The global Medical Device Analytical Testing Outsourcing Market size is expected to reach USD 10.6 billion by 2030, registering a CAGR of 8.1% over the forecast period, according to a new report by Grand View Research, Inc. Several medical device companies outsource analytical testing operations to decrease business risks, accelerate product market entrance, and lower expenses. As a result of this considerable rise in spending levels, medical device Original Equipment Manufacturers (OEMs) quickly shift to outsourcing as a cost-cutting technique. Medical device testing remained consistent in 2021. The testing requirements of Medical Device Manufacturers (MDMs) reflected variations in the medical/healthcare market as it recovered from the COVID-19 slowdown.
In 2021, the need for European Medical Device
Regulation (MDR) remediation standards, as well as the ever-increasing
regulatory demands in the Leachables & extractables (E&L) arena,
accounted for a significant portion of the testing effort. However, due to
delays and a lack of external resources and labor, labs’ ability to expand
capacity has been limited. Regulatory authorities are focusing on testing
technique validation, especially data quality, including repeatability and
reproducibility. There is also a trend toward more deterministic testing
methods. This enables companies to acquire more statistically reliable data to
determine if their products meet the criteria. For example, the medical device
sector and testing labs confront considerable hurdles in adopting ISO
10993-18:2020 E&L testing regulations while still meeting FDA expectations.
The FDA had requested the use of conservative techniques to reduce areas of
ambiguity or potential inaccuracy in E&L testing throughout 2021.
Related Press Release@ Medical Device Analytical Testing Outsourcing Market Report
Medical Device Analytical Testing
Outsourcing Market Report Highlights
- The material characterization services segment accounted for the
largest share of the global revenue in 2021
- The cardiology therapeutic area segment held the largest revenue
share in 2021 due to the high demand for cardiovascular devices as a
result of the increased prevalence of related conditions
- Reprocessed devices are projected to witness the fastest CAGR
during the forecast period due to the low prices of these devices. They
cost about 30 to 40% less than new devices; thus, the demand for such
products is significant in price-sensitive low- and medium-income
countries
- Based on end-use, the hospital segment accounted for the largest
revenue share in 2021 due to high patient volume and increased hospital
management budget allocation for these surgeries
- Asia Pacific led the global market in 2021 and is projected to
witness the fastest CAGR during the forecast period. This is owing to the
region’s large population base, low per capita income, and demand for
accessible treatment solutions
Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, the company offers market intelligence studies ensuring relevant and fact-based research across a range of industries including technology, chemicals, materials, healthcare and energy.
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