 3.3. Technological Advancements
• 3.4. Pricing Model Analysis
• 3.5. Market Analysis Tools
  • 3.5.1. Porter's Five Analysis
  • 3.5.2. PESTEL by SWOT Analysis
  • 3.5.3. COVID-19 Impact Analysis

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

• 4.1. Medical Device Testing Services Market, By Service: Segment Dashboard
• 4.2. Medical Device Testing Services Market, By Service: Movement Analysis
• 4.3. Medical Device Testing Services Market Estimates & Forecasts, By Service, 2018 - 2030
• 4.4. Biocompatibility Tests
  • 4.4.1. Biocompatibility Tests Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.2. Cardiovascular Device's Biocompatibility Tests
    • 4.4.2.1. Cardiovascular Device's Biocompatibility Tests Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.3. Orthopedic Device's Biocompatibility Tests
    • 4.4.3.1. Orthopedic Device's Biocompatibility Tests Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.4. Dental Implant Devices' Biocompatibility Tests
    • 4.4.4.1. Dental Implant Devices' Biocompatibility Tests Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.5. Dermal Filler's Biocompatibility Tests
    • 4.4.5.1. Dermal Filler's Biocompatibility Tests Market Estimates and Forecasts, 2018 - 2030 (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, 2018 - 2030 (USD Million)
  • 4.4.7. Neurosurgical Implantation Devices Biocompatibility Tests
    • 4.4.7.1. Neurosurgical Implantation Devices Biocompatibility Tests Market Estimates and Forecasts, 2018 - 2030 (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, 2018 - 2030 (USD Million)
  • 4.4.9. Others
    • 4.4.9.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.5. Chemistry Test
  • 4.5.1. Chemistry Test Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.2. Chemical characterization (E&L)
    • 4.5.2.1. Chemical Characterization (E&L) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.3. Analytical method development and validation
    • 4.5.3.1. Analytical Method Development and Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.4. Toxicological Risk Assessment and consulting
    • 4.5.4.1. Toxicological Risk Assessment and Consulting Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.6. Microbiology & Sterility Testing
  • 4.6.1. Microbiology & Sterility Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.2. Bioburden Determination
    • 4.6.2.1. Bioburden Determination Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.3. Pyrogen & Endotoxin Testing
    • 4.6.3.1. Pyrogen & Endotoxin Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.4. Sterility Test & Validation
    • 4.6.4.1. Sterility Test & Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.5. Antimicrobial Testing
    • 4.6.5.1. Antimicrobial Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.6. Others
    • 4.6.6.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.7. Package Validation
  • 4.7.1. Package Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)

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

• 5.1. Medical Device Testing Services Market, By Phase: Segment Dashboard
• 5.2. Medical Device Testing Services Market, By Phase: Movement Analysis
• 5.3. Medical Device Testing Services Market Estimates & Forecasts, By Phase, 2018 - 2030
• 5.4. Preclinical
  • 5.4.1. Preclinical Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.4.2. Small Animals
    • 5.4.2.1. Small Animals Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 5.4.2.2. Biocompatibility Tests
      • 5.4.2.2.1. Biocompatibility Tests Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 5.4.2.3. Chemistry Tests
      • 5.4.2.3.1. Chemistry Tests Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 5.4.2.4. Microbiology & Sterility Tests
      • 5.4.2.4.1. Microbiology & Sterility Tests Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.4.3. Large Animals
    • 5.4.3.1. Large Animals Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 5.4.3.2. Biocompatibility Tests
      • 5.4.3.2.1. Biocompatibility Tests Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 5.4.3.3. Chemistry Tests
      • 5.4.3.3.1. Chemistry Tests Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 5.4.3.4. Microbiology & Sterility Tests
      • 5.4.3.4.1. Microbiology & Sterility Tests Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.4.4. Others
    • 5.4.4.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.5. Clinical
  • 5.5.1. Clinical Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. Medical Device Testing Services Market: Regional Estimates & Trend Analysis

