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  • Published On : Mar 2022
  • Code : CMI2641
  • Industry : Medical Devices
  • Pages : 154
  • Formats :

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

Medical Devices Outsourcing  | Coherent Market Insights

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.

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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

Medical Devices Outsourcing  | Coherent Market Insights

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.

Medical device outsourcing is contracting with the third party for the product designing, manufacturing, packaging, validation, and prototyping of medical devices. Medical device outsourcing helps both manufacturer and the supply chain. It permits the original equipment manufacturers to focus on their primary operations, such as marketing and product innovation. It also helps in reducing the overall cost and time to enter the market.  Companies can save up 10-15% on production by outsourcing their products. Overall medical device outsourcing provides benefits such as early product launch into the market, reduced manufacturing time, and quality check approvals to match regulatory criteria.

Global medical devices outsourcing market is propelled 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 rising geriatric population and their susceptibility to diseases is the vital factor that is propelling the market growth. For instance, according to the U.S census Bureau, there were more than 54 million citizens 65 years and older.

Market Dynamics

The rising research and development activities for the development of novel technologies, and increasing adoption of inorganic growth strategies such as mergers, acquisitions, partnerships, and collaborations by key players operating in the market are the major factors that are expected to drive growth of the global medical device outsourcing market over the forecast period.

For instance, according to National Center for Biotechnology Information (NCBI), article published in April 2018, over one million cardiac pacemakers are published every year globally. Out of which 200,000 are implanted in the U.S alone.

Key features of the study:

  • This report provides in-depth analysis of the global medical devices outsourcing market, and provides market size (US$ Mn) and compound annual growth rate (CAGR%) for the forecast period (2021–2028), considering 2020 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global medical devices outsourcing market based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study 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.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The global medical devices outsourcing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global medical devices outsourcing market

Detailed Segmentation:

  • Global Medical Devices 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 Country
        • U.S.
        • Canada
    • Latin America
      • By Country
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Country
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Country
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Country
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Country/Region
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • SGS SA *
      • Company Overview
      • Material Portfolio
      • Financial Performance
      • Key Highlights
      • Market Strategies
    • 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.
    • West Pharmaceuticals Services Inc.

“*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

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.
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.
Cardiovascular segment is expected to hold major market share.
North America holds the largest market share in 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.
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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