e-clinical Trial Solutions Market to 2018

Transcription

1 e-clinical Trial Solutions Market to 2018 Growing Complexity of Clinical Trials and Increased Focus on Accuracy and Efficiency Drive Trial Sponsors to Adopt Novel Technologies

2 GBI Research Report Guidance GBI Research Report Guidance The report discusses the eclinical trial solutions market. It includes an executive summary that captures the key takeaways from the report. Chapter three provides an overview of the eclinial trial solutions and its different segments based on their functionality: Clinical Trial Management System, Electronic Data Capture, Electronic Patient Report Outcome and Interactive Voice Response System market. Chapter four gives an overview of the market characteristics, market size, market forecast, key players in the different segments, drivers, challenges and trends. Chapter five describes the technology trends and business models adopted by various companies for clinical data management. Chapter six highlights competitive benchmarking on the basis of solutions offered for eclinical trials. Page 2

3 eclinical Trial Solutions Market: Executive Summary The major challenges that eclinical solutions decipher are functionality, security, features, compliance and price. Executive Summary GBI Research finds that eclinical trial solutions are now widely adopted by pharmaceutical companies and Clinical Research Organizations (CROs) around the world, because of the advantages gained by introducing the technology into the market. The market has seen huge progress over the years, and various drivers are pushing the market towards growth. eclinical Trial Solutions are Witnessing Increased Innovation, with Companies Shifting Towards Allocating Special Budgets to Increase their Annual Savings The growing complexity of clinical trials and an increased focus on accuracy and costs have brought several eclinical technologies into the market over the years. These include Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Electronic Patient Reported Outcomes (epros), Radio Frequency Identification Tags (RFIDs) and ediaries. The eclinical trial market is witnessing increasing innovation, as companies are shifting towards allocating special budgets to spend on technologies that would help improve regulatory compliance and increase annual savings. The major challenges that eclinical solutions address are functionality, security, features, compliance and price. Electronic Data Capture to Witness Huge Growth in the Next Five Years; EDC Vendors to Focus on More Complex Issues to Meet Industry Expectations EDC is currently the most commonly used method in clinical trials for capturing data electronically, in place of paper-based methods. Although many companies were initially reluctant to adapt to EDC, the trend has changed and they are now ready to incorporate this new technology. With the increase in demand, EDC vendors are willing to spend more time focusing on the high value topics of site management, query management and data integration. The market will witness huge growth over the next five years. eclinical Trial Solutions Market, Global, EDC System - Cost Saving Scenario, 2012 EDC for a Clinical Trial Data QA The cost is as high as $XX/page. Cost Elimination for XX pages and XX patients = $XX Multi Center Study XX Sites Number of Patients - XX CRF s - XX Double Key Data Entry The cost is as high as $XX/page x XX. Cost Elimination for XX pages and XX patients = $XX Printing the CRF The cost is as high as $XX/book. Cost Elimination for XX patients = $XX + Shipping resources + Direct Shipping Cost Monitoring One of travel + One day of monitoring + Travel cost is $XX/site Cost Elimination for XX sites = $ XX Query Management Estimated in-house cost of query management is $XX/query Cost Elimination on XX% reduction in Queries = $ XX Net Savings = $XX Source: GBI Research, Contemporary Clinical Trials Journal, PLoS One Journal, Journal of Medical Internet Research Page 3

4 Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures eclinical Trial Solutions Market - Introduction Introduction to eclinical Trial Solutions Need for eclinical Trial Solutions Technological Overview eclinical Trial Solutions Market - Overview of eclinical Trials Clinical Trial Planning Clinical Trial Project Planning Pain Points in Clinical Trial Project Planning Clinical Trial Supply Chain Planning Pain Points in Clinical Trial Supply Chain Management Planning Issues Manufacturing Issues Distribution Issues Visibility Issues Clinical Data Capture Pain Points in Data Capturing Issues with Paper-Based Data Collection Issues with Paper-Based Diaries Issues with Paper-Based Data Management Clinical Data Management Pain Points in Clinical Data Management Clinical Data Analysis and Reporting Pain Points in Clinical Data Analysis and Reporting Overview of eclinical Trial Solutions Clinical Trial Management Systems (CTMS) Benefits of Clinical Trial Management Systems Electronic Data Capture (EDC) Cost Saving Scenario in EDC Cost Saving Scenario for Phase I and Phase II Trials SaaS-based EDC Electronic Patient Report Outcome System (epro) Cost Saving Scenario with ediaries epro Adoption Rates Interactive Voice Response Systems (IVRS) Clinical Data Management Systems (CDMS) Clinical Trial Supply Chain Management System eclinical Trial Solutions Market - Market Characterization Market Size and Forecasts for eclinical Trial Solutions Clinical Trial Management System Market Key Players in the CTMS Market Electronic Data Capture Market Key Players in the EDC Market epro Market Key Players in the epro Market IVRS Market Key Players in the IVRS Market Emerging Trend of Virtual Clinical Trials...42 Page 5

