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Medical Device Outsourcing Market

Global Medical Device Outsourcing Market Share, Size, Growth, Forecast: By Services: Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Product Testing & Sterilization Services, Others; By Product Type; By Device Type; By Applications; By End User; Regional Analysis; Supplier Landscape; 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.

 

medical device outsourcing market by region

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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

REPORT FEATURES DETAILS
Base Year 2023
Historical Period 2017-2023
Forecast Period 2024-2032
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Services
  • Product Type
  • Device Type
  • Applications
  • End User
  • Region
Breakup by Services
  • Quality Assurance
  • Regulatory Affairs Services
  • Product Design and Development Services
  • Product Testing & Sterilization Services
  • Product Implementation Services
  • Product Upgrade Services
  • Product Maintenance Services
  • Raw Material Services
  • Medical Electrical Equipment Services
  • Contract Manufacturing
  • Materials & Chemical Characterization
  • Others
Breakup by Product Type
  • Finished Goods
  • Electronics
  • Raw Materials
Breakup by Device Type
  • Class-I
  • Class -II
  • Class -III
Breakup by Applications
  • Cardiology
  • Diagnostic Imaging
  • Orthopedic
  • IVD
  • Ophthalmic General
  • Plastic Surgery
  • Drug Delivery
  • Dental
  • Endoscopy
  • Diabetes Care
  • Others
Breakup by End User
  • Small Medical Device Company
  • Medium Medical Device Company
  • Large Medical Device Company
  • Others
Breakup by Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Supplier Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Mergers and Acquisitions
    • Certifications
Companies Covered
  • SGS SA
  • TOXIKON
  • Pace Analytical
  • Intertek Group plc.
  • WuXi AppTec
  • North American Science Associates, Inc.
  • American Preclinical Services, LLC.
  • Sterigenics
  • Charles River Laboratories
  • Celestica Inc.
  • Creganna
  • FLEX LTD.
  • Heraeus Holding
  • Integer Holdings Corporation
  • Nortech Systems, Inc.
  • Plexus Corp.
  • Sanmina Corporation
  • EUROFINS SCIENTIFIC
  • TE Connectivity, ICON plc
  • Parexel International Corporation
  • Labcorp Drug Development
  • Tecomet, Inc.
  • IQVIA
  • Syneos Health
  • PROVIDIEN LLC.

 

*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.

1    Preface
    1.1    Objectives of the Study
    1.2    Key Assumptions
    1.3    Report Coverage – Key Segmentation and Scope
    1.4    Research Methodology
2    Executive Summary
3    Global Medical Device Outsourcing Market Overview 

