The global medical device outsourcing market size in terms of revenue is expected to reach USD 193.6 billion in 2025. The global medical device outsourcing market is expected to experience a CAGR of 10.7% during the forecast period. Growing demand for medical devices tied with growing trend of off-shoring is expected to drive the market during the forecast period.
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Rising geriatric population is also influencing the demand for medical devices. This demographic shapes a large customer base with limited health resource, thereby approaching manufacturers towards subcontracting of activities such as packaging, assembling, and many others. For instance, new entrants in the medical device industry are likely to outsource device designing in order to be technologically updated and meet demands of patients.
Growing competition among medical device manufacturers is the primary reason to making of products at lower and reasonable cost. This factor is positively impacting the growth of global medical device outsourcing market. Continuous change in regulatory landscape and growing awareness and inclination towards outsourcing services such as quality assurance, product implementation, and regulatory consulting are also expected to augment the global medical device outsourcing market during the forecast period.
Moreover, increasing complexities in the product manufacturing coupled with growing number of new entrants globally are expected to outline the future of the global medical device outsourcing market. Increasing occurrence of chronic disorders among the global population is raising the demand for medical devices. This factor, in turn, is working in favour of the market.
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Additionally, growing importance by regulatory bodies to maintain quality of healthcare devices offered to public is increasingly becoming cumbersome to handle. In order to carter the regulatory situation, regulatory consulting services are being availed by industry players. For instance, the European Medical Device Regulation (EMDR) undertakes special unannounced scrutiny of outsourced products in order to check for quality and conformity with standards.
However, some major regulatory changes are expected to occur across the globe, which is expected to have an impact on the medical device outsourcing market over the forecast period.
Few major changes in regulations are:
• Alteration in ISO certification related to medical device
• Adoption of medical device single audit program
Many other regulatory reforms including the above are expected to add to the demand for outsourcing services, thereby offering a tremendous drive to the market during the forecast period. In order to gain substantial share in the specific market segment large CROs are collaborating with specialized service providers.
The global medical outsourcing market is segmented into service, therapeutic area, and regions. On the basis of service the global medical outsourcing market is segmented into Product Implementation Services, Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Product Testing & Sterilization Services, Product Upgrade Services, Product Maintenance Services, and Contract Manufacturing. Regulatory Affairs Services is further sub-segmented into Clinical trials applications and product registrations, Regulatory writing and publishing, Legal representation, and others.
Product Design and Development Services segment is further sub-segmented among Designing & engineering, Machining, Molding, and packaging. Contract Manufacturing segment is further sub-segmented into Accessories manufacturing, Assembly manufacturing, Component manufacturing and Device manufacturing. On the basis of Therapeutic Area, the global medical device outsourcing market is segmented into cardiology, Diagnostic imaging, Orthopedic, IVD, Ophthalmic, General and plastic surgery, Drug delivery, Dental, Endoscopy, Diabetes care and others. Each of the Therapeutic Area segment is further sub-segmented into class I, class II and class III. On the basis of region the global medical device outsourcing market is segmented into Latin America, Europe, Asia Pacific, North America, and Middle East & Africa.
The global contract manufacturing market is expected to reach 103.9 billion by 2025, expanding at a CAGR of 10.3% from 2018 to 2025. In terms of service, quality assurance is expected to grow the fastest during the forecast period. Asia Pacific medical device outsourcing market is expected to dominate during the forecast period. North America and Europe constituted considerable cumulative share in 2016 attributable to well established manufacturing infrastructure for expensive and complex medical devices.
The key players catering to the global medical device outsourcing market are Integer; Tecomet; Jabil; Flextronics; Celestica; Sanmina; Plexus; SGS SA; Toxikon Inc.; Eurofins Scientific; Pace Analytical Services; Intertek Group; MAPI; PPD; Freyr Solutions; and Wuxi Apptec. The global players are continuously investing in R&D activities and innovating to have updated technology based product portfolio to attract more and more business opportunity from the emerging nation such as that in Asia Pacific countries.
