세계의 규제정보관리시스템(RIMS) 시장 규모, 점유율, 동향 분석 보고서 : 최종 용도별, 지역별, 부문 예측(2024-2030년)

Regulatory Information Management System Market Growth & Trends:

The global regulatory information management system market size is anticipated to reach USD 4.12 billion by 2030 and is projected to grow at a CAGR of 10.4% from 2024 to 2030, according to a new report by Grand View Research, Inc. Increasing adoption of centralized RIMS among the pharmaceutical and medical device industry along with technological advancements would likely drive the market growth over the forecast period.

The pharmaceutical sector's rapid expansion to meet global demand for innovative drugs increases regulatory complexity. To address this, companies are investing in RIM technology, leveraging automation and Artificial Intelligence (AI) to enhance regulatory workflows. Trends include outsourcing, reliance on business interaction, and the use of high-quality data for intelligent applications. For instance, in August 2022, Calyx's long-term client Krka expanded its investment in the Calyx RIM system for over 5 years, signalling a positive industry shift toward RIMS technology for effective regulatory compliance management.

The integration of advanced technologies offers a lucrative opportunity for market growth. Leveraging cutting-edge technologies, such as AI, ML, & predictive analytics, significantly bolsters risk assessment and mitigation strategies. These advanced tools enable the RIMS to rapidly analyze vast datasets, identifying patterns and potential risks that might go unnoticed through traditional methods.

Moreover, the automation capabilities of these technologies streamline processes, reducing the likelihood of human error and providing real-time insights into emerging risks. Integrating blockchain technology further enhances data security and transparency in risk management processes. For instance, IQVIA unveiled IQVIA RIM Smart, the industry's first fully integrated, comprehensive regulatory information management system which is cloud-based. Machine learning (ML) and artificial intelligence (AI) are being used more and more by businesses to enable intelligent management of a product portfolio's whole regulatory lifecycle.

Companies operating in the market are increasingly entering into strategic partnerships with RIMS solution providers to leverage their expertise & guidance in understanding global regulatory submission requirements. For example, in May 2023, LexisNexis Reed Tech, known for its analytic and data management solutions in the life sciences industry, expanded its collaboration with RegDesk, a well-known RIMS provider. Such ongoing strategic initiatives by market players are expected to fuel the adoption of RIMS.

Regulatory Information Management System Market Report Highlights:

• Based on end-use, the pharmaceutical segment led the market with the largest revenue share of 42.8% in 2023. This is attributed to implementation of strict regulation and need for RIM systems with streamlined, encrypted, unified, and compatible platforms. The medical device segment is expected to grow at the fastest CAGR over the forecast period
• North America dominated the market with the revenue share of over 37.1% in 2023, owing to an increase in advancement in the field of pharmaceutical, MedTech, and related sectors of end-of-life care, and growing awareness and rising demand for the RIM systems to bring in a better product for the end consumers/manufacturer's
• With China, India, and Japan all expected to see rapid development throughout the forecast period, the Asia-Pacific region is expected to grow at the significant CAGR over the forecast period. These include rising rates of pharmaceutical-based products and medical devices and rising regulatory-related concerns. In addition, there has been an increase in the need for RIM-related software as a solution due to rising regulatory compliance and associated data maintenance requirements

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation and Scope
  • 1.1.1. Estimates & Forecast Timeline
• 1.2. Market Definition
• 1.3. Research Methodology
  • 1.3.1. Information Procurement
  • 1.3.2. Purchased Database
  • 1.3.3. GVR's Internal Database
  • 1.3.4. Primary Research
• 1.4. Model Details
  • 1.4.1. Consensus-Based Estimates & Forecasting
  • 1.4.2. Commodity Flow Analysis
    • 1.4.2.1. Mapped Notable Products of RIMS and Related Software Providers
  • 1.4.3. End-use Segment Market analysis
  • 1.4.4. Market Survey Research Methodology
    • 1.4.4.1. General Methodology
  • 1.4.5. Country Level Assumptions
• 1.5. List of Data Sources

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Regulatory Information Management System: Market Variables, Trends & Scope

