Overview


According to FutureWise analysis the market for Medical Device Outsourcing in 2023 is US$ 131.98 billion, and is expected to reach US$ 334.31 billion by 2031 at a CAGR of 12.32%.

Medical Device Outsourcing refers to the practice of contracting out certain manufacturing or development processes of medical devices to third-party companies. Medical device outsourcing can include a range of services, such as product development and designing, prototyping, testing, regulatory compliance, and manufacturing. Medical device outsourcing is a common practice in the medical device industry as it allows companies to leverage the expertise and resources of external partners to bring their products to market faster and at a lower cost. Outsourcing also enables medical device companies to focus on their core competencies, such as product design and marketing, while leaving the manufacturing and other processes to external partners.

Outsourcing in the medical device industry can take several forms, including contract manufacturing, contract research and development, and contract design. Contract manufacturing involves outsourcing the manufacturing of medical devices to third-party companies, while contract research and development involves outsourcing research and development activities to external partners. Contract design refers to outsourcing the product design and engineering processes to external partners. Medical device outsourcing is a complex process that requires careful selection of external partners and close collaboration between the outsourcing company and its partners. Outsourcing companies must ensure that their partners meet the required quality standards and regulatory requirements and that their intellectual property is protected.

FutureWise Market Research has published a report that provides an insightful analysis of Medical Device Outsourcing Market trends that are affecting the overall market growth. This report will provide a detailed analysis of market share, regional insights, and competitor analysis that includes stature of key manufacturers operational in this industry. By the end of the forecast period FutureWise research analysts projects that Medical Device Outsourcing Market will experience a significant growth.

According to the analysis done, this report will help understand the information referring to the total valuation held by this industry. Additionally, this report will help in understanding the growth opportunities held by various segments of this market, further assist in making better strategic and expansion decisions by key stakeholders of an organization.

  • 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.
  • Onex Corporation
  • Cardinal Health, Inc.
  • Heraeus Holding GmbH

(Note: The list of the major players will be updated with the latest market scenario and trends)

Recent developments by key players in Medical Device Outsourcing Market:

  • In December 2021, To broaden its product line and provide testing services for the pharmaceutical, medical device, and other sectors, the life sciences business Laboratory Corporation of America Holdings purchased a CRO, Toxikon Inc.

The medical device outsourcing market is a rapidly growing market that includes the outsourcing of various aspects of medical device manufacturing, such as design and development, engineering, prototyping, testing, regulatory compliance, and supply chain management. One of the key drivers of the medical device outsourcing market is the increasing demand for medical devices, driven by the aging population and the rising prevalence of chronic diseases. As the demand for medical devices continues to grow, medical device manufacturers are looking for ways to reduce costs and improve efficiency, which is driving the outsourcing of various aspects of medical device manufacturing. Another factor driving the growth of the medical device outsourcing market is the increasing complexity of medical devices and the need for specialized expertise in areas such as design, engineering, and testing. By outsourcing these functions to specialized vendors, medical device manufacturers can access the expertise they need without investing in specialized equipment and personnel. In addition, outsourcing can help medical device manufacturers reduce their time to market, as outsourcing vendors can often provide faster turnaround times for design, prototyping, and testing them in-house teams. This can be particularly important in the highly competitive medical device industry, where time to market can be a critical factor in success.

While the medical device outsourcing market is expected to grow, there are also several factors that may restrain the market growth. One major challenge facing the market is the increasing regulatory scrutiny and complexity in the healthcare industry. As medical devices become more complex and specialized, regulatory compliance becomes more challenging, which can increase costs and create barriers to entry for smaller outsourcing vendors.

By Service

  • Quality Assurance
  • Regulatory Affairs Services
    • Clinical trials applications and product registrations
    • Regulatory writing and publishing
    • Legal representation
    • Other
  • Product Design and Development Services
    • Designing and engineering
    • Machining
    • Molding
    • Packaging
  • Product Design and Sterilisation Services
  • Product Implementation Services
  • Product Upgrade Services
  • Product Maintenance Services
  • Contract Manufacturing
    • Accessories manufacturing
    • Assembly manufacturing
    • Component manufacturing
    • Device manufacturing

By Application

  • Cardiology
  • Diagnostic Imaging
  • Orthopedic
  • IVD
  • Ophthalmic
  • General and plastic surgery
  • Drug delivery
  • Dental
  • Endoscopy
  • Diabetes care
  • Others

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

This market research report also emphasis on factors affecting the growth rate in various regions listed above. A deep-down analysis of region will also be provided in the final version of this market which is based on conclusion of primary interviews and secondary data point gathered during the process.

