Regulatory Information Management System Market (By End-Use: Pharmaceutical Sector, Medical Device Sector, Other)- Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2022-2030

The global regulatory information management system size was estimated at around USD 1.7 billion in 2021 and it is projected to hit around USD 4.38 billion by 2030, growing at a CAGR of 11.09% from 2022 to 2030.

As a result of the rapid adoption of the software by the pharmaceutical companies, competitors in the regulatory information management (RIM) system or software market are seeing enormous growth, and this growth is anticipated to continue.

Furthermore, the pharmaceutical industry nowadays also has a big job when it comes to keeping regulatory data for a product’s life cycle. The complexity is brought on by the enormous amount of fragmented data stored across several systems and supported by inefficient software applications. The complicated rules that are always expanding and changing, the higher standards for product quality, and the quickly changing digital technology environment all present opportunities and obstacles for innovation for medical device companies. For companies to succeed in this climate, they must also figure out how to maximize return on investment by producing goods as cheaply and efficiently as feasible.

Additionally, to compete for business internationally, providers such as medical device providers must supply items under many strict international standards and follow each nation's unique submission method. Additionally, they must consider the evolving and more complex client expectations. These tasks also need to be completed more swiftly as time goes on. Therefore, if medical device businesses are to compete in this competitive climate, they need a more automated and comprehensive method to handle these processes. Systems for regulatory information management (RIM) accomplish precisely that, and as more people use them, thus the market is expected to expand throughout the forecast period.

Furthermore, especially in the food industry, rapid mistake detection is essential to prevent losing R&D time or, worse still, consumer difficulties and non-conformity problems. Managing non-conformity may quickly grow time-consuming and difficult. Furthermore, non-conformity may be costly and damaging to a brand's image. As a result, software providers are steadily increasing their interest in the food industry. Unlike the pharmaceutical industry, one strategy that software providers are using in this expanding market is by providing comprehensive single software as one solution that does provide user management. All of the aforementioned requirements consult for in-hand regulatory information management systems, which is possible with the aid of digital components such as software.

Scope of The Report

End-Use Insights

On the basis of end-use, the market is segmented into three types - pharmaceutical sector, medical device sector, and others (biologics, cosmetics, foods, etc.). The medical device and pharmaceutical sectors both retained a good competitive presence in the market in 2021, with corresponding revenue shares of approximately 36% and 34%. As a result of the rapid adoption of the software by the pharmaceutical companies, competitors in the Regulatory Information Management (RIM) System/Software market are seeing enormous growth, and this growth is anticipated to continue.

Furthermore, the pharmaceutical industry nowadays also has a big job when it comes to keeping regulatory data for a product’s life cycle. The complexity is brought on by the enormous amount of fragmented data stored across several systems and supported by inefficient software applications.

Furthermore, the overall regulatory landscape is now being transformed, including the fragmented systems being consolidated and changed into a tightly unified platform. Additionally, the goal is to guarantee a comprehensive picture of regulatory information from product discovery through launch and to also streamline and increase the flexibility of solutions with compatibility. Therefore, it is important to provide transparency, process efficiency, and productivity while driving compliance requirements. In the end, this is possible due to RIM software systems that have been upgraded for digitization.

For instance, Veeva's Vault RIM Suite uses digital technology to retain files and records in a more structured way. Additionally, the advent of digital technologies like blockchain networks, metadata management, and technical analysis has revolutionized how business is currently performed. These technologies provide edge accountability of regulatory events while digitally monitoring records maintenance.

While there is specialized software for regulatory information management in mature and competitive sectors like the pharmaceutical and medical device industries due to the stringency of the regulatory system as well as the expectations for information management in such industries. As a result, industries including the food industry, cost-effective healthcare cosmetics, etc. have begun to attract the attention of software providers now that the majority of the two major healthcare markets have witnessed a huge penetration of regulatory information management. For instance, companies in the cosmetics industry, like Ithos Global, have begun offering software as a defense against rivals, with their solutions covering all regulatory-related elements, including RIMS.

As a consequence of the regulatory authorities' development of stringent regulations and related importance in an effort to provide end-users better assurance of the consumer products, the market is expected to expand during the forecast period. Thereafter, the manufacturer would largely switch to the platform offering specialized solutions like RIMS.

Regional Insights

Due to the U.S. and Canada's well-established and technologically advanced pharmaceutical enterprises as well as the expanding medical device sector, North America is likely the one to see a notable presence in the global regulatory information management system market in 2021. Furthermore, because there are several suppliers of regulatory information management systems that provide integrated regulatory solutions like RIM, Regulatory submission, etc., North America held the largest share of over 34% in 2021.

In the U.S. it is difficult for businesses to effectively follow regulatory changes, gather, organize, and communicate product information to regulatory authorities in multiple countries due to the dynamic global regulatory landscape, manual business procedures, complex enterprise ecosystems, and resource limitations.

In order to integrate, evaluate, and manage worldwide regulatory data, submission planning, activity status, agency correspondence, and obligations for the goods they make, top life sciences companies such as Novartis, GSK, etc., are using regulatory information management systems (RIMS). A strong digital regulatory thread is created by RIMS when combined with sophisticated analytics, machine learning, extended reality, and robotic process automation. This thread offers connection, traceability, automation, and predictive insights

Life sciences companies may get Accel for RIM, a valuable implementation accelerator for a RIM system, from a specific provider in businesses like Kalypso. This clearly demonstrated the strategic use of product bundling, whereby the integration of two solutions into a single package would eventually distinguish the company from its rivals in terms of price points and product offerings.

Additionally, since RIM is gaining popularity, especially in the pharmaceutical industry, manufacturers are developing long-term relationships with RIM providers, which is driving market expansion overall. Additionally, manufacturers are developing long-term relationships with RIM providers, which is driving market expansion overall. For instance, a provider such as Calyx reported on October 25, 2021, that one of the top ten pharmaceutical companies in the world has signed a contract to continue using the Calyx Regulatory Information Management (RIM) system for crucial submissions of clinical trial data to international regulators through 2026.

With increased awareness of Regulatory Information Management (RIM) systems, Asia Pacific (APAC), Europe, and Latin America (LATAM) are expected to be the fastest-growing region in the overall Regulatory Information Management (RIM) System or Software as a Service (SaaS) Market.

In the Asia Pacific region, for instance, in Japan, there is no substitute for compliance and since how businesses approach compliance has a direct bearing on their ability to compete, the installation of regulatory information management software has grown significantly. In addition to the pharmaceutical industry, other industries where compliance management software is being used are also contributing to Japan's growth. For instance, UL LLC, a U.S.-based firm, offers exclusive chemical management software in Japan as well, demonstrating its presence in the market.

Key Players

• Veeva system
• Kalypso
• DDI
• Korber AG
• ArisGlobal
• PhlexGlobal
• AmpleLogic
• Calyx
• Amplexore Life Sciences
• Ennov
• MastarControl
• Rimsys
• Ithos global Inc.
• Lorenz

Market Segmentation

• By End-Use Outlook

• Pharmaceutical Sector
• Medical Device Sector
• Other
• By Regional Outlook
• North America

• U.S.
• Canada
• Europe
• U.K.
• Germany
• Switzerland
• Asia Pacific
• Japan
• China
• India
• Latin America
• Brazil
• Middle East & Africa
• South Africa