The Global Medical Device Testing Services Market is anticipated to reach US$ 14,660.1 Mn in 2027 from US$ 5,505.4 in 2018. The market is projected to grow with a CAGR of 11.7% from 2019-2027.
Innovative product development, collaborations, mergers and acquisitions, the stringent regulatory scenario for medical device approval are boosting the growth of the market over the years. Also, the developments in the medical device industry is likely to have a positive impact on the demand for the market during the forecast period. However, the growth of the market is restrained by factors such as interruptions in contractual obligations.
Some of the major primary and secondary sources included in the report are, Food and Drug Administration, World Health Organization, International Trade Administration (ITA), Federal Commission for Protection against Sanitary Risk (COFEPRIS), Medicines and Healthcare products Regulatory Agency (MHRA), Federal Institute for Drugs and Medical Devices.
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Medical device testing needs strong experience of the domain, native and national legislations, and information about the devices, infrastructure, and ability to support the testing. The healthcare and medical device industry is an active one due to continuous development and advanced solutions. The enhancements in medical device technology have significantly enhanced the efficiency of patient care in the last few decades. As per the FDA in 2018, stated that there are above 80,000 incidents identified since 2008, due to the medical device injury. Since, last few years, medical device companies and doctors have observed that spinal-cord stimulators have helped the patients who suffer from pain disorders. Due to this, it has become one of the most rising products in the $400 billion medical device industry. Therefore, the increasing incidences of product recall and higher demand for quality products are growing the need for testing of medical devices. Hence, it will boost the market for medical device testing services.
However, a number of problems inhibit medical devices from undertaking the standard formulary agency review process applied to drugs. In recent years, approximately thirty percent of respondents experienced a significant supply shortage or disruption that was mostly due to supply shortages, quality issues in manufacturing, and delays in regulatory approvals.
Global medical device testing services market is segmented by Service and Phase. On the basis of service, the market is segmented into biocompatibility test, chemistry test, microbiology & sterility testing, and package validation. On the basis of Phase, the market is segmented into preclinical and clinical. In 2018, the microbiology & sterility testing held the most significant market share 53.55% of the medical device testing services market, by service whereas the preclinical segment by Phase, held a considerable market share of 68.17% in 2018.
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