DUBLIN, Oct. 4, 2023 /PRNewswire/ — 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 market for medical device testing services is projected to reach a size of USD 16.29 billion by 2030, with an expected annual growth rate of 9.0% from 2023 to 2030
The increasing intricacy in product design and stringent governmental regulations are fueling the demand for these services.
A noteworthy trend in the pharmaceutical and medical device sectors is the substantial increase in preclinical spending, making a significant contribution to market expansion. According to global health data, supporting preclinical research for pharmaceuticals took 73 months and cost USD 7 million, while for biologics, it took 47 months and cost USD 6.3 million.
As modern medical devices incorporate complex functionalities, it becomes crucial to subject them to rigorous testing to ensure compliance with regulatory standards. This rigorous testing not only enhances accuracy, ease of use, and durability but also provides a competitive edge to manufacturers.
Furthermore, the market is driven by the growing need for production efficiency, safety, and adherence to escalating regulatory requirements for medical devices. Regulatory bodies like the European Medicines Agency, U.S. Food and Drug Administration, Therapeutic Goods Administration, and other national regulatory entities mandate documentation and testing to certify that medical devices meet efficacy and safety standards before they can be distributed to patients and healthcare providers.
The COVID-19 pandemic has generated an unprecedented demand for medical device testing services, primarily due to the increased need for COVID-19-related products like masks, PPE, and respiratory equipment. Countries like Mexico, Spain, and France have established specific specifications and standards (e.g., UNE 0064-1, UNE 0064-2, AFNOR-SPEC-S76 & UNE 0065) that must be met before masks can be sold.
- Microbiology and sterility testing emerged as the leading segment in 2022, holding a market share of 34.2%, and are expected to maintain their dominance. Ensuring the safety and efficacy of products is a top priority for medical device manufacturers, with sterility assurance playing a pivotal role in achieving this.
- The biocompatibility testing segment held a significant share in 2022 due to stringent requirements set by global regulatory bodies to ensure the safety of devices before market release.
- In 2022, the clinical phase segment dominated the market, representing 68.8% of the market share. This phase primarily focuses on assessing the safety and biocompatibility of medical devices.
- Conversely, the preclinical phase segment is poised for substantial growth in the forecast period. Preclinical testing encompasses evaluating the efficacy, safety, and biocompatibility of prosthesis, biomaterials, and medical devices.
- Factors such as raw materials, packaging, and design significantly impact device safety and compatibility. Thus, preclinical testing of these elements is a crucial step in gauging a device’s market potential.
- Asia Pacific captured the largest market share globally in 2022, accounting for 41.0% of revenue. This can be attributed to the growing demand for medical devices in developing countries like India and China.
- North America is expected to register a noteworthy CAGR during the forecast period, given its status as a top manufacturing hub for highly reliable, complex, and advanced medical devices.
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
- 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/sigjf0
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