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Innovative product development, collaborations, mergers and acquisitions, the stringent regulatory scenario for medical device approval are boosting the growth of the market over the years. Also, the developments in the medical device industry is likely to have a positive impact on the demand for the market during the forecast period. However, the growth of the market is restrained by factors such as interruptions in contractual obligations.
Medical device testing needs strong experience of the domain, native and national legislations, and information about the devices, infrastructure, and ability to support the testing. The healthcare and medical device industry is an active one due to continuous development and advanced solutions. The enhancements in medical device technology have significantly enhanced the efficiency of patient care in the last few decades. As per the FDA in 2018, stated that there are above 80,000 incidents identified since 2008, due to the medical device injury. Since, last few years, medical device companies and doctors have observed that spinal-cord stimulators have helped the patients who suffer from pain disorders. Due to this, it has become one of the most rising products in the $400 billion medical device industry. Therefore, the increasing incidences of product recall and higher demand for quality products are growing the need for testing of medical devices. Hence, it will boost the market for medical device testing services.
However, a number of problems inhibit medical devices from undertaking the standard formulary agency review process applied to drugs. In recent years, approximately thirty percent of respondents experienced a significant supply shortage or disruption that was mostly due to supply shortages, quality issues in manufacturing, and delays in regulatory approvals.
Global medical device testing services market is segmented by Service and Phase. On the basis of service, the market is segmented into biocompatibility test, chemistry test, microbiology & sterility testing, and package validation. On the basis of Phase, the market is segmented into preclinical and clinical. In 2018, the microbiology & sterility testing held the most significant market share 53.55% of the medical device testing services market, by service whereas the preclinical segment by Phase, held a considerable market share of 68.17% in 2018.
Some of the major primary and secondary sources included in the report are, Food and Drug Administration, World Health Organization, International Trade Administration (ITA), Federal Commission for Protection against Sanitary Risk (COFEPRIS), Medicines and Healthcare products Regulatory Agency (MHRA), Federal Institute for Drugs and Medical Devices.
1. Introduction
1.1 Scope of the Study
1.2 The Insight Partners Research Report Guidance
1.3 Market Segmentation
1.3.1 Global Medical Device Testing Services Market – By Service
1.3.2 Global Medical Device Testing Services Market – By Phase
1.3.3 Global Medical Device Testing Services Market – By Geography
2. Global Medical Device Testing Services Market – Key Takeaways
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. Global Medical Device Testing Services Market Landscape
4.1 Overview
4.2 PEST Analysis
4.2.1 North America PEST Analysis
4.2.2 Europe PEST Analysis
4.2.3 Asia Pacific PEST Analysis
4.2.4 Middle East & Africa PEST Analysis
4.2.5 South & Central America PEST Analysis
5. Global Medical Device Testing Services Market – Key Industry Dynamics
5.1 Key Market Drivers
5.1.1 Rising Demand of Testing for Medical Devices
5.1.2 Growing Number of Small and Medium-Sized Enterprises (SMEs) Requiring Domestic Analysis
5.1.3 Stringent Regulatory Scenario
5.2 Key Market Restraints
5.2.1 Interruptions in Contractual Obligations
5.3 Key Market Opportunities
5.3.1 Development in the Medical Device Industry
5.4 Future Trend
5.4.1 Rising Market Consolidation
5.5 Impact Analysis
6. Medical Device Testing Services Market – Global Analysis
6.1 Global Medical Device Testing Services Market Revenue Forecasts And Analysis
6.2 Global Medical Device Testing Services Market, By Geography - Forecasts And Analysis
6.3 Market Positioning of Key Players
7. Medical Device Testing Services Market Analysis And Forecasts To 2027 – Service
7.1 Overview
7.2 Global Medical Device Testing Services Market Share By Service 2018 & 2027 (%)
7.3 Microbiology & Sterility Testing
7.3.1 Overview
7.3.2 Microbiology & Sterility Testing Market Revenue and Forecast to 2027 (US$ Mn)
7.4 Chemistry Test
7.4.1 Overview
7.4.2 Chemistry Test Market Revenue and Forecast to 2027 (US$ Mn)
7.5 Biocompatibility Test
7.5.1 Overview
7.5.2 Biocompatibility Test Market Revenue and Forecast to 2027 (US$ Mn)
7.6 Package Validation
7.6.1 Overview
7.6.2 Package Validation Market Revenue and Forecast to 2027 (US$ Mn)
8. Medical Device Testing Services Market Analysis And Forecasts To 2027 – Phase
8.1 Overview
8.2 Global Medical Device Testing Services Market Share By Phase 2018 & 2027 (%)
8.3 Preclinical
8.3.1 Overview
8.3.2 Global Preclinical Market Revenue and Forecasts to 2027 (US$ Mn)
8.4 Clinical
8.4.1 Overview
8.4.2 Clinical Market Revenue and Forecast to 2027 (US$ Mn)
9. Medical Device Testing Services Market Revenue and Forecasts to 2027 – Geographical Analysis
9.1 North America Medical Device Testing Services Market Revenue And Forecasts To 2027
9.2 Overview
9.3 North America Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
9.4 North America Medical Device Testing Services Market Revenue And Forecasts to 2027, By service (US$ Mn)
9.5 North America Medical Device Testing Services Market Revenue And Forecasts to 2027, By phase (US$ Mn)
9.6 North America Medical Device Testing Services Market Revenue And Forecasts to 2027, By Country (%)
9.7 US Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
9.7.1 US Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
9.7.2 US Medical Device Testing Services market Revenue And Forecasts to 2027, By Service (US$ Mn)
9.7.3 US Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
9.8 Canada Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
9.8.1 Canada Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
