Clinical Trial Management System Market Report 2025 (Global Edition)

CURRENT SCENARIO OF THE CLINICAL TRIAL MANAGEMENT SYSTEMS MARKET

Key Factors Driving the Grwoth of the Clinical Trial Management Systems Market

• Increasing Number of Clinical Trials Propel Market Growth 

Clinical trials are a crucial part of evidence-based medicine because they help predict the effectiveness of novel medications, diagnostic tools, and vaccinations. To make sure the novel intervention is secure and efficient, they usually engage big crowds of individuals. Most of the trials are conducted when a medicine is being developed. 

According to the data provided by the National Library of Medicine (NLM), ~52,000 new studies were registered with NLM (ClinicalTrials.gov) in 2020, which increased to ~58,000 in 2023. In January 2023, the NLM reported 38,837 active clinical trials in the US and 105,172 active trials worldwide. 

According to the European Medicine Agency, in the European Union (EU), ~4,000 clinical trials are authorized annually, of which about 60% of clinical trials are associated with the pharmaceutical industry. 
(Source:https://www.efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/clinical-trials/)

The market for clinical trials is expanding as a result of an increase in studies for new, effective medicines as chronic diseases are becoming more commonplace worldwide. Clinical trials are become increasingly difficult due to larger sample numbers, a wider range of patient demographics, and various study sites. Trial operations can be made more efficient with the use of CTMS systems, which also enhance data management and stakeholder cooperation. Clinical investigations also generate enormous amounts of data that need to be meticulously gathered, handled, and examined. With the use of CTMS platforms' data integration, real-time reporting, and data visualization capabilities, sponsors and researchers may streamline trials and make more informed decisions. 

Furthermore, in the highly regulated pharmaceutical industry, adherence to regulatory criteria is crucial. By offering capabilities for managing regulatory documents, ensuring procedure adherence, and preserving data integrity, CTMS solutions improve compliance processes. 

Furthermore, the launch of advanced innovations by market players is boosting the growth of the market during 2022-2030. 

For instance, in 2023, Oracle Corporation, a prominent technology company, introduced its newest CTMS solution, called Oracle Health Sciences Clinical One CTMS. This new solution boasts advanced features such as real-time data analytics, centralized data management, and improved compliance capabilities that aim to simplify clinical trial processes and enhance overall efficiency
(Source:https://www.efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/clinical-trials/)

• Importing of clinical trials is encouraged by rising disease prevalence which is propelling the growth of clinical trial management system market.

The number of drugs in development that need extensive clinical trials before approval has significantly increased due to the rising prevalence of chronic diseases like diabetes, cancer, and AIDS in various parts of the world. Due to the high prevalence of cancer, diabetes, and respiratory diseases, emerging nations like China and India performed about 31% of the world's clinical trials. The region's need for improved clinical trials has also grown due to various lifestyle-related illnesses and genetic disorders in Middle Eastern and North African nations. The demand for clinical trial management systems has increased due to the developing of more drugs to treat more prevalent diseases.

Increase in prevalence of chronic diseases such as diabetes, cancer, and AIDS in different parts of the world has significantly increased the number of pipeline drugs that require extensive clinical trials before approval 

About 21% of the elderly in India reportedly have at least one chronic disease. Seventeen percent elderly in rural areas and 29% in urban areas suffer from a chronic disease. Hypertension and diabetes account for about 68% of all chronic diseases.
(Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8916671/#:~:text=About%2021%25%20of%20the%20elderly,68%25%20of%20all%20chronic%20diseases.)

According to Australian National Health Survey, Eight in ten (81.4%) people had at least one long-term health condition and One in two (49.9%) people had at least one chronic condition.
(Source:https://www.abs.gov.au/statistics/health/health-conditions-and-risks/health-conditions-prevalence/latest-release)

Additionally, various lifestyle associated diseases and genetic disorders in countries in the Middle East and North Africa have increased the need for enhanced clinical trials in the region. 

Factors Hampering the Growth of the Market

• Longer approval time for clinical trials to hamper clinical trial management system market 

There is a great deal of pressure on pharmaceutical and biotechnology businesses to launch more therapeutic treatments in order to offset the income losses resulting from the recent patent expiration of popular drugs. The availability of a suitable patient population, contract and budget negotiation and approval, institutional review board (IRB) or ethical committee (EC) approval, protocol creation and refinement, and legal evaluations are a few examples of the variables that might cause delays in the drug approval process. Before beginning a clinical study, pharmaceutical and biopharmaceutical businesses must obtain approval from the appropriate regulatory authorities in each nation. The duration of regulatory clearances might range from one week to over a year in different nations. The longer approval period for clinical studies going forward is a result of these factors, which is one thing that is predicted to impede the market expansion for clinical trial management systems.

When it comes to conducting clinical trials, small and mid-sized client facilities sometimes face financial hurdles because of a lack of private investment, stringent regulatory regulations, and financial outlooks. Included are poor study and trial execution, inadequate site selection, safety issues, and dropouts brought on by monetary or logistical challenges. Every trial phase also costs more money and takes longer to finish. The entire cost of a Phase III failure comprises the money spent on all previous phases as well as the time lost on evaluating an alternative medication. Every failed trial drives up the cost of research and development for biopharmaceuticals. Start-ups and SMEs continue to encounter financial obstacles that affect their decision to invest in CTMS solutions, despite the fact that R&D spending in the life sciences sector is rising.

