Medical Device Outsourcing Market Size Worth $194.9B by 2025

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The global medical device outsourcing services market size is expected to reach $194.9 billion by 2025, according to a new report by Grand View Research, Inc., progressing at a CAGR of 10.9% during the forecast period. Rising demand for medical devices coupled with growing trend of offshoring is expected to drive the market during the forecast period.

Recent regulatory changes in Europe with respect to medical device is 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 over the forecast period. 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 over the forecast period. 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.

Further key findings from the report suggest:

• The global contract manufacturing market is anticipated to reach 104.5 billion by 2025, expanding at a CAGR of 10.2% from 2018 to 2025
• In terms of service, quality assurance is expected to experience the fastest growth during the forecast period
• Asia Pacific is expected to dominate the medical device outsourcing market during the forecast period
• North America and Europe commanded sizeable cumulative share in 2016 owing to well established manufacturing infrastructure for high end and complex medical devices
• Some of the key companies present in the market are Integer; Tecomet; Jabil; Flextronics; Celestica; Sanmina; Plexus; SGS SA; Toxikon Inc.; Eurofins Scientific; Pace Analytical Services; Intertek Group; MAPI; PPD; Freyr Solutions; and Wuxi Apptec.