Growing Chronic Diseases and Lifestyle-Related Disorders Boosts the Growth of Clinical Trial Management System Market
The growing prevalence of chronic diseases and lifestyle-related disorders is one of the major factors for the growth of CTMS market. Globally, chronic diseases kill more than 38 million people each year. It is primarily related to cardiovascular diseases, cancer, respiratory diseases, and diabetes. Consequently, this demands more new drugs, devices, and procedures to be developed and reach the market. Thus, increasing the demand for a large number of clinical trials in collaboration with universities and private companies in multiple regions. The surging demand for CTMS for proper management of clinical trials is driving the market.Other factors, such as a rise in the outsourcing of the clinical trials and implementation by contract research organization (CRO) and increasing number of hospital chains synchronizing the hospital information system (HIS) with CTMS are driving the market.
Concerns Related to Data Security Hinders the Growth of Clinical Trial Management System Market
The technological advancements are producing an enormous volume of information during the clinical trials, which poses a challenge in interpreting and using the data. This is resulting in an increased demand for clinical trial management systems. Moreover, along with the volume, the approachability of data is also increasing, which in turn increases the risk of privacy and confidentiality of the records. In the United States alone, 11 million cases of medical data security breaches were recorded in 2015. The medical data available in clinical trial databases can be used to forge fake documents, which can then be used to file insurance claims or illegally buy controlled drug substances. Since the pharmaceutical and life sciences organizations often use these sensitive personal health information during the clinical trials, they should make security a top priority to safeguard the medical data, in order to protect the general public and insurance companies against fraudulent claims and preserve the public’s trust in the life sciences industry. However, as of now, many organizations lack transparency in their data management practices, and in order to address the data security issues, several regulations have been established by government agencies. One such regulation established by the US FDA is the Part 11 of Title 21 of the Code of Federal Regulations (also known as, 21 CFR Part 11), which mandates life sciences organizations to implement several controls over their electronic signatures (ERES) and electronic records to ensure the authenticity, integrity, and confidentiality of clinical data. Furthermore, data security has remained a major restraint for the big pharmaceutical and biotechnology companies, due to which, the companies are reluctant in adopting the web- and cloud-based CTMS solutions, thereby restarting the market growth.
Market Segmentation Insights for the Clinical Trial Management System Market
By delivery mode, it is further segmented into web-based, on-premise and cloud-based clinical trial management system. Web-based has the largest share in the market as they are highly useful to store the sensitive data on the cloud and want all the encrypted data. A cloud-based clinical trial management system is growing rapidly with the highest CAGR of 14.99% in the forecast period.
By component, it is further segmented into software, hardware and services. Hardware has the highest share in the market which is 66% due to the technological innovations in hardware, like increasing usage of tablets and iPads have allowed for greater flexibility to clinical research teams, which can bring long-term savings in efficiency, and also provide users with a more intuitive way of working. The software has the highest CAGR in the component segment during the forecast period.
By end user, the market is segmented into pharmaceuticals, clinical research organization and others. Pharmaceuticals have the largest share in the market which is 59% as it is a customizable software system helps to manage the clinical trial data generated by pharmaceutical companies. It also maintains and manages the up to date clinical trial data starting from developing the research proposal to the preparation, conduct, and report generation. However, the emergence of technologically advanced forms of CTMS performs play a major role in the clinical trial management in the pharmaceutical industry and is expected to witness substantial growth, over forecast periods. However, the Clinical Research Organization (CRO) is rapidly growing with a CAGR of 14.67% in the future forecast.In the type of system, Licensed Enterprise-based Clinical Trial Management System is dominating the market due to the rising interest in application-based enterprise solutions and price discounts by leading market vendors.
North America to Dominate the Clinical Trial Management System Market
North America is expected to dominate this market in the forecast period due to favourable government initiatives, including support from government bodies such as NCI, FDA, and NIH. Moreover, raising awareness among people regarding diseases increases their participation in clinical trials. Asia-Pacific is also expected to grow tremendously during the forecast period owing to factors, such as huge, diverse patient pool, outsourcing of clinical trials to CROs, and rising healthcare facilities in the region.
