Medical Device Testing Market by Service Type (Testing and Certification) Location, Technology (Active Implant, Active Medical, In-Vitro Diagnostic, Ophthalmic, Orthopedic and Dental, Vascular), Device Class, and Geography – Global Forecast to 2027

  • Report ID:MRHC - 104435
  • Pages: 200
  • Oct 2020
  • Formats*: PDF
  • Category: Healthcare
  • Delivery: 2 to 4 Hours

1.    Introduction
       1.1.    Market Definition
       1.2.    Market Ecosystem
       1.3.    Currency and Limitations
                 1.3.1.    Currency
                 1.3.2.    Limitations
       1.4.    Key Stakeholders

2.    Research Methodology
       2.1.    Research Approach
       2.2.    Data Collection & Validation
                 2.2.1.    Secondary Research
                 2.2.2.    Primary Research
       2.3.    Market Assessment
                 2.3.1.    Market Size Estimation
                 2.3.2.    Bottom-Up Approach
                 2.3.3.    Top-Down Approach
                 2.3.4.    Growth Forecast
       2.4.    Assumptions for the Study

3.    Executive Summary
       3.1.    Overview
       3.2.    Market Analysis, by Service Type
       3.3.    Market Analysis, by Sourcing Type
       3.4.    Market Analysis, by Technology
       3.5.    Market Analysis, by Device Class
       3.6.    Market Analysis, by Geography
       3.7.    Competitive Analysis

4.    Market Insights
       4.1.    Introduction
       4.2.    Drivers
                 4.2.1.    Increasing Need of Validation and Verification of Medical Devices
                 4.2.2.    Stringent Government Regulations and Standards across Medical Devices and Medical Device Technologies
       4.3.    Restraints
                 4.3.1.    Dynamic Regulations/Standards across Regions
                 4.3.2.    Lack of Testing Facilities and Skilled Resources
       4.4.    Opportunities
                 4.4.1.    Growing Medical Device Industries in Emerging Countries
                 4.4.2.    Integration of Mobile and Medical Devices
       4.5.    Challenges
                 4.5.1.    Reliability Concerns among New Service Providers
       4.6.    Trend
                 4.6.1.    Growing Inclination toward Outsourcing Medical Device Testing Services
       4.7.    Impact of Covid-19 on the Medical Device Testing Market

5.   Medical Device Testing Market, by Service Type
       5.1.    Introduction
       5.2.    Testing
                 5.2.1.    Physical Testing
                             5.2.1.1.    Electrical Safety Testing
                             5.2.1.2.    Functional Safety Testing
                             5.2.1.3.    EMC Testing                             
                             5.2.1.4.    Environmental Testing
                             5.2.1.5.    Others
                 5.2.2.    Chemical/Biological Testing
                             5.2.2.1.    Biological Evaluation & Biocompatibility Testing
                             5.2.2.2.    Biological, Physical, & Chemical Testing
                 5.2.3.    Cybersecurity Testing
       5.3.    Certification

6.    Medical Device Testing Market, by Sourcing Type
       6.1.    Introduction
       6.2.    In-House
       6.3.    Outsourced

7.    Medical Device Testing Market, by Technology
       7.1.    Introduction
       7.2.    Active Implant Medical Device
       7.3.    Active Medical Device
       7.4.    Non-Active Medical Device
       7.5.    In-Vitro Diagnostic Medical Device
       7.6.    Ophthalmic Medical Device
       7.7.    Orthopedic and Dental Medical Device
       7.8.    Vascular Medical Device
       7.9.    Other

8.    Medical Device Testing Market, by Device Class
       8.1.    Introduction
       8.2.    Class-1
       8.3.    Class-2
       8.4.    Class-3

9.    Global Medical Device Testing Market, by Geography
       9.1.    Introduction
       9.2.    North America
                 9.2.1.    U.S
                 9.2.2.    Canada
       9.3.    Europe
                 9.3.1.    Germany
                 9.3.2.    U.K
                 9.3.3.    France
                 9.3.4.    Italy
                 9.3.5.    Spain
                 9.3.6.    Rest of Europe
       9.4.    Asia-Pacific
                 9.4.1.    China
                 9.4.2.    Japan
                 9.4.3.    India
                 9.4.4.    Rest of Asia-Pacific
       9.5.    Latin America
       9.6.    Middle East & Africa

