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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; 2023-2031
Global Medical Device Outsourcing Market Outlook
The global medical device outsourcing market size attained a value of USD 105.8 billion in 2022. The market is likely to grow at a CAGR of 11.8% during the forecast period of 2023-2031 to attain a value of USD 288.79 billion by 2031.
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.
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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 | 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:
|
| Breakup by Services |
|
| Breakup by Product Type |
|
| Breakup by Device Type |
|
| Breakup by Applications |
|
| Breakup by End User |
|
| Breakup by Region |
|
| Market Dynamics |
|
| Supplier Landscape |
|
| Companies Covered |
|
*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 (2016-2022)
3.2 Global Medical Device Outsourcing Market Forecast Value (2023-2031)
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 105.8 billion in 2022.
The market is expected to grow at a CAGR of 11.8% from 2023 to 2031 to reach a value of USD 288.79 billion by 2031.
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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