GVR Report cover Regulatory Information Management System Market Size, Share & Trends Report

Regulatory Information Management System Market Size, Share & Trends Analysis Report By End-Use (Pharmaceutical Sector, Medical Device Sector, Other), And Segment Forecasts, 2022 - 2030

  • Report ID: GVR-4-68039-971-6
  • Number of Pages: 150
  • Format: Electronic (PDF)
  • Historical Range: 2017 - 2020
  • Industry: Healthcare

Report Overview

The global regulatory information management system market size was estimated at USD 1.56 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 11.0% from 2022 to 2030. The regulatory environment tends to be extremely crucial and constantly changing at regular intervals in sectors like pharmaceuticals, medical devices, and other products like cosmetics and food. As a result, capable regulatory information management software has been created and is now being used by manufacturers in the sector. Additionally, data is the upcoming currency or data is the fuel, so a company/manufacturer has to implement methods or practices that differ from that, and then it must let individuals working for a pharmaceutical company freely utilize the accessible data across functions, borders, and systems.

U.S. regulatory information management system market size, by end-use, 2020 - 2030 (USD Million) 

Thus, the increased complexity and demand for a complete integrated end-to-end navigation data system solution necessitated by the need for regulatory requirements led to the necessity for the present digitization notion, in this case, regulatory information management (RIM) software or systems.

This demonstrates the growing appeal of RIM software, which is in accordance with the primary's input, which specifically states that conventional RIM is no longer in use:

“In order to comply with the requirements for drug approval, traditional methods of RIM are not possible to follow because they take a lot of time, and time is crucial in the pharmaceutical industry. If we compromise on timing, we risk losing the drug's royalties or experiencing other similar consequences, so adopting such technological advancements as Veeva Vaults RIM software gives us the leverage of working effectively.”

- Pharmaceutical companies market expert, India.

For instance, a well-known pharmaceutical business noted in its customers' feedback for Veeva's Vault RIM Suite that RIM is one of the change and digitalization strategies that they are continually forcing themselves to think about when exploring the data-driven regulatory information solution.

The WHO reports that more than 300 research trials are now underway to find a treatment for COVID-19 infection. By the year 2020, more than 550 clinical studies for COVID-19 had been filed, which amply illustrates the ambition of numerous organizations to contribute to the market. This is due to the fact that it gives my players the chance to promote people's health, which will ultimately lead them to be ousted from the competition as a consequence of its success.

Consequently, the increase in clinical trials directly leads to the increase in the need for regulatory information management systems, ultimately having a positive overall impact on this market.

The ability of the RIM to uniquely cover several regulatory components is what initially caught the attention of manufacturers. The table below shows the RIMS-inclusive components.

RIMS COMPONENTS LIST

Components of RIM

1) Submission Forecasting and Resource Planning

9) Regulatory Archive

2) Dossier Management

10) Label Management (Content Control and also Compliance Tracking)

3) Submission Production

11) Analytics, Reporting, Dashboard

4) Submission Document Management

12) Data Standards and Governance Management

5) Submission Planning and Tracking

13) Design History File - Medical Device

6) Product Registration Management

14) Regulatory Intelligence

7) Health Authority Commitment Management

15) Ad / Promo

8) Health Authority Interactions

 

 

In addition, the need for RIM systems with streamlined, encrypted, unified, and compatible platforms is increasing as a result of the pharmaceutical and related healthcare industry's requirement to manage enormous quantities and diversity of data types. Furthermore, as the consumer's goals for development are realized and the RIM suppliers are able to ensure more advanced technologies, automated information merging, and data performance monitoring, thus the market is also anticipated to grow over the course of the forecast period. 

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 software by pharmaceutical companies, competitors in the Regulatory Information Management (RIM) System/Software market are seeing enormous growth, and this growth is anticipated to continue.

Global regulatory information management system market share, by end-use, 2021 (%)

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

Regulatory Information Management System Market Trends by Region

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 Companies & Market Share Insights

Companies that are primarily active in the U.S. have increased their operations in China as a result of an increase in clinical trials as well as increased regulatory requirements. For instance, rivals like ClinChoice, which is present in the U.S. and has increased its position in China and Japan, as competitors. This amplifies the company's apparent hint of increased consumer interest as well as the escalating demand for handling regulatory information.

Furthermore, companies in the market are attempting to enter the market through their other marketing methods, which include offering various regulatory-related elements like software that might draw a variety of manufacturers’ attention. Various regulatory software products are currently on the market. For instance, Freyr Solutions provides regulatory solutions through the products like Freyr SPAR, a RIM Solution that enables Health Science managers to improve information more effectively from monitoring product enrollment to trying to generate periodic data.   

Furthermore, in a rapidly growing market such as India, a growing competitive advantage exists in the market for regulation information management for promising product launches. For instance, IQVIA unveiled IQVIA RIM Smart, the industry's first fully integrated, comprehensive regulatory information management system which is cloud-based. Machine learning (ML) and artificial intelligence (AI) are being used more and more by businesses to enable intelligent management of a product portfolio's whole regulatory lifecycle.

This is in line with the primary call's remark, in which the speaker referred to the system update occurring as pharmaceutical firms transition to a more integrated, unified system.

“All pharmaceutical firms are currently concentrating on RIM. RIM, as you can see, functions more as a separate team that is only responsible for the RIM software and associated responsibilities. As a result, companies are essentially looking for fully integrated solutions even though the software should provide end-to-end solutions. For instance, the company (where the person works) previously used two different software programs to manage some information, but very recently switched to Veeva's Vault and is pleased with the information management because AI is typically used to replicate things and bring in a perspective with little to no human error.”
- Pharmaceutical companies market expert, India

Some of the prominent players in the regulatory information management system market include:

  • Veeva system

  • Kalypso

  • DDI

  • Korber AG

  • ArisGlobal

  • PhlexGlobal

  • AmpleLogic

  • Calyx

  • Amplexore Life Sciences

  • Ennov

  • MastarControl

  • Rimsys

  • Ithos global Inc.

  • Lorenz

Regulatory Information Management System Market Report Scope

Report Attribute

Details

Market size value in 2022

USD 1.78 billion

Revenue forecast in 2030

USD 4.12 billion

Growth rate

CAGR of 11.0% from 2022 to 2030

Base year for estimation

2021

Historical data

2017 - 2020

Forecast period

2022 - 2030

Quantitative units

Revenue in million and CAGR from 2022 to 2030

Report Coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments Covered

End-Use, Region

Regional scope

North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Country scope

U.S.; Canada; Germany; U.K.; Switzerland; China; Japan; India; Brazil; South Africa

Key companies profiled

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

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope.

Pricing and purchase options

Avail customized purchase options to meet your exact research needs. Explore purchase options

 

Global Regulatory Information Management System Market Segmentation

This report forecasts revenue growth at global, regional, & country levels, and provides an analysis of the industry trends in each of the sub-segments from 2017 to 2030. For this study, Grand View Research has segmented the global regulatory information management system market report based on end-use and region:

Global Regulatory Information Management System Market Segmentation

  • End-Use Outlook (Revenue, Million, 2017 - 2030)

    • Pharmaceutical Sector

    • Medical Device Sector

    • Other

  • Regional Outlook (Revenue, Million, 2017 - 2030)

    • North America

      • U.S.

      • Canada

    • Europe

      • U.K.

      • Germany

      • Switzerland

    • Asia Pacific

      • Japan

      • China

      • India

    • Latin America

      • Brazil

    • Middle East & Africa

      • South Africa

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