The regulatory information management market value is estimated to be around US$ 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 US$ 6,119.9 million by 2034 end.
Market Trends & Analysis
Report Attribute | Details |
---|---|
Market Revenue (2024) | US$ 2,155.6 million |
Market Anticipated Forecast Value (2034) | US$ 6,119.9 million |
Market Projected Growth Rate (2024 to 2034) | 11% |
Don't pay for what you don't need
Customize your report by selecting specific countries or regions and save 30%!
As per the numbers mentioned in an earlier report, the net worth of the market for regulatory information management solutions was around US$ 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 US$ 1,946.5 million.
Attributes | Details |
---|---|
Regulatory Information Management Market Size (2019) | US$ 1,343.2 million |
Market Value (2023) | US$ 1,946.5 million |
Market (CAGR 2019 to 2023) | 9.7% |
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.
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 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:
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:
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:
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:
BFSI institutions involved in the dissemination of new financial services find adopting regulatory information solutions advantageous through the product development cycle.
Get the data you need at a Fraction of the cost
Personalize your report by choosing insights you need
and save 40%!
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
Attribute | Details |
---|---|
Estimated Market Size (2024) | US$ 2,155.6 million |
Projected Market Size (2034) | US$ 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 | US$ 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 |
|
Report Coverage | Market Forecast, Company Share Analysis, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, and Strategic Growth Initiatives |
Customization & Pricing | Available upon Request |
The global regulatory information management market is to grow at 11% during the forecast period.
The regulatory information management market is predicted to be valued at US$ 6,119.9 million by 2034.
The regulatory information management market was valued at US$ 1,946.5 million in 2023.
The RIM software segment to account for nearly 81% share of the revenue in 2024.
Australia to witness a CAGR of 14.5% in the adoption of regulatory information management solutions through 2034.
