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Clinical Trials Software Market: Distribution by Type of Deployment, Type of Delivery, Features of software and Geographical Regions, Industry Trends and Global Forecasts, 2022-2035

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    Report

  • 141 Pages
  • January 2022
  • Region: Global
  • Roots Analysis
  • ID: 5557624
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.


Scope of the Report



The Clinical Trials Software Market, 2022-2035: Distribution by Type of Deployment (on-cloud, on-premises), Type of Delivery (web-based, remote monitoring), 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:


  • An overview of clinical trials software market, featuring a detailed market landscape analysis based on several relevant parameters, such as type of deployment (on-cloud, on-premises), type of delivery (web-based, remote monitoring), type of end-user (pharmaceuticals, biotechnology, CROs), features of software (EDC, eCOA/ePRO, eConsent), trial design (decentralized, site-based, hybrid, randomized, case control, cohort), type of technology (IVRS, IWRS). It also provides insights on developer landscape along with the analysis based on year of establishment, company size, location of headquarters.
  • An insightful competitiveness analysis of clinical trials software developers, taking into consideration the supplier strength (based on expertise of the manufacturer), product portfolio strength and service applicability.
  • An analysis of the partnerships that have been inked by various stakeholders engaged in the development of clinical trials software, during the period 2016-2021, covering service agreements, research agreements, licensing agreements, product development, product integration, product utilization and other types of partnership deals.
  • An analysis of the mergers and acquisitions of various stakeholders engaged in the development of clinical trials software, during the period 2016-2021.
  • An analysis of the investments made at various stages of development of clinical trials software companies engaged in this field, covering instances of seed funding, venture capital funding, debt financing, grant and other equity.
  • Tabulated profiles of the key players providing clinical trials software. Each profile includes an overview of the company, product portfolio, recent developments, and an informed future outlook.


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 2021-2035. For this purpose, we have segmented the future opportunity across the following market segments: type of deployment (on-cloud, on-premises), type of delivery (web-based, remote monitoring), key players 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.


Key Questions Answered


  • Who are the leading players engaged in the development of clinical trials software solutions?
  • Which region(s) will occupy the maximum market share in clinical trials software domain?
  • Who are the key venture capitalists / strategic investors funding the clinical trials software development initiatives?
  • Which partnership models are commonly adopted by stakeholders engaged in the development of clinical trials software solutions?
  • Which factors are likely to influence the evolution of this market?
  • How is the current and future market opportunity likely to be distributed across key market segments?

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 Data14. Appendix 2: List of Companies and Organizations

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • ClinOne
  • Clinical Ink
  • DatStat (Acquired by SCI Solutions)
  • Advarra
  • Castor
  • Kayentis
  • Interlace Health
  • Crucial Data Solutions (CDS)
  • Cloudbyz
  • Datacubed Health
  • TransCelerate Biopharma
  • 5thPort
  • Datatrak
  • THREAD
  • Dacima
  • IBM
  • REDcap Cloud
  • Axiom
  • Evado
  • DSG
  • AssistRx
  • Jeeva Informatics
  • eClinicalHealth
  • ObvioHealth
  • StudyKIK (Acquired by Syneos Health)
  • Clinion
  • TrialStat
  • Acceliant
  • DFnet
  • DM 365
  • Clindox
  • OnlineCRF
  • SMART-TRIAL
  • MEDNET
  • Octalsoft
  • Clinevo
  • Ennov
  • XClinical
  • RodanoTech
  • ITClinical
  • CROS NT
  • IDDI
  • CRScube
  • IVR Clinical Concepts
  • Prelude Dynamics
  • Clinical Biometrics Solutions
  • Medidata
  • Signant Health
  • Medrio
  • Medable
  • DrugDev (Acquired by IQVIA)
  • McDougall Scientific
  • Anju Software
  • ECLIPSE
  • IQVIA
  • Calyx
  • Oracle Cloud Infrastructure
  • CLINDEX FORTRESS MEDICAL SYSTEMS
  • ClinCapture
  • Climedo Health
  • OpenClinica
  • Science 37
  • VirTrial (Acquired by Signant Health)
  • Curavit
  • BSI
  • Realtime
  • Veeva Systems
  • encapsia
  • ArisGlobal
  • Quanticate
  • Arithmos
  • Healthentia
  • Clario (Bioclinica and ERT)
  • Xolomon

Methodology

 

 

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