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.

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• 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.

Regulatory information services remain the leading solution in regulatory information management market due to a significant rise in number of regulatory solution providers that help companies implement regulatory processes seamlessly, and with high precision.

Regulatory Information Management – Competitive Landscape

The market for regulatory information management is highly fragmented with a wide pool of small scale companies operating in this industry. Companies, including

• Veeva/ Sparta Systems
• DXC Technology
• Parexel
• Aris Global

are leading the market owing to their broader and best-in-industry portfolios, in addition to their robust geographical reach.

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While the attractiveness of RIM remains high for health authority management, the rapidly changing portfolios of drug manufacturers are compelling RIM service providers to align their regulatory training and management offerings with product specifications and regulations in the region of deployment.

Promising product launches hold a competitive advantage in regulation information management market. For instance, IQVIA™ has recently launched IQVIA RIM Smart, the first fully integrated, cloud-based, complete regulatory information management solution for life sciences. Companies are increasingly leveraging artificial intelligence (AI) and machine learning (ML) to enable intelligent management of the complete regulatory lifecycle of a product portfolio.

Leading players in the RIM market are eying IDMP (Identification of Medicinal Products) regulatory changes as an opportunity for business improvement. Increased focus of market forerunners on establishing a data model and supporting system that allows seamless data sharing across manufacturing, registration, labeling, and submission domains, is likely to heighten the scope of sales.

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Additionally, growing number of regulatory information management providers are entering partnerships with pharmaceutical giants to gain a stronghold in the market. For instance, Boehringer Ingelheim has chosen the Ennov regulatory information management platform for their global RIM needs across human and veterinary sectors.