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Medical Device Outsourcing Market

Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Services (Quality Assurance, Contract Manufacturing), By Therapeutic Area (Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmic, General And Plastic Surgery, Drug Delivery), By Class (Class I, Class II, And Class III), By Region, And Segment Forecasts, 2023-2031

Report ID : 1698 | Published : 2024-03-20 | Pages: 180 | Format:

The Global Medical Device Outsourcing Market Size is valued at 117.78 billion in 2022 and is predicted to reach 312.61 billion by the year 2031 at a 11.68% CAGR during the forecast period for 2023-2031.

Medical device outsourcing is a supply chain management phenomenon that focuses on contracting with a third party for product design, production, packaging, testing, prototyping, and verification of medical equipment in a sterile and regulated environment. Typically, outsourcing entails a contract between the client company and the supplier or external outsourced service provider. Over the forecast period, the increased frequency of chronic diseases such as cancer is expected to drive the expansion of the worldwide medical devices outsourcing market. Cancer has become much more common in the last few decades.

Medical Device Outsourcing Market

However, the global outbreak of COVID-19 has interrupted healthcare workflows. The sickness has compelled a number of sectors, including various sub-domains of healthcare, to temporarily close their doors. The COVID-19 epidemic had an overall detrimental impact on key participants in the medical device outsourcing business. In the framework of the medical device outsourcing sector, the COVID-19 pandemic has caused supply chain interruptions and a delay in production. 

Recent Developments:

  • In December 2021, Oscor Inc. was purchased by Integer Holdings, a US-based advanced medical device outsourcing business, for $220 million. By broadening the product selection in steerable sheaths and cardiac and neurostimulation leads and by introducing low-cost manufacturing capability to support expansion, this purchase of Oscor improves Integer's capabilities to service clients. Oscor is a US-based business that provides outsourcing services for medical devices. 

Competitive Landscape:

Some of the medical device outsourcing market players are:

  • SGS SA
  • Laboratory Corporation of America Holdings
  • Euro fins Scientific
  • Pace Analytical Services, Inc.
  • Intertek Group plc
  • WuXiAppTec
  • North American Science Associates, LLC
  • TÜV SÜD
  • Sterigenics U.S.
  • LLC (GTCR, LLC)
  • Charles River Laboratories
  • Medical Device Testing Services
  • RJR Consulting, Inc.
  • Mandala International.
  • Freyr
  • Global Regulatory Partners
  • PAREXEL International Corporation (EQT Private Equity and Goldman Sachs Asset Management)
  • Emergo (UL LLC)
  • Bioteknica
  • Accell Clinical Research, LLC
  • ; Criterium, Inc.
  • Promedica International
  • Med pace
  • ICON plc.
  • IQVIA Inc.
  • Integer Holdings Corporation
  • Tecomet Inc. (Charlesbank Capital Partners, LLC)
  • Jabil Inc.
  • FLEX LTD.
  • Celestica Inc.
  • Sanmina Corporation.
  • Plexus Corp.
  • Phillips Medisize (Molex, LLC)
  • Cantel Medical Corp. (STERIS plc)
  • West Pharmaceutical Services, Inc 

Market Segmentation:

The medical device outsourcing market is segmented on the basis of service outlook, type, and application. Based on service outlook, the market is segmented as quality assurance, regulatory affairs 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, and contract manufacturing (accessories manufacturing, assembly manufacturing, component manufacturing, and device manufacturing). The class type segment includes Class I, Class II, and Class III. By application, the market is segmented into cardiology, diagnostic imaging, Orthopedic, IVD, ophthalmic, general and plastic surgery, drug delivery, dental, endoscopy, diabetes care, and others. 

Based On Service, The Contrast Manufacturing Segment Is Accounted As A Substantial Contributor In The Medical Device Outsourcing Market

The contrast manufacturing category is expected to hold a significant share of the global medical device outsourcing market in 2022. The focus on lowering production costs is intensifying, which is accelerating this market's expansion. The complexity of manufacturing is also a factor in the market's expansion. The production of safe and high-quality medical equipment is a top priority for medical device makers. There are several layers of rules and regulations as a result of the rigorous examination process used in the development of medical devices. Thus, there is a demand for manufacturing services as a result.

The Cardiology Segment Witnessed Growth At A Rapid Rate

The cardiology segment is projected to grow at a rapid rate in the global medical device outsourcing market. This is brought on by the high prevalence of diseases such as congenital heart disease, hypertension, rheumatic heart disease, atrial fibrillation, angina pectoris, and myocardial infarction. The need for cardiovascular devices is rising due to the growing prevalence of CVDs worldwide. Additionally, due to the high complexity of cardiovascular devices, the need for technical know-how, and the high cost of producing these devices, OEMs are more likely to outsource the production of these devices.