5 Table of Contents 4.2 Market Drivers Cutting Down Clinical Trial Costs is the Driving Motivation for the Adoption of eclinical Trial Solutions Improved Data Standardization Increases Adoption of IT Solutions Adaptive Clinical Trials are Preferred by Large Biopharmaceutical Companies Increasing Phase III and Phase II Trials Escalates eclinical Solution Adoption Expansion of Indication for the Existing Drugs is a New Market Opportunity Market Challenges The Traditional Approaching Activities of Pharmaceutical Companies Towards eclinical Trial Solutions Lack of Standardization of Data Collection Methods Might Limit the Value of eclinical Trial Technologies The Need for Improvisation of Solutions Market Trends Clinical Trial Spending is Increasing at a Faster Rate R&D Spending is High in the US Phase II Spending is Highest in the US and Europe Market Potential for eclinical Solutions by Phases (US and Europe) is Largely from Phase III Electronic Data Capture will Witness the Highest Investment for the Next Five Years Adoption Trends eclinical Trial Solutions Market - Technology Trends Business Models Outsourcing of Clinical Data Management Individual Project Outsourcing Model Full Time Equivalent Model Functional Service Provider Model The Need for Outsourcing Recent Developments in CDISC Standards SDTM ADaM ODM LAB CRT-DDS Protocol standard CDISC Sponsored Studies Save Time and Costs eclinical Trial Solutions Market: Competetive Landscape Competitive Benchmarking by Solution Offerings eclinical Trial Solutions Market - Appendix Market Definitions Abbreviations Bibliography Research Methodology Coverage Secondary Research Primary Research Expert Panel Validation Contact Us Disclaimer...70 Page 6

6 Table of Contents 1.1 List of Tables Table 1: eclinical Trial Solutions Market, Global, Phase I-II Cost Saving Scenario by Adopting EDC, Table 2: eclinical Trial Solutions Market, Global, Data Management Set Up Cost in India, Table 3: eclinical Trial Solutions Market, Global, CDISC Sponsored Studies, Table 4: eclinical Trial Solutions Market, Global, Competitive Benchmarking by Solutions Offering, List of Figures Figure 1: eclinical Trial Solutions Market, Global, Segmentation by Activities, Figure 2: eclinical Trial Solutions Market, Global, Supply Chain in Clinical Trials, Figure 3: eclinical Trial Solutions Market, Global, Paper CRF Method of Data Capturing, Figure 4: eclinical Trial Solutions Market, Global, Typical Clinical Trial Management System, Figure 5: eclinical Trial Solutions Market, Global, Electronic Data Capture Through e-crf, Figure 6: eclinical Trial Solutions Market, Global, EDC System - Cost Saving Scenario, Figure 7: eclinical Trial Solutions Market, Global, Data Quality Gap, Figure 8: eclinical Trial Solutions Market, Global, SaaS-based EDC System, Figure 9: eclinical Trial Solutions Market, Global, Cost Saving Scenario of epro Solutions, Figure 10: eclinical Trial Solutions Market, Global, Case Study of epro Solutions, Figure 11: eclinical Trial Solutions Market, Global, Case Study of epro Solutions, Figure 12: eclinical Trial Solutions Market, Global, Clinical Data Management Flow, Figure 13: eclinical Trial Solutions Market, Global, Clinical Trial Supply Chain Management System, Figure 14: eclinical Trial Solutions Market, Global, Clinical Trial Management System Market ($m), Figure 15: eclinical Trial Solutions Market, Global, Electronic Data Capture Market ($m), Figure 16: eclinical Trial Solutions Market, Global, Electronic Patient Reported Outcomes Market ($m), Figure 17: eclinical Trial Solutions Market, Global, Interactive Voice Response System Market ($m), Figure 18: eclinical Trial Solutions Market, Global, Cutting Down Clinical Trial Cost is a High Priority Task for Pharmaceutical Companies - Impact Analysis, Figure 19: eclinical Trial Solutions Market, Global, Research and Development Spending Split by Phases - Impact Analysis, Figure 20: eclinical Trial Solutions Market, Global, Adaptive Clinical Trials are Preferred by Large Biopharmaceutical Companies - Impact Analysis, Figure 21: eclinical Trial Solutions Market, Global, Increasing Phase III and Phase II Trials Escalates eclinical Solution Adoption - Impact Analysis, Figure 22: eclinical Trial Solutions Market, Global, Increasing Phase III and Phase II Trials Escalates eclinical Solution Adoption - Impact Analysis, Figure 23: eclinical Trial Solutions Market, Global, the Need for Improvisation of Solutions - Impact Analysis, Figure 24: eclinical Trial Solutions Market, Global, Research and Development Spending Split by Phases - Impact Analysis (%), Figure 25: eclinical Trial Solutions Market, Global, Spending on Research and Development in the US and Europe, Figure 26: eclinical Trial Solutions Market, Global, Value of Spending in R&D by Clinical Trial Phases, Figure 27: eclinical Trial Solutions Market, Global, Market Potential for eclinical Trial Solutions, Figure 28: eclinical Trial Solutions Market, Global, Investment Trends in Future eclinical Trial Solutions, Figure 29: eclinical Trial Solutions Market, Global, CTMS - Technology Adoption, Figure 30: eclinical Trial Solutions Market, Global, Investigator Portal - Technology Adoption, Figure 31: eclinical Trial Solutions Market, Global, System Integration - Technology Adoption, Figure 32: eclinical Trial Solutions Market, Global, epro Solutions - Technology Adoption, Figure 33: eclinical Trial Solutions Market, Global, IVRS Solutions - Technology Adoption, Figure 34: eclinical Trial Solutions Market, Global, Factors Impacting Clinical Data Management Outsourcing Page 7

