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Report Description
It is a well-known fact that clinical trials form an integral part of the overall drug development process, enabling innovators to assess safety and efficacy of their drug candidates / devices. These studies account for around 50% of the total time and capital invested in the development process. However, the conduct of trials is often fraught with several challenges, including scientific and operational complexity, concerns associated with recruitment and retention of suitable patients, issues related to data handling and increasingly stringent regulatory guidelines. In fact, the failure of a clinical trial can impose an enormous financial burden on sponsors, estimated to be in the range of USD 800 million (in case of therapies with limited applications) to USD 1.4 billion (for a drug that is anticipated to be a blockbuster). Further, during the COVID-19 pandemic, the conduct of clinical trials has become increasingly difficult. In order to address these challenges, players engaged in the pharmaceutical industry have leveraged novel and advanced digital health technologies, such as mobile devices, advanced applications, remote monitoring devices, telemedicine, and online social interaction platforms for virtual conduct of clinical trials. Various clinical trials software, including EDC, eCOA/ePRO, and eConsent integrated clinical study automation software, are also being recruited to collect data at each stage of the trial, improve trial participant recruitment and retention, provide eConsent, measure real-time clinical outcomes, and track adverse events in real-time.
Virtual clinical trials software solutions have the potential to induce substantial digital changes in clinical research methodology, resulting in a more patient-centric, cost-effective and easy to manage approach. They enable the participants to participate from the comfort of their own homes rather than traveling to a study location, which enhance participant engagement and retention. At present, several companies are engaged in the development of clinical trials software, which allow drug developers to enhance the quality of their clinical products and reduce the time to get a product to market. The market has witnessed substantial partnership activity over the last few years. The activity in this segment has also attracted the attention of both private and public sector investors / investment funds, which have extended financial support to the initiatives of capable developer companies. Driven by the substantial progress in this domain, encouraging virtual clinical trial results, and ongoing technological advancement, the clinical trials software market is anticipated to grow at a commendable pace in the mid to long term.
The Clinical Trials Software Market, 2022-2035: Distribution by Features of software (EDC, eCOA/ePRO, eConsent) and Geographical Regions (North America, Europe and Asia-Pacific) report features an extensive study of the current market landscape and future opportunity for the players involved in the development of clinical trials software. The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different geographies. Amongst other elements, the report includes:
One of the key objectives of the report was to estimate the future growth potential of clinical trials software market, over the coming decade. We have provided informed estimates on the financial evolution of the market for the period 2022-2035. For this purpose, we have segmented the future opportunity across the following market segments: features of software (EDC, eCOA/ePRO and eConsent) and geographical regions (North America, Europe and Asia-Pacific). In order to account for uncertainties and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic tracks of the anticipated industry’s growth.
Contents
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the clinical trials software market and its likely evolution in the short to-mid to long term
Chapter 3 highlights the existing constraints in clinical research and patient recruitment and retention-related challenges. It provides an overview of the virtual clinical trials and various clinical trials software. In addition, it discusses various opportunities and challenges associated with virtual clinical trials management and the future perspectives.
Chapter 4 presents a detailed assessment of the current market landscape of clinical trials software along with information on type of deployment (on-cloud, on-premises), type of delivery (web-based, remote monitoring) and end-users (pharmaceuticals, CROs, biotechnology), trial design (decentralized, site-based, hybrid, randomized, case control, cohort), and type of technology (IVRS, IWRS). In addition, it provides an overview of the clinical trials software developer landscape, highlighting the players that are active in this domain. It includes information on their year of establishment, company size (in terms of number of employees) and location of their respective headquarters. Further, we have presented a logo landscape, highlighting the distribution of the developers based on company size and location of headquarters.
Chapter 5 includes profiles of the key players engaged in the development of clinical trials software (shortlisted based on company size). Each profile features a brief overview of the company, details on product portfolio, recent developments, and an informed future outlook.
Chapter 6 is an insightful three-dimensional bubble chart representation, highlighting the competitive analysis of clinical trials software developers, taking into consideration the supplier strength (based on the expertise of the manufacturer), product portfolio strength, and service applicability.
