The global medical device outsourcing services market size is expected to reach $194.9 billion by 2025, at a compound annual growth rate (CAGR) of 10.9% during the forecast period, according to a new report by Grand View Research, Inc. Rising demand for medical devices coupled with a growing trend of offshoring is expected to drive the market during the forecast period, the analyst report.
Recent regulatory changes in Europe with respect to medical devices also is 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 medical device regulation and in vitro device regulation is expected to increase the demand for quality management system service providers, thereby supplementing the growth of the overall market.
According to the report, other major regulatory changes around the globe that are expected to have an impact on the medical device outsourcing market over the forecast period include:
- A possible amendment in ISO certification related to medical devices
- Adoption of medical device single audit program
- Changes in Brazil Good Manufacturing Practice quality management system requirements
- Simplification of Korea Good Manufacturing Practice rules
These regulatory reforms are estimated by the analysts to augment the demand for outsourcing services, thereby providing a tremendous push to the market over the forecast period. Also, there has been a significant consolidation in the medical device outsourcing space in recent years. While large contract research organizations are collaborating with specialized service providers to gain substantial share in the specific market segment.
Other 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.
- The Asian-Pacific region 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.