Medical Device Contract Manufacturing Global Market estimated to be worth $97.2 billion by 2026

Medical device contract manufacturing (MDCM) is a form of outsourcing in which a manufacturing company makes the whole medical device or certain components of medical devices as per the specifications of Original equipment manufacturer (OEM). Despite the challenges of stringent regulatory demands and consolidation of healthcare providers, the medical device industry is continuously evolving with process advancements and product innovations. Medical device outsourcing helps the OEMs to focus on their core competencies or activities and to bring technologically advanced, innovative and versatile medical devices to market in a short span of time without making huge investments on manufacturing facilities. The MDCMs have grown and evolved by updating their value propositions to become a trusted ‘concept to commercialization’ partner of the OEMs by providing a complete package of services for the product development.

The medical device contract manufacturing global market is expected to grow at a high single digit CAGR to reach $97,239.4 million by 2026. Some of the factors such as increasing prevalence of chronic and infectious diseases, technological advancements of medical devices, advanced manufacturing capabilities of the contract manufacturers, increase in surgeries and rapidly aging worldwide population are driving the market. The need to reduce manufacturing cost and accelerate time to market of efficient and regulatory compliant medical devices is fuelling the medical device contract manufacturing market. For instance in August 2018, Johnson & Johnson entered into collaboration with Jabil Inc., to outsource the manufacturing of J&J’s DePuy Synthes (orthopedic) and Ethicon Endo (minimally invasive surgical devices) products. This outsourcing strategy is expected to save the company between $600 million and $800 million annually by early 2022. In the same year, Integer Holdings (U.S.) has made a 10 year strategic partner and supplier agreement with Neuros Medical Inc., for the company’s patented Altius High Frequency Electrical Nerve Block technology. Some of the hindrances to the market growth are loss of confidential information, emergence of alternative technologies.

The medical device contract manufacturing global market is classified based on the device type, service, product, application and geography. Based on the device type, the market is segmented as Electronic Medical Device Contract Manufacturing and Non-Electronic Medical Device Contract Manufacturing. The Electronic Medical Device Contract Manufacturing segment accounted for the largest revenue in 2019 and is expected to grow at a high single digit CAGR from 2019 to 2026 due to increasing demand of technologically innovative medical devices, advanced manufacturing capabilities of the contract manufacturers, increasing prevalence of chronic and infectious diseases, increase in surgeries and rapidly aging worldwide population. The Non-Electronic Medical Device Contract Manufacturing segment is expected to grow at a mid single digit CAGR from 2019 to 2026.

Among the various services provided by the medical device contract manufacturers, Product Manufacturing and Assembly Service segment holds the largest share in 2019 and is expected to grow at a high single digit CAGR from 2019 to 2026 due to increasing demand for the large scale production of various types of medical devices.

Among the various MDCM products types, the Therapeutic Devices segment holds the largest share in 2019 and is expected to grow at a high single digit CAGR from 2019 to 2026 due to the high prevalence of various chronic and infectious diseases and the rapidly increasing geriatric population requiring various life sustaining and patient assistive devices.

Among the various applications, in-vitro diagnostics (IVD) segment holds the largest share in 2019 and it is expected to grow at a high single digit CAGR from 2019 to 2026, due to increasing prevalence of chronic and infectious diseases and the growing demand for early detection of diseases. Cardiology segment is expected to grow at a low double digit CAGR from 2019 to 2026 due to increase in the incidence of cardiovascular diseases, obesity, growing geriatric population coupled with an increasing susceptibility for heart ailments, increasing regulatory approvals of cardiac devices, growing investments in cardiovascular research for the development of technological advanced patient centric devices. Among the 88 newest medical devices that received FDA clearance during 2018–2020, Cardiology devices accounted (29.5%), in-vitro diagnostics (13.6%) and orthopedic devices (10.2%).

