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CLINICAL TRIAL SOFTWARE MARKET: OVERVIEW

As per Roots Analysis, the global clinical trial software market is estimated to grow from USD 0.69 billion in the current year to USD 3.68 billion by 2035, at a CAGR of 14% during the forecast period, till 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Deployment

• On-Cloud
• On-Premises

Type of Delivery

• Web-Based
• Remote Monitoring

Features of Software

• EDC
• eCOA/ePRO
• eConsent

End Users

• Pharmaceutical / Biotechnology Industries
• Academic and Research Institutes
• Other Industries

Geographical Regions

• North America
• Europe
• Asia-Pacific

CLINICAL TRIAL SOFTWARE MARKET: GROWTH AND TRENDS

Clinical trials are prospective biomedical research studies designed to evaluate medical, surgical or behavioral interventions in people and investigate novel approaches for the diagnosis and prevention / treatment of diseases. In order to gain marketing approval from regulatory authorities for a novel therapeutic intervention, highly accurate and elaborate clinical trial data is required to validate the drug's safety and effectiveness towards a specific target indication. However, there are several challenges associated with this traditional way of clinical research. Some of these include high capital investment, low patient recruitment rates and lack of robust data faced by companies involved in the development of various therapeutic interventions. This leads to inefficiency in generating sufficient clinical evidence, resulting in massive capital losses for drug developers, as well as patients accessing these life-saving therapies. In fact, manual conventional clinical trials consume almost 50% of the time during drug development. In this context, clinical trial software has gained significant attention owing to its ability for real-time analysis, data management, and tracking of the adverse impact of drugs.

In recent years, various players have developed a number of clinical trial software / clinical trial management systems, including EDC, eCOA / ePRO, and eConsent. These tools enable real-time clinical studies and improve patient compliance for drug testing and analysis. Owing to its significance, several clinical trial software market players are currently engaged in this field to develop innovative technologies. Notably, these technologies encourage successful outcomes of clinical trials and reduce the burden of pharmaceutical companies. Given the increasing demand for automated clinical trial software, the market is expected to witness substantial growth during the forecast period.

CLINICAL TRIAL SOFTWARE MARKET: KEY INSIGHTS

The report delves into the current state of the clinical trial software market and identifies potential growth opportunities within the industry. Some key findings from the report include:

• 70+ companies worldwide claim to have developed software solutions allowing decentralization of the clinical research process, optimizing time and cost spent on clinical trials.
• The current market landscape is highly fragmented, with the presence of both established players and new entrants offering clinical trials software with advanced features. In fact, since 2000, over 51 start-ups focused on developing clinical trials software have been established.
• In pursuit of building a competitive edge, companies are actively expanding their existing capabilities to enhance their respective offerings and comply with evolving industry benchmarks.
• Foreseeing lucrative returns, many public and private investors have significant investments, marking a surge in funding activity. Notably, North America witnessed around 90% of funding instances in this domain.

• The domain has witnessed a considerable increase in partnerships and collaborations over the past few years, indicating the rising interest of stakeholders.
• Notably, most of the M&A instances were reported in 2023, indicating a gradual shift towards consolidation. Further, majority (87%) of agreements were acquisitions, followed by mergers.
• We expect the market to grow at an annualized rate of 14% in the coming decade; the opportunity is likely to be well distributed across type of deployment, features of software, type of delivery and geographical regions.

CLINICAL TRIAL SOFTWARE MARKET: KEY SEGMENTS

The eConsent Software Segment Holds the Largest Share of the Global Clinical Trial Software Market

Based on the features of software, the global market for clinical trial software is segmented into EDC, eCOA/ePRO and eConsent software. Currently, the majority of the clinical trial software market is captured by eConsent software. It is worth highlighting that the global clinical trial software market for eCOA / ePRO segment is likely to grow at a relatively higher CAGR.

North America Accounts for the Largest Share of the Market

Based on the geographical regions, the market is segmented into North America, Europe and Asia-Pacific. In the current scenario, North America is likely to capture the largest market share while the market in Asia-Pacific is anticipated to demonstrate lucrative growth during the forecast period.

Example Players in the Clinical Trial Software Market

• Advarra
• Arisglobal
• AssistRx
• Calyx
• Clario
• IBM
• IQVIA
• Medidata
• Oracle
• Signant Health
• Veeva