Table Of Contents:
CHAPTER 1. INDUSTRY OVERVIEW
1.1. Definition and Scope
1.1.1. Definition of Medical Device Outsourcing
1.1.2. Market Segmentation
1.1.3. List of Abbreviations
1.2. Summary
1.2.1. Market Snapshot
1.2.2. Medical Device Outsourcing Market By Services
1.2.2.1. Global Medical Device Outsourcing Market Revenue and Growth Rate Comparison By Services (2015-2026)
1.2.2.2. Global Medical Device Outsourcing Market Revenue Share By Services in 2017
1.2.2.3. Quality Assurance
1.2.2.4. Regulatory Affairs Services
1.2.2.5. Product Design and Development Services
1.2.2.6. Product Testing & Sterilization Services
1.2.2.7. Product Implementation Services
1.2.2.8. Product Upgrade Services
1.2.2.9. Product Maintenance Services
1.2.2.10. Contract Manufacturing
1.2.2.11. Others
1.2.3. Medical Device Outsourcing Market By Therapeutic Area
1.2.3.1. Global Medical Device Outsourcing Market Revenue and Growth Rate Comparison By Therapeutic Area (2015-2026)
1.2.3.2. Global Medical Device Outsourcing Market Revenue Share By Therapeutic Area in 2017
1.2.3.3. Cardiology
1.2.3.4. Diagnostic imaging
1.2.3.5. Orthopedic
1.2.3.6. IVD
1.2.3.7. Ophthalmic
1.2.3.8. General and plastic surgery
1.2.3.9. Drug delivery
1.2.3.10. Dental
1.2.3.11. Endoscopy
1.2.3.12. Diabetes care
1.2.3.13. Others
1.2.4. Medical Device Outsourcing Market by Geography
1.2.4.1. Global Medical Device Outsourcing Market Revenue and Growth Rate Comparison by Geography (2015-2026)
1.2.4.2. North America Medical Device Outsourcing Market Revenue and Growth Rate (2015-2026)
1.2.4.3. Europe Medical Device Outsourcing Market Revenue and Growth Rate (2015-2026)
1.2.4.4. Asia-Pacific Medical Device Outsourcing Market Revenue and Growth Rate (2015-2026)
1.2.4.5. Latin America Medical Device Outsourcing Market Revenue and Growth Rate (2015-2026)
1.2.4.6. Middle East and Africa (MEA) Medical Device Outsourcing Market Revenue and Growth Rate (2015-2026)
CHAPTER 2. MARKET DYNAMICS AND COMPETITION ANALYSIS
2.1. Market Drivers
2.2. Restraints and Challenges
2.3. Growth Opportunities
2.4. Porter’s Five Forces Analysis
2.4.1. Bargaining Power of Suppliers
2.4.2. Bargaining Power of Buyers
2.4.3. Threat of Substitute
2.4.4. Threat of New Entrants
2.4.5. Degree of Competition
2.5. Value Chain Analysis
2.6. Cost Structure Analysis
2.6.1. Raw Material and Suppliers
2.6.2. Manufacturing Process Analysis
2.7. Regulatory Compliance
2.8. Competitive Landscape, 2017
2.8.1. Player Positioning Analysis
2.8.2. Key Strategies Adopted By Leading Players
CHAPTER 3. MANUFACTURING PLANTS ANALYSIS
3.1. Capacity and Commercial Production Date of Global Medical Device Outsourcing Major Manufacturers in 2017
3.2. Manufacturing Plants Distribution of Global Medical Device Outsourcing Major Manufacturers in 2017
3.3. R&D Status and Technology Source of Global Medical Device Outsourcing Major Manufacturers in 2017
3.4. Raw Materials Sources Analysis of Global Medical Device Outsourcing Major Manufacturers in 2017
CHAPTER 4. MEDICAL DEVICE OUTSOURCING MARKET BY SERVICES
4.1. Global Medical Device Outsourcing Revenue By Services
4.2. Quality Assurance
4.2.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
4.2.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
4.3. Regulatory Affairs Services
4.3.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
4.3.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
4.4. Product Design and Development Services
4.4.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
4.4.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
4.5. Product Testing & Sterilization Services
4.5.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
4.5.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
4.6. Product Implementation Services
4.6.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
4.6.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
4.7. Product Upgrade Services
4.7.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
4.7.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
4.8. Product Maintenance Services
4.8.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
4.8.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
4.9. Contract Manufacturing
4.9.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
4.9.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
4.10. Others
4.10.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
4.10.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
CHAPTER 5. MEDICAL DEVICE OUTSOURCING MARKET BY THERAPEUTIC AREA
5.1. Global Medical Device Outsourcing Revenue By Therapeutic Area
