Reports

Amid Ukraine-Russia crisis, our analysts and industry experts are closely monitoring the markets and working hard to identify, gather and timely deliver analysis of the impact of the situation and the impact that it has on various markets. All our reports are updated with the latest impact on the market before being sent out to our customers.

Global Medical Device Outsourcing Market Share, Size, Growth, Forecast: By Service Type: Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Contract Manufacturing, Product Testing and Sterilisation, Product Implementation, Others; By Application; Regional Analysis; Competitive Landscape; 2023-2028

Global Medical Device Outsourcing Market Outlook

The global medical device outsourcing market size reached a value of more than USD 105.83 billion in 2022. The market is further estimated to grow at a CAGR of 11.80% in the forecast period of 2023-2028.

 

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.

 

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 2022
Historical Period 2018-2022
Forecast Period 2023-2028
Scope of the Report

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

  • Service Type
  • Application
  • Region
Breakup by Service Type
  • Quality Assurance
  • Regulatory Affairs Services
  • Product Design and Development Services
  • Contract Manufacturing
  • Product Testing and Sterilisation
  • Product Implementation
  • Product Upgrade
  • Product Maintenance
Breakup by Application
  • Cardiology
  • Diagnostic Imaging
  • Orthopaedic
  • IVD
  • Ophthalmic
  • General and Plastic Surgery
  • Drug delivery
  • Dental
  • Endoscopy
  • Diabetes Care
  • Others
Breakup by Region
  • North America
    • United States of America 
    • Canada
  • Europe
    • United Kingdom
    • Germany
    • France
    • Italy
    • Others
  • Asia Pacific
    • China
    • Japan
    • India
    • ASEAN
    • Australia
    • Others
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • United Arab Emirates
    • Nigeria
    • South Africa
    • Others
Market Dynamics
  • SWOT
  • Porter's Five Forces
  • Key Indicators for Demand
  • Key Indicators for Price
Competitive Landscape
  • Market Structure
  • Company Profiles
    • Company Overview
    • Product Portfolio
    • Demographic Reach and Achievements
    • Certifications
Companies Covered
  • Flex Ltd.
  • Sterling Medical Devices
  • Integer Holdings Corporation
  • Eurofins Scientific
  • Plexus Corp.
  • Others

 

*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 
2    Report Coverage – Key Segmentation and Scope
3    Report Description

    3.1    Market Definition and Outlook
    3.2    Properties and Applications
    3.3    Market Analysis
    3.4    Key Players
4    Key Assumptions   
5    Executive Summary

    5.1    Overview
    5.2    Key Drivers
    5.3    Key Developments  
    5.4    Competitive Structure
    5.5    Key Industrial Trends
6    Market Snapshot
    6.1    Global
    6.2    Region
7    Industry Opportunities and Challenges  
8    Global Medical Device Outsourcing Market Analysis

