Infinium Global Research and Consulting Solutions

The global biocompatibility testing services for medical devices market was valued at USD 7.1 billion in 2022 and is expected to reach USD 13.81 billion by 2030 and grow at a CAGR of 8.7% over the forecast period. The increasing government regulations led to the increasing demand for verification and validation for medical devices is the primary growth factor of the market. International forums such as WHO, IMDRF, and MDSAP have prescribed global standards for risk classification, nomenclature, QMS, and post-market surveillance, which have been adopted by governments of numerous countries. The governments are encouraged to follow the growing movement towards harmonized regulatory systems for the medical device sector. Furthermore, the growing number of small medical device companies that lack in-house expertise fuels the demand for biocompatibility testing for medical devices. The factors such as complexity in high cost, increased competition, and strict approval norms restraints small medical device companies to develop in-house expertise. In-house testing demonstrates the stringency of these procedures as the receipt of any complaints regarding the product’s flaws results in its removal from the market. On the other side, a lack of insight into the submission process challenges to market growth. Compare to European bodies, some South American and Asian regulatory agencies will approve devices in a shorter period. Moreover, growing medical devices industries in emerging countries provide opportunities to the market. The factors such as rising income and availability of insurance, improving medical infrastructure, and increasing consumer demand drives the medical device demand in emerging countries.