Medical Device Outsourcing Market to Grow 10.9 Percent

The global medical device outsourcing services market size is expected to reach USD 194.9 billion by 2025, according to a new report by Grand View Research, Inc., progressing at a CAGR of 10.9 percent. Rising demand for medical devices coupled with growing trend of offshoring is expected to drive the market. Recent regulatory changes in Europe with respect to medical device are also expected to fuel the demand for quality assurance and regulatory affairs services, thereby contributing to the growth of the market in the region. For instance, implementation of MDR and IVDR is expected to increase the demand for QMS service providers, thereby supplementing the growth of the overall market. Some major regulatory changes are expected to occur across the globe, which can have an impact on the medical device outsourcing market. Some of the major changes are:

• Amendment in ISO certification related to medical device
• Adoption of medical device single audit program
• Implementation of medical device regulation and in vitro diagnostics regulation in the EU region
• Changes in Brazil Good Manufacturing Practice (BGMP) Quality Management System (QMS) requirements
• Simplification of Korea Good Manufacturing Practice (KGMP) rules

These regulatory reforms are estimated to augment the demand for outsourcing services, thereby providing a tremendous push to the market. There has been a significant consolidation in the medical device outsourcing space in recent years. Large CROs are collaborating with specialized service providers to gain substantial share in the specific market segment. – Grand View Research