Clinical trials form an integral part of the overall drug development process, enabling the necessary evaluation of the safety and efficacy of a drug candidate. Studies suggest that around 40% of the total investment made for the development of drug candidate is dedicated to clinical trials; this is equivalent to an expenditure of USD 78 billion annually. However, the conduct of such trials is often fraught with challenges, including scientific and operational complexity, concerns associated with recruitment and retention of suitable patients, issues related to data handling and increasingly stringent regulatory guidelines. Further, owing to the inherent complexity of the overall process and involvement of several different stakeholders, these trials are prone to delays. In fact, over 80% of the clinical trials are delayed by at least one to six months, while only 10% of the studies are completed on time and one of the key reasons is believed to be site management.
Site management organizations (SMOs) has emerged as a viable option for various developers. Currently, around 245 companies claim to be actively providing clinical site management services to drug and medical device developers across the world. Recently, there has been a lot of activity within the site management market, primarily focused on consolidation of affiliated capabilities, service portfolio expansions and collaborations to extend geographical reach. The aforementioned developments may be attributed to the growing preference for one-stop-shops among sponsor companies, and the gradual acceptance of outsourcing as a viable and beneficial operating model for conducting clinical trials and managing research sites. With the growing complexity, as well as rise in the number of clinical trials being registered, the demand for SMOs is anticipated to grow at a steady pace in the coming years.
Stakeholders Involved in Site Management Organizations Domain
Currently, close to 245 companies that are actively involved in offering various site management services. The SMOs market is highly fragmented, featuring the presence of small (57%), as well as mid-sized (31%) and large (12%) players. Further, majority (43%) of the SMOs are based in North America, followed by those headquartered in Asia-Pacific (32%). In terms of therapeutic area, most of the players in this domain provide services focused on oncological and cardiovascular disorders. Additionally, 130 companies offer clinical trial site management services for studies evaluating medical devices.
It is worth highlighting that 145 service providers in this domain offer site management services for trials planned to be conducted in North America, while 113 and 148 players provide these services in Europe and Asia-Pacific region, respectively. A total of 61 companies claim to have the capabilities to offer clinical trial site management services across the globe.
Billions of Dollars are Being Invested in Funding the Initiatives of Various Players Engaged in the Clinical Trial Site Management Domain
Maximum number of instances (five each) were reported in the year 2015 and 2017. This was followed by four instances each, recorded in the year 2016 and 2019. It is also worth mentioning that seven funding instances were reported in 2021 (till September). Further, Most of the funding instances reported by site management organizations were venture capital rounds (12). Given the current trend, it can be inferred that investment from venture funding rounds is a key enabler for the growth in this domain.
Current Annual Demand for Clinical Trial Study Participants
As the clinical research activity within the pharmaceutical industry is increasing, the global demand for clinical trial participants (outsourced) in 2021 is likely to be 8.1 million patients, and this number is likely to increase to 25 million patients by 2035, growing at a CAGR of 8.2%.
Further, the global demand for clinical trial participants in phase III and phase IV trials is likely to increase from 3.5 million and 3.1 million patients, respectively, in 2021 to 11 million and 9.4 million patients, respectively by 2035.
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