The clinical trials software market is expected to grow at a CAGR of 15.35% from 2022 to 2027 and is projected to reach $ 2.1 billion by 2027 from $930.22 million in 2021. Clinical trials play an essential role in discovering new treatments for diseases and better ways to detect diseases, diagnose, and prevent the chance of developing the disease. The clinical trial process indicates what works for humans and what doesn't by testing them on humans in a professional setup. The clinical trials software market growth is due to the increasing demand from pharmaceutical organizations to minimize the cost of medical research, reduce the burden, and increase access to advanced technologies.
Clinical trial software is also known as a clinical trial management system (CTMS). The software is used to manage research activities by the contract research organization (CROs). Increasing clinical trials worldwide drive the demand for new standard software solutions that enable easy access to activities for sponsors, CROs, medical device manufacturers, and outsourcing organizations engaged in medical research activities.
In global biopharmaceutical industries, there are significant changes addressed in the last decades, such as externalizing drugs research and development activities and manufacturing with the help of crucial strategies such as a partnership with small-medium size biopharma companies, academic institutes, government research institutes, and centers, etc. As a part of the significant changes in those industries, CROs became essential to clinical trial services. It helps speed up drug development processes and increase the manufacturing capabilities per the market's needs. But the introduction of CTMS solved several challenges. It allowed the CROs and sponsors to overcome the restraint burden in clinical trials, from drug discovery to clinical trial phases and the approval cycle of drugs.
Recently, the COVID-19 crisis increased the digitalization of medical trials, and the adoption of digital tools and remote monitoring devices in the virtual clinical trial process has risen sharply. High focus on R&D activities, increasing demand for specialty medicines, and real-world evidence are some factors that led to the adoption of clinical trial management software solutions.
Remote clinical trial monitoring is the new standard for performing research in recent times. Clinical trials are a highly complex and expensive, and time-consuming process. So, with the increasing burden of medical research activities, most biopharma companies complete clinical trials with their in-house capabilities or by contract research organizations. So, vendors are adopting remote monitoring software due to the growing security purpose, well-established protocol, and ensuring that the research site conducts the clinical trials as per the protocol.
The COVID-19 pandemic has accelerated the ongoing shift toward remote monitoring through clinical trial management software solutions. It is one of the essential elements in the medical practice and is one of the most critical connections between CROs, sponsors, and the research site.
Cloud computing is a rapidly growing concept leveraging opportunities for market vendors. The shift from traditional methods such as paperwork to complete electronic tool applications will provide lucrative opportunities for market growth. The electronic data capture, transcribing data, Smart devices, and wearable solutions help directly collect data from patients without visiting the trial site. It helps collect data faster without disturbing patients' daily life activities. It helps in the retention of patients. It reduced transportation and travel cost. Conversely, the growing craze for virtual research activities among the biopharma and medical device organizations will drive the demand for Clinical trials management software.
Due to insufficient recruitment and retention of participants in the study population, more than 80% of the research is failing, getting extended, and adding new study sites. Virtual clinical trials are witnessing growth due to increased patient enrolment through software solutions. In contrast, virtual patient recruitment software allows recruiting patients from across the globe, fulfills the demand, and increases the chances of success. It helps to eliminate the frequent traveling to study sites and do automation in medical data collection, increasing patient engagement and retention.
Virtual collaboration strategies in medical research, using clinical trials management software, allow businesses to work rapidly and more efficiently, eliminate the need for document sharing to additional office locations, and reduce the burden.
Key players prefer the usage of unified platforms for conducting medical research. This provides multiple features that companies can use to conduct research. Medidata, a large clinical trials software provider, has one of the most robust unified platforms most customers use.
As per the Clinical Trials Arena article in 2022, IQVIA is one of the leading pharma companies in cloud computing. It shows that the filing of the companies in the pharmaceutical industry increased by 12% between Q2 to Q3 in 2021.
One of the factors driving the market growth is the increasing complexity of clinical trial processes. Stringent regulation, the longer lifecycle of research, and the high cost significantly increased the adoption of digital tools in tests to reduce the cost and timeline challenges.
During the COVID-19 pandemic, most biopharma companies rapidly turned toward vaccine production. As well as running clinical trials were conducted using software solutions like remote monitoring and more.
The market is segmented into on-enterprises and on-site segments. In 2021, the on-enterprises segment accounted for 78.75% market share and dominated the deployment segment. Due to increasing technology adoption in biopharmaceutical companies and rising clinical trial management systems usage, on-enterprises deployment is in higher demand. On-site deployment offers numerous advantages to contracting research organizations, sponsors, and academic and government institutes looking for new drug development. Biopharmaceutical companies have their own IT infrastructure, which helps them easily handle the CTMS solution for their research activities and reduces the cost and timeline in patient data management, documentation, and scheduling of tasks. It is a one-time investment for organizations that delivers long-life services.
In 2021, the web-based delivery segment dominated the market with a 44.79% market share. Major biopharmaceuticals use web-based delivery. Web-based software instantly changes the current landscape, such as data management, statistical analysis, medical writing, and regulatory submission. Their reviews are quickly done by the web-based clinical trials management software delivery methods. Increasing competitiveness in biopharma and contract research companies demands technology adoption and propelling the growth of software adoption. So, the delivery method through the web reduces the data entry and confusion between a broad range of data and helps direct data collection from participants through internet platforms. SaaS solutions have a lot of benefits that influence market growth. The rising acceptance of SaaS- (Software as a service) in CTMS is helping in faster delivery.
The global clinical trials software market is segmented into EDC, eCOA/ePRO, and eConsent. EDC is also referred to as electronic case report form (eCRF), which is vital software. Due to increasing medical research studies worldwide, data accuracy is becoming more critical. EDC is used to collect patient data and analyze the data produced during medical research studies. Increasing demand for patient participants and the rising use of EDC for data capturing drive the growth of the global clinical trials management system market. EDC dominated the global market with a share of 46.32% in 2021.
In 2021, CROs accounted for 45.95% of the clinical trials management system market share. The CRO organization experienced significant medical research demands from biopharmaceutical companies, medical device manufacturers, and other medical research authorities. Increasing competition in research development by biotech and pharmaceutical companies, high capital investment, and low success rate of clinical trials are some factors driving the demand for CROs.
North America is the leading clinical trials software market, with a market share of 34.03% in 2021. North America's clinical trials management system market was valued at USD 316.55 million in 2021. In North America, the presence of market players, a high number of biopharma companies, and research and development expenditure are the major factors propelling the market growth in the North American region.
Increasing collaboration, rising adoption of cloud-based platforms, and new solution availabilities are factors that influence the high competition in the global clinical trial software market. Many regional clinical trial software companies also invest in the latest software products in Europe, APAC, and North America. Regional and local companies threaten global players due to their innovative and cost-effective products and technologies. This indicates that the market offers tremendous growth opportunities for existing and emerging players.
Every year number of new market players enter the market, which will positively influence the competition in the market.
- BSI Business Systems Integration
- Dassault Systemes
- Labcorp Drug Development