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  • Published Date:
    6 Oct 2021
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    Healthcare & Pharmaceuticals
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Impact Analysis on the Growth of Market

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Market Overview:

The global medical device outsourcing market is expected to intensify at a compound annual growth rate (CAGR) of around 12% during the forecast period 2022-2030. During the forecast period, the increasing demand for medical devices, coupled with intensified price competition, is expected to promote the development of the market. In addition, the increasing difficulty of product engineering and the increase in the number of new entrants are expected to shape the future of the market.


The increasing prevalence of chronic diseases is driving the demand for medical devices. In turn, this is good for the market. Implantable medical devices (IMD) are widely used to improve patients; medical outcomes. IMD designers must balance complexity, reliability, power consumption, and cost. As a result, the company is shifting its focus from secondary activities to innovation, thereby outsourcing these activities to launch efficient equipment. The revision of ISO standards is expected to drive demand for quality assurance and regulatory affairs service providers in the United States and Europe, as small and medium-sized enterprises (SMEs) will need third-party assistance to comply with the new rules.


It is expected that subcontractors and original equipment manufacturers (OEMs) in developed countries such as Canada will adopt these new standards earlier than in developing countries. However, the coronavirus pandemic has caused severe disruptions in the supply chain, leading to shortages and a severe slowdown in production. He emphasized that OEMs need scalable manufacturing operations, especially those that produce test kits and diagnostic systems. Due to supply chain issues, full-service contract manufacturing organizations (CMOs) continue to gain more participation from original equipment manufacturers. However, the current pandemic is a push for product sterilization services. As the pandemic continues, the need for disinfection of disposable medical devices and personal protective equipment (PPE) remains high. In late March, the U.S. Environmental Protection Agency (EPA) and Becton, Dickson & Company reached an agreement to increase the number of equipment the company disinfects during the pandemic.


The contract manufacturing service sector leads the global medical device outsourcing market, accounting for more than 55% of global revenue in 2020. Due to increasing focus on cost reduction, it is expected to maintain its leading position during the forecast period. Production. In addition, the increase in manufacturing complexity has also contributed to the growth of this market segment. Manufacturing high-quality, safe equipment for patient care is a major concern for medical device manufacturers. In addition, high-level inspections during the development of medical devices have also created layers of standards and regulations. Therefore, this creates a demand for manufacturing services. However, the quality assurance services sector is expected to record the fastest compound annual growth rate of 13.6% between 2021 and 2028. Maintaining an effective quality management system is an indispensable part of all product manufacturing and medical services. equipment. One of these quality management systems is ISO 13485, which involves the development, implementation and maintenance of products for medical device manufacturers and suppliers. Medical device manufacturers outsource quality management services to medical device consulting companies to ensure compliance and provide high-quality components and safe and effective finished medical devices.


The cardiology department has the highest revenue share in 2020, exceeding 20%, and may maintain a dominant position throughout the forecast period. Due to the high incidence of related diseases, the demand for cardiovascular equipment continues to grow, which is attributed to the increase in outsourcing of these equipment. In addition, the complexity of cardiovascular equipment and the need for technical expertise have led to an increase in the outsourcing of these equipment. On the other hand, the plastic surgery and general surgery departments are expected to show the fastest compound annual growth rate during the forecast period. This growth can be attributed to the availability of capable outsourcing companies, meeting regulatory requirements, and increasing demand for cosmetic surgery. In addition, the introduction of minimally invasive and non-invasive surgery has led to more operations within a year. This requires innovation and specific equipment for each program.


The Asia-Pacific region is the main regional market in 2020, with a revenue share of over 41%. Due to the easy availability of qualified human resources, the regional market will further expand at a constant compound annual growth rate from 2021 to 2028. In addition, the existence of key companies and competitive prices are other supporting factors that are expected to promote the development of the regional market. Due to the increase in chronic disease cases, the demand for medical devices continues to increase, driving the growth of the market in this region. Due to mature high-end, consistent and complex medical product manufacturing centers, North America will account for a large share of revenue in 2020. equipment. In addition, the technologically advanced electronics industry in the region is driving the growth of the North American market. There are also numerous medical device companies in the region, which outsource part of the regulatory and consulting functions to regulatory service providers, thus contributing to the growth of the entire market.


