Medical device outsourcing market

Medical Device Outsourcing Market, by Product  (Finished Goods, Electronics, and Raw Material), by Device Type (Class I Devices, Class II Devices, and Class III Devices), by Application (Orthopedics and Spine, Cardiovascular, Radiology, General Medical Devices, and Others), by Services (Prototype Development, Finished Device Manufacturing, Assembly & Packaging, and Testing & Regulatory Support Services), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2022 - 2028

  • Mar 2022
  • CMI2641
  • 154 Pages
  • Excel & Pdf
  • Medical Devices

Medical devices outsourcing is the outsourced fabrication of a medical devices. Medical device companies can utilize outsourcing to perform recurring manufacturing and benefit from costing efficiencies, streamlined supply chain, and logistical alignment all of these factors help them to deliver commercial products to market while ensuring that all the industry requisites are met.

The component of the medical device outsourced to contract manufacturers and service providers covers several aspects such as design consultation, device assembly, and packaging for shipment, manufacturing process designing, and package testing validation service, identification of process improvement, recurring processing services and sterilization validation.

Global medical devices outsourcing market is driven by the increasing needs for quality healthcare services. Medical device manufacturers are majorly dependent on innovation as the product life cycles are short and increasing buyer awareness levels has forced manufacturers to adhere to business strategies involving persistent R&D investments and innovative product launch. Medical device Original Equipment Manufacturers (OEMs), adhering to outsourcing services as a cost effective curbing tool. Moreover, medical outsourcing services have benefited the OEMs by reducing cost and time as the medical device market has gained high competitiveness in the previous couple of years.

The global medical devices outsourcing market is estimated to be valued at US$ 56,687.9 Mn in 2021, and is expected to exhibit a CAGR 12.4% of over the forecast period (2021-2028).

Figure 1. Global Medical Devices Outsourcing Market Share (%), by Region, 2021

The increasing cases of cardiovascular diseases such as bradycardia which would increase the demand of medical devices, is expected to drive growth of the global medical devices outsourcing market over the forecast period.

For instance, according to the National Centre for Biotechnology Information (NCBI), over one million pacemakers are implanted every year worldwide. Of which around 200,000 are implanted in the U.S alone. Combined with an aging population and increasing pacing indications, these numbers are expected to grow in the future.

Medical Devices Outsourcing Market Report Coverage

Report Coverage Details
Base Year: 2020 Market Size in 2021: US$ 56,687.9 Mn
Historical Data for: 2017 to 2020 Forecast Period: 2021 to 2028
Forecast Period 2021 to 2028 CAGR: 12.4 % 2028 Value Projection: US$ 128,758.5 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Product: Finished Goods, Electronics, Raw Material
  • By Device Type: Class I Devices, Class II Devices, Class III Devices
  • By Application: Orthopedics and Spine, Cardiovascular, Radiology, General Medical Devices, Others
  • By Services: Prototype Development, Finished Device Manufacturing, Assembly & Packaging, Testing & Regulatory Support Services
Companies covered:

SGS SA, Intertek Group PLC, Wuxi Apptec, TüvSüd AG, Toxikon, INC., American Preclinical Services, Eurofins Scientific, Sterigenics International LLC, Pace Analytical Services LLC., Charles River Laboratories International, Inc., North American Science Associates, Inc., IQVIA, Accellent Inc., Celestica Inc., Benchmark Electronic Inc., Cadence Inc., Providien LLC, Thermo Fischer Scientific Inc., and West Pharmaceuticals Services Inc.

Growth Drivers:
  • Increasing population of cardiovascular diseases
  • Rising research and development activities in the cardiovascular segment
  • Increasing products approvals and launches
Restraints & Challenges:
  • Consolidation in the medical devices market
  • Uncertainty of meeting regulatory requirements

Figure 2. Global Medical Devices Outsourcing Market Value (US$ Mn), by Application 2021

The increasing research and development activities for the treatment of cardiovascular diseases is expected to drive the market growth over the forecast period.

For instance, in December 2021, Boston Scientific Corporation, had initiated the MODULAR ATP clinical trial to evaluate the safety, performance, and effectiveness of the mCRM modular therapy system. The mCRM system comprises two cardiac rhythm management (CRM) devices planned to work together to coordinate therapy, the EMBLEM MRI Subcutaneous Implantable Defibrillator (S-ICD) system and the EMPOWER Modular Pacing System (MPS), this is the first leadless pacemaker capable of both bradycardia pacing support and ant tachycardia pacing (ATP), the clinical study expected to be completed by December 2028.

The increasing product launches and approvals are expected to drive the market growth over the forecast period.

For instance, in August 2021, Terumo Aortic had received the U.S Food and Drug Administration (FDA) approval for Relay Pro Thoracic Stent-Graft System for the sale in the U.S for treatment of patients with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAUs).

