Clinical Trial Management System Market Size Report | 2022-2030

Coverage: Clinical Trial Management System Market covers analysis By Type (Enterprise and On-Site); Delivery (Web-Hosted, Cloud-Based, and On-Premise) End-user (Pharmaceutical & Biotechnology companies, Medical Device companies, Contract Research Organizations [CROs] & Others) and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South & Central America)

  • Report Code : TIPHC00002241
  • Category : Healthcare IT
  • Status : Upcoming
  • No. of Pages : 150
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[Research Report] The Clinical Trial Management System Market size is expected to grow from US$ 1410.98 million in 2022 to US$ 2061.86 million by 2030; the market is estimated to register a CAGR of 12.56% from 2022 to 2030.

Analyst’s Viewpoint

The Clinical Trial Management System Market analysis entails market drivers, such as the rising number of novel chronic diseases and drug development activities, which have resulted in an increasing number of clinical trials. The increasing number of clinical trials, in turn, propels the demand for clinical trial management systems. However, the budget constraint is expected to hinder the growth of the market during the forecast period. Based on type, the market is segmented into enterprise and on-site; the software segment accounted for the largest market share in 2022. Further, the integration of CTMS with existing software is creating opportunities in the Clinical Trial Management System Market during 2023–2030. Based on type, the Clinical Trial Management System Market is segmented into Enterprise and On-Site. The Enterprise segment accounted for the largest market share in 2022 and is anticipated to grow with the highest CAGR.

Clinical trials are experiments conducted to ensure the safety and effectiveness of new treatments. Pharmaceutical, biotechnical, or medical device companies sponsor these trials to seek approval from the FDA or an international regulatory authority for their medication or device. Clinical Trial Management System (CTMS) is designed to track intuitively and logically structure information, enabling life science teams to monitor and report on clinical trial progress, make better-informed decisions, and provide the best quality data while ensuring patient safety.

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Clinical Trial Management System Market: Strategic Insights

Clinical Trial Management System Market

  • CAGR (2023 - 2031)
    12.56%
  • Market Size 2023
    US$ 1.59 Billion
  • Market Size 2031
    US$ 4.09 Billion

Market Dynamics

GROWTH DRIVERS
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FUTURE TRENDS
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OPPORTUNITIES
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Key Players

  • Oracle
  • Medidata Solutions Inc.
  • PAREXEL International Corporation.
  • MedNet Solutions, Inc.
  • Bioclinica
  • BioOptronics, Inc.
  • DATATRAK Int.
  • ERT Clinical
  • FORTE
  • ICON plc

Regional Overview

  • North America
  • Europe
  • Asia-Pacific
  • South and Central America
  • Middle East and Africa

Market Segmentation

Type
  • Enterprise and On-Site
Delivery
  • Web-Hosted
  • Cloud-Based
  • On-Premise End-user
Geography
  • North America
  • Europe
  • Asia-Pacific
  • Middle East & Africa
  • South & Central America
  • Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.

Market Insights

Increasing Number of Clinical Trials Propel Market Growth

Clinical trials are an important component of evidence-based medicine because they assist in determining how new medical treatments, diagnostics, or vaccines will perform. They frequently involve large groups of people to ensure that the new intervention is safe and effective. The trials are mainly carried out during drug development. 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. An increasing number of clinical trials for developing different effective treatments due to the rising prevalence of chronic diseases globally is fueling the growth of the clinical trials market. With bigger sample sizes, diversified patient demographics, and multiple study sites, clinical trials are becoming more complex. CTMS systems help to streamline trial operations, improve data management, and improve stakeholder cooperation. In addition, clinical studies create massive volumes of data that must be carefully collected, processed, and analyzed. CTMS platforms include data integration, real-time reporting, and data visualization features, allowing researchers and sponsors to make educated decisions and increase trial efficiency. Moreover, compliance with regulatory requirements is critical in the pharmaceutical sector, which is highly regulated. CTMS systems enhance compliance activities by providing tools for managing regulatory documentation, guaranteeing protocol adherence, and maintaining data integrity.

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.

