GVR Report cover Medical Device Outsourcing Market Size, Share & Trends Report

Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Service (Quality Assurance, Contract Manufacturing), By Application (Cardiology, General & Plastic Surgery), And Segment Forecasts, 2021 - 2028

  • Published Date: Feb, 2021
  • Base Year for Estimate: 2020
  • Report ID: 978-1-68038-279-2
  • Format: Electronic (PDF)
  • Historical Data: 2016 - 2019
  • Number of Pages: 240

Report Overview

The global medical device outsourcing market size was valued at USD 99.9 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 11.2% over the forecast period. Increasing demand for medical devices combined with rising price competition is expected to drive the market during the forecast period. In addition, growing difficulties in product engineering along with the rising number of new entrants are anticipated to shape the future of the market. The increasing prevalence of chronic disorders is boosting the demand for medical devices. This, in turn, is working in favor of the market. Implantable Medical Devices (IMDs) are widely used to improve patients’ medical outcomes. Designers of IMDs have to balance complexity, reliability, power consumption, and costs.

The U.S. medical device outsourcing market size, by service, 2016 - 2028 (USD Billion)

As a result, companies are shifting their focus from non-core activities to innovation, therefore outsourcing these activities to launch efficient devices. Amendments in the ISO standards are expected to boost the demand for quality assurance and regulatory affairs service providers in the U.S. and Europe region, as Small- and Medium-sized Enterprises (SMEs) would require third-party assistance to comply with the new standards. Subcontractors and Original Equipment Manufacturers (OEMs) in developed countries like Canada are expected to adopt these new standards earlier than those in the developing countries.

However, the coronavirus pandemic has caused a severe disruption in the supply chain, which has led to shortages and a severe slowing of production. It has stressed the need for scalable manufacturing operations among OEMs, particularly those undertaking production associated to test kits and diagnostic systems. Full-service Contract Manufacturing Organizations (CMOs) continue to garner increased OEM engagement, owing to supply chain issues.

COVID19 impact: Increased production of PPE by more than 100%

Pandemic Impact

Post COVID Outlook

With a significantly increasing number of COVID-19 cases worldwide, countries had to shut down their manufacturing plants and establish quarantine zones to contain the spread, which has negatively impacted the medical devices manufacturing companies.

High adoption of additive manufacturing/3D printing technology is enabling companies to shift their sourcing of parts to the company’s on-site production facilities parts from locations such as China.

The COVID-19 pandemic is a disrupter unlike any the global supply chain has seen, and with disruption comes increased risk. Companies have had to streamline and simplify operations more than ever before, which can impact quality assurance.

In July 2020, the European Medical Devices Regulation (EU MDR) application was postponed due to the pandemic in order to free up resources to address COVID-19 supply chain bottlenecks. This is turn will provide manufacturers with the must-needed time to catch up with the regulatory reforms needed. The entire process is expected to be in action by 2025.


However, the current pandemic was a booster for product sterilization services. The demand to sterilize single-use medical instruments and Personal Protective Equipment (PPE) remains high as long as the pandemic continues. In late March, the Environmental Protection Agency (EPA) and the Becton, Dickson & Company had reached an agreement to enhance the number of devices the company sterilizes during the pandemic.

Service Insights

The contract manufacturing services segment led the global medical device outsourcing market and accounted for more than 55% of the global revenue share in 2020. It is projected to maintain its leading position over the forecast period due to increasing focus on decreasing the cost of production. Moreover, growing complexity in manufacturing is contributing to the segment growth. Manufacturing high-quality and safe devices for patient care is a major concern for medical device manufacturers. In addition, the high level of inspection in developing medical devices has created layers of standards and regulations. Hence, this is creating demand for manufacturing services.

However, the quality assurance services segment is projected to register the fastest CAGR of 13.6% from 2021 to 2028. The maintenance of an effective quality management system is an integral part of the production of every medical 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. Medical device manufacturers are outsourcing quality management services to medical device consulting companies to ensure compliance and provide high-quality components alongside safe and effective finished medical devices.

Application Insights

The cardiology segment accounted for the maximum revenue share of over 20% in 2020 and is likely to remain dominant throughout the forecast period. The rising demand for cardiovascular devices, as a result of a high prevalence of associated conditions, is attributed to the increased outsourcing of these devices. Moreover, the complexity of cardiovascular devices and the need for technical expertise result in higher outsourcing of these devices.

Global medical device outsourcing market share, by application, 2020 (%)

On the other hand, the general & plastic surgery segment is anticipated to exhibit the fastest CAGR over the forecast period. This growth can be attributed to the availability of competent outsourcing firms, which comply with the regulatory requirements and rising demand for cosmetic surgeries. Moreover, the introduction of minimally invasive and non-invasive procedures has led to an increased number of surgeries being performed in a year. This calls for innovative and procedure-specific devices.

