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The clinical trial management system (CTMS) market size is forecast to increase by USD 1.45 billion, at a CAGR of 12.81% between 2022 and 2027. Market growth hinges on various factors, notably the escalating healthcare expenditure, fueling investments in medical research and clinical trials for drugs. Additionally, the surge in CTMS adoption enhances operational efficiency and regulatory compliance, driving market expansion. As healthcare organizations prioritize innovation and efficiency in trial management, the demand for CTMS solutions continues to rise, reflecting a broader trend toward modernizing clinical trial processes to meet evolving industry standards and regulatory requirements.
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The market is driven by the increasing reliance on Healthcare IT solutions by biotechnology and pharmaceutical firms. The demand for efficient management of clinical trials, particularly for vaccines, is bolstered by support from organizations like the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the World Health Organization (WHO). EDC systems streamline accruals and deviations, ensuring robust reporting and facilitating the tracking and management of regulatory processes. Market dynamics also include collaborations between multinational companies and local CROs, with companies like Clario and ERT emerging as leaders in clinical endpoint technology. Investment in pharmaceutical companies further drives the market forward.
Furthermore, this report extensively covers market segmentation by deployment (on-premise and cloud), end-user (pharmaceutical and biotechnology companies, CROs, and others), and geography (North America, Europe, Asia, and the Rest of the World (ROW)). It also includes an in-depth analysis of drivers, trends, and challenges. Furthermore, the report includes historic market data from 2017 to 2021.
The market share growth by the On-premise segment will be significant during the forecast period. In this segment, owning and maintaining a server increases the perceived level of data security. Hence, large firms with enough resources are less likely to shift to other solutions. Siebel and IMPACT are on-premises CTMS majorly available in the market. Thus, such factors are expected to drive the growth of the segment in the global CTMS market during the forecast period.
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The on-premise segment was valued at USD 648.20 million in 2017. CTMS, generally deployed on-premises, provides better data security with high control compared with that of cloud-based deployment. However, the on-premises model requires large investments in infrastructure. Moreover, owing to the high cost associated with its maintenance, firms are looking for an alternative solution. Such factors are expected to hamper the CTMS demand in the global CTMS market during the forecast period.
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North America is estimated to contribute 44% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional market trends and drivers that shape the market during the forecast period. Factors such as ease of the regulatory process, a high number of pharmaceutical and biotechnology companies and CROs in the region, and considerable investments in clinical trial research, will increase the CTMS market in North America at a significant pace in the global market during the forecast period. The major revenue-contributing countries in North America include the US, followed by Canada and Mexico. There has been an increase in the number of clinical trials in these countries, which increased the demand for CTMS in recent years, 2020-2022. As clinical trials are conducted with ease in these economies, along with increased research in leading countries such as the US and Canada, the market is likely to witness growth in the region.
The market drivers include the rapid adoption of cloud-based CTMS and the shift towards decentralized clinical trials (DCTs), enhancing efficiency and patient engagement. Additionally, the surge in telemedicine solutions and regulatory support from organizations like the World Health Organization (WHO) fuel market growth. However, challenges persist in navigating regulatory policies and ensuring scalability to meet the diverse needs of healthcare and life sciences companies. Addressing these challenges while leveraging innovations like IWRS/RTSM and eCOA is crucial for market expansion amidst increasing outsourcing and externalization trends. Our researchers analyzed the data with 2022 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
Increasing healthcare expenditure is the major driver fueling the market growth. With the increasing prevalence of chronic diseases and the rising disposable incomes of people around the world, healthcare expenditure is increasing. For the management of highly critical clinical trials, doctors may use CTMS. Moreover, the growing awareness about the need for early diagnosis, as well as the risks of negligence in seeking timely medical help, is making people health-conscious, which, in turn, is leading to an increase in their healthcare expenditure. Healthcare expenditure in most developed countries is higher than that in the rest of the world.
However, emerging markets, such as China, India, and Brazil, are witnessing an increase in healthcare spending due to the rising disposable incomes of the people. Therefore, increasing healthcare expenditure is expected to drive the growth of the market during the forecast period.
Significant Market Trend
Integration of CTMS with other systems is the major trend influencing the market growth. There is considerable overlap between CTMS and other systems, which results in a high degree of integration. Because of integration, the information can be passed electronically between systems, making it more rapidly available wherever needed, while avoiding transcription errors. Further, this integration is possible because of access to the Internet, which enables widespread access to CTMS through web browsers. Internet results in the reality of devolution of CTMS access to a wider community of more occasional users. Currently, CTMS integrates with hospital systems to obtain data on patient demographics and laboratory data for patients participating in clinical trials. There is also an opportunity for data to flow from a CTMS to an electronic medical record (EMR) to help with both patient billing and patient safety.
