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Market Overview

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The clinical trials software market is projected to experience a compound annual growth rate (CAGR) of 15.35% from 2022 to 2027, reaching a value of $2.1 billion by 2027, up from $930.22 million in 2021. Clinical trials play a crucial role in the discovery of new disease treatments and improved methods for disease detection, diagnosis, and prevention. By testing on human subjects in a professional setting, clinical trials determine what treatments are effective and what are not. The growth of the clinical trials software market can be attributed to the increasing demand from pharmaceutical organizations to reduce the costs of medical research, alleviate the burden, and enhance access to advanced technologies.

Clinical trial software, also known as a clinical trial management system (CTMS), is used by contract research organizations (CROs) to manage research activities. The global increase in clinical trials has driven the demand for new software solutions that provide easy access to activities for sponsors, CROs, medical device manufacturers, and outsourcing organizations involved in medical research.

In recent decades, the global biopharmaceutical industry has undergone significant changes, including the externalization of drug research and development activities and manufacturing. This has been facilitated through strategies such as partnering with small-medium size biopharma companies, academic institutes, government research institutes, and centers. As a result of these changes, CROs have become integral to clinical trial services, accelerating drug development processes and enhancing manufacturing capabilities to meet market demands. However, the introduction of CTMS has addressed several challenges faced by CROs and sponsors, streamlining the clinical trial process from drug discovery to approval.

The COVID-19 pandemic has accelerated the digitization of medical trials, leading to a sharp rise in the adoption of digital tools and remote monitoring devices in virtual clinical trials. Factors such as a strong focus on research and development, increased demand for specialty medicines, and the importance of real-world evidence have contributed to the adoption of clinical trial management software solutions.

Remote clinical trial monitoring has become the new norm for research, as clinical trials are complex, expensive, and time-consuming. To alleviate the burden of medical research activities, most biopharma companies either conduct clinical trials in-house or outsource them to contract research organizations. Consequently, vendors are embracing remote monitoring software to improve security, adhere to established protocols, and ensure compliance with the clinical trial protocol at research sites.

Cloud computing is a rapidly growing concept that presents opportunities for market vendors. The transition from traditional methods like paperwork to electronic tools offers lucrative prospects for market expansion. Electronic data capture, smart devices, wearable solutions, and data transcribing allow for direct data collection from patients without requiring them to visit the trial site. This enables faster data collection without disrupting patients’ daily activities, improves patient retention, and reduces transportation and travel costs. Furthermore, the growing demand for virtual research activities in the biopharma and medical device industries will drive the need for clinical trial management software.

Insufficient recruitment and retention of participants pose challenges in conducting clinical research, with over 80% of studies facing recruitment issues, delays, and the addition of new study sites. Virtual clinical trials are gaining traction due to software solutions that enable increased patient enrollment. Virtual patient recruitment software allows for the recruitment of patients worldwide, meeting demand and increasing the likelihood of success. It eliminates the need for frequent travel to study sites, automates medical data collection, and enhances patient engagement and retention.

Virtual collaboration strategies in medical research, facilitated by clinical trial management software, enable businesses to work more efficiently, eliminate the need for document sharing across multiple office locations, and reduce burdens.

Key players in the industry prefer unified platforms for conducting medical research, providing a range of features that companies can utilize. Medidata, a prominent provider of clinical trials software, offers one of the most comprehensive unified platforms, which is widely used by customers.

According to a 2022 Clinical Trials Arena article, IQVIA is one of the leading pharmaceutical companies in cloud computing. The article highlights a 12% increase in the number of company filings in the pharmaceutical industry between Q2 and Q3 of 2021.

The increasing complexity of clinical trial processes, stringent regulations, longer research lifecycles, and high costs have led to a significant adoption of digital tools to address cost and timeline challenges.

During the COVID-19 pandemic, many biopharma companies swiftly pivoted towards vaccine production, utilizing software solutions such as remote monitoring and more for conducting clinical trials.

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Market Segmentation

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The market is segmented based on various factors, including deployment, delivery, feature, end-user, and geography.

