Regulatory Information Management Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028, Segmented by Component (Solution v/s Services), By Deployment Mode (On-Premises v/s Cloud), By Application (Registration Management, Regulatory Intelligence, Labeling Management, Submission Planning & Tracking Management, Publishing, Document Management, and Others), By End User (Pharmaceutical, Medical Devices, and Others), By Region and Competition

The Global Regulatory Information Management System Market is anticipated to witness impressive growth during the forecast period. This can be ascribed to the growing prevalence to deliver effective applications and proper planning in the procedures. Additionally, the growing number of new players and rising adoption of the latest techniques to develop productivity demand for the Regulatory Information Management System Market across different parts of the globe. Additionally, increasing in the investments by public and private organizations and increasing support from the IT sector is further expected to increase the demand for regulatory information management system, thereby fuelling the market growth through 2028. In 2016, the U.S. spent $3,337 billion, or 17.9 percent of the gross domestic product (GDP), on national health expenditures, of which $329 billion was spent on prescription drugs. Similarly, the growing demand for real-time monitoring of regulations in the clinical trial sector is the major factor fuelling the growth of the market over the years. RIMS solutions provide a centralized platform for managing regulatory information, such as product data, registrations, and submissions. The solutions automate regulatory processes, such as document management, change control, and reporting, which can help organizations save time and reduce errors. RIMS solutions can also provide real-time visibility into regulatory compliance status, which can help organizations identify and mitigate compliance risks more effectively. The benefits of RIMS solutions are particularly evident in the pharmaceutical and biotechnology industries, which are highly regulated. In these industries, RIMS solutions can help organizations manage regulatory compliance across the entire product lifecycle, from research and development through to commercialization. RIMS solutions can also help organizations maintain product quality and safety, which is critical in these industries. The use of RIMS solutions is also increasing in the medical devices industry, which is facing increasing regulatory scrutiny. RIMS solutions can help organizations manage the regulatory requirements associated with medical devices, such as premarket submissions, post-market surveillance, and adverse event reporting. In the food and beverages industry, RIMS solutions can help organizations manage regulatory compliance across a range of areas, such as labeling, advertising, and safety. RIMS solutions can also help organizations comply with food safety regulations, such as the Food Safety Modernization Act (FSMA) in the United States. The adoption of RIMS solutions is also increasing in the cosmetics industry, which is facing increasing regulatory scrutiny in areas such as ingredient safety, labeling, and advertising. RIMS solutions can help organizations manage regulatory compliance across these areas and reduce the risk of non-compliance. Overall, the adoption of RIMS solutions is increasing as organizations seek to manage their regulatory compliance processes more efficiently and effectively. RIMS solutions can help organizations save time and reduce errors, maintain product quality and safety, and reduce the risk of non-compliance. As the regulatory landscape continues to evolve, RIMS solutions are likely to become an increasingly important tool for organizations across a range of industries. Implementing a RIMS solution can be a complex and costly process, especially for smaller organizations. The cost of software licensing, hardware, training, and consulting services can be a significant barrier to adoption, which may limit the market growth. Many organizations have existing systems in place for managing regulatory information, such as spreadsheets, databases, and paper-based systems. Integrating these legacy systems with new RIMS solutions can be a challenge, which may slow down adoption. RIMS solutions involve the management of sensitive regulatory information, which can be subject to security breaches and data privacy regulations. Ensuring the security and privacy of this information is a critical challenge for RIMS vendors and users. The regulatory landscape is complex and varied across different countries and regions, which can make it challenging to develop standardized RIMS solutions that meet the needs of all users. Lack of standardization can lead to interoperability issues and limit the adoption of RIMS solutions. The implementation and maintenance of RIMS solutions require skilled professionals with expertise in regulatory compliance and information technology. The limited availability of such professionals can be a challenge for organizations looking to adopt RIMS solutions. The regulatory landscape is constantly evolving, with new regulations and guidelines being introduced regularly. This can make it challenging for RIMS vendors and users to keep up with the latest requirements, which can impact the effectiveness of RIMS solutions.

Increasing Product Development

Rapidly evolving regulatory framework and changing product approval requisites continue to propel developers to stay abreast of latest regulations and connected with market players to ensure software efficiency for error-free regulation compliance processes. Increasing transformations in regulation paradigms within pharmaceuticals, medical devices, and life science sectors is expected to boost the demand for regulatory information management systems during the forecast period. In pharmaceutical sector, regulatory information management system facilitates robust application of planning, viewing, publishing, registration, and management of products throughout its life cycle. The software also allows effective compliant management of regulations and regulatory information. Further, in April 2020, Oracle built and donated a COVID-19 Therapeutic Learning System to the U.S government that allows physicians and patients to record the effectiveness of promising COVID-19 drug therapies. As the regulatory landscape becomes increasingly complex and stringent, organizations are looking for ways to streamline their compliance processes and ensure they stay on top of regulatory changes. RIMS solutions can help organizations manage and streamline their regulatory compliance processes, which is driving demand for these solutions. The pharmaceutical and biotechnology industries are expanding rapidly, which is driving demand for RIMS solutions. These industries are highly regulated, and RIMS solutions can help organizations manage regulatory compliance and maintain product quality.

