리스크 관리 컨설팅 소프트웨어 시장 : 기능, 제공 형태, 최종 사용자별 - 세계 예측(2025-2030년)

The Risk-based Monitoring Software Market was valued at USD 409.38 million in 2023, expected to reach USD 452.94 million in 2024, and is projected to grow at a CAGR of 10.91%, to USD 845.13 million by 2030.

Risk-based Monitoring (RBM) Software revolutionizes how organizations handle clinical trials by prioritizing critical data and adjusting monitoring efforts based on potential risk factors. RBM software facilitates the efficient allocation of resources, optimizing both time and costs, crucial in large-scale trials. It is imperative given the increasing complexity and size of clinical trials, mandated protocol compliance, and the shift towards more adaptive trial designs which demand real-time data oversight. Applications extend beyond the pharmaceutical sector to biotechnology, medical device industries, and healthcare organizations, reflecting its growing end-use scope. Key growth factors in this market include rising R&D expenditure, the necessity for shorter drug development cycles, and enhanced regulatory scrutiny. The COVID-19 pandemic has spurred digital transformation across clinical trials, boosting RBM software deployment for remote monitoring. Opportunities lie in software enhancements that offer advanced predictive analytics and AI-driven risk assessments, enabling greater precision and efficiency in trial management. Moreover, expansion into emerging markets, which are increasingly adopting digital health solutions, promises significant growth potential. Nonetheless, challenges persist, including high software implementation costs and the need for extensive training to adapt traditional monitoring staff to new technologies. Data security is another limitation, with the increasing reliance on digital platforms intensifying concerns over data breaches. To overcome these challenges and drive innovation, investing in integrated platforms that combine RBM with other clinical trial management tools could be pivotal. Innovations in blockchain technology could enhance transparency and data security, addressing major market concerns. The RBM software market is characterized by rapid technological advancements and regulatory dynamics, necessitating adaptive strategies. Businesses should focus on robust partnerships with technology firms and healthcare providers to stay competitive and capitalize on new opportunities in personalized medicine and decentralized trials.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Risk-based Monitoring Software Market

The Risk-based Monitoring Software Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Need for proactive approach to monitoring clinical trials with the use of risk-based monitoring software
  • Rising number of clinical trials to determine new form of treatment and effectiveness of drugs
  • Government grants and regulatory compliance for the quality and safety of clinical trials
• Market Restraints
  • Complex implementation of the RBM software and organization reluctance to RBM software
• Market Opportunities
  • Technological advancements in risk-based monitoring software
  • Rising trend of outsourcing end-to-end services by pharmaceutical companies
• Market Challenges
  • Data security and privacy concerns associated with RBM software

Porter's Five Forces: A Strategic Tool for Navigating the Risk-based Monitoring Software Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Risk-based Monitoring Software Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Risk-based Monitoring Software Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Risk-based Monitoring Software Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Risk-based Monitoring Software Market

A detailed market share analysis in the Risk-based Monitoring Software Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Risk-based Monitoring Software Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Risk-based Monitoring Software Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Key Company Profiles

The report delves into recent significant developments in the Risk-based Monitoring Software Market, highlighting leading vendors and their innovative profiles. These include Anju Software, Inc., ArisGlobal LLC, CGI Inc., Change Healthcare LLC, Clario, CluePoints S.A., Dassault Systemes S.E., DATATRAK International, Inc., DSG, Inc., eClinical Solutions LLC, ICON PLC, Infosys Limited, International Business Machines Corporation, IQVIA Inc., JMP Statistical Discovery LLC, Laboratory Corporation of America Holdings, LexisNexis Risk Solutions Group, MasterControl Solutions Inc., Mednet, Microsoft Corporation, Octalsoft by Glorant, LLC, Oracle Corporation, Parexel International Corporation, Quanticate International Limited, Scrut Automation, Securitas AB, Signant Health, Sphera Solutions, Inc., TATA Consultancy Services Limited, Veeva Systems Inc., and Wipro Limited.

Market Segmentation & Coverage

This research report categorizes the Risk-based Monitoring Software Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Function, market is studied across Centralized Monitoring, Reduced Monitoring, Remote Monitoring, and Triggered Monitoring.
• Based on Delivery Mode, market is studied across Cloud-Based, Licensed Enterprise, and Web-Based.
• Based on End-User, market is studied across Contract Research Organization, Medical Device Companies, and Pharmaceutical & Biopharmaceutical Companies.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Need for proactive approach to monitoring clinical trials with the use of risk-based monitoring software
    • 5.1.1.2. Rising number of clinical trials to determine new form of treatment and effectiveness of drugs
    • 5.1.1.3. Government grants and regulatory compliance for the quality and safety of clinical trials
  • 5.1.2. Restraints
    • 5.1.2.1. Complex implementation of the RBM software and organization reluctance to RBM software
  • 5.1.3. Opportunities
    • 5.1.3.1. Technological advancements in risk-based monitoring software
    • 5.1.3.2. Rising trend of outsourcing end-to-end services by pharmaceutical companies
  • 5.1.4. Challenges
    • 5.1.4.1. Data security and privacy concerns associated with RBM software
• 5.2. Market Segmentation Analysis
  • 5.2.1. Function: Emergence of risk-based monitoring softwares for remote monitoring activities
  • 5.2.2. Delivery Mode: Advancements in cloud-based delivery of risk-based monitoring softwares
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental
• 5.5. Client Customization

