Medical Device Outsourcing Market Report

Medical Device Outsourcing Market Analysis Report By Services (Quality Assurance, Contract Manufacturing), By Therapeutic Area (Cardiology, General & Plastic Surgery), And Segment Forecasts, 2018 - 2025

  • Published Date: Aug, 2018
  • Base Year for Estimate: 2017
  • Report ID: 978-1-68038-279-2
  • Format: Electronic (PDF)
  • Historical Data: 2014 - 2016
  • Number of Pages: 240

Industry Insights

The global medical device outsourcing market size was valued at USD 84.9 billion in 2017. It is expected to witness a CAGR of 10.9% over the forecast period. Rising competition among manufacturers is leading to development of products at lower cost. This is positively influencing the growth of the market. Changing regulatory landscape and growing inclination towards outsourcing services such as regulatory consulting, quality assurance, and product implementation are also anticipated to augment the market during the forecast period.

Furthermore, growing complexities in product engineering coupled with increasing number of new entrants are estimated to shape the future of the market. Rising prevalence of chronic disorders is escalating the demand for medical devices. This, in turn, is working in favor of the market. 

U.S. medical device outsourcing market

Growing geriatric population is also boosting the demand for medical devices. This demographic forms a large customer base with limited health resources, thereby pushing manufacturers towards subcontracting of activities such as assembling, packaging, and others. For instance, new entrants in the medical device industry are anticipated to outsource device designing in order to be technologically updated and meet demands of patients.

Apart from this, growing emphasis by regulatory bodies to maintain quality of healthcare devices provided to public is gradually becoming cumbersome to handle. In order to meet the regulatory scenario, services such as regulatory consulting are being availed by industry players. For instance, the European Medical Device Regulation (EMDR) undertake special unannounced scrutiny of outsourced products to check for quality and conformity with standards..

Service Insights

Medical device outsourcing encompasses several services, including quality assurance, regulatory consulting, product design and development, product testing and sterilization, product implementation, product upgrade, product maintenance, and contract manufacturing. Regulatory consulting services are likely to witness significant increase in demand over the forecast period owing to rising awareness regarding timely filing and auditing of regulatory documents.

The contract manufacturing segment is expected to dominate the market until 2025. It held more than 55.0% in the market in 2017. Growing focus on reducing the cost of production is supplementing the growth of the segment. On the other hand, quality assurance services are poised to be the fastest growing segment, exhibiting a CAGR of 13.5% during the forecast period.

Therapeutic Area Insights

Based on therapeutic area, the global medical device outsourcing market can be segmented into cardiology, diagnostic imaging, in - vitro diagnostic (IVD), orthopedic, dental, drug delivery, general and plastic surgery, endoscopy, ophthalmic, and diabetes care. The cardiology segment is likely to dominate the market throughout the forecast horizon due to increasing incidence of associated conditions.

General & plastic surgery is projected to be the most promising segment during the same period. Rising number of injuries to bones, joints, and tissues and spiraling cases of chronic conditions requiring surgery as a part of the treatment are some of the key factors stimulating the growth of the segment.

Regional Insights

Asia Pacific dominated the global market in 2017 and accounted for approximately 41.0% of the overall market revenue. A large number of global players prefer outsourcing their products to the region, owing to low labor cost and improving R&D and manufacturing set up. Besides this, surging demand for medical devices due to widening base of patients suffering from chronic diseases is supporting the growth of the regional market.

Global medical device outsourcing market

North America is also anticipated to represent a sizeable share in the market in 2018. This is attributed to presence of strong manufacturing hubs for reliable, complex, and high - end medical devices. In addition, presence of highly developed electronic sector is helping North America edge over other regions.

Medical Device Outsourcing Market Share Insights

Some of the key players operating in the 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

Numerous companies are poised to enter the market over the forecast period owing to rising demand for medical devices across the globe. This is estimated to boost the level of competition in the global arena.

Furthermore, collaborations between existing players and niche service offerings to enhance quality and competency are likely to increase over the forecast period. Established players of the market are anticipated to widen their portfolio and provide one - stop shop options to sustain aggressive competition over the forecast period. In July 2017, ICON Plc, a leading CRO, acquired Mapi Group to strengthen its commercialization presence and strategic regulatory expertise. The acquisition is projected to help Mapi Group expand its global footprints and increase its service portfolio for life science companies

Report Scope



Base year for estimation


Actual estimates/Historical data

2014 - 2016

Forecast period

2018 - 2025

Market representation

Revenue in USD Million & CAGR from 2018 to 2025

Regional scope

North America, Europe, Asia Pacific, Latin America, MEA

Report coverage      

Revenue forecast, company share, competitive landscape, growth factors, and trends

Country Scope

U.S., Canada, U.K., Germany, Sweden, France, Italy, Russia, Netherlands, Spain, Japan, China, India, Australia, Singapore, Thailand , Taiwan, Indonesia, Korea, Malaysia, Brazil, Mexico, Argentine, South Africa, Saudi Arabia, Israel & U.A.E.

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Segments Covered in the Report

This report forecasts revenue growth at global, regional & country levels and provides an analysis of the industry trends in each of the sub - segments from 2014 to 2025.For the purpose of this study, Grand View Research, Inc. has segmented the global medical device outsourcing market report on the basis of service, therapeutic area, and region:

  • Service Outlook (Revenue, USD Million, 2014 - 2025)

    • 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

  • Therapeutic Area Outlook (Revenue, USD Million, 2014 - 2025)

    • 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

  • Regional Outlook (Revenue, USD Million, 2014 - 2025)

    • North America

      • U.S.

      • Canada

    • Europe

      • France

      • Germany

      • U.K.

      • Italy

      • Spain

      • Netherlands

      • Switzerland

      • Sweden

    • Asia Pacific

      • Japan

      • China

      • India

      • Indonesia

      • Malaysia

      • Singapore

      • Korea

      • Thailand

      • Taiwan

      • Australia

    • Latin America

      • Brazil

      • Mexico

      • Argentina

      • Colombia

    • Middle East and Africa (MEA)

      • South Africa

      • Saudi Arabia

      • UAE

      • Israel

Key questions answered by the report
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