Product (CDMS/EDC Solutions, CTMS Solutions, eCOA Solutions, RTMS Solutions, Safety Solutions, Analytics and Reporting Platforms, Integration Platforms, eTMF, Others); Delivery Mode (Web-based (on-demand) Model, Licensed enterprise (on-premise) Model, Cloud-based (SAAS) Model); Clinical Trial Phase (Phase I, Phase II, Phase III, Phase IV); End-User (Pharmaceutical and Biopharmaceutical Companies, Contract Research Organizations, Consulting Service Companies, Medical Device Manufacturers, Hospitals, Academic Research Institutions); Regions/Country
E-Clinical Solutions Market is expected to exceed the market valuation of more than US$ XX billion in 2027 and is expected to grow at a significant CAGR of XX% during the forecast period (2021-2027). eClinical platform vendors bundle applications and services into a single, integrated solution for running clinical trials. Life science CIOs are seeking to improve trial speed, quality and resource use should use this research as a planning for e-clinical platform adoption. eClinical platforms reduce IT infrastructure costs, let companies manage the burgeoning stream of data from both sites and mobile devices, maintain compliance with changing safety regulations, and incorporate the technologies clinical researchers and sponsors need, more quickly and easily. This increased speed, flexibility and cost reduction is vital to meeting new expectations in clinical development. Additionally, a SaaS-based, eClinical platform enables the industry to address today’s clinical needs, while being ready to adapt to new developments and innovation.
Key reasons for the growth of the eClinical Solutions Market include the costs and risks that are associated with the development of new therapeutics, which are majorly related to drug trials, which continue to rise. This trend is expected to gain momentum with the advent of personalized medicines and the proliferation of virtual pharma companies, emerging as entities without the traditional large-scale pharma capabilities. With increasing prevalence of the Internet of Things (IoT) and digitalization of healthcare, the amount of data that is produced is enormous and contains information, which can easily be accessed with electronic data mining that was impossible with paper records earlier. According to the 2019 records of the World Economic Forum, hospitals produce around 50 petabytes of data per year. The information encompasses a variety of areas like clinical notes, medical images, lab tests, genomics, sensor readings, and operational and financial data. eClinical Solutions are expected to have an impact on all these areas. Additionally, in low and middle-income countries, healthcare infrastructure faces many challenges that provide high quality, affordable and universally accessible care. In response, policy makers, donors and program implementers are searching for innovative approaches to eliminate the geographical and financial barriers to healthcare. Furthermore, the need to maintain transparency and eliminate redundancy and forgery of medical research related data are the primary reasons for the widespread adoption of eClinical Solutions in the market.
All-in-One eClinical Platforms
Oracle Corporation, Medidata Solutions, Inc., Parexel International Corporation, BioClinica, Inc., Signant Health, Datatrak International, Inc., ERT, eClinical Solutions, Inc., MaxisIT Inc., and Bio-Optronics, Inc. are some of the prominent players operating in the EClinical Solutions market. Several M&As along with partnerships have been undertaken by these players to facilitate customers with hi-tech and innovative products/technologies.
Insights Presented in the Report
“Amongst Product, CTMS segment holds the major share”
Based on Product, the eClinical Solutions Market is segmented into CDMS/EDC Solutions, CTMS Solutions, eCOA Solutions, RTMS Solutions, Safety Solutions, Analytics and Reporting Platforms, Integration Platforms, eTMF, and Others. CTMS is the clinical trial management system which is the essential set of tools to effectively plan, manage and track your clinical study portfolio. It is a specialized, comprehensive project management application that takes the study team from startup, through enrollment and monitoring, to study close. In recent years, clinical trials have become even more intricate as R&D costs have increased to an average of $1.4 billion USD per clinical trial.
“Amongst Delivery Mode, Cloud Based (SAAS) Model Segment holds the major share”
Based on Delivery Mode, the eClinical Solutions Market is segmented into Web-based (on-demand) Model, Licensed enterprise (on-premise) Model, and Cloud-based (saas) Model. In 2018, technology giant Oracle launched a new holistic, unified cloud-based eClinical solution which was intended to bring new drugs to the market in a timely manner, while maintaining quality and safety. The new “Clinical One Platform” will unify clinical development operations and information in a single environment with shared functions and an easy-to-use interface for sites, clinical coordinators and their counterparts. The holistic, unified cloud solution is being built from the ground to address the needs of the entire drug development lifecycle –everyone and every process required to get a drug to the market.
“Amongst Clinical Trial Phase, Phase III segment holds the major share”
Based on Clinical Trial Phase, the eClinical Solutions Market is segmented into Phase I, Phase II, Phase III, and Phase IV. The need for clinical data management software to curb overall cost and improve process efficiency is contributing to the growth of the segment. Increased number of drugs successfully reaching phase III is providing a significant push to the growth of the segment. Phase III involves the study of the efficacy of a drug by using a group of more than 1,000 patients. The complexity of the study increases with an increase in the number of patients, which triggers the demand for computer based systems for data management, thereby revving up the adoption of eClinical solutions.
