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Over the years, outsourcing has become an indispensable business strategy within the global medical devices market. Moreover, the increasing regulatory stringency worldwide, is causing many innovator companies to rely on the expertise of CROs to liaise regulators and handle the intricacies associated with product approval. As per our analysis, we expect the overall medical device CRO market to be worth USD 8.5 billion in 2020, and this value is projected to reach USD 15.7 billion by 2030, growing at a CAGR of 6.4%.
In terms of scale of operation, the market for CROs offering services for clinical scale development of medical devices is likely to be worth USD 6.6 billion, and this value is projected to be USD 12.5 billion by 2030. It is important to highlight that clinical CROs presently capture a higher share in the overall medical device CROs market and this can be attributed to the increasing number of clinical trials being conducted for medical devices, as well as higher costs associated with conducting clinical studies, as compared to preclinical research activities. Additionally, the market for medical device CROs offering preclinical services is anticipated to increase from USD 1.9 billion (2020) to USD 3.2 billion (2030).
Further, in terms of preclinical services being offered, sterility and microbiology testing services presently capture the highest share (35%) in the overall medical device CROs market (in terms of service revenues). In 2020, the market for the aforementioned services CROs is likely to be worth USD 0.7 billion, and this value is projected to reach USD 1.2 billion by 2030.
In terms of therapeutic area, in 2020, services offered for the development / approval of devices intended for the treatment / management of CNS disorders capture the highest market share (in terms of service revenues) and this trend is unlikely to change in the foreseen future; this segment is anticipated to be worth USD 2.2 billion by 2030. In addition, in terms of device class, class III devices represent the highest market share (48%), followed by class II devices (45%), and this trend is unlikely to change in the foreseen future as well.
In terms of geography, North America (41%) currently represents the highest market share (in terms of service revenues), followed by Europe (32%). By 2030, the market in the aforementioned regions is likely to be worth USD 6.2 billion and USD 5.0 billion, respectively. On the other hand, the medical device CROs market within Asia-Pacific and other regions of the world is projected to grow at relatively faster pace, representing CAGRs of 7.1% and 10.1% respectively.