Segmentation by Deployment
On-enterprises
On-Site

Segmentation by Delivery
Web-based
SaaS
On-Premises

Segmentation by Feature
EDC
eCOA/ePRO
eConsent

Segmentation by End-User
CROs
Bio-Pharmaceutical Companies
Medical Device Manufacturer
Others

Segmentation by Geography
North America – US, Canada
Europe – Germany, France, UK, Italy, Spain
APAC – China, Japan, India, South Korea, Australia
Latin America – Brazil, Mexico, Argentina
Middle East & Africa – South Africa, Saudi Arabia, Turkey, UAE

The market for clinical trial software is divided into two segments: on-enterprises and on-site. In 2021, the on-enterprises segment held a dominant position in the deployment segment, accounting for 78.75% of the market share. This can be attributed to the increasing adoption of technology in biopharmaceutical companies and the growing usage of clinical trial management systems. On-site deployment offers several advantages to contracting research organizations, sponsors, and academic and government institutes involved in new drug development. Biopharmaceutical companies, having their own IT infrastructure, find it easier to handle the CTMS solution for their research activities. This reduces costs and timelines in patient data management, documentation, and task scheduling, making it a one-time investment with long-term benefits.

In 2021, web-based delivery was the dominant segment in the market, accounting for a market share of 44.79%. Major biopharmaceuticals prefer web-based delivery as it facilitates seamless data management, statistical analysis, medical writing, and regulatory submission. Web-based clinical trials management software enables quick reviews and enhances the efficiency of data collection from participants through internet platforms, reducing data entry errors and confusion. The rising competitiveness in the biopharma and contract research industries necessitates the adoption of technology, thus driving the demand for software. The web-based delivery method provides the advantage of faster delivery and is associated with the increasing acceptance of Software-as-a-Service (SaaS) in CTMS.

The global clinical trials software market is further segmented into EDC (Electronic Data Capture), eCOA/ePRO (Electronic Clinical Outcome Assessment/Electronic Patient-Reported Outcomes), and eConsent. EDC, also known as electronic case report form (eCRF), is a vital software used for collecting and analyzing patient data in medical research studies. With the increasing demand for participant data and the growing use of EDC for data capture, the global clinical trials management system market is witnessing significant growth. In 2021, EDC dominated the market with a share of 46.32%.

CROs (Contract Research Organizations) accounted for 45.95% of the clinical trials management system market share in 2021. These organizations have experienced a surge in demand for medical research from biopharmaceutical companies, medical device manufacturers, and other medical research authorities. Factors such as intense competition in research and development by biotech and pharmaceutical companies, high capital investments, and a low success rate of clinical trials contribute to the increased demand for CROs.

North America holds the largest market share in the clinical trials software market, with 34.03% in 2021. The region’s market was valued at USD 316.55 million in the same year. Factors driving the growth in North America include the presence of key market players, a high number of biopharmaceutical companies, and significant research and development expenditure in the region.

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Competitive Landscape

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The high level of competition in the global clinical trial software market is driven by increasing collaboration, the growing adoption of cloud-based platforms, and the availability of new solutions. In addition, regional clinical trial software companies in Europe, APAC, and North America are investing in cutting-edge software products. These regional and local companies pose a threat to global players by offering innovative and cost-effective products and technologies. This signifies that the market presents significant growth opportunities for both existing and emerging players.

Key companies profiled in this report include BSI Business Systems Integration, Clario, Dassault Systemes, IQVIA, Labcorp Drug Development, Oracle, Paraxel, Advarra, ArisGlobal, AstraCOre, Axiom Real-time Metirics, Castor EDC, ClinCapture, DataTrial, DataTrak, IBM, Florence Healthcare, Fortress Medical, Medrio, Reify Health, Signant Health, SofPromed, Statsols, Veeva Systems.

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Key Questions Answered

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What was the valuation of the global clinical trials management software market in 2021?

The global clinical trials management software market was valued at USD 930.22 million in 2021 and is projected to reach USD 2.1 billion by 2027.

How large is the clinical trials management system market?

The revenue of the global clinical trials management software market is estimated to reach USD 2.1 billion by 2027.

Who are the key vendors in the clinical trials management systems market?

The key vendors in the clinical trials management systems market include BSI, Clario, Dassault Systemes, IQVIA, Labcorp Drug Development, Oracle, and Paraxel.

What are the factors driving the growth of the clinical trials management software market?

Some of the factors driving the growth of the clinical trials management software market include the adoption of cloud computing in clinical trials, the entry of start-ups and small biopharma companies in drug discovery, and increased expenditure on research and development by big biopharma companies.