Due to the growing global demand for medical equipment, many start-up companies are expected to enter the market. This is expected to increase the level of competition on the global stage. In addition, cooperation between existing participants and professional service products to improve product quality may drive market growth during the forecast period. It is expected that mature market participants will expand their product portfolio and provide comprehensive solutions to withstand fierce competition during the forecast period. For example, in January 2021, SGS SA was approved by the US FDA to participate in and provide services for third-party 510(k) pre-market medical device shipments. In addition, during the pandemic, the company continued to work hard to serve the industry. For example, since the beginning of the pandemic, Toxikon has managed to operate safely and efficiently as a single supplier of pre-clinical safety and effectiveness testing to ensure the delivery of healthcare products to patients. In addition, in April 2020, Eurofins announced that its laboratories in the United States, Asia and Europe are providing global service products for inspection, testing and regulatory services, with a focus on medical clothing, gloves and masks, as well as medical devices and respiratory protection. Equipment and its components and materials to meet the growing demand due to the pandemic. Some of the major players in the global medical device outsourcing market include: SGS SAI Q VIA Toxikon, Inc. Eurofins Scientific SEPace Analytical Services, Inc. Intertek Group plc WuXi AppTec, Inc. North American Science Associates, Inc. Charles River Laboratories International, Inc. PAREXEL International Corp.


The report forecasts global, regional and national revenue growth, and analyzes the latest industry trends in each sub-segment from 2022-2030. For the purpose of this research, Kenneth Research. has segmented the global medical device outsourcing market report based on service, application and region: Service Outlook (Revenue, USD million, 2022-2030): Regulatory Affairs to Ensure Service Quality Serving clinical trial product application and registration drafting and issuing regulations and laws representing others.
Product design and development service design and engineering machining forming packaging product testing and sterilization service product implementation service product upgrade service product maintenance service OEM manufacturing accessories manufacturing assembly manufacturing component manufacturing and plastic surgery Class III Dentro III drugs.

Geography Analysis:

The report further discusses the market opportunity, compound annual growth rate (CAGR) growth rate, competition, new technology innovations, market players analysis, government guidelines, export and import (EXIM) analysis, historical revenues, future forecasts etc. in the following regions and/or countries:

  • North America (U.S. & Canada) Market size, Y-O-Y growth, Market Players Analysis & Opportunity Outlook
  • Latin America (Brazil, Mexico, Argentina, Rest of Latin America) Market size, Y-O-Y growth & Market Players Analysis & Opportunity Outlook
  • Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC(Finland, Sweden, Norway, Denmark), Ireland, Switzerland, Austria, Poland, Turkey, Russia, Rest of Europe), Poland, Turkey, Russia, Rest of Europe) Market size, Y-O-Y growth Market Players Analys  & Opportunity Outlook
  • Asia-Pacific (China, India, Japan, South Korea, Singapore, Indonesia, Malaysia, Australia, New Zealand, Rest of Asia-Pacific) Market size, Y-O-Y growth & Market Players Analysis & Opportunity Outlook
  • Middle East and Africa  (Israel, GCC (Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman), North Africa, South Africa, Rest of Middle East and Africa) Market size, Y-O-Y growth Market Players Analysis & Opportunity Outlook


1.1 Overview of the Market
1.2 Scope of Report
1.3 Assumptions


3.1 Data Mining
3.2 Validation
3.3 Primary Interviews
3.4 List of Data Sources

4.1 Overview
4.2 Market Dynamics
4.2.1 Drivers
4.2.2 Restraints
4.2.3 Opportunities
4.3 Porters Five Force Model
4.4 Value Chain Analysis

5.1 Overview
5.2 Quality Assurance
5.3 Regulatory Affairs Services
5.4 Product Design and Development Services
5.5 Product Testing & Sterilization Services
5.6 Product Implementation Services
5.7 Others
6.1 Overview
6.2 Cardiology
6.3 Diagnostic imaging
6.4 Orthopedic
6.5 IVD
6.6 Ophthalmic
6.7 General and plastic surgery
6.8 Drug delivery
6.9 Others
7.1 Overview
7.2 North America
7.2.1 U.S.
7.2.2 Canada
7.2.3 Mexico
7.3 Europe
7.3.1 Germany
7.3.2 U.K.
7.3.3 France
7.3.4 Rest of Europe
7.4 Asia Pacific
7.4.1 China
7.4.2 Japan
7.4.3 India
7.4.4 Rest of Asia Pacific
7.5 Rest of the World

8.1 Overview
8.2 Company Market Ranking
8.3 Vendor Landscape
8.4 Key Development Strategies

9.1 Eurofins Scientific
9.2 Integer
9.3 Plexus
9.4 Pace Analytical Services
9.5 Tecomet
9.6 Intertek Group
9.7 Jabil
9.8 MAPI
9.9 Celestica
9.10 SGS SA

10 Appendix
10.1 Related Reports

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