Chapter 7 features a detailed analysis of the partnerships and collaborations that have been inked in this domain since 2016, covering product development agreements, research and development agreements, licensing agreements, clinical trial agreements, licensing and manufacturing agreements, product development and commercialization manufacturing agreements, joint venture, acquisition and other relevant types of deals
Chapter 8 features a detailed analysis of the mergers and acquisitions that have been inked in this domain since 2016, covering mergers and acquisitions.
Chapter 9 provides an analysis of the key investments made since 2016 at various stages of development of companies engaged in this domain, based on the year of investment, number of funding instances, amount invested and type of funding, highlighting most active players (in terms of number of funding instances and amount raised) and most active investors (in terms of number of funding instances).
Chapter 10 features an elaborate discussion on the future market potential of clinical trials software. The chapter provides insights on the likely distribution of the current and forecasted opportunity across features of software (EDC. eCOA/ePRO and eConsent) and geographical regions (North America, Europe and Asia-Pacific).
Chapter 11 is a summary of the overall report, wherein we have mentioned all the key facts and figures described in the previous chapters.
Chapter 12 is an appendix that contains tabulated data and numbers for all the figures provided in the report.
Chapter 13 is an appendix, which provides a list of companies and organizations mentioned in the report.
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 Factors Affecting Cost of Clinical Trials
3.2.3. Evolving Regulatory Standards
3.2.4. Patient Recruitment and Retention-Related Challenges
3.2.5. Inefficient Data Handling
3.3. Virtual Clinical Trials
3.3.1. Electronic Data Capture Solutions (EDC)
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: Developer Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Geography
4.2.4. Analysis by Type of Deployment
4.2.5. Analysis by Type of Delivery
4.2.6. Analysis by End-User
4.2.7. Analysis by Features of Clinical Trials Software
4.2.8. Analysis by Trial Design
4.2.9. Analysis by Type of Technology
5. CLINICAL TRIALS SOFTWARE DEVELOPERS: 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. Calyx
5.5.1. Company Overview
5.5.2. Product Portfolio: Clinical Trials Software
5.5.3. Recent Developments and Future Outlook
5.6. Clario
5.6.1. Company Overview
5.6.2. Product Portfolio: Clinical Trials Software
5.6.3. Recent Developments and Future Outlook
5.7. IBM
5.7.1. Company Overview
5.7.2. Product Portfolio: Clinical Trials Software
5.7.3. Recent Developments and Future Outlook
5.8. IQVIA
5.8.1. Company Overview
5.8.2. Product Portfolio: Clinical Trials Software
5.8.3. Recent Developments and Future Outlook
5.9. Medidata
5.9.1. Company Overview
5.9.2. Product Portfolio: Clinical Trials Software
5.9.3. Recent Developments and Future Outlook
5.10. Oracle
5.10.1. Company Overview
5.10.2. Product Portfolio: Clinical Trials Software
5.11. Signant Health
5.11.1. Company Overview
5.11.2. Product Portfolio: Clinical Trials Software
5.11.3. Recent Developments and Future Outlook
5.12. Veeva
5.12.1. Company Overview
5.12.2. Product Portfolio: Clinical Trials Software
5.12.3. Recent Developments and Future Outlook
6. COMPANY COMPETITIVENESS ANALYSIS
6.1. Chapter Overview
6.2. Assumptions/Key Parameters
6.3. Methodology
6.4. Competitiveness Analysis: Companies providing clinical trials software in North America
6.5. Competitiveness Analysis: Companies providing clinical trials software in Europe
6.6. Competitiveness Analysis: Companies providing clinical trials software in Asia-Pacific
7. PARTNERSHIPS AND COLLABORATIONS
7.1. Chapter Overview
7.2. Partnership Models
7.3. Clinical Trials Software Market: Partnerships and Collaborations
