Regulatory Information Management System Market Report 2025

The regulatory information management system market size has grown rapidly in recent years. It will grow from $1.99 billion in 2024 to $2.22 billion in 2025 at a compound annual growth rate (CAGR) of 11.7%. The growth in the historic period can be attributed to stringent regulatory compliance requirements, pharmaceutical industry growth, globalization of supply chains, increasing volume of regulatory data, and emphasis on data security.

The regulatory information management system market size is expected to see rapid growth in the next few years. It will grow to $3.38 billion in 2029 at a compound annual growth rate (CAGR) of 11.1%. The growth in the forecast period can be attributed to integration with artificial intelligence (AI), increased complexity of regulatory landscape, expansion of rims in emerging markets, demand for cloud-based solutions, focus on real-time regulatory monitoring. Major trends in the forecast period include advancements in technology, collaboration and integration with external partners, blockchain technology for data integrity, mobile access and user-friendly interfaces, and cross-functional collaboration platforms.

The increasing number of clinical trials is playing a significant role in the growth of the regulatory information management system market in the future. Clinical trials involve studies in which individuals are utilized as test subjects for therapeutic, surgical, or behavioral interventions. The regulatory information management system is employed to track, manage, and simplify the expanding regulatory requirements and complexities associated with clinical trials. For example, in February 2023, the World Health Organization (WHO), a Switzerland-based intergovernmental agency focused on international public health, reported that the number of clinical trials in the Southeast Asia region rose from 10,966 in 2021 to 11,030 in 2022. Therefore, the increase in clinical trials will drive the regulatory information management system market.

The continuous growth of digitization is expected to be a significant driver of the regulatory information management system market. Digitization, involving the conversion of analog information into digital data, is increasingly leveraging regulatory information management systems (RIMS) to streamline the management of regulatory data, compliance documentation, and submissions. According to data from Augusta Free Press in December 2022, global spending on digital transformation reached about $1.85 trillion, reflecting a 16% increase from the previous year. This shift toward digitization is a pivotal factor driving the adoption of regulatory information management systems.

A noteworthy trend is the emphasis on product innovations by major companies. To maintain a competitive edge, these companies are launching innovative products tailored to the unique demands of the life sciences and medical device sectors. For instance, in February 2023, ArisGlobal, LLC introduced the Investigational Product Regulatory Information Management System (RIMS), a pre-validated turnkey solution designed to meet the specific needs of life sciences and medical device firms during the research and development stages of drug development. This product incorporates features such as clinical trial authorization tracking, investigational submission and dossier planning, and health authority commitment management to enhance efficiency and compliance.

Strategic partnerships are playing a crucial role in simplifying the adoption of efficient sharing of regulatory information in the regulatory information management system market. Companies are leveraging strategic partnerships to enhance their strengths and resources for mutual benefits and success. For instance, in August 2023, Vitality TechNet Inc. partnered with Fluree, aiming to enable pharmaceutical regulatory information management and expedite drug discovery processes.

In May 2023, Ennov, a France-based provider of content and data management software for the life sciences industry, acquired Samarind Limited, a UK-based provider of regulatory information management (RIM) software and services. This strategic acquisition enriches Ennov’s position in the regulatory information management system market, particularly in the medical device sector.

Major companies operating in the regulatory information management system market include Deloitte Touche Tohmatsu Limited, DXC Technology Company, IQVIA Inc., Wipro Ltd, Parexel International Corporation, Korber Pharma, Veeva Systems Inc, Dovel Technologies Inc., Calyx, ArisGlobal LLC, DDi Inc., NNIT A/S, Freyr Software Services Private Limite, Navitas Life Sciences, MasterControl Solutions Inc., Sparta Systems Inc., Instem PLC, Phlexglobal Ltd., Ennov SA, LORENZ Life Sciences Group, Extedo GmbH, Gimmal, Dot Compliance Ltd., Kalypso LP, Rimsys Inc., Virtify Inc., Glemser Technologies Corporation, RegDesk, AmpleLogic, Ithos Global Inc.

North America was the largest region in the regulatory information management system market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the regulatory information management system market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the regulatory information management system market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

A regulatory information management system is a centralized software platform designed to streamline the tracking of product applications and registrations within the regulatory industry. It facilitates the tracking and recording of regulatory processes from initiation to completion, catering to various segments such as pharmaceuticals, biologics, and cosmetics.

The main components utilized in regulatory information management systems include solutions and services. Software solutions are designed to address specific client problems, and deployment options encompass on-premises and cloud-based solutions. These systems are applicable to enterprises of various sizes, including small and medium enterprises as well as large enterprises. The applications covered by these systems include registration management, regulatory intelligence, labeling management, submission planning and tracking management, publishing, document management, and others. These applications find use across various end-users, including the pharmaceutical sector, medical device sector, and others.

The regulatory information management system market research report is one of a series of new reports that provides regulatory information management system market statistics, including regulatory information management system industry global market size, regional shares, competitors with a regulatory information management system market share, detailed regulatory information management system market segments, market trends and opportunities, and any further data you may need to thrive in the regulatory information management system industry. This regulatory information management system market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The regulatory information management system market consists of revenues earned by providing services such as data management, dossier management, product registration lifecycle management services, and easy-to-configure dashboards and reports. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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