    3.1    Global Medical Device Outsourcing Market Historical Value (2017-2023) 
    3.2    Global Medical Device Outsourcing Market Forecast Value (2024-2032)
4    Global Medical Device Outsourcing Market Landscape
    4.1    Global Medical Device Outsourcing Developers Landscape
        4.1.1    Analysis by Year of Establishment
        4.1.2    Analysis by Company Size
        4.1.3    Analysis by Region
    4.2    Global Medical Device Outsourcing Product Landscape
        4.2.1    Analysis by Product Type
        4.2.2    Analysis by Applications
        4.2.3    Analysis by End User
5    Global Medical Device Outsourcing Market Dynamics
    5.1    Market Drivers and Constraints
    5.2    SWOT Analysis
    5.3    Porter’s Five Forces Model 
    5.4    Key Demand Indicators
    5.5    Key Price Indicators
    5.6    Industry Events, Initiatives, and Trends 
    5.7    Value Chain Analysis
6    Global Medical Device Outsourcing Market Segmentation
    6.1    Global Medical Device Outsourcing Market by Services
        6.1.1    Market Overview
        6.1.2    Quality Assurance
        6.1.3    Regulatory Affairs Services
        6.1.4    Product Design and Development Services
        6.1.5    Product Testing & Sterilization Services
        6.1.6    Product Implementation Services
        6.1.7    Product Upgrade Services
        6.1.8    Product Maintenance Services
        6.1.9    Raw Material Services
        6.1.10    Medical Electrical Equipment Services
        6.1.11    Contract Manufacturing
        6.1.12    Materials & Chemical Characterization
        6.1.13    Others
    6.2    Global Medical Device Outsourcing Market by Product Type
        6.2.1    Market Overview
        6.2.2    Finished Goods
        6.2.3    Electronics
        6.2.4    Raw Materials
    6.3    Global Medical Device Outsourcing Market by Device Type
        6.3.1    Market Overview
        6.3.2    Class-I
        6.3.3    Class -II
        6.3.4    Class -III
    6.4    Global Medical Device Outsourcing Market by Applications
        6.4.1    Market Overview
        6.4.2    Cardiology
        6.4.3    Diagnostic Imaging
        6.4.4    Orthopedic
        6.4.5    IVD
        6.4.6    Ophthalmic General
        6.4.7    Plastic Surgery
        6.4.8    Drug Delivery
        6.4.9    Dental
        6.4.10    Endoscopy 
        6.4.11    Diabetes Care 
        6.4.12    Others
    6.5    Global Medical Device Outsourcing Market by End User
        6.5.1    Market Overview
        6.5.2    Small Medical Device Company
        6.5.3    Medium Medical Device Company
        6.5.4    Large Medical Device Company
        6.5.5    Others
    6.6    Global Medical Device Outsourcing Market by Region
        6.6.1    Market Overview
        6.6.2    North America 
        6.6.3    Europe
        6.6.4    Asia Pacific
        6.6.5    Latin America
        6.6.6    Middle East and Africa
7    North America Medical Device Outsourcing Market
    7.1    Market Share by Country
    7.2    United States of America
    7.3    Canada
8    Europe Medical Device Outsourcing Market
    8.1    Market Share by Country
    8.2    United Kingdom
    8.3    Germany
    8.4    France
    8.5    Italy
    8.6    Others
9    Asia Pacific Medical Device Outsourcing Market
    9.1    Market Share by Country
    9.2    China
    9.3    Japan
    9.4    India
    9.5    ASEAN
    9.6    Australia
    9.7    Others
10    Latin America Medical Device Outsourcing Market
    10.1    Market Share by Country
    10.2    Brazil
    10.3    Argentina
    10.4    Mexico
    10.5    Others
11    Middle East and Africa Medical Device Outsourcing Market
    11.1    Market Share by Country
    11.2    Saudi Arabia
    11.3    United Arab Emirates
    11.4    Nigeria
    11.5    South Africa
    11.6    Others
12    Patent Analysis
    12.1    Analysis by Type of Patent
    12.2    Analysis by Publication year
    12.3    Analysis by Issuing Authority
    12.4    Analysis by Patent Age
    12.5    Analysis by CPC Analysis
    12.6    Analysis by Patent Valuation 
    12.7    Analysis by Key Players
13    Grants Analysis
    13.1    Analysis by year
    13.2    Analysis by Amount Awarded
    13.3    Analysis by Issuing Authority
    13.4    Analysis by Grant Application
    13.5    Analysis by Funding Institute
    13.6    Analysis by NIH Departments
    13.7    Analysis by Recipient Organization 
14    Funding Analysis
    14.1    Analysis by Funding Instances
    14.2    Analysis by Type of Funding
    14.3    Analysis by Funding Amount
    14.4    Analysis by Leading Players
    14.5    Analysis by Leading Investors
    14.6    Analysis by Geography
15    Partnership and Collaborations Analysis
    15.1    Analysis by Partnership Instances
    15.2    Analysis by Type of Partnership
    15.3    Analysis by Leading Players
    15.4    Analysis by Geography
16    Regulatory Framework
    16.1    Regulatory Overview
        16.1.1    US FDA
        16.1.2    EU EMA
        16.1.3    INDIA CDSCO
        16.1.4    JAPAN PMDA
        16.1.5    Others
17    Supplier Landscape
    17.1    SGS SA
        17.1.1    Financial Analysis
        17.1.2    Product Portfolio
        17.1.3    Demographic Reach and Achievements
        17.1.4    Mergers and Acquisitions
        17.1.5    Certifications
    17.2    TOXIKON
        17.2.1    Financial Analysis
        17.2.2    Product Portfolio
        17.2.3    Demographic Reach and Achievements
        17.2.4    Mergers and Acquisitions
        17.2.5    Certifications
    17.3    Pace Analytical
        17.3.1    Financial Analysis
        17.3.2    Product Portfolio