CLINICAL TRIAL SOFTWARE MARKET: RESEARCH COVERAGE

• Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global clinical trial software market, focusing on key market segments, including [A] type of deployment, [B] type of delivery, [C] features of software, [D] end users and [E] geographical regions.
• Clinical Trials Software Market Landscape: A comprehensive evaluation of clinical trials software market, based on several relevant parameters, such as [A] type of deployment, [B] type of delivery, [C] type of end-user, [D] features of software, [E] trial design and [F] type of technology. Additionally, a comprehensive evaluation of the companies engaged in developing clinical trials software, based on several relevant parameters, such as [G] year of establishment, [H] company and [I] location of headquarters.
• Company Profiles: In-depth profiles of key players engaged in the development of clinical trials software, focusing on [A] overview of the company, [B] product portfolio, and [C] recent developments and [D] an informed future outlook.
• Company Competitiveness Analysis: A comprehensive competitive analysis of clinical trials software developers, examining factors, such as [A] supplier strength, [B] product portfolio strength and [C] service applicability.
• Partnerships and Collaborations: An insightful analysis of the deals inked by stakeholders in the global clinical trials software market, based on several parameters, such as [A] year of partnership, [B] type of partnership, [C] geographical distribution of partnership activity and [D] most active players (in terms of the number of partnerships signed).
• Mergers and Acquisitions: An in-depth analysis of the mergers and acquisitions undertaken in this domain, based on relevant parameters, such as [A] type of agreement, [B] year of mergers and acquisitions, [C] geographical location and [D] most active players (in terms of the number of mergers and acquisitions).
• Funding and Investment Analysis: An in-depth analysis of the fundings raised by companies engaged in this domain, based on relevant parameters, such as [A] year of funding, [B] type of funding, [C] amount invested, [D] most active players and [F] most active investors.

KEY QUESTIONS ANSWERED IN THIS REPORT

• How many companies are currently engaged in this market?
• Which are the leading companies in this market?
• What factors are likely to influence the evolution of this market?
• What is the current and future market size?
• What is the CAGR of this market?
• How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

• The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
• Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
• The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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TABLE OF CONTENTS

1. PREFACE

• 1.1. Scope of the Report
• 1.2. Research Methodology
• 1.3. Key Questions Answered
• 1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

• 3.1. Chapter Overview
• 3.2. Existing Constraints in Clinical Research
  • 3.2.1. Increasing Trial Costs and Complexity
  • 3.2.2. Evolving Regulatory Standards
  • 3.2.3. Patient Recruitment and Retention-Related Challenges
  • 3.2.4. Inefficient Data Handling
• 3.3. Virtual Clinical Trials
  • 3.3.1. Electronic Data Capture Solutions
  • 3.3.2. Electronic Clinical Outcome Assessment and Electronic Patient Reported Outcome Solutions (eCOA / ePRO)
  • 3.3.3. Electronic Consent Solutions
• 3.4. Opportunities and challenges associated with Virtual Clinical Trials Management
• 3.5 Future Perspectives

4 MARKET LANDSCAPE: CLINICAL TRIALS SOFTWARE MARKET

• 4.1. Chapter Overview
• 4.2. Clinical Trials Software Market: List of Products
  • 4.2.1. Analysis by Type of Deployment
  • 4.2.2. Analysis by Type of Delivery
  • 4.2.3. Analysis by End-User
  • 4.2.4. Analysis by Features of Software
  • 4.2.5. Analysis by Trial Design
  • 4.2.6. Analysis by Type of Technology
• 4.3. Clinical Trials Software Market: Developer Landscape
  • 4.3.1. Analysis by Year of Establishment
  • 4.3.2. Analysis by Company Size
  • 4.3.3. Analysis by Geography

5 CLINICAL TRIALS SOFTWARE DEVELOPERS IN NORTH AMERICA: COMPANY PROFILES

• 5.1. Chapter Overview
• 5.2. Advarra
  • 5.2.1. Company Overview
  • 5.2.2. Product Portfolio: Clinical Trials Software
  • 5.2.3. Recent Developments and Future Outlook
• 5.3. Arisglobal
  • 5.3.1. Company Overview
  • 5.3.2. Product Portfolio: Clinical Trials Software
  • 5.3.3. Recent Developments and Future Outlook
• 5.4. AssistRx
  • 5.4.1. Company Overview
  • 5.4.2. Product Portfolio: Clinical Trials Software
  • 5.4.3. Recent Developments and Future Outlook
• 5.5. Clario
  • 5.5.1. Company Overview
  • 5.5.2. Product Portfolio: Clinical Trials Software
  • 5.5.3. Recent Developments and Future Outlook
• 5.6. IBM
  • 5.6.1. Company Overview
  • 5.6.2. Product Portfolio: Clinical Trials Software
  • 5.6.3. Recent Developments and Future Outlook
• 5.7. IQVIA
  • 5.7.1. Company Overview
  • 5.7.2. Product Portfolio: Clinical Trials Software
  • 5.7.3. Recent Developments and Future Outlook
• 5.8. Medidata
  • 5.8.1. Company Overview
  • 5.8.2. Product Portfolio: Clinical Trials Software
  • 5.8.3. Recent Developments and Future Outlook
• 5.9. Oracle
  • 5.9.1. Company Overview
  • 5.9.2. Product Portfolio: Clinical Trials Software
  • 5.9.3. Recent Developments and Future Outlook
• 5.10. Signant Health
  • 5.10.1. Company Overview
  • 5.10.2. Product Portfolio: Clinical Trials Software
  • 5.10.3. Recent Developments and Future Outlook
• 5.11. Veeva
  • 5.11.1. Company Overview
  • 5.11.2. Product Portfolio: Clinical Trials Software
  • 5.11.3. Recent Developments and Future Outlook

