The Rise of Medical Device CROs

According to the World Bank, more than 50,000 different types of Medical Device are currently being used every day in health care facilities worldwide.  In 2018, the global medical devices market is estimated to reach a net worth of approximately USD 450 billion. However, a relatively larger proportion of device developers lack the required internal resources and technical expertise to conduct in-house clinical trials. Moreover, the costs associated with acquiring the necessary infrastructure / capabilities for such elaborate research initiatives are high. The aforementioned challenges have led several players in the industry to outsource a significant part of their clinical stage research efforts to capable contract research organizations (CROs).

Presently, more than 300 CROs are actively engaged in providing a variety of preclinical and clinical services to medical device developers

Medical Device landscape comprises of over 300 CROs. over 95% of the players offering services for clinical operation management followed by 89% for regulatory affairs

Majority of the players are based in developed regions; in addition to established players, several start-ups / small sized companies offer services for medical device development.

Companies involved in this domain are steadily expanding their capabilities to enhance the range of services they offer and comply to existing industry benchmarks.

Close to 7,000 clinical trials, focused on medical devices, have been registered across the globe in the last five years, highlighting the increasing demand for contract service providers

Over 60% of clinical trials are currently in recruiting trial status majority of them were registered in North America.

In order to comply with multiple regional regulatory standards, a number of CROs have already established capabilities to offer support services in this area.

The domain has witnessed over 30 acquisitions, valued between USD 100 million and USD 5 billion, in past six years alone.

With a potential of over USD 10 billion, the market will continue to be led primarily by the clinical service providers over the coming decade.

Driven by the growing demand for effective treatment modalities across various therapeutic areas, the market is poised to witness sustained growth across different device classes

The overall market for Medical Device CROs is fragmented across various segments therapeutic area and device class being the prominent one

Clinical operations management is anticipated to lead the pack in the mid-long term; companies based in North America are expected to retain the higher market share.

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