U.S. Medical Device Outsourcing Market Size, Share & Trends Report

U.S. Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Services (Quality Assurance, Contract Manufacturing), By Application (Cardiology, Diagnostic Imaging, IVD), By Class, And Segment Forecasts, 2023 - 2030

  • Report ID: 978-1-68038-600-4
  • Number of Report Pages: 240
  • Format: PDF, Horizon Databook
  • Historical Range: 2018 - 2021
  • Forecast Period: 2023 - 2030 
  • Industry: Healthcare

Market Segmentation

  • U.S. Medical Device Outsourcing Service Outlook (Revenue, USD Million, 2018 - 2030)
    • Quality Assurance
    • Regulatory Consulting Services
      • Clinical trials applications and product registrations
      • Regulatory writing and publishing
      • Legal representation
      • Other
    • Product Design and 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
  • U.S. Medical Device Outsourcing Application Outlook (Revenue, USD Million, 2018 - 2030)
    • Cardiology
      • Class I
      • Class II
      • Class III
    • Diagnostic imaging
      • Class I
      • Class II
      • Class III
    • Orthopedic
      • Class I
      • Class II
      • Class III
    • IVD
      • Class I
      • Class II
      • Class III
    • Ophthalmic
      • Class I
      • Class II
      • Class III
    • General and plastic surgery
      • Class I
      • Class II
      • Class III
    • Drug delivery
      • Class I
      • Class II
      • Class III
    • Dental
      • Class I
      • Class II
      • Class III
    • Endoscopy
      • Class I
      • Class II
      • Class III
    • Diabetes care
      • Class I
      • Class II
      • Class III
    • Others
      • Class I
      • Class II
      • Class III
  • U.S. Medical Device Outsourcing Class Outlook (Revenue, USD Million, 2018 - 2030)
    • Class I
    • Class II
    • Class III

U.S. Medical Device Outsourcing Market Dynamics

Driver: Changing regulatory landscape

There are anticipated regulatory changes on a global scale that could impact the medical device outsourcing market in the coming years. These changes include amendments to ISO certification related to medical devices and adopting a single audit program. These regulatory changes and other adjustments made by individual countries to align their registration and market access processes are expected to drive the growth of the medical device outsourcing market worldwide. The amendments in ISO standards are expected to increase the demand for quality assurance and regulatory affairs service providers in the United States. Small and Medium-sized Enterprises (SMEs) will require third-party assistance to comply with the new ISO standards. Subcontractors and Original Equipment Manufacturers (OEMs) in the U.S. are likely to adopt these new standards earlier than their counterparts in developing countries. Changes in BGMP, such as the elimination of application fees and the removal of BGMP requirements, are expected to expedite the approval process for low-risk Class I and II devices. Similarly, new KGMP rules are expected to streamline the approval process for Class II and III devices. These rules are also anticipated to encourage the use of third-party auditors by OEMs and contract manufacturers to ensure compliance. The growth of the medical devices market in emerging countries is also expected to drive the demand for manufacturing and consulting services in those regions. Medical device companies are likely to prioritize emerging countries as they seek to access new markets, which will contribute to their revenue growth.

Driver: Rising price competition and the requirement to reduce cost

The medical device industry is currently experiencing complex challenges. One of the significant issues faced by medical device manufacturers is the sharp reduction in public spending in the U.S. This, along with increasing prices, profitability pressure, and intense competition, has a significant impact on the medical device outsourcing market. Health insurers and governments worldwide are implementing measures to control costs, resulting in lower reimbursements for private facilities and tighter budgets for public hospitals. Additionally, categories such as coronary stents, orthopedic devices, and wound care are reaching maturity, making it challenging to identify high-impact scientific innovations. Smaller companies are gaining market share by offering lower prices and introducing innovative business models. The competition in the industry is continuously growing globally, with emerging economies like Brazil, Korea, Taiwan, and China becoming formidable competitors alongside countries like the Netherlands, Germany, Bermuda, and Japan. Many medical device manufacturers have chosen to adopt an outsourcing business model to address these challenges and changing market dynamics. This allows them to reduce costs, manage business risks, and improve service delivery. Recent studies have shown significant opportunities for suppliers and buyers in the medical device industry. Smaller companies can effectively cut costs by outsourcing manufacturing and development work, while larger companies can focus on their core business and drive future growth by outsourcing certain activities. Outsourcing is expected to help medical device companies reduce their product development costs by 10 to 30 percent.

Restraint: Compliance issues while outsourcing

Developing countries' service providers may not adhere to new regulations in the United States, resulting in compliance problems. Consequently, American original equipment manufacturers (OEMs) would prefer to utilize domestic service providers or establish in-house manufacturing facilities to address the expenses associated with compliance and remediation. Nevertheless, as infrastructure improves and the demand for high-quality products grows, contract manufacturing companies worldwide are encountering challenges related to complying with the latest regulatory standards. Consequently, they are compelled to engage third-party entities that offer services such as compliance, remediation, and quality management systems (QMS) to ensure adherence to these standards. Consequently, changes in U.S. regulations are anticipated to exacerbate compliance issues when outsourcing services to contract service providers.

What Does This Report Include?

This section will provide insights into the contents included in this U.S. medical device outsourcing market report and help gain clarity on the structure of the report to assist readers in navigating smoothly.

U.S. medical device outsourcing market qualitative analysis

  • Industry overview

  • Industry trends

  • Market drivers and restraints

  • Market size

  • Growth prospects

  • Porter’s analysis

  • PESTEL analysis

  • Key market opportunities prioritized

  • Competitive landscape

    • Company overview

    • Financial performance

    • Product benchmarking

    • Latest strategic developments

U.S. medical device outsourcing market quantitative analysis

  • Market size, estimates, and forecast from 2018 to 2030

  • Market estimates and forecast for product segments up to 2030

  • Regional market size and forecast for product segments up to 2030

  • Market estimates and forecast for application segments up to 2030

  • Regional market size and forecast for application segments up to 2030

  • Company financial performance

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