The global medical device outsourcing market is projected to generate $273.0 billion revenue by 2030, advancing at a CAGR of 11.8% during 2022–2030. This can be ascribed to the increasing aging population, rising prevalence of chronic disorders, surging R&D investments, and growing innovative product launches. Furthermore, the mounting competition among medical device manufacturers and surging awareness regarding medical device outsourcing across the globe are driving the market growth.
Based on service type, the market is categorized into quality assurance; regulatory affair; design and development; testing; implementation; upgradation; maintenance; and contract manufacturing. Of these, the quality assurance category will witness the fastest growth, with a CAGR of over 10%, during the coming years. This is due to the stringent regulatory requirements; mounting number of manufacturers, and escalating number of surgical equipment OEMs across the world.
Based on device type, the market is bifurcated into class I, class II, and class III. Among these, the class II category contributed the highest revenue in 2022, and it is expected to maintain its position during the predicted period. This can be attributed to the fact that the majority of medical devices, such as catheters, blood pressure cuffs, X-ray machines, syringes, surgical drapes, and infusion pumps, are categorized as class II devices.
Additionally, the class I category will witness significant growth in the coming years owing to the fact that devices under this category are noninvasive. They are exempt from regulatory procedures owing to their low-risk levels and are easily available.
Based on application, the market is classified into orthopedics & spine; cardiology; diagnostic imaging; in-vitro diagnostic; ophthalmology; plastic surgery; and others. Among these, the cardiology category accounted for the largest revenue share in 2022, and it is will maintain its position during the coming years. This is due to the extensive pipeline of cardiac devices which are expected to be launched in the coming years; and surging prevalence of cardiac ailments.
Geographically, APAC will register the fastest growth during the coming years due to the rising healthcare infrastructure, growing concern towards outsourcing medical devices owing to cost-efficiency, growing aging population, and rising prevalence of chronic diseases.
Whereas the North American region held the highest revenue share in 2022, and it will continue to do so during the forecast period. This can be attributed to the developed healthcare sector, integration of advanced technology, high R&D spending by industry players, and favorable government norms are driving the market growth.
From the time and cost perspectives, contract manufacturing has become a conventional method in the medical device outsourcing market. The primary factor driving the market is shorter time consumption by the contract manufacturing organization (CMO) to manufacture the product. Moreover, outsourcing different phases of production to different partners reduces the development time for new products.
Moreover, the quality and safety of medical devices are better to ensure from the outside in case of outsourcing since the time taken to hire and then train people on how to operate is saved at the end of manufacturers. In addition, engaging full-service contract manufacturers in the design and development phase of the product’s lifecycle also helps to shorten the overall timeline. Hence, outsourcing the production of medical devices to CMOs ensures fast manufacturing and cost-effectiveness, thereby, driving the global market.
Some of the major players in the medical device outsourcing market are Flex Ltd., Integer Holdings Corporation, TE Connectivity Ltd., Heraeus Group, Onex Corporation, IQVIA Inc., and Sanmina Corporation.