7.3.1. Analysis by Year of Partnership
7.3.2. Analysis by Type of Partnership
7.3.3. Analysis by Year and Type of Partnership
7.4. Geographical Analysis
7.4.1. Analysis by Intracontinental and Intercontinental Agreements
7.5. Most Active Players: Analysis by Number of Partnerships
8. MERGERS AND ACQUISITIONS
8.1. Chapter Overview
8.2. Mergers and Acquisitions Models
8.3. Clinical Trials Software Providers: Mergers and Acquisitions
8.3.1. Analysis by Type of Deal
8.3.2. Analysis by Year of Acquisitions
8.4. Analysis by Geography
8.4.1. Mergers and Acquisitions: Intercontinental and Intracontinental Deals
8.5. Prominent Acquires: Analysis by Number of Acquisitions and Mergers
9. FUNDING AND INVESTMENT ANALYSIS
9.1. Chapter Overview
9.2. Types of Funding Instances
9.3. Clinical Trials Software Market: Recent Funding Instances
9.3.1. Analysis by Year of Investment
9.3.2. Analysis by Amount Invested
9.3.3. Analysis by Type of Funding
9.4. Most Active Players: Analysis by Number of Funding Instances
9.5. Regional Analysis by Amount Invested
9.6. Concluding Remarks
10. MARKET FORECAST AND OPPORTUNITY ANALYSIS
10.1. Chapter Overview
10.2. Forecast Methodology and Key Assumptions
10.3. Global Clinical Trials Software Market, 2022-2035
10.3.1. Clinical Trials Software Market, 2022-2035: Distribution by Features of Software
10.3.1.1 Clinical Trials Software Market for Electronic Data Capture, 2022-2035
10.3.1.2 Clinical Trials Software Market for eCOA/ePRO, 2022-2035
10.3.1.3 Clinical Trials Software Market for eConsent, 2022-2035
10.3.4. Clinical Trials Software Market, 2022-2035: Distribution by Geographical Region
10.3.4.1. Clinical Trials Software Market in North America, 2022-2035
10.3.4.2. Clinical Trials Software Market in Europe, 2022-2035
10.3.4.3. Clinical Trials Software Market in Asia-Pacific, 2022-2035
11. CONCLUDING REMARKS
12. EXECUTIVE INSIGHTS
12.1. Chapter Overview
12.2. Evado
12.2.1. Company Snapshot
12.2.2. Interview Transcript: Jennie Anderson, Chief Executive Officer, Evado
13. APPENDIX 1: TABULATED DATA
14. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
Figure 2.1 Executive Summary: Current Market Landscape of Clinical Trials Software Providers
Figure 2.2 Executive Summary: Partnerships and Collaborations
Figure 2.3 Executive Summary: Funding and Investment Analysis
Figure 2.4 Executive Summary: Market Forecast and Opportunity Analysis
Figure 3.1 Existing Constraints in Clinical Research
Figure 3.2 Factors Affecting Cost of Clinical Trials
Figure 3.3 Drug Development Costs: Historical Trend (USD Million)
Figure 3.4 An Overview of Virtual Trial Model
Figure 4.1 Clinical Trials Software Developers: Distribution by Year of Establishment
Figure 4.2 Clinical Trials Software Developers: Distribution by Company Size
Figure 4.3 Clinical Trials Software Developers: Distribution by Headquarters
Figure 4.4 Clinical Trials Software: Distribution by Type of Deployment
Figure 4.5 Clinical Trials Software: Distribution by Type of Delivery
Figure 4.6 Clinical Trials Software: Distribution by Type of End-User
Figure 4.7 Clinical Trials Software: Distribution by Features of Software
Figure 4.8 Clinical Trials Software: Distribution by Trial Design
Figure 4.9 Clinical Trials Software: Distribution by Type of Technology
Figure 6.1 Company Competitiveness Analysis: Clinical Trials Software Developers in North America
Figure 6.2 Company Competitiveness Analysis: Clinical Trials Software Developers in Europe
Figure 6.3 Company Competitiveness Analysis: Clinical Trials Software Developers in Asia Pacific
Figure 7.1 Partnerships and Collaborations: Distribution by Year of Partnership
Figure 7.2 Partnerships and Collaborations: Distribution by Type of Partnership
Figure 7.3 Partnerships and Collaborations: Distribution by Year and Type of Partnership
Figure 7.4 Partnerships and Collaborations: Geographical Analysis
Figure 7.5 Partnerships and Collaborations: Distribution by Intracontinental and Intercontinental Agreement
