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Preclinical Medical Device Testing Services Market Size, Share & Trends Analysis Report by Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Testing, Package Validation), by Region, and Segment Forecasts, 2022-2030

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    Report

  • 275 Pages
  • August 2022
  • Region: Global
  • Grand View Research
  • ID: 5649357
Description Jump to:
The global preclinical medical device testing services market share is expected to reach USD 4.9 billion by 2030, according to this report. 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

  • The Microbiology & sterility testing segment dominated the market with a revenue share of 34.2% in 2021. It is one of the main tests included in pre-clinical medical device testing These examinations aid in identifying the occurrence of microorganisms in the device
  • Based on microbiology & sterility test type, sterility test and validation dominated the market with a revenue share of 45.6% in 2021
  • The chemistry test segment is anticipated to exhibit the fastest CAGR of 9.0%. 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 2021 and is projected to witness the fastest CAGR of 9.0% 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
1.1.1. Services
1.2. Research Methodology
1.3. Information Procurement
1.3.1. Purchased database
1.3.2. internal database
1.3.3. Secondary sources
1.3.4. Primary research
1.4. Information or Data Analysis
1.4.1. Data analysis models
1.5. Market Formulation & Validation
1.6. Model Details
1.6.1. Commodity flow analysis (Model 1)
1.6.2. Volume price analysis (Model 2)
1.7. List of Secondary Sources
1.8. List of Primary Sources
1.9. Objectives
1.9.1. Objective 1
1.9.2. Objective 2
1.9.3. Objective 3
1.9.4. Objective 4
Chapter 2. Executive Summary
2.1. Market Outlook
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. Penetration & Growth Prospect Mapping
3.3. Market Dynamics
3.3.1. Market driver analysis
3.3.1.1. Complexity in Product design
3.3.1.2. Strict Approval Norms
3.3.1.3. Increase in number of small medical device lacking in-house testing capabilities
3.3.2. Market restraint analysis
3.3.2.1. Legal and Regulatory Issues
3.3.3. Penetration & Growth Prospect Mapping
3.3.4. COVID Impact Analysis
3.3.5. Major Deals and Strategic Alliances Analysis
3.3.6. Industry Analysis - Porter’s Five Forces Analysis
3.3.7. Pestle Analysis
Chapter 4. Preclinical Medical Device Testing Services Market: Services Segment Analysis
4.1. Preclinical Medical Device Testing Services Market: Definition & Scope
4.2. Preclinical Medical Device Testing Services Market: Services Market Share Analysis, 2021 & 2030
4.3. Biocompatibility Tests
4.3.1. Biocompatibility Tests Market, 2018 - 2030 (USD Million)
4.4. Chemistry Test
4.4.1. Chemistry Test Market, 2018 - 2030 (USD Million)
4.5. Microbiology & Sterility Testing
4.5.1. Microbiology & Sterility Testing Market, 2018 - 2030 (USD Million)
4.5.2. Bioburden Determination
4.5.2.1. Bioburden Determination Market, 2018 - 2030 (USD Million)
4.5.3. Pyrogen & Endotoxin Testing
4.5.3.1. Pyrogen & Endotoxin Testing Market, 2018 - 2030 (USD Million)
4.5.4. Sterility Test and Validation
4.5.4.1. Sterility Test and Validation Market, 2018 - 2030 (USD Million)
4.5.4.2. Ethylene Oxide (EO) gas sterilization
4.5.4.2.1. Ethylene Oxide (EO) gas sterilization Market, 2018 - 2030 (USD Million)
4.5.4.3. Gamma-irradiation
4.5.4.3.1. Gamma-irradiation Market, 2018 - 2030 (USD Million)
4.5.4.4. E-beam sterilization
4.5.4.4.1. E-beam Sterilization Market, 2018 - 2030 (USD Million)
4.5.4.5. X-ray sterilization
4.5.4.5.1. X-ray sterilization Market, 2018 - 2030 (USD Million)
4.5.5. Antimicrobial activity testing
4.5.5.1. Antimicrobial activity testing Market, 2018 - 2030 (USD Million)
4.5.6. Others
4.5.6.1. Others Market, 2018 - 2030 (USD Million)
4.6. Packaging Validation
4.6.1. Packaging Validation Market, 2018 - 2030 (USD Million)
Chapter 5. Preclinical Medical Device Testing Services Market: Regional Analysis
5.1. Preclinical Medical Device Testing Services Market: Definition & Scope
5.2. Preclinical Medical Device Testing Services Market: Regional Market Share Analysis, 2021 & 2030
5.3. North America
5.3.1. North America preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.3.2. U.S.
5.3.2.1. U.S. preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.3.3. Canada
5.3.3.1. Canada preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.4. Europe
5.4.1. Europe preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.4.2. U.K.
5.4.2.1. U.K. preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.4.3. Germany
5.4.3.1. Germany preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.4.4. France
5.4.4.1. France preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.4.5. Italy
5.4.5.1. Italy preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.4.6. Spain
5.4.6.1. Spain preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.4.7. Netherlands
5.4.7.1. Netherlands preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.4.8. Belgium
5.4.8.1. Belgium preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.4.9. Switzerland
5.4.9.1. Switzerland preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.4.10. Russia
5.4.10.1. Russia preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.4.11. Sweden
5.4.11.1. Sweden preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.5. Asia Pacific
5.5.1. Asia Pacific preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.5.2. Japan
5.5.2.1. Japan preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.5.3. China
5.5.3.1. China preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.5.4. India
5.5.4.1. India preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.5.5. Australia
