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

Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Application (Cardiology, General & Plastic Surgery, IVD), By Service (Contract Manufacturing, Quality Assurance), By Region, And Segment Forecasts, 2022 - 2030

  • Report ID: 978-1-68038-279-2
  • Number of Pages: 275
  • Format: Electronic (PDF)
  • Historical Range: 2018 - 2020
  • Industry: Healthcare

Report Overview

The global medical device outsourcing market size was valued at USD 107.92 billion in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 12.1% over the forecast period. Increasing demand for medical devices combined with the rising price competition and requirement to reduce the cost is expected to drive the market during the forecast period. In addition, growing difficulties in product engineering along with the increasing number of new entrants are anticipated to shape the future of the market. The COVID-19 pandemic had created a significant demand for RT-PCR and COVID-19 antigen test kits for testing. The ongoing pandemic is likely to have a positive impact on the market. The increasing prevalence of chronic disorders is boosting the demand for medical devices.

U.S. Medical Device Outsourcing Market Size, By Service, 2020 - 2030 (USD Billion)

This, in turn, is working in favor of the market. Implantable Medical Devices (IMDs) are being used increasingly to improve patients’ medical outcomes. Designers of implantable medical devices have to balance complexity, reliability, power consumption, and costs. Consequently, companies are shifting their focus to innovation rather than non-core activities and 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 new ISO standards.

Subcontractors and Original Equipment Manufacturers (OEMs) in developed countries like the U.S., Canada, Japan, and EU countries are expected to adopt these new standards earlier than those in the developing countries. However, the COVID-19 pandemic had caused a temporary disruption in the supply chain, which had 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 & diagnostic systems. However, the current pandemic was a booster for product sterilization services.

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.


The demand to sterilize single-use medical instruments and Personal Protective Equipment (PPE) remains high as long as the pandemic continues. The pandemic also created an urgent need for COVID-19 test kits, different public organizations also provided funding for scaling the production of these devices, apart from this, regulatory agencies like the U.S. FDA and the European Union had provided Emergency Use Authorization (EUA) for the test kits, which have further boosted the market growth.

Service Insights

The contract manufacturing segment led the market and accounted for more than 55.0% share of the global revenue in 2021. It is also projected to maintain its dominant position over the forecast period. Increasing focus on decreasing the cost of production is augmenting the growth of this segment. In addition, increasing complexity in manufacturing is contributing to market growth. Manufacturing high-quality and safe devices for patient care is a major concern of medical device manufacturers.Also, 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 grow at the fastest CAGR during the forecast period. The maintenance of an effective quality management system is an integral part of the production of everymedical 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 share of 20.65% in 2021 and is likely to remain dominant throughout the forecast period. The WHO states that Cardiovascular Diseases (CVDs) are one of the major causes of death worldwide, leading to 17.9 million deaths each year. This is due to the high prevalence of conditions, such as angina pectoris, myocardial infarction, hypertensive heart disease, rheumatic heart diseases, atrial fibrillation, and congenital heart disease. The high prevalence of CVDs globally is increasing the demand for cardiovascular devices

Moreover, high complexity of cardiovascular devices and the need for technical expertise. In addition, manufacturing these devices may also lead to the high cost to the OEMs, which is likely to result in the higher outsourcing of these devices.

Global Medical Device Outsourcing Market Share, By Therapeutic Area, 2021 (%)

General and plastic surgery devices outsourcing is anticipated to exhibit the fastest CAGR from 2022 to 2030. The availability of competent outsourcing firms, which comply with the regulatory requirements, and rising demand for cosmetic surgeries are expected to contribute to the growth of this segment. The awareness and consciousness about physical appearance have significantly increased in recent years, which has increased the demand for cosmetic surgeries globally. Surgical devices like fixation devices, extremity splints, and epilators require specialized molding and machining processes, which increases the demand for outsourcing these devices. The introduction of minimally invasive and noninvasive surgeries has led to a rise in the number of surgeries performed in a year. This calls for innovative and procedure-specific devices.

Regional Insights

On the basis of geographies, the global market has been divided into Asia Pacific, North America, Latin America, and MEA. Asia Pacific region dominated the global market in 2021 with the largest revenue share of 41.52%. The presence of market players and competitive pricing are other supporting factors that are anticipated to drive this regional market. Also, the increasing demand for medical devices owing to the growing patient population suffering from chronic and infectious diseases is fueling the market growth in this region. For instance, during the first wave of COVID-19, there was a growing demand for CT scanners in India to detect pneumonia.

North America is also anticipated to register significant growth over the forecast period. This is owing to the well-established manufacturing hubs for high-end, consistent, and complex medical devices. Also, the existence of the technologically advanced electronic sector is helping North America edge over other regions. This 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 to the growth of the regional market.