1. Executive Summary
1.1. Global Market Outlook
1.2. Demand-side Trends
1.3. Supply-side Trends
1.4. Technology Roadmap Analysis
1.5. Analysis and Recommendations
2. Market Overview
2.1. Market Coverage / Taxonomy
2.2. Market Definition / Scope / Limitations
3. Market Background
3.1. Market Dynamics
3.1.1. Drivers
3.1.2. Restraints
3.1.3. Opportunity
3.1.4. Trends
3.2. Scenario Forecast
3.2.1. Demand in Optimistic Scenario
3.2.2. Demand in Likely Scenario
3.2.3. Demand in Conservative Scenario
3.3. Opportunity Map Analysis
3.4. Investment Feasibility Matrix
3.5. PESTLE and Porter’s Analysis
3.6. Regulatory Landscape
3.6.1. By Key Regions
3.6.2. By Key Countries
3.7. Regional Parent Market Outlook
4. Global Market Analysis 2019 to 2023 and Forecast, 2024 to 2034
4.1. Historical Market Size Value (US$ Million) Analysis, 2019 to 2023
4.2. Current and Future Market Size Value (US$ Million) Projections, 2024 to 2034
4.2.1. Y-o-Y Growth Trend Analysis
4.2.2. Absolute $ Opportunity Analysis
5. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Solution
5.1. Introduction / Key Findings
5.2. Historical Market Size Value (US$ Million) Analysis By Solution, 2019 to 2023
5.3. Current and Future Market Size Value (US$ Million) Analysis and Forecast By Solution, 2024 to 2034
5.3.1. Software
5.3.1.1. Cloud
5.3.1.2. On-premise
5.3.2. Services
5.3.2.1. Training & Support
5.3.2.2. Consulting
5.4. Y-o-Y Growth Trend Analysis By Solution, 2019 to 2023
5.5. Absolute $ Opportunity Analysis By Solution, 2024 to 2034
6. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Company Size
6.1. Introduction / Key Findings
6.2. Historical Market Size Value (US$ Million) Analysis By Company Size, 2019 to 2023
6.3. Current and Future Market Size Value (US$ Million) Analysis and Forecast By Company Size, 2024 to 2034
6.3.1. Small & Medium Enterprises (SMEs)
6.3.2. Large Enterprises
6.4. Y-o-Y Growth Trend Analysis By Company Size, 2019 to 2023
6.5. Absolute $ Opportunity Analysis By Company Size, 2024 to 2034
7. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Vertical
7.1. Introduction / Key Findings
7.2. Historical Market Size Value (US$ Million) Analysis By Vertical , 2019 to 2023
7.3. Current and Future Market Size Value (US$ Million) Analysis and Forecast By Vertical , 2024 to 2034
7.3.1. Pharmaceuticals
7.3.2. Cosmetics
7.3.3. Medical Devices
7.3.4. Biologics
7.3.5. Nutraceuticals
7.4. Y-o-Y Growth Trend Analysis By Vertical , 2019 to 2023
7.5. Absolute $ Opportunity Analysis By Vertical , 2024 to 2034
8. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Region
8.1. Introduction
8.2. Historical Market Size Value (US$ Million) Analysis By Region, 2019 to 2023
8.3. Current Market Size Value (US$ Million) Analysis and Forecast By Region, 2024 to 2034
8.3.1. North America
8.3.2. Latin America
8.3.3. Western Europe
8.3.4. Eastern Europe
8.3.5. South Asia and Pacific
8.3.6. East Asia
8.3.7. Middle East and Africa
8.4. Market Attractiveness Analysis By Region
9. North America Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
9.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
9.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
9.2.1. By Country
9.2.1.1. U.S.
9.2.1.2. Canada
9.2.2. By Solution
9.2.3. By Company Size
9.2.4. By Vertical
9.3. Market Attractiveness Analysis
9.3.1. By Country
9.3.2. By Solution
9.3.3. By Company Size
9.3.4. By Vertical
9.4. Key Takeaways
10. Latin America Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
10.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
10.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
10.2.1. By Country
10.2.1.1. Brazil
10.2.1.2. Mexico
10.2.1.3. Rest of Latin America
10.2.2. By Solution
10.2.3. By Company Size
10.2.4. By Vertical
10.3. Market Attractiveness Analysis
10.3.1. By Country
10.3.2. By Solution
10.3.3. By Company Size
10.3.4. By Vertical
10.4. Key Takeaways
11. Western Europe Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
11.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
11.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
11.2.1. By Country
11.2.1.1. Germany
11.2.1.2. U.K.
11.2.1.3. France
