San Francisco, 17 December 2024: The Report North America And Europe Preclinical Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Testing, Package Validation), By Region, And Segment Forecasts, 2030 - 2030
The North America and Europe preclinical medical device testing services market size is expected to reach USD 3.14 billion by 2030, expanding at a CAGR of 9.3% from 2030 to 2030, according to a new report by Grand View Research, Inc. The increase in the number of small medical devices lacking in-house testing capabilities and complexity in product design are the major factors driving the growth of the market.
There has been an increase in the number of players operating in the market over the last decade. Due to this large number, it has witnessed fierce competition. To sustain the market, a mix of defensive and offensive marketing strategies is used. For instance, extensive R&D, competitive pricing, new product launches, collaborative development, regional expansion, and mergers and acquisitions.
The COVID-19 pandemic has created a huge demand for these services. The rise was not significant in the first half, but it became more significant in the second as the industry adapted to operating during the pandemic. There has been an increase in the production and testing of personal protective equipment, and several projects that were put on hold because of COVID have resumed personal protective equipment. The epidemic has increased demand for a wide range of medical gadgets, diverting attention from those needed for surgery. COVID-19 vaccinations, ventilators, and pulse oximeters are the main goods seeing an increase in demand.
The market is driven by emerging players operating in this industry over the past decade. Medical device companies today are operating at a rapid pace across the globe. In developed countries, such as the U.S., there is pricing pressure; hence, operators are exploring every possible way to reduce costs throughout the value chain. On the other hand, developing countries holds the actual potential. However, developing regions are likely to be price sensitive. Hence, market players today are striving hard to reduce the overall cost of devices. Outsourcing testing operations helps companies focus on product development and enhance marketing efforts.
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Moreover, in such an intensely competitive environment, companies must reduce the time to market from the developmental phase. Considering that the approval processes for medical devices are not simple, companies need to have a sound knowledge of updated regulatory norms and protocols. As a result, medical device companies prefer to outsource it to a specialized firm.
North America And Europe Preclinical Medical Device Testing Services Market Highlights
• In 2024, the biocompatibility tests segment dominated the market, accounting for a revenue share of 44.7%. Manufacturing safe and effective goods is a top priority for medical device manufacturers, and quality assurance is crucial in accomplishing this aim. • The chemistry test segment is expected to rise with the fastest CAGR of 9.6% in the forecast period. Chemistry tests support the medical device industry across the value chain. • North America preclinical medical device testing services market dominated in 2024 with a larger share of 55.0%.
The European Commission mentioned that it has adopted revised harmonized standards to expedite the production of sterilization devices & disinfectants, gloves, medical face masks, and containers for intravenous injections, as well as to alter the specific requirements for emergency & transport ventilators. In collaboration with the European Committee for Electro Technical Standardization (CENELEC) and the European Committee for Standardization (CEN), the European Commission has agreed to make several harmonized standards freely available.
North America And Europe Preclinical Medical Device Testing Services Market Report Scope
Report Attribute Details Market size value in 2030 USD 2.01 billion Revenue forecast in 2030 USD 3.14 billion Growth rate CAGR of 9.3% from 2030 to 2030 Historical data 2018 - 2024 Forecast period 2030 - 2030
Most medical devices are classified by the FDA as Class II or Class III. These classes require higher control and monitoring. Class II devices need pre-market notification, whereas Class III devices need pre-market approval (PMA) from the regulatory bodies. Apart from this special compliance, the basic ones include labeling requirements, manufacturing plant-established registration, medical device listing, quality systems regulation, and Medical Device Reporting (MDR). The FDA’s Center for Devices and Radiological Health (CDRH) mandates the framework and standards regarding the manufacturing, labeling, packaging, and storage of imported devices sold in the U.S.
The global medical device testing services market size is expected to reach USD 14.
Download Free Sample Report @ https://www.radiantinsights.com/research/medical-device-testing-services-market/request-sample Significant rise in preclinical spending is a recent trend among pharmaceutical and medical device companies, which is expected to significantly contribute to market growth.
This is expected to deliver competitive advantage to manufacturers.
Further key findings from the report suggest: • By service, biocompatibility tests held the largest share in the global market in 2019 owing to increasing demand for in-vitro testing • Based on phase, the preclinical segment accounted for the dominant share in 2019 and is expected to retain its lead throughout the forecast period • North America dominated the global medical device testing services market in 2019, fueled by increasing demand for new technologies and presence of advanced healthcare infrastructure • Asia Pacific is projected to witness the fastest growth during the forecast period owing to increasing number of diabetic patients in this region • Some of the key market players are Eurofins Scientific, LLC; WuXi AppTec Group; North American Science Associates, Inc.; Sterigenics International LLC; and SGS S.A.
Rising prevalence of chronic disease3.4.1.3.
Improving healthcare infrastructure in emerging economies3.4.2.
