Medical Device Outsourcing Market: Quality Assurance Services Segment Is Projected To Grow At The Fastest CAGR
Medical Device Outsourcing Industry Overview
The global medical device outsourcing market size is expected to reach USD 292.93 billion by 2030, registering a CAGR of 12.1% during the forecast period, according to a new report by Grand View Research, Inc. 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.
For example, the European Medical Device Regulation undertake special spontaneous inspection of outsourced products to test the quality as well as conformity with standards. Contract manufacturers, especially in developed countries like the U.S., EU nations, and Japan, comply with the international standards for a quality management system, which makes them a preferred option as compared with contract manufacturers in India and China. However, regulatory changes anticipated in developing countries ensure compliance by contract manufacturers. The demand for regulatory compliance is expected to boost the growth of consulting services, such as remediation, compliance, and QMS, thereby contributing to the growth of the market.
Medical Device Outsourcing Market Segmentation
Grand View Research has segmented the global medical device outsourcing market based on service, application, and region:
Based on the Service Insights, the market is segmented into Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Product Testing & Sterilization Services, Product Implementation Services, Product Upgrade Services, Product Maintenance Services, and Contract Manufacturing.
- 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. In addition, increasing complexity in manufacturing is contributing to market growth. Manufacturing high-quality and safe devices for patient care is a major concern of medical device manufacturers.
- 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.
Based on the Application Insights, the market is segmented into Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmic, General & Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care, and Others.
- 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. This is due to the high prevalence of conditions, such as angina pectoris, myocardial infarction, hypertensive heart disease, rheumatic heart diseases, atrial fibrillation, and congenital heart disease. The high prevalence of CVDs globally is increasing the demand for cardiovascular 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. The awareness and consciousness about physical appearance have significantly increased in recent years, which has increased the demand for cosmetic surgeries globally.
Medical Device Outsourcing Regional Outlook
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa (MEA)
Key Companies Profile & Market Share Insights
Many new companies are anticipated to venture into this space due to the increasing demand for medical devices around the globe. This is projected to boost the competition level in the global arena. In addition, collaborations among existing players and niche service offerings to boost quality are likely to fuel market growth over the forecast period. Established players in the market are expected to broaden their portfolio and provide one-stop solutions to withstand aggressive competition. For instance, in January 2021, SGS SA received the FDA approval to participate & provide services for third-party 510(k) premarket submissions for medical devices. Market players are also adopting the strategy of acquisition to enhance their service portfolio.
For instance, in December 2021, the life sciences company, Labcorp, acquired a CRO, Toxikon Inc., to expand its offerings by providing testing services for medical devices, pharmaceuticals, and other industries. Also, during the pandemic, players continued to work hard to serve the industry since the beginning of COVID-19. For instance, in April 2020, Eurofins announced that its laboratories through Europe, U.S., and Asia are providing worldwide service offering for inspection, testing, and regulatory services focused on medical gowns, gloves, & face masks along with respiratory protective devices & equipment, its component & materials to serve the mounting demand due to the pandemic. Some prominent players in the global medical device outsourcing market include:
- 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 Corp.
- Tecomet Inc.
- Jabil Inc.
- Flex Ltd.
- Celestica Inc.
- Sanmina Corp.
- Plexus Corp.
- Phillips Medisize
- Cantel Medical Corp.
- West Pharmaceutical Services, Inc.
Order a free sample PDF of the Medical Device Outsourcing Market Intelligence Study, published by Grand View Research.
About Grand View Research
Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research Helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.
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