By region, the market is segmented into North America, Latin America, Europe, Asia-Pacific, and Middle East & Africa. Asia-Pacific region registered the highest share in the global market in 2022. The Asia Pacific region has been dominating the Medical Device Outsourcing Market in recent years. This is due to several factors, including a large population, increasing healthcare expenditures, growing demand for medical devices, and a favourable regulatory environment. The region has a significant advantage in terms of cost competitiveness, as labour and manufacturing costs are relatively low compared to other regions. This has increased the number of medical device manufacturers outsourcing their production processes to countries in the Asia Pacific region, particularly China, India, and Japan. In addition, the APAC region has a well-established healthcare infrastructure and a rapidly aging population, which is driving demand for medical devices such as pacemakers, orthopaedic implants, and diagnostic equipment. This demand, coupled with the region's low labour and manufacturing costs, has made it an attractive destination for medical device outsourcing. Furthermore, many countries in the region have favourable regulatory environments that support medical device outsourcing. For example, the Indian government has implemented policies that encourage foreign investment in the country's medical device industry, while China has introduced measures to speed up the procedure for medical device clearance by the government.

  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants

  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth

  • To provide with an exhaustive analysis on the Medical Device Outsourcing Market By Service, By Application and By Region.
  • To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  • To evaluate and forecast micro-markets and the overall market
  • To predict the market size, in key regions— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  • To record and evaluate competitive landscape mapping- product launches, technological advancements, mergers and expansions

  • We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
  • The customisations offered are free of charge with purchase of any license of the report
  • You can directly share your requirements/changes to the current table of content to: sales@futurewiseresearch.com

Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1. Years Considered for the Study
         3.2. Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders
  • 2.   Research Methodology
    •   1. Research Data
         1.1. Secondary Data
          1.1.1. Key Data from Secondary Sources
         1.2. Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study
  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Medical Device Outsourcing Market Variables, Trends and Scope

    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Type Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Medical Device Outsourcing Market Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Medical Device Outsourcing Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Type Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Type Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Medical Device Outsourcing Market, By Service Historical Analysis and Forecast 2023-2031 (USD Million)

    •   1. Quality Assurance
        2. Regulatory Affairs Services
         2.1. Clinical trials applications and product registrations
         2.2. Regulatory writing and publishing
         2.3. Legal representation
         2.4. Other
        3. Product Design and Development Services
         3.1. Designing and engineering
         3.2. Machining
         3.3. Molding
         3.4. Packaging
        4. Product Testing and Sterilisation Services
        5. Product Implementation Services
        6. Product Upgrade Services
        7. Product Maintenance Services
        8. Contract Manufacturing
         8.1. Accessories manufacturing
         8.2. Assembly manufacturing
         8.3. Component manufacturing
         8.4. Device manufacturing

  • 8.   Medical Device Outsourcing Market, By Application Historical Analysis and Forecast 2023-2031 (USD Million)

    •   1. Cardiology
        2. Diagnostic Imaging
        3. Orthopedic
        4. IVD
        5. Ophthalmic
        6. General and plastic surgery
        7. Drug delivery
        8. Dental
        9. Endoscopy
        10. Diabetes care
        11. Others

  • 9.   North America Medical Device Outsourcing Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2023-2031

  • 10.   Latin America Medical Device Outsourcing Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2023-2031

  • 11.   Europe Medical Device Outsourcing Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2023-2031

  • 12.   Asia Pacific Medical Device Outsourcing Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2023-2031

  • 13.   Middle East and Africa Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2023-2031

  • 14.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 15.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)

    •   1. SGS SA
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. Toxikon, INC.
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Eurofins Scientific
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. Pace Analytical Services LLC.
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. Intertek Group PLC
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. Wuxi Apptec
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. North American Science Associates, Inc.
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. Tüv Süd AG
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9. American Preclinical Services
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview
        10. Sterigenics International LLC
         10.1. Company Overview
         10.2. Product Portfolio
         10.3. SWOT Analysis
         10.4. Financial Overview
         10.5. Strategic Overview
        11. Charles River Laboratories International, Inc.
         11.1. Company Overview
         11.2. Product Portfolio
         11.3. SWOT Analysis
         11.4. Financial Overview
         11.5. Strategic Overview
        12. Onex Corporation
         12.1. Company Overview
         12.2. Product Portfolio
         12.3. SWOT Analysis
         12.4. Financial Overview
         12.5. Strategic Overview
        13. Cardinal Health, Inc.
         13.1. Company Overview
         13.2. Product Portfolio
         13.3. SWOT Analysis
         13.4. Financial Overview
         13.5. Strategic Overview
        14. Heraeus Holding GmbH.
         14.1. Company Overview
         14.2. Product Portfolio
         14.3. SWOT Analysis
         14.4. Financial Overview
         14.5. Strategic Overview

  • 16.   Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the healthcare regulations initiated by administrations
        5. The overall economic slowdown of the developing and developed nations
  • 17.   FutureWise SME Key Takeaway Points for Client

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