Regulatory Information Management Market

Regulatory Information Management Market Outlook

According to estimates, the market for regulatory information management systems will reach US$ 1.78 billion in 2022 and grow to US$ 5.09 billion by 2032, with a compound annual growth rate CAGR of 11.2%.

Industry sectors like biotechnology, pharmaceuticals, and clinical research have very crucial regulatory environments that frequently change. Due to this, competent regulatory information management software has been developed and is now being used by business participants. One of the key elements influencing the adoption of regulatory information management software is the constantly shifting regulatory environment in these industries.

One of the key reasons projected to drive the market in the upcoming years is an increase in the number of clinical studies worldwide. The need for regulatory information management systems is projected to increase with the growing demand for real-time monitoring of regulations in the clinical trial industry. The demand for regulatory information management systems is expected to increase due to the growing global demand for automated management of the full workflow of product operations in real time.

The market for regulatory information management systems is also anticipated to expand due to convenient access and the growing need to decrease human errors in regulatory processes. The demand for regulatory information management systems is projected to increase due to increased complexity, new methods of handling registrations, and increased data exchange.

In the pharmaceutical, biotechnology, and clinical research industries, which are constantly updated, regulatory scenarios are extremely important. Consequently, it is projected that during the forecast period, demand for regulatory information management systems will rise. It is anticipated that increasing end-user adoption of cloud-based regulatory information management systems would increase demand for these systems globally.

The technological advancements and novel methods in the regulatory information management has unlocked potential for the companies, which are striving to provide regulatory information management software. The regulatory information management software has developed with new technologies, and improved process to ensure effective management of regulatory information.

The pharmaceutical companies involved in the development, dissemination, capture, and control the regulatory information through the product development cycle. Regulatory information management is a solution for pharmaceutical companies in terms of efficient value communication of regulations.

The technology tools, product & service platforms, creates the opportunities for the automating business practices. RIM is enables deliver powerful submission of planning, viewing, publishing, registration and management of products throughout the life cycle. RIMS allows ensure effective, compliant management of regulations and regulatory information.

It has advantages such as submission of plan, e-submission viewer, and product registration and tracking. It enables track the periodic safety updated reports (PSUR) and real time access of regulatory information. Global Regulatory Information Management Market is anticipated to exhibit a significant CAGR coupled with annual growth rates over the forecast period.

Regulatory Information Management Market Restraint

However, it is anticipated that the market would face challenges during the forecast period due to a lack of qualified people and the high cost of regulatory information management systems. The worldwide regulatory information management market is also anticipated to develop as a result of the decrease in manual errors in regulatory process software combined with convenient access. Over the projected period, the North American regulatory information management market is anticipated to see the highest CAGR.

Due to the significant presence of pharmaceutical firms in nations like the United States and Canada, including Amgen, GlaxoSmithKline, Novartis, Johnson & Johnson, and Gilead Sciences, North America is predicted to dominate the regulatory information management market. Additionally, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA), North America will account for 49.0% of global pharmaceutical sales in 2022, vs. Europe's 21.5%.

This illustrates the potential for regulatory information management software adoption in both the North American and European sectors. A developing pharmaceuticals industry in nations like China and India explains why Asia Pacific has a larger market share in the regulatory information management market than North America.

Regulatory Information Management Market: Drivers and Restraints

Regulatory Information Management Market provides wide range of benefits to pharmaceutical companies, increased amount of data to be collected and provided by regulatory bodies such as U.S. Food and Drug Administration (FDA), European Medicines Agency.

According to the EVMPD regulation, all pharmaceutical companies harmonized exchanged format to manage the drug safety product information, which effected on July 02, 2012. The regulatory bodies are majorly fuelling the global regulatory information management market over the forecast period.

Pharmaceutical companies are always fond of advanced technologies such as regulatory information management system, which enables easy access of information any time possible, thus most of the pharma companies are inclined towards the regulatory information management market. The reduction in manual errors in regulatory process coupled with easy access are further expected to contribute in the growth of global regulatory information management market

However, there are some disadvantages in the use of Regulatory Information Management system that includes the need to train the sales professionals to manage advanced technologies. Also Regulatory Information Management is costlier than conventional method. These factors can act as major road blocks for the growth Regulatory Information Management Market.

Sudip Saha

Principal Consultant

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Regulatory Information Management Market: Overview

The demand of Regulatory Information Management Market is increasing in pharmaceutical and biopharmaceutical companies due to its efficiency and effectiveness in regulatory approval of pharmaceuticals. Through regulatory information management market companies can share their product updates. The global Regulatory Information Management Market is expected to unlock the potential of market over the forecast period.

Regulatory Information Management Market: Region-Wise Outlook

Regulatory Information Management Market is segmented into seven key regions: Those are North America, Latin America, Eastern Europe, Western Europe, and APEJ, Japan, Middle East and Africa. North America is anticipated to dominate the regulatory information management market due to the presence of pharmaceutical stalwarts in the countries like US and Canada.

North America is followed by Asia Pacific in terms of market share of regulatory information management market owing to the rise of pharmaceuticals industry in the countries like China and India. Europe is growing at a modest CAGR in the global regulatory information management market. Latin America and Middle East and Africa are at a nascent stage in the global regulatory information management market and is expected to have a significant contribution in the market in the forecast period.

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Regulatory Information Management Market: Key players

Some of the key players are

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

The Research report presents a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, and statistically supported and industry-validated market data. It also contains projections using a suitable set of assumptions and methodologies. The research report provides analysis and information according to categories such as market segments, geographies, types, technology and applications.

The report covers exhaustive analysis on

• Market Segments
• Market Dynamics
• Market Size
• Supply & Demand
• Current Trends/Issues/Challenges
• Competition & Companies involved
• Technology
• Value Chain

Regional analysis includes

• North America (U.S., Canada)
• Latin America (Mexico, Brazil)
• Western Europe (Germany, Italy, U.K, Spain, France, Rest of Western Europe)
• Eastern Europe (Russia)
• Asia Pacific (China, India, ASEAN, Australia & New Zealand)
• Japan
• Middle East and Africa (GCC, S. Africa)

The report is a compilation of first-hand information, qualitative and quantitative assessment by industry analysts, inputs from industry experts and industry participants across the value chain. The report provides in-depth analysis of parent market trends, macro-economic indicators and governing factors along with market attractiveness as per segments. The report also maps the qualitative impact of various market factors on market segments and geographies.

Regulatory Information Management Market: Segmentation

Global Regulatory Information Management Market can be segmented as following types:

• By Product:
• Software
• Hardware
• By End User
• Pharmaceutical Industry
• Biotechnology Industry
• Clinical Research organizations