Key Developments in the Market
- Jan 2018- ERT Clinical showcased Voice Assistant Data Capture Solution, which improved the patient data management in clinical trials through simplified patient data collection.
- Nov 2017- Bioclinica launched Bioclinica Clinical Adjudication enabling the independent adjudication of clinical events.
Reasons to Purchase the Report
- Current and future of clinical trial management market outlook in the developed and emerging markets
- Analysis of various perspectives of the market with the help of Porter’s five forces analysis
- The segment that is expected to dominate the market
- Regions that are expected to witness the fastest growth during the forecast period
- Identify the latest developments, market shares, and strategies employed by the major market players
- 3 months analyst support, along with the market estimate sheet (in Excel)
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1.1 Market Definition
2. Research Methodology
3. Executive Summary
4. Key Inferences
5. Clinical Trial Management System Market Overview
5.1 Current Market Scenario
5.2 Porter's Five Forces Analysis
5.2.1 Bargaining Power of Suppliers
5.2.2 Bargaining Power of Consumers
5.2.3 Threat of New Entrants
5.2.4 Threat of Substitute Products and Services
5.2.5 Competitive Rivalry within the Industry
6. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)
6.1 Clinical Trial Management System Market Drivers
6.1.1 Rising Incidences of Chronic Diseases and Lifestyle-Related Disorders
6.1.2 Rise in Outsourcing of Clinical Trials and Implementation by Contract Research Organizations
6.1.3 Synchronization of Hospital Information System (HIS) with CTMS
6.2 Clinical Trial Management System Market Restraints
6.2.1 Data Security Issues
6.2.2 High Cost Associated with CTMS
6.2.3 Lack of Qualified and Skilled Labor to Handle CTMS
6.3 Clinical Trial Management System Market Opportunities
6.4 Clinical Trial Management System Market Key Challenges
7. Market Segmentation
7.1 Clinical Trial Management System Market By Delivery Mode
7.1.1 Web-based Clinical Trial Management System
7.1.2 On-premise Clinical Trial Management System
7.1.3 Cloud-based Clinical Trial Management System
7.2 Clinical Trial Management System Market By Components
7.3 Clinical Trial Management System Market By End User
7.3.2 Clinical Research Organization
7.3.3 Healthcare Providers
7.4 Clinical Trial Management System Market By Type of System
7.4.1 Site-based Clinical Trial Management System
7.4.2 Licensed Enterprise-based Clinical Trial Management System
7.5 Clinical Trial Management System Market By Geography
7.5.1 North America
220.127.116.11 United States
18.104.22.168 Rest of North America
22.214.171.124 United Kingdom
126.96.36.199 Rest of Europe
188.8.131.52 South Korea
184.108.40.206 Rest of Asia-Pacific
7.5.4 Middle East & Africa
220.127.116.11 South Africa
18.104.22.168 Rest of the Middle East & Africa
7.5.5 South America
22.214.171.124 Rest of South America
8. Clinical Trial Management System Market Competitive Landscape
8.1 Mergers & Acquisition Analysis
8.2 Agreements, Collaborations, and Partnerships
8.3 New Products Launches
9. Clinical Trial Management System Market Major Players
9.2 Bio-Optronics, Inc.
9.3 DATATRAK International, Inc.
9.4 ERT Clinical
9.5 IBM Watson Health
9.6 Medidata Solutions, Inc.
9.7 MedNet Solutions, Inc.
9.8 Oracle Corporation
9.9 Parexel International Corporation
9.10 Sparta Systems, Inc.
*List not Exhaustive
10. Future of the Clinical Trial Management System Market
- Bio-Optronics, Inc.
- DATATRAK International, Inc.
- ERT Clinical
- IBM Watson Health
- Medidata Solutions, Inc.
- MedNet Solutions, Inc.
- Oracle Corporation
- Parexel International Corporation
- Sparta Systems, Inc.