The global clinical trials software market 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). The biotechnology and pharmaceutical sectors employ a clinical trial management system (CTMS) as a software tool to handle clinical trials for clinical research. The system keeps track of participant contact information, deadlines, and milestones, as well as planning, performing and reporting activities. Clinical trial software, initially available on web-based platforms, is now known as SaaS (software as a service) platform. Electronic data capture (EDC), electronic clinical outcome assessment and electronic patient-reported outcome (eCOA and ePRO), and eConsent are three significant features of clinical trial software that are widely used in the market.
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Growing Use of Cloud Computing in Clinical Trials
Clinical trials transformed from the paper-driven model to the electronic model. Companies increasingly deploy eClinical software solutions, and around 70%-80% of life science companies use cloud-hosted eClinical software. The primary reason for this increased use of cloud-based platforms is their convenience for companies in compliance, privacy, data ownership, and auditing. IT departments eliminate unnecessary costs by removing extensive, complex infrastructure and deploying cloud solutions, mainly hosted or supported by external vendors. New organizations in the market also adopt cloud-based solutions. Cloud-based solutions allow easier cross-organizational collaboration and better data flow control for newly formed or smaller organizations.
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. Implementing cloud systems for clinical trials positively influences the use of cloud computing systems in clinical trials. The cloud storage of clinical trial data gives centralized access to patient data. Clinical trial investigators can easily store patient data in the cloud without the risk of privacy violation. These elements fuel clinical trial cloud computing usage and market expansion.
Advent of Drug Discovery Start-Ups and Small Biopharma Companies
Small pharma start-ups focused on drug discovery depend on outsourcing services due to the need for more infrastructure and technology. There is an increase in investments by start-ups and small biopharma companies in R&D activities. Large biopharma companies have clinical trial services, and their R&D expenditure is lower than that of smaller biopharma companies.
Large pharmaceutical companies collaborate with other companies or acquire start-ups to access new drugs. Start-ups are better at R&D activities, as they majorly outsource clinical trials. The Indian biotech industry alone accounts for 2,700 start-ups, and the estimated number will increase to 10,000 by 2024. Globally, there are more than 2,093,000 pharma start-ups. As smaller companies grow, clinical trials must be outsourced, which drives the need for clinical trial software.
Stringent Regulatory Guidelines Related to Data Handling
A tremendous amount of data is required in different clinical trial phases. Biopharmaceutical companies need to process this data to proceed with clinical trials. CDM's operational challenges are collecting, cleaning, and transforming clinical trial data. Operational data management needs to be improved regarding data completeness, quality, cleaning, regulatory audits, access, and others. These issues led to delays in clinical trials. Small biopharma companies seek high-quality data management platforms, which usually need to be more affordable. Stringent regulations in the bio-pharma industry constitute a significant challenge in clinical trial activities. Globally conducted clinical trials are more complex as they require coordination between multiple sites and real-time data transfer between partners, thereby hampering the market's growth.
New Technologies in Clinical Trials
Drug development is one of the healthcare industries that has been disrupted by adopting new technologies. Technology advancements and changes can significantly impact the planning, execution, and effectiveness of clinical trials. Clinical trial challenges are addressed with the aid of new technologies. Clinical trial breakthrough technologies like wearable technology, big data analytics, artificial intelligence (AI), synthetic biology, telehealth and telemedicine, and mobile communication apps are driving the rapid growth of the clinical trial software market.
In clinical trials, people are using more and more technologies, like remote monitoring, that help them do their jobs better. The increased adoption of new technologies increases the demand for new software to monitor clinical trials. Large CROs in the industry move from paper-based systems and workflows to digital platforms, hybrid clinical trials, and virtual clinical trials. Clinical trial sites must be entirely digital to support next-generation clinical trial technologies. Sponsors are willing to reimburse clinical trial sites for their technology costs as a part of the study cost. CROs also offer return-on-investment plans to vendors. Companies invest money in creating user-friendly, high-quality software platforms for clinical trials. By working with sponsors on technology initiatives, CROs reduce the cost of adopting new technology, creating opportunities for market growth.