• 6.1. Regional Market Share Analysis, 2024 & 2030
• 6.2. Regional Market Dashboard
• 6.3. Global Regional Market Snapshot
• 6.4. North America
  • 6.4.1. North America Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.2. U.S
    • 6.4.2.1. Key Country Dynamics
    • 6.4.2.2. Competitive Scenario
    • 6.4.2.3. Regulatory Framework
    • 6.4.2.4. U.S. Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.3. Canada
    • 6.4.3.1. Key Country Dynamics
    • 6.4.3.2. Competitive Scenario
    • 6.4.3.3. Regulatory Framework
    • 6.4.3.4. Canada Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.4. Mexico
    • 6.4.4.1. Key Country Dynamics
    • 6.4.4.2. Competitive Scenario
    • 6.4.4.3. Regulatory Framework
    • 6.4.4.4. Mexico Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.5. Europe
  • 6.5.1. Europe Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.2. UK
    • 6.5.2.1. Key Country Dynamics
    • 6.5.2.2. Competitive Scenario
    • 6.5.2.3. Regulatory Framework
    • 6.5.2.4. UK Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.3. Germany
    • 6.5.3.1. Key Country Dynamics
    • 6.5.3.2. Competitive Scenario
    • 6.5.3.3. Regulatory Framework
    • 6.5.3.4. Germany Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.4. France
    • 6.5.4.1. Key Country Dynamics
    • 6.5.4.2. Competitive Scenario
    • 6.5.4.3. Regulatory Framework
    • 6.5.4.4. France Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.5. Italy
    • 6.5.5.1. Key Country Dynamics
    • 6.5.5.2. Competitive Scenario
    • 6.5.5.3. Regulatory Framework
    • 6.5.5.4. Italy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.6. Spain
    • 6.5.6.1. Key Country Dynamics
    • 6.5.6.2. Competitive Scenario
    • 6.5.6.3. Regulatory Framework
    • 6.5.6.4. Spain Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.7. Denmark
    • 6.5.7.1. Key Country Dynamics
    • 6.5.7.2. Competitive Scenario
    • 6.5.7.3. Regulatory Framework
    • 6.5.7.4. Denmark Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.8. Sweden
    • 6.5.8.1. Key Country Dynamics
    • 6.5.8.2. Competitive Scenario
    • 6.5.8.3. Regulatory Framework
    • 6.5.8.4. Sweden Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.9. Norway
    • 6.5.9.1. Key Country Dynamics
    • 6.5.9.2. Competitive Scenario
    • 6.5.9.3. Regulatory Framework
    • 6.5.9.4. Norway Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.10. Netherlands
    • 6.5.10.1. Key Country Dynamics
    • 6.5.10.2. Competitive Scenario
    • 6.5.10.3. Regulatory Framework
    • 6.5.10.4. Netherlands Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.11. Belgium
    • 6.5.11.1. Key Country Dynamics
    • 6.5.11.2. Competitive Scenario
    • 6.5.11.3. Regulatory Framework
    • 6.5.11.4. Belgium Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.12. Switzerland
    • 6.5.12.1. Key Country Dynamics
    • 6.5.12.2. Competitive Scenario
    • 6.5.12.3. Regulatory Framework
    • 6.5.12.4. Switzerland Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.6. Asia Pacific
  • 6.6.1. Asia Pacific Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.2. Japan
    • 6.6.2.1. Key Country Dynamics
    • 6.6.2.2. Competitive Scenario
    • 6.6.2.3. Regulatory Framework
    • 6.6.2.4. Japan Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.3. China
    • 6.6.3.1. Key Country Dynamics
    • 6.6.3.2. Competitive Scenario
    • 6.6.3.3. Regulatory Framework
    • 6.6.3.4. China Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.4. India
    • 6.6.4.1. Key Country Dynamics
    • 6.6.4.2. Competitive Scenario
    • 6.6.4.3. Regulatory Framework
    • 6.6.4.4. India Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.5. Australia
    • 6.6.5.1. Key Country Dynamics
    • 6.6.5.2. Competitive Scenario
    • 6.6.5.3. Regulatory Framework
    • 6.6.5.4. Australia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.6. South Korea
    • 6.6.6.1. Key Country Dynamics
    • 6.6.6.2. Competitive Scenario
    • 6.6.6.3. Regulatory Framework
    • 6.6.6.4. South Korea Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.7. Malaysia
    • 6.6.7.1. Key Country Dynamics
    • 6.6.7.2. Competitive Scenario
    • 6.6.7.3. Regulatory Framework
    • 6.6.7.4. Malaysia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.8. Indonesia
    • 6.6.8.1. Key Country Dynamics
    • 6.6.8.2. Competitive Scenario
    • 6.6.8.3. Regulatory Framework
    • 6.6.8.4. Indonesia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.9. Singapore
    • 6.6.9.1. Key Country Dynamics
    • 6.6.9.2. Competitive Scenario
