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.
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.
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Medical Device Analytical Testing Outsourcing Market Report Highlights
- 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