Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service (Biocompatibility Tests, Chemistry Test, Package Validation), By Phase (Preclinical, Clinical), By Region, And Segment Forecasts, 2022 - 2030

Medical Device Testing Services Market Growth & Trends

The global medical device testing services market is expected to reach USD 22.8 billion by 2030, registering a CAGR of 11.3% during the forecast period, according to a new report by Grand View Research, Inc.Increasing complexity in product design and stringent government regulations are driving demand for the medical device testing services. The COVID-19 pandemic has created an unprecedented demand for medical device testing services in 2020, and the trend was expected to continue in 2021. The majority of medical equipment being tested is Personal Protective Equipment (PPE).

A significant rise in preclinical spending is a recent trend among pharmaceutical and medical device companies, which is expected to significantly contribute to market growth. As per the survey carried out by the International Federation of Pharmaceutical Manufacturers & Associations in 2017, around USD 149.8 billion is spent on preclinical trials, every year.

With modern medical devices offering a host of complex functions, the need for the 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 a competitive advantage to the manufacturers.

The COVID-19 pandemic has created an unprecedented demand for medical device testing services in 2020. This is largely due to the increasing demand for COVID-19-related products such as masks, PPE, & respiratory equipment. 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

  • Microbiology &sterility testing was the leading segment in 2021 with a market share of 34.2% & is likely to remain dominant during the forecast period. Producing safe & effective products is a core goal of medical device manufacturers, and sterility assurance is a major component for achieving it
  • The preclinical phase dominated the market in 2021 and accounted for 65.8% of the market share as this stage is mostly focused on assessing the safety & biocompatibility of the medical devices
  • Raw materials, packaging & design all have an impact on a device's safety and compatibility, and preclinical testing of all these factors is an important step in determining a device's market potential.
  • Asia Pacific held the maximum share of the global market and accounted for 42.2% of the revenue share in 2021. This is due to the rising demand for the medical devices in developing nations such as India & China
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Chapter 1 Methodology and Scope
1.1 Market Segmentation & Scope
1.1.1 Service
1.1.2 Phase
1.1.3 Regional Scope
1.1.4 Estimates And Forecast TimelinE
1.2 Research Methodology
1.3 Information Procurement
1.3.1 Purchased Database
1.3.2 Gvr’s Internal Database
1.3.3 Secondary Sources
1.3.4 Primary Research
1.3.5 Details Of Primary Research
1.4 Information or Data Analysis
1.4.1 Data Analysis Models
1.5 Market Formulation & Validation
1.5.1 Region Wise Market Calculation
1.5.2 Region Wise Market: Base Estimates
1.5.3 Global Market: CAGR Calculation
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 Abbreviations
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
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 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 Intensifying competition
3.3.1.3 Increasing number of small medical devices lacking in-house testing capabilities
3.3.1.4 Strict approval norms
3.3.2 Market Restraint Analysis
3.3.2.1 Legal & regulatory issues
3.3.2.2 Delays in contractual obligations
3.3.3 Industry Challenges
