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Medical Device Testing Services Market Size, Share & Trends Analysis Report by Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Test, Package Validation), Phase, Region, and Segment Forecasts, 2021-2028

  • ID: 4538724
  • Report
  • May 2021
  • Region: Global
  • 100 pages
  • Grand View Research
The global medical device testing services market size is expected to reach USD 18.6 billion by 2028. The market is expected to expand at a CAGR of 11.6% from 2021 to 2028. Increasing complexity in product design and stringent government regulations are driving the market.



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 a survey carried out by the International Federation of Pharmaceutical Manufacturers and Associations in 2017, around USD 149.8 billion is spent on preclinical trials every year.

With modern medical equipment 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 a competitive advantage to 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-10 related products such as masks, PPE, and 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 and UNE 0065 which must be met until a mask can be sold.

Medical Device Testing Services Market Report Highlights

  • The microbiology and sterility testing segment dominated the market in 2020 and accounted for the largest revenue share of 34.1%. The segment is likely to remain dominant over the forecast period
  • Producing safe and effective products is a core goal of medical equipment manufacturers and sterility assurance is a major component for achieving it
  • The preclinical phase segment dominated the market in 2020 and accounted for 65.7% of the revenue share as this stage is mostly focused on assessing the safety and biocompatibility of medical devices
  • Raw materials, packaging, and design all have an impact on a device's safety and compatibility, and preclinical testing of all of these factors is an important step in determining a device's market potential
  • Asia Pacific dominated the market and accounted for 41.8% of the revenue share in 2020. This is due to the rising demand for medical devices in developing nations such as India and China

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Note: Product cover images may vary from those shown
Chapter 1 Methodology and Scope
1.1 Market Segmentation & Scope
1.2 Research Methodology
1.3 Information Procurement
1.4 Information or Data Analysis
1.5 Market Formulation & Validation
1.6 Model Details
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 Outlook
2.3 Competitive Insights

Chapter 3 Medical Device Testing Services Market: Variables, Trends, & Scope
3.1 Market Lineage Outlook
3.2 Penetration & Growth Prospect Mapping
3.3 Market Dynamics
3.4 Medical Device Testing Services: Market Analysis Tools
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 EU
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, 2020 & 2028
5.2 Biocompatibility Tests
5.3 Chemistry Test
5.4 Microbiology & Sterility Testing
5.5 Package Validation

Chapter 6 Medical Device Testing Services Market: Phase Segment Analysis
6.1 Medical Device Testing Services Market: Phase Market Share Analysis, 2020 & 2028
6.2 Preclinical
6.3 Clinical

Chapter 7 Medical Device Testing Services Market: Regional Segment Analysis
7.1 Medical Device Testing Services Market: Regional Market Share Analysis, 2020 & 2028
7.2 North America
7.3 Europe
7.4 Asia Pacific
7.5 Latin America
7.6 Middle East & Africa

Chapter 8 Medical Device Testing Services Market: Competitive Analysis
8.1 Company Profiles