10.    Competitive Landscape
         10.1.    Key Growth Strategies
         10.2.    Competitive Benchmarking
         10.3.    Market Share Analysis

11.    Company Profiles (Business Overview, Financial Overview, Product Portfolio, Strategic Development)
         11.1.    SGS S.A
         11.2.    Bureau Veritas S.A.
         11.3.    Intertek Group PLC
         11.4.    TÜV SÜD
         11.5.    Dekra SE
         11.6.    TÜV Rheinland Ag Group
         11.7.    Eurofins Scientific Se
         11.8.    British Standards Institution (BSI) Group
         11.9.    Element Materials Technology Ltd.
         11.10.    UL LLC
         11.11.    Pace Analytical Services, LLC
         11.12.    North American Science Associates, Inc. (NAMSA)
         11.13.    Medistri SA
         11.14.    Avomeen Analytical Services

12.    Appendix
         12.1.    Questionnaire
         12.2.    Available Customization

List of Tables

Table 1 Currency Conversion Rate into USD, 2016-2019
Table 2 Impact Assessment of Covid-19 on Medical Device Testing Market ($Billion)
Table 3 Global Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 4 Global Medical Device Testing Market Size, by Testing Type, 2018-2027 ($Million)
Table 5 Global Medical Device Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 6 Global Medical Device Testing Services Market Size, by Physical Testing, 2018-2027 ($Million)
Table 7    Global Medical Device Physical Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 8    Global Medical Device Electrical Safety Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 9    Global Medical Device Functional Safety Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 10    Global Medical Device EMC Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 11    Global Medical Device Environment Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 12    Global Medical Device In-House Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 13    Global Medical Device Testing Market Size, by Chemical Biological Testing, 2018-2027 ($Million)
Table 14    Global Medical Device In-House Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 15    Global Medical Device In-House Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 16    Global Medical Device In-House Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 17    Global Medical Device Cybersecurity Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 18    Global Medical Device Certification Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 19    Global Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 20    Global Medical Device In-House Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 21    Global Medical Device Outsourced Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 22    Global Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 23    Global Active Implant Medical Device Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 24    Global Active Medical Device Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 25    Global Non-Active Medical Device Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 26    Global In-Vitro Diagnostic Medical Device Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 27    Global Ophthalmic Medical Device Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 28    Global Orthopedic and Dental Medical Device Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 29    Global Vascular Medical Device Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 30    Global Other Medical Device Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 31    Global Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 32    Global Class-1 Medical Device Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 33    Global Class-1 Medical Device Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 34    Global Class-1 Medical Device Testing Services Market Size, by Country/Region, 2018-2027 ($Million)
Table 35    Global Medical Device Testing Market Size, by Country/Region, 2018-2027 ($Million)
Table 36 North America: Medical Device Testing Market Size, by Country, 2018-2027 ($Million)
Table 37 North America: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 38 North America: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 39 North America: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 40 North America: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 41 North America: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 42 North America: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 43 North America: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 44 U.S.: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 45 U.S.: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 46 U.S.: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 47 U.S.: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 48 U.S.: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 49 U.S.: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 50 U.S.: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 51 Canada: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 52 Canada: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 53 Canada: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 54 Canada: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 55 Canada: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 56 Canada: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 57 Canada: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 58 Europe: Medical Device Testing Market Size, by Country, 2018-2027 ($Million)
Table 59 Europe: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 60 Europe: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 61 Europe: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 62 Europe: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 63 Europe: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 64 Europe: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 65 Europe: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 66 Germany: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 67 Germany: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 68 Germany: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 69 Germany: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 70 Germany: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 71 Germany: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 72 Germany: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 73 U.K.: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 74 U.K.: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 75 U.K.: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 76 U.K.: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 77 U.K.: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 78 U.K.: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 79 U.K.: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 80 France: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 81 France: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 82 France: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 83 France: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 84 France: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 85 France: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 86 France: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 87 Italy: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 88 Italy: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 89 Italy: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 90 Italy: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 91 Italy: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 92 Italy: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 93 Italy: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 94 Spain: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 95 Spain: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 96 Spain: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 97  Spain: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 98 Spain: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 99 Spain: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 100    Spain: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 101    Rest of Europe: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 102    Rest of Europe: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 103    Rest of Europe: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 104    Rest of Europe: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 105    Rest of Europe: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 106    Rest of Europe: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 107    Rest of Europe: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 108    Asia-Pacific: Medical Device Testing Market Size, by Country, 2018-2027 ($Million)
Table 109    Asia-Pacific: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 110    Asia-Pacific: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 111    Asia-Pacific: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 112    Asia-Pacific: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 113    Asia-Pacific: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 114    Asia-Pacific: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 115    Asia-Pacific: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 116    China: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 117    China: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 118    China: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 119    China: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 120    China: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 121    China: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 122    China: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 123    Japan: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 124    Japan: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 125    Japan: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 126    Japan: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 127    Japan: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 128    Japan: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 129    Japan: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 130    India: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 131    India: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 132    India: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 133    India: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 134    India: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 135    India: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 136    India: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 137    Rest of APAC: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 138    Rest of APAC: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 139    Rest of APAC: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 140    Rest of APAC: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 141    Rest of APAC: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 142    Rest of APAC: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 143    Rest of APAC: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 144    Latin America: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 145    Latin America: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 146    Latin America: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 147    Latin America: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 148    Latin America: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 149    Latin America: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 150    Latin America: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 151    Middle East & Africa: Medical Device Testing Market Size, by Service Type, 2018-2027 ($Million)
Table 152    Middle East & Africa: Medical Device Testing Market Size, by Testing Services, 2018-2027 ($Million)
Table 153    Middle East & Africa: Medical Device Testing Market Size, by Physical Testing, 2018-2027 ($Million)
Table 154    Middle East & Africa: Medical Device Testing Market Size, by Chemical/Biological Testing, 2018-2027 ($Million)
Table 155    Middle East & Africa: Medical Device Testing Market Size, by Sourcing Type, 2018-2027 ($Million)
Table 156    Middle East & Africa: Medical Device Testing Market Size, by Technology, 2018-2027 ($Million)
Table 157    Middle East & Africa: Medical Device Testing Market Size, by Device Class, 2018-2027 ($Million)
Table 158    Recent Developments by Major Players during 2016-2019