In The Region, The Asia Pacific Medical Device Outsourcing Market Holds A Significant Revenue Share

Asia Pacific medical device outsourcing market is expected to register the highest market share in terms of revenue in the near future. The supporting aspects expected to drive this regional market include the presence of market players and competitive pricing. In addition, the growing patient population suffering from chronic and infectious diseases is propelling market expansion in this region. Moreover, North America is also expected to grow significantly during the predicted period. Due to the well-established production hubs for high-end, consistent, and complex medical equipment, this is the case. Furthermore, North America's highly advanced electronic industry gives it an advantage over other regions. This region is also home to a large number of medical device businesses, which outsource a portion of their regulatory and consulting functions to regulatory service providers, contributing to the regional market's growth. 

Medical Device Outsourcing Market Report Scope:

Report Attribute

Specifications

Market size value in 2022

USD 117.78 Bn

Revenue forecast in 2031

USD 312.61 Bn

Growth rate CAGR

CAGR of 11.68 % from 2023 to 2031

Quantitative units

Representation of revenue in US$ Billion, and CAGR from 2023 to 2031

Historic Year

2019 to 2022

Forecast Year

2023-2031

Report coverage

The forecast of revenue, the position of the company, the competitive market statistics, growth prospects, and trends

Segments covered

Service Outlook, Type, And Application

Regional scope

North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Country scope

U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; The UK; France; Italy; Spain; China; Japan; India; South Korea; Southeast Asia; South Korea; Southeast Asia

Competitive Landscape

SGS SA; Laboratory Corporation of America Holdings; Euro fins Scientific; Pace Analytical Services, Inc.; Intertek Group plc; WuXiAppTec; North American Science Associates, LLC; TÜV SÜD; Sterigenics U.S., LLC (GTCR, LLC); Charles River Laboratories; Medical Device Testing Services; RJR Consulting, Inc.; Mandala International.; Freyr; Global Regulatory Partners; PAREXEL International Corporation (EQT Private Equity and Goldman Sachs Asset Management); Emergo (UL LLC); Bioteknica; Accell Clinical Research, LLC; Genpact.; Criterium, Inc.; ; Promedica International; Med pace; ICON plc.; IQVIA Inc.; Integer Holdings Corporation; Tecomet Inc. (Charlesbank Capital Partners, LLC); Jabil Inc.; FLEX LTD.; Celestica Inc.; Sanmina Corporation.; Plexus Corp.; Phillips Medisize (Molex, LLC); Cantel Medical Corp. (STERIS plc) and West Pharmaceutical Services, Inc.

Customization scope

Free customization report with the procurement of the report, Modifications to the regional and segment scope. Particular Geographic competitive landscape.

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Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions

Chapter 2. Executive Summary

Chapter 3. Global Medical Device Outsourcing Market Snapshot

Chapter 4. Global Medical Device Outsourcing Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Industry Analysis – Porter’s Five Forces Analysis
4.7. Competitive Landscape & Market Share Analysis
4.8. Impact of Covid-19 Analysis

Chapter 5. Market Segmentation 1: by Service Estimates & Trend Analysis
5.1. by Service & Market Share, 2019 & 2031
5.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by Service:

5.2.1. Quality Assurance

5.2.2. Regulatory Affairs Services

5.2.2.1. Clinical trials applications and product registrations
5.2.2.2. Regulatory writing and publishing
5.2.2.3. Legal representation
5.2.2.4. Other

5.2.3. Product Design and Development Services

5.2.3.1. Designing & Engineering
5.2.3.2. Machining
5.2.3.3. Molding
5.2.3.4. Packaging

5.2.4. Product Testing & Sterilization Services
5.2.5. Product Implementation Services
5.2.6. Product Upgrade Services
5.2.7. Product Maintenance Services

5.2.8. Contract Manufacturing

5.2.8.1. Accessories Manufacturing
5.2.8.2. Assembly Manufacturing
5.2.8.3. Component Manufacturing
5.2.8.4. Device Manufacturing

Chapter 6. Market Segmentation 2: by Class Type Estimates & Trend Analysis
6.1. by Class Type & Market Share, 2019 & 2031
6.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by Class Type:

6.2.1. Class I
6.2.2. Class II
6.2.3. Class III

Chapter 7. Market Segmentation 3: by Application Estimates & Trend Analysis
7.1. by Application & Market Share, 2019 & 2031
7.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by Application:

7.2.1. Cardiology
7.2.2. Diagnostic imaging
7.2.3. Orthopedic
7.2.4. IVD
7.2.5. Ophthalmic
7.2.6. General and plastic surgery
7.2.7. Drug delivery
7.2.8. Dental
7.2.9. Endoscopy
7.2.10. Diabetes care
7.2.11. Others

Chapter 8. Medical Device Outsourcing Market Segmentation 4: Regional Estimates & Trend Analysis

8.1. North America

8.1.1. North America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2023-2031
8.1.2. North America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2023-2031
8.1.3. North America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2023-2031
8.1.4. North America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2023-2031

8.2. Europe

8.2.1. Europe Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2023-2031
8.2.2. Europe Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2023-2031
8.2.3. Europe Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2023-2031
8.2.4. Europe Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2023-2031

