Regulatory Information Management Market

Global Regulatory Information Management Market Outlook for 2024 to 2034

The regulatory information management market value is estimated to be around USD 2,155.6 million in 2024. The adoption of regulatory information management solutions is increasing in pharmaceutical and biopharmaceutical companies due to their efficiency and effectiveness in approving new formulations.

According to market estimates for 2024 to 2034, demand for regulatory information management systems is likely to register a compound annual growth rate of 11%. The report also predicts the net valuation of the regulatory information management industry to reach up to USD 6,119.9 million by 2034 end.

Market Trends & Analysis

• Industry sectors like biotechnology, pharmaceuticals, and clinical research follow strict regulatory environments that frequently change with time and region. Due to this, competent life science regulatory solutions have become essential and are used by companies operating in the healthcare sector.
• The importance of integrated regulatory information management systems has risen due to the emerging trend of automated management of the full workflow of product operations in real time. For instance, LifeSphere Regulatory solutions allow users to manage all aspects of their regulatory compliance with one cohesive suite. So, contemporary market players strive to develop effective solutions compliant with global regulatory standards and documentation.

Report Attribute	Details
Market Revenue (2024)	USD 2,155.6 million
Market Anticipated Forecast Value (2034)	USD 6,119.9 million
Market Projected Growth Rate (2024 to 2034)	11%

Regulatory Information Management Market Analysis During Historical Period from 2019 to 2023 Compared to Forecast Outlook for 2024 to 2034

As per the numbers mentioned in an earlier report, the net worth of the market for regulatory information management solutions was around USD 1,343.2 million in 2019. In the following years, the overall market was figured out to expand at an impressive CAGR of 9.7% on average for five years.

The need for regulatory information management systems increased enormously in 2020 and 2021 with the growing demand for real-time monitoring and regulations of the clinical trials for the COVID-19 vaccine. By 2023 end, the total valuation was observed to have reached USD 1,946.5 million.

Attributes	Details
Regulatory Information Management Market Size (2019)	USD 1,343.2 million
Market Value (2023)	USD 1,946.5 million
Market (CAGR 2019 to 2023)	9.7%

Prominent Factors for the Global Regulatory Information Management Industry Growth

Regulatory data repositories and management solutions are extremely important in the pharmaceutical, biotechnology, and clinical research industries, which are constantly updated. Consequently, the demand for regulatory information management systems is likely to rise with the expansion of the pharmaceutical industries during the forecast period.

The relevance of regulatory compliance solutions is likely to improve further with the growing complexity of information tracking and planning requiring increased data exchange. Moreover, new methods of handling registrations and the ongoing models of regulatory consulting are anticipated to fuel the development of RIM software solutions further.

Country-wise Insights

The table below indexes the CAGR for some top-performing countries in the broad geographical regions of North America, Europe, and Asia Pacific. North America is anticipated to dominate the regulatory information management market due to the presence of pharmaceutical stalwarts in countries like the United States and Canada.

North America is followed by Asia Pacific regarding market share in the regulatory information management industry owing to rapidly industrializing countries like China, Japan, South Korea, and India.

Regional Market Comparison	CAGR (2024 to 2034)
United States	7.9%
Germany	10.5%
China	11.5%
Japan	12.2%
Australia	14.5%

The United States Leads in the Advancement of Regulatory Processes and Technologies

The market for regulatory information management systems in the United States is predicted to follow a modest CAGR of 7.9% between 2024 and 2034. Central factors that are projected to retain the dominance of the country through the forecast years include:

• The technological advancements and novel methods in regulatory information management have unlocked huge potential for companies based here.
• According to the EVMPD regulation since 2012, all pharmaceutical companies need to harmonize information exchange formats to manage drug safety.
• Lastly, the presence of leading pharmaceutical firms, including Amgen, GlaxoSmithKline, Novartis, Johnson & Johnson, and Gilead Sciences, among others.

Australia to Emerge as a Lucrative Market for Global Players

Australia is at a nascent stage in the regulatory information management market and is expected to follow a 14.5% CAGR through the forecast period. Some of the key reasons that are expected to drive the Australian regulatory document management market in the upcoming years include:

• The regulatory protocols for finance and biopharmaceutical companies have strengthened in Australia in the last few years.
• Regulatory information systems streamline the exports of Australian pharmaceutical companies by enabling compliance with regulatory bodies such as the USFDA and European Medicines Agency.
• The regional regulatory information management systems (RIMS) market is also anticipated to develop due to an insufficient workforce in the island country.

Category-wise Insights

RIM Software Segment Dominates the Market in Terms of Revenue

Though the hardware segment has made a significant contribution to establishing the RIMS market, in terms of revenue, the software segment is estimated to account for 81% of the share in 2024.