3.3.3.1 Managing Relationships
3.4 Medical Device Testing Services: Market Analysis Tools
3.4.1 Industry Analysis - Porter’s Five Forces Analysis
3.4.2 PESTEL Analysis
3.5 Major Deals and Strategic Alliances Analysis
Chapter 4 Medical Device Testing Services Market: COVID-19 Impact
4.1 Covid-19 Impact on the Market
4.2 Impact of COVID-19 on Regulatory Approvals in the EU
4.2.1 Postponement of EU-MDR applications
4.2.2 European standards and other technical documents are available for free
4.2.3 PPE & relevant medical devices may be placed without CE marking
4.2.4 Suspension of inspection by NBS
4.3 Impact of COVID-19 on regulatory approvals in the U.S.
4.4 Impact on Clinical Trials and IRB Reviews
Chapter 5 Medical Device Testing Services Market: Service Segment Analysis
5.1 Medical Device Testing Services Market: Service Market Share Analysis, 2021 & 2030
5.2 Biocompatibility Tests
5.2.1 Biocompatibility tests market, 2017 - 2030 (USD Million)
5.3 Chemistry Test
5.3.1 Chemistry test market, 2017 - 2030 (USD Million)
5.4 Microbiology & Sterility Testing
5.4.1 Microbiology & sterility testing market, 2017 - 2030 (USD Million)
5.4.2 Bioburden Determination
5.4.2.1 Bioburden determination market, 2017 - 2030 (USD Million)
5.4.3 Pyrogen & Endotoxin Testing
5.4.3.1 Pyrogen & endotoxin testing market, 2017 - 2030 (USD Million)
5.4.4 Sterility Test and Validation
5.4.4.1 Sterility test and validation market, 2017 - 2030 (USD Million)
5.4.5 Anti-microbial Activity Testing
5.4.5.1 Anti-microbial activity testing market, 2017 - 2030 (USD Million)
5.4.6 Others
5.4.6.1 Others market, 2017 - 2030 (USD Million)
5.5 Package Validation
5.5.1 Package validation market, 2017 - 2030 (USD Million)
Chapter 6 Medical Device Testing Services Market: Phase Segment Analysis
6.1 Medical Device Testing Services Market: Phase Market Share Analysis, 2021 & 2030
6.2 Preclinical
6.2.1 Preclinical market, 2017 - 2030 (USD Million)
6.3 Clinical
6.3.1 Clinical market, 2017 - 2030 (USD Million)
Chapter 7 Medical Device Testing Services Market: Regional Segment Analysis
7.1 Medical Device Testing Services Market: Regional Market Share Analysis, 2021 & 2030
7.2 North America
7.2.1 North America medical device testing services market, 2017 - 2030 (USD Million)
7.2.2 U.S.
7.2.2.1 U.S. medical device testing services market, 2017 - 2030 (USD Million)
7.2.3 Canada
7.2.3.1 Canada medical device testing services market, 2017 - 2030 (USD Million)
7.3 Europe
7.3.1 Europe medical device testing services market, 2017 - 2030 (USD Million)
7.3.2 U.K.
7.3.2.1 UK medical device testing services market, 2017 - 2030 (USD Million)
7.3.3 Germany
7.3.3.1 Germany medical device testing services market, 2017 - 2030 (USD Million)
7.3.4 France
7.3.4.1 France medical device testing services market, 2017 - 2030 (USD Million)
7.3.5 Italy
7.3.5.1 Italy medical device testing services market, 2017 - 2030 (USD Million)
7.3.6 Spain
7.3.6.1 Spain medical device testing services market, 2017 - 2030 (USD Million)
7.3.7 Netherlands
7.3.7.1 Netherlands medical device testing services market, 2017 - 2030 (USD Million)
7.3.8 Belgium
7.3.8.1 Belgium medical device testing services market, 2017 - 2030 (USD Million)
7.3.9 Switzerland
7.3.9.1 Switzerland medical device testing services market, 2017 - 2030 (USD Million)
7.3.10 Russia
7.3.10.1 Russia medical device testing services market, 2017 - 2030 (USD Million)
7.3.11 Sweden
7.3.11.1 Sweden medical device testing services market, 2017 - 2030 (USD Million)
7.4 Asia Pacific
7.4.1 Asia Pacific medical device testing services market, 2017 - 2030 (USD Million)
7.4.2 China
7.4.2.1 China medical device testing services market, 2017 - 2030 (USD Million)
7.4.3 Japan