Moreover, patient safety can be better served when healthcare providers can use the EMR to recognize that their patient is registered for a clinical trial. Similarly, the availability of the latest billing grid information from the CTMS to inform patients helps ensure Medicare or Medicaid billing compliance. Hence, this eliminates the need to re-enter this data into a CTMS, thereby preventing data copy errors. Hence, a link between EMR and clinical trial research improves data collection and processing. Further, with the trend of e-systems, the opportunities for integration with other systems will increase, thereby boosting the market growth during the forecast period.
The rising cost of clinical trials is a major hindrance to the market growth. Clinical trial management has changed dramatically over the years, and the rising costs of clinical trials are a concern. The cost of clinical trials increases because of many factors. For instance, drugs undergo a difficult and slow process during clinical trials. The initial difficulty is patient enrolment, which is followed by making sure patients continue the trial and do not drop out of the research study. A second factor that contributes to the rising costs is the increasing need to collect more clinical data.
Newer regulations stipulate more thorough and prolonged safety testing during clinical trials. As a result, clinical trials, especially for drugs attempting to alleviate chronic diseases, tend to be complex and sometimes prohibitively expensive. Thus, the longer the trial goes on for the abovementioned issues, the costs keep increasing, and clinical research associates (CRAs) will avoid the management systems and prefer manual work for cost-cutting in trial research, thus hindering market growth.
The market forecasting report includes the adoption lifecycle of the market research and growth, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth and forecasting strategies.
Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
Advarra Inc.: The company offers a clinical trial management system namely Clinical Conductor CTMS.
The report also includes detailed analyses of the competitive landscape of the market and information about 15 market companies, including:
Qualitative and quantitative analysis of vendors has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize vendors as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize vendors as dominant, leading, strong, tentative, and weak.
The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD Billion" for the period 2023 to 2027, as well as historical data from 2017 to 2021 for the following segments.
The Clinical Trials Management System market thrives on the integration of cutting-edge technologies like AI, analytics, and machine learning algorithms to streamline processes. Regulatory compliance is ensured through collaboration with entities such as the World Health Organization (WHO), National Library of Medicine, and FDA (Food and Drug Administration). Key players offer comprehensive solutions like RealTime’s Enterprise CTMS for centralizing recruitment and managing regulatory procedures. Emphasizing system security and data quality, CTM systems provide network-wide visibility and oversight while enabling digitalization and supporting personalized medicine initiatives. With offerings spanning Platform as a Service (PaaS), Infrastructure as a Service (IaaS), and Software as a Service (SaaS), the market caters to diverse needs from trial planning to participant safety on mobile and online platforms.
Furthermore, the market is experiencing significant growth, particularly with the advent of the COVID-NMA era. CTMS solutions offer crucial functionalities such as backups, upgrades, and ensuring uptime consistency to streamline clinical trial operations. They enable the centralization of data and automation of processes, providing clinical trial managers with easy access to data across devices like workstations, laptops, and tablets through an online dashboard. These systems track country and site progress, monitor activities, and manage supplies and finance, all on a subscription basis at enterprise or site levels. CTMS also ensures compliance with regulatory norms and simplifies document management processes. Leading providers like Clinion and Bioclinica offer comprehensive solutions covering eRegulatory, eSOURCE, accounting, aggregate reporting, and advanced trial models to enhance evidence collection and streamline facilities management, establishing them as key players in the industry.
Market Scope |
|
Report Coverage |
Details |
Page number |
160 |
Base year |
2022 |
Historic period |
2017-2021 |
Forecast period |
2023-2027 |
Growth momentum & CAGR |
Accelerate at a CAGR of 12.81% |
Market growth 2023-2027 |
USD 1.45 billion |
Market structure |
Fragmented |
YoY growth 2022-2023(%) |
12.06 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 44% |
Key countries |
US, Canada, Germany, UK, and China |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
ArisGlobal LLC, eResearchTechnology GmbH, Advarra Inc., Dassault Systemes SE, DATATRAK International Inc., International Business Machines Corp., Medpace Holdings Inc., Oracle Corp., Parexel International Corp., Veeva Systems Inc., Laboratory Corp. of America Holdings, DSG Inc., MasterControl Inc., Wipro Ltd., MedNet, Medfiles USA, Crucial Data Solutions Inc., Ennov SAS, RealTime Software Solutions LLC, and PHARMASEAL |
Market dynamics |
Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, and Market condition analysis for the market forecast period. |
Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Deployment
7 Market Segmentation by End-user
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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