6. Risk-based Monitoring Software Market, by Function

• 6.1. Introduction
• 6.2. Centralized Monitoring
• 6.3. Reduced Monitoring
• 6.4. Remote Monitoring
• 6.5. Triggered Monitoring

7. Risk-based Monitoring Software Market, by Delivery Mode

• 7.1. Introduction
• 7.2. Cloud-Based
• 7.3. Licensed Enterprise
• 7.4. Web-Based

8. Risk-based Monitoring Software Market, by End-User

• 8.1. Introduction
• 8.2. Contract Research Organization
• 8.3. Medical Device Companies
• 8.4. Pharmaceutical & Biopharmaceutical Companies

9. Americas Risk-based Monitoring Software Market

• 9.1. Introduction
• 9.2. Argentina
• 9.3. Brazil
• 9.4. Canada
• 9.5. Mexico
• 9.6. United States

10. Asia-Pacific Risk-based Monitoring Software Market

• 10.1. Introduction
• 10.2. Australia
• 10.3. China
• 10.4. India
• 10.5. Indonesia
• 10.6. Japan
• 10.7. Malaysia
• 10.8. Philippines
• 10.9. Singapore
• 10.10. South Korea
• 10.11. Taiwan
• 10.12. Thailand
• 10.13. Vietnam

11. Europe, Middle East & Africa Risk-based Monitoring Software Market

• 11.1. Introduction
• 11.2. Denmark
• 11.3. Egypt
• 11.4. Finland
• 11.5. France
• 11.6. Germany
• 11.7. Israel
• 11.8. Italy
• 11.9. Netherlands
• 11.10. Nigeria
• 11.11. Norway
• 11.12. Poland
• 11.13. Qatar
• 11.14. Russia
• 11.15. Saudi Arabia
• 11.16. South Africa
• 11.17. Spain
• 11.18. Sweden
• 11.19. Switzerland
• 11.20. Turkey
• 11.21. United Arab Emirates
• 11.22. United Kingdom

12. Competitive Landscape

• 12.1. Market Share Analysis, 2023
• 12.2. FPNV Positioning Matrix, 2023
• 12.3. Competitive Scenario Analysis
  • 12.3.1. Cloudbyz Unveiled Groundbreaking Electronic Data Capture Solution to Streamline Clinical Research and Accelerate Launch of New Therapies
  • 12.3.2. Clario Launched Cloud-Based Image Viewer for Clinical Trials
  • 12.3.3. ClinChoice Acquired CROMSOURCE, Expanding its Global Presence
  • 12.3.4. Scrut Automation Raised USD 7.5 Million From Massmutual Ventures
  • 12.3.5. EMA launched a pilot project on analysis of raw data from clinical trials
  • 12.3.6. Q2 Solutions Launched Innovative Self-Collection Safety Lab Panel in Collaboration With Tasso
  • 12.3.7. Medidata Announced Rapid Expansion of its Sensor Cloud Network with the Addition of 10 Health Technology Innovators
  • 12.3.8. Medidata Launches New Clinical Operations Technologies to Address Critical Issues in Clinical Trial Oversight
  • 12.3.9. Novotech and Medidata expanded partnership to continue advancements in clinical research
  • 12.3.10. Veeva Vault CTMS Enabled Proactive Clinical Trial Management for More than 150 Companies
  • 12.3.11. TCS launches risk-based monitoring solution
  • 12.3.12. Thread and Amazon Web Services Modernized Clinical Research with Launch of Cloud-based, AI-driven Decentralized Clinical Trials Technology

Companies Mentioned

• 1. Anju Software, Inc.
• 2. ArisGlobal LLC
• 3. CGI Inc.
• 4. Change Healthcare LLC
• 5. Clario
• 6. CluePoints S.A.
• 7. Dassault Systemes S.E.
• 8. DATATRAK International, Inc.
• 9. DSG, Inc.
• 10. eClinical Solutions LLC
• 11. ICON PLC
• 12. Infosys Limited
• 13. International Business Machines Corporation
• 14. IQVIA Inc.
• 15. JMP Statistical Discovery LLC
• 16. Laboratory Corporation of America Holdings
• 17. LexisNexis Risk Solutions Group
• 18. MasterControl Solutions Inc.
• 19. Mednet
• 20. Microsoft Corporation
• 21. Octalsoft by Glorant, LLC
• 22. Oracle Corporation
• 23. Parexel International Corporation
• 24. Quanticate International Limited
• 25. Scrut Automation
• 26. Securitas AB
• 27. Signant Health
• 28. Sphera Solutions, Inc.
• 29. TATA Consultancy Services Limited
• 30. Veeva Systems Inc.
• 31. Wipro Limited