1 Table of Contents
1 Table of Contents 3
1.1 List of Tables 6
1.2 List of Figures 7
2 Lifesciences IT - 2011 Yearbook: Introduction 9
2.1 GBI Research Report Guidance 9
3 Lifesciences IT - 2011 Yearbook: The Need for Information Technology in Lifesciences Industry 10
3.1 Declining ROI on R&D Investment is Among the Biggest Concerns in the Current Pharmaceutical Industry 10
3.1.1 R&D Costs Increase against Revenue Growth for the Top 10 Pharma Companies 12
3.2 Generic Competition and Increasing Number of Patent Challenges 13
3.3 Layoff in the Pharmaceutical Companies 15
3.4 Shrinking Field Force Model 16
4 Lifesciences IT - 2011 Yearbook: Information Technology in Drug Discovery 17
4.1 Drug Discovery Value Chain 17
4.1.1 Target Discovery 17
4.1.2 Target Validation 17
4.1.3 Lead Identification 17
4.1.4 Lead Optimization 17
4.1.5 Preclinical Testing 17
4.2 IT in Drug Discovery Value Chain 17
4.3 Computerized Combinatorial Chemistry and 3D Molecular Modeling 18
4.3.1 Overview 18
4.3.2 Service Providers 19
4.3.3 Case Studies 20
4.4 Molecular Bioimaging 21
4.4.1 Overview 21
4.4.2 Service Providers 21
4.4.3 Case Study 21
4.5 Omics-Technology and Bioinformatics 22
4.5.1 Overview 22
4.5.2 Service Providers 22
4.5.3 Case Study 23
4.6 High-Throughput Screening (HTS) 24
4.6.1 Overview 24
4.6.2 Case Study 24
4.7 Database Systems 25
4.7.1 Overview 25
4.7.2 Case Studies 25
4.8 Using Virtual Technology to Reduce R&D Costs and Time 26
4.9 Technology Support Inevitable For Personalized Medicine: The Future Class of Medicines 27
5 Lifesciences IT - 2011 Yearbook: Information Technology in Drug Development 28
5.1 Overview 28
5.2 Electronic Data Capture (EDC) 29
5.2.1 Cost Saving Scenario in EDC 30
5.2.2 Cost Saving Scenario for Phase I and Phase II Trial 32
5.2.3 SaaS based EDC 33
5.2.4 Case Studies 34
5.3 Electronic Patient Report Outcome System (ePRO) 35
5.3.1 Cost Saving Scenario with eDiaries 36
5.4 Interactive Voice Response Systems (IVRS) 37
5.4.1 Case Studies 37
5.5 Clinical Data Management Systems (CDMS) 39
5.6 Clinical Trial Supply Chain Management System 39
5.6.1 Case Studies 41
5.7 Radio Frequency Identification Tag Architectures 42
5.7.1 RFID IT Architecture 42
5.8 Analysis and Reporting Tools 43
5.8.1 Analysis and Reporting Solutions 43
5.8.2 OnDemand Tools in Analysis and Reporting 43
5.8.3 Clinical Research Intelligence 43
5.8.4 Case Studies 44
5.9 Market Drivers 46
5.9.1 Cutting Down Clinical Trial Cost is the Driving Motivation for the Adoption of eClinical Trial Solutions 46
5.9.2 Improved Data Standardization Increases Adoption of IT Solutions 47
5.9.3 Adaptive Clinical Trials are Preferred by Large Biopharmaceutical Companies 48
5.9.4 Increasing Phase III and Phase II Trials escalates eClinical Solution Adoption 49
5.10 Market Trends 50
5.10.1 Clinical Trial Spending is Increasing at a Faster Rate 50
5.10.2 Electronic Data Capture will Witness High Investments for the Next Five years 51
5.11 Adoption Trends 52
5.11.1 Outsourcing of Clinical Data Management 54
5.11.2 Individual Project Outsourcing Model 55
5.11.3 Full Time Equivalent Model 55
5.11.4 Functional Service Provider Model 55
5.11.5 The Need for Outsourcing 55
5.11.6 A Full Time Equivalent Model Service Provider 56
5.11.7 Outsourcing to India 57
5.11.8 Cost of Setting up a Clinical Data Management Setup in India 58
5.11.9 Case Studies 59
5.12 CDISC Standards & Compliance 60
5.12.1 SDTM 60
5.12.2 ADaM 60
5.12.3 ODM 60
5.12.4 LAB 61
5.12.5 CRT-DDS 61
5.12.6 Protocol standard 61
5.12.7 CDISC Sponsored studies save time and costs 61
5.13 Competitive Benchmarking by Solution Offerings 62
5.14 e-Clinical Trial Solutions - Company Profiles 64
5.14.1 KIKA Medical 64
5.14.2 Omnicomm Systems 64
5.14.3 eResearch Technology 64
5.14.4 Prelude Dynamics 64
5.14.5 Clinipace 64
5.14.6 Phase Forward 65
5.14.7 Perceptive Informatics 65
5.14.8 Clinplus 65
5.14.9 Oracle 65
5.14.10 SAS 65