Rising demand for Software-Based Work

Increasing the number of clinical trials demand for managing and controlling the processes of releasing new data and maintain existingi8ng product data is the major factor expected to boost the market growth during the forecasting period. The rising need to reduce manual errors in regulatory processes and easy access are further anticipated to create a lucrative growth of Global Regulatory Information Management System Market during forecast period. Furthermore, increasing adoption of cloud based regulatory information management systems among end users to prepare accurate data is an important factor which propels the market growth during the forecast period. Due to manual error increasing demand for real time monitoring of regulations in the clinical trial sector and automated management of the entire workflow of product process worldwide in real time further fuel the market growth in the upcoming years. In the United States, the total amount of money spent on medicines reached approximately 574 billion U.S. dollars in 2021. Technological advancements in RIMS solutions, such as cloud-based systems and advanced analytics, are making it easier for organizations to manage their regulatory compliance processes. These advancements are driving demand for RIMS solutions. The complexity of regulatory reporting is increasing, which is driving demand for RIMS solutions that can help organizations manage these processes more efficiently. Regulatory compliance processes require large amounts of data to be collected, managed, and reported. RIMS solutions can help organizations manage this data more efficiently and effectively, which is driving demand for these solutions. RIMS solutions can help organizations save costs by reducing the time and resources required for regulatory compliance processes. This is a key driver for organizations looking to improve their efficiency and bottom line.

Recent Development

• 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.
• Sparta Systems launched TrackWise Digital in 2020, which is a cloud-based platform that offers regulatory information management capabilities. The platform includes tools for document management, change control, and submission tracking.
• ArisGlobal launched LifeSphere RIMS in 2020, which is a cloud-based regulatory information management platform. LifeSphere RIMS offers regulatory submission management, product registration management, and health authority interaction capabilities.
• Ennov launched its RIM software platform in 2019, which offers regulatory information management capabilities such as regulatory submissions, registrations, and product lifecycle management. The platform also includes tools for document management, change control, and workflow management.
• MasterControl launched Regulatory Excellence in 2019, which is a software platform that helps organizations manage the regulatory submission process, including document management, change control, and submission tracking. The platform also provides real-time visibility into the submission status, which can help organizations identify and address issues quickly.
• Veeva Systems launched Veeva Vault RIM in 2019, which is a cloud-based software platform that offers end-to-end regulatory information management capabilities. Veeva Vault RIM helps organizations manage regulatory submissions, product registrations, and health authority interactions.

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Market Segmentation

The global regulatory information management system market can be segmented by component, by deployment mode, application and by region. Based on component, the market can be divided into Solution and Services. Based on deployment mode, the market can be divided into On-Premises and Cloud. Based on application, the market can be grouped into Registration Management, Regulatory Intelligence, Labeling Management, Submission Planning & Tracking Management, Publishing, Document Management, and Others. Based on end user, the market can be segmented into Pharmaceutical, Medical Devices, and Others. Regionally, North America dominated the market among Asia Pacific, Europe, Middle East & Africa, and South America. Amongst different countries, the United States dominate The Global Regulatory Information Management System Market on account of growing demand for error free data.

Market Players

ArisGlobal LLC, Arivis AG, DDi, Inc., Ennov SA, Extedo Gmbh, Glemser Technologies Corporation, Instem Group, MasterControl, Inc., Parexel International Corporation, Samarind Ltd., Sparta Systems, Inc., Acuta LLC, Virtify, Inc., Amplexor International SA, Veeva Systems Inc. are some of the leading players operating in the Global Regulatory Information Management System Market.

Report Scope:

In this report, global regulatory information management system market has been segmented into following categories, in addition to the industry trends which have also been detailed below:

• Regulatory Information Management System Market, By Component:

o    Solution

o    Services

• Regulatory Information Management System Market, By Deployment Mode:

o    On-Premises

o    Cloud

• Regulatory Information Management System Market, By Application:

o    Registration Management

o    Regulatory Intelligence

o    Labeling Management

o    Submission Planning & Tracking Management

o    Publishing

o    Document Management

o    Others

• Regulatory Information Management System Market, By End User:

o    Pharmaceutical

o    Medical Devices

o    Others

• Regulatory Information Management System Market, By Region:
• North America
• United States
• Canada
• Mexico
• Europe
• France
• Germany
• United Kingdom
• Italy
• Spain
• Asia Pacific
• China
• India
• Japan
• South Korea
• Australia
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in Global Regulatory Information Management System Market.

Available Customizations:

With the given market data, TechSci Research offers customizations according to a company’s specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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