List of Figure

Figure 1 Research Process
Figure 2 Primary Research Techniques
Figure 3 Key Executives Interviewed
Figure 4 Breakdowns of Primary Interviews (Supply Side & Demand Side)
Figure 5 Market Sizing and Growth Forecast Approach
Figure 6 Key Insights
Figure 7 Testing Services Segment Is Expected To Grow At The Highest CAGR
Figure 8 Medical Device Testing Market, by Sourcing Type, 2020 VS 2027 ($Million)
Figure 9 Non-Active Medical Device Segment Is Expected To Grow At The Highest CAGR
Figure 10    Medical Device Testing Market Size, by Device Class, 2020 Vs. 2027
Figure 11    Geographic Snapshot: Medical Device Testing Market
Figure 12    Market Dynamics
Figure 13    China: Medical Devices Market Size, 2016-2019 ($Billion)
Figure 14    South Africa: Medical Devices Market Size, 2018-2020 ($Million)
Figure 15    Impact Assessment of Covid-19 on The Medical Device Testing Market (Market Growth)
Figure 16    Global Medical Device Testing Market Size, by Service Type, 2020-2027 ($Million)
Figure 17    Global Medical Device Testing Market Size, by Sourcing Type, 2020-2027 ($Million)
Figure 18    Global Medical Device Testing Market Size, by Technology, 2020-2027 ($Million)
Figure 19    Global Medical Device Testing Market Size, by Device Class, 2020-2027 ($Million)
Figure 20    Global Medical Device Testing Market Size, by Geography, 2020-2027 ($Million)
Figure 21    U.K Healthcare Expenditure per Year in Pound Billion (2014-2018)
Figure 22    Growth Strategies Adopted by the Key Players
Figure 23    Medical Device Testing Market: Competitive Benchmarking
Figure 24    Global Automotive Tic Market Share, by Key Players, 2019
Figure 25    SGS S.A: Financial Overview (2017-2019)
Figure 26    Bureau Veritas S.A.: Financial Overview (2017-2019)
Figure 27    Intertek Group PLC: Financial Overview (2017-2019)
Figure 28    TÜV SÜD: Financial Overview (2017-2019)
Figure 29    Dekra SE: Financial Overview (2017-2019)
Figure 30    TÜV Rheinland Ag Group: Financial Overview (2017-2019)
Figure 31    Eurofins Scientific Se: Financial Overview (2017-2019)
Figure 32    British Standards Institution (BSI) Group: Financial Overview (2017-2019)

