The regulatory information management (RIM) market is envisaged to surpass revenues worth US$ 893 Mn in 2019, according to a recent study by Fact.MR. Growing requirement for seamless regulatory submission data and product labeling management across enterprises is providing a fillip to the installation of regulatory information management software. Dire need of companies to alleviate the ‘time to market’ (TTM) cycle is a significant factor providing an impetus to the growth of regulatory information management market.

The study opines that as the regional and international authorities continue to set the ever-changing reporting requirements, the call for proper RIM solution deployment will grow louder. The demand for regulatory information management solutions will be further assisted by the growing number of firms realizing the significance of the strategic role of product data.

According to the report, deployment of regulatory information management software for health authority management will remain high across pharmaceuticals industry, with the global deployment across different verticals estimated to surpass US$ 252 Mn in 2019. Reduction in manual errors in regulatory processes, along with an easy access to dossier, continues to contribute to the growth of the regulatory information management market.

A wide range of small and medium enterprises are implementing a broad regulatory information management platform to eliminate various data hand-offs and for better overall data quality and visibility. As per the study, global deployment of regulatory information management across small and medium enterprises exceeded US$ 513 Mn in 2018, and will witness a robust yearly growth in 2019 and ahead.

The study also highlights that the deployment of regulatory information management software is growing at a steady pace, driven by a plethora of categories. However, health authority management will particularly remain an attractive category. Furthermore, the demand for unified regulatory information management software will remain sustained in health authority management, as it enables effective control of data for a leaner, higher quality submission. This further translates to a more efficient review process for authorities and builds credibility, potentially reducing regulatory burden of enterprises, and thereby augmenting the deployment of unified regulatory information management platforms.

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Evolving Regulatory Framework Triggering NPDs

The study opines that compliance modernization is no longer optional, with international authorities continuously setting new and often arduous reporting requirements. In view of the constantly changing regulatory paradigms, enterprises with different verticals, such as pharmaceuticals, medical devices, and nutraceuticals are expecting more from the software that helps them log and keep track of everything. This has further accelerated the trend of new product development (NPD) in the regulatory information management market, finds the study. Additionally, sensing the pain points related to disparate systems, exacerbated by IDMP (Identification of Medicinal Products) requirements, more players in regulatory information management market are drifting to unified platforms through NPD.

As per the study, growing demand for a solution that can manage, control and fasten the process of bringing novel products to market, maintain existing products, and manage interactions with authorities is favoring deployment of RIM software. Furthermore, high penetration of small scale companies in regulatory information management market is another significant factor that continues to shape the growth of this industry.

As per the Fact.MR study, North America will continue to lead the market for regulatory information management due to growing stringency of rapidly changing norms enforced by several regulatory bodies in the region. The study opines that services segment of regulatory information management will underpin higher revenues in North America owing to high quality assurance and support benefits offered by regulatory management organizations in this region.

Although developed economies are spearheading the regulatory information management market, developing regions are estimated to pick pace through 2029. The study opines that East Asia is envisaged to remain the high growth market for regulatory information management, as verticals of regional companies have plans afoot for significant investments in platforms for proper regulatory information management. A plethora of companies across the emerging economies of East Asia, China in particular are transitioning toward regulatory information management software to alleviate their product time to market, amid growing clinical trials in the region.

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