Clinical trial is a medical research study performed on humans to check the safety and efficacy of drugs, devices and therapeutic products before they are finally launched in the market. Proper management of clinical trials has become a priority for hospitals, pharmaceutical companies and clinical research organizations (CRO).Clinical trial management system (CTMS) is a software solution for proper management, storage and analysis of drugs associated clinical data. CTMS is primarily employed to manage the large amount of data involved in a clinical trial including planning, preparation and reporting. CTMS also provides data to a business intelligence system. It provides a user-friendly infrastructure that enables clinicians to manage trials of varying complexity.
North America is a traditional clinical trial region. The percentage share of global clinical trials conducted in North America has reduced. This was due to regulatory and legal considerations, which shifted the clinical trial market from North America to developing countries such as India and China. Countries in Central and Eastern Europe provide abundant opportunities to life science companies for clinical development. Similarly, improved industry regulatory laws and patent expiration laws in various countries including Japan, China and India, have led to the expansion of the clinical trials market in Asia, which has lower cost of conducting clinical trials compared to Europe or the U.S.
Increasing R&D investment in pharmaceuticals, life science and clinical research industries, rising prevalence of diseases and increased clinical research outsourcing are key growth drivers for the CTMS market. In addition, integration of CTMS with a Hospital Information System (HIS) provides more accurate and time saving documentation over paper based information systems. On the other hand, long approval time for clinical trials and difficulties related to recruiting and enrolling patients for clinical trials are some of the major concerns for the industry. Approval from Institutional Review Board (IRB), contract and budget negotiation and approval, availability of appropriate patient population and protocol design and legal review are major factors that delay a drug approval process. Similarly, increasing regulatory requirements in many countries has resulted in increased complexity for clinical trial protocols.
This report provides an in-depth analysis of estimation of the CTMS market for the period 2013-2019, considering 2013 as the base year for calculation. In addition, data pertaining to current market dynamics including market drivers, restraints, trends and recent developments has been provided in the report. The CTMS market is categorized on the basis of type of CTMS, end users, components, mode of delivery and geography. Based on mode of delivery, the CTMS market comprises on-premise CTMS, Web based CTMS and cloud based CTMS. The end user market comprises pharmaceuticals, clinical research organizations and healthcare providers.
In the geographical analysis, the report identifies and analyses market size and forecast of North America, Europe, Asia and Rest of the World (RoW). North America is further segmented into the U.S. and rest of North America. Similarly, Europe is further segmented into Germany, France and Poland. Asia is further segmented into South Korea and China. Some of the major players in the CTMS market are Oracle Corporation, Bio-Optronics, MedNet Solutions, PAREXEL International Corporation, Medidata Solutions and BioClinica. These key market players have been profiled on the basis of attributes such as company overview, recent developments, growth strategies, sustainability and financial overview.
Clinical trials, which are used for testing the efficacy and safety of a medical devices, drug, of any other therapeutic product, are currently on the rise. The global clinical trial management system market was valued at US$ 0.8 Bn in 2013, which is expected to reach US$ 1.8 Bn by 2019 end. The global clinical trial management system market will witness an impressive CAGR of 14.0% over the six-year forecast period 2013-2019.
Key Market Dynamics
As hospitals, pharmaceutical companies, and clinical research centers invest a lot of efforts in managing clinical trials and the data generated post-clinical trials, the demand for CTMS is likely to propel for the ease of information management. This data is related to planning, development, and reporting of clinical trials, resulting in major consumption by hospitals and clinical research agencies.
Increasing prevalence of chronic diseases will spur the demand for effective and efficient management of data, documentation, and hospital information within medical organizations. This is expected to be a key factor favoring the growth of the CTMS market. The increasing number healthcare service providers and exploding number of healthcare end-users will further accelerate CTMS adoption in market. High accuracy of the information provided by clinical trial management systems is foreseen to be a major driver to market growth.
However, lengthy approvals, and stringency in patient recruitment and enrollment will remain the key challenges. In addition, the Institutional Review Board (IRB) approval, contract and budget negotiation and approval, availability of appropriate patient population, and protocol design and legal review will also be the challenging factors inhibiting the market growth. Strict regulations in various countries leading to complex clinical trial protocols will also continue to restrain the market growth by 2019 end.
The global clinical trial management system market is segmented on the basis of type, component, mode of delivery, and end-user.
By mode of delivery, the global clinical trial management system market is segmented into web-based, cloud-based, and on-premise clinical trial management systems. Web-based sub-segment will represent a major market, expanding at a robust CAGR of 15.0%.
Based on component, software sub-segment will attain a value of US$ 1.27 Bn by the end of the forecast period. The estimated CAGR for this segment is of 13.9%, which is higher than that of the other two sub-segments, including hardware and services.
Pharmaceutical industry is the largest end-user of clinical trial management systems and CROs sub-segment is expected to register the fastest CAGR throughout the forecast period.
On the basis of regional analysis, the global CTMS market is classified into four key segments, including North America, Europe, Asia-Pacific, and RoW.
North America will remain a dominant segment and expand at a CAGR of nearly 13.6%. This regional market was valued at US$ 0.5 Bn in 2013 and is predicted to reach US$ 1.1 Bn by 2019 end. However, the revenue share percentage may decline due to increasing share of the Asian market.
As the clinical trial market has gradually been shifting to Asia Pacific due to several legal and regulatory measures, and patent expiration laws. China and India are especially expected to grow into lucrative markets for clinical trial management systems.
The European market will also reflect significant growth. Some countries in the Central and Eastern Europe will provide abundant opportunities for clinical development.
Key Market Players
Oracle Corporation, Merge Healthcare Incorporated, Medidata Solutions Inc., PAREXEL International Corporation, BioClinica, MedNet Solutions, Inc., Bio-Optronics, Inc., DSG, Inc., eClinForce, Inc., and Forte Research Systems, Inc. are a few of the prominent players competing in the global CTMS market.