5.2. Cardiology
5.2.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
5.2.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
5.3. Diagnostic imaging
5.3.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
5.3.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
5.4. Orthopedic
5.4.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
5.4.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
5.5. IVD
5.5.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
5.5.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
5.6. Ophthalmic
5.6.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
5.6.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
5.7. General and plastic surgery
5.7.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
5.7.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
5.8. Drug delivery
5.8.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
5.8.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
5.9. Dental
5.9.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
5.9.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
5.10. Endoscopy
5.10.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
5.10.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
5.11. Diabetes care
5.11.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
5.11.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
5.12. Others
5.12.1. Market Revenue and Growth Rate, 2015 – 2026 ($Million)
5.12.2. Market Revenue and Forecast, By Region, 2015 – 2026 ($Million)
CHAPTER 6. NORTH AMERICA MEDICAL DEVICE OUTSOURCING MARKET BY COUNTRY
6.1. North America Medical Device Outsourcing Market Revenue and Growth Rate, 2015 – 2026 ($Million)
6.2. North America Medical Device Outsourcing Market Revenue Share Comparison, 2015 & 2026 (%)
6.3. U.S.
6.3.1. U.S. Medical Device Outsourcing Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
6.3.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
6.4. Canada
6.4.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
6.4.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
6.5. Mexico
6.5.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
6.5.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
CHAPTER 7. EUROPE MEDICAL DEVICE OUTSOURCING MARKET BY COUNTRY
7.1. Europe Medical Device Outsourcing Market Revenue and Growth Rate, 2015 – 2026 ($Million)
7.2. Europe Medical Device Outsourcing Market Revenue Share Comparison, 2015 & 2026 (%)
7.3. UK
7.3.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
7.3.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
7.4. Germany
7.4.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
7.4.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
7.5. France
7.5.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
7.5.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
7.6. Spain
7.6.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
7.6.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
7.7. Rest of Europe
7.7.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
7.7.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
CHAPTER 8. ASIA-PACIFIC MEDICAL DEVICE OUTSOURCING MARKET BY COUNTRY
8.1. Asia-Pacific Medical Device Outsourcing Market Revenue and Growth Rate, 2015 – 2026 ($Million)
8.2. Asia-Pacific Medical Device Outsourcing Market Revenue Share Comparison, 2015 & 2026 (%)
8.3. China
8.3.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
8.3.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
8.4. Japan
8.4.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
8.4.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
8.5. India
8.5.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
8.5.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
8.6. Australia
8.6.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
8.6.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
8.7. South Korea
8.7.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
8.7.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
8.8. Rest of Asia-Pacific
8.8.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
8.8.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
CHAPTER 9. LATIN AMERICA MEDICAL DEVICE OUTSOURCING MARKET BY COUNTRY
9.1. Latin America Medical Device Outsourcing Market Revenue and Growth Rate, 2015 – 2026 ($Million)
9.2. Latin America Medical Device Outsourcing Market Revenue Share Comparison, 2015 & 2026 (%)
9.3. Brazil
9.3.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
9.3.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
9.4. Argentina