The medical device contract manufacturing global market by geography is segmented into North America, Europe, Asia-Pacific and the Rest of the world (RoW). North America region dominated the medical device contract manufacturing global market in 2019 and it is expected to grow at a high single digit CAGR from 2019 to 2026 due to growing healthcare expenditure and increasing focus on healthcare, increase in the number of surgical procedures, increasing medical device requisites of the rapidly aging population and availability of skilled personnel. The Asia-Pacific is the fastest-growing region with high single digit CAGR from 2019 to 2026 due to increasing income and affordability of the population, increasing prevalence of chronic and infectious diseases, growing geriatric population, increasing awareness and public spending in healthcare, increasing private investment in healthcare sector, increasing penetration of health insurance schemes, innovations promoted by public private partnership (PPP), huge manufacturing facilities and low labor cost. Among the APAC countries, China, S.Korea, Taiwan, India and Malaysia are rapidly becoming the most preferred destinations for medical device contract manufacturing. China has 3,838 FDA registered medical device contract manufacturing sites, S.Korea has xx sites, Taiwan has xx sites, India has 223 sites and Malaysia has xx manufacturing sites. Low labor costs, availability of technical expertise and high-end infrastructure facilities, updated regulatory landscape of these countries are boosting the medical device contract manufacturing sector.

Technological advancements are rapidly revolutionizing the medical device industry with new innovative devices emerging in the market every other day. Some of the major advancements in this field include Augmented, virtual and mixed reality devices, blue tooth and Internet of Things (IoT) enabled devices, 3D and bio printing technology, mobility and cloud access for the devices, ultra high definition imaging technologies, surgical robotic systems, sensor technologies, photonic products and others. The promotion of digital health innovation by FDA through its Digital Health Innovation Action Plan involving De Novo applications, which help in speeding up the approval process, will optimally foster the medical device market that will lead to an increase in the outsourcing activity of the device manufacturers. To gain more market share by bringing innovative and differentiated products to the market in a shorter time and to stay abreast in the patient-driven market with smart and superior medical devices, the medical device OEMs are outsource their manufacturing processes to the contract manufacturers.

Medical device contract manufacturing market has huge opportunity for existing players and new entrants. According to IQ4I analysis, global medical device market is estimated to be $xx billion in 2019. The manufacturing cost spent by OEMs is estimated to be $xx billion. The MDCMs market is valued at $xx billion in 2019, indicating a penetration of xx% with an opportunity of xx% for MDCMs in the market. The market penetration rate of MDCMs is expected to reach xx% or $xx billion by 2026 due to the attractiveness of the market, many companies are venturing out into the medical device contract manufacturing sector. In August 2016, Molex, a leading electronic component developer and supplier diversified its business and successfully entered into the more lucrative medical device contract manufacturing sector by acquiring various medical device companies like Protek Medical Ltd., assets of Soligie Inc., and Phillips-Medisize. By these acquisitions Molex transformed itself into an end to end solution provider for medical device companies.

Most of the medical device contract manufacturing companies are trying to expand and enhance their manufacturing competencies and their service offerings so as to provide one stop solutions to their medical device clients and to maintain their leadership status in the market. Some of the key capabilities adopted by the major MDCMs to differentiate themselves and gain a competitive edge over their counterparts are 3-D printing or additive manufacturing (AM), high volume automated manufacturing of devices, fine-tuned systems engineering process, plasma and resistance welding, laser cutting technology, mechatronics enabled medical device design and manufacturing, miniaturized component technologies and others.

To enhance their core capabilities and service offerings, companies are adopting the strategy of acquisition. In September 2019, Viant (U.S.) acquired Meraqi Medical (U.S.) to expand its service offerings in bioelectronics, minimally invasive surgical devices and interventional technologies. In April 2018, NN Inc. (U.S.) acquired single-use surgical instruments contract manufacturer. Paragon Medical Inc (U.S.) to improve its capabilities and to offer end to end contract manufacturing solutions in its orthopedic trauma device segment. In June 2018, Tecomet (U.S.) acquired HD Surgical to strengthen its precision instrument capabilities. Similarly, in February 2018, Confluent Medical Technologies acquired Corpus Medical to expand its design and manufacturing capabilities.

The medical device contract manufacturing market is fragmented with the top ten players occupying xx% of the market share and the remaining xx% of the market being occupied by other players. The orthopedic device contract manufacturing market is fragmented with the top five players occupying xx% of the market share and the remaining xx% of the market being occupied by other players. The top players in the MDCM global market are Flex (Singapore), Jabil (U.S.), Integer Holdings (U.S.), Celestica (Canada), Sanmina (U.S.), Plexus (U.S.), Gerresheimer (Germany), Molex (U.S.), Tecomet (U.S.), West Pharmaceuticals (U.S), Benchmark Electronics (U.S.), Orchid Orthopedic Solutions (U.S.) and TE Connectivity (Switzerland).