SAN FRANCISCO, Feb. 24, 2021 /PRNewswire/ -- The global medical device analytical testing outsourcing market size is expected to reach USD 9.7 billion by 2028, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 7.6% from 2021 to 2028. Numerous medical device companies outsource analytical testing operations to minimize business risks, hasten product market entry, and reduce costs. These procedures lead to a significant rise in expenditure levels and, therefore, original equipment manufacturers of medical instruments rapidly switch to outsourcing as one of the effective cost curbing tools.
Key suggestions from the report:
The material characterization segment dominated the market in 2020 and is likely to grow at a lucrative rate during the forecast period
Other tests that are inclusive of cleaning, reprocessing, method development and validation, accelerated stability testing, biocompatibility, validation checking for packaging materials (container closure permeation), and transport stability are anticipated to witness the fastest growth over the forecast period
North America accounted for significant market share owing to the fact that it is one of the top manufacturing hubs of highly reliable, complex, and high-end medical instruments, with the presence of abundant service providers
Implantable Medical Devices (IMDs) are being used increasingly in order to improve patients' health outcomes. Designers of IMDs have to balance complexity, reliability, power consumption, and costs. Consequently, companies are shifting their focus to innovation rather than non-core activities and, therefore, outsourcing these activities to launch efficient instruments. All these factors are expected to drive the market over the forecast period.
In this complex ecosystem, it is necessary for the equipment to provide accurate results, to have durability, and easy operation. To match these parameters, devices now have to undergo shear checking in accelerated conditions to obtain marketing approval and have a competitive advantage. Conducting this in-house is a matter of time, labor, and cost; outsourcing these tests helps overcome these limitations. For instance, the ISO 10993 has revised the Analytical Evaluation Threshold (AET) for better toxicological safety assessment. Lack of awareness with regards to these tests among the manufacturers of medical instruments may lead to reworking, which is usually avoided when outsourced to third-parties. Hence it is very important to be aware of AET as regulators will review the analytical report to check whether the AET was followed or not. Also, it is the duty of the medical device manufacturer to ensure that AET is applied to the checking process.
Various companies globally have increased the manufacturing of medical devices such as personal protective equipment (PPE) kits, ventilators, and N-95 masks. This has created opportunities for the players in the Testing, Inspection, and Certification (TIC) Market to test and certify these instruments. Many companies such as TÜV SÜD and Eurofins have started checking these medical instruments, thus increasing the demand for analytical testing services from the healthcare industry. Also with increasing cases of COVID-19 globally, the demand for analytical testing services will surge in the coming months.
Grand View Research has segmented the global medical device analytical testing outsourcing market based on services, therapeutic areas, device type, end-use, and region:
Medical Device Analytical Testing Outsourcing Services Outlook (Revenue, USD Million, 2016 - 2028)
Extractable and leachable
Medical Device Analytical Testing Outsourcing Therapeutic Areas Outlook (Revenue, USD Million, 2016 - 2028)
General & Plastic Surgery
Medical Device Analytical Testing Outsourcing Device Type Outlook (Revenue, USD Million, 2016 - 2028)
Medical Device Analytical Testing Outsourcing End-use Outlook (Revenue, USD Million, 2016 - 2028)
Medical Device Analytical Testing Outsourcing Regional Outlook (Revenue, USD Million, 2016 - 2028)
Middle East & Africa
List of Key Players of Medical Device Analytical Testing Outsourcing Market
Bioburden Testing Market – The global bioburden testing market size was valued at USD 727.0 million in 2018 and is expected to witness lucrative CAGR of 13.7% over the forecast period.
Medical Device Testing Services Market– The global medical device testing services market size was estimated at 6.9 billion in 2019 and is anticipated to expand at a CAGR of 9.4 % over the forecast period.
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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.