        17.3.3    Demographic Reach and Achievements
        17.3.4    Mergers and Acquisitions
        17.3.5    Certifications
    17.4    Intertek Group plc.
        17.4.1    Financial Analysis
        17.4.2    Product Portfolio
        17.4.3    Demographic Reach and Achievements
        17.4.4    Mergers and Acquisitions
        17.4.5    Certifications
    17.5    WuXi AppTec
        17.5.1    Financial Analysis
        17.5.2    Product Portfolio
        17.5.3    Demographic Reach and Achievements
        17.5.4    Mergers and Acquisitions
        17.5.5    Certifications
    17.6    North American Science Associates, Inc.
        17.6.1    Financial Analysis
        17.6.2    Product Portfolio
        17.6.3    Demographic Reach and Achievements
        17.6.4    Mergers and Acquisitions
        17.6.5    Certifications
    17.7    American Preclinical Services, LLC.
        17.7.1    Financial Analysis
        17.7.2    Product Portfolio
        17.7.3    Demographic Reach and Achievements
        17.7.4    Mergers and Acquisitions
        17.7.5    Certifications
    17.8    Sterigenics
        17.8.1    Financial Analysis
        17.8.2    Product Portfolio
        17.8.3    Demographic Reach and Achievements
        17.8.4    Mergers and Acquisitions
        17.8.5    Certifications
    17.9    Charles River Laboratories
        17.9.1    Financial Analysis
        17.9.2    Product Portfolio
        17.9.3    Demographic Reach and Achievements
        17.9.4    Mergers and Acquisitions
        17.9.5    Certifications
    17.10    Celestica Inc.
        17.10.1    Financial Analysis
        17.10.2    Product Portfolio
        17.10.3    Demographic Reach and Achievements
        17.10.4    Mergers and Acquisitions
        17.10.5    Certifications
    17.11    Creganna
        17.11.1    Financial Analysis
        17.11.2    Product Portfolio
        17.11.3    Demographic Reach and Achievements
        17.11.4    Mergers and Acquisitions
        17.11.5    Certifications
    17.12    FLEX LTD.
        17.12.1    Financial Analysis
        17.12.2    Product Portfolio
        17.12.3    Demographic Reach and Achievements
        17.12.4    Mergers and Acquisitions
        17.12.5    Certifications
    17.13    Heraeus Holding
        17.13.1    Financial Analysis
        17.13.2    Product Portfolio
        17.13.3    Demographic Reach and Achievements
        17.13.4    Mergers and Acquisitions
        17.13.5    Certifications
    17.14    Integer Holdings Corporation
        17.14.1    Financial Analysis
        17.14.2    Product Portfolio
        17.14.3    Demographic Reach and Achievements
        17.14.4    Mergers and Acquisitions
        17.14.5    Certifications
    17.15    Nortech Systems, Inc.
        17.15.1    Financial Analysis
        17.15.2    Product Portfolio
        17.15.3    Demographic Reach and Achievements
        17.15.4    Mergers and Acquisitions
        17.15.5    Certifications
    17.16    Plexus Corp.
        17.16.1    Financial Analysis
        17.16.2    Product Portfolio
        17.16.3    Demographic Reach and Achievements
        17.16.4    Mergers and Acquisitions
        17.16.5    Certifications
    17.17    Sanmina Corporation
        17.17.1    Financial Analysis
        17.17.2    Product Portfolio
        17.17.3    Demographic Reach and Achievements
        17.17.4    Mergers and Acquisitions
        17.17.5    Certifications
    17.18    EUROFINS SCIENTIFIC
        17.18.1    Financial Analysis
        17.18.2    Product Portfolio
        17.18.3    Demographic Reach and Achievements
        17.18.4    Mergers and Acquisitions
        17.18.5    Certifications
    17.19    TE Connectivity, ICON plc
        17.19.1    Financial Analysis
        17.19.2    Product Portfolio
        17.19.3    Demographic Reach and Achievements
        17.19.4    Mergers and Acquisitions
        17.19.5    Certifications
    17.20    Parexel International Corporation
        17.20.1    Financial Analysis
        17.20.2    Product Portfolio
        17.20.3    Demographic Reach and Achievements
        17.20.4    Mergers and Acquisitions
        17.20.5    Certifications
    17.21    Labcorp Drug Development
        17.21.1    Financial Analysis
        17.21.2    Product Portfolio
        17.21.3    Demographic Reach and Achievements
        17.21.4    Mergers and Acquisitions
        17.21.5    Certifications
    17.22    Tecomet, Inc.
        17.22.1    Financial Analysis
        17.22.2    Product Portfolio
        17.22.3    Demographic Reach and Achievements
        17.22.4    Mergers and Acquisitions
        17.22.5    Certifications
    17.23    IQVIA
        17.23.1    Financial Analysis
        17.23.2    Product Portfolio
        17.23.3    Demographic Reach and Achievements
        17.23.4    Mergers and Acquisitions
        17.23.5    Certifications
    17.24    Syneos Health
        17.24.1    Financial Analysis
        17.24.2    Product Portfolio
        17.24.3    Demographic Reach and Achievements
        17.24.4    Mergers and Acquisitions
        17.24.5    Certifications
    17.25    PROVIDIEN LLC.
        17.25.1    Financial Analysis
        17.25.2    Product Portfolio
        17.25.3    Demographic Reach and Achievements
        17.25.4    Mergers and Acquisitions
        17.25.5    Certifications
18    Global Medical Device Outsourcing Market - Distribution Model (Additional Insight)
    18.1    Overview 
    18.2    Potential Distributors 
    18.3    Key Parameters for Distribution Partner Assessment 
19    Key Opinion Leaders (KOL) Insights (Additional Insight)
20    Company Competitiveness Analysis (Additional Insight)