Global Medical Devices Outsourcing Market – Impact of Coronavirus (COVID-19) Pandemic

Coronavirus (COVID-19) outbreak was first reported on December 31, 2019, in Wuhan, China. The World Health Organization declared COVID-19, as a pandemic on March 11, 2020. According to the Coronavirus (COVID-19) Weekly Epidemiological Update by the World Health Organization, over 193,657,725 cases and 4,154,660 deaths due to coronavirus disease (COVID-19) were reported till July 25, 2021, across the globe.

With a serious increasing number of COVID-19 cases worldwide, companies had to shut down their manufacturing plants in order to reduce the spread of the virus, which has negatively impacted the medical devices manufacturing companies.

Global Medical Devices Outsourcing Market - Restraint

Giant medical device manufacturers are acquiring small companies to enhance their internal capability. This may limit to CMOs, given that big companies will have capabilities to carry out manufacturing in house. For instance, Linden acquired AvalignTechnologies Medical in December 2018, which provided Linden opportunities for future growth and considerably added to its capabilities.

Key Players

Major players operating in the global medical devices outsourcing market include SGS SA, Intertek Group PLC, Wuxi Apptec, TüvSüd AG, Toxikon, INC., American Preclinical Services, Eurofins Scientific, Sterigenics International LLC, Pace Analytical Services LLC., Charles River Laboratories International, Inc., North American Science Associates, Inc., IQVIA, Accellent Inc., Celestica Inc., Benchmark Electronic Inc., Cadence Inc., Providien LLC, Thermo Fischer Scientific Inc., and West Pharmaceuticals Services Inc.

Table of Contents

  1. Research Objectives and Assumptions
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Product
      • Market Snippet, By Device Type
      • Market Snippet, By Application
      • Market Snippet, By Services
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Pipeline Analysis
    • PEST Analysis
    • Regulatory Scenario
    • Market Trends
    • Key Highlights
    • Reimbursement Scenario
    • Mergers & Acquisitions
  4. Global Medical Devices Outsourcing Market – Impact of Coronavirus (COVID-19) Pandemic
    • Economic Impact
    • Government Initiatives
    • Impact on Supply and Demand
  5. Global Medical Device Outsourcing Market, By Product, 2017 – 2028, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2021 and 2028 (%)
      • Y-o-Y Growth Analysis, 2018 – 2028
      • Segment Trends
    • Finished Goods
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
    • Electronics
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
    • Raw Material
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
  6. Global Medical Device Outsourcing Market, By Device Type, 2017 – 2028, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2021 and 2028 (%)
      • Y-o-Y Growth Analysis, 2018 – 2028
      • Segment Trends
    • Class I Devices
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
    • Class II Devices
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
    • Class III Devices
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
  7. Global Medical Device Outsourcing Market, By Application, 2017 – 2028, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2021 and 2028 (%)
      • Y-o-Y Growth Analysis, 2018 – 2028
      • Segment Trends
    • Orthopedics and Spine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
    • Cardiovascular
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
    • Radiology
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
    • General Medical Devices
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
  8. Global Medical Device Outsourcing Market, By Services, 2017 – 2028, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2021 and 2028 (%)
      • Y-o-Y Growth Analysis, 2018 – 2028
      • Segment Trends
    • Prototype Development
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
    • Finished Device Manufacturing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
    • Assembly & Packaging
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
    • Testing & Regulatory Support Services
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
  9. Global Medical Device Outsourcing Market, By Region, 2017 – 2028, (US$ Mn)
    • Introduction
      • Market Share Analysis, By Region, 2021 and 2028 (%)
      • Y-o-Y Growth Analysis, For Regions, 2018–2028
    • North America
      • Market Size and Forecast, By Product, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Device Type, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Application, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Services, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Country, 2017 – 2028, (US$ Mn)
        • U.S.
        • Canada
    • Latin America
      • Market Size and Forecast, By Product, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Device Type, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Application, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Services, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Country, 2017 – 2028, (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • Market Size and Forecast, By Product, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Device Type, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Application, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Services, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Country, 2017 – 2028, (US$ Mn)
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Product, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Device Type, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Application, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Services, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Country, 2017 – 2028, (US$ Mn)
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • Market Size and Forecast, By Product, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Device Type, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Application, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Services, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Country, 2017 – 2028, (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • Market Size and Forecast, By Product, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Device Type, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Application, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Services, 2017 – 2028, (US$ Mn)
      • Market Size and Forecast, By Region/Country, 2017 – 2028, (US$ Mn)
        • South Africa
        • Central Africa
        • North Africa
  10. Competitive Landscape
    • Heat Map Analysis
    • Market Share Analysis
      • SGS SA
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Intertek Group PLC
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Wuxi Apptec
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • TüvSüd AG
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Toxikon, INC
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • American Preclinical Services
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Eurofins Scientific
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Sterigenics International LLC
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Pace Analytical Services LLC
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Charles River Laboratories International, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • North American Science Associates, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • IQVIA
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Accellent Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Celestica Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Benchmark Electronic Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Cadence Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Providien LLC
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Thermo Fischer Scientific Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • West Pharmaceuticals Services Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
    • Analyst Views
  11. Section
    • References
    • Research Methodology
    • About Us and Sales Contact

*Browse 38 market data tables and 26 figures on "Medical Devices Outsourcing Market” - Global forecast to 2028

