Regulatory Information Management System Market To Reach $4.12 Billion By 2030

Regulatory Information Management System Market Growth & Trends

The global regulatory information management system market size is anticipated to reach USD 4.12 billion by 2030 and is projected to grow at a CAGR of 10.4% from 2024 to 2030, according to a new report by Grand View Research, Inc. Increasing adoption of centralized RIMS among the pharmaceutical and medical device industry along with technological advancements would likely drive the market growth over the forecast period.

The pharmaceutical sector's rapid expansion to meet global demand for innovative drugs increases regulatory complexity. To address this, companies are investing in RIM technology, leveraging automation and Artificial Intelligence (AI) to enhance regulatory workflows. Trends include outsourcing, reliance on business interaction, and the use of high-quality data for intelligent applications. For instance, in August 2022, Calyx's long-term client Krka expanded its investment in the Calyx RIM system for over 5 years, signalling a positive industry shift toward RIMS technology for effective regulatory compliance management.

The integration of advanced technologies offers a lucrative opportunity for market growth. Leveraging cutting-edge technologies, such as AI, ML, & predictive analytics, significantly bolsters risk assessment and mitigation strategies. These advanced tools enable the RIMS to rapidly analyze vast datasets, identifying patterns and potential risks that might go unnoticed through traditional methods.

Moreover, the automation capabilities of these technologies streamline processes, reducing the likelihood of human error and providing real-time insights into emerging risks. Integrating blockchain technology further enhances data security and transparency in risk management processes. 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.

Companies operating in the market are increasingly entering into strategic partnerships with RIMS solution providers to leverage their expertise & guidance in understanding global regulatory submission requirements. For example, in May 2023, LexisNexis Reed Tech, known for its analytic and data management solutions in the life sciences industry, expanded its collaboration with RegDesk, a well-known RIMS provider. Such ongoing strategic initiatives by market players are expected to fuel the adoption of RIMS.

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Regulatory Information Management System Market Report Highlights

• Based on end-use, the pharmaceutical segment led the market with the largest revenue share of 42.8% in 2023. This is attributed to implementation of strict regulation and need for RIM systems with streamlined, encrypted, unified, and compatible platforms. The medical device segment is expected to grow at the fastest CAGR over the forecast period

• North America dominated the market with the revenue share of over 37.1% in 2023, owing to an increase in advancement in the field of pharmaceutical, MedTech, and related sectors of end-of-life care, and growing awareness and rising demand for the RIM systems to bring in a better product for the end consumers/manufacturer’s

• With China, India, and Japan all expected to see rapid development throughout the forecast period, the Asia-Pacific region is expected to grow at the significant CAGR over the forecast period. These include rising rates of pharmaceutical-based products and medical devices and rising regulatory-related concerns. In addition, there has been an increase in the need for RIM-related software as a solution due to rising regulatory compliance and associated data maintenance requirements

Regulatory Information Management System Market Segmentation

Grand View Research has segmented the global regulatory information management system market report based on end-use, and region:

Regulatory Information Management System End-use Outlook (Revenue, Million, 2017 - 2030)

• Pharmaceutical Sector

• Medical Device Sector

• Other 

Regulatory Information Management System Regional Outlook (Revenue, USD Million, 2017 - 2030)

• North America

  • U.S

  • Canada

• Europe

  • Germany

  • UK

  • France

  • Italy

  • Spain

  • Switzerland

  • Sweden

  • Denmark

  • Norway

• Asia Pacific

  • China

  • Japan

  • India

  • South Korea

  • Australia

  • Thailand

• Latin America

  • Brazil

  • Mexico

  • Argentina

• Middle East and Africa (MEA)

  • Saudi Arabia

  • UAE

  • South Africa

  • Kuwait 

List of Key Players in the Regulatory Information Management System Market

• Veeva Systems

• Kalypso (Rockwell Automation)

• DDi

• Körber AG

• ArisGlobal

• PhlexGlobal

• AmpleLogic

• Calyx

• Amplexor Life Sciences

• Ennov

• MasterControl

• Rimsys

• Ithos Global Inc. (Cordance Group)

• LORENZ Life Sciences Group