According to the report, the global medical device & IVD regulatory affairs
outsourcing market
In terms of service, the global medical device & IVD regulatory
affairs outsourcing market has been classified into regulatory writing &
submissions, regulatory registration services, regulatory consulting, and
others. Based of software, the market has been divided into cloud-based
software and on-premises software. Increase in regulatory requirements and
expansion of the medical device industry boost the global medical device &
IVD regulatory affairs outsourcing market.
North America dominated the global medical device & IVD regulatory
affairs outsourcing market in 2019, and the trend is anticipated to continue
during the forecast period. Stringent government regulations, presence of
large-scale research units, and increase in clinical research are key factors
attributed to the prominent share held by North America in the global market.
Furthermore, increase in patient awareness regarding cost savings and easy
access to global expertise resulted in enhanced adoption of regulatory affairs
outsourcing activities by medical device companies.
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Asia Pacific is expected to be a highly lucrative market for medical
device & IVD regulatory affairs outsourcing during the forecast period.
This can be ascribed to increase in approvals of Asia-based CMOs by the U.S.
FDA to pursue their regulatory services operations and rise in completion of
good manufacturing practice (GMP) certification. Preference for business
expansion in countries such as India and China by companies due to favorable
business environment is likely to boost the regulatory affairs outsourcing
market in these countries.
Expansion of Medical Device Industry and Increase
in Regulatory Requirements to Drive Global Market
The medical device industry is expanding at a rapid pace, driven by
innovative technology, and improvement in diagnosis, treatment, and delivery.
The medical device industry has made rapid progress in the last decade, owing
to government initiatives to increase product access. Moreover, recent
technological and scientific advantages with adoption of digital technologies
and expansion in emerging markets further boost the medical device industry. A
surge in the demand for technologically advanced products, owing to rise in
prevalence of various chronic diseases is likely to fuel industry growth.
Hence, the expansion of the medical device industry is leading to the
requirement for regulations on newly launched products, and regulatory affair
paper submission and registration process.
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Regulatory Writing & Submissions to be
Main Services
In terms of service, the global medical device & IVD regulatory
affairs outsourcing market has been classified into regulatory writing &
submissions, regulatory registration services, regulatory consulting, and
others. The regulatory writing & submissions segment dominated the global
medical device & IVD regulatory affairs outsourcing market in 2019. The
segment dominated the market due to increase in clinical trials, government
support, and investment by players toward regulatory affair outsourcing.
However, the regulatory consulting segment is estimated to expand at a notable
CAGR during the forecast period.
Medical device manufacturers commonly outsource various regulatory
consulting services, owing to increase in regulatory pressure. This, in turn,
is projected to propel the segment.
Low Cost of Cloud-based Software to Drive
Demand
Based on software, the global medical device & IVD regulatory
affairs outsourcing market has been classified into cloud-based software and
on-premises software. The cloud-based software segment dominated the global
medical device & IVD regulatory affairs outsourcing market in 2019. Low
cost of cloud-based technology and rapid implementation are key factors likely
to augment the segment.
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Competition Landscape
Freyr, Covance, ICON plc, and Emergo are the four major companies
operating in the global medical device & IVD regulatory affairs outsourcing
market. The global medical device & IVD regulatory affairs outsourcing
market is fragmented in terms of number of players. Key players in the global
market include RegIQ Solutions, LORENZ Life Sciences Group, AxSource
Consulting Inc., Freyr Solutions, Covance, Promedica International, Assent
Compliance Inc., MakroCare, Emergo by UL, and ICON. New product development
through robust R&D activities and merger & acquisitions are key
strategies adopted by these players to operate business in the global medical
device & IVD regulatory affairs outsourcing market.
Global Medical Device & IVD Regulatory Affairs
Outsourcing Market: Segmentation
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