Increasing need for clinical research organizations (CROs) is attributed to several factors such as expected patent expirations of blockbuster drugs, and increased regulatory scrutiny with respect to price and quality of the drugs. In addition, expensive clinical trials, and demand for reduced time required for commercialization of new drugs will further support the growth of regulatory affairs outsourcing market. Regulatory affairs and operations encompass a wide range of processes such as country regulatory affairs, report publishing, submission planning, regulatory data management, regulatory strategy, dossier conversion, literature searches, and others.
Regulatory service providers are constantly refining their service offering strategies in order to ensure increased consistency and reliability. For instance, Quintiles employs Hub and Spoke model to serve their clients. This has resulted in continuous evolution of CROs to become an integral part of drug discovery and development from being a provider of non-core services.
The global regulatory affairs outsourcing market was valued at US$ 1,978.4 Mn in 2014 and is projected to reach US$ 5,746.5 Mn by 2023, expanding at a CAGR of 11.5% during the forecast period from 2015 to 2023. Factors such as extensive documentation involved during drug/device manufacturing, increasing preference for outsourcing regulatory affairs along with enhanced cost efficiencies result in increased demand for the regulatory affairs outsourcing activities and drive the market growth. On the other hand, factors such as system access, data security, loss of control, increased compliance risk, and third party performance are some of the concerns that would hamper the market growth.
Regulatory affairs outsourcing services constitute an essential component of several medical devices, biotechnology and pharmaceutical companies in order to mitigate the risks associated with product failure resultant of dynamic and competitive regulatory requirements from the respective regulatory agencies worldwide. With more than 35% market share of the total regulatory affairs outsourcing market, regulatory writing and publishing segment accounted for the largest market service segment as compared to other services. This attributed to the increased frequency of outsourcing the medical writing, clinical trial summaries, drafting of informed consent forms and other services. Clinical trial applications and product registration service segment is anticipated to record highest growth rate during the forecast period from 2015 to 2023. This attributed to increasing standardization of regulations and guidelines specifically for emerging markets in conjunction with increasing preference for immediate approvals and minimal queries constitute the factors driving the market growth. In addition, increasing use of technological platforms in ensuring effective clinical data management will further favor the market growth. Other regulatory services such as regulatory consultation and legal representation services segment is also anticipated to record second highest growth rate during the forecast period owing to the increasing need for the consultation specifically with respect to country wise filing strategies and for gap analysis.
North America and Europe regions accounted for the largest market share of the total regulatory affairs outsourcing market, reason being the majority of the large CROs are domiciled in these regions. U.S. regulatory affairs outsourcing market accounted for the largest market share as compared to Canada market owing to implementation of well-structured regulatory policies along with huge presence of leading pharmaceutical companies. In addition, implementation of certain legislative reforms such as Health Information Technology for Economic and Clinical Health Act (HITECH), American Recovery and Reinvestment Act (ARRA) and Patient Protection and Affordable Care Act (PPACA) contribute towards increased outsourcing of pharmaceutical companies business elements including regulatory activities.
However, increasing research and development expenditures along with increasing preference for conducting clinical trials in Asia Pacific and Latin American countries, the market for regulatory affairs outsourcing in these regions is anticipated to record highest growth rate during the forecast period from 2015 to 2023.