8.3. Asia Pacific

8.3.1. Asia Pacific Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2023-2031
8.3.2. Asia Pacific Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2023-2031
8.3.3. Asia-Pacific Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2023-2031
8.3.4. Asia Pacific Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2023-2031

8.4. Latin America

8.4.1. Latin America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2023-2031
8.4.2. Latin America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2023-2031
8.4.3. Latin America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2023-2031
8.4.4. Latin America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2023-2031

8.5. Middle East & Africa

8.5.1. Middle East & Africa Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2023-2031
8.5.2. Middle East & Africa Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2023-2031
8.5.3. Middle East & Africa Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2023-2031
8.5.4. Middle East & Africa Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2023-2031

Chapter 9. Competitive Landscape

9.1. Major Mergers and Acquisitions/Strategic Alliances

9.2. Company Profiles


9.2.1. SGS SA
9.2.2. Laboratory Corporation of America Holdings
9.2.3. Euro fins Scientific
9.2.4. Pace Analytical Services, Inc.
9.2.5. Intertek Group plc
9.2.6. WuXiAppTec
9.2.7. North American Science Associates, LLC
9.2.8. TÜV SÜD
9.2.9. Sterigenics U.S.
9.2.10. LLC (GTCR, LLC)
9.2.11. Charles River Laboratories
9.2.12. Medical Device Testing Services
9.2.13. RJR Consulting, Inc.
9.2.14. Mandala International.
9.2.15. Freyr
9.2.16. Global Regulatory Partners
9.2.17. PAREXEL International Corporation (EQT Private Equity and Goldman Sachs Asset Management)
9.2.18. Emergo (UL LLC)
9.2.19. Bioteknica
9.2.20. Accell Clinical Research, LLC
9.2.21. Genpact.; Criterium, Inc.
9.2.22. Promedica International
9.2.23. Med pace
9.2.24. ICON plc.
9.2.25. IQVIA Inc.
9.2.26. Integer Holdings Corporation
9.2.27. Tecomet Inc. (Charlesbank Capital Partners, LLC)
9.2.28. Jabil Inc.
9.2.29. FLEX LTD.
9.2.30. Celestica Inc.
9.2.31. Sanmina Corporation.
9.2.32. Plexus Corp.
9.2.33. Phillips Medisize (Molex, LLC)
9.2.34. Cantel Medical Corp. (STERIS plc)
9.2.35. West Pharmaceutical Services, Inc.
9.2.36. Other Prominent Players

Segmentation of Medical Device Outsourcing Market-

Medical Device Outsourcing Market By Service-

  • Quality Assurance
  • Regulatory Affairs 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

Medical Device Outsourcing Market

Medical Device Outsourcing Market By Class Type-

  • Class I
  • Class II
  • Class III

Medical Device Outsourcing Market By Application

  • Cardiology
  • Diagnostic imaging
  • Orthopedic
  • IVD
  • Ophthalmic
  • General and plastic surgery
  • Drug delivery
  • Dental
  • Endoscopy
  • Diabetes care
  • Others

Medical Device Outsourcing Market By Region-

North America-

  • The US
  • Canada
  • Mexico

Europe-

  • Germany
  • The UK
  • France
  • Italy
  • Spain
  • Rest of Europe

Asia-Pacific-

  • China
  • Japan
  • India
  • South Korea
  • Southeast Asia
  • Rest of Asia Pacific

Latin America-

  • Brazil
  • Argentina
  • Rest of Latin America

 Middle East & Africa-

  • GCC Countries
  • South Africa
  • Rest of the Middle East and Africa

InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.

Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.

Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.

Secondary research

The secondary research sources that are typically mentioned to include, but are not limited to:

  • Company websites, financial reports, annual reports, investor presentations, broker reports, and SEC filings.
  • External and internal proprietary databases, regulatory databases, and relevant patent analysis
  • Statistical databases, National government documents, and market reports
  • Press releases, news articles, and webcasts specific to the companies operating in the market

The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista

Primary Research:

Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies

The contributors who typically take part in such a course include, but are not limited to: 

  • Industry participants: CEOs, CBO, CMO, VPs, marketing/ type managers, corporate strategy managers, and national sales managers, technical personnel, purchasing managers, resellers, and distributors.
  • Outside experts: Valuation experts, Investment bankers, research analysts specializing in specific markets
  • Key opinion leaders (KOLs) specializing in unique areas corresponding to various industry verticals
  • End-users: Vary mainly depending upon the market

Data Modeling and Analysis:

In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.

The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.

To know more about the research methodology used for this study, kindly contact us/click here.

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Frequently Asked Questions

How big is the Medical Device Outsourcing Market?

Medical Device Outsourcing Market expected to grow at a 11.68% CAGR during the forecast period for 2023-2031

SGS SA; Laboratory Corporation of America Holdings; Euro fins Scientific; Pace Analytical Services, Inc.; Intertek Group plc; WuXiAppTec; North Americ

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