7 Table of Contents Figure 35: eclinical Trial Solutions Market, Global, End-to-End Services Offered by Large IT Vendors, Figure 36: eclinical Trial Solutions Market, Global, Supply Chain in Clinical Trials, Page 8

8 eclinical Trial Solutions Market: Introduction 2 eclinical Trial Solutions Market - Introduction 2.1 Introduction to eclinical Trial Solutions The term eclinical is used to encompass the shift in clinical studies to electronic computer-assisted capture and management methodologies, to increase efficiencies and quality by replacing manual and paper-based systems. The eclinical universe includes electronic data capture (EDC), clinical data management systems (CDMS), clinical trial management systems (CTMS), interactive voice response systems (IVRS), and patient reported outcomes (PRO), amongst others. With increased levels of outsourcing, the drug development process has become globalized, bringing about a transformation in the clinical trial industry. eclinical trial solutions are technologies that are utilized by the pharmaceutical industry to reduce drug development costs, whilst optimizing and speeding up the clinical trial process. eclinical trial solutions are now widely adopted by pharmaceutical companies and clinical research organizations (CRO) around the world, because of the aforementioned advantages gained by introducing the technology into the market. Various drivers push this market forward. The market for eclinical trials has evolved over the years. There has been enormous innovation and change in the past few years, and it has become an individual market segment where many companies have started providing solutions and services to pharmaceutical companies and CROs Need for eclinical Trial Solutions In order to reduce costs and accelerate the clinical trial process, eclinical trial solutions came into existence. A wide variety of technological options have entered the market to serve the clinical trials industry. In line with this, the complexity and volume of clinical trial data continues to grow. Meanwhile, stringent regulatory requirements for safety and efficacy demand that much attention be placed on various processes like gathering, organizing and analyzing the clinical trial data in the most innovative, fast and efficient manner. IT has taken up all these challenges to build robust solutions which transform the way clinical trials are conducted by the pharmaceutical industry The Changing Face of R&D Over the last few years, R&D has experienced various changes. With pharmaceutical companies experiencing declining productivity, increased spending on new drug development, large post-approval studies and increased regulatory demands, companies are making huge progress in addressing these challenges. Their primary objective is to improve trial efficiency, reduce clinical trial costs and increase productivity of trial participants. While R&D has always remained an integral and fundamental function of the pharmaceutical industry, its declining productivity has raised alarm among the key stakeholders of the industry. One of the simplest yet most important indicators of the declining Return on Investment (ROI) has been the widening gap between the R&D expenditure and the number of new drug approvals, especially since The pharmaceutical industry is also facing a severe shortage in the R&D pipeline, as the number of new products (and therefore blockbusters) in the pipeline has reduced. In the current pipeline status of pharmaceutical companies, XX% of the entire late-stage pipeline is made up of Lifecycle Management (LCM) projects. In the pharmaceutical pipeline of the top 20 companies, 28% is currently devoted to LCM research, of which XX% is currently in late-stage investigation. One of the major drivers of New Molecular Entity (NME) discovery and new drug launches is the expenditure on R&D that every major pharmaceutical company dedicates to keep the company running in the long term. Traditionally, the R&D expenses of the big pharmaceutical companies were paid for by the sales generated from their blockbuster drugs. However, in the last few years, several blockbuster drugs have gone off-patent, while many others are set to expire in the next five years, meaning that funding R&D programs has become a major concern for the big pharmaceutical companies. Over the years, the Food and Drug Administration (the regulatory agency for the US pharmaceutical market) has adopted a stricter regime for drug approval, which has resulted in a significant decrease in the number of NMEs that have been approved over the past decade. In the past few years, the FDA has been continuously criticized for its overly strict standards for drug approvals. After the cases of Vioxx, Exubera (insulin human [rdna origin]), as well as product recalls of Made in China drugs, the agency has been more cautious in analyzing the risk-benefit profile of drugs before it approves them. Page 9