7.4.3.1 Japan medical device testing services market, 2017 - 2030 (USD Million)
7.4.4 India
7.4.4.1 India medical device testing services market, 2017 - 2030 (USD Million)
7.4.5 Australia
7.4.5.1 Australia medical device testing services market, 2017 - 2030 (USD Million)
7.4.6 South Korea
7.4.6.1 South Korea medical device testing services market, 2017 - 2030 (USD Million)
7.4.7 Malaysia
7.4.7.1 Malaysia medical device testing services market, 2017 - 2030 (USD Million)
7.4.8 Indonesia
7.4.8.1 Indonesia medical device testing services market, 2017 - 2030 (USD Million)
7.4.9 Singapore
7.4.9.1 Singapore medical device testing services market, 2017 - 2030 (USD Million)
7.4.10 Philippines
7.4.10.1 Philippines medical device testing services market, 2017 - 2030 (USD Million)
7.4.11 Thailand
7.4.11.1 Thailand medical device testing services market, 2017 - 2030 (USD Million)
7.5 Latin America
7.5.1 Latin America medical device testing services market, 2017 - 2030 (USD Million)
7.5.2 Brazil
7.5.2.1 Brazil medical device testing services market, 2017 - 2030 (USD Million)
7.5.3 Mexico
7.5.3.1 Mexico medical device testing services market, 2017 - 2030 (USD Million)
7.5.4 Argentina
7.5.4.1 Argentina medical device testing services market, 2017 - 2030 (USD Million)
7.5.5 Colombia
7.5.5.1 Colombia medical device testing services market, 2017 - 2030 (USD Million)
7.5.6 Chile
7.5.6.1 Chile medical device testing services market, 2017 - 2030 (USD Million)
7.6 Middle East & Africa
7.6.1 Middle East & Africa medical device testing services market, 2017 - 2030 (USD Million)
7.6.2 South Africa
7.6.2.1 South Africa medical device testing services market, 2017 - 2030 (USD Million)
7.6.3 Saudi Arabia
7.6.3.1 Saudi Arabia medical device testing services market, 2017 - 2030 (USD Million)
7.6.4 UAE
7.6.4.1 UAE medical device testing services market, 2017 - 2030 (USD Million)
7.6.5 Israel
7.6.5.1 Israel medical device testing services market, 2017 - 2030 (USD Million)
7.6.6 Egypt
7.6.6.1 Egypt medical device testing services market, 2017 - 2030 (USD Million)
Chapter 8 Medical Device Testing Services Market: Competitive Analysis
8.1 Company Profiles
8.1.1 SGS SA
8.1.1.1 Company overview
8.1.1.2 Financial performance
8.1.1.3 Service benchmarking
8.1.1.4 Strategic initiatives
8.1.2 Eurofins Scientific
8.1.2.1 Company overview
8.1.2.2 Financial performance
8.1.2.3 Service benchmarking
8.1.2.4 Strategic initiatives
8.1.3 PACE Analytics services LLC
8.1.3.1 Company overview
8.1.3.2 Service benchmarking
8.1.3.3 Strategy initiatives
8.1.4 Intertek PLC
8.1.4.1 Company overview
8.1.4.2 Financial Performance
8.1.4.3 Service benchmarking
8.1.4.4 Strategic Initiatives
8.1.5 WUXI Apptec
8.1.5.1 Company overview
8.1.5.2 Financial Performance
8.1.5.3 Service benchmarking
8.1.5.4 Strategic initiatives
8.1.6 North America Science Associates, Inc.
8.1.6.1 Company overview
8.1.6.2 Service benchmarking
8.1.6.3 Strategy Initiatives
8.1.7 TUV SUD AG
8.1.7.1 Company overview
8.1.7.2 Financial performance
8.1.7.3 Service benchmarking
8.1.7.4 Strategy intiatives
8.1.8 American Preclinical Services
8.1.8.1 Company overview
8.1.8.2 Service benchmarking
8.1.8.3 Strategy Initiatives
8.1.9 Sterigenics International LLC
8.1.9.1 Company overview
8.1.9.2 Service benchmarking
8.1.9.3 Strategy intiatives
8.1.10 Charles River Laboratories International, Inc.
8.1.10.1 Company overview
8.1.10.2 Financial performance
8.1.10.3 Service benchmarking
8.1.10.4 Strategy intiatives
8.1.11 Medical Device Testing Services
8.1.11.1 Company overview
8.1.11.2 Service benchmarking
8.1.12 Toxikon, Inc.
8.1.12.1 Company overview
8.1.12.2 Service benchmarking

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