North America Medical Device Outsourcing Market, By Services (Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Product Testing and Sterilization Services, Product Implementation Services, Product Upgrade Services, Product Maintenance Services, Raw Material Services, Medical Electrical Equipment Services, Contract Manufacturing, Materials and Chemical Characterization), Product (Finished Goods, Electronics, Raw Materials), Device Type (Class I, Class II, Class III), Application (Cardiology, Diagnostic Imaging, Orthopaedic, IVD, Ophthalmic, General and Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care and Others), End User (Small Medical Device Company, Medium Medical Device Company, Large Medical Device Company and Others) – Industry Trends and Forecast to 2031.
North America Medical Device Outsourcing Market Analysis and Size
The medical devices outsourcing market is experiencing significant advancement, driven by the integration of the latest methods and technologies. This trend fuels increased efficiency and innovation in manufacturing processes, enhancing the quality and functionality of medical devices. Such advancements not only improve patient care but also foster growth opportunities within the outsourcing sector, reflecting a dynamic landscape poised for further expansion and development.
The North America medical device outsourcing market size was valued at USD 62.69 billion in 2023, is projected to reach USD 164.32 billion by 2031, with a CAGR of 12.8% during the forecast period 2024 to 2031. This indicates that the market value. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.
Report Scope and Market Segmentation
|
Report Metric
|
Details
|
|
Forecast Period
|
2024 to 2031
|
|
Base Year
|
2023
|
|
Historic Years
|
2022 (Customizable to 2016-2021)
|
|
Quantitative Units
|
Revenue in USD Billion, Volumes in Units, Pricing in USD
|
|
Segments Covered
|
Services (Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Product Testing and Sterilization Services, Product Implementation Services, Product Upgrade Services, Product Maintenance Services, Raw Material Services, Medical Electrical Equipment Services, Contract Manufacturing, Materials and Chemical Characterization), Product (Finished Goods, Electronics, Raw Materials), Device Type (Class I, Class II, Class III), Application (Cardiology, Diagnostic Imaging, Orthopaedic, IVD, Ophthalmic, General and Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care and Others), End User (Small Medical Device Company, Medium Medical Device Company, Large Medical Device Company and Others)
|
|
Countries Covered
|
U.S., Canada and Mexico
|
|
Market Players Covered
|
Pace Analytical Services, LLC (U.S.), North American Science Associates, LLC (U.S.), Sterigenics U.S., LLC (U.S.), Charles River Laboratories (U.S.), Celestica Inc. (Canada), Integer Holdings Corporation (U.S.), Nortech Systems, Inc. (U.S.), Plexus Corp. (U.S.), Sanmina Corporation (U.S.), Parexel International (MA) Corporation (U.S.), Labcorp Drug Development (U.S.), Tecomet, Inc. (U.S.), IQVIA (U.S.), Jabil Inc. (U.S.), Syneos Health (U.S.), PROVIDIEN LLC (U.S.), and East West Manufacturing (U.S.)
|
|
Market Opportunities
|
|
Market Definition
Medical devices outsourcing refers to the practice of delegating the design, manufacturing, testing, and distribution of medical equipment to external vendors or contractors. This strategy allows companies to focus on core competencies while leveraging specialized expertise, reducing costs, and accelerating product development. Outsourcing may encompass various stages of the device lifecycle, ensuring quality, compliance, and timely delivery in the healthcare industry.
North America Medical Device Outsourcing Market Dynamics
Drivers
- Access to Specialized Expertise
Outsourcing in the medical devices sector catalyses market growth by offering access to specialized expertise and technologies unattainable in-house. For instance, a company focused on cardiac monitoring devices may lack expertise in microelectromechanical systems (MEMS) fabrication. By outsourcing this specialized process to a firm with expertise in MEMS technology, the company can enhance product capabilities and competitiveness, driving market expansion.
- Focus on Core Competencies
Outsourcing non-core functions such as manufacturing, assembly, and packaging allows medical device firms to concentrate on core competencies such as research, development, and innovation. This strategic focus drives the market by accelerating product innovation and enhancing competitive advantage. For instance, a company specializing in cardiac device innovation can allocate more resources to research and development, leading to breakthroughs in life-saving technologies.
Opportunities
- Regulatory Compliance and Quality Assurance
Outsourcing in the medical device industry is driven by the need for regulatory compliance and quality assurance. External partners possess robust quality management systems and regulatory expertise, ensuring adherence to stringent standards such as FDA regulations. For instance, a medical device company collaborating with a contract manufacturer benefits from their proven track record in meeting regulatory requirements, enhancing market competitiveness and customer trust.