Opportunities

Integration of CTMS with Existing Systems is Creating Opportunities for CTMS Market

CTMS systems that seamlessly integrate with EHR systems can better manage patient data throughout clinical trials. Integrating electronic medical record (EMR) software with clinical trial software is seen as the logical next step in data processing, following the introduction of electronic data capture (EDC) technology that replaced paper. This integration would enable more accurate and efficient clinical trial data collection, particularly in multi-site trials. According to an article published by BMC 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).

In October 2022, RealTime Software Solutions, LLC collaborated with Aspen Insights to incorporate world-class EMR/EHR patient identification technologies into RealTime's world-class 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.

Report Segmentation and Scope

Type-Based Insights

Based on type, the clinical trial management system market is segmented into enterprise CTMS and on-site CTMS. The enterprise segment held the largest market share in 2022; it is anticipated to register the highest CAGR during 2022–2030. The enterprise CTMS is a complete clinical research management system for mid-to large-sized organizations with demanding requirements. The segment is growing due to technological advancements in the healthcare sector and growing product launches by the leading market players in the CTMS market.

In October 2022, Veeva Vault CTMS, launched by Veeva Systems, was chosen by 40 Contract Research Organizations (CROs), including four of the top six global CROs, to ensure faster and more efficient clinical trials. Vault CTMS is an enterprise trial management system that has been selected by more than 120 sponsors, including 9 of the top 20 pharmaceutical companies.

Delivery-Based Insights

Based on delivery, the clinical trial management system market is segmented into web-hosted, cloud-based, and on-premise. The web-hosted segment held the largest market share in 2022 owing to its benefits, including improved clinical trial quality and efficiency, better time management, and ease of access. The cloud-based segment is anticipated to register the highest CAGR during 2022–2030 owing to the various product launches by leading market players. In December 2021, SureClinical, a leading provider of cloud-native eClinical applications, announced the launch of their new Clinical Ecosystem (ECO) Applications and Platform Bundle. The ECO Bundle is specifically designed to cater to the unique needs of Clinical Research Organizations. It connects people, programs, projects, and processes across the board for a seamless view of clinical data. The ECO Bundle centralizes clinical intelligence and reporting across multiple applications, data points, and systems, thus enabling distributed clinical research teams to collaborate within a single, modern, and easy-to-use application experience.

End User-Based Insights

In terms of end-users, the clinical trial management system market is classified into pharmaceutical and biotechnology companies, medical device companies, CROs, and others. The pharmaceutical and biotechnological companies segment held the largest share of the market in 2022, and the CROs segment is anticipated to register the highest CAGR during 2022–2030 owing to the shift of clinical trial studies to the CROs as the life science sector is actively involved in outsourcing the drug development and clinical trial studies to CROs. CROs assist in successfully implementing clinical trials through the services offered using high-quality facilities and deep subject matter expertise. CROs have begun acting as a backbone of the clinical trial industry through their efficient and cost-effective operations benefitting trial sponsors. According to the blog published on Thermo Fisher Scientific, in 2022, ~3 out of 4 clinical trials were carried out by CROs to reassure the clinical programs of drug developers, provide a wealth of expertise, drive time and cost efficiencies, and deliver customized, high-quality data. Thus, the development of cost-effective solutions and decreasing errors in CROs during the drug development process are driving the clinical trials market growth.

Regional Analysis

The North American clinical trial management system market is segmented into the US, Canada, and Mexico. The market growth is attributed to the increasing number of clinical trials due to ongoing drug development studies. The US has emerged as a leading clinical research destination. Nearly half of the total clinical trials are conducted in the US. Additionally, most pharma research companies prefer to perform clinical trials in the US owing to established medical infrastructure, fast approval timelines, a favorable regulatory framework, and accepted clinical trial-generated data globally. A World Health Organization (WHO) report states that the US registered the highest number of clinical trials (157,618) in 2021. Further, the Asia-Pacific region is expected to grow with the highest CAGR during 2022-2030. 