    20.1    Very Small Companies
    20.2    Small Companies
    20.3    Mid-Sized Companies
    20.4    Large Companies
    20.5    Very Large Companies
21    Payment Methods (Additional Insight)
    21.1    Government Funded
    21.2    Private Insurance
    21.3    Out-of-Pocket

 

*Additional insights provided are customisable as per client requirements.

Key Questions Answered in the Report

The medical device outsourcing market was valued at USD 118.28 billion in 2023.

The market is expected to grow at a CAGR of 11.8% from 2024 to 2032 to reach a value of USD 322.78 billion by 2032.

The major market drivers include the growing prevalence of chronic diseases, the increasing geriatric population, the rising preference for outsourcing of medical devices to avoid regulatory breaches, and high return on investment offered by medical device outsourcing.

Technological advancements, rapid digitisation, and innovations are expected to lead the revolution of medical devices. Furthermore, improving healthcare services, increasing R&D investments, and the growing trend of outsourcing the R&D and outsourcing of in the medical sector to minimise business risks and lower costs are likely to fuel innovations in medical devices.

The major regions in the market are North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa.

The key market trends guiding the growth of the market include the rising need to reduce production costs of medical devices while maintaining their quality, the increasing demand for medical devices, and  the surging competition between leading market players.

The significant service types of medical device outsourcing include quality assurance, regulatory affairs services, product design and development services, contract manufacturing, product testing and sterilisation, product implementation, product upgrade, and product maintenance.

The various applications of medical device outsourcing include cardiology, diagnostic imaging, orthopaedic, IVD, ophthalmic, general and plastic surgery, drug delivery, dental, endoscopy, and diabetes care, among others.

The major players in the market are Flex Ltd., Sterling Medical Devices, Integer Holdings Corporation, Eurofins Scientific, and Plexus Corp., among others.

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