“Amongst End-User, Contract Research Organizations segment holds the major share”
Based on End-User, the eClinical Solutions Market is segmented into Pharmaceutical and Biopharmaceutical Companies, Contract Research Organizations, Consulting Service Companies, Medical Device Manufacturers, Hospitals, and Academic Research Institutions. According to Research a 7.4% compound annual growth rate is predicted for the CRO market through 2019 and a market penetration rate of 72% by 2020. This growth is due to the growing demand for outsourcing clinical trial to various CROs to maximize the R&D expenses by Pharma and Biotech companies. Furthermore, electronic data capture (EDC) and clinical data management system (CTMS) which is the most prominent eClinical solution adopted by various CROs companies will fuel the market growth.
“North America represents one of the largest markets of eClinical Solutions market”
For a better understanding of the market dynamics of the eClinical Solutions market, a detailed analysis was conducted for different regions across India including North America (US, Canada, Rest of North America), Europe (Germany, UK, France, Spain, Italy, Rest of Europe), Asia-Pacific (China, Japan, India, Australia, Rest of Asia-Pacific), Rest of World. North America dominated the market and grabbed around XX% market share owing to increasing aging population in the region.
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Analyzing the historical market, estimation of the current market, and forecasting the future market of the eClinical Solutions market were the three major steps undertaken to create and analyze the adoption of eClinical Solutions in major regions globally. Exhaustive secondary research was conducted to collect the historical market numbers and estimate the current market size. Secondly, to validate these insights, numerous findings and assumptions were taken into consideration. Moreover, exhaustive primary interviews were also conducted, with industry experts across the value chain of the eClinical Solutions market. Post assumption and validation of market numbers through primary interviews, we employed a top-down/bottom-up approach to forecasting the complete market size. Thereafter, market breakdown and data triangulation methods were adopted to estimate and analyze the market size of segments and sub-segments the industry pertains to. Detailed methodology is explained below:
Analysis of Historical Market Size
Step 1: In-Depth Study of Secondary Sources:
Detail secondary study was conducted to obtain the historical market size of the eClinical Solutions through company internal sources such as annual report & financial statements, performance presentations, press releases, etc., and external sources including journals, news & articles, government publications, competitor publications, sector reports, third-party database, and other credible publications.
Step 2: Market Segmentation:
After obtaining the historical market size of the eClinical Solutions market, we conducted a detailed secondary analysis to gather historical market insights and share for different segments & sub-segments for major regions. Major segments included in the report as Product, Delivery Mode, Clinical Trial Phase, and End-User. Further country-level analyses were conducted to evaluate the overall adoption of eClinical Solutions in that region.
Step 3: Factor Analysis:
After acquiring the historical market size of different segments and sub-segments, we conducted a detailed factor analysis to estimate the current market size of eClinical Solutions. Further, we conducted factor analysis using dependent and independent variables such as increased prevalence of chronic diseases and the need for more remote healthcare access. A thorough analysis was conducted for demand and supply-side scenarios considering top partnerships, merger and acquisition, business expansion, and product launches in the eClinical Solutions sector across the globe.
Current Market Size Estimate & Forecast
Current Market Sizing: Based on actionable insights from the above 3 steps, we arrived at the current market size, key players in the eClinical Solutions market, and market shares of the segments. All the required percentage shares split, and market breakdowns were determined using the above-mentioned secondary approach and were verified through primary interviews.
Estimation & Forecasting: For market estimation and forecast, weights were assigned to different factors including drivers & trends, restraints, and opportunities available for the stakeholders. After analyzing these factors, relevant forecasting techniques i.e., top-down/bottom-up approach was applied to arrive at the market forecast about 2027 for different segments and sub segments across the major markets globally. The research methodology adopted to estimate the market size encompasses:
Market Size and Share Validation
Primary Research: In-depth interviews were conducted with the Key Opinion Leaders (KOLs) including Top Level Executives (CXO/VPs, Sales Head, Marketing Head, Operational Head, and Regional Head, Country Head, etc.) across major regions. Primary research findings were then summarized, and statistical analysis was performed to prove the stated hypothesis. Inputs from primary research were consolidated with secondary findings, hence turning information into actionable insights.
Split of Primary Participants in Different Regions
Market Engineering
Data triangulation technique was employed to complete the overall market estimation and to arrive at precise statistical numbers of each segment and sub-segment of the eClinical Solutions market. Data was split into several segments & sub-segments post studying various parameters and trends in the areas of type and their type of the EClinical Solutions market.
The main objective of the eClinical Solutions Market Study
The current & future market trends of eClinical Solutions were pinpointed in the study. Investors can gain strategic insights to base their discretion for investments from the qualitative and quantitative analysis performed in the study. Current and future market trends were determined the overall attractiveness of the market at a regional level, providing a platform for the industrial participant to exploit the untapped market to benefit as a first-mover advantage. Other quantitative goals of the studies include:
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