Medical Device Outsourcing Market (By Service: Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Product Testing & Sterilization Services, Product Implementation Services, Product Upgrade Services, Product Maintenance Services, Contract Manufacturing; By Application: Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmic, General and Plastic Surgery, Drug delivery, Dental, Endoscopy, Diabetes care) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook 2022 2030

The global medical device outsourcing market size was valued at USD 106.92 billion in 2021, and is predicted to be worth around USD 291.93 billion by 2030, registering a CAGR of 11.1% during the forecast period 2022 to 2030.

Medical Device Outsourcing Market Size 2021 to 2030

Growth Factors

The rising demand for advanced medical products and a growing trend of offshoring are fueling the growth of this market. Various initiatives by public organizations promoting testing for COVID-19 are also enhancing market growth. Regulatory bodies are emphasizing the quality of the healthcare devices provided to the public that is becoming burdensome to handle. To meet the regulatory scenario, various services like regulatory consulting are being utilized by the industry players.

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.

Report Coverage

Report Scope Details
Market Size US$ 291.93 billion by 2030
Growth Rate CAGR of 11.1% From 2022 to 2030
Largest Market Asia Pacific
Base Year 2021
Forecast Period 2022 to 2030
Segments Covered Services, Application
Regional Scope North America, Europe, Asia Pacific, Latin America, Middle East & Africa
Companies Mentioned 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

By Service Analysis

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. 

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.

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.

By Application Analysis

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.

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.

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. 

By Regional Analysis

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, 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.

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.

Key Players

  • 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. 

Market Segmentation

  • By Service 

    • 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

  • By Application 

    • 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

  • Regional

    • 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

The medical device outsourcing market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of medical device outsourcing market for the base year 2022 and the forecast between 2022 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global medical device outsourcing market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the medical device outsourcing market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted medical device outsourcing market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the medical device outsourcing capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of medical device outsourcing by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global medical device outsourcing market. These figures have been provided in terms of both revenue and volume for the period 2019 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major medical device outsourcing market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of medical device outsourcing market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the medical device outsourcing industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

medical device outsourcing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to medical device outsourcing market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of medical device outsourcing market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new medical device outsourcing market. These factors have benefited the growth of the global market for medical device outsourcing. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for medical device outsourcing. The global market is segmented on the basis of region, application, end-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of medical device outsourcing are as follows:

  • History Year: 2019-2021
  • Base Year: 2022
  • Forecast Year 2022  to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2019-2022) and forecast (2022-2030);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market

To strategically profile the key players and comprehensively analyze their growth strategies.

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