Global Clinical Trials Software Market Size is Projected to Reach USD 3,947.13 million by 2031, Growing at a CAGR of 15.55%: Straits Research

New clinical trial methods enable better and more cost-effective clinical research and organizational success. The electronic transcription of data and the use of smart devices and wearable solutions help directly collect data from patients without visiting trial sites.


New York, United States, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Clinical trial management systems (CTMSs), also known as clinical trial software, are digital tools used to manage clinical trials. Initially accessible via web-based platforms, clinical trial software is now accessible via SaaS (software as a service) platforms. Electronic data capture (EDC), electronic clinical outcome assessment, electronic patient-reported outcome (eCOA and ePRO), and eConsent are the critical features of widely used clinical trial software.

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Growing Use of Cloud Computing in Clinical Trials Drives the Global Market

According to Straits Research, “The global clinical trials software market size was valued at USD 1,074.86 million in 2022. It is estimated to reach USD 3,947.13 million by 2031, growing at a CAGR of 15.55% during the forecast period (2023–2031).” Clinical trials have shifted from a paper-based to an electronic format. This increased use of cloud-based platforms is primarily due to the ease of compliance, privacy, data ownership, and auditing they provide for businesses. IT departments can eliminate unnecessary expenses by removing extensive, complex infrastructure and deploying cloud solutions, primarily hosted or supported by external vendors.

Additionally, the electronic transcription of data and the use of smart devices and wearable solutions facilitate the direct collection of patient data without the need to visit trial sites. The cloud storage of clinical trial data gives centralized access to patient data. Investigators of clinical trials can easily store patient data in the cloud without risking a privacy breach. These factors drive the use of cloud computing in clinical trials and market expansion.

New Technologies in Clinical Trials Creates Tremendous Opportunities

Increased adoption of new technologies increases the demand for new clinical trial monitoring software. Wearable technology, big data analytics, artificial intelligence (AI), synthetic biology, telehealth and telemedicine, and mobile communication apps are driving the rapid expansion of the clinical trial software market. In addition, clinical trial sites must be entirely digital to support next-generation clinical trial technologies. Sponsors are willing to pay for some of the technology costs at clinical trial sites as a part of the total cost of the study. CROs also provide vendors with return-on-investment plans. For clinical trials, companies invest in developing user-friendly, high-quality software platforms. CROs work with sponsors on technology projects to lower the cost of adopting new technology, thereby creating growth opportunities for the market.

Regional Analysis

North America clinical trials software market share is anticipated to grow at a CAGR of 14.93% during the forecast period. The United States and Canada conduct the most significant number of clinical trials in North America. This region is home to over 530 regenerative medicine companies, including manufacturers of cell and gene therapy and stem cell-based medicines. More people use clinical trial software when there are more virtual clinical trials in a region. As a result of the expansion of biopharmaceutical companies and advancements in clinical trial methods, this region is home to many businesses that employ cutting-edge technology platforms, such as unified clinical trial platforms. In addition, CROs conduct most clinical trials in North America due to the stringent regulations and high cost of clinical trials.

Europe is expected to grow at a CAGR of 16.09% over the forecast period. In the European clinical trial software market, the adoption of new technology is increasing significantly. Most pharmaceutical companies seek CROs in the region because clinical trials are less expensive than in the United States. European nations support clinical research and trials, contributing to the region's robust healthcare system. Approximately 60% of European clinical trials are conducted by pharmaceutical companies and 40% by academic institutions. To conduct clinical trials, pharmaceutical companies anticipate CROs to adopt advanced technology platforms. Multiple research projects in the life sciences are conducted in various European nations. These fields require an extensive infrastructure for research and development to manage complex data. This demand necessitates the utilization of technological platforms, such as clinical trial software.

Key Highlights

  • By deployment, the global clinical trials software market is divided into on-enterprises and on-site. The on-enterprises segment is responsible for the largest market share and is anticipated to grow at a CAGR of 16.01% over the forecast period.
  • By delivery, the global clinical trials software market is segmented into web-based, SaaS, and on-premises. The web-based delivery segment owns the market and is expected to grow at a CAGR of 15.01% for the forecast period.
  • By feature, the global clinical trials software market is segmented into EDC, eCOA/ePRO, and eConsent. The EDC segment is the highest contributor to the market and is estimated to grow at a CAGR of 15.86% over the forecast period.
  • By end-user, the global clinical trials software market is segmented into CROs, bio-pharmaceutical companies, medical device manufacturers, and others. The CROs segment owns the highest market share and is expected to grow at a CAGR of 16.07% during the forecast period.
  • North America is the most significant global clinical trials software market shareholder and is anticipated to grow at a CAGR of 14.93% during the forecast period.

Competitive Players

The Top 10 players in the global clinical trials software market are BSI Business Systems Integration, Clario, Dassault Systemes, IQVIA, Labcorp Drug Development, Oracle, Paraxel, Advarra, ArisGlobal, AstraCOre, Axiom Real-Time Metrics, Castor EDC, ClinCapture, DataTrial, DataTrak, IBM, Florence Healthcare, Fortress Medical, Medrio, Reify Health, Signant Health, SofPromed, Statsols and Veeva Systems (20)

Market News

  • In November 2022, IQVIA Holdings Inc. announced a long-term partnership with Clalit, the biggest provider of healthcare services in Israel, to open the nation's first Prime Site. The partnership combines IQVIA and Clalit's strengths in data, genomics, real-world research, and clinical trial delivery.
  • In October 2022, Labcorp completed transactions that set up a long-term laboratory relationship with Ascension, one of the largest non-profit and Catholic health systems in the United States.

Global Clinical Trials Software Market: Segmentation

By Deployment

  • On-Enterprises
  • On-Site

By Delivery

  • Web-based
  • SaaS
  • On-Premises

By Feature

  • EDC
  • eCOA/ePRO
  • eConsent

By End-User

  • CROs
  • Bio-Pharmaceutical Companies
  • Medical Device Manufacturer
  • Others

By Regions

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • The Middle East and Africa

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