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Stricter approval norms and regulations imposed by regulatory authorities serve several essential purposes, and their emphasis has a direct impact on the demand for testing services. The primary objective of strict approval norms is to ensure the safety of patients and users of medical devices. By mandating comprehensive testing and evaluation of devices, regulatory bodies aim to identify and mitigate potential risks associated with these products. The focus on patient safety increases the demand for testing services to thoroughly assess the devices before they reach the market.
Additionally, adherence to stringent approval norms helps reduce the likelihood of product recalls and legal liabilities for manufacturers. By ensuring that medical devices have undergone thorough testing, potential issues and risks are identified and addressed early in the development process, minimizing the chances of defects and failures after the devices are on the market.
Further, stricter approval norms push manufacturers to invest in research and innovation to meet regulatory requirements. This, in turn, stimulates the development of novel and more advanced medical devices. As manufacturers innovate, they seek specialized testing services to validate the safety and performance of these cutting-edge products. Thus, the growing focus on strict approval norms is instrumental in driving the market progress for medical device testing services.
The microbiology & sterility testing segment accounted for over USD 2.7 billion in 2022 as ensuring sterility and microbial control is crucial in preventing infections and complications, thereby safeguarding patient safety.
The global market for medical device testing services was valued at around USD 7.5 billion in 2022 and is anticipated to record a CAGR of 8.5% during 2023 and 2032.
North America medical device testing services market was valued at over USD 2.1 billion in 2022, attributed to the fact that North America is at the forefront of technological advancements in the medical device sector.
Charles River Laboratories, American Preclinical Services, North America Science Associates Inc., Element Materials Technology, WuXiAppTec Group, Eurofins Scientific, Labcorp (Toxikon, Inc), and T