List of Tables
Table 1 List of Secondary Sources
Table 2 List of Abbreviations
Table 3 Global Medical Device Testing Services Market, by Region, 2016-2028 (USD Million)
Table 4 Global Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 5 Global Medical Device Testing Services Market, by Test Type, 2016-2028 (USD Million)
Table 6 Global Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 7 North America Medical Device Testing Services Market, by Country, 2016-2028 (USD Million)
Table 8 North America Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 9 North America Medical Device Testing Services Market, by Test Type, 2016-2028 (USD Million)
Table 10 North America Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 11 U.S. Medical Device Testing Services Market, by Services, 2016-2028 (USD Million)
Table 12 U.S. Medical Device Testing Services Market, by Test Type, 2016-2028 (USD Million)
Table 13 U.S. Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 14 Canada Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 15 Canada Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 16 Canada Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 17 Europe Medical Device Testing Services Market, by Country, 2016-2028 (USD Million)
Table 18 Europe Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 19 Europe Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 20 Europe Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 21 U.K. Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 22 U.K. Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 23 U.K. Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 24 Germany Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 25 Germany Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 26 Germany Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 27 France Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 28 France Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 29 France Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 30 Italy Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 31 Italy Medical Device Testing Services Market, by Test Type, 2016-2028 (USD Million)
Table 32 Italy Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 33 Spain Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 34 Spain Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 35 Spain Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 36 Netherlands Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 37 Netherlands Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 38 Netherlands Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 39 Belgium Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 40 Belgium Medical Device Testing Services Market, by Test Type, 2016-2028 (USD Million)
Table 41 Belgium Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 42 Switzerland Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 43 Switzerland Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 44 Switzerland Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 45 Russia Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 46 Russia Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 47 Russia Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 48 Sweden Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 49 Sweden Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 50 Sweden Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 51 Asia Pacific Medical Device Testing Services Market, by Country, 2016-2028 (USD Million)
Table 52 Asia Pacific Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 53 Asia Pacific Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 54 Asia Pacific Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 55 India Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 56 India Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 57 India Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 58 Japan Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 59 Japan Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 60 Japan Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 61 China Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 62 China Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 63 China Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 64 Australia Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 65 Australia Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 66 Australia Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 67 South Korea Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 68 South Korea Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 69 South Korea Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 70 Malaysia Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 71 Malaysia Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 72 Malaysia Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 73 Indonesia Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 74 Indonesia Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 75 Indonesia Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 76 Singapore Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 77 Singapore Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 78 Singapore Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 79 Philippines Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 80 Philippines Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 81 Philippines Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 82 Thailand Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 83 Thailand Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 84 Thailand Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 85 Latin America Medical Device Testing Services Market, by Country, 2016-2028 (USD Million)
