Clinical Trial Management System (CTMS) Market Forecasts to 2028 – Global Analysis By Component (Hardware, Software, Services), Application (Patient Management Solutions, Data Management Solutions) and By Geography

Clinical Trial Management System (CTMS) Market Forecasts to 2028 – Global Analysis By Component (Hardware, Software, Services), Application (Patient Management Solutions, Data Management Solutions) and By Geography

According to Stratistics MRC, the Global Clinical Trial Management System (CTMS) Market is accounted for $918.75 million in 2021 and is expected to reach $2,708.27 million by 2028 growing at a CAGR of 16.7% during the forecast period. Clinical Trial Management System (CTMS) is a software system that is customizable and aims at managing the clinical trial data generated in clinical trials conducted by different pharmaceutical companies and clinical research organizations. The management system allows the ease in tracking and monitoring of patients involved in the clinical trials and analyzes huge amounts of data which helps in deciding the safety factors of the products undergoing clinical trials.

Market Dynamics:

Driver:

Availability of advanced CTMS solutions

The life science industry is witnessing a global increase in the number of clinical trials. The growth in the number of clinical trials can be attributed to factors such as the high prevalence of chronic diseases, the expiry of blockbuster drugs, the availability of government funds for clinical trials, and fierce competition in the pharmaceutical industry. In recent years, leading players have launched many CTMS solutions in the market that claim superior performance than their traditional counterparts. These products are cost-effective, easy to use, provide effective patient safety and regulatory compliance, and enhance the financial management capabilities of users. They enable organizations to implement a full-featured CTMS without the complex configuration and heavy capital investment associated with traditional solutions.

Restraint:

Financial constraints

The prevalence of financial constraints for clinical trials is often due to limited private funding, strict regulatory mandates, and financial outlook. This also includes ineffective site selection, poor study design & trial execution, safety issues, and dropouts due to practical or financial issues. Although R&D spending in the life science industry is rising, start-ups and SMEs still face budget constraints, which affect their decision to purchase CTMS solutions. Due to uncertainties and undue delays in product approvals and long gestation periods, private investors usually prefer established firms to invest in rather than start-ups and SMEs.

Opportunity:

Increased innovations by pharma companies

Even though the supply of technology has been increasing and the regulation of innovative methods is easing, pharmaceutical companies have been slow to use emerging technologies due to the uncertainty prevailing around this space and a highly fragmented supply market. Lately, pharma companies have increased expenditure on AI and big data analytics, given their transformative supremacy over the R&D process and cost savings. Fear of rivalry in the market and the need for business transformation and agility are key forces driving huge investments in R&D technologies. Hence, pharma companies must recognize outward innovation through supplier benchmarking in each of these categories and be involved in early engagement through co-development to stay competitive. This would provide ample opportunities for the market.

Threat:

Lack of skilled professionals

The lack of skilled professionals for handling advanced digital solutions in research teams is a major challenge faced by the CTMS market. With severe time constraints and increasing cost cuts, CROs and pharmaceutical companies are reluctant to invest in training their research employees. Hence, a huge gap exists between the available and required skilled manpower in the clinical research industry, restricting the adoption and utilization of complex software solutions in clinical trials. The development of user-friendly software solutions could act as a key growth opportunity for software vendors in this market.

The web-based (on-demand) segment is expected to be the largest during the forecast period

Web-based systems are the most preferred CTM systems. High growth rate is attributed to various advantages associated with web-based solution such as remote access to data and minimal technical issues. Web-based CTMS uses secure enterprise-class data centers to store, update, and back-up on a daily basis. Also, web-based software allows the centralization of data, which facilitates access to data from any location and they help minimize cost associated with system security, backups, upgrades, and uptime consistency.

The software segment is expected to have the highest CAGR during the forecast period

The CTMS software performs various critical functions such as comprehensive management of trial planning, country & site progress and monitoring activities among others. Also, rising number of clinical trials across the globe will increase the acceptance rate, thereby augmenting the industry value over the forecast timeframe. In addition, advancements in CTMS software to ensure effective management of clinical trials data generated by biotech and pharmaceutical companies will accelerate new product launch, thereby supplementing the industry demand.