Regional Insights

Asia Pacific was the dominant regional market in 2020 and accounted for a revenue share of over 41%. The regional market will expand further at a steady CAGR from 2021 to 2028 due to the easy availability of skilled human resources. In addition, the presence of key companies and competitive pricing are other supporting factors that are anticipated to drive this regional market. The increasing demand for medical devices owing to growing cases of chronic diseases is fueling the market growth in this region.

North America accounted for a significant revenue share in 2020 owing to the well-established manufacturing hubs for high-end, consistent, and complex medical devices. Moreover, the technologically advanced electronic sector of the region is boosting the market growth in North America. The region is also home to numerous medical device companies, which are outsourcing part of their regulatory and consulting functions to regulatory service providers, thereby contributing toward the growth of the overall market.

Key Companies & Market Share Insights

Many new companies are anticipated to venture into this market due to the increasing demand for medical devices around the globe. This is projected to boost the competition level in the global arena. In addition, collaborations among existing players and niche service offerings to boost product quality are likely to fuel market growth over the forecast period. Established players in the market are expected to broaden their portfolio and provide one-stop solutions to withstand aggressive competition over the forecast period. For instance, in January 2021, SGS SA received U.S. FDA approval to participate and provide services for third-party 510(k) premarket submissions for medical devices.

In addition, during the pandemic, companies continued to work hard to serve the industry. For instance, since the beginning of the pandemic, Toxikon managed to operate safely and efficiently to serve as a single-source provider for preclinical safety & efficacy testing to ensure delivery of healthcare products to patients. Also, in April 2020, Eurofins announced that its laboratories across the U.S.A., Asia, and Europe, are providing a worldwide service offer for inspection, testing, and regulatory services focused on medical gowns, gloves, & face masks along with respiratory protective devices & equipment, its component & materials, to serve the rising demand due to the pandemic. Some prominent players in the global medical device outsourcing market include:

  • SGS SA


  • Toxikon, Inc.

  • Eurofins Scientific SE

  • Pace Analytical Services, Inc.

  • Intertek Group plc

  • WuXi AppTec, Inc.

  • North American Science Associates, Inc.

  • Charles River Laboratories International, Inc.

  • PAREXEL International Corp.

Medical Device Outsourcing Market Report Scope

Report Attribute


Market Size value in 2021

USD 107.9 billion

Revenue forecast in 2028

USD 227.1 billion

Growth rate

CAGR of 11.2% from 2021 to 2028

Base year for estimation


Historical data

2016 - 2019

Forecast period

2021 - 2028

Quantitative units

Revenue in USD million/billion and CAGR from 2021 to 2028

Report coverage

Revenue forecast, company ranking, 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; France; U.K.; Germany; Italy; Spain; The Netherlands; Switzerland; Sweden; Belgium; Russia; Japan; China; Taiwan; India; Indonesia; Malaysia; Singapore; Korea; Thailand; Australia; Philippines; Brazil; Mexico; Argentina; Colombia; Chile; South Africa; Saudi Arabia; Israel; UAE; Egypt

Report coverage

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

Key companies profiled

SGS SA; IQVIA; Toxikon, Inc.; Eurofins Scientific SE; Pace Analytical Services, Inc.; Intertek Group plc; WuXi AppTec, Inc.; North American Science Associates, Inc.; Charles River Laboratories International, Inc.; PAREXEL International Corp.

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

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research, Inc. has segmented the global medical device outsourcing market report on the basis of service, application, and region:

  • Service Outlook (Revenue, USD Million, 2016 - 2028)

    • Quality Assurance Services

    • Regulatory Affairs Services

      • Clinical Trials Applications & Product Registrations

      • Regulatory Writing & Publishing

      • Legal Representation

      • Other

    • Product Design & 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 - 2028)

    • 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 & 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 - 2028)

    • North America

      • U.S.

      • Canada

    • Europe

      • France

      • U.K.

      • Germany

      • Italy

      • Spain

      • The Netherlands

      • Switzerland

      • Sweden

      • Belgium

      • Russia

    • Asia Pacific

      • Japan

      • China

      • Taiwan

      • India

      • Indonesia

      • Malaysia

      • Singapore

      • Korea

      • Thailand

      • Australia

      • Philippines

    • Latin America

      • Brazil

      • Mexico

      • Argentina

      • Colombia

      • Chile

    • Middle East & Africa (MEA)

      • South Africa

      • Saudi Arabia

      • Israel

      • UAE

      • Egypt

Frequently Asked Questions About This Report

gvr icn


gvr icn

This FREE sample includes market data points, ranging from trend analyses to market estimates & forecasts. See for yourself...

gvr icn


We can customize every report - free of charge - including purchasing stand-alone sections or country-level reports, as well as offer affordable discounts for start-ups & universities.

Contact us now to get our best pricing.

BBB icon D&B icon

We are GDPR and CCPA compliant! Your transaction & personal information is safe and secure.