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.
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Regulatory Information Management Market in Numbers
- The regulatory information management market registered a CAGR of nearly 8% during the period 2014 to 2018. This industry remains influenced by rapid transformations in regulation paradigms, from pharmaceuticals to medical devices verticals, thereby, witnessing an increased demand for software, such as regulatory information management.
- The regulatory information management market has been envisaged to surpass revenues worth US$ 893 Mn in 2019, and record a Y-o-Y growth at nearly 9% in 2020.
- North America will remain the leading market for regulatory information management, upheld by the availability of pharmaceutical stalwarts in the countries, such as US and Canada.
- East Asia is expected to be the high-growth market for regulatory information management, with gains mainly driven by rising number of clinical trials taking place in the region, coupled with immense untapped opportunities in China.
Key Growth Drivers of Regulatory Information Management Market
- Growing regulatory reporting requirements and business financial imperatives are driving a regulatory shift from a mainly document-based model to data-based paradigm. Managing structured as well as unstructured content and a large amount of metadata demands a new level of precision in executing regulatory responsibilities, which is provided by regulatory information management software.
- Rapidly transforming regulatory compliance of life sciences with no loss of momentum has made the regulatory approval more complex, thereby, increasing the burden - both direct costs and indirect costs, of compliance for most organizations. With no alternative to compliance, and for the fact that companies’ approach to compliance holds a direct impact on their competitive stature, installation of regulatory information management software has increased considerably.
- The world is driven by ever-increasing demand for speed to market, which continues to make it difficult for brands to maintain pharmaceutical regulatory compliance. Unification of information enabled by an efficient regulatory information management software coupled with benefits such as improved consistency and reduced wasted efforts is favoring its deployment across verticals.
End User Demand for Regulatory Information Management Services Remains High
In light of the growing enforcement of different regulations and standards across various countries, regulatory information management has emerged as a key challenge for regulatory submissions in life sciences companies. Companies are facing challenges resultant of high confusion and accumulation of massive documentation due to market-specific and highly dissimilar regulations, which is necessitating consulting with professional trainers, thereby, creating further demand for regulatory information management services.
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