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.
| Report Attribute | Specifications |
| Market size value in 2024 | USD 145.12 Bn |
| Revenue forecast in 2034 | USD 439.36 Bn |
| Growth rate CAGR | CAGR of 11.8% from 2025 to 2034 |
| Quantitative units | Representation of revenue in US$ Billion, and CAGR from 2025 to 2034 |
| Historic Year | 2021 to 2024 |
| Forecast Year | 2025-2034 |
| 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; 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. |
| Pricing and available payment methods | Explore pricing alternatives that are customized to your particular study requirements. |
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-
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