    8.1    Key Industry Highlights
    8.2    Global Medical Device Outsourcing Historical Market (2018-2022) 
    8.3    Global Medical Device Outsourcing Market Forecast (2023-2028)
    8.4    Global Medical Device Outsourcing Market by Service Type
        8.4.1    Quality Assurance
            8.4.1.1    Market Share
            8.4.1.2    Historical Trend (2018-2022)
            8.4.1.3    Forecast Trend (2023-2028)
        8.4.2    Regulatory Affairs Services
            8.4.2.1    Market Share
            8.4.2.2    Historical Trend (2018-2022)
            8.4.2.3    Forecast Trend (2023-2028)
            8.4.2.4    Breakup by Services Type
                8.4.2.4.1    Clinical Trials Applications and Product Registrations
                8.4.2.4.2    Regulatory Writing and Publishing
                8.4.2.4.3    Legal Representation
                8.4.2.4.4    Others
        8.4.3    Product Design and Development Services
            8.4.3.1    Market Share
            8.4.3.2    Historical Trend (2018-2022)
            8.4.3.3    Forecast Trend (2023-2028)
            8.4.3.4    Breakup by Type
                8.4.3.4.1    Designing and Engineering
                8.4.3.4.2    Machining
                8.4.3.4.3    Moulding
                8.4.3.4.4    Packaging
        8.4.4    Contract Manufacturing
            8.4.4.1    Market Share
            8.4.4.2    Historical Trend (2018-2022)
            8.4.4.3    Forecast Trend (2023-2028)
            8.4.4.4    Breakup by Contract Manufacturing Type
                8.4.4.4.1    Accessories Manufacturing
                8.4.4.4.2    Assembly Manufacturing
                8.4.4.4.3    Component Manufacturing
                8.4.4.4.4    Device Manufacturing
        8.4.5    Product Testing and Sterilisation 
            8.4.5.1    Market Share
            8.4.5.2    Historical Trend (2018-2022)
            8.4.5.3    Forecast Trend (2023-2028)
        8.4.6    Product Implementation
            8.4.6.1    Market Share
            8.4.6.2    Historical Trend (2018-2022)
            8.4.6.3    Forecast Trend (2023-2028)
        8.4.7    Product Upgrade
            8.4.7.1    Market Share
            8.4.7.2    Historical Trend (2018-2022)
            8.4.7.3    Forecast Trend (2023-2028)
        8.4.8    Product Maintenance
            8.4.8.1    Market Share
            8.4.8.2    Historical Trend (2018-2022)
            8.4.8.3    Forecast Trend (2023-2028)
    8.5    Global Medical Device Outsourcing Market by Application
        8.5.1    Cardiology
            8.5.1.1    Market Share
            8.5.1.2    Historical Trend (2018-2022)
            8.5.1.3    Forecast Trend (2023-2028)
        8.5.2    Diagnostic Imaging
            8.5.2.1    Market Share
            8.5.2.2    Historical Trend (2018-2022)
            8.5.2.3    Forecast Trend (2023-2028)
        8.5.3    Orthopaedic
            8.5.3.1    Market Share
            8.5.3.2    Historical Trend (2018-2022)
            8.5.3.3    Forecast Trend (2023-2028)
        8.5.4    IVD
            8.5.4.1    Market Share
            8.5.4.2    Historical Trend (2018-2022)
            8.5.4.3    Forecast Trend (2023-2028)
        8.5.5    Ophthalmic
            8.5.5.1    Market Share
            8.5.5.2    Historical Trend (2018-2022)
            8.5.5.3    Forecast Trend (2023-2028)
        8.5.6    General and Plastic Surgery
            8.5.6.1    Market Share
            8.5.6.2    Historical Trend (2018-2022)
            8.5.6.3    Forecast Trend (2023-2028)
        8.5.7    Drug delivery
            8.5.7.1    Market Share
            8.5.7.2    Historical Trend (2018-2022)
            8.5.7.3    Forecast Trend (2023-2028)
        8.5.8    Dental
            8.5.8.1    Market Share
            8.5.8.2    Historical Trend (2018-2022)
            8.5.8.3    Forecast Trend (2023-2028)
        8.5.9    Endoscopy
            8.5.9.1    Market Share
            8.5.9.2    Historical Trend (2018-2022)
            8.5.9.3    Forecast Trend (2023-2028)
        8.5.10    Diabetes Care
            8.5.10.1    Market Share
            8.5.10.2    Historical Trend (2018-2022)
            8.5.10.3    Forecast Trend (2023-2028)
        8.5.11    Others
    8.6    Global Medical Device Outsourcing Market by Region
        8.6.1    Market Share
            8.6.1.1    North America
            8.6.1.2    Europe
            8.6.1.3    Asia Pacific
            8.6.1.4    Latin America
            8.6.1.5    Middle East and Africa
9    Regional Analysis
    9.1    North America
    9.1.1    Historical Trend (2018-2022)
    9.1.2    Forecast Trend (2023-2028)
    9.1.3    Breakup by Country
    9.1.3.1    United States of America 
    9.1.3.2    Canada
    9.2    Europe
        9.2.1    Historical Trend (2018-2022)
        9.2.2    Forecast Trend (2023-2028)
        9.2.3    Breakup by Country 
            9.2.3.1    United Kingdom
            9.2.3.2    Germany
            9.2.3.3    France
            9.2.3.4    Italy
            9.2.3.5    Others
    9.3    Asia Pacific
        9.3.1    Historical Trend (2018-2022)
        9.3.2    Forecast Trend (2023-2028)
        9.3.3    Breakup by Country
            9.3.3.1    China
            9.3.3.2    Japan
            9.3.3.3    India
            9.3.3.4    ASEAN
            9.3.3.5    Australia
            9.3.3.6    Others
    9.4    Latin America
        9.4.1    Historical Trend (2018-2022)
        9.4.2    Forecast Trend (2023-2028)
        9.4.3    Breakup by Country
            9.4.3.1    Brazil
            9.4.3.2    Argentina
            9.4.3.3    Mexico
            9.4.3.4    Others
    9.5    Middle East and Africa
        9.5.1    Historical Trend (2018-2022)
        9.5.2    Forecast Trend (2023-2028)
        9.5.3    Breakup by Country
            9.5.3.1    Saudi Arabia
            9.5.3.2    United Arab Emirates
            9.5.3.3    Nigeria
            9.5.3.4    South Africa
            9.5.3.5    Others
10    Market Dynamics
    10.1    SWOT Analysis
        10.1.1    Strengths
        10.1.2    Weaknesses
        10.1.3    Opportunities
        10.1.4    Threats
    10.2    Porter’s Five Forces Analysis
        10.2.1    Supplier’s Power
        10.2.2    Buyer’s Power
        10.2.3    Threat of New Entrants
        10.2.4    Degree of Rivalry
        10.2.5    Threat of Substitutes
    10.3    Key Indicators for Demand
    10.4    Key Indicators for Price
11    Competitive Landscape
    11.1    Market Structure
    11.2    Company Profiles
        11.2.1    Flex Ltd.
            11.2.1.1    Company Overview
            11.2.1.2    Product Portfolio
            11.2.1.3    Demographic Reach and Achievements
            11.2.1.4    Certifications
        11.2.2    Sterling Medical Devices 
            11.2.2.1    Company Overview
            11.2.2.2    Product Portfolio
            11.2.2.3    Demographic Reach and Achievements
            11.2.2.4    Certifications
        11.2.3    Integer Holdings Corporation
            11.2.3.1    Company Overview
            11.2.3.2    Product Portfolio
            11.2.3.3    Demographic Reach and Achievements
            11.2.3.4    Certifications
        11.2.4    Eurofins Scientific
            11.2.4.1    Company Overview
            11.2.4.2    Product Portfolio
            11.2.4.3    Demographic Reach and Achievements
            11.2.4.4    Certifications
        11.2.5    Plexus Corp.
            11.2.5.1    Company Overview
            11.2.5.2    Product Portfolio
            11.2.5.3    Demographic Reach and Achievements
            11.2.5.4    Certifications
        11.2.6    Others
12    Industry Events and Developments

