DUBLIN–(BUSINESS WIRE)–The “Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Test), By Phase (Preclinical, Clinical), By Region, And Segment Forecasts, 2023-2030” report has been added to ResearchAndMarkets.com’s offering.
The global medical device testing services market size is expected to reach USD 16.29 billion by 2030 and is expected to expand at a CAGR of 9.0% from 2023 to 2030
The demand for medical device testing services is on the rise, driven by increasing product design complexity and stringent government regulations.
A notable trend among pharmaceutical and medical device companies is a significant increase in preclinical spending, which is expected to make a substantial contribution to market growth. According to data from the global health center, supporting preclinical research for pharmaceuticals required an average of 73 months and cost USD 7 million, while for biologics, it took 47 months and cost USD 6.3 million.
As modern medical devices offer a myriad of complex functions, ensuring compliance with regulatory requirements through appropriate testing has become crucial. Manufacturers are emphasizing extensive testing to achieve enhanced accuracy, ease of use, and durability, which can provide them with a competitive advantage in the market.
On the other hand, an increase in the need for production efficiency and safety and rising regulatory requirements for medical devices are some of the major factors driving the market growth. Regulatory bodies such as the European Medicines Agency, U.S. Food and Drug Administration, Therapeutic Goods Administration, and other country regulatory bodies require documentation and testing to certify that medical devices meet efficacy and safety standards prior they can be sold and marketed to patients and healthcare providers.
The COVID-19 pandemic has created an unprecedented demand for medical device testing services. This is largely due to the increasing demand for COVID-10 related products such as masks, PPE, & respiratory equipments. Besides, countries such as Mexico, Spain, and France have published pertinent specifications and standards, namely the UNE 0064-1, UNE 0064-2, AFNOR-SPEC-S76 & UNE 0065, which must be met until a mask can be sold.
Medical Device Testing Services Market Report Highlights
The microbiology and sterility testing was the leading segment in 2022 with a market share of 34.2% and is likely to remain dominant over the forecast period. Producing safe and effective products is a core goal of medical device manufacturers, and sterility assurance is a major component for achieving it
The biocompatibility test segment held a significant share in the 2022. This is attributed to strict requirements for biocompatibility testing set by global regulatory bodies to ensure that their devices are safe to use before being made available in the market
The clinical phase segment dominated the market in 2022 and accounted for 68.8% of the market share as this stage is mostly focused on assessing safety & biocompatibility of medical devices
On the other hand, the preclinical phase segment is also expected to show significant growth over the forecast period. The preclinical phase of medical device includes determination of efficacy, safety, and biocompatibility of prosthesis, biomaterials, and medical devices
Raw materials, packaging, and design all have an impact on a device’s safety and compatibility, and preclinical testing of all of these factors is an important step in determining a device’s market potential
Asia Pacific held the maximum share of the global market and accounted for 41.0% of the revenue share in 2022. This is due to rising demand for medical devices in developing nations such as India and china
North America is anticipated to register a significant CAGR over the forecast period. This can be attributed to the fact that it is one of the top manufacturing hubs of highly reliable, complex, and high-end medical devices
Market Dynamics
Market Driver Analysis
Complexity in Product design
Intensifying competition
Increase in number of small medical device lacking in-house testing capabilities
Strict approval norms
Market Restraint Analysis
Legal and Regulatory Issues
Delays in contractual obligations
Medical Device Testing Services Market Analysis Tools
Industry Analysis – Porter’s
PESTEL Analysis
Companies Mentioned
SGS SA
Toxikon, Inc
American Preclinical Services
Sterigenics International LLC
Charles River Laboratories
Element Minnetonka
North American Science Associates, LLC
Eurofins Scientific
Pace Analytical Services LLC
Intertek Group Plc
For more information about this report visit https://www.researchandmarkets.com/r/xusscy
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
For E.S.T Office Hours Call 1-917-300-0470
For U.S./ CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