9.8.2 Canada Medical Device Testing Services market Revenue And Forecasts to 2027, By Service (US$ Mn)
9.8.3 Canada Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
9.9 Mexico Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
9.9.1 Mexico Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
9.9.2 Mexico Medical Device Testing Services market Revenue And Forecasts to 2027, By Service (US$ Mn)
9.9.3 Mexico Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
10. Europe Medical Device Testing Services Market Revenue and Forecasts to 2027
10.1 Overview
10.2 Europe Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
10.3 Europe Medical Device Testing Services Market Revenue And Forecasts to 2027, By service (US$ Mn)
10.4 Europe Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
10.5 Europe Medical Device Testing Services Market Revenue And Forecasts to 2027, By Country (%)
10.6 UK Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
10.6.1 UK Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
10.6.2 UK Medical Device Testing Services market Revenue And Forecasts to 2027, By Service (US$ Mn)
10.6.3 UK Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
10.7 Germany Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
10.7.1 Germany Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
10.7.2 Germany Medical Device Testing Services market Revenue And Forecasts to 2027, By Service (US$ Mn)
10.7.3 Germany Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
10.8 France Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
10.8.1 France Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
10.8.2 France Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
10.8.3 France Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
10.9 Italy Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
10.9.1 Italy Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
10.9.2 Italy Medical Device Testing Services market Revenue And Forecasts to 2027, By Service (US$ Mn)
10.9.3 Italy Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
10.10 Spain Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
10.10.1 Spain Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
10.10.2 Spain Medical Device Testing Services market Revenue And Forecasts to 2027, By Service (US$ Mn)
10.10.3 Spain Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11. Asia Pacific Medical Device Testing Services Market Revenue and Forecasts to 2027
11.1 Overview
11.2 Asia Pacific Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.3 Asia Pacific Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.4 Asia Pacific Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11.5 Asia Pacific Medical Device Testing Services Market Revenue And Forecasts to 2027, By Country (%)
11.6 Japan Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.6.1 Japan Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.6.2 Japan Medical Device Testing Services market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.6.3 Japan Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11.7 China Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.7.1 China Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.7.2 China Medical Device Testing Services market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.7.3 China Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11.7.4 India Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.7.4.1 India Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.7.4.2 India Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.7.4.3 India Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11.7.5 South Korea Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.7.5.1 South Korea Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.7.5.2 South Korea Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.7.5.3 South Korea Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11.7.6 Australia Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.7.6.1 Australia Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.7.6.2 Australia Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.7.6.3 Australia Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11.8 Middle East & Africa Medical Device Testing Services Market Revenue And Forecasts To 2027
11.8.1 Middle East & Africa Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.8.2 Middle East & Africa Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.8.3 Middle East & Africa Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11.8.4 Middle East & Africa Medical Device Testing Services Market Revenue and Forecasts to 2027, By Country (%)
11.8.5 UAE Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.8.5.1 UAE Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.8.5.2 UAE Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.8.5.3 UAE Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11.8.6 Saudi Arabia Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.8.6.1 Saudi Arabia Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.8.6.2 Saudi Arabia Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.8.6.3 Saudi Arabia Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11.8.7 South Africa Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.8.7.1 South Africa Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.8.7.2 South Africa Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.8.7.3 South Africa Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11.9 South And Central America Medical Device Testing Services Market Revenue And Forecasts To 2027
11.9.1 South and Central America Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.9.2 South and Central America Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.9.3 South and Central America Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11.9.4 South and Central America Medical Device Testing Services Market Revenue and Forecasts to 2027, By Country (%)
11.9.5 Argentina Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.9.5.1 Argentina Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.9.5.2 Argentina Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.9.5.3 Argentina Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
11.9.6 Brazil Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.9.6.1 Brazil Medical Device Testing Services Market Revenue and Forecasts to 2027 (US$ Mn)
