Market Overview:

The Clinical Trials Management Software Market Size Was Valued At $969.4 million in 2022, and is projected to reach $2,810.5 million by 2030, registering a CAGR of 11.2% from 2023 to 2030.

 The growing number of new deadly diseases has created a great demand for vaccinations and drugs. These requirements cannot be met unless these immunizations and drugs have been introduced to meet certain criteria in clinical trials. 

The number of clinical trials conducted in response to the growing demand and the need to satisfy it is expanding regularly, which has fuelled the popularity and market expansion of clinical trial management software.

Technological advancements have taken the demand for clinical trial management software to new heights. Such progress was made by a research team at the Asan Medical Center (AMC) in Seoul, South Korea. We developed a new system that can manage image data acquisition and extraction for clinical trials.

This is expected to be a major breakthrough in the test management system since it will make clinical trials faster and more efficient than ever before. The research team led by Professor Kyungwon Kim of the Department of Radiology claims to follow the standards of the Clinical Data Exchange Standardization Consortium (CDISC).

Veeva Systems Inc. is a leader in this field, and the system's popularity has been attributed to its claims of speeding up clinical trials that involve research management.

These systems are also scalable, enabling organizations to easily integrate multiple operating models and complex study designs.

Significant Market Dynamics:

Market Drivers

Rapid Development of CTMS Solutions 

The number of clinical trials conducted in the life sciences industry is increasing day by day, and this tremendous growth is due to the rapid development of this system.

An increasing number of people suffering from rare and chronic diseases have emerged as a major driver for the market, pushing revenue to new heights.

Innovation in research and development 

Government support is enabling key market participants to engage in multiple research and development initiatives to bring new drugs to market. Government funding for clinical trials has also significantly expanded the market. The large amount of data coming in through research programs is managed with the help of clinical trial management systems.

Market restraints

Budget Restrictions

Clinical trial management systems are necessary for managing and streamlining complex clinical trial processes and ensuring the accuracy of data, but the cost of such systems can be an important barrier for prospective clients. Clinical trials are already expensive, and the cost of the clinical trial management system can regularly exceed the budget for the trial.

Unwillingness of most of the clinical trial sponsors to invest in a long-term system

In addition, the unwillingness of most of the clinical trial sponsors to invest in a long-term system makes it difficult to justify the expenses of an expensive clinical trial management system. This budget constraint is a significant impediment to the market expansion of clinical trial management systems.

Market Challenges

The high cost associated with clinical trials 

Significant financial support is required to conduct successful clinical trials, which presents a major challenge for major market players. These burdens contribute to the growth of clinical trial management systems used for processing data obtained after the completion of the process. The total amount of time required to conduct a clinical trial imposes heavy costs on key market players that are difficult to deal with in the long run.

Lack of skilled experts  

Lack of expert experience and skills has emerged as a major obstacle to the growth of the clinical trial management system market. Various factors, such as safety concerns, inefficient site selection, poor trial execution, and poor study design, present challenging factors for market growth during the forecast period.

Market Opportunities

Growing Acceptance of Technological Advances -

With the rapid increase in acceptance of technological advancements, the Radius healthcare industry has adopted modern clinical research test management systems that have emerged as a major opportunity for market growth. 

Investment in efficient digital infrastructure

Clinical Trial Management Systems (CTMS) are intended to expedite clinical trial processes and offer real-time data and analytics to facilitate the efficient and effective management of clinical trials. With a growing emphasis on digital infrastructure and technological adoption agility, it is anticipated that the market will expand significantly in the coming years. As pharmaceutical companies, clinical research organizations (CROs), and non-profit organizations increasingly adopt CTMS, the market is anticipated to expand significantly.

Market segmentation

By Type

Based on type, the market is segmented into enterprise-wide and on-site CTMS, web-based (on-demand), licensed enterprise (on-premises), and cloud-based (SaaS) clinical trial management systems. In 2019, the market was dominated by internet-based services. This segment's large share can be attributed to the benefits provided by web-based software, including simple access, increased productivity, and time and cost efficiency.

By Application

On the basis of end users, the market has been segmented into large pharma-biotech companies, small and mid-sized pharma-biotech companies, contract research organizations (CROs), medical device manufacturers, and other end users. An increasing emphasis on R&D is one of the primary drivers of CTMS adoption.

By Component

Based on the components, the market is segmented into software and hardware. Due to the availability of enhanced software, the development of medical software, and the rise in patient population, the software segment was the largest contributor in 2020 and is anticipated to maintain its lead throughout the forecast period.  

Regional Insights

In 2022, approximately 50% of the Clinical Trials Management System (CTMS) market's revenue was generated in North America. Due to the presence of major companies and the rising adoption of technology in R&D, North America accounts for a large portion of the global market.


This regional growth can also be attributed to favorable regulatory policies and rising pharmaceutical company investment. 

In the coming years, it is anticipated that Asia-Pacific will have the highest CAGR, around 18%. This is a result of increasing R&D activities in the region, the availability of a large patient cohort, the rising number of clinical trials conducted in the region, and the outsourcing of clinical trials. Clinical research investigations can be conducted at a lower cost in Asian nations. This factor is expected to enhance the regional market over the projected time period. 

Latin America is another burgeoning clinical trial market. According to clinicaltrials.gov, a growing number of clinical trials are being conducted in Latin American nations, such as Mexico, Brazil, and Argentina.

