by The global medical device outsourcing market size was valued at USD 106.92 billion in 2021, and is predicted to be worth around USD 291.93 billion by 2030, registering a CAGR of 11.1% during the forecast period 2022 to 2030.
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Table of Contents
Medical Device Outsourcing Market Growth Factors
The rising demand for advanced medical products and a growing trend of offshoring are fueling the growth of this market. Various initiatives by public organizations promoting testing for COVID-19 are also enhancing market growth. Regulatory bodies are emphasizing the quality of the healthcare devices provided to the public that is becoming burdensome to handle. To meet the regulatory scenario, various services like regulatory consulting are being utilized by the industry players.
Increasing demand for medical devices combined with the rising price competition and requirement to reduce the cost is expected to drive the market during the forecast period. In addition, growing difficulties in product engineering along with the increasing number of new entrants are anticipated to shape the future of the market. The COVID-19 pandemic had created a significant demand for RT-PCR and COVID-19 antigen test kits for testing. The ongoing pandemic is likely to have a positive impact on the market. The increasing prevalence of chronic disorders is boosting the demand for medical devices.
Medical Device Outsourcing Market Report Coverage
| Report Scope | Details |
| Market Size | US$ 291.93 billion by 2030 |
| Growth Rate | CAGR of 11.1% From 2022 to 2030 |
| Largest Market | Asia Pacific |
| Base Year | 2021 |
| Forecast Period | 2022 to 2030 |
| Segments Covered | Services, Application |
| Regional Scope | North America, Europe, Asia Pacific, Latin America, Middle East & Africa |
| Companies Mentioned | SGS SA; Labcorp; Eurofins Scientific; Pace Analytical Services, Inc.; Intertek Group Plc; WuXi AppTec, Inc.; North American Science Associates, Inc.; TUV SUD AG; American Preclinical Services; Sterigenics International LLC; Charles River Laboratories International, Inc.; Medical Device Testing Services; RJR Consulting, Inc.; Mandala International.; Freyr; Global Regulatory Partners, LLC; Parexel International Corp.; Emergo; Bioteknica; Accell Clinical Research; Genpact Ltd.; Criterium, Inc.; PRA Health Sciences; Promedica International; Medpace Holdings, Inc.; Icon PLC.; Iqvia Holdings Inc.; Integer Holdings Corporation; Tecomet Inc.; Jabil Inc.; Flex Ltd.; Celestica Inc.; Sanmina Corp.; Plexus Corp.; Phillips Medisize; Cantel Medical Corp. and West Pharmaceutical Services, Inc |
By Service Analysis
The contract manufacturing segment led the market and accounted for more than 55.0% share of the global revenue in 2021. It is also projected to maintain its dominant position over the forecast period. Increasing focus on decreasing the cost of production is augmenting the growth of this segment.
Manufacturing high-quality and safe devices for patient care is a major concern of medical device manufacturers.Also, the high level of inspection in developing medical devices has created layers of standards and regulations. Hence, this is creating demand for manufacturing services.
The quality assurance services segment is projected to grow at the fastest CAGR during the forecast period. The maintenance of an effective quality management system is an integral part of the production of everymedical device.
One such quality management system is ISO 13485, which involves the development, implementation, and maintenance of products intended for use by medical device manufacturers and suppliers.
By Application Analysis
The cardiology segment accounted for the maximum share of 20.65% in 2021 and is likely to remain dominant throughout the forecast period. The WHO states that Cardiovascular Diseases (CVDs) are one of the major causes of death worldwide, leading to 17.9 million deaths each year.
High complexity of cardiovascular devices and the need for technical expertise. In addition, manufacturing these devices may also lead to the high cost to the OEMs, which is likely to result in the higher outsourcing of these devices.
General and plastic surgery devices outsourcing is anticipated to exhibit the fastest CAGR from 2022 to 2030. The availability of competent outsourcing firms, which comply with the regulatory requirements, and rising demand for cosmetic surgeries are expected to contribute to the growth of this segment.
By Regional Analysis
On the basis of geographies, the global market has been divided into Asia Pacific, North America, Latin America, and MEA. Asia Pacific region dominated the global market in 2021 with the largest revenue share of 41.52%.