5.5.5.1. Australia preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.5.6. South Korea
5.5.6.1. South Korea preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.5.7. Malaysia
5.5.7.1. Malaysia preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.5.8. Indonesia
5.5.8.1. Indonesia preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.5.9. Singapore
5.5.9.1. Singapore preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.5.10. Philippines
5.5.10.1. Philippines preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.5.11. Thailand
5.5.11.1. Thailand preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.6. Latin America
5.6.1. Latin America preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.6.2. Brazil
5.6.2.1. Brazil preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.6.3. Mexico
5.6.3.1. Mexico preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.6.4. Argentina
5.6.4.1. Argentina preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.6.5. Colombia
5.6.5.1. Colombia preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.6.6. Chile
5.6.6.1. Chile preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.7. MEA
5.7.1. MEA preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.7.2. South Africa
5.7.2.1. South Africa preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.7.3. South Arabia
5.7.3.1. South Arabia preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.7.4. UAE
5.7.4.1. UAE preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.7.5. Israel
5.7.5.1. Israel preclinical medical device testing services market, 2018 - 2030 (USD Million)
5.7.6. Egypt
5.7.6.1. Egypt preclinical medical device testing services market, 2018 - 2030 (USD Million)
Chapter 6. Competitive Landscape
6.1. Company Profiles
6.1.1. SGS SA,
6.1.1.1. Company overview
6.1.1.2. Financial performance
6.1.1.3. Service benchmarking
6.1.1.4. Strategic initiatives
6.1.2. LabCorp
6.1.2.1. Company overview
6.1.2.2. Financial performance
6.1.2.3. Service benchmarking
6.1.2.4. Strategic initiatives
6.1.3. Eurofins Scientific
6.1.3.1. Company overview
6.1.3.2. Financial performance
6.1.3.3. Service benchmarking
6.1.3.4. Strategic initiatives
6.1.4. Pace Analytical Services Llc
6.1.4.1. Company overview
6.1.4.2. Financial performance
6.1.4.3. Service benchmarking
6.1.4.4. Strategic initiatives
6.1.5. Intertek Group PLC
6.1.5.1. Company overview
6.1.5.2. Financial performance
6.1.5.3. Service benchmarking
6.1.5.4. Strategic initiatives
6.1.6. Wuxi AppTec
6.1.6.1. Company overview
6.1.6.2. Financial performance
6.1.6.3. Service benchmarking
6.1.6.4. Strategic initiatives
6.1.7. Tüv Süd Ag
6.1.7.1. Company overview
6.1.7.2. Financial performance
6.1.7.3. Service benchmarking
6.1.7.4. Strategic initiatives
6.1.8. Sterigenics International LLC
6.1.8.1. Company overview
6.1.8.2. Financial performance
6.1.8.3. Service benchmarking
6.1.8.4. Strategic initiatives
6.1.9. Nelson Labs
6.1.9.1. Company overview
6.1.9.2. Financial performance
6.1.9.3. Service benchmarking
6.1.9.4. Strategic initiatives
6.1.10. North American Science Associates, Inc.
6.1.10.1. Company overview
6.1.10.2. Financial performance
6.1.10.3. Service benchmarking
6.1.10.4. Strategic initiatives
6.1.11. Charles River Laboratories International, Inc.
6.1.11.1. Company overview
6.1.11.2. Financial performance
6.1.11.3. Service benchmarking
6.1.11.4. Strategic initiatives
List of Tables
Table 1 List of Secondary Sources
Table 2 List of Abbreviations
Table 3 Global preclinical medical device testing services market, by region, 2018 - 2030 (USD Million)
Table 4 Global preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 5 North America preclinical medical device testing services market, by country, 2018 - 2030 (USD Million)
Table 6 North America preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 7 U.S. preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 8 Canada preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 9 Europe preclinical medical device testing services market, by country, 2018 - 2030 (USD Million)
Table 10 Europe preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 11 U.K. preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 12 Germany preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 13 France preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 14 Italy preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 15 Spain preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 16 Netherlands preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 17 Belgium preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 18 Switzerland preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 19 Russia preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 20 Sweden preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 21 Asia pacific preclinical medical device testing services market, by country, 2018 - 2030 (USD Million)
Table 22 Asia pacific preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 23 Japan preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 24 India preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 25 China preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 26 Thailand preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 27 South Korea preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 28 Malaysia preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 29 Indonesia preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 30 Singapore preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 31 Philippines preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 32 Latin America preclinical medical device testing services market, by country, 2018 - 2030 (USD Million)
