Regulatory Affairs Outsourcing Market to Touch US$5.7 bn by 2023, Spending on Clinical Trial Application and Product Registration to Rise Substantially According to a new market report published by Transparency Market Research “Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 - 2023,� the global regulatory affairs outsourcing market was valued at US$1.9 bn in 2014 and is expected to reach US$5.7 bn by 2023, at a CAGR of 11.5% during the forecast period from 2015 to 2023. Contract research organization (CRO) is an organization contracted by a sponsor to manage various drug development activities including conducting pre-clinical studies, clinical trial data management, medical writing, regulatory submission and others. In recent years several small and large biopharmaceutical companies are increasingly relying on the CROs and other clinical research service providers with respect to clinical trial and other drug development activities.
Biopharmaceutical companies are outsourcing their regulatory affairs in order to access new capabilities of CROs, focusing on core competencies, focused towards variable costs than fixed costs and expand their geographical presence. Reduction of fixed costs and internal resource utilization, risk mitigation, efficient execution of services, and speed up the commercialization of new drugs constitute some of the benefits rendered by regulatory affairs outsourcing activities to the sponsors. Contract research organizations (CROs) provide several regulatory support services to large pharmaceutical companies such as regulatory intelligence, regulatory document submissions, product labeling, liaison with regulatory authorities, setting up of regulatory strategies and others. Currently, majority of the pharmaceutical companies are outsourcing submissions management activities such as content authoring, component coordination and assembly, dispatch and archiving, and internal review among others. Stability of CROs, use of technological advances, flexibility, staffing, reputation and location of the CROs represent some of the factors scrutinized by the pharmaceutical companies to select their outsourcing partner. Factors such as increasing importance for the huge documentation mandated during the drug approval process and high costs of research and development and clinical trial activities might favor the market growth. On the other hand, factors such as high