Region with largest share:

North America is projected to hold the largest market share owing to the strong presence of major pharma and biopharmaceutical companies as well as CROs. Also, extensive drug development activities in the region will further stimulate the usage of clinical trial management system software to manage the data volume. Moreover, the growing clinical research activities in U.S. and rapid shift from manual data elucidation to real-time data analysis during clinical studies will further accelerate the expansion of the CTMS market. Growing concern regarding efficient management of large and confidential data volume will increase the acceptance of CTMS solutions and boost the industry progression in the region.

Region with highest CAGR:

Asia Pacific is projected to have the highest CAGR due to increasing government funding to support clinical trials, the presence of less stringent regulatory guidelines as compared to developed nations, a large patient base, faster rate of patient recruitment for clinical trials than mature nations, low operating costs for conducting clinical trials, and the growing number of pharmaceutical companies and CROs in the region.

Key players in the market

Some of the key players profiled in the Clinical Trial Management System (CTMS) Market include IBM, Oracle, Bioclinica, Veeva Systems, Parexel International Corporation, PHARMASEAL, Advarra Technology Solutions, Merge Healthcare, Medidata Solutions, Bio-Optronics, Mednet Solutions, DZS Clinical Services (WDB Holdings Co. Ltd), Arisglobal, Mastercontrol, and Datastat.

Key developments:

In January 2020: Veeva System launched its Vault Payment, a new application for Vault CTMS that help in managing and reimbursement process to clinical research site. This launching strategy enabled company to add value to their existing services portfolio in clinical research and data management, thereby strengthening their business revenue and market presence.

In June 2019: Parexel International Corporation (US) launched an enhanced integrated outsourcing delivery model for functional service provider (FSP) services at the DIA 2019 Global Annual Meeting in San Diego, US.

In May 2019: Bio-optronics launched three products to the CCTrialSuite basket application, namely CCeSource, CCeReg & CCeConsent. These offer users with a range of benefits designed to increase efficiency, cost-effectiveness, and patient-centricity.

In January 2019: PHARMASEAL launched Engility CTMS, the first product to be released from its Engility B2B platform. This strategy enabled company to expand its service offerings and increase its revenue from its sales.

In June 2018: Bioclinica launched eClinical solution namely the SMART Technology Suite. It is available with medical imaging, electronic data capture and interactive response technology combined. SMART allows plug-in functionality with Bioclinica site & patient payments, cardiac safety (ECG and ABPM), and clinical event adjudication, as well as third-party providers.

Components Covered:
Hardware
Software
Services

Delivery Modes Covered:
Cloud-Based (Software as a Service (SaaS))
Web-Based (On-Demand)
Licensed Enterprise (On-Premises)

Deployments Covered:
On-Site
Enterprise-Wide

Applications Covered:
Patient Management Solutions
Data Management Solutions
Site Management Solutions
Document Management Solutions

End Users Covered:
Healthcare Providers
Medical Device Manufacturers
Academic Research Centers
Contract Research Organizations (CROs)
Small & Mid-Sized Pharma-Biotech Companies
Large Pharma-Biotech Companies

Regions Covered:
North America
US
Canada
Mexico
Europe
Germany
UK
Italy
France
Spain
Rest of Europe
Asia Pacific
Japan
China
India
Australia
New Zealand
South Korea
Rest of Asia Pacific
South America
Argentina
Brazil
Chile
Rest of South America
Middle East & Africa
Saudi Arabia
UAE
Qatar
South Africa
Rest of Middle East & Africa

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2020, 2021, 2022, 2025, and 2028
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements

Free Customization Offerings:
All the customers of this report will be entitled to receive one of the following free customization options:
Company Profiling
Comprehensive profiling of additional market players (up to 3)
SWOT Analysis of key players (up to 3)
Regional Segmentation
Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
Competitive Benchmarking
Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances