Medical Device Testing Market: Segmented: 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), And Region - Global Analysis of Market Size, Share & Trends For 2019-2021 And Forecasts To 2031
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.
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.
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.
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.
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.
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.
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.
Company Overview, Business Strategy, Key Product Offerings, Financial Performance, Key Performance Indicators, Risk Analysis, Recent Development, Regional Presence, SWOT Analysis
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.
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.
|Market size value in 2021
|USD 9.8 billion
|Revenue forecast in 2031
|USD 20.7 billion
|CAGR of 7.8% from 2021 to 2031
|Base year for estimation
|Revenue in USD million and CAGR from 2021 to 2031
|Revenue forecast, company ranking, competitive landscape, growth factors, and trends
|Service Type, Sourcing Type, Device Class, Technology, and Region
|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.
Medical Device Testing Market size was estimated at USD 0.89 million in 2021 and is expected to reach USD 1.8 billion by 2031.
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.
Testing Services segment is anticipated to hold the Agriculture Analytics market share.
Stringent regulation by the Government is the key market booster and Current Developments in the Medical Industry to Impact Positively
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.
Select License Type
US : +1 (716) 218-3733
UK : +44 (208) 1235555
Select License Type
FATPOS CLIENT Appriciation DURING THE PROJECT