The presence of market players and competitive pricing are other supporting factors that are anticipated to drive this regional market, the increasing demand for medical devices owing to the growing patient population suffering from chronic and infectious diseases is fueling the market growth in this region.
North America is also anticipated to register significant growth over the forecast period. This is owing to the well-established manufacturing hubs for high-end, consistent, and complex medical devices.
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Major Key Players Covered in The Medical Device Outsourcing Market Report include
- SGS SA
- Labcorp
- Eurofins Scientific
- Pace Analytical Services, Inc.
- Intertek Group Plc
- WuXi AppTec, Inc.
- North American Science Associates, Inc.
- TUV SUD AG
- American Preclinical Services
- Sterigenics International LLC
- Charles River Laboratories International, Inc.
- Medical Device Testing Services
- RJR Consulting, Inc.
- Mandala International
- Freyr
- Global Regulatory Partners, LLC
- Parexel International Corp.
- Emergo
- Bioteknica
- Accell Clinical Research
- Genpact Ltd.
- Criterium, Inc.
- PRA Health Sciences
- Promedica International
- Medpace Holdings, Inc.
- Icon PLC.
- Iqvia Holdings Inc.
- Integer Holdings Corp.
- Tecomet Inc.
- Jabil Inc.
- Flex Ltd.
- Celestica Inc.
- Sanmina Corp.
- Plexus Corp.
- Phillips Medisize
- Cantel Medical Corp.
- West Pharmaceutical Services, Inc.
Medical Device Outsourcing Market Market Segmentation
- By Service
- Quality Assurance
- Regulatory Affairs Services
- Clinical Trials Applications & Product Registrations
- Regulatory Writing & 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
- By Application
- Cardiology
- Class I
- Class II
- Class III
- Diagnostic Imaging
- Class I
- Class II
- Class III
- Orthopedic
- Class I
- Class II
- Class III
- IVD
- Class I
- Class II
- Class III
- Ophthalmic
- Class I
- Class II
- Class III
- General and Plastic Surgery
- Class I
- Class II
- Class III
- Drug delivery
- Class I
- Class II
- Class III
- Dental
- Class I
- Class II
- Class III
- Endoscopy
- Class I
- Class II
- Class III
- Diabetes care
- Class I
- Class II
- Class III
- Others
- Class I
- Class II
- Class III
- Cardiology
- Regional
- North America
- U.S.
- Canada
- Europe
- U.K.
- Germany
- France
- Italy
- Spain
- Switzerland
- The Netherlands
- Sweden
- Belgium
- Russia
- Asia Pacific
- Japan
- China
- India
- Australia
- South Korea
- Singapore
- Malaysia
- Thailand
- Taiwan
- Indonesia
- Philippines
- Latin America
- Brazil
- Mexico
- Argentina
- Colombia
- Chile
- Middle East and Africa (MEA)
- South Africa
- Saudi Arabia
- Israel
- UAE
- Egypt
- North America
Research Methodology:
In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.
This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.