• 3.1. Regulatory Information Management System Market: Market Dynamics
• 3.2. Regulatory Information Management System Market Lineage Outlook
  • 3.2.1. Parent Market Outlook
• 3.3. Market Drivers Analysis
  • 3.3.1. Enhanced Efficiency in RIM through Technologically Advanced Systems
    • 3.3.1.1. Key Insights from Orion Systems Integrators, LLC Case Study
  • 3.3.2. Rising Demand and Increasing Adoption Of Centralized RIMS among Medical Device Companies
• 3.4. Market Restraint Analysis
  • 3.4.1. Data Security And Privacy Concerns
• 3.5. Unmet Needs/Opportunity Analysis
  • 3.5.1. Implementing Product Bundling And Providing End-To-End Regulatory-Related Solutions
  • 3.5.2. Integration of Advanced Technology In RIMS
  • 3.5.3. Customization for Industry-Specific Needs
• 3.6. Regulatory Information Management System Market - Porter's Analysis
• 3.7. Regulatory Information Management System Market - PEST Analysis
• 3.8. Regulatory Framework
• 3.9. COVID-19 Impact On Regulatory Information Management System Market

Chapter 4. Regulatory Information Management System Market: End-use Estimates & Trend Analysis

• 4.1. Regulatory Information Management System Market: End-use Outlook And Key Takeaways
• 4.2. Regulatory Information Management System Market: End-use Movement Analysis
• 4.3. Pharmaceutical Sector
  • 4.3.1. Market estimates and forecasts, 2017 - 2030 (USD Million)
• 4.4. Medical Device Sector
  • 4.4.1. Market estimates and forecasts, 2017 - 2030 (USD Million)
• 4.5. Others (Biologics, Cosmetics, Foods)
  • 4.5.1. Market estimates and forecasts, 2017 - 2030 (USD Million)

Chapter 5. Regulatory Information Management System Market: Regional Estimates & Trend Analysis, By End-use

• 5.1. Regional Dashboard
• 5.2. Market Size & Forecasts and Trend Analysis, 2017 to 2030
• 5.3. North America
  • 5.3.1. North America Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (USD Million)
  • 5.3.2. U.S.
    • 5.3.2.1. U.S. Macrodynamics
    • 5.3.2.2. U.S. Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.3.3. Canada
    • 5.3.3.1. Canada Macrodynamics
    • 5.3.3.2. Canada Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
• 5.4. Europe
  • 5.4.1. Europe Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (USD Million)
  • 5.4.2. UK
    • 5.4.2.1. UK Macrodynamics
    • 5.4.2.2. UK Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.4.3. Germany
    • 5.4.3.1. Germany Macrodynamics
    • 5.4.3.2. Germany Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.4.4. Switzerland
    • 5.4.4.1. Switzerland Macrodynamics
    • 5.4.4.2. Switzerland Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.4.5. Spain
    • 5.4.5.1. Spain Macrodynamics
    • 5.4.5.2. Spain Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.4.6. Italy
    • 5.4.6.1. Italy Macrodynamics
    • 5.4.6.2. Italy Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.4.7. Sweden
    • 5.4.7.1. Sweden Macrodynamics
    • 5.4.7.2. Sweden Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.4.8. Denmark
    • 5.4.8.1. Denmark Macrodynamics
    • 5.4.8.2. Denmark Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.4.9. Norway
    • 5.4.9.1. Norway Macrodynamics
    • 5.4.9.2. Norway Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
• 5.5. Asia Pacific
  • 5.5.1. Asia Pacific Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (USD Million)
  • 5.5.2. China
    • 5.5.2.1. China Macrodynamics
    • 5.5.2.2. China Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.5.3. Japan
    • 5.5.3.1. Japan Macrodynamics
    • 5.5.3.2. Japan Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.5.4. India
    • 5.5.4.1. India Macrodynamics
    • 5.5.4.2. India Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.5.5. South Korea
    • 5.5.5.1. South Korea Macrodynamics
    • 5.5.5.2. South Korea Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.5.6. Thailand
    • 5.5.6.1. Thailand Macrodynamics
    • 5.5.6.2. Thailand Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.5.7. Australia
    • 5.5.7.1. Australia Macrodynamics
    • 5.5.7.2. Australia Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
• 5.6. Latin America
  • 5.6.1. Latin America Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (USD Million)
  • 5.6.2. Brazil
    • 5.6.2.1. Brazil Macrodynamics
    • 5.6.2.2. Brazil Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.6.3. Mexico
    • 5.6.3.1. Mexico Macrodynamics
    • 5.6.3.2. Mexico Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.6.4. Argentina
    • 5.6.4.1. Argentina Macrodynamics
    • 5.6.4.2. Argentina Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
• 5.7. Middle East & Africa
  • 5.7.1. Middle East & Africa Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (USD Million)
  • 5.7.2. South Africa
    • 5.7.2.1. South Africa Macrodynamics
    • 5.7.2.2. South Africa Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.7.3. UAE
    • 5.7.3.1. UAE Macrodynamics
    • 5.7.3.2. UAE Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.7.4. Saudi Arabia
    • 5.7.4.1. Saudi Arabia Macrodynamics
    • 5.7.4.2. Saudi Arabia Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)
  • 5.7.5. Kuwait
    • 5.7.5.1. Kuwait Macrodynamics
    • 5.7.5.2. Kuwait Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (USD Million)