11.2.1.4. Spain
11.2.1.5. Italy
11.2.1.6. Rest of Western Europe
11.2.2. By Solution
11.2.3. By Company Size
11.2.4. By Vertical
11.3. Market Attractiveness Analysis
11.3.1. By Country
11.3.2. By Solution
11.3.3. By Company Size
11.3.4. By Vertical
11.4. Key Takeaways
12. Eastern Europe Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
12.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
12.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
12.2.1. By Country
12.2.1.1. Poland
12.2.1.2. Russia
12.2.1.3. Czech Republic
12.2.1.4. Romania
12.2.1.5. Rest of Eastern Europe
12.2.2. By Solution
12.2.3. By Company Size
12.2.4. By Vertical
12.3. Market Attractiveness Analysis
12.3.1. By Country
12.3.2. By Solution
12.3.3. By Company Size
12.3.4. By Vertical
12.4. Key Takeaways
13. South Asia and Pacific Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
13.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
13.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
13.2.1. By Country
13.2.1.1. India
13.2.1.2. Bangladesh
13.2.1.3. Australia
13.2.1.4. New Zealand
13.2.1.5. Rest of South Asia and Pacific
13.2.2. By Solution
13.2.3. By Company Size
13.2.4. By Vertical
13.3. Market Attractiveness Analysis
13.3.1. By Country
13.3.2. By Solution
13.3.3. By Company Size
13.3.4. By Vertical
13.4. Key Takeaways
14. East Asia Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
14.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
14.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
14.2.1. By Country
14.2.1.1. China
14.2.1.2. Japan
14.2.1.3. South Korea
14.2.2. By Solution
14.2.3. By Company Size
14.2.4. By Vertical
14.3. Market Attractiveness Analysis
14.3.1. By Country
14.3.2. By Solution
14.3.3. By Company Size
14.3.4. By Vertical
14.4. Key Takeaways
15. Middle East and Africa Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
15.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
15.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
15.2.1. By Country
15.2.1.1. GCC Countries
15.2.1.2. South Africa
15.2.1.3. Israel
15.2.1.4. Rest of MEA
15.2.2. By Solution
15.2.3. By Company Size
15.2.4. By Vertical
15.3. Market Attractiveness Analysis
15.3.1. By Country
15.3.2. By Solution
15.3.3. By Company Size
15.3.4. By Vertical
15.4. Key Takeaways
16. Key Countries Market Analysis
16.1. U.S.
16.1.1. Pricing Analysis
16.1.2. Market Share Analysis, 2023
16.1.2.1. By Solution
16.1.2.2. By Company Size
16.1.2.3. By Vertical
16.2. Canada
16.2.1. Pricing Analysis
16.2.2. Market Share Analysis, 2023
16.2.2.1. By Solution
16.2.2.2. By Company Size
16.2.2.3. By Vertical
16.3. Brazil
16.3.1. Pricing Analysis
16.3.2. Market Share Analysis, 2023
16.3.2.1. By Solution
16.3.2.2. By Company Size
16.3.2.3. By Vertical
16.4. Mexico
16.4.1. Pricing Analysis
16.4.2. Market Share Analysis, 2023
16.4.2.1. By Solution
16.4.2.2. By Company Size
16.4.2.3. By Vertical
16.5. Germany
16.5.1. Pricing Analysis
16.5.2. Market Share Analysis, 2023
16.5.2.1. By Solution
16.5.2.2. By Company Size
16.5.2.3. By Vertical
16.6. U.K.
16.6.1. Pricing Analysis
16.6.2. Market Share Analysis, 2023
16.6.2.1. By Solution
16.6.2.2. By Company Size
16.6.2.3. By Vertical
16.7. France
16.7.1. Pricing Analysis
16.7.2. Market Share Analysis, 2023
16.7.2.1. By Solution
16.7.2.2. By Company Size
16.7.2.3. By Vertical
16.8. Spain
16.8.1. Pricing Analysis
16.8.2. Market Share Analysis, 2023
16.8.2.1. By Solution
16.8.2.2. By Company Size
16.8.2.3. By Vertical
16.9. Italy
16.9.1. Pricing Analysis
16.9.2. Market Share Analysis, 2023
16.9.2.1. By Solution
16.9.2.2. By Company Size
16.9.2.3. By Vertical
16.10. Poland
16.10.1. Pricing Analysis
16.10.2. Market Share Analysis, 2023
16.10.2.1. By Solution
16.10.2.2. By Company Size
16.10.2.3. By Vertical
16.11. Russia
16.11.1. Pricing Analysis
16.11.2. Market Share Analysis, 2023
16.11.2.1. By Solution
16.11.2.2. By Company Size
16.11.2.3. By Vertical
16.12. Czech Republic
16.12.1. Pricing Analysis
16.12.2. Market Share Analysis, 2023
16.12.2.1. By Solution
16.12.2.2. By Company Size
16.12.2.3. By Vertical
16.13. Romania
16.13.1. Pricing Analysis
