Regulatory Information Management Market By Product Type (Software and Hardware), By End Use Industry (Pharmaceutical Industry, Biotechnology Industry, and Clinical Research Organization), and Region (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa) - Trends, Analysis and Forecast till 2034

Regulatory Information Management Market was valued at USD 1.9 Billion in 2024 and is projected to grow at a CAGR of 11.80% to reach USD 5.8 Billion by 2034.

Regulatory Information Management (RIMS) is software that aids in efficient and effective gathering, storage, and retrieval of regulatory information. Regulatory information management helps organizations develop and handle new and existing product information pertaining to, during,g and after drug registration. Life sciences or pharmaceutical companies or similarly regulated industries need to have a fast and efficient management system so as to easily locate critical documents and respond to required actions, especially during inspections of quality processes. The regulatory information management tools, help companies to take necessary, and prompt actions so as to identify and respond to every element of an inspection or audit. 

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Rising initiatives by government bodies

A major factor driving growth of the global regulatory information management market is increasing number of stringent regulatory norms by regulatory bodies. In addition, rising demand from pharmaceutical industry and biotechnology is another factor further fueling growth of the global market. Stringent drug approval regulation in countries such as UK, USA coupled with frequent changing drug and product approval regulations are other factors further propelling growth of the market. Increasing adoption from clinical research department is a factor expected to create lucrative opportunities for major vendors in the global regulatory information management market during the forecast period. Moreover, technological advancements and improved data quality collection method for managing vital regulatory information are other factors expected to support growth of the global market during the next five years. Increasing adoption of regulatory information management to collect regulatory information from public and private sources is seen as a major opportunity for the fueling market growth. For instance, Vistara- a global regulatory intelligence tool from Makro Care has been developed in such a way that it utilizes Neuro-Linguistic Programming (NLP) and machine learning platform to collect related data.

However, major factor hampering growth of the global regulatory information management market is high cost of software as compared to traditional method. In addition, lack of skilled professionals to operate information management software especially in developing and underdeveloped countries is another factor hampering growth of the global market to certain extent.

The global regulatory information management market is segmented based on product type, end user industry, and region.

On the basis of product type, the global regulatory information management market is segmented into software and hardware. On basis of end user industry, the global regulatory information management market is segmented into pharmaceutical industry, biotechnology industry, and clinical research organizations.

Report Scope:

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2020 to 2030. For the purpose of this study, has segmented the global regulatory information management market report based on product type, end-use industry and region.

Global Regulatory Information Management Market, By Region:

• • • North America
      • • U.S.
        • Canada
    • Europe
      • • Germany
        • UK
        • France
        • Russia
        • Italy
        • Rest of Europe
    • Asia Pacific
      • • China
        • India
        • Japan
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • • Brazil
        • Mexico
        • Rest of Latin America
    • Middle East & Africa
      • • GCC
        • Israel
        • South Africa
        • Rest of Middle East & Africa

Regional Insights:

In the region, the global regulatory information management market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America is expected to account for a major revenue share as compared to that of other regions and is expected to maintain its dominance in the global market over the forecast period. This dominance can be attributed to the presence of major life science companies in this region.

Key Players:   

The key players operating in the global regulatory information management market include Acuta, LLC, Parexel International Corporation, Computer Sciences Corp (CSC), Aris Global, Virtify Inc., Ennov Inc., Amplexor, Samarind Ltd., Dovel Technologies, Inc., and Informa.

• Acuta, LLC.
• Parexel International Corporation
• Computer Sciences Corp (CSC)
• Aris Global
• Virtify Inc.
• Ennov Inc.
• Amplexor
• Samarind Ltd
• Dovel Technologies, Inc.
• Informa