Chapter 6. Regulatory Information Management System Market: Competitive Landscape

• 6.1. Company Categorization
• 6.2. Company Heat Map Analysis
• 6.3. Participants' Overview
• 6.4. Financial Performance
• 6.5. Product Benchmarking
• 6.6. Strategy Mapping
  • 6.6.1. Mergers & Acquisitions
  • 6.6.2. Collaborations and Partnerships
  • 6.6.3. New Product/Service Launches
  • 6.6.4. Other

Chapter 7. Company Profiles

• 7.1. Veeva system
  • 7.1.1. Company Overview
  • 7.1.2. Financial Performance
  • 7.1.3. Product Benchmarking
  • 7.1.4. Strategic Initiatives
• 7.2. Kalypso
  • 7.2.1. Company Overview
  • 7.2.2. Financial Performance
  • 7.2.3. Product Benchmarking
  • 7.2.4. Strategic Initiatives
• 7.3. DDI
  • 7.3.1. Company Overview
  • 7.3.2. Financial Performance
  • 7.3.3. Product Benchmarking
  • 7.3.4. Strategic Initiatives
• 7.4. Korber AG
  • 7.4.1. Company Overview
  • 7.4.2. Financial Performance
  • 7.4.3. Product Benchmarking
  • 7.4.4. Strategic Initiatives
• 7.5. ArisGlobal
  • 7.5.1. Company Overview
  • 7.5.2. Financial Performance
  • 7.5.3. Product Benchmarking
  • 7.5.4. Strategic Initiatives
• 7.6. PhlexGlobal
  • 7.6.1. Company Overview
  • 7.6.2. Financial Performance
  • 7.6.3. Product Benchmarking
  • 7.6.4. Strategic Initiatives
• 7.7. AmpleLogic
  • 7.7.1. Company Overview
  • 7.7.2. Financial Performance
  • 7.7.3. Product Benchmarking
  • 7.7.4. Strategic Initiatives
• 7.8. Calyx
  • 7.8.1. Company Overview
  • 7.8.2. Financial Performance
  • 7.8.3. Product Benchmarking
  • 7.8.4. Strategic Initiatives
• 7.9. Amplexor Life Sciences
  • 7.9.1. Company Overview
  • 7.9.2. Financial Performance
  • 7.9.3. Product Benchmarking
  • 7.9.4. Strategic Initiatives
• 7.10. Ennov
  • 7.10.1. Company Overview
  • 7.10.2. Financial Performance
  • 7.10.3. Product Benchmarking
  • 7.10.4. Strategic Initiatives
• 7.11. MastarControl
  • 7.11.1. Company Overview
  • 7.11.2. Financial Performance
  • 7.11.3. Product Benchmarking
  • 7.11.4. Strategic Initiatives
• 7.12. Rimsys
  • 7.12.1. Company Overview
  • 7.12.2. Financial Performance
  • 7.12.3. Product Benchmarking
  • 7.12.4. Strategic Initiatives
• 7.13. Ithos Global Inc
  • 7.13.1. Company Overview
  • 7.13.2. Financial Performance
  • 7.13.3. Product Benchmarking
  • 7.13.4. Strategic Initiatives
• 7.14. Lorenz
  • 7.14.1. Company Overview
  • 7.14.2. Financial Performance
  • 7.14.3. Product Benchmarking
  • 7.14.4. Strategic Initiatives