Global Medical Device Testing Services Market Analysis Report 2023-2030: Strict Approval Norms & Intensifying Competition Fueling Market Growth - ResearchAndMarkets.com

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

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