Medical Devices Outsourcing Market to Hit USD 232.8 Bn by 2028 | Transparency Market Research


Steadily rising trend of product design and development in the medical device industry is estimated to offer significant business opportunities to companies in the global medical devices outsourcing market

Wilmington, Delaware, United States, April 21, 2023 (GLOBE NEWSWIRE) — The medical devices outsourcing market is projected to advance at a CAGR of 11.2% from 2021 to 2028, and is anticipated to reach US$ 232.8 Bn by 2028.

Rapid increase in usage of embedded software in smart medical devices is likely to boost the demand for medical devices outsourcing services. Growing trend of adoption of patient-centric drug development approach is also likely to fuel the demand for medical devices outsourcing by biopharmaceutical organizations. Rapid increase in aging populations in several countries is expected to fuel the demand for smart medical devices in order to diagnose and treat chronic conditions.


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Market Snapshot:

Attribute  Detail
Market Size Value  US$ 102.6 Bn in 2020
Market Forecast Value  US$ 232.8 Bn by 2028
CAGR  11.2%  
Forecast Period  2021–2028

Rise in adoption of patient-centric medical devices is a key trend that is expected to offer significant business growth opportunities to companies in the medical devices outsourcing market. Outsourcing companies are offering expertise in the design, engineering, and testing of smart medical devices such as wearable and diagnostic devices. Surge in demand for software outsourcing platforms among medical devices manufacturers is expected to bolster the market growth.

Key Findings of Study

  • Surge in Demand for Outsourcing for Medical Devices Design & Development: Rise in demand for outsourcing services for medical devices design & development is a key factor that is estimated to offer significant business opportunities to companies in the market. Rapid increase in usage of smart infusion pumps to treat chronic diseases is likely to bolster the market. Extensive usage of infusion pumps at healthcare settings, such as in the home, clinics, and hospitals, is also expected to augment the market outlook in the next few years. Demand for implants, dialysis machines, and smart wearable in developed countries is likely to increase considerably due to surge in incidence of chronic diseases. Growing trend of outsourcing of cardiac implantable electronic devices design and development is a notable example.
  • Rapid Increase in Trend of Patient-Centric Product Development to Offer Lucrative Opportunities: Rise in demand for smart medical devices, globally, to cater to requirements of diagnostics and therapeutics for the management of chronic diseases is estimated to augment the market value in the near future. Surge in focus on patient-centric product development could be ascribed to the rise in usage of medical devices to meet personalized patient’s personal preferences. Growing adoption of prefilled syringes, autoinjectors, and smart wearables in drug delivery applications is expected to positively influence the medical devices outsourcing industry. A case in point is surge in application of in vitro and companion diagnostics in the healthcare industry. Rise in demand for vascular treatment devices is estimated to accelerate medical devices outsourcing market growth.

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Key Drivers

  • Surge in demand for smart and patient-centric medical devices is estimated to drive the medical devices outsourcing market. Rise in prevalence of chronic diseases, including cancer, cardiovascular disease, and diabetes, is likely to accelerate medical devices outsourcing market development.
  • Rise in focus of healthcare providers on patient safety and quality of health services in several developing and developed countries is anticipated to boost the medical devices outsourcing market value. Increase in implementation of quality system regulations in the medical device industry is likely to augment the market size in near future.

Regional Growth Dynamics

Developed regions, especially Europe and North America, are estimated to be lucrative markets for medical devices outsourcing, driven by stringent implementation of regulations by outsourcing service providers. Notable regulations include ISO 13485 Medical Devices Quality Management System, ISO 14971:2019, and ISO 9001 and related standards. These standards comprise a wide range of requirements and specifications pertaining to quality system for the medical device industry.

Outsourcing service providers, especially manufacturers of medical components and accessories in the U.S. and the European Union, are adhering to these guidelines. This factor is significantly influencing the market growth dynamics positively in the last few years. Several small-sized providers, however, lack awareness about these regulations and hence do not comply with accreditations to these certifications. This presents an unmet market demand, and hence outsourcing companies and global certification service are working together to address this gap.

Competition Landscape

The business landscape is fragmented, with the presence of several local and global players in the medical devices outsourcing market. Key players operating in the medical devices outsourcing market are Accellent, Inc., Cirtec Medical Systems LLC, Active Implants Corporation, MDMI Technologies, Inc., Micro Systems Engineering GmbH, Creganna-Tactx Medical, and Avail Medical Product

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Medical Devices Outsourcing Market Segmentation

Services Outsourced for Medical Devices

  • Product Design & Development
  • Regulatory Consulting & Other Services
  • Product Testing & Certification
  • Product Implementation
  • Product Maintenance
  • Product Upgrade

Class of Medical Devices

  • Class III
  • Class II
  • Class I


  • Cardiology
  • Neurology
  • Radiology
  • Anesthesia
  • Orthopedic
  • Others


  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

About Transparency Market Research

Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. The firm scrutinizes factors shaping the dynamics of demand in various markets. The insights and perspectives on the markets evaluate opportunities in various segments. The opportunities in the segments based on source, application, demographics, sales channel, and end-use are analysed, which will determine growth in the markets over the next decade.

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