Table 33 Latin America preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 34 Brazil preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 35 Mexico preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 36 Argentina preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 37 Colombia preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 38 Chile preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 39 MEA preclinical medical device testing services market, by country, 2018 - 2030 (USD Million)
Table 40 MEA preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 41 South Africa preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 42 South Arabia preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 43 UAE preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 44 Israel preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
Table 45 Egypt preclinical medical device testing services market, by services, 2018 - 2030 (USD Million)
List of Figures
FIG. 1 Market research process
Fig. 2 Information procurement
Fig. 3 Primary research pattern
Fig. 4 Market research approaches
Fig. 5 Preclinical Medical Device Testing Services market snapshot (2021)
Fig. 6 Preclinical Medical Device Testing Services market segmentation
Fig. 7 Parent market outlook
Fig. 8 Related/ancillary market outlook
Fig. 9 Penetration & growth prospect mapping
Fig. 10 Market driver relevance analysis (Current & future impact)
Fig. 11 Market restraint relevance analysis (Current & future impact)
Fig. 12 Porter’s five forces analysis
Fig. 13 SWOT analysis, by factor (political & legal, economic and technological)
Fig. 14 Preclinical Medical Device Testing Services market outlook: Segment dashboard
Fig. 15 Preclinical Medical Device Testing Services market: Service movement analysis
Fig. 16 Biocompatibility Tests market, 2018 - 2030 (USD Million)
Fig. 17 Chemistry Test market, 2018 - 2030 (USD Million)
Fig. 18 Microbiology & Sterility Testing market, 2018 - 2030 (USD Million)
Fig. 19 Bioburden Determination market, 2018 - 2030 (USD Million)
Fig. 20 Pyrogen & Endotoxin Testing market, 2018 - 2030 (USD Million)
Fig. 21 Sterility Test and Validation market, 2018 - 2030 (USD Million)
Fig. 22 Ethylene Oxide (EO) gas sterilization market, 2018 - 2030 (USD Million)
Fig. 23 Gamma-irradiation market, 2018 - 2030 (USD Million)
Fig. 24 E-beam sterilization market, 2018 - 2030 (USD Million)
Fig. 25 X-ray sterilization market, 2018 - 2030 (USD Million)
Fig. 26 Antimicrobial activity testing market, 2018 - 2030 (USD Million)
Fig. 27 Others market, 2018 - 2030 (USD Million)
Fig. 28 Package validation market, 2018 - 2030 (USD Million)
Fig. 29 Global preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 30 North America preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 31 U.S. preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 32 Canada preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 33 Europe preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 34 France preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 35 Germany preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 36 U.K. preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 37 Italy preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 38 Spain preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 39 Netherlands preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 40 Belgium preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 41 Switzerland preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 42 Russia preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 43 Sweden preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 44 Asia pacific preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 45 Japan preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 46 China preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 47 India preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 48 Australia preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 49 South Korea preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 50 Malaysia preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 51 Indonesia preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 52 Singapore preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 53 Philippines preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 54 Thailand preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 55 Latin America preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 56 Brazil preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 57 Mexico preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 58 Argentina preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 59 Colombia preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 60 Chile preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 61 MEA preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 62 South Africa preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 63 South Arabia preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 64 UAE preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 65 Israel preclinical medical device testing services market, 2018 - 2030 (USD Million)
Fig. 66 Egypt preclinical medical device testing services market, 2018 - 2030 (USD Million)

Companies Mentioned

  • SGS SA,
  • LabCorp
  • Eurofins Scientific
  • Pace Analytical Services Llc
  • Intertek Group PLC
  • Wuxi AppTec
  • Tüv Süd Ag
  • Sterigenics International LLC
  • Nelson Labs
  • North American Science Associates, Inc.
  • Charles River Laboratories International, Inc.

Methodology

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Table Information

Report AttributeDetails
No. of Pages275
PublishedAugust 2022
Forecast Period2022 - 2030
Estimated Market Value ( USD ) in 2022 $ 2.5 Billion
Forecasted Market Value ( USD ) by 2030 $ 4.9 Billion
Compound Annual Growth Rate8.6%
Regions CoveredGlobal
No. of Companies Mentioned11

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