Reasons to Purchase this Report:
– Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
– Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
– Market value USD Million and volume Units Million data for each segment and sub-segment
– Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
– Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
Table of Contents
Chapter 1. Introduction
1.1. Research Objective
1.2. Scope of the Study
1.3. Definition
Chapter 2. Research Methodology
2.1. Research Approach
2.2. Data Sources
2.3. Assumptions & Limitations
Chapter 3. Executive Summary
3.1. Market Snapshot
Chapter 4. Market Variables and Scope
4.1. Introduction
4.2. Market Classification and Scope
4.3. Industry Value Chain Analysis
4.3.1. Raw Material Procurement Analysis
4.3.2. Sales and Distribution Channel Analysis
4.3.3. Downstream Buyer Analysis
Chapter 5. Market Dynamics Analysis and Trends
5.1. Market Dynamics
5.1.1. Market Drivers
5.1.2. Market Restraints
5.1.3. Market Opportunities
5.2. Porter’s Five Forces Analysis
5.2.1. Bargaining power of suppliers
5.2.2. Bargaining power of buyers
5.2.3. Threat of substitute
5.2.4. Threat of new entrants
5.2.5. Degree of competition
Chapter 6. Competitive Landscape
6.1.1. Company Market Share/Positioning Analysis
6.1.2. Key Strategies Adopted by Players
6.1.3. Vendor Landscape
6.1.3.1. List of Suppliers
6.1.3.2. List of Buyers
Chapter 7. Global Medical Device Outsourcing Market, By Service
7.1. Medical Device Outsourcing Market, by Service, 2021-2030
7.1.1. Quality Assurance
7.1.1.1. Market Revenue and Forecast (2019-2030)
7.1.2. Regulatory Affairs Services
7.1.2.1. Market Revenue and Forecast (2019-2030)
7.1.3. Product Design and Development Services
7.1.3.1. Market Revenue and Forecast (2019-2030)
7.1.4. Product Testing & Sterilization Services
7.1.4.1. Market Revenue and Forecast (2019-2030)
7.1.5. Product Implementation Services
7.1.5.1. Market Revenue and Forecast (2019-2030)
7.1.6. Product Upgrade Services
7.1.6.1. Market Revenue and Forecast (2019-2030)
7.1.7. Product Maintenance Services
7.1.7.1. Market Revenue and Forecast (2019-2030)
7.1.8. Contract Manufacturing
7.1.8.1. Market Revenue and Forecast (2019-2030)
Chapter 8. Global Medical Device Outsourcing Market, By Application
8.1. Medical Device Outsourcing Market, by Application, 2021-2030
8.1.1. Cardiology
8.1.1.1. Market Revenue and Forecast (2019-2030)
8.1.2. Diagnostic Imaging
8.1.2.1. Market Revenue and Forecast (2019-2030)
8.1.3. Orthopedic
8.1.3.1. Market Revenue and Forecast (2019-2030)
8.1.4. IVD
8.1.4.1. Market Revenue and Forecast (2019-2030)
8.1.5. Ophthalmic
8.1.5.1. Market Revenue and Forecast (2019-2030)
8.1.6. General and Plastic Surgery
8.1.6.1. Market Revenue and Forecast (2019-2030)
8.1.7. Drug delivery
8.1.7.1. Market Revenue and Forecast (2019-2030)
8.1.8. Dental
8.1.8.1. Market Revenue and Forecast (2019-2030)
8.1.9. Endoscopy
8.1.9.1. Market Revenue and Forecast (2019-2030)
8.1.10. Diabetes care
8.1.10.1. Market Revenue and Forecast (2019-2030)
Chapter 9. Global Medical Device Outsourcing Market, Regional Estimates and Trend Forecast
9.1. North America
9.1.1. Market Revenue and Forecast, by Service (2019-2030)
9.1.2. Market Revenue and Forecast, by Application (2019-2030)
9.1.3. U.S.
9.1.3.1. Market Revenue and Forecast, by Service (2019-2030)
9.1.3.2. Market Revenue and Forecast, by Application (2019-2030)
9.1.4. Rest of North America
9.1.4.1. Market Revenue and Forecast, by Service (2019-2030)
9.1.4.2. Market Revenue and Forecast, by Application (2019-2030)
9.2. Europe
9.2.1. Market Revenue and Forecast, by Service (2019-2030)
9.2.2. Market Revenue and Forecast, by Application (2019-2030)
9.2.3. UK
9.2.3.1. Market Revenue and Forecast, by Service (2019-2030)
9.2.3.2. Market Revenue and Forecast, by Application (2019-2030)
9.2.4. Germany
