Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Service (Quality Assurance, Regulatory Affairs Services), By Application (Cardiology, Diagnostic Imaging, Orthopedic), By Region, And Segment Forecasts, 2020 - 2027

Industry Insights

The global medical device outsourcing market size was estimated at 104.5 billion in 2019 and is anticipated to expand at a CAGR of 10.4 % over the forecast period. Various factors such as globalization of large and small medical device manufactures along with increasing complexity of medical devices are expected to fuel market growth during the review period. Due to increasing spending on contract research organization (CRO) services the market for medical device outsourcing is expected to increase during the forecast period. In addition, rising prevalence of chronic diseases is increasing demand for medical devices worldwide.

Implantable medical devices are electronic devices which are implanted within the body to monitor the patients’ medical condition. These are most widely used nowadays in order to improve the medical outcome of patients. As there is increasing demand for medical devices due to rising prevalence of chronic diseases, hence various companies are shifting their focus on research and development and outsourcing of medical devices.

Changes in ISO standards are likely to drive demand for regulatory affairs and quality assurance service providers in U.S. This is attributed to growing requirement of third-party assistance among small medium enterprises (SMEs) to comply with new ISO standards. Original equipment manufacturers (OEMs) and subcontractors in developed countries such as Canada, Japan, U.S., and European Union (EU) countries are anticipated to adopt new ISO standards, thereby driving the market for medical device outsourcing.

Apart from this, recent regulatory changes in Europe relating to quality and outsourcing of medical devices are also anticipated to increase the demand for regulatory affairs, and quality assurance services, thus contributing to the regional market growth. For instance, the application of in vitro diagnostic regulation (IVDR) and medical devices regulation (MDR) is projected to increase the demand for quality management system (QMS) service providers. This, in turn, is supplementing the growth of the market for medical device outsourcing.

Application Insights

On the basis of application, the market for medical device outsourcing is segmented into cardiology, diagnostic imaging, orthopedic, IVD, ophthalmic, general and plastic surgery, drug delivery, dental, endoscopy, diabetes care, and others. Cardiology is estimated to be the fastest growing segment over the forecast period.

Due to the rising incidence of chronic diseases the demand for medical device outsourcing is expected to increase in future. This segment led the market for medical device outsourcing in 2019 and is likely to remain dominant throughout the forecast period owing to the growing prevalence of associated conditions. The IVD segment is also expected to grow significantly over the forecast period.

Service Insights

Based on service, the medical device outsourcing market is categorized into quality assurance, regulatory affairs services, product design and development services, product testing and sterilization services, product implementation services, product upgrade services, product maintenance services, and contract manufacturing.

Contract manufacturing holds the largest market share of 55.8 % in 2019 and is expected to dominate the market for medical device outsourcing over forecast period. Whereas increasing focus on reducing the cost of medical devices is boosting segment growth. Alternatively, the quality assurance service segment is anticipated to register fastest CAGR throughout the forecast period.

Regional Insights

Asia Pacific dominated the market for medical device outsourcingin 2019 and is expected to remain dominant throughout the forecast period. This can be attributed to increasing R&D in this region, and increasing adoption of new technology in medical devices. Increasing availability of skilled human resources and lower cost of devices are also anticipated to drive the market for medical device outsourcing in future. Owing to increasing prevalence of chronic diseases the demand for medical device outsourcing is also rising. This factor is fueling the regional market growth over forecast period.  Whereas, North America accounted for sizeable market share in 2019 due to technologically advanced electronic sector.

Medical Device Outsourcing Market Share Insights

The market for medical device outsourcing is highly competitive. Some of the players operating in the market are SGS SA; Toxikon, INC.; Eurofins Scientific; Pace Analytical Services LLC.; Intertek Group PLC; Wuxi Apptec; North American Science Associates, Inc.; Tüv Süd AG; American Preclinical Services; Sterigenics International LLC; Charles River Laboratories International, Inc.; Medical Device Testing Services; RJR Consulting, INC.; Mandala International.; Mapi Group; Freyr; Global Regulatory Partners-LLC; Parexel International Corporation; Emergo; Bioteknica; Accell Clinical Research; Genpact LTD.; Criterium, INC.; PRA Health Sciences; Promedica International; Medpace; ICON PLC.; Quintilesims; Covance, Inc.; Integer Holdings Corporation; Tecomet Inc.; JABIL INC.; FLEX LTD.; Celestica Inc.; Sanmina Corporation.; Plexus Corp.; Phillips Medisize; Cantel Medical Corp.; and West Pharmaceutical Services, Inc.

Key parameters affecting the competitive nature of the market for medical device outsourcingare rapid adoption of advanced healthcare technology for improved healthcare. Also, in order to retain market share and diversify the product portfolio, major players are often undertaking mergers and acquisitions along with new product launches.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global medical device outsourcing market report on the basis of service, application, and region:

• Service Outlook (Revenue, USD Million, 2016 - 2027)

  • 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

• Application Outlook (Revenue, USD Million, 2016 - 2027)

  • 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, 2016 - 2027)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Spain

    • Italy

    • Netherlands

    • Belgium

    • Switzerland

    • Russia

    • Sweden

  • Asia Pacific

    • India

    • Japan

    • China

    • Australia

    • South Korea

    • Malaysia

    • Indonesia

    • Singapore

    • Philippines

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Israel

    • Egypt