The global medical device outsourcing market size was valued at USD 104.5 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 10.4% from 2020 to 2027. Various factors such as the globalization of large and small medical device manufacturers 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 that 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 an increasing demand for medical devices due to the 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 the U.S. This is attributed to the 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.
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 the 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.
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 the 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 the fastest CAGR throughout the forecast period.
Asia Pacific dominated the market for medical device outsourcing in 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 the future. Owing to the increasing prevalence of chronic diseases the demand for medical device outsourcing is also rising. This factor is fueling the regional market growth over the forecast period. Whereas, North America accounted for sizeable market share in 2019 due to the technologically advanced electronic sector.
Key parameters affecting the competitive nature of the market for medical device outsourcing are the 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. Some of the prominent players in the medical device outsourcing market include:
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.
Report Attribute |
Details |
Market size value in 2020 |
USD 115.9 billion |
Revenue forecast in 2027 |
USD 231.2 billion |
Growth Rate |
CAGR of 10.4% from 2020 to 2027 |
Base year for estimation |
2019 |
Historical data |
2016 - 2018 |
Forecast period |
2020 - 2027 |
Quantitative units |
Revenue in USD million and CAGR from 2020 to 2027 |
Report coverage |
Revenue forecast, company share, competitive landscape, growth factors and trends |
Segments covered |
Service, application, region |
Regional scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
Country scope |
U.S.; Canada; U.K.; Germany; France; Italy; Spain; Netherlands; Belgium; Switzerland; Russia; Sweden; China; India; Japan; Australia; South Korea; Malaysia; Indonesia; Singapore; Philippines; Thailand; Mexico; Brazil; Argentina; Colombia; Chile; South Africa; Saudi Arabia; UAE; Israel; Egypt |
Key companies profiled |
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. |
Customization scope |
Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
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
The U.S.
Canada
Europe
The 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
b. The global medical device outsourcing market size was estimated at USD 104.4 billion in 2019 and is expected to reach USD 115.9 billion in 2020.
b. The global medical device outsourcing market is expected to grow at a compound annual growth rate of 10.4% from 2020 to 2027 to reach USD 231.2 billion by 2027.
b. The Asia Pacific dominated the medical device outsourcing market with a share of 41.2% in 2019. This is attributable to increasing R&D in this region, increasing the adoption of new technology in medical devices, increasing availability of skilled human resources, and lower cost of devices.
b. Some of the players operating in the medical device outsourcing 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.
b. Key factors that are driving the market growth include changing regulatory landscape, increase in offshoring medical device manufacturing to emerging countries, and rising demand for advanced products.
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With Covid-19 infections rising globally, the apprehension regarding a shortage of essential life-saving devices and other essential medical supplies in order to prevent the spread of this pandemic and provide optimum care to the infected also widens. In addition, till a pharmacological treatment is developed, ventilators act as a vital treatment preference for the COVID-19 patients, who may require critical care. Moreover, there is an urgent need for a rapid acceleration in the manufacturing process for a wide range of test-kits (antibody tests, self-administered, and others). The report will account for Covid19 as a key market contributor.