16.13.2. Market Share Analysis, 2023
16.13.2.1. By Solution
16.13.2.2. By Company Size
16.13.2.3. By Vertical
16.14. India
16.14.1. Pricing Analysis
16.14.2. Market Share Analysis, 2023
16.14.2.1. By Solution
16.14.2.2. By Company Size
16.14.2.3. By Vertical
16.15. Bangladesh
16.15.1. Pricing Analysis
16.15.2. Market Share Analysis, 2023
16.15.2.1. By Solution
16.15.2.2. By Company Size
16.15.2.3. By Vertical
16.16. Australia
16.16.1. Pricing Analysis
16.16.2. Market Share Analysis, 2023
16.16.2.1. By Solution
16.16.2.2. By Company Size
16.16.2.3. By Vertical
16.17. New Zealand
16.17.1. Pricing Analysis
16.17.2. Market Share Analysis, 2023
16.17.2.1. By Solution
16.17.2.2. By Company Size
16.17.2.3. By Vertical
16.18. China
16.18.1. Pricing Analysis
16.18.2. Market Share Analysis, 2023
16.18.2.1. By Solution
16.18.2.2. By Company Size
16.18.2.3. By Vertical
16.19. Japan
16.19.1. Pricing Analysis
16.19.2. Market Share Analysis, 2023
16.19.2.1. By Solution
16.19.2.2. By Company Size
16.19.2.3. By Vertical
16.20. South Korea
16.20.1. Pricing Analysis
16.20.2. Market Share Analysis, 2023
16.20.2.1. By Solution
16.20.2.2. By Company Size
16.20.2.3. By Vertical
16.21. GCC Countries
16.21.1. Pricing Analysis
16.21.2. Market Share Analysis, 2023
16.21.2.1. By Solution
16.21.2.2. By Company Size
16.21.2.3. By Vertical
16.22. South Africa
16.22.1. Pricing Analysis
16.22.2. Market Share Analysis, 2023
16.22.2.1. By Solution
16.22.2.2. By Company Size
16.22.2.3. By Vertical
16.23. Israel
16.23.1. Pricing Analysis
16.23.2. Market Share Analysis, 2023
16.23.2.1. By Solution
16.23.2.2. By Company Size
16.23.2.3. By Vertical
17. Market Structure Analysis
17.1. Competition Dashboard
17.2. Competition Benchmarking
17.3. Market Share Analysis of Top Players
17.3.1. By Regional
17.3.2. By Solution
17.3.3. By Company Size
17.3.4. By Vertical
18. Competition Analysis
18.1. Competition Deep Dive
18.1.1. Veeva system
18.1.1.1. Overview
18.1.1.2. Product Portfolio
18.1.1.3. Profitability by Market Segments
18.1.1.4. Sales Footprint
18.1.1.5. Strategy Overview
18.1.1.5.1. Marketing Strategy
18.1.2. Kalypso
18.1.2.1. Overview
18.1.2.2. Product Portfolio
18.1.2.3. Profitability by Market Segments
18.1.2.4. Sales Footprint
18.1.2.5. Strategy Overview
18.1.2.5.1. Marketing Strategy
18.1.3. DDI
18.1.3.1. Overview
18.1.3.2. Product Portfolio
18.1.3.3. Profitability by Market Segments
18.1.3.4. Sales Footprint
18.1.3.5. Strategy Overview
18.1.3.5.1. Marketing Strategy
18.1.4. Korber AG
18.1.4.1. Overview
18.1.4.2. Product Portfolio
18.1.4.3. Profitability by Market Segments
18.1.4.4. Sales Footprint
18.1.4.5. Strategy Overview
18.1.4.5.1. Marketing Strategy
18.1.5. ArisGlobal
18.1.5.1. Overview
18.1.5.2. Product Portfolio
18.1.5.3. Profitability by Market Segments
18.1.5.4. Sales Footprint
18.1.5.5. Strategy Overview
18.1.5.5.1. Marketing Strategy
18.1.6. PhlexGlobal
18.1.6.1. Overview
18.1.6.2. Product Portfolio
18.1.6.3. Profitability by Market Segments
18.1.6.4. Sales Footprint
18.1.6.5. Strategy Overview
18.1.6.5.1. Marketing Strategy
18.1.7. AmpleLogic
18.1.7.1. Overview
18.1.7.2. Product Portfolio
18.1.7.3. Profitability by Market Segments
18.1.7.4. Sales Footprint
18.1.7.5. Strategy Overview
18.1.7.5.1. Marketing Strategy
18.1.8. Calyx
18.1.8.1. Overview
18.1.8.2. Product Portfolio
18.1.8.3. Profitability by Market Segments
18.1.8.4. Sales Footprint
18.1.8.5. Strategy Overview
18.1.8.5.1. Marketing Strategy
18.1.9. Amplexore Life Sciences
18.1.9.1. Overview
18.1.9.2. Product Portfolio
18.1.9.3. Profitability by Market Segments
18.1.9.4. Sales Footprint
18.1.9.5. Strategy Overview
18.1.9.5.1. Marketing Strategy
18.1.10. Ennov
18.1.10.1. Overview
18.1.10.2. Product Portfolio
18.1.10.3. Profitability by Market Segments
18.1.10.4. Sales Footprint
18.1.10.5. Strategy Overview
18.1.10.5.1. Marketing Strategy
18.1.11. MastarControl
18.1.11.1. Overview
18.1.11.2. Product Portfolio
18.1.11.3. Profitability by Market Segments
18.1.11.4. Sales Footprint
18.1.11.5. Strategy Overview
18.1.11.5.1. Marketing Strategy
19. Assumptions & Acronyms Used
20. Research Methodology
Explore Technology Insights
View Reports