Attributes	Details
Top Product Type or Segment	RIM Software
Market Share in 2024	81%

The market segment for RIM software is anticipated to retain its dominance through the projected years for the following reasons:

• The adoption of RIM software is increasing due to convenient access and the growing need to decrease human errors in regulatory processes.
• Integration of advantageous features such as electronic regulatory submissions of plans, e-submission software, and online product registration and tracking.
• Regulatory information management systems are emerging as an apt solution for government organizations in terms of efficient value communication of regulations.

Large Enterprises are Better Equipped to Adopt Regulatory Affairs Technologies

Large enterprises are expected to account for 31.1% of the total share in 2024, based on the size of the enterprises requiring regulatory management solutions.

Attributes	Details
Top End User Vertical Segment	Large Enterprises
Market Share in 2024	31.1%

Some underlying factors that are expected to keep the players focused on the large enterprises market segment through the forecast years include:

• Large enterprises are always likely to promptly adopt advanced technologies, including regulatory affairs software, due to their higher spending capacity.
• Increasing adoption of life sciences regulatory information management solutions is likely to augment the demand from large pharmaceutical enterprises further.

BFSI institutions involved in the dissemination of new financial services find adopting regulatory information solutions advantageous through the product development cycle.

Competitive Landscape

The prominent players mainly hold a greater share of the total services in demand, resulting in consolidation of the regulatory information management system (RIMS) market. However, the advent of cloud-based regulatory information management systems, affordable tools, and product & service platforms have created more opportunities for regional businesses to provide lenient regulatory compliance practices.

Recent Developments in the Regulatory Information Management Industry

• In June 2020, ArisGlobal introduced a new cloud-based information management platform designed to simplify the handling of regulatory data. ArisGlobal is a leading software vendor for life science companies and is hopeful to extend its services to more companies with such cloud-based solutions.
• Vitality TechNet and Fluree Company joined together in August 2023 to develop a digital regulatory data management platform for pharmaceutical firms to expedite drug research. Fluree is a database management startup, and the collaboration is anticipated to lead to quicker and more effective regulatory reporting, besides saving expenses and enhancing drug development pipelines.
• In August 2023, Boyds developed and released a new regulatory operations and management service to assist its clients' whole drug development project lifecycle. The firm is a leading drug development consultant and employs LORENZ docuBridge, a well-liked RIMS software tool that handles its service entirely in-house.

Key Players Profiled in Regulatory Information Management Industry Report

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

Regulatory Information Management Market Report Scope

Attribute	Details
Estimated Market Size (2024)	USD 2,155.6 million
Projected Market Size (2034)	USD 6,119.9 million
Anticipated Growth Rate (2024 to 2034)	11%
Forecast Period	2024 to 2034
Historical Data Available for	2019 to 2023
Market Analysis	USD million or billion for Value and Units for Volume
Key Regions Covered	North America; Latin America; Europe; the Middle East & Africa (MEA); East Asia; South Asia and Oceania
Key Countries Covered	United States, Canada, Brazil, Mexico, Germany, Spain, Italy, France, United Kingdom, Russia, China, India, Australia & New Zealand, GCC Countries, and South Africa
Key Segments Covered	By Product Type, By End User Verticals, and By Region
Key Companies Profiled	ACUTA, LLC.; Parexel; Computer Sciences Corp (CSC); ArisGlobal; Virtify; Ennov; Amplexor; Samarind Ltd; Dovel Technologies, Inc.; Informa
Report Coverage	Market Forecast, Company Share Analysis, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, and Strategic Growth Initiatives
Customization & Pricing	Available upon Request

Key Segments Covered by Regulatory Information Management Industry Survey Report

By Product Type:

• Software
• Hardware

By Enterprise Size:

• Large Enterprises
• Small and Medium Enterprises (SMEs)

By End User:

• Pharmaceutical Industry
• Biotechnology Industry
• Clinical Research organizations
• Other End-user Verticals

By Region:

• North America
• Latin America
• Europe
• East Asia
• South Asia and Pacific
• The Middle East and Africa (MEA)

Frequently Asked Questions

What is the Growth Outlook of the Regulatory Information Management Market?

The global regulatory information management market is to grow at 11% during the forecast period.

What is the Projected Value of the Regulatory Information Management Market by 2034?

The regulatory information management market is predicted to be valued at USD 6,119.9 million by 2034.

What was the Historical Size of the Regulatory Information Management Market?

The regulatory information management market was valued at USD 1,946.5 million in 2023.

Which Product Segment Dominates the Global Regulatory Information Management Market?

The RIM software segment to account for nearly 81% share of the revenue in 2024.

Which Regional Regulatory Information Management Market Has Significant Growth Potential?

Australia to witness a CAGR of 14.5% in the adoption of regulatory information management solutions through 2034.