Market Research Report Search Engine Added "Regulatory Affairs Outsourcing Market (Services - Regulatory Submissions, Clinical Trial Application and Product Registration, Regulatory Writing and Publishing, Regulatory Consulting and Legal Representation and Other Regulatory Affairs) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 - 2023" to its database.

1. Regulatory Affairs Outsourcing Market Analysis, Trends,
Growth, Sales, Supply, Demands, Research and Industry share
2023
Report Description
Increasing need for clinical research organizations (CROs) is
attributed to several factors such as expected patent

2. 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.
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regulatory-affairs-outsourcing-market

3. 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.
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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

4. 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

5. 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

6. 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.
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North America and Europe regions accounted for the largest
market share of the total regulatory affairs outsourcing

7. 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.

8. 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.
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