 

List of Key Figures and Tables

1.    Global Medical Device Outsourcing Market: Key Industry Highlights, 2018 and 2028
2.    Global Medical Device Outsourcing Historical Market: Breakup by Service Type (USD Billion), 2018-2022
3.    Global Medical Device Outsourcing Market Forecast: Breakup by Service Type (USD Billion), 2023-2028
4.    Global Medical Device Outsourcing Historical Market: Breakup by Application (USD Billion), 2018-2022
5.    Global Medical Device Outsourcing Market Forecast: Breakup by Application (USD Billion), 2023-2028
6.    Global Medical Device Outsourcing Historical Market: Breakup by Region (USD Billion), 2018-2022
7.    Global Medical Device Outsourcing Market Forecast: Breakup by Region (USD Billion), 2023-2028
8.    North America Medical Device Outsourcing Historical Market: Breakup by Country (USD Billion), 2018-2022
9.    North America Medical Device Outsourcing Market Forecast: Breakup by Country (USD Billion), 2023-2028
10.    Europe Medical Device Outsourcing Historical Market: Breakup by Country (USD Billion), 2018-2022
11.    Europe Medical Device Outsourcing Market Forecast: Breakup by Country (USD Billion), 2023-2028
12.    Asia Pacific Medical Device Outsourcing Historical Market: Breakup by Country (USD Billion), 2018-2022
13.    Asia Pacific Medical Device Outsourcing Market Forecast: Breakup by Country (USD Billion), 2023-2028
14.    Latin America Medical Device Outsourcing Historical Market: Breakup by Country (USD Billion), 2018-2022
15.    Latin America Medical Device Outsourcing Market Forecast: Breakup by Country (USD Billion), 2023-2028
16.    Middle East and Africa Medical Device Outsourcing Historical Market: Breakup by Country (USD Billion), 2018-2022
17.    Middle East and Africa Medical Device Outsourcing Market Forecast: Breakup by Country (USD Billion), 2023-2028
18.    Global Medical Device Outsourcing Market Structure.

Key Questions Answered in the Report

In 2022, the market attained a value of more than USD 105.83 billion.

The market is assessed to grow at a CAGR of 11.80% between 2023 and 2028.

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.

Purchase Full Report

Mini Report

$ 2199     $1799
  • Selected Sections, One User
  • Printing Not Allowed
  • Email Delivery in PDF
  • Free Limited Customisation
  • Post Sales Analyst Support
  • 50% Discount on Next Update

Single User License

$ 3199     $2999
  • All Sections, One User
  • One Print Allowed
  • Email Delivery in PDF
  • Free Limited Customisation
  • Post Sales Analyst Support
  • 50% Discount on Next Update

Five User License

$ 4199     $3999
  • All Sections, Five Users
  • Five Prints Allowed
  • Email Delivery in PDF
  • Free Limited Customisation
  • Post Sales Analyst Support
  • 50% Discount on Next Update

Corporate License

$ 5199     $4999
  • All Sections, Unlimited Users
  • Unlimited Prints Allowed
  • Email Delivery in PDF + Excel
  • Free Limited Customisation
  • Post Sales Analyst Support
  • 50% Discount on Next Update

Any Question? Speak With An Analyst

Contact Analyst

View A Sample

Request Sample

Did You Miss Anything, Ask Now

Request Customisation
Why Expert Market Research?

Right People

We are technically excellent, strategic, practical, experienced and efficient; our analysts are hand-picked based on having the right attributes to work successfully and execute projects based on your expectations.

Right Methodology

We leverage our cutting-edge technology, our access to trusted databases, and our knowledge of the current models used in the market to deliver you research solutions that are tailored to your needs and put you ahead of the curve.

Right Price

We deliver in-depth and superior quality research in prices that are reasonable, unmatchable, and shows our understanding of your resource structure. We, additionally, offer attractive discounts on our upcoming reports.

Right Support

Our team of expert analysts are at your beck and call to deliver you optimum results that are customised to meet your precise needs within the specified timeframe and help you form a better understanding of the industry.

NEWSLETTER