6 CLINICAL TRIALS SOFTWARE DEVELOPERS IN EUROPE: COMPANY PROFILES

• 6.1. Chapter overview
• 6.2. Calyx
  • 6.2.1. Company Overview
  • 6.2.2. Product Portfolio: Clinical Trials Software
  • 6.2.3. Recent Developments and Future Outlook

7 COMPANY COMPETITIVENESS ANALYSIS

• 7.1. Chapter Overview
• 7.2. Key Parameters and Methodology
• 7.3. Competitiveness Analysis: Companies providing clinical trials software developers
• 7.4. Competitiveness Analysis: Companies providing clinical trials software in North America
• 7.5. Competitiveness Analysis: Companies providing clinical trials software in Europe
• 7.6. Competitiveness Analysis: Companies providing clinical trials software in Asia-Pacific

8 Partnerships and Collaborations

• 8.1. Chapter Overview
• 8.2. Partnership Models
• 8.3. Clinical Trials Software Market: Partnerships and Collaborations
  • 8.3.1. Analysis by Year of Partnership
  • 8.3.2. Analysis by Type of Partnership
  • 8.3.3. Analysis by Type and Year of Partnership
• 8.4. Geographical Analysis
  • 8.4.1. Analysis by Intracontinental and Intercontinental Agreements
  • 8.4.2. Analysis by Local and International Agreements
• 8.5. Most Active Players: Analysis by Number of Partnerships

9 MERGERS AND ACQUISITIONS

• 9.1. Chapter Overview
• 9.2. Mergers and Acquisitions Models
• 9.3. Clinical Trials Software Market: Mergers and Acquisitions
  • 9.3.1. Analysis by Type of Agreement
  • 9.3.2. Analysis by Year of Mergers and Acquisitions
• 9.4. Analysis by Geographical Activity
  • 9.4.1. Region-wise Analysis
  • 9.4.2. Mergers and Acquisitions: Intercontinental and Intracontinental Deals
• 9.5. Most Active Players: Analysis by Number of Instances Acquisitions and Mergers

10 FUNDING AND INVESTMENT ANALYSIS

• 10.1. Chapter Overview
• 10.2. Types of Funding Instances
• 10.3. Clinical Trials Software Market: Recent Funding Instances
  • 10.3.1. Analysis by Year of Investment
  • 10.3.2. Analysis by Amount Invested
  • 10.3.3. Analysis by Type of Funding
• 10.4. Most Active Players: Analysis by Number of Funding Instances
• 10.5. Regional Analysis by Amount Invested
• 10.6. Concluding Remarks

11 MARKET FORECAST AND OPPORTUNITY ANALYSIS

• 11.1. Chapter Overview
• 11.2. Forecast Methodology and Key Assumptions
• 11.3. Global Clinical Trials Software Market, 2021-2035
  • 11.3.1. Clinical Trials Software Market, 2021-2035: Distribution by Type of Deployment
  • 11.3.2. Clinical Trials Software Market, 2021-2035: Distribution by Type of Delivery
  • 11.3.3. Clinical Trials Software Market, 2021-2035: Distribution by Features of Software
  • 11.3.4. Clinical Trials Software Market, 2021-2035: Distribution by Geographical Region
    • 11.3.4.1. Clinical Trials Software Market in North America, 2021-2035
      • 11.3.4.1.1. Clinical Trials Software Market in North America, 2021-2035: Distribution by Type of Deployment
      • 11.3.4.1.2. Clinical Trials Software Market in North America, 2021-2035: Distribution by Type of Delivery
      • 11.3.4.1.3. Clinical Trials Software Market in North America, 2021-2035: Distribution by Features of Software
    • 11.3.4.2. Clinical Trials Software Market in Europe, 2021-2035
      • 11.3.4.2.1. Clinical Trials Software Market in Europe, 2021-2035: Distribution by Type of Deployment
      • 11.3.4.2.2. Clinical Trials Software Market in Europe, 2021-2035: Distribution by Type of Delivery
      • 11.3.4.2.3. Clinical Trials Software Market in Europe, 2021-2035: Distribution by Features of Software
    • 11.3.4.3. Clinical Trials Software Market in Asia-Pacific, 2021-2035
      • 11.3.4.3.1. Clinical Trials Software Market in Asia-Pacific, 2021-2035: Distribution by Type of Deployment
      • 11.3.4.3.2. Clinical Trials Software Market Asia-Pacific, 2021-2035: Distribution by Type of Delivery
      • 11.3.4.3.3. Clinical Trials Software Market Asia-Pacific, 2021-2035: Distribution by Features of Software

12. CONCLUSION

• 12.1. Chapter Overview

13. Appendix 1: Tabulated Data

14. Appendix 2: List of Companies and Organizations