Key Companies and Market Share Insights

Many new companies are anticipated to venture into this space 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 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. For instance, in January 2021, SGS SA received the FDA approval to participate & provide services for third-party 510(k) premarket submissions for medical devices. Market players are also adopting the strategy of acquisition to enhance their service portfolio.

For instance, in December 2021, the life sciences company, Labcorp, acquired a CRO, Toxikon Inc., to expand its offerings by providing testing services for medical devices, pharmaceuticals, and other industries. Also, during the pandemic, players continued to work hard to serve the industry since the beginning of COVID-19. For instance, in April 2020, Eurofins announced that its laboratories through Europe, U.S., and Asia are providing worldwide service offering 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 mounting demand due to the pandemic. Some prominent players in the global medical device outsourcing market include:

  • SGS SA

  • Labcorp

  • Eurofins Scientific

  • Pace Analytical Services, Inc.

  • Intertek Group Plc

  • WuXi AppTec, Inc.

  • North American Science Associates, Inc.


  • American Preclinical Services

  • Sterigenics International LLC

  • Charles River Laboratories International, Inc.

  • Medical Device Testing Services

  • RJR Consulting, Inc.

  • Mandala International

  • Freyr

  • Global Regulatory Partners, LLC

  • Parexel International Corp.

  • Emergo

  • Bioteknica

  • Accell Clinical Research

  • Genpact Ltd.

  • Criterium, Inc.

  • PRA Health Sciences

  • Promedica International

  • Medpace Holdings, Inc.

  • Icon PLC.

  • Iqvia Holdings Inc.

  • Integer Holdings Corp.

  • Tecomet Inc.

  • Jabil Inc.

  • Flex Ltd.

  • Celestica Inc.

  • Sanmina Corp.

  • Plexus Corp.

  • Phillips Medisize

  • Cantel Medical Corp.

  • West Pharmaceutical Services, Inc.

Medical Device Outsourcing Market Report Scope

Report Attribute


Market Size value in 2022

USD 117.47 billion

Revenue forecast in 2030

USD 292.93 billion

Growth rate

CAGR 12.1% from 2022 to 2030

Base year for estimation


Historical data

2018 - 2020

Forecast period

2022 - 2030

Quantitative units

Revenue in USD million/billion and CAGR from 2022 to 2030

Report coverage

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

Segments covered

Services, application, class, region

Regional scope

North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Country scope

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

Report coverage

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

Key companies profiled

SGS SA; Labcorp; Eurofins Scientific; Pace Analytical Services, Inc.; Intertek Group Plc; WuXi AppTec, Inc.; North American Science Associates, Inc.; TUV SUD AG; American Preclinical Services; Sterigenics International LLC; Charles River Laboratories International, Inc.; Medical Device Testing Services; RJR Consulting, Inc.; Mandala International.; Freyr; Global Regulatory Partners, LLC; Parexel International Corp.; Emergo; Bioteknica; Accell Clinical Research; Genpact Ltd.; Criterium, Inc.; PRA Health Sciences; Promedica International; Medpace Holdings, Inc.; Icon PLC.; Iqvia Holdings Inc.; Integer Holdings Corporation; Tecomet Inc.; Jabil Inc.; Flex Ltd.; Celestica Inc.; Sanmina Corp.; Plexus Corp.; Phillips Medisize; Cantel Medical Corp. and West Pharmaceutical Services, Inc.

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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 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global medical device outsourcing market report on the basis of service, application, class and region:

  • Service Outlook (Revenue, USD Million, 2018 - 2030)

    • Quality Assurance

    • Regulatory Affairs Services

      • Clinical Trials Applications & Product Registrations

      • Regulatory Writing & 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, 2018 - 2030)

    • 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

  • Class Outlook (Revenue, USD Million, 2018 - 2030)
    • Class I

    • Class II

    • Class III

  • Regional Outlook (Revenue, USD Million, 2018 - 2030)

    • North America

      • U.S.

      • Canada

    • Europe

      • U.K.

      • Germany

      • France

      • Italy

      • Spain

      • Switzerland

      • The Netherlands

      • Sweden

      • Belgium

      • Russia

    • Asia Pacific

      • Japan

      • China

      • India

      • Australia

      • South Korea

      • Singapore

      • Malaysia

      • Thailand

      • Taiwan

      • Indonesia

      • Philippines

    • Latin America

      • Brazil

      • Mexico

      • Argentina

      • Colombia

      • Chile

    • Middle East and Africa (MEA)

      • South Africa

      • Saudi Arabia

      • Israel

      • UAE

      • Egypt

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