Table 86 Latin America Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 87 Latin America Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 88 Latin America Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 89 Brazil Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 90 Brazil Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 91 Brazil Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 92 Mexico Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 93 Mexico Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 94 Mexico Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 95 Argentina Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 96 Argentina Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 97 Argentina Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 98 Colombia Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 99 Colombia Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 100 Colombia Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 101 Chile Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 102 Chile Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 103 Chile Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 104 Middle East & Africa Medical Device Testing Services Market, by Country, 2016-2028 (USD Million)
Table 105 Middle East & Africa Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 106 Middle East & Africa Medical Device Testing Services Market, by Test Type, 2016-2028 (USD Million)
Table 107 Middle East & Africa Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 108 South Africa Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 109 South Africa Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 110 South Africa Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 111 Saudi Arabia Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 112 Saudi Arabia Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 113 Saudi Arabia Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 114 UAE Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 115 UAE Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 116 UAE Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 117 Israel Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 118 Israel Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 119 Israel Medical Device Testing Services Market, by Phase, 2016-2028 (USD Million)
Table 120 Egypt Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 121 Egypt Medical Device Testing Services Market, by Test type, 2016-2028 (USD Million)
Table 122 Egypt Medical Device Testing Services Market, by Phase, 2016-2028 (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 QFD modeling for market share assessment
Fig. 6 Market formulation & validation
Fig. 7 Commodity flow analysis
Fig. 8 Volume price analysis
Fig. 9 Medical device testing services market snapshot (2020)
Fig. 10 Medical device testing services market segmentation
Fig. 11 Medical device testing services market: Strategic framework
Fig. 12 Parent market outlook
Fig. 13 Related/ancillary market outlook
Fig. 14 Penetration & growth prospect mapping
Fig. 15 Market driver relevance analysis (Current & future impact)
Fig. 16 Market restraint relevance analysis (Current & future impact)
Fig. 17 Porter’s five forces analysis
Fig. 18 SWOT analysis, by factor (political & legal, economic and technological)
Fig. 19 Medical device testing service market service outlook: Segment dashboard
Fig. 20 Medical device testing service market: service movement analysis
Fig. 21 Biocompatibility tests market, 2016-2028 (USD Million)
Fig. 22 Chemistry test market, 2016-2028 (USD Million)
Fig. 23 Microbiology & sterility testing market, 2016-2028 (USD Million)
Fig. 24 Bioburden determination market, 2016-2028 (USD Million)
Fig. 25 Pyrogen & endotoxin testing market, 2016-2028 (USD Million)
Fig. 26 Sterility test and validation market, 2016-2028 (USD Million)
Fig. 27 Antimicrobial activity testing market, 2016-2028 (USD Million)
Fig. 28 Others market, 2016-2028 (USD Million)
Fig. 29 Package validation market, 2016-2028 (USD Million)
Fig. 30 Medical device testing service market phase outlook: Segment dashboard
Fig. 31 Medical device testing service market: Phase movement analysis
Fig. 32 Preclinical market, 2016-2028 (USD Million)
Fig. 33 Clinical market, 2016-2028 (USD Million)
Fig. 34 Medical device testing services market regional outlook: Segment dashboard
Fig. 35 Medical device testing services market: Regional movement analysis
Fig. 36 North America market, 2016-2028 (USD Million)
Fig. 37 U.S. market, 2016-2028 (USD Million)
Fig. 38 Canada market, 2016-2028 (USD Million)
Fig. 39 Europe market, 2016-2028 (USD Million)
Fig. 40 U.K. market, 2016-2028 (USD Million)
Fig. 41 Germany market, 2016-2028 (USD Million)
Fig. 42 France market, 2016-2028 (USD Million)
Fig. 43 Italy market, 2016-2028 (USD Million)
Fig. 44 Spain market, 2016-2028 (USD Million)
Fig. 45 Netherlands market, 2016-2028 (USD Million)
Fig. 46 Belgium market, 2016-2028 (USD Million)
Fig. 47 Switzerland market, 2016-2028 (USD Million)
Fig. 48 Russia market, 2016-2028 (USD Million)
Fig. 49 Sweden market, 2016-2028 (USD Million)
Fig. 50 Asia Pacific market, 2016-2028 (USD Million)
Fig. 51 China market, 2016-2028 (USD Million)
Fig. 52 Japan market, 2016-2028 (USD Million)
Fig. 53 India market, 2016-2028 (USD Million)
Fig. 54 Australia market, 2016-2028 (USD Million)
Fig. 55 South Korea market, 2016-2028 (USD Million)
Fig. 56 Malaysia market, 2016-2028 (USD Million)
Fig. 57 Indonesia market, 2016-2028 (USD Million)
Fig. 58 Singapore market, 2016-2028 (USD Million)
Fig. 59 Philippines market, 2016-2028 (USD Million)
Fig. 60 Thailand market, 2016-2028 (USD Million)
Fig. 61 Latin America market, 2016-2028 (USD Million)
Fig. 62 Brazil market, 2016-2028 (USD Million)
Fig. 63 Mexico market, 2016-2028 (USD Million)
Fig. 64 Argentina market, 2016-2028 (USD Million)
Fig. 65 Colombia market, 2016-2028 (USD Million)
Fig. 66 Chile market, 2016-2028 (USD Million)
Fig. 67 Middle East & Africa market, 2016-2028 (USD Million)
Fig. 68 South Africa market, 2016-2028 (USD Million)
Fig. 69 Saudi Arabia market, 2016-2028 (USD Million)
Fig. 70 UAE market, 2016-2028 (USD Million)
Fig. 71 Israel market, 2016-2028 (USD Million)
Fig. 72 Egypt market, 2016-2028 (USD Million)
Note: Product cover images may vary from those shown
  • SGS SA
  • Eurofins Scientific
  • PACE Analytics services LLC
  • Intertek PLC
  • WUXI Apptec
  • North America Science Associates, INC
  • TUV SUD AG
  • American Preclinical Services
  • Sterigenics International LLC
  • Charles River Laboratories International, Inc.
  • Medical Device Testing Services
  • Toxikon, Inc.
Note: Product cover images may vary from those shown

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