The global clinical trials software market is segmented by storage architecture, storage type, and end-user.
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. The on-enterprise deployment of clinical trial software gives visibility into all aspects of clinical trial activities with a proven, comprehensive, and standardized clinical trial management system. It helps accurate auditing and monitoring of multiple centralized clinical trial activities. Around seven to eight years are required on average for the approval of a drug, and around 80% of clinical trial studies fail at patient recruitment and retention within the required timelines. Clinical trial software solutions overcome these challenges in clinical trials. Also, the capital investment needed to develop new drugs is high. Around 80% of clinical trials do not get approvals after the last phase of clinical trials. Clinical trial management systems overcome these challenges by helping companies better analyze data.
On-site deployment involves site analysis and evaluating clinical trials by sponsors or representatives at clinical trial operating sites. Increased technology adoption at clinical research sites allows remote monitoring through software solutions. On-site clinical trial management software has various tools and support mechanisms to help conduct clinical trials. Software providers also educate users about protocols using live and recorded training, study manuals, and a centralized website for trial information. Large CROs invest in the robust training of site professionals and educate them about compliance with protocols and other regulatory requirements.
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. The web-based delivery segment shows significant market growth opportunities due to the rise in its adoption by pharmaceutical and biotech companies for easy software delivery and reduced timelines between two clinical trial activities. The increased number of small and mid-size biopharmaceutical companies drives market growth opportunities through the web-based software delivery segment. Advanced technologies enable easy access to patients’ data. Web-based clinical trial management systems are popular among biopharmaceutical companies as they allow better management of clinical trials and related costs. Web-based solutions provide centralized coordination, reduce the timeline of clinical trials, allow easy access to data by clinical teams, help reduce trial costs and provide operational transparency between sponsors and CROs.
SaaS is a software system for data management, communication, and coordination. SaaS-based technologies help to speed-up clinical trial activities from Phase I to Phase IV. This method provides better solutions to CROs and is more beneficial than other delivery methods. Cloud-based clinical trial software is a type of SaaS and the safest software available. The cloud storage of data is reliable and secure. There is an increase in the adoption of cloud-based technology in clinical trials globally—the use of cloud-based clinical trial software help to handle these complexities. Clinical trial procedures are time-consuming and involve research, documentation, patient recruitment, data management, and analysis. SaaS solutions help reduce clinical trial timelines, increasing their market demand.
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. EDC is a common platform used in clinical trial studies to capture participants’/patients’ data. An EDC system streamlines data collection, and clinical trial sites can easily access the EDC systems from any computer. This platform ensures data authenticity, security, and integrity and helps access data quickly. It also accelerates data cleaning. An EDC system collects different data types from clinical trials for various therapeutic areas. The growing digitalization of clinical trials drives the use of EDC systems in the biopharmaceutical industry.
eCOA is an advanced platform that helps obtain real-time data from patients or clinical trial participants. It helps to accelerate clinical outcomes and achieve clinical trial goals. eCOA is a highly secured cloud-based platform that accelerates clinical data collection and ensures data quality. Most CROs, CMOs, biotech, and pharma companies choose eCOA for their clinical trial activities to better understand patients’ real-time experiences. One of the significant factors in clinical trials is the feedback from patients regarding trials. eCOA is often used by patients on mobile devices to send symptoms and experiences to clinical trial staff remotely. There is a high requirement for data analysis in Phase I to Phase III trials. Many drugs are in the development phase, which drives market growth through eCOA.
