Regulatory Information Management Market

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.
• 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.

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.

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.

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.
• Organizations are increasingly taking efforts to gain additional value from their product data, as they realize strategically important role data could play in driving new productivity, competence and competitive differentiation. This, coupled with the growing importance to make product as well as regulatory information more shareable among and beyond specific functions, are driving the deployment of regulatory information management software.
• The implementation of new European requirements, and the fact that other regions are considering adoption of similar requirements, companies will need to submit higher volumes of structured product information across demographics. A unified regulatory information management capability is vital to sourcing and linking data and submission, reinforcing the broader supply chain with authentic and accessible product data.

Key Challenges Faced by Stakeholders in Regulatory Information Management Market

• Rapidly evolving regulatory framework and changing product approval requisites continue to propel developers to stay abreast of latest regulations, and connected with market players to ensure software efficiency for error-free regulation compliance processes. This constant hassle is making the regulatory information management software less attractive to many companies.
• The level of training required to operate regulatory information management software has been impeding its adoption, particularly in the small-scale enterprises that remain wary of additional costs associated with training employees.

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.

Research Methodology

A realistic methodology along with a holistic approach forms the base for the incisive insights offered in the regulatory information management market for the foreseeable period. The Fact.MR report presents detailed information on the growth prospects of regulatory information management industry along with riveting insights into the projection analysis of the market.

Extensive primary as well as secondary research has been performed to garner valuable insights into the forecast analysis of regulatory information management market. The report on regulatory information management has further gone through cross-validation by in-house analysts to make the report one-of-its-kind with the utmost credibility.