The global market for Medical Device Outsourcing is projected to reach US$101.6 billion by 2024, driven by the rising pressure to reduce manufacturing costs and accelerate time-to-market new products in a scenario where product lifecycles are getting shorter, technologies are becoming increasingly sophisticated and the window of opportunity keeps continuously shrinking. Also supporting growth in the number of outsourcing contracts is the rising incidence of diseases specifically cardiac and neurological disorders and the ensuing higher demand for a wide variety of medical devices such as cardiac monitors, implanted cerebella stimulators, and replacement heart valves, among others. The focus on curbing escalating healthcare costs and making universal health coverage sustainable is resulting in increased importance shed on the role played by manufacturers. In addition to efficiency of service provision, there is growing emphasis laid on enhancing production efficiencies and lowering manufacturing costs for achieving affordable drugs and medical device pricing. As medical devices play an important part in diagnosing, treating and preventing disease, their high price is a major cause for concern. As value-based price, also known as value optimized pricing becomes the pricing strategy of choice, outsourcing is emerging into a critical strategy for manufacturers to remain relevant in the market. Benefits of medical device outsourcing include operational efficiencies, cost savings, lower production costs, improved margins, fluid cash flow, reduced risk of penalties arising from regulatory non-compliance to rigid quality & safety standards, lower prices, more affordable healthcare products and services, improved product quality, superior clinical outcomes and higher patient satisfaction. The availability of myriad outsourcing models ranging from full service end-to-end manufacturing to selected functions such as product design & development, engineering services, clinical trials management, packaging & marketing, etc., is additionally helping drive up adoption rates. The United States represents the largest market worldwide, followed by Europe. Asia-Pacific is forecast to record the fastest CAGR of 14.6% over the analysis period, led by the emergence of the region as the global hub for medical manufacturing due to low labor costs and higher focus on adherence to stringent international quality standards; and formulation of favorable policies and strategies to encourage growth of Asian economies as cost-effective destinations for medical device and instrumentation production.  

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Company and Industry News & Stories
  • Venclose Partners with Viant in a Move to Manufacture Next-Generation VENCLOSE TM RF Ablation Catheter
  • Eptam Snaps Up Relius Medical, a Supplier of Precision Components to Medical Device OEMs
  • Plexus to Build New Manufacturing Facility in Guadalajara, Mexico in a Move to Strengthen its Presence in the Country
  • West Pharmaceutical Services Establishes New Facility in Waterford, Ireland, a Global Center of Excellence for West's Advanced Manufacturing Network
  • WuXi AppTec Inaugurates New Medical Device Testing Center in Suzhou, China in a Bid to Strengthen its Laboratory Testing Division

Outlook in Key Market Segments
  • Through 2024, Class II devices will remain the largest market, followed by Class III devices.
  • Class II devices are projected to witness the fastest growth driven by the increasing number of surgical procedures being performed and the growing complexity of device designs.

Product Definition & Scope
  • Medical Device Outsourcing involves a third-party operating a part or entire client’s technology assets. Medical device manufacturers (original equipment manufacturers or OEMs) sometimes hire a contract manufacturer to perform contract manufacturing services such as product prototype, production, injection molding, silicone compression molding, welding, assembly and packaging in a controlled environment, cleanroom and other auxiliary services such as metal machining. Medical device outsourcing can lower operational costs, increase business efficiency and boost productivity thus providing tangible, bottom line benefits to organizations. In addition to contract manufacturing, medical device outsourcing services include design, development, & implementation; testing & certification services; consulting services (including regulatory); and maintenance & upgrade services for medical devices.

Timeline for Analysis
  • Market Estimates and Forecasts for 2016-2024
  • Historic Review 2011-2015

Geographic Markets Analyzed
  • US, Canada, Japan, Europe (France, Germany, Italy, UK, Spain, and Rest of Europe), Asia-Pacific, and Rest of World

Market Segmentation & Classification
  • Device Category:
    • Class I, Class II, and Class III
  • Application Area:
    • Radiology, Orthopedic, Neurology, Cardiology, and Others

Major Players
  • Integer Holdings Corporation
  • Phillips-Medisize Corporation
  • Tecomet, Inc.
  • Creganna Medical
  • HCL Technologies Limited
  • Thermo Fisher Scientific, Inc.
  • West Pharmaceutical Services, Inc.
  • ICON plc

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