Scope of the Report

Key Market Updates:

• In June 2019, Parexel International Corporation (USA) launched an enhanced integrated outsourcing delivery model for Functional Service Provider (FSP) services at the DIA 2019 Global Annual Meeting in San Diego, USA.
• In May 2019, Bio-optronics (USA) released three products for its CCTrialSuite basket applications: CCeSource, CCeReg, and CCeConsent.
• In June 2018, Bioclinica (USA) launched SMART Technology Suite, an e-clinical solution.
• Acquisition of Zafgen by Accenture: In April 2021, Accenture announced the acquisition of Zafgen, a provider of Clinical Trial Management Systems (CTMS). This transaction increases Accenture's capabilities in clinical trial management and analytics.
• Oracle's Acquisition of ICON: In November of 2020, Oracle Corporation announced that it would acquire ICON, a provider of CTMS services. The deal expands Oracle’s global presence in the life sciences sector and enables organizations to expedite the development of novel treatments and therapies.
• Acquisition of Medidata Solutions by IQVIA: In May 2019, IQVIA Technologies announced its acquisition of Medidata Solutions, a cloud-based CTMS solutions provider. This transaction increased IQVIA's presence in the market for clinical trial management.
• Oracle's Acquisition of Comprehend Systems: Oracle Corporation announced in March 2019 that it had acquired Comprehend Systems, a provider of cloud-based clinical trial management solutions. This transaction increases Oracle's capabilities in the healthcare and life sciences industries.
• Acquisition of Cloud Nine by Veeva: In December 2018, Veeva Systems announced the acquisition of Cloud Nine, a provider of cloud-based clinical trial management solutions. The transaction improves Veeva's portfolio of clinical trial management solutions.

Key vendors

Oracle Oracle Cloud Infrastructure, established in 1977, provides increased efficiency, security, and cost savings. It is designed to facilitate the migration of workloads from on-premises systems to the cloud, in addition to between the cloud, on-premises, and other clouds. Oracle Cloud applications provide business leaders with contemporary applications that assist them in innovating, achieving sustainable development, and becoming more resilient. 

Medidata Solutions The American technology company Medidata Solution develops and markets software as a service (SaaS) for clinical trials. These include protocol developments, clinical site collaboration and management, randomization and trial supply chain management, data capture via web forms, mobile health (mHealth) devices, laboratory reports, imaging systems, quality monitor management, safety event capture and monitoring, and business analytics. Medidata has offices in China, Japan, Singapore, South Korea, the United Kingdom, and the United States, in addition to its headquarters in New York City. This company was established in 1999.

PAREXEL Parexel is one of the largest clinical research organizations (CRO) in the world, offering a complete spectrum of Phase I to IV clinical development services to expedite the delivery of life-saving treatments to patients. It was established in 1982 with headquarters located at Durham, North Carolina, U.S. Newton, Massachusetts. It is the second largest medical research organization in the world and has helped develop approximately 95% of the 200 top-selling biopharmaceuticals on the market today.

Bioclinica Clario is now the combined corporation of ERT, the global leader in clinical end-point technology, and Bioclinica, the technological and scientific leader in medical imaging.

Clario is a technology company that produces the most significant clinical proof by combining science knowledge and global scope with the most comprehensive endpoint technology platform. Clario will thereby allow its collaborators to transform lives. Clario is dedicated to innovating the future of clinical trials through technology and improving global healthcare.

Their specialties include Imaging Core Lab, Phases 1-4, Electronic Data Capture (EDC) and eSource, Cardiac Safety Services, Clinical Trial Management System (CTMS), Clinical Adjudication, Clinical Trial Technology, Randomization & Trial Supply Management & Optimization (RTSM), Site Payments & Forecasting, Clinical, and Pharmacovigilance. 

MedNet MedNet is a healthcare technology company that specializes in e-Clinical solutions for the life sciences community globally. The flexible, electronic data capture (EDC)-centric e-Clinical platform from MedNet increases the productivity of all categories of clinical research. Beyond EDC, MedNet's comprehensive solution set provides the tools necessary to build and manage all forms of clinical investigations, while adapting to changing needs. Pharmaceutical, medical device, biotechnology, and Contract Research Organizations (CROs) from around the world have relied on MedNet for the past two decades to provide the technology development, experience, and dependability they need to achieve success. For more information, please visit mednetsolutions.com.

Market Key Players:

• Oracle
• Medidata Solutions
• PAREXEL
• Bioclinica
• IBM
• Veeva Systems
• ERT
• DSG
• Forte Research Systems
• MedNet Solutions
• Bio-Optronics
• DATATRAK
• Master Control
• DZS Software Solutions
• Medrio
• Flex Databases
• Integrated Clinical Solutions

Major Market Segments Covered

By Type:

• Web-based CTMS
• Licensed Enterprise (On-premise) CTMS
• Cloud-based (SaaS) CTMS
• Other

By Application:

• Hospitals
• Clinics
• Pharma & Biopharmaceutical
• Medical Device
• Others

By components

• Software 
• Hardware

By Region:

In 2021, North America accounted for over 50 percent of the market. The large share of North America can be attributed to the presence of significant corporations and the increased adoption of technology in R&D. In addition to advantageous regulatory policies and increased investment by pharmaceutical companies, this regional growth can be attributed to these factors. Clinical endpoint technology leader ERT merged with Bioclinica in November 2021 to form Clario. This has allowed the company to achieve its clinical trial objective by implementing a technologically-based therapeutic domain solution.

Conclusion

As a consequence of technological advancements, the demand for clinical trial management software has skyrocketed. Government support permits key market participants to participate in multiple drug development research and development initiatives. Clinical trial administration systems are utilized to manage the voluminous amounts of data generated by research programs. Clinical trial management systems are necessary for managing and streamlining complex clinical trial processes and ensuring data accuracy, but the cost of these systems can be a significant barrier for prospective clients. Clinical Trial Management Systems (CTMS) are intended to facilitate the efficient and effective management of clinical trials through the provision of real-time data and analytics.