Figure 7.6 Most Active Players: Distribution by Number of Partnerships
Figure 8.1 Mergers and Acquisitions: Distribution by Type of Merger and Acquisition
Figure 8.2 Mergers and Acquisitions: Distribution by Year of Merger and Acquisition
Figure 8.3 Mergers and Acquisitions: Distribution by Geographical Activity
Figure 8.4 Mergers and Acquisitions: Continent-wise Distribution
Figure 8.5 Mergers and Acquisitions: Intercontinental and Intracontinental Deals
Figure 8.6 Most Active Players: Distribution by Number of Instances
Figure 9.1 Funding and Investments: Distribution by Year of Investment
Figure 9.2 Funding and Investments: Distribution by Amount Invested
Figure 9.3 Funding and Investments: Distribution by Year-wise Trend of Amount Invested, 2016-2021
Figure 9.4 Funding and Investments: Distribution by Type of Funding
Figure 9.5 Funding and Investments: Distribution of Amount Invested by Type of Funding
Figure 9.6 Most Active Players: Distribution by Amount invested
Figure 9.7 Funding and Investments: Geographical Distribution by Amount Invested, 2016-2021
Figure 10.1 Clinical Trials Software Market, 2022-2035 (USD Million)
Figure 10.2 Clinical Trials Software Market: Analysis by Electronic Data Capture, 2022-2035 (USD Million)
Figure 10.3 Clinical Trials Software Market: Analysis by eCOA/ePRO, 2022-2035 (USD Million)
Figure 10.4 Clinical Trials Software Market: Analysis by eConsent, 2022-2035 (USD Million)
Figure 10.5 Clinical Trials Software Market: Distribution by Region, 2022-2035
Figure 10.6 Clinical Trials Software Market in North America, 2022-2035 (USD Million)
Figure 10.7 Clinical Trials Software Market in Europe, 2022-2035 (USD Million)
Figure 10.8 Clinical Trials Software Market in Asia-Pacific, 2022-2035 (USD Million)
Figure 12.1 Concluding Remarks: Current Market Landscape Of Clinical Trials Software Providers
Figure 12.2 Concluding Remarks: Partnerships and Collaborations
Figure 12.3 Concluding Remarks: Acquisitions and Mergers
Figure 12.4 Concluding Remarks: Funding and Investment Analysis
Figure 12.5 Concluding Remarks: Market Sizing and Opportunity Analysis
Table 4.1 Clinical Trials Software Market Developers: Information of Year of Establishment, Company Size, Location of Headquarters and Region
Table 4.2 Clinical Trials Software Market: Information on Type of Deployment
Table 4.3 Clinical Trials Software Market: Information on Type of Delivery
Table 4.4 Clinical Trials Software Market: Information on End-Users
Table 4.5 Clinical Trials Software Market: Information on Features of Software
Table 4.6 Clinical Trials Software Market: Information on Trial Design
Table 4.7 Clinical Trials Software Market: Information on Technology
Table 5.1 Clinical Trials Software Developers: List of Profiled Companies
Table 5.2 Advarra: Company Snapshot
Table 5.3 Clinical Conductor: Key Features
Table 5.4 Advarra: Recent Developments and Future Outlook
Table 5.5 ArisGlobal: Company Snapshot
Table 5.6 Lifesphere: Key Features
Table 5.7 ArisGlobal: Recent Developments and Future Outlook
Table 5.8 AssistRx: Company Snapshot
Table 5.9 iAssist: Key Features
Table 5.10 AssistRx: Recent Developments and Future Outlook
Table 5.11 Calyx: Company Snapshot
Table 5.12 Calyx’s Software: Key Features
Table 5.13 Calyx: Recent Developments and Future Outlook
Table 5.14 Clario: Company Snapshot
Table 5.15 Clario: Key Features
Table 5.16 IBM: Company Snapshot
Table 5.17 IBM’s Software: Key Features
Table 5.18 IQVIA: Company Snapshot
Table 5.19 IQVIA: Key Features
Table 5.20 IQVIA: Recent Developments and Future Outlook
Table 5.21 Medidata: Company Snapshot
Table 5.22 Medidata: Key Features
Table 5.23 Medidata: Recent Developments and Future Outlook
Table 5.24 Oracle: Company Snapshot
Table 5.25 Siebel: Key Features
Table 5.26 Signant Health: Company Snapshot
Table 5.27 Smart Signals: Key Features
Table 5.28 Signant Health: Recent Developments and Future Outlook