9.2.4.1. Market Revenue and Forecast, by Service (2019-2030)
9.2.4.2. Market Revenue and Forecast, by Application (2019-2030)
9.2.5. France
9.2.5.1. Market Revenue and Forecast, by Service (2019-2030)
9.2.5.2. Market Revenue and Forecast, by Application (2019-2030)
9.2.6. Rest of Europe
9.2.6.1. Market Revenue and Forecast, by Service (2019-2030)
9.2.6.2. Market Revenue and Forecast, by Application (2019-2030)
9.3. APAC
9.3.1. Market Revenue and Forecast, by Service (2019-2030)
9.3.2. Market Revenue and Forecast, by Application (2019-2030)
9.3.3. India
9.3.3.1. Market Revenue and Forecast, by Service (2019-2030)
9.3.3.2. Market Revenue and Forecast, by Application (2019-2030)
9.3.4. China
9.3.4.1. Market Revenue and Forecast, by Service (2019-2030)
9.3.4.2. Market Revenue and Forecast, by Application (2019-2030)
9.3.5. Japan
9.3.5.1. Market Revenue and Forecast, by Service (2019-2030)
9.3.5.2. Market Revenue and Forecast, by Application (2019-2030)
9.3.6. Rest of APAC
9.3.6.1. Market Revenue and Forecast, by Service (2019-2030)
9.3.6.2. Market Revenue and Forecast, by Application (2019-2030)
9.4. MEA
9.4.1. Market Revenue and Forecast, by Service (2019-2030)
9.4.2. Market Revenue and Forecast, by Application (2019-2030)
9.4.3. GCC
9.4.3.1. Market Revenue and Forecast, by Service (2019-2030)
9.4.3.2. Market Revenue and Forecast, by Application (2019-2030)
9.4.4. North Africa
9.4.4.1. Market Revenue and Forecast, by Service (2019-2030)
9.4.4.2. Market Revenue and Forecast, by Application (2019-2030)
9.4.5. South Africa
9.4.5.1. Market Revenue and Forecast, by Service (2019-2030)
9.4.5.2. Market Revenue and Forecast, by Application (2019-2030)
9.4.6. Rest of MEA
9.4.6.1. Market Revenue and Forecast, by Service (2019-2030)
9.4.6.2. Market Revenue and Forecast, by Application (2019-2030)
9.5. Latin America
9.5.1. Market Revenue and Forecast, by Service (2019-2030)
9.5.2. Market Revenue and Forecast, by Application (2019-2030)
9.5.3. Brazil
9.5.3.1. Market Revenue and Forecast, by Service (2019-2030)
9.5.3.2. Market Revenue and Forecast, by Application (2019-2030)
9.5.4. Rest of LATAM
9.5.4.1. Market Revenue and Forecast, by Service (2019-2030)
9.5.4.2. Market Revenue and Forecast, by Application (2019-2030)
Chapter 10. Company Profiles
10.1. SGS SA
10.1.1. Company Overview
10.1.2. Service Offerings
10.1.3. Financial Performance
10.1.4. Recent Initiatives
10.2. Labcorp
10.2.1. Company Overview
10.2.2. Service Offerings
10.2.3. Financial Performance
10.2.4. Recent Initiatives
10.3. Eurofins Scientific
10.3.1. Company Overview
10.3.2. Service Offerings
10.3.3. Financial Performance
10.3.4. Recent Initiatives
10.4. Pace Analytical Services, Inc.
10.4.1. Company Overview
10.4.2. Service Offerings
10.4.3. Financial Performance
10.4.4. Recent Initiatives
10.5. Intertek Group Plc
10.5.1. Company Overview
10.5.2. Service Offerings
10.5.3. Financial Performance
10.5.4. Recent Initiatives
10.6. WuXi AppTec, Inc.
10.6.1. Company Overview
10.6.2. Service Offerings
10.6.3. Financial Performance
10.6.4. Recent Initiatives
10.7. North American Science Associates, Inc.
10.7.1. Company Overview
10.7.2. Service Offerings
10.7.3. Financial Performance
10.7.4. Recent Initiatives
10.8. TUV SUD AG
10.8.1. Company Overview
10.8.2. Service Offerings
10.8.3. Financial Performance
10.8.4. Recent Initiatives
10.9. American Preclinical Services
10.9.1. Company Overview
10.9.2. Service Offerings
10.9.3. Financial Performance
10.9.4. Recent Initiatives
10.10. Sterigenics International LLC
10.10.1. Company Overview
10.10.2. Service Offerings
10.10.3. Financial Performance
10.10.4. Recent Initiatives
Chapter 11. Research Methodology
11.1. Primary Research
11.2. Secondary Research
11.3. Assumptions
Chapter 12. Appendix
12.1. About Us
Glossary of Terms
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