11.9.6.2 Brazil Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
11.9.6.3 Brazil Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
12. Medical Device Testing Services Market– Industry Landscape
12.1 Overview
12.2 Growth Strategies In The Medical Device Testing Services Market, 2016-2019
12.3 Inorganic Growth Strategies
12.3.1 Overview
12.4 Inorganic Growth Strategies in the Medical Device Testing Services Market, 2016-2019 (%)
12.4.1 Merger and Acquisition
12.4.1.1 Recent Merger and Acquisition By Players In The Medical Device Testing Services Market
12.5 Organic Growth Strategies
12.5.1 Overview
12.5.2 Service Launch and Expansions
12.5.2.1 Service Launch and Expansions By Players In The Medical Device Testing Services Market
13. Medical Device Testing Services Market–Key Company Profiles
13.1 SGS SA
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
13.2 Toxikon Corporation
13.2.1 Key Facts
13.2.2 Business Description
13.2.3 Products and Services
13.2.4 Financial Overview
13.2.5 SWOT Analysis
13.2.6 Key Developments
13.3 Eurofins Scientific
13.3.1 Key Facts
13.3.2 Business Description
13.3.3 Products and Services
13.3.4 Financial Overview
13.3.5 SWOT Analysis
13.3.6 Key Developments
13.4 Pace Analytical Services, LLC
13.4.1 Key Facts
13.4.2 Business Description
13.4.3 Products and Services
13.4.4 Financial Overview
13.4.5 SWOT Analysis
13.4.6 Key Developments
13.5 Intertek Group plc
13.5.1 Key Facts
13.5.2 Business Description
13.5.3 Products and Services
13.5.4 Financial Overview
13.5.5 SWOT Analysis
13.5.6 Key Developments
13.6 NORTH AMERICAN SCIENCE ASSOCIATES INC.
13.6.1 Key Facts
13.6.2 Business Description
13.6.3 Products and Services
13.6.4 Financial Overview
13.6.5 SWOT Analysis
13.7 CHARLES RIVER
13.7.1 Key Facts
13.7.2 Business Description
13.7.3 Products and Services
13.7.4 Financial Overview
13.7.5 SWOT Analysis
13.7.6 Key Developments
13.8 WuXi AppTec.
13.8.1 Key Facts
13.8.2 Business Description
13.8.3 Products and Services
13.8.4 Financial Overview
13.8.5 SWOT Analysis
13.8.6 Key Developments
13.9 Element Materials Technology
13.9.1 Key Facts
13.9.2 Business Description
13.9.3 Products and Services
13.9.4 Financial Overview
13.9.5 SWOT Analysis
13.9.6 Key Developments
13.10 TÜV SÜD AG
13.10.1 Key Facts
13.10.2 Business Description
13.10.3 Products and Services
13.10.4 Financial Overview
13.10.5 SWOT Analysis
14. Appendix
14.1 About The Insight Partners
14.2 Glossary of Terms
Table 1. Medical Device Market in China
Table 2. North America Medical Device Testing Services Market Revenue And Forecasts to 2027, By service (US$ Mn)
Table 3. North America Medical Device Testing Services Market Revenue And Forecasts to 2027, By service (US$ Mn)
Table 4. US: R&D investments by Medical Device companies, (2018)
Table 5. US Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 6. US Medical Device Testing Services Market Revenue And Forecasts to 2027, By phase (US$ Mn)
Table 7. Canada Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 8. Canada Medical Device Testing Services Market Revenue And Forecasts to 2027, By phase (US$ Mn)
Table 9. Mexico Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 10. Mexico Medical Device Testing Services Market Revenue And Forecasts to 2027, By phase (US$ Mn)
Table 11. Europe Medical Device Testing Services Market Revenue And Forecasts to 2027, By service (US$ Mn)