5.15 Pharmacovigilance 66
5.15.1 Pharmacovigilance in Different Countries 66
6 Lifesciences IT - 2011 Yearbook: Information Technology in Manufacturing & Supply Chain 67
6.1.1 E-Pedigree Solutions 67
6.1.2 Track and Trace Solutions 69
6.1.3 Product Callback Management 70
6.1.4 Authentication of Drugs in the Supply Chain 70
6.1.5 Inventory Management 70
6.1.6 Sample Distribution Management 71
6.1.7 Clinical Trial Solutions 71
7 Lifesciences IT - 2011 Yearbook: Information Technology in Sales & Marketing 72
7.1 CRM 72
7.2 Sales Force Automation 72
7.2.1 Pharma CRM Vendors 72
7.3 Closed Loop Marketing 73
7.3.1 Benefits for Sales & Physicians 74
7.3.2 Benefits for Analytics 74
7.3.3 Benefits for Legal & Regulatory Departments 74
7.3.4 Benefits for Marketing 74
7.3.5 Case Studies 74
7.4 Examining Strategies 78
7.4.1 Promotional Response Model 79
7.4.2 Closed Loop Marketing Vendors 80
7.5 Sales Force Effectiveness Dashboards 80
7.6 New Sales Strategies Implemented 81
7.7 The Future Strategies to be Implemented 82
7.8 Predictive Modeling in Sales & Marketing 85
7.8.1 Case Studies 88
7.9 Key Opinion Leaders Management 88
7.9.1 Key Opinion Leaders in the Pharmaceutical Industry 88
8 Lifesciences IT - 2011 Yearbook: Appendix 90
8.1 Market Definitions 90
8.2 Abbreviations 90
8.3 Research Methodology 91
8.3.1 Coverage 91
8.3.2 Secondary Research 91
8.3.3 Primary Research 91
8.3.4 Expert Panel Validation 92
8.4 Contact Us 92
8.5 Disclaimer 92
8.6 Sources 92
1.1 List of Tables
Table 1: Lifesciences IT - 2011 Yearbook, Pharmaceutical and Biotech R&D Expenditure ($bn) vs. Number of NME/BLA Approvals, The US, 1995–2009 11
Table 2: Lifesciences IT - 2011 Yearbook, Comparison of CAGR of R&D Expenditure v Turnover for the Top Ten Pharmaceutical Companies in 2009, 2004–2009 12
Table 3: Lifesciences IT - 2011 Yearbook, Phase I-II Cost Saving Scenario by Adopting EDC , 2009 32
Table 4: Lifesciences IT - 2011 Yearbook, Data Management Set Up Cost in India, 2009 58
Table 5: Lifesciences IT - 2011 Yearbook, CDISC Sponsored Studies, 2009 61
Table 6: Lifesciences IT - 2011 Yearbook, Global, Competitive Benchmarking by Solutions Offering, 2009 62
1.2 List of Figures
Figure 1: Lifesciences IT - 2011 Yearbook, Pharmaceutical and Biotech R&D Expenditure ($bn) vs. Number of NME/BLA Approvals, the US, 1995–2009 10
Figure 2: Lifesciences IT - 2011 Yearbook, Comparison of CAGR of R&D Expenditure v Turnover for the Top Ten Pharmaceutical Companies in 2009, 2004–2009 12
Figure 3: Lifesciences IT - 2011 Yearbook, Results Breakdown of Patent Challenges, The US, 2001–2008 14
Figure 4: Lifesciences IT - 2011 Yearbook, Pharmaceutical Industry, Global, Layoffs by Pharmaceutical Companies, 2009 15
Figure 5: Lifesciences IT - 2011 Yearbook, Pharmaceutical Industry, Global, Sales Force Layoffs, 2007-2009 16
Figure 6: Lifesciences IT - 2011 Yearbook, Service Providers in Combinatorial Chemistry and 3D Molecular Modeling 20
Figure 7: Lifesciences IT - 2011 Yearbook, Service Providers of Omics Technology and Bioinformatics 23
Figure 8: Lifesciences IT - 2011 Yearbook, Potential of Genomic Sequencing in Personalized Medicine, ICGC Scientists Statement, April 2010 27
Figure 9: Lifesciences IT - 2011 Yearbook, Global, Electronic Data Capture through e-CRF, 2009 29
Figure 10: Lifesciences IT - 2011 Yearbook, EDC System- Cost Saving Scenario, 2009 30
Figure 11: Lifesciences IT - 2011 Yearbook, Data Quality Gap, 2009 31
Figure 12: Lifesciences IT - 2011 Yearbook, SaaS based EDC System, 2009 33
Figure 13:Lifesciences IT - 2011 Yearbook, EDC Cost Saving in Clinical Trials – Therapy Wise, 2009 34
Figure 14: Lifesciences IT - 2011 Yearbook, Cost Saving Scenario of ePRO Solutions, 2009 36
Figure 15: Lifesciences IT - 2011 Yearbook, Case Study of ePRO Solutions, 2009 36
Figure 16: Lifesciences IT - 2011 Yearbook, Integration of IVR with other Systems, 2009 37
