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.

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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 risk associated with the data security along with the hidden costs and huge price fluctuations offered by various CROs might hamper the market growth.

Regulatory writing and publishing segment accounted for the largest market share followed by clinical trial application and product registration segment. Clinical study protocols, standard operating procedures, ethics submission, regulatory submission, patient informed consent forms, and other pharmacology details represent some of the regulatory writing and publishing services. Regulatory writing and publishing services account for one of the major services outsourced frequently by the pharmaceutical companies as compared to other regulatory services.

On the other hand with the increasing use of technological platforms for clinical data management activities along with increasing number of clinical trials worldwide result in anticipated highest growth rate for clinical trial application and product registration segment during the forecast period from 2015 to 2023. Regulatory consulting and legal representation service segment is estimated to record second highest growth rate of more than 12% during the forecast period owing to need for consistent client interactions with the regulatory agencies, increasing demand for consultation with respect to country wise filing strategies and gap analysis. Regulatory submissions service comprise pre-approval submissions and post-approval regulatory activities involved during the product approval process. This segment accounted for the third largest market share of the total regulatory affairs outsourcing market.

The regulatory affairs outsourcing market represents a consolidated market where a few companies account for major market share. Several large CROs are looking forward for acquiring small size CROs to scale up their operations and offer diverse specialized regulatory services with high efficiency. Furthermore, increasing multi-year strategic collaboration with several pharmaceutical and biotechnology companies will further favor the market growth during the forecast period from 2015 to 2023. Quintiles Transnational Corporation, Covance, Inc., (LabCorp), Parexel International Corporation, Pharmaceutical Product Development LLC and ICON plc are some of the key players operating in regulatory affairs outsourcing market. The global regulatory affairs outsourcing market is influenced by the presence of large regional players and predominant in developed economies as compared to other developing economies. However, these companies are focusing on expansion in emerging economies especially in countries like India, China and Australia.

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The global regulatory affairs outsourcing market is segmented into the following categories:
• Global Regulatory Affairs Outsourcing Market, by Services
o Regulatory Submissions
o Clinical Trial Applications and Product Registrations
o Regulatory Writing and Publishing
o Regulatory Consulting and Legal Representation
o Other Regulatory Affairs
• Global Regulatory Affairs Outsourcing Market, by Geography
o North America
 U.S.
 Canada
o Europe
 U.K.
 Germany
 Rest of Europe
o Asia Pacific (APAC)
 India
 China
 Japan
 Rest of APAC
o Latin America (LATAM)
 Brazil
 Mexico
 Rest of LATAM
o Middle East and Africa (MEA)
 South Africa
 Rest of MEA


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