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. Clinical trial software helps CROs instantly share data, documents, protocols, and more with clinical trial sponsors, leading to more efficient trial outcomes. The clinical trial and approval from regulatory bodies is a complex procedure. It requires high capital investments, specific staff, and constant contact between patients and clinical trial sites. Due to the need for more infrastructure and staff, many biopharmaceutical and medical device manufacturing companies must be equipped to perform these procedures. Advanced clinical trial software makes these processes simple. Competition among biotech and pharmaceutical companies, high capital investments, and low success rate of clinical trials increase the dependence on CROs for clinical trials.
Biopharmaceutical companies use clinical trial software for development activities from Phase I to Phase IV. Clinical trial software reduces the cost of clinical trials, timelines, and errors in data analysis. Pharmaceutical companies increased clinical trial activity-related expenditure delivers high opportunities for clinical trial software providers. In the past, drug manufacturing companies conducted clinical trials for approvals to introduce drugs or devices in the market. Biotech and pharmaceutical companies require software solutions that can design assays, plan and run clinical trials, and help in data management. Cloud-based, on-premise, and SaaS deployment clinical trial software are some solutions that help biotech and pharmaceutical companies achieve this goal. Large pharmaceutical companies pay for advanced technologies used in clinical trials for a better investment return, accelerating the adoption of clinical trial software.
By region, the global clinical trials software is divided into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America Dominates the Global Market
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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. Advanced clinical trial software is increasingly in demand in this area. The US and Canada are the two countries that conduct the most clinical trials in North America. There are more than 530 regenerative medicine companies in this region, including cell and gene therapy and stem cell-based medicine manufacturers. During the time before the pandemic, more people in North America used virtual clinical trials than in other places. In addition, significant people use clinical trial software when there are more virtual clinical trials. Due to the growth of biopharmaceutical companies and improvements in clinical trial methods, this area has a lot of companies that use the latest technology platforms, such as unified clinical trial platforms. CROs run most clinical trials in North America because of the strict rules and high cost of clinical trials.
Europe is expected to grow at a CAGR of 16.09% over the forecast period. Europe is a highly dynamic clinical trial software market. There is a significant increase in the adoption of new technology in the European clinical trial software market. Most pharmaceutical companies seek CROs in the region due to the low cost of clinical trials compared with the US. European countries promote clinical research and trials, which makes the healthcare system in the region strong. Around 60% of European clinical trials are conducted by pharmaceutical companies and 40% by academia. Pharmaceutical companies expect CROs to adopt advanced technology platforms to conduct clinical trials. Multiple life sciences research projects are conducted in various European countries. Europe ranks second after North America in cell and gene therapy and genome sequencing and demands extensive R&D infrastructure to handle complex data. This demand drives using technology platforms, such as clinical trial software.
Asia-Pacific is one of the leading destinations for clinical trials globally due to its high patient population, low cost of trials, and transparent workflow by regulatory authorities. These reasons accelerate clinical trial activities in the region. There has been a 138% increase in oncology clinical trials in the last ten years in the Asia Pacific. Clinical trial software is likely to be used more in the area as the number of clinical trials increases. There is already a rise in the number of clinical trials in the region that use remote monitoring software and telehealth-based platforms. In addition, India and China host the most significant clinical trials. Lifesciences R&D, significant investments in clinical trials, and new regulatory guidelines issued by governments drive the adoption of clinical trial software in the region.
Latin America is one of the preferred destinations for clinical trials. Around 80% of the population lives in cities, which is beneficial for clinical trial enrollment. Easy patient recruitment for clinical trials; heterogeneous, ethnic, and epidemiological profile of the region; and language factors that save time, cost, and personnel requirement are factors that accelerate clinical trial activities in the area and drive the market growth through the increased application rate of software.
In the Middle East and Africa, there is an impressive growth in the absolute number of clinical trials, especially with Turkey and Egypt as the major destinations for CROs, drug developers, and medical device manufacturers to conduct clinical trials for their products. Developed countries host almost an equal share of Phase I, II, and III/IV clinical trials. However, the Middle East and Africa host mostly Phase III and post-marketing trials because some regional countries do not allow early Phase I and II trials due to safety concerns.
The key 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)