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 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.
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.
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
3. INTRODUCTION
4. MARKET LANDSCAPE: CLINICAL TRIALS SOFTWARE MARKET
5. CLINICAL TRIALS SOFTWARE DEVELOPERS IN NORTH AMERICA: COMPANY PROFILES
6. CLINICAL TRIALS SOFTWARE DEVELOPERS IN EUROPE: COMPANY PROFILES
7. COMPANY COMPETITIVENESS ANALYSIS
8. PARTNERSHIPS AND COLLABORATIONS
9. MERGERS AND ACQUISITIONS
10. FUNDING AND INVESTMENT ANALYSIS
11. MARKET FORECAST AND OPPORTUNITY ANALYSIS
12. CONCLUSION
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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