    • 6.6.9.3. Regulatory Framework
    • 6.6.9.4. Singapore Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.10. Philippines
    • 6.6.10.1. Key Country Dynamics
    • 6.6.10.2. Competitive Scenario
    • 6.6.10.3. Regulatory Framework
    • 6.6.10.4. Thailand Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.11. Thailand
    • 6.6.11.1. Key Country Dynamics
    • 6.6.11.2. Competitive Scenario
    • 6.6.11.3. Regulatory Framework
    • 6.6.11.4. Thailand Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.7. Latin America
  • 6.7.1. Latin America Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.7.2. Brazil
    • 6.7.2.1. Key Country Dynamics
    • 6.7.2.2. Competitive Scenario
    • 6.7.2.3. Regulatory Framework
    • 6.7.2.4. Brazil Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.7.3. Argentina
    • 6.7.3.1. Key Country Dynamics
    • 6.7.3.2. Competitive Scenario
    • 6.7.3.3. Regulatory Framework
    • 6.7.3.4. Argentina Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.7.4. Colombia
    • 6.7.4.1. Key Country Dynamics
    • 6.7.4.2. Competitive Scenario
    • 6.7.4.3. Regulatory Framework
    • 6.7.4.4. Colombia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.7.5. Chile
    • 6.7.5.1. Key Country Dynamics
    • 6.7.5.2. Competitive Scenario
    • 6.7.5.3. Regulatory Framework
    • 6.7.5.4. Chile Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.8. MEA
  • 6.8.1. MEA Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.8.2. South Africa
    • 6.8.2.1. Key Country Dynamics
    • 6.8.2.2. Competitive Scenario
    • 6.8.2.3. Regulatory Framework
    • 6.8.2.4. South Africa Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.8.3. Saudi Arabia
    • 6.8.3.1. Key Country Dynamics
    • 6.8.3.2. Competitive Scenario
    • 6.8.3.3. Regulatory Framework
    • 6.8.3.4. Saudi Arabia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.8.4. UAE
    • 6.8.4.1. Key Country Dynamics
    • 6.8.4.2. Competitive Scenario
    • 6.8.4.3. Regulatory Framework
    • 6.8.4.4. UAE Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.8.5. Kuwait
    • 6.8.5.1. Key Country Dynamics
    • 6.8.5.2. Competitive Scenario
    • 6.8.5.3. Regulatory Framework
    • 6.8.5.4. Kuwait Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.8.6. Israel
    • 6.8.6.1. Key Country Dynamics
    • 6.8.6.2. Competitive Scenario
    • 6.8.6.3. Regulatory Framework
    • 6.8.6.4. Israel Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.8.7. Egypt
    • 6.8.7.1. Key Country Dynamics
    • 6.8.7.2. Competitive Scenario
    • 6.8.7.3. Regulatory Framework
    • 6.8.7.4. Egypt Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Market Participant Categorization
• 7.2. Company Market Share Analysis, 2024
• 7.3. Company Profiles
  • 7.3.1. SGS SA
    • 7.3.1.1. Company Overview
    • 7.3.1.2. Financial Performance
    • 7.3.1.3. Service Benchmarking
    • 7.3.1.4. Strategic Initiatives
  • 7.3.2. Laboratory Corporation of America Holdings
    • 7.3.2.1. Company Overview
    • 7.3.2.2. Financial Performance
    • 7.3.2.3. Service Benchmarking
    • 7.3.2.4. Strategic Initiatives
  • 7.3.3. Nelson Laboratories, LLC
    • 7.3.3.1. Company Overview
    • 7.3.3.2. Financial Performance
    • 7.3.3.3. Service Benchmarking
    • 7.3.3.4. Strategic Initiatives
  • 7.3.4. TUV SUD
    • 7.3.4.1. Company Overview
    • 7.3.4.2. Financial Performance
    • 7.3.4.3. Service Benchmarking
    • 7.3.4.4. Strategic Initiatives
  • 7.3.5. Charles River Laboratories
    • 7.3.5.1. Company Overview
    • 7.3.5.2. Financial Performance
    • 7.3.5.3. Service Benchmarking
    • 7.3.5.4. Strategic Initiatives
  • 7.3.6. Element Minnetonka
    • 7.3.6.1. Company Overview
    • 7.3.6.2. Financial Performance
    • 7.3.6.3. Service Benchmarking
    • 7.3.6.4. Strategic Initiatives
  • 7.3.7. Eurofins Scientific
    • 7.3.7.1. Company Overview
    • 7.3.7.2. Financial Performance
    • 7.3.7.3. Service Benchmarking
    • 7.3.7.4. Strategic Initiatives
  • 7.3.8. Pace Analytical Services LLC
    • 7.3.8.1. Company Overview
    • 7.3.8.2. Financial Performance
    • 7.3.8.3. Service Benchmarking
    • 7.3.8.4. Strategic Initiatives
  • 7.3.9. Intertek Group Plc
    • 7.3.9.1. Company Overview
    • 7.3.9.2. Financial Performance
    • 7.3.9.3. Service Benchmarking
    • 7.3.9.4. Strategic Initiatives
  • 7.3.10. North America Science Associates Inc. (NAMSA) (WuXi AppTec)
    • 7.3.10.1. Company Overview
    • 7.3.10.2. Financial Performance
    • 7.3.10.3. Service Benchmarking
    • 7.3.10.4. Strategic Initiatives