COVID-19

This report provides pre & post COVID-19 market estimates

Download sample here

The medical device testing market is expected to reach $12.5 billion by 2027, at a CAGR of 4.7% during the forecast period of 2020 to 2027. The growth in this market is mainly driven by the increasing need for validation and verification of medical devices and stringent government regulations and standards across medical devices and medical device technologies. Furthermore, growing medical devices industries in emerging countries and the integration of mobile and medical devices are offering prominent opportunities for market growth. However, dynamic regulations/standards across regions and lack of testing facilities and skilled resources can obstruct market growth.

Medical Device Testing Market

Impact of COVID-19 on the Medical Device Testing Market

In the first quarter of 2020, the world was hit by COVID-19. The outbreak was declared as a global pandemic by WHO as it spread across many countries. The COVID-19 pandemic has adversely hit many economies around the globe. This pandemic has had a debilitating impact on the healthcare system. Healthcare systems are overwhelmed, and adequate medical care delivery to all patients has become a global challenge. Industries, markets, and businesses worldwide have been turned upside down by COVID-19, and this impact has been especially profound within the medical devices sector.

However, while the pandemic's impact has been overwhelmingly negative in many areas, the MedTech industry has experienced both ups and downs throughout the crisis. Manufacturers of medical devices have not escaped the effects of the pandemic. Like pharmaceutical firms, medical devices manufacturers rely heavily on healthcare facilities to obtain data from clinical trials. Most medical device products must pass pre-and post-market clinical trials before manufacturers can receive regulatory approval certificates. While the COVID-19 pandemic continues, medical device companies struggle to make informed decisions about their products, supply chains, and regulatory responsibilities amid uncertainty. Announcements from the governing bodies and discussions with key decision-makers and regulatory experts are critical to the medical device industry’s success.

The majority of surgeries have been given less priority due to COVID-19, a restraining factor for medical devices adoption. Many aesthetic procedures, the vast majority of which are cosmetic surgeries like breast implantation, lipoplasty, and non-essential dental procedures — have been delayed due to the crisis. To free-up limited space for people being treated for the virus, hospitals have postponed or canceled many elective operations - especially those deemed to be non-essential or non-urgent. For instance, NHS hospitals in the U.K. have suspended all non-urgent aesthetic surgeries for at least three months in an attempt to free-up resources.

In crucial times, the regulatory landscape is acting as a key challenge for medical device companies for necessary compliance for the approval of the devices. For example, China has expedited the registration process for medical protective clothing if it meets regulatory standards from Japan, the European Union, or the United States (April 2020). Furthermore, Singapore has exempted the registration requirements of certain devices, such as particulate respirators, protective gear, surgical masks, and thermometers during the COVID-19 pandemic (April 2020). Most MedTech players have seen a dramatic drop in revenues with Medtronic reporting a ~60% drop in mid-April, Boston Scientific reporting a 50% drop, and Becton Dickinson's surgical revenues falling by 50-70%.

In the time of crisis, medical device companies and local governments are trying to revive the glooming healthcare industry by adopting several bailout strategies and packages, which is a positive sign for the growth of the market.

Rising need of the verification and validation of medical devices drives the growth of the market

The methods of verification and validation are widespread and extensively being used in the healthcare industry. In general, verification is the developmental phase of a product if it complies with the specified requirements, whereas validation checks if the intended use has been met and thus, usability specifics are fulfilled. The most common types of verification and validation for medical devices are design, process, and software verification and validation. Medical devices are also becoming smaller and more complex in design, sometimes using advanced, engineered plastics. This makes the process of validation and verification (V&V) all the more important. The result is better repeatability, fewer mistakes, less rework and redesign, faster time to market, improved competitiveness, and lower production costs. Additionally, increasing standards and regulations pertaining to medical device validation and verification services are anticipated to drive the growth of the medical device testing market.

Key findings in the global medical device testing market study:

In 2020, the testing services segment to dominate the medical device testing market.

