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

Preclinical Medical Device Testing Services Market Growth & Trends:

The global preclinical medical device testing services market size is expected to reach USD 6.55 billion by 2030, registering a CAGR of 9.20%, according to a new report by Grand View Research, Inc. The rising incidence of diseases has provided manufacturers with different approaches for the formation of medical devices and increasing demand for technologically advanced medical devices are the main factors driving the market growth.

The pace of technological advancement in the healthcare industry has vastly increased in recent years. Medical device technology advancements support simple, painless treatment during disease management. Additionally, advancements in medical device technology help with accurate and quick disease diagnosis results, as well as the affordability of technology-based therapeutic tools for disease treatment. Furthermore, numerous governmental agencies and healthcare institutions support medical research facilities. This funding is primarily intended to promote global health care innovations. The growth of medical device testing in the anticipated period is therefore supported by expanding innovation and technological advancement.

Preclinical testing plays a crucial role in the process of creating new products. Before beginning human testing, most of this testing has been completed and reports should be available. According to ISO-10993, biocompatibility testing results are needed to be included in 510(k) notifications for Class II equipment that has immediate patient contact or contact with the blood supply. This shows that the new device's risks are "substantially equivalent" to the predicate device's risks. In order to show the utility of the new device, validate electrical safety, or examine electromagnetic interference, the testing also involves animal and bench studies.

COVID-19 has created an enormous demand for these services. The growth was not significant during the first half, but it became more significant during the second as the industry adopted the new norms at a faster pace amid the pandemic. Numerous projects that were halted because of COVID have been restarted and PPE kits are witnessing an increase in production and testing. During the pandemic, many medical devices in high demand diverted attention from the equipment needed for surgery. The COVID-19 vaccines, ventilators, and pulse oximeters are the main products that witnessed a spike in demand.

Preclinical Medical Device Testing Services Market Report Highlights:

• In 2024, the biocompatibility tests segment dominated the market, accounting for a revenue share of 45.06%. The test is a critical step for medical device development where an assessment of biocompatibility helps medical device manufacturers ensure the device's safety for patients & provides data that can be used to support regulatory compliance.
• The chemistry test segment is anticipated to exhibit the fastest CAGR of 9.63%. The test is conducted in order to categorize, recognize, and understand the chemicals used in the production of medical devices
• Asia Pacific led the global market in 2024 and is projected to witness the fastest CAGR of 9.47% during the forecast years due to the low cost of outsourcing medical device testing services

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

• 4.1. Segment Dashboard
• 4.2. Global Preclinical Medical Device Testing Services Market; Method Movement Analysis
• 4.3. Global 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. 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)
• 5.5. Asia Pacific
  • 5.5.1. Asia Pacific Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 5.5.2. Japan
    • 5.5.2.1. Key country dynamics
    • 5.5.2.2. Competitive scenario
    • 5.5.2.3. Regulatory framework
    • 5.5.2.4. Japan market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.5.3. China
    • 5.5.3.1. Key country dynamics
    • 5.5.3.2. Competitive scenario
    • 5.5.3.3. Regulatory framework
    • 5.5.3.4. China market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.5.4. India
    • 5.5.4.1. Key country dynamics
    • 5.5.4.2. Competitive scenario
    • 5.5.4.3. Regulatory framework
    • 5.5.4.4. India market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.5.5. Australia
    • 5.5.5.1. Key country dynamics
    • 5.5.5.2. Competitive scenario
    • 5.5.5.3. Regulatory framework
    • 5.5.5.4. Australia market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.5.6. South Korea
    • 5.5.6.1. Key country dynamics
    • 5.5.6.2. Competitive scenario
    • 5.5.6.3. Regulatory framework
    • 5.5.6.4. South Korea market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.5.7. Thailand
    • 5.5.7.1. Key country dynamics
    • 5.5.7.2. Competitive scenario
    • 5.5.7.3. Regulatory framework
    • 5.5.7.4. Thailand market estimates and forecasts 2018 to 2030 (USD Million)
• 5.6. Latin America
  • 5.6.1. Latin America Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 5.6.2. Brazil
    • 5.6.2.1. Key country dynamics
    • 5.6.2.2. Competitive scenario
    • 5.6.2.3. Regulatory framework
    • 5.6.2.4. Brazil market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.6.3. Argentina
    • 5.6.3.1. Key country dynamics
    • 5.6.3.2. Competitive scenario
    • 5.6.3.3. Regulatory framework
    • 5.6.3.4. Argentina market estimates and forecasts 2018 to 2030 (USD Million)
• 5.7. MEA
  • 5.7.1. MEA Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 5.7.2. South Africa
    • 5.7.2.1. Key country dynamics
    • 5.7.2.2. Competitive scenario
    • 5.7.2.3. Regulatory framework
    • 5.7.2.4. South Africa market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.7.3. Saudi Arabia
    • 5.7.3.1. Key country dynamics
    • 5.7.3.2. Competitive scenario
    • 5.7.3.3. Regulatory framework
    • 5.7.3.4. Saudi Arabia market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.7.4. UAE
    • 5.7.4.1. Key country dynamics
    • 5.7.4.2. Competitive scenario
    • 5.7.4.3. Regulatory framework
    • 5.7.4.4. UAE market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.7.5. Kuwait
    • 5.7.5.1. Key country dynamics
    • 5.7.5.2. Competitive scenario
    • 5.7.5.3. Regulatory framework
    • 5.7.5.4. Kuwait market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 6. Competitive Landscape

• 6.1. Company Categorization
• 6.2. Company Market Position Analysis, 2024
• 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. Eurofins Scientific
    • 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. Pace Analytical Services 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. Intertek Group Plc
    • 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. WUXI APPTEC
    • 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. TUV SUD AG
    • 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. Sterigenics International LLC
    • 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. Nelson Labs
    • 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. North American Science Associates, Inc.
    • 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. Charles River Laboratories International, 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