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