The global regulatory affairs outsourcing market is fragmented and a
very small number of players have been able to acquire dominance in
the market. There exists a large number of small and medium-sized
companies in the market which is granting high bargaining power to
clients and buyers. The competition between market players is
extremely high. The players are competing with each other by
differentiating their products and providing products in cheaper
prices. The acceptance of electronic submissions on account of
technological advancements by healthcare authorities and compliance
agencies will drive the growth prospects of the global regulatory
affairs outsourcing market, states Transparency Market Research
(TMR).
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According to Transparency Market Research, the global regulatory
affairs outsourcing market will be worth US$5.7 bn by 2023. On the
basis of type of regulatory affairs services, it is expected that
clinical trial applications and product registration segment will be
gaining immense traction on account of patent expires, and need for
developing new products due to the growing prevalence of chronic,
bacterial, and viral diseases. As a number of products in clinical
trials is increasing, the demand for product registration services
and clinical trial application services is increasing.
On the basis of geography it is expected that the emerging nations in
Latin America and Asia Pacific will turn out to be extremely
promising markets for regulatory affairs outsourcing. product
development, rise in the commercialization units, increasing number
of researches and availability of cheap resources and raw materials
will drive the growth of this market in emerging economies. Also, the
vast pool of patient population in Asia Pacific will create a
favourable environment for growth. Many new entrants are using
emerging nations for launching themselves in order to later on
venture into the bigger markets of North America and Europe.
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According to the lead author of the support, the rising pace with
which innovations are taking place in the medical sector, growing
investments in research and development activities, and increasing
competition between the players are helping the regulatory affairs
outsourcing market to grow. Companies within the market are finding
ways of reducing cost in order to attract more customers. The market
is also growing due to the rising awareness and realization that
outsourcing is cost-effective and resource effective way for the
managing of data generated during approvals, clinical trials, and
patent approvals.
Also, in many countries there is a presence of strict regulatory
framework which governs each aspect of development and marketing of
clinical drugs and medical devices, which makes it necessary that the
regulatory documents be as per the define guidelines. This is driving
the preference for professional service providers who all free
services such as efficient handling of data relating to regulatory
affairs.
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