Based on service type, the testing services segment is estimated to command the largest share of the medical device testing market in 2020. This can be attributed to the high demand for quality and safe products and strong recommendations from regulatory authorities to ensure the safety, quality, and efficiency of products. As several class-2 and class-3 medical devices are embedded with microelectronic chips, meticulous device testing has become vital to ensure user safety and product performance.

The in-house segment dominates the overall medical device testing market through 2027.

Based on sourcing type, the in-house segment is estimated to command the largest share of the medical device testing market in 2020. Conducting in-house testing services allow manufacturers to exert higher levels of control by keeping services and personnel under check. Furthermore, the outsourcing segment is anticipated to grow with the fastest CAGR during the forecast period.

North America: The largest regional market

North America is estimated to command the largest share of the overall medical device testing market in 2020, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa. The large share of the region is attributed to the increased focus on the quality of the medical devices and the presence of a large number of companies that serve the medical devices industry.

Key Players

The report includes a competitive landscape based on the extensive assessment of the key strategic developments adopted by leading market participants in the medical device testing market over the last 4-5 years. The key players profiled in the global medical device testing market are SGS S.A (Switzerland), Bureau Veritas S.A. (France), Intertek Group Plc. (U.K.), Dekra SE (Germany), TÜV SÜD (Germany), TÜV Rheinland Ag Group (U.S.), Eurofins Scientific SE (Luxembourg), British Standards Institution (BSI) Group (U.K.), Element Materials Technology Ltd. (U.K.), UL LLC (U.S.), Pace Analytical Services, LLC (Germany), North American Science Associates, Inc. (NAMSA) (U.S.), Medistri SA (Switzerland), and Avomeen Analytical Services (U.S.), among others.

Scope of the report:

Medical Device Testing Market by Service Type                                  

  • Testing
    • Physical Testing
      • Electrical Safety Testing
      • Functional Safety Testing
      • EMC Testing
      • Environmental Testing
      • Others
  • Chemical/Biological Testing
    • Biological Evaluation & Biocompatibility Testing
    • Biological, Physical, & Chemical Testing
  • Cybersecurity Testing
  • Certification

Medical Device Testing Market by Sourcing Type                                               

  • In-house
  • Outsourced

Medical Device Testing Market by Technology                    

  • Active Implant Medical Device
  • Active Medical Device
  • Non-active Medical Device
  • In-vitro Diagnostic Medical Device
  • Ophthalmic Medical Device
  • Orthopedic and Dental Medical Device
  • Vascular Medical Device
  • Other                    

Medical Device Testing Market by Device Class                   

  • Class l Devices
  • Class ll Devices
  • Class lll Devices

Medical Device Testing Market by Geography

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
    • Italy
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Rest of Asia-Pacific
  • Latin America
  • The Middle East and Africa

Key questions answered in the report:

The medical device testing market is projected to reach $12.5 billion by 2027 at a 4.7% CAGR during the forecast period
Based on service type, the testing services segment is estimated to command the largest share of the medical device testing market in 2020. The large share of this segment is attributed to the high demand for quality and safety products and strong recommendations from regulatory authorities to ensure the safety, quality, and efficiency of products.
Based on technology, the in-vitro diagnostic devices segment is estimated to account for the largest share of the medical device testing market in 2020. The marketplace has witnessed rapid growth driven by technological advancements, better diagnostic tools, improved treatment monitoring, and increased availability of over-the-counter tests.
The growth in this market is mainly driven by the increasing need for validation and verification of medical devices and stringent government regulations and standards across medical devices and medical device technologies. Furthermore, growing medical devices industries in emerging countries and the integration of mobile and medical devices are offering prominent opportunities for market growth
The key players operating in the medical device testing market are SGS S.A (Switzerland), Bureau Veritas S.A. (France), Intertek Group Plc. (U.K.), Dekra SE (Germany), TÜV SÜD (Germany), TÜV Rheinland Ag Group (U.S.), Eurofins Scientific SE (Luxembourg), British Standards Institution (BSI) Group (U.K.), Element Materials Technology Ltd. (U.K.), UL LLC (U.S.), Pace Analytical Services, LLC (Germany), North American Science Associates, Inc. (NAMSA) (U.S.), Medistri SA (Switzerland), and Avomeen Analytical Services (U.S.), among others.
At present, North America dominated the medical device testing market. However, Europe is expected to grow with the fastest growth rate over the coming years.
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Tags: Healthcare Medical Technologies
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