9 eclinical Trial Solutions Market: Market Characterization CTMS has highest potential in the US, as several trials in the US are still conducted using traditional methods. 4 eclinical Trial Solutions Market - Market Characterization 4.1 Market Size and Forecasts for eclinical Trial Solutions Clinical Trial Management System Market Introduction to Clinical Trial Management Systems A clinical trial management system is used to simplify clinical development operations and manage multiple trials. It helps in maintaining and managing the planning, preparation, performance and reporting of clinical trials. It also helps in maintaining up-to-date contact information for participants and tracking deadlines and milestones of the trial. CTMS has the highest potential in the US, as several trials in the US are still conducted using traditional methods. Followed by the US, Europe also has huge potential, while the Asia-Pacific market is projected to grow faster during the forecast period Market Size and Forecasts Figure 14: eclinical Trial Solutions Market, Global, Clinical Trial Management System Market ($m), CAGR : XX% Market Size ($m) Year Source: GBI Research, Contemporary Clinical Trials Journal, PLoS One Journal, Journal of Medical Internet Research The CTMS market was valued at $XXm in 2010, and is expected to reach $XX billion by The market will grow at a CAGR of XX% between 2010 and High unmet need and increasing penetration are the main factors responsible for the growth of the CTMS market. Page 31

10 eclinical Trial Solutions Market: Market Characterization 4.5 Adoption Trends Figure 29: eclinical Trial Solutions Market, Global, CTMS - Technology Adoption, 2009 May be important Not important Important Very important Source: Survey from Winchester Business Systems According to a survey of XX companies by Winchester Business Systems, CTMS for clinical trials is an important priority for company investments. XX% of the surveyed companies rated CTMS as very important. XX% of the companies rated CTMS as important. XX% of the surveyed companies are speculative on the importance of CTMS. XX% of the companies feel that CTMS is not important. Overall, more than XX% of the companies rated CTMS as at least important (Winchester Business Systems, 2009). Page 53

11 eclinical Trial Solutions Market: Appendix 7 eclinical Trial Solutions Market - Appendix 7.1 Market Definitions Some of the terms used in this report are described below: eclincal: The term eclinical is used to encompass the shift in clinical studies to electronic computer-assisted capture and management methodologies, which increase efficiencies and quality by replacing manual and paperbased systems. Data Integration: Data integration involves combining data residing in different sources and providing users with a unified view of the data. Data Management: Data management is the development and execution of architectures, policies, practices and procedures that properly manage the full data lifecycle needs of an enterprise. Data Mining and Analysis: Data mining is the process of extracting patterns from data, and data analysis is a process of gathering, modeling, and transforming data with the goal of highlighting useful information, suggesting conclusions, and supporting decision making. 7.2 Abbreviations API - CDISC - CDMS - cgmp - CRA - CRF - CRO - CTMS - CTPM - DM - DB - ectd - Active Pharmaceutical Ingredient Clinical Data Interchange Standards Consortium Clinical Data Management Systems Current Good Manufacturing Practices Clinical Research Associate Case Report Format Clinical Research Organization Clinical Trial Management Systems Clinical Trial Process Manager Data Management Database Electronic Common Technical Document ediaries - Electronic Diaries EDC - epro - esub - FDA - GCP - IVRS - IWR - LCM - LIMS - Electronic Data Capture Electronic Patient Reported Outcomes Electronic Submission Food and Drug Association Good Clinical Practice Interactive Voice Response System Interactive Web Response Lifecycle Management Laboratory Information Management System Page 67