Detailed Segmentation:

  • Global Medical Device Outsourcing Market, By Product:
    • Finished Goods
    • Electronics
    • Raw Material
  • Global Medical Devices Outsourcing Market, By Device Type:
    • Class I Devices
    • Class II Devices
    • Class III Devices
  • Global Medical Devices Outsourcing Market, By Application:
    • Orthopedics and Spine
    • Cardiovascular
    • Radiology
    • General Medical Devices
    • Others
  • Global Medical Devices Outsourcing Market, By Services:
    • Prototype Development
    • Finished Device Manufacturing
    • Assembly & Packaging
    • Testing & Regulatory Support Services
  • Global Medical Devices Outsourcing Market, By Region:
    • North America
      • By Product
        • Finished Goods
        • Electronics
        • Raw Material
      • By Device Type
        • Class I Devices
        • Class II Devices
        • Class III Devices
      • By Application
        • Orthopedics and Spine
        • Cardiovascular
        • Radiology
        • General Medical Devices
        • Others
      • By Services
        • Prototype Development
        • Finished Device Manufacturing
        • Assembly & Packaging
        • Testing & Regulatory Support Services
      • By Country
        • U.S.
        • Canada
    • Latin America
      • By Product
        • Finished Goods
        • Electronics
        • Raw Material
      • By Device Type
        • Class I Devices
        • Class II Devices
        • Class III Devices
      • By Application
        • Orthopedics and Spine
        • Cardiovascular
        • Radiology
        • General Medical Devices
        • Others
      • By Services
        • Prototype Development
        • Finished Device Manufacturing
        • Assembly & Packaging
        • Testing & Regulatory Support Services
      • By Country
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Product
        • Finished Goods
        • Electronics
        • Raw Material
      • By Device Type
        • Class I Devices
        • Class II Devices
        • Class III Devices
      • By Application
        • Orthopedics and Spine
        • Cardiovascular
        • Radiology
        • General Medical Devices
        • Others
      • By Services
        • Prototype Development
        • Finished Device Manufacturing
        • Assembly & Packaging
        • Testing & Regulatory Support Services
      • By Country
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Product
        • Finished Goods
        • Electronics
        • Raw Material
      • By Device Type
        • Class I Devices
        • Class II Devices
        • Class III Devices
      • By Application
        • Orthopedics and Spine
        • Cardiovascular
        • Radiology
        • General Medical Devices
        • Others
      • By Services
        • Prototype Development
        • Finished Device Manufacturing
        • Assembly & Packaging
        • Testing & Regulatory Support Services
      • By Country
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Product
        • Finished Goods
        • Electronics
        • Raw Material
      • By Device Type
        • Class I Devices
        • Class II Devices
        • Class III Devices
      • By Application
        • Orthopedics and Spine
        • Cardiovascular
        • Radiology
        • General Medical Devices
        • Others
      • By Services
        • Prototype Development
        • Finished Device Manufacturing
        • Assembly & Packaging
        • Testing & Regulatory Support Services
      • By Country
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Product
        • Finished Goods
        • Electronics
        • Raw Material
      • By Device Type      
        • Class I Devices
        • Class II Devices
        • Class III Devices
      • By Application
        • Orthopedics and Spine
        • Cardiovascular
        • Radiology
        • General Medical Devices
        • Others
      • By Services
        • Prototype Development
        • Finished Device Manufacturing
        • Assembly & Packaging
        • Testing & Regulatory Support Services
      • By Country/Region
        • South Africa
        • Central Africa
        • North Africa
- Frequently Asked Questions -

What is the current market size and compound annual growth rate (CAGR) of the global medical devices outsourcing market during the forecast period (2021-2028)?

The medical devices outsourcing market size is estimated to be valued at US$ 56,687.9 Mn in 2021, and is expected to exhibit a CAGR of 12.4% between 2021 and 2028.

What are the major factors driving the market growth?

The increasing cases of cardiovascular diseases such as bradycardia which would increase the demand of medical devices, the increasing research and development activities for the treatment of cardiovascular diseases, and the increasing product launches and approvals are expected to drive the market growth over the forecast period.

Which is the leading application type segment in the market?

Cardiovascular segment is expected to hold major market share.

Which region holds the largest market share in the market?

North America holds the largest market share in the market. 

What are the key factors hampering growth of the market?

Giant medical devices manufacturers are acquiring small companies to enhance their internal capability. This may limit to CMOs, given that big companies will have capabilities to carry out manufacturing in house.

Which are the major players operating in the market?

Major players operating in the market include SGS SA, Intertek Group PLC, Wuxi Apptec, TüvSüd AG, Toxikon, INC., American Preclinical Services, Eurofins Scientific, Sterigenics International LLC, Pace Analytical Services LLC., Charles River Laboratories International, Inc., North American Science Associates, Inc., IQVIA, Accellent Inc., Celestica Inc., Benchmark Electronic Inc., Cadence Inc., Providien LLC, Thermo Fischer Scientific Inc., and West Pharmaceuticals Services Inc.
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