Regulatory Affairs Outsourcing Market

Regulatory Affairs Outsourcing Market - The Pharmaceutical Industry Has Been
Constantly Evolving As Traditional Methods Of Drug Development Continue To
Expand
The global regulatory affairs outsourcing market was valued at US$ 4,236.2 Mn in
2017 and is expected to expand at a CAGR of 13.1% from 2018 to 2026, according
to a new report published by Transparency Market Research (TMR) titled “Regulatory
Affairs Outsourcing Market – Global Industry Analysis, Size, Share, Growth, Trends,
and Forecast, 2018–2026.” North America region is expected to hold the dominant
revenue share, with the market in the region expanding at a CAGR of above 10%.
The global regulatory affairs outsourcing market is mainly driven by growing
stringent government regulations and automation in regulatory affairs.
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Improving return on investment by timely approvals, and rise in research and
development activities especially in life sciences industry globally driving the market
The pharmaceutical industry has been constantly evolving as traditional methods of
drug development continue to expand. There is constant pressure on pharmaceutical
and medical devices industry to reduce cost of prescription drugs and critical
healthcare devices. As companies continue to expand their business in the global
market, timely clinical approvals from regulators is becoming key to their success.
Toward this end, biopharmaceutical and medical device companies have strengthened
their in-house regulatory department or outsourced this function to regulatory affairs
consulting firms. As pressure to improve return on investment grows, limitation on
finding experienced workforce especially in smaller companies for internal R&D, and
reduced drug development timeline with increasing stringent government regulations
have led to the growth of the regulatory affairs market globally. Also, increasing
research and development activities, along with patent expirations, have been
identified as major factors fueling the growth of the regulatory affairs outsourcing
market.
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Growing adoption of regulatory writing and publishing a crucial factor in the
expansion of the market
The regulatory affairs outsourcing market can be segmented based on service and
region. The service segment is classified into regulatory submissions; clinical trial
applications and product registrations; regulatory writing and publishing; regulatory
consulting and legal representation;and others. The others segment includes
maintenance and post-marketing surveillance. The growth in regulatory writing and
publishing is attributed to the increased frequency of outsourcing medical writing,
clinical trial summaries, drafting of informed consent forms and other services. Also,
the regulatory consulting and legal representation segment is expected to expand at
the highest CAGR during the forecast period. This is due to the increasing need for
the consultation specifically with respect to country wise filing strategies and for gap
analysis.

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