Figure 17: Lifesciences IT - 2011 Yearbook, Clinical Data Management Flow, 2009 39
Figure 18: Lifesciences IT - 2011 Yearbook, Clinical Trial Supply Management System, 2009 40
Figure 19: Lifesciences IT - 2011 Yearbook, RFID Technologies in Clinical Trials, 2009 42
Figure 20: Lifesciences IT - 2011 Yearbook, Cost Saving Scenario of a Predictive Modeling Solution, 2009 45
Figure 21: Lifesciences IT - 2011 Yearbook, Cutting Down Clinical Trial Cost is a High Priority Task for Pharmaceutical Companies- Impact Analysis, 2009 46
Figure 22: Lifesciences IT - 2011 Yearbook, Research and Development Spending Split by Phases – Impact Analysis 47
Figure 23: Lifesciences IT - 2011 Yearbook, Adaptive Clinical Trials are Preferred by Large Biopharmaceutical Companies - Impact Analysis, 2009 48
Figure 24: Lifesciences IT - 2011 Yearbook, Increasing Phase III and phase II trials escalates eClinical Solution Adoption – Impact Analysis, 2009 49
Figure 25: Lifesciences IT - 2011 Yearbook, Research and Development Spending Split by Phases – Impact Analysis, 2009 50
Figure 26: Lifesciences IT - 2011 Yearbook, Investment Trends in Future eClinical Trial Solutions 51
Figure 27: Lifesciences IT - 2011 Yearbook, CTMS – Technology Adoption, 2009 52
Figure 28: Lifesciences IT - 2011 Yearbook, Investigator Portal – Technology Adoption, 2009 52
Figure 29: Lifesciences IT - 2011 Yearbook, System Integration – Technology Adoption, 2009 53
Figure 30: Lifesciences IT - 2011 Yearbook, ePRO Solutions – Technology Adoption, 2009 53
Figure 31: Lifesciences IT - 2011 Yearbook, IVRS Solutions – Technology Adoption, 2009 54
Figure 32: Lifesciences IT - 2011 Yearbook, Factors Impacting Clinical Data Management Outsourcing, 2009 55
Figure 33: Lifesciences IT - 2011 Yearbook, End-to-End Services Offered by Large IT Vendors , 2009 56
Figure 34: Lifesciences IT - 2011 Yearbook, Supply Chain in Clinical Trials , 2009 57
Figure 35: Lifesciences IT - 2011 Yearbook, e-Pedigree in a Pharmaceutical Supply Chain 67
Figure 36: Lifesciences IT - 2011 Yearbook, Paper Based Pedigree in a Pharmaceutical Supply Chain 68
Figure 37: Lifesciences IT - 2011 Yearbook, Information Flow in Track-and-Trace Applications 69
Figure 38: Lifesciences IT - 2011 Yearbook, CLM Enabled Commercial Organization 73
Figure 39: Lifesciences IT - 2011 Yearbook, Wyeth’s Target Selection Model 75
Figure 40: Lifesciences IT - 2011 Yearbook, Wyeth’s Segmentation Model 75
Figure 41: Lifesciences IT - 2011 Yearbook, Benefits of CLM for Wyeth 76
Figure 42: Lifesciences IT - 2011 Yearbook, Customer Response Framework for CLM 76
Figure 43: Lifesciences IT - 2011 Yearbook, Customer Response Success Rate for CLM 77
Figure 44: Lifesciences IT - 2011 Yearbook, Wyeth and its CLM Process 77
Figure 45: Lifesciences IT - 2011 Yearbook, Sales Index vs. Sales Strategy 78
Figure 46: Lifesciences IT - 2011 Yearbook, Promotional Response Model 79
Figure 47: Lifesciences IT - 2011 Yearbook, Promotional Response Model on Sales 79
Figure 48: Lifesciences IT - 2011 Yearbook, Global, Implemented Sales Strategies in Pharmaceutical Companies, %, 81
Figure 49: Lifesciences IT - 2011 Yearbook, Global, Sales Strategies to be Implemented in Future, %, 82
Figure 50: Lifesciences IT - 2011 Yearbook, Physician Satisfaction Vs. Decrease in the Sales Force, The US, 2009 83
Figure 51: Lifesciences IT - 2011 Yearbook, Traditional Outsourcing Applications 84
Figure 52: Lifesciences IT - 2011 Yearbook, Modern Outsourcing Applications 85
Figure 53: Lifesciences IT - 2011 Yearbook, Predictive Modeling Data Integration 86
Figure 54: Lifesciences IT - 2011 Yearbook, Predictive Modeling 87
Figure 55: Lifesciences IT - 2011 Yearbook, Predictive Modeling Process 87
Figure 56: Lifesciences IT - 2011 Yearbook, KOL Strategy 89
Companies Mentioned
KIKA Medical
Omnicomm Systems
eResearch Technology
Prelude Dynamics
Clinipace
Phase Forward
Perceptive Informatics
Clinplus
Oracle
SAS
