U.S. Medical Device Outsourcing Market (By Service (Product Upgrade Services, Product Design & Development Services, Quality Assurance, Contract Manufacturing) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2022 – 2030

Published Date : May 2022 | No. of Pages : 150+ Pages | Category : Healthcare

The U.S. medical device outsourcing market was estimated at USD 25.3 billion in 2021 it is expected to hit around USD 62 billion by 2030, expanding growth at a CAGR of 11.5% over the forecast period 2022 to 2030.

U.S. Medical Device Outsourcing Market Size 2021 to 2030

During the crisis, medical devices and supplies played an important role in assisting COVID-19 patients and medical professionals. The diagnostic tests and kits were manufactured and played an important role in fighting the coronavirus. But the manufacturing was disrupted as few supplies were imported from other countries. This dependency hampered the timely availability of raw materials/consumables required for the manufacturing of medical devices.

The government authorities have escalated funds for the research & development of essential devices, thus driving the market. Major companies have solely relied on contract manufacturers to ramp up the production of COVID-19-related medical components, such as test kits, ventilators, and respirators. The major reasons for outsourcing amid the COVID-19 crisis include a streamlined supply chain and cost efficiencies. The market has started to recover as the manufacturing of medical devices used for other diseases has commenced. Furthermore, the barriers are reduced leading to smooth import of supplies. The growing complexity in product engineering and an increasing number of small-sized manufacturers are also anticipated to contribute to the market growth.

The medical device industry has always been highly competitive and categories, such as coronary stents, orthopedic devices, and wound care, are moving towards maturity. As high-impact scientific innovation in the above categories is difficult to achieve and is a time-consuming process, smaller companies are gaining market share by offering low prices and introducing innovative business models. Due to the convergence of mounting challenges and changing market dynamics, many medical device manufacturers have opted for outsourcing business models to reduce cost, manage business risks, and improve service delivery. This factor is also expected to propel market growth over the forecast period.

Service Insights

The contract manufacturing services segment dominated the market in 2021 and accounted for the largest share of more than 56.00% of the overall market revenue. On the basis of services, the market is categorized into quality assurance, regulatory affairs services, product design & development services, product testing & sterilization services, product implementation, product upgrade, product maintenance, and contract manufacturing services. Regulatory affairs, product design & development as well as contract manufacturing services have been further analyzed in this study.

Product design and development partners help in reducing time-to-market for a new device, thus, speeding up the Return on Investment (ROI). Product design and development outsourcing has proved to be a crucial strategic tool facilitating the firms to gain or retain leadership or help in international expansion. The outsourcing of product design and development services held the second-largest share of the market in 2021. This segment is further divided into designing & engineering, machining, molding, and packaging.

Key Players

  • Integer Holdings Corp.
  • Avail Medical Products Inc.
  • Active Implants
  • Omnica Corp.
  • Teleflex, Inc.
  • Kinematic Climax, Inc.
  • Cantel Medical Corp.

Market Segmentation

Service Outlook

    • Quality Assurance
    • Regulatory Consulting Services
      • Clinical Trials Applications & Product Registrations
      • Regulatory Writing & Publishing
      • Legal Representation
      • Other
    • Product Design & Development Services
      • Designing & Engineering
      • Machining
      • Molding
      • Packaging
    • Product Testing & Sterilization Services
    • Product Implementation Services
    • Product Upgrade Services
    • Product Maintenance Services
    • Contract Manufacturing
      • Accessories Manufacturing
      • Assembly Manufacturing
      • Component Manufacturing
      • Device Manufacturing

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