The report profiles leading players operating in the global clinical trial management system market. These include Advarra Inc., Clario, Deloitte Touche Tohmatsu Limited, IBM Corporation, Medideta Solution Inc., Mednet Solution Inc., Oracle Corporation, PAREXEL International Corporation, Thermo Fisher Scientific, Inc., and Veeva System Inc. These players focus on expanding and diversifying their market presence and acquiring a novel customer base, tapping prevailing business opportunities in the clinical trial management system market.

A few of the examples of recent developments in the clinical trial management system market are mentioned below:

  • In September 2023, Zelta partnered with BSI Life Sciences, which is an important move towards creating a seamless experience for CROs and sponsors in accessing and integrating their data throughout the clinical trial process. The CTMS and eTMF capabilities offer comprehensive functionalities for every aspect of a clinical trial, from study setup to closeout. These capabilities include management and monitoring of sites and investigators, fully integrated trial master files (eTMF), and trial supply management, making them accessible and suitable for clinical trials worldwide.
  • In April 2022, Bristol Myers Squibb implemented Veeva Vault CTMS globally, replacing a heritage Celgene CTMS and a heritage Bristol Myers Squibb CTMS. Veeva Vault CTMS is now tightly integrated with Veeva’s eTMF and Study Startup applications. By implementing Veeva’s industry-leading trial management and monitoring solution companywide, Bristol Myers Squibb aims to simplify trial processes, making clinical trials faster and more efficient. This unified and agile solution is expected to drive end-to-end trial management.
  • In February 2021, eClinical Solutions LLC, a global provider of cloud-based enterprise software and software-driven clinical data services, launched the Elluminate Clinical Trial Management System (CTMS). The Elluminate platform accelerates digitization and reduces clinical data review cycle times. The introduction of Elluminate CTMS facilitated faster and more informed decision-making.

Clinical Trial Management System Market Report Scope

Report Attribute Details
Market size in 2023 US$ 1.59 Billion
Market Size by 2031 US$ 4.09 Billion
Global CAGR (2023 - 2031) 12.56%
Historical Data 2021-2022
Forecast period 2024-2031
Segments Covered By Type
  • Enterprise and On-Site
By Delivery
  • Web-Hosted
  • Cloud-Based
  • On-Premise End-user
By Geography
  • North America
  • Europe
  • Asia-Pacific
  • Middle East & Africa
  • South & Central America
Regions and Countries Covered North America
  • US
  • Canada
  • Mexico
Europe
  • UK
  • Germany
  • France
  • Russia
  • Italy
  • Rest of Europe
Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
South and Central America
  • Brazil
  • Argentina
  • Rest of South and Central America
Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa
Market leaders and key company profiles
  • Oracle
  • Medidata Solutions Inc.
  • PAREXEL International Corporation.
  • MedNet Solutions, Inc.
  • Bioclinica
  • BioOptronics, Inc.
  • DATATRAK Int.
  • ERT Clinical
  • FORTE
  • ICON plc
    • Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
    Report Coverage
    Report Coverage

    Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

    Segment Covered
    Segment Covered

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    to segments covered.

    Regional Scope
    Regional Scope

    North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

    Country Scope
    Country Scope

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    to country scope.

    The List of Companies

    1. Oracle
    2. Medidata Solutions Inc.
    3. PAREXEL International Corporation.
    4. MedNet Solutions, Inc.
    5. Bioclinica
    6. BioOptronics, Inc.
    7. DATATRAK Int.
    8. ERT Clinical
    9. FORTE
    10. ICON plc

    The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

    1. Data Collection and Secondary Research:

    As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

    Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

    1. Primary Research:

    The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

    For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

    A typical research interview fulfils the following functions:

    • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
    • Validates and strengthens in-house secondary research findings
    • Develops the analysis team’s expertise and market understanding

    Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

    • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
    • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

    Below is the breakup of our primary respondents by company, designation, and region:

    Research Methodology

    Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

    1. Data Analysis:

    Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

    • 3.1 Macro-Economic Factor Analysis:

    We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

    • 3.2 Country Level Data:

    Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

    • 3.3 Company Profile:

    The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

    • 3.4 Developing Base Number:

    Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

    1. Data Triangulation and Final Review:

    The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

    We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

    We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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