Table 5.29 Veeva: Company Snapshot
Table 5.30 Veeva Vault: Key Features
Table 5.31 Veeva: Recent Developments and Future Outlook
Table 7.1 Clinical Trials Software Market: List of Partnerships and Collaborations, 2016- 2021 (till September)
Table 8.1 Clinical Trials Software Market: List of Mergers and Acquisitions, 2016-2021 (till September)
Table 9.1 Clinical Trials Software Market: List of Funding Instances, 2016-2021 (till September)
Table 12.1 Evado: Key Highlights
Table 13.1 Clinical Trials Software Market: Distribution by Year of Establishment
Table 13.2 Clinical Trials Software Market: Distribution by Company Size
Table 13.3 Clinical Trials Software Market: Distribution by Location of Headquarters
Table 13.4 Clinical Trials Software Market: Distribution by Type of Deployment
Table 13.5 Clinical Trials Software Market: Distribution by Type of Delivery
Table 13.6 Clinical Trials Software Market: Distribution by End-user
Table 13.7 Clinical Trials Software Market: Distribution by Features of Software
Table 13.8 Clinical Trials Software Market: Information on Trial Design
Table 13.9 Clinical Trials Software Market: Information on Type of Technology
Table 13.10 Partnerships and Collaborations: Cumulative Year-wise Trend, 2016-2021 (till September)
Table 13.11 Partnerships and Collaborations: Analysis by Type of Partnerships, 2016-2021 (till September)
Table 13.12 Partnerships and Collaborations: Analysis by Year and Type of Partnerships, 2016-2021 (till September)
Table 13.13 Most Active Players: Distribution by Number of Partnerships
Table 13.14 Partnerships and Collaborations: Regional Distribution
Table 13.15 Partnerships and Collaborations: Intercontinental Agreements
Table 13.16 Partnerships and Collaborations: Intracontinental Agreements
Table 13.17 Mergers and Acquisitions: Distribution by Type of Deal
Table 13.18 Mergers and Acquisitions: Cumulative Year-Wise Distribution, 2016-2021 (till September)
Table 13.19 Mergers and Acquisitions: Analysis by Geography
Table 13.20 Mergers and Acquisitions: Intercontinental Agreements
Table 13.21 Mergers and Acquisitions: Intracontinental Agreements
Table 13.22 Mergers and Acquisitions: Prominent Acquirers
Table 13.23 Clinical trial software market: List of Funding Instances, 2016-2021 (till September)
Table 13.24 Funding and Investments: Cumulative Amount Invested by Year, 2017-2021 (till September) (USD Million)
Table 13.25 Funding Instances: Year-wise Trend of Amount Invested, 2016-2021 (USD Million)
Table 13.26 Funding and Investments: Distribution by Type of Funding
Table 13.27 Funding and Investments: Distribution by Venture Capital Funding (USD Million)
Table 13.28 Funding and Investments: Distribution of Amount Invested by Type of Funding (USD Million)
Table 13.29 Funding and Investments: Distribution of Amount Invested in Venture Capital Funding
Table 13.30 Most Active Players: Distribution by Number of Funding Instances
Table 13.31 Most Active Players: Distribution by Amount Raised, 2016-2021 (USD Million)
Table 13.32 Funding and Investment Analysis: Regional Distribution of Total Amount Invested, 2016-2021 (USD Million)
Table 13.33 Global Clinical Trials Software Market 2022-2035 (USD Billion)
Table 13.34 Clinical Trials Software Market: Analysis by Electronic Data Capture, 2022-2035 (USD Million)
Table 13.35 Clinical Trials Software Market: Analysis by eCOA/ePRO, 2022-2035 (USD Million)
Table 13.36 Clinical Trials Software Market: Analysis by eConsent, 2022-2035 (USD Million)
Table 13.37 Clinical Trials Software Market: Distribution by Region 2022-2035 (USD Million)
Table 13.38 Clinical Trials Software Market in North America, 2022-2035 (USD Million)
Table 13.39 Clinical Trials Software Market in Europe, 2022-2035 (USD Million)
Table 13.40 Clinical Trials Software Market in Asia-Pacific, 2022-2035 (USD Million)
The following companies / institutes / government bodies and organizations have been mentioned in this report.