Medical Device Outsourcing Market Size is valued at 145.12 billion in 2024 and is predicted to reach 439.36 billion by the year 2034 at a 11.8% CAGR during the forecast period for 2025-2034
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.
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.
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.
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 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.
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.
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Report Attribute |
Specifications |
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Market size value in 2024 |
USD 145.12 Bn |
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Revenue forecast in 2034 |
USD 439.36 Bn |
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Growth rate CAGR |
CAGR of 11.8% from 2025 to 2034 |
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Quantitative units |
Representation of revenue in US$ Billion, and CAGR from 2025 to 2034 |
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Historic Year |
2021 to 2024 |
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Forecast Year |
2025-2034 |
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Report coverage |
The forecast of revenue, the position of the company, the competitive market statistics, growth prospects, and trends |
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Segments covered |
Service Outlook, Type, And Application |
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Regional scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; The UK; France; Italy; Spain; South Korea; Southeast Asia |
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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. |
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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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Pricing and available payment methods |
Explore pricing alternatives that are customized to your particular study requirements. |
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, 2024 & 2034
5.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2021 to 2034 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, 2024 & 2034
6.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2021 to 2034 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, 2024 & 2034
7.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2021 to 2034 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, 2021-2034
8.1.2. North America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2021-2034
8.1.3. North America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
8.1.4. North America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
8.2. Europe
8.2.1. Europe Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2021-2034
8.2.2. Europe Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2021-2034
8.2.3. Europe Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
8.2.4. Europe Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
8.3. Asia Pacific
8.3.1. Asia Pacific Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2021-2034
8.3.2. Asia Pacific Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2021-2034
8.3.3. Asia-Pacific Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
8.3.4. Asia Pacific Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
8.4. Latin America
8.4.1. Latin America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2021-2034
8.4.2. Latin America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2021-2034
8.4.3. Latin America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
8.4.4. Latin America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
8.5. Middle East & Africa
8.5.1. Middle East & Africa Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2021-2034
8.5.2. Middle East & Africa Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2021-2034
8.5.3. Middle East & Africa Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
8.5.4. Middle East & Africa Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
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
Medical Device Outsourcing Market By Service-
Medical Device Outsourcing Market By Class Type-
Medical Device Outsourcing Market By Application
Medical Device Outsourcing Market By Region-
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & 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:
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:
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.
