Published: June 2020
Owing to the numerous complexities associated with clinical research, medical device developers rely on contract service providers in order to reduce the risk of device recalls and expedite the time to market
Roots Analysis has announced the addition of the “Medical Device CRO Market (2nd Edition), 2020-2030” report to its list of offerings.
Given the complex R&D protocols and the increasing demand for clinical evidence of therapeutic benefit, there seems to be a lucrative opportunity for contract research providers engaged in the medical devices’ domain. In fact, since 2000, 150 new CROs have been established that offer a variety of cost-efficient services and solutions to medical device developers.
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Over 300 CROs presently offer a wide range of preclinical and clinical research-related services to medical device developers
It worth noting that more than 85% CROs offer clinical development services to sponsor companies. Further, the market is currently dominated by the presence of very small and small companies (less than 51 employees), that represent over 50% of the total players.
Close to 50% CROs claim to have elaborate clinical service portfolio, offering end-to-end solutions
Majority of such players offer assistance in clinical trial monitoring (83%) and clinical data management (83%); other popular services include (in terms of number of companies offering them) those provided for initiating clinical studies (79%), medical writing (78%), devising a clinical strategy (75%), and clinical project management (70%).
More than 70% of medical device CROs are based in North America and Europe
Within North America, majority of the service providers are headquartered in the US, in fact, over 50% of preclinical service providers are US-based; whereas, in Europe, most of the CROs are distributed across France, Germany, Switzerland, Spain, Italy and Sweden. Further, a significant number of such players (30%) are headquartered in Asia-Pacific and other developing countries of the world.
7,500+ medical device focused clinical trials have been registered worldwide
Of these, close to 70% trials are actively recruiting participants. So far, close to 2.9 million patients have been enrolled in ongoing / planned trials of medical devices. Interestingly, maximum number of patients were enrolled in studies being conducted in Asia-Pacific, during the period 2015-2020.
M&A activity in this domain increased at a CAGR of 47%, during 2015-2019
Key drivers behind acquisitions include geographical consolidation, geographical expansion, service portfolio consolidation and service portfolio expansion. Examples of acquisitions carried out to expand the acquirer company’s geographical reach include (in reverse chronological order) the acquisition of The Clinical Trial by Veristat (January 2020), Target Health by dMed (June 2019), Citoxlab by Charles River Laboratories (April 2019), and MedicSense by genae (January 2019).
North America and Europe are anticipated to capture over 65% of the market share by 2030
In the long term, the market in Asia-Pacific is expected to grow at a relatively faster pace. Further, in terms of device class, class III medical devices currently represent the highest share and this trend is unlikely to change in the foreseen future.
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The USD 15.7 billion (by 2030) financial opportunity within the antibody contract manufacturing market has been analyzed across the following segments:
The report features inputs from eminent industry stakeholders, according to whom, the requirement of high technical expertise and experienced personnel for conducting clinical research has compelled developers to outsource various aspects of their clinical operations. Experts further suggest that, at present, most outsourced activities by sponsor companies include regulatory affairs management, clinical trial site selection, trial monitoring and project management. The report includes detailed transcripts of discussions held with the following experts:
The research covers profiles of key players; each profile features an overview of the company, financial details (if available), medical device focused service portfolio and an informed future outlook.
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