Global Medical Device Outsourcing Market Report and Forecast 2024-2032

Global Medical Device Outsourcing Market Outlook

The global medical device outsourcing market size attained a value of USD 118.28 billion in 2023. The market is likely to grow at a CAGR of 11.8% during the forecast period of 2024-2032 to attain a value of USD 322.78 billion by 2032.

Increasing Demand for Regulatory Affairs Outsourcing Services to Aid the Market Growth

Based on service type, the demand for regulatory affairs outsourcing services is witnessing a rapid growth. The importance of regulatory affairs in the successful rollout of medical devices is increasing the adoption of outsourcing among manufacturers to ensure timely approvals of novel devices. 

Medical device manufacturers are increasingly resorting to outsourcing firms to help with submissions, auditing quality systems, conducting clinical trials, and for deeper regulatory knowledge. Additionally, the growing difficulty of original equipment manufacturers to afford or find qualified expertise with medical device-specific skills for dealing with regulatory needs is driving the medical device outsourcing market development. The introduction of stringent regulations by governments worldwide to ensure the availability of superior-quality medical devices is likely to further stimulate the market over the forecast period.

Market Segmentation

Medical device outsourcing is the means of contracting a process including the production, supply chain management, and product designing, among others, to a third party to reduce production costs and maintain the quality of the medical devices.

The medical device outsourcing market by service type is divided into:

• Quality Assurance

• Regulatory Affairs Services
  • Clinical Trials Applications and Product Registrations
  • Regulatory Writing and Publishing
  • Legal Representation
  • Others
• Product Design and Development Services
  • Designing and Engineering
  • Machining
  • Moulding
  • Packaging
• Contract Manufacturing
  • Accessories Manufacturing
  • Assembly Manufacturing
  • Component Manufacturing
  • Device Manufacturing
• Product Testing and Sterilisation

• Product Implementation

• Product Upgrade

• Product Maintenance

Based on application, the market is segmented into:

• Cardiology

• Diagnostic Imaging

• Orthopaedic

• IVD

• Ophthalmic

• General and Plastic Surgery

• Drug Delivery

• Dental

• Endoscopy

• Diabetes Care

• Others

The regional markets for medical device outsourcing can be divided into North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa.

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Rising Need to Reduce Medical Devices Manufacturing Costs to Drive the Market Growth of Medical Device Outsourcing

The rising need to reduce production costs of medical devices while maintaining their quality is contributing to the medical device outsourcing market expansion. There is a growing demand for efficient medical devices owing to the worldwide prevalence of chronic diseases and the increasing geriatric population, which is propelling market development. 

The increasing competition among medical device manufacturers to develop innovative devices, meet evolving customer demands, prevent regulatory breaches, and increase return on investment is leading to the rapid adoption of medical device outsourcing services. Moreover, original equipment manufacturers are increasingly outsourcing medical device manufacturing to enhance their research and development capabilities.

Various favourable government initiatives towards an equitable healthcare system are boosting the availability of innovative medical devices, hence aiding the market growth. Over the forecast period, the strong presence of market players, the development of new technologies, and the stringent regulations regarding medical devices are expected to strengthen the medical device outsourcing market.

Key Players in the Global Market for Medical Device Outsourcing

The report gives a detailed analysis of the following key players in the global medical device outsourcing market, covering their competitive landscape, capacity, and latest developments like mergers, acquisitions, and investments, expansions of capacity, and plant turnarounds:

• Flex Ltd.

• Sterling Medical Devices

• Integer Holdings Corporation

• Eurofins Scientific

• Plexus Corp.

• Others

The comprehensive EMR report provides an in-depth assessment of the market based on the Porter's five forces model along with giving a SWOT analysis.

Key Highlights of the Report