The changes, according to Grand View Research, will propel the medical device outsourcing services market to nearly $195 billion by 2025.
Rising demand for medical devices will be coupled with the growing trend of offshoring, said the report, and is expected to drive the market at a compound annual growth rate of 10.9%.
In Europe, implementation of medical device regulation (MDR) and in vitro diagnostic regulation (IVDR) will boost the demand for service providers in quality management systems (QMS), supplementing the growth of the entire industry.
Changes to ISO 13485, which is scheduled for systemic review in early 2019, could contain an amendment relating to the adoption of MDSAP (the medical device single audit program). In addition, good manufacturing practices in both Brazil and Korea will go through revisions.
Such regulatory reforms would further the need for QMS services for global medical device companies. Due to these changes, quality assurance is expected to see the fastest growth in the immediate future, exhibiting a CAGR of 13.5% during the forecast period.
Medical device outsourcing includes services such as quality assurance, regulatory consulting, product design and development, product testing and sterilization, product implementation, product upgrade, product maintenance and contract manufacturing. Regulatory consulting services are likely to see a significant increase in demand over the forecast period owing to rising awareness regarding timely filing and auditing of regulatory documents, according to the report.
The contract manufacturing segment is expected to dominate the market until 2025. It held more than 55.0% in the market in 2017. Growing focus on reducing the cost of production is supplementing the growth of the segment. 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.
Beyond demand for improved QMS, the growth of the aging population is increasing demand for medical devices, the report said. New entrants to the medtech market are expected to rely on outsourcing partners for assembly, packaging, and other services to keep up with technology and market demands.
There has been a significant consolidation in the medical device outsourcing, which MDO has covered extensively. As these large CROs collaborate with specialized service providers they gain substantial share in the specific market segment.
Companies in North America and the EU have well-established manufacturing infrastructure for high end and complex medical devices. Although these entities commanded a sizable share in 2016, Grand View expects the Asia Pacific region to dominate the market over the next seven years.
Key companies cited in the report include Integer, Tecomet, Jabil, Flextronics, Celestica, Sanmina, Plexus, SGS SA, Toxikon, Eurofins Scientific, Pace Analytical Services, Intertek Group, MAPI, PPD, Freyr Solutions, and Wuxi Apptec.