12 eclinical Trial Solutions Market: Appendix NME - PDA - PRO - RFID - ROI - SaaS - SOP - New Molecular Entity Personal Digital Assistant Patient Reported Outcomes Radio Frequency Identification Return on Investment Software as a Service Standard Operating Procedure 7.3 Bibliography CDISC (2011). CDISC: Adoption Trends, Benefits and Addressing Barriers. Available from: [Accessed May 25, 2012] European Medicines Agency (2011). Reflection paper on risk based quality management in clinical trials. Available from: 59.pdf [Accessed May 10, 2012]. Food and Drug Administration (2008). Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the ectd Specifications. Available from: pdf [Accessed May 17, 2012]. Kern, Miklavcic and Pavlovic (2009). Comparison of paper-based and electronic data collection process in clinical trials: Costs simulation study. Contemp Clin Trials;30: Mitchel T, et al (2008). The Impact of Electronic Data Capture on Clinical Data Management. Monitor. Available from: The Pharmaceutical Research and Manufacturers of America (2011). Pharmaceutical industry profile report Available from: [Accessed May 16, 2012]. Winchester Business Systems (2009). A 2020 Vision for eclinical Systems. Available from: [Accessed May 24, 2012]. 7.4 Research Methodology GBI Research s dedicated research and analysis teams consist of experienced professionals with marketing, market research and consulting backgrounds in the medical devices industry as well as advanced statistical expertise. GBI Research adheres to the codes of practice of the Market Research Society ( and the Strategic and Competitive Intelligence Professionals ( All GBI Research databases are continuously updated and revised Coverage The objective of updating GBI Research coverage is to ensure that it represents the most up to date vision of the industry possible. Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources. Company coverage is based on three key factors: market capitalization, revenues and media attention/innovation/market potential. Page 68

13 eclinical Trial Solutions Market: Appendix An exhaustive search of 56 member exchanges is conducted and companies are prioritized on the basis of their market capitalization. The estimated revenues of all major companies, including private and governmental, are gathered and used to prioritize coverage. Companies which are making the news, or which are of particular interest due to their innovative approach are prioritized. GBI Research aims to cover all major news events and deals in the medical industry, updated on a daily basis. The coverage is further streamlined and strengthened with additional inputs from GBI Research s expert panel (see below) Secondary Research The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market. The secondary research sources that are typically referred to include, but are not limited to: Company websites, annual reports, financial reports, broker reports, investor presentations and SEC Filings. Industry trade journals, scientific journals and other technical literature. Internal and external proprietary databases. Relevant patent and regulatory databases. National government documents, statistical databases and market reports. Procedure registries. News articles, press releases and web-casts specific to the companies operating in the market Primary Research GBI Research conducts hundreds of primary interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions: It provides first-hand information on the market size, market trends, growth trends, competitive landscape and future outlook. It helps in validating and strengthening the secondary research findings. It further develops the analysis team s expertise and market understanding. Primary research involves interactions and telephone interviews as well as face-to-face 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: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers. Hospital stores, laboratories, pharmacies, distributors and paramedics. Outside experts: Investment bankers, valuation experts, research analysts specializing in specific medical equipment markets. Key Opinion Leaders: Physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of medical equipment. Page 69

14 eclinical Trial Solutions Market: Appendix Expert Panel Validation GBI Research uses a panel of experts to cross verify its databases and forecasts. GBI Research expert panel comprises marketing managers, product specialists, international sales managers from medical device companies; academics from research universities and key opinion leaders from hospitals. Historic data and forecasts are relayed to GBI Research s expert panel for feedback and are adjusted in accordance with their feedback. 7.6 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GBI Research. Page 70