9.4.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
9.4.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
9.5. Rest of Latin America
9.5.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
9.5.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
CHAPTER 10. MIDDLE EAST MEDICAL DEVICE OUTSOURCING MARKET BY COUNTRY
10.1. Middle East Medical Device Outsourcing Market Revenue and Growth Rate, 2015 – 2026 ($Million)
10.2. Middle East Medical Device Outsourcing Market Revenue Share Comparison, 2015 & 2026 (%)
10.3. Saudi Arabia
10.3.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
10.3.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
10.4. UAE
10.4.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
10.4.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
10.5. Rest of Middle East
10.5.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
10.5.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
CHAPTER 11. AFRICA MEDICAL DEVICE OUTSOURCING MARKET BY COUNTRY
11.1. Africa Medical Device Outsourcing Market Revenue and Growth Rate, 2015 – 2026 ($Million)
11.2. Africa Medical Device Outsourcing Market Revenue Share Comparison, 2015 & 2026 (%)
11.3. South Africa
11.3.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
11.3.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
11.4. Egypt
11.4.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
11.4.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
11.5. Rest of Africa
11.5.1. Market Revenue and Forecast By Services, 2015 – 2026 ($Million)
11.5.2. Market Revenue and Forecast By Therapeutic Area, 2015 – 2026 ($Million)
CHAPTER 12. COMPANY PROFILE
12.1. Integer
12.1.1. Company Snapshot
12.1.2. Overview
12.1.3. Financial Overview
12.1.4. Product Portfolio
12.1.5. Key Developments
12.1.6. Strategies
12.2. Tecomet
12.2.1. Company Snapshot
12.2.2. Overview
12.2.3. Financial Overview
12.2.4. Product Portfolio
12.2.5. Key Developments
12.2.6. Strategies
12.3. Jabil
12.3.1. Company Snapshot
12.3.2. Overview
12.3.3. Financial Overview
12.3.4. Product Portfolio
12.3.5. Key Developments
12.3.6. Strategies
12.4. Flextronics
12.4.1. Company Snapshot
12.4.2. Overview
12.4.3. Financial Overview
12.4.4. Product Portfolio
12.4.5. Key Developments
12.4.6. Strategies
12.5. Flextronics
12.5.1. Company Snapshot
12.5.2. Overview
12.5.3. Financial Overview
12.5.4. Product Portfolio
12.5.5. Key Developments
12.5.6. Strategies
12.6. Sanmina
12.6.1. Company Snapshot
12.6.2. Overview
12.6.3. Financial Overview
12.6.4. Product Portfolio
12.6.5. Key Developments
12.6.6. Strategies
12.7. Plexus
12.7.1. Company Snapshot
12.7.2. Overview
12.7.3. Financial Overview
12.7.4. Product Portfolio
12.7.5. Key Developments
12.7.6. Strategies
12.8. SGS SA
12.8.1. Company Snapshot
12.8.2. Overview
12.8.3. Financial Overview
12.8.4. Product Portfolio
12.8.5. Key Developments
12.8.6. Strategies
12.9. Toxikon Inc.
12.9.1. Company Snapshot
12.9.2. Overview
12.9.3. Financial Overview
12.9.4. Product Portfolio
12.9.5. Key Developments
12.9.6. Strategies
12.10. Eurofins Scientific
12.10.1. Company Snapshot
12.10.2. Overview
12.10.3. Financial Overview
12.10.4. Product Portfolio
12.10.5. Key Developments
12.10.6. Strategies
12.11. Pace Analytical Services
12.11.1. Company Snapshot
12.11.2. Overview
12.11.3. Financial Overview
12.11.4. Product Portfolio
12.11.5. Key Developments
12.11.6. Strategies
12.12. Intertek Group
12.12.1. Company Snapshot
12.12.2. Overview
12.12.3. Financial Overview
12.12.4. Product Portfolio
12.12.5. Key Developments
12.12.6. Strategies
12.13. MAPI
12.13.1. Company Snapshot
12.13.2. Overview
12.13.3. Financial Overview
12.13.4. Product Portfolio
12.13.5. Key Developments
12.13.6. Strategies
12.14. PPD
12.14.1. Company Snapshot
12.14.2. Overview
12.14.3. Financial Overview
12.14.4. Product Portfolio
12.14.5. Key Developments
12.14.6. Strategies
12.15. Freyr Solutions
12.15.1. Company Snapshot
12.15.2. Overview
12.15.3. Financial Overview
12.15.4. Product Portfolio
12.15.5. Key Developments
12.15.6. Strategies
12.16. Wuxi Apptec
12.16.1. Company Snapshot
12.16.2. Overview
12.16.3. Financial Overview
12.16.4. Product Portfolio
12.16.5. Key Developments
12.16.6. Strategies
12.17. Others
12.17.1. Company Snapshot
12.17.2. Overview
12.17.3. Financial Overview
12.17.4. Product Portfolio
12.17.5. Key Developments
12.17.6. Strategies
CHAPTER 13. RESEARCH APPROACH
13.1. Research Methodology
13.1.1. Initial Data Search
13.1.2. Secondary Research
13.1.3. Primary Research
13.2. Assumptions and Scope
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