ICT RESEARCH REPORTS Regulatory-Information-Management-Market | Seite 2

Software segment accounted for largest market share in 2017
Among product type, software segment is expected to account for the largest market share by
2026. Need to cope up with ever-changing regulatory scenario, especially in the field of
pharmaceuticals, is increasing and this has led organizations to opt for regulatory information
management software. The software for regulatory information management is among the most
feasible and easy way to keep track of the production and manufacturing scenario in accordance
with the updated regulatory norms in the respective region.
Pharmaceutical industry is expected to hold largest market share by 2026
Regulatory information management software are offered with various features, which help
organizations to follow updated regulations. The innovation and advancement in the field of
software with improved process to ensure effective management of regulatory information, the
software also ensures reduction in turnaround time for any issues or malpractices in the system.
Pharmaceutical companies are involved in development, dissemination, and control of the
regulatory information throughout the product development cycle. Regulatory information
management is an important solution for pharmaceutical companies as it effectively
communicates regulations. The technology tools, product & service platforms, creates
opportunities for automating business practices resulting in optimum business output with rigid
observance of the set norms in the industry by regulatory bodies and government. In
pharmaceutical industries, regulatory information management software facilitates robust
application of planning, viewing, publishing, registration, and management of products
throughout its life cycle. The software also allows effective compliant management of regulations
and regulatory information. It has advantages such as submission of plan, e-submission viewer,
and product registration and tracking. The software enables tracking the periodic safety updated
reports (PSUR) and real time access of regulatory information.
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North America regulatory information management market is expected to exhibit the
highest CAGR over the forecast period
North America is anticipated to be dominant in the regulatory information management market,
due to high presence of pharmaceutical companies such as Amgen, GlaxoSmith, Novartis,
Johnson & Johnson, and Gilead Sciences among others in countries such as the U.S. and Canada.
Furthermore, according to a report by European Federation of Pharmaceutical Industries and
Associations (EFPIA), in 2016, North America accounted for 49.0% of world pharmaceutical sales
compared to 21.5% of Europe. According to IMS Health data (MIDAS May 2017), 64.7% of sales of
new medicines launched during the period 2011-2016 were in the U.S. market, compared to
17.5% in the European market. This depicts the potential of North American as well as European
markets for adoption of regulatory information management software. North America is followed
by Asia Pacific in terms of market share in the regulatory information management market,
owing to growing pharmaceuticals industry in countries such as China and India. This is evident