Opportunities

• Integration of CTMS with other systems is the major trend influencing the clinical trial management system market growth.

There is a high level of integration between CTMS and other systems due to their significant overlap. Integration allows data to be electronically transferred between systems, reducing latency and increasing availability of information at the point of need without introducing transcription errors. Additionally, the availability of the Internet makes this connection feasible since it permits broad access to CTMS via web browsers. The reality of CTMS access devolving to a larger population of more infrequent users is brought about by the internet. At the moment, CTMS interfaces with hospital systems to get laboratory results and patient demographic information for patients taking part in clinical trials. Additionally, data transfer from a CTMS to an electronic medical record (EMR) can be utilized to support patient safety and billing.

Furthermore, when medical professionals can utilize the EMR to identify that a patient is enrolled in a clinical trial, patient safety may be enhanced. In a similar vein, ensuring Medicare or Medicaid billing compliance is facilitated by providing patients with access to the most recent billing grid information obtained from the CTMS. Thus, data copy errors are avoided because there is no need to re-enter this data into a CTMS. Therefore, a connection between clinical trial research and EMR enhances data processing and gathering. Additionally, as e-systems become more common, there will be more opportunities for system integration, which will accelerate market expansion over the course of the projected period.

In April 2023, a study was carried out to develop an integrated clinical trial management system to optimize the management process of clinical trials through system development methods, standardization protocols, efficient integration with external business systems, and data security and privacy protection. Efficient data integration was achieved through the use of extract-transform-load, message queue, and remote procedure call services, which connected the CTMS with external systems such as the Hospital Information System (HIS), Laboratory Information System (LIS), Electronic Medical Record (EMR), and Clinical Data Repository (CDR).

And, in October 2022, RealTime Software Solutions, LLC collaborated with Aspen Insights to incorporate world-class EMR/EHR patient identification technologies into RealTime's worldclass Clinical Trial Management System (CTMS). The company's integration allowed clinical research sites to mine structured and unstructured EMR/EHR data for study feasibility analysis, practice population eligibility analysis, physician evaluation, and direct delivery of pre-qualified participants into RealTime-CTMS
(Source:https://realtime-ctms.com/2022/10/05/aspen-realtime-press-release/)

How did COVID–19 Impact the Clinical Trial Management Systems Market?

The Clinical Trials Management System (CTMS) market was greatly impacted by the COVID-19 epidemic. These included delays or cancellations of research, difficulties in patient recruiting, and disturbances in clinical trials. To secure the continuation of R&D, governments, regulatory agencies, and industry participants implemented a number of calculated steps that progressively lessened the adverse effect. Decentralized clinical trials have become increasingly popular as a result of the necessity to create coronavirus vaccines.

As per a study published in the U.S. National Library of Medicine in 2020, the pandemic resulted in delayed subject enrollment and operational gaps in most ongoing clinical trials. This in turn negatively impacted trial programs and data integrity. Globally, most sites conducting clinical trials other than COVID-19 were found to experience delays in timelines. In some cases, clinical trials were found to reach a complete halt of operations, thus impacting clinical research outcomes. 
(Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538012/)

In March 2020, the U.S. FDA published a guidance document on the Conduct of Clinical Trials of Medical Products during the pandemic. Similar guidelines supported the recovery of the clinical trial operations, and the number is anticipated to increase over time.

Post-pandemic - In a world where traditional, in-person procedures were no longer an option, people involved in clinical trials had to quickly adapt to support alternate means of monitoring and caring for clinical trial participants. The pandemic hastened the widespread adoption of novel techniques, tools, and frameworks, many of which had previously only been carefully investigated and tested in pilot programs.
Even though this forced transition was unsettling and undoubtedly concerning, once the pandemic ends, the effects of these adjustments are largely viewed as beneficial. 

• The industry is confidence in the data generated from newly adopted clinical trial methods; 

• The adoption of new clinical trial methods during the pandemic had a beneficial 
influence on clinical trials; and 

• These newly adopted clinical trial methods will continue in the post-pandemic world. 

Furthermore, the industry now knows when and how to apply fit-for-purpose, hybrid, and decentralized clinical trial models to enhance clinical research, thanks to the forced adoption of these models during the epidemic. The survey's results show that respondents anticipate these models to be used going forward in the post-pandemic environment and that patients will be given the freedom to decide how they want to participate in clinical trials.

Thankfully, the industry will be able to continue with clinical trials into the future because to the software and technology that support these developments in clinical research. Teams conducting clinical trials can be confident that technological advancements won't impede their progress.

Our study will explain complete manufacturing process along with major raw materials required to manufacture end-product. This report helps to make effective decisions determining product position and will assist you to understand opportunities and threats around the globe.

The Global Clinical Trial Management System Market is witnessing significant growth in the near future.

In 2023, the Enterprise CTMS segment accounted for noticeable share of global Clinical Trial Management System Market and is projected to experience significant growth in the near future.

The Large Pharma-biotech Companies segment is expected to expand at the significant CAGR retaining position throughout the forecast period.

Some of the key companies ArisGlobal LLC , Dassault Systemes SE and others are focusing on its strategy building model to strengthen its product portfolio and expand its business in the global market.

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