Summary

[ 170 + Pages Research Report ] Medical Device Testing Market to surpass USD 20.7 billion by 2031 from USD 9.8 billion in 2021 at a CAGR of 7.8% in the coming years, i.e., 2021-2031.

Product Overview
Process of establishing that medical equipment will work reliably and safely in use is known as medical device testing. Design Validation Testing is used extensively in the creation of new products. Performance testing, toxicity and chemical analysis, and human factors and clinical testing are all examples of this. Continuous quality assurance testing is usually restricted. Dimensional checks, certain functional testing, and package verification are frequently included. To effectively bring their goods to market, medical device makers must adhere to severe regulatory requirements set forth by the US FDA, ISO, and ASTM International.

Market Highlights
Global Medical Device Testing Market is anticipated to project a remarkable CAGR of 7.8% by 2031

Several market drivers include the synchronization of standards, rising medical device use in emerging nations, and the expanding requirement for medical device validation and verification. Other factors driving the medical device testing market include the implementation of stringent government regulations, the growing tendency of outsourcing medical device testing services, and medical device standards.



Global Medical Device Testing Market: Segments
Testing Services segment is expected to grow with the highest CAGR during 2021-31

On the basis of Service Type, the global Medical Device Testing Market is fragmented into Testing Services, Inspection Services, and Certification Services. Among other things, the Testing Services category is expected to lead the market. Testing services in the medical device testing market ensure that goods meet quality, safety, and performance regulatory standards. Laboratories and research facilities provide testing services. Testing services help manufacturers improve the marketability of their medical equipment while also cutting pre-production expenditures.

In-Vitro Diagnostic Medical Device segment is expected to gain maximum traction during 2021-31

Global Medical Device Testing Market is classified on the basis of Technology into 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, and Other Medical Device Technologies. Over the projection period, the In-Vitro Diagnostic Medical Device sector is expected to lead. IVD brings substantial value to the therapy and medical diagnosis processes, improving public health at the same time. Infections are detected, medical diseases are diagnosed, and drug regimens are monitored using these devices.



Market Dynamics
Drivers
Stringent regulation by the Government is the key market booster

The market is primarily driven by the government's rising influence, which has resulted in an increase in demand for medical device verification and validation. In addition, the growing number of small medical device companies with little in-house expertise is fueling market expansion. Furthermore, advances in technology such as artificial intelligence (AI) and wearable products, along with a focus on real-time patient monitoring, have resulted in a complicated medical device ecosystem. To acquire marketing approval, these devices should go through rigorous testing under expedited settings.

Current Developments in the Medical Industry to Impact Positively

Constant technological advancements in the medical industry are expected to boost demand for testing services during the forecast period. The development and standardization of novel in-vitro test methods, especially for sensitization, cytotoxicity, and irritation, is also expected to drive market expansion. These are some of the most fundamental tests that all medical equipment must pass.

Restraint
High costs associated with the Medical Device Testing

Excessive regulations, mainly in the home environment, may act as a barrier to local device innovation. It has the potential to hinder domestic innovation by requiring new technology to go through a lengthy and expensive licensing process, adding expense and time to the cost of manufacturing medical equipment for local producers.

Global Medical Device Testing Market: Key Players
SGS SA
Company Overview, Business Strategy, Key Product Offerings, Financial Performance, Key Performance Indicators, Risk Analysis, Recent Development, Regional Presence, SWOT Analysis

Toxikon, Inc
American Preclinical Services
Sterigenics International LLC
River Laboratories International Inc
Medical Device Testing Services
North America Science Associates Inc
Euro fins Scientific
Pace Analytical Services LLC
Intertek Group Plc
Other Prominent Players
Global Medical Device Testing Market: Regions
Global Medical Device Testing Market is segmented based on regional analysis into five major regions: North America, Latin America, Europe, Asia Pacific and the Middle East and Africa. The medical device testing sector is rapidly developing in APAC, due to rising per capita income among the middle class. Consumers are now alert and becoming aware of the significance of certification. India's medical device testing market is predicted to grow at the fastest rate over the forecast period. North America, on the other hand, holds the largest share of the global medical device testing market, thanks to stringent government regulations intended at maintaining industry quality and safety standards, which boosts demand for TIC services in the area.



Impact of COVID-19 on Medical Device Testing Market
A worldwide health and economic crisis has ensued from the COVID-19 calamity. As a result, some businesses have shut down their factories and suspended most of their operations. The COVID-19 epidemic in 2019 highlighted the even greater need for new low-cost medical devices. Manufacturers are investing heavily in testing these devices since they must meet stringent medical device regulations.

Global Medical Device Testing Market is further segmented by region into:

North America Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – United States, Mexico, and Canada
Latin America Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – Latin America
Europe Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – United Kingdom, France, Germany, Italy, Spain, and Rest of Europe
Asia Pacific Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – India, China, South Korea, Japan, Australia and Rest of Asia Pacific
Middle East and Africa Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – North Africa, South Africa, and Rest of Middle East and Africa
Global Medical Device Testing Market report also contains analysis on:
Medical Device Testing Market Segments:

By Service Type
Testing Services
Inspection Services
Certification Services
By Sourcing Type
In-House
Outsourced
By Device Class
Class I
Class II
Class III
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 Technologies
Medical Device Testing Market Dynamics
Medical Device Testing Market Size
Supply & Demand
Current Trends/Issues/Challenges
Competition & Companies Involved in the Market
Value Chain of the Market
Market Drivers and Restraints
Medical Device Testing Market Report Scope and Segmentation
Report Attribute Details
Market size value in 2021 USD 9.8 billion
Revenue forecast in 2031 USD 20.7 billion
Growth Rate CAGR of 7.8% from 2021 to 2031
Base year for estimation 2020
Quantitative units Revenue in USD million and CAGR from 2021 to 2031
Report coverage Revenue forecast, company ranking, competitive landscape, growth factors, and trends
Segments covered Service Type, Sourcing Type, Device Class, Technology, and Region
Regional scope North America, Europe, Asia Pacific, Latin America, Middle East & Africa (MEA)
Key companies profiled

SGS SA, Toxikon, Inc, American Preclinical Services, Sterigenics International LLC, River Laboratories International Inc, Medical Device Testing Services, North America Science Associates Inc, Euro fins Scientific, Pace Analytical Services LLC, Intertek Group Plc, and Other Prominent Players.

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