- Rising Flexibility and Scalability
Outsourcing in the medical devices sector offers unparalleled flexibility and scalability, enabling companies to swiftly adjust production levels according to market demand without hefty infrastructure investments. For instance, a medical device start up can seamlessly ramp up production during a sudden surge in demand for a new lifesaving device, without being burdened by the costs of expanding their own manufacturing facilities.
Restraints/Challenges
- Intellectual Property Protection
Intellectual Property Protection presents a formidable obstacle in the medical devices outsourcing market. Entrusting third-party manufacturers with proprietary technologies heightens the risk of IP theft and compromise. This challenge stifles market growth, engendering mistrust and reluctance among companies to outsource critical manufacturing processes.
- Dependency on Outsourcing Partners
Over-reliance on outsourcing partners for crucial manufacturing processes can jeopardize market stability. If vendors face financial issues, change ownership, or breach contracts, disruptions occur, impacting supply chains and product availability. Such dependencies heighten vulnerability, amplifying risks without clear solutions.
This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.
Recent Development
- In May 2023, Emergo partnered with the Shanghai Center for Medical Testing and Inspection (CMTC) to conduct ongoing usability tests for medical devices in China. This collaboration aimed to ensure adherence to Human Factors Engineering (HFE) guidelines set by China’s National Medical Products Administration (NMPA), enhancing the usability and safety of medical devices in the region
- In September 2022, North American Science Associates, LLC (NAMSA), and InspireMD, Inc. formed a strategic outsourcing partnership aimed at expediting the development and commercialization of medical devices. This collaboration leveraged NAMSA's expertise in regulatory compliance and InspireMD's innovative technology to accelerate the market entry of new medical solutions
- In July 2021, BREATHE and IQVIA initiated a collaborative effort to expedite the early detection and treatment of respiratory ailments in the U.K. This strategic partnership aimed to enhance health outcomes and improve the quality of life for individuals grappling with respiratory conditions by leveraging advanced diagnostic tools and healthcare insights provided by IQVIA
North America Medical Device Outsourcing Market Scope
The market is segmented on the basis of services, product, device type, application, and end user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.
Services
- Quality Assurance
- Regulatory Affairs Services
- Product Design and Development Services
- Product Testing and Sterilization Services
- Product Implementation Services
- Product Upgrade Services
- Product Maintenance Services
- Raw Material Services
- Medical Electrical Equipment Services
- Contract Manufacturing
- Materials and Chemical Characterization
Product
- Finished Goods
- Electronics
- Raw Materials
Device Type
- Class I
- Class II
- Class III
Application
- Cardiology
- Diagnostic Imaging
- Orthopaedic
- IVD
- Ophthalmic
- General and Plastic Surgery
- Drug Delivery
- Dental
- Endoscopy
- Diabetes Care
- Others
End User
- Small Medical Device Company
- Medium Medical Device Company
- Large Medical Device Company
- Others
North America Medical Device Outsourcing Market Regional Analysis/Insights
The market is analysed and market size insights and trends are provided by country, services, product, device type, application, and end user as referenced above.
The countries covered in the market report are U.S., Canada and Mexico.
U.S. is expected to dominate the medical device outsourcing in North America, sustained by FDA-approved services, escalating demand for chronic wound treatments, growing medical device outsourcing trends, and a growing elderly demographic. These factors position the nation as a hub for innovative, reliable, and compliant medical outsourcing solutions.
The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.
Healthcare Infrastructure growth Installed base and New Technology Penetration
The market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the market. The data is available for historic period 2016-2021.
Competitive Landscape and North America Medical Device Outsourcing Market Share Analysis
The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.
Some of the major players operating in the market are:
- Pace Analytical Services, LLC (U.S.)
- North American Science Associates, LLC (U.S.)
- Sterigenics U.S., LLC (U.S.)
- Charles River Laboratories (U.S.)
- Celestica Inc. (Canada)
- Integer Holdings Corporation (U.S.)
- Nortech Systems, Inc. (U.S.)
- Plexus Corp. (U.S.)
- Sanmina Corporation (U.S.)
- Parexel International (MA) Corporation (U.S.)
- Labcorp Drug Development (U.S.)
- Tecomet, Inc. (U.S.)
- IQVIA (U.S.)
- Jabil Inc. (U.S.)
- Syneos Health (U.S.)
- PROVIDIEN LLC (U.S.)
- East West Manufacturing (U.S.)
SKU-