Table 12. Europe Medical Device Testing Services Market Revenue And Forecasts to 2027, By phase (US$ Mn)
Table 13. UK Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 14. UK Medical Device Testing Services Market Revenue And Forecasts to 2027, By phase (US$ Mn)
Table 15. Germany Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 16. Germany Medical Device Testing Services Market Revenue And Forecasts to 2027, By phase (US$ Mn)
Table 17. France Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 18. France Medical Device Testing Services Market Revenue And Forecasts to 2027, By phase (US$ Mn)
Table 19. Italy Medical Device Market
Table 20. Italy Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 21. Italy Medical Device Testing Services Market Revenue And Forecasts to 2027, By phase (US$ Mn)
Table 22. Spain Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 23. Spain Medical Device Testing Services Market Revenue And Forecasts to 2027, By phase (US$ Mn)
Table 24. Asia Pacific Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 25. Asia Pacific Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
Table 26. Japan Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 27. Japan Medical Device Testing Services Market Revenue And Forecasts to 2027, By phase (US$ Mn)
Table 28. China Medical Device Market
Table 29. China Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 30. China Medical Device Testing Services Market Revenue And Forecasts to 2027, By phase (US$ Mn)
Table 31. India Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 32. India Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
Table 33. South Korea Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 34. South Korea Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
Table 35. Australia Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 36. Australia Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
Table 37. Middle East & Africa Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 38. Middle East & Africa Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
Table 39. UAE Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 40. UAE Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
Table 41. Saudi Arabia Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 42. Saudi Arabia Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
Table 43. South Africa Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 44. South Africa Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
Table 45. South and Central America Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 46. South and Central America Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
Table 47. Argentina Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 48. Argentina Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
Table 49. Brazil Medical Device Testing Services Market Revenue And Forecasts to 2027, By Service (US$ Mn)
Table 50. Brazil Medical Device Testing Services Market Revenue And Forecasts to 2027, By Phase (US$ Mn)
Table 51. Recent Merger and Acquisition in the Medical Device Testing Services Market
Table 52. Service Launch and Expansions By Players In The Medical Device Testing Services Market
Table 53. Glossary of Terms, Medical Device Testing Services Market
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