LONDON, Oct. 13, 2020 /PRNewsCentre/ — According to a new market research report titled, "Medical Device Testing Market by Service Type (Testing, & Certification) Location, Technology (Active Implant, Active Medical, In-Vitro Diagnostic, Ophthalmic, Orthopedic and Dental, Vascular), Device Class, and Region – Global Forecast to 2027", the medical device testing market is expected to grow at a CAGR of 4.7% from 2020 to 2027 to reach $12.5 billion by 2027.
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Healthcare technologies and medical devices are constantly evolving to improve accuracy, safety, and wellness. This rapid progress also leaves these devices increasingly susceptible to cybersecurity issues. Medical device testing is the process of demonstrating that the device will reliably and safely perform in use. It is a critical step in transforming an innovative design into a reliable and marketable product. This is a standard procedure performed by government-certified agencies to check whether a medical device can meet the current safety and performance standards.
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 device industries in emerging countries and the integration of mobile and medical devices are offering significant opportunities for market growth. However, dynamic regulations/standards across regions and lack of testing facilities and skilled resources can obstruct market growth.
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 the 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.
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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. To free-up limited space for people being treated for the virus, hospitals have postponed, or canceled, many elective operations — especially those deemed 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.
As always, in crucial times, the regulatory landscape is acting as a key challenge for medical device companies, for necessary compliances for the approval of devices. According to the German Federal Ministries of Labour and Social Affairs and Health, PPE and medical devices may be placed on the market without CE marking temporarily and individually. The European Commission adopted a proposal on April 3, 2020, to postpone the MDR’s application date for one year. Furthermore, Singapore has exempted the registration requirements of certain devices, such as particulate respirators, protective gears, surgical masks, and thermometers during the COVID-19 pandemic (April 2020). Most MedTech players have seen a dramatic drop in revenues with Medtronic reporting ~60% drop in mid-April, Boston Scientific reported 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 this market.
The medical device testing market study presents historical market data in terms of value (2018 and 2019), estimated current data (2020), and forecasts for 2027. The market is segmented on the basis of service type, sourcing type, technology, device class, and region. The study also evaluates industry competitors and analyses the market at a country level.
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Based on Service Type, the testing services segment is estimated to command the largest share of the overall 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. However, certification services are expected to grow at the fastest CAGR during the forecast period, owing to the increasing number of specified standards by governments and international standardization institutions. As the medical devices market is expanding continuously, consumers are getting more inclined towards safe, reliable, and eco-friendly products validated by certifications.
Based on Sourcing Type, the in-house segment is estimated to account for the largest share of the overall medical device testing market in 2020. Conducting in-house testing services allows manufacturers to exert higher control levels by keeping services and personnel under direct control. Furthermore, the outsourcing segment is anticipated to grow with the fastest CAGR during the forecast period. Outsourcing offers various benefits, such as access to skilled expertise, focus on core activities, better risk management, and increasing in-house efficiency.
Based on Technology, the in-vitro diagnostics segment is estimated to account for the largest share of the overall 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. Furthermore, the active implant medical devices segment is expected to grow at the highest CAGR during the forecast period.
Geographically, the North American region is expected to command the largest share of the global medical device testing market in 2020. The large share of the region is attributed to the increased focus on the quality of medical devices and the presence of a large number of companies that serve the medical devices industry. Furthermore, increasing aging population, rising rate of chronic diseases, and advancement in digital technologies are the other factors driving the growth of this regional segment. However, Asia-Pacific region is expected to witness rapid growth during the forecast period. The adoption of medical device testing services is still low in Asia-Pacific region than the other developed markets, which is expected to provide numerous opportunities for the growth of this market.
The global medical device testing market is consolidated and dominated by few major players, namely, 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.
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Scope of the Report
Medical Device Testing Market by Service Type
Medical Device Testing Market by Sourcing Type
Medical Device Testing Market by Technology
Medical Device Testing Market by Device Class
Medical Device Testing Market by Geography
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