TABLE OF CONTENTS
Executive Summary 14
Market Overview 20
•Definitions 21
•Overview of Inflammatory Bowel Disease 23
oIncidence and Prevalence of Inflammatory Bowel Disease 24
oDiagnosis of Inflammatory Bowel Disease 25
oClinical Severity of Inflammatory Bowel Disease 27
oAssessment of Disease Activity in IBD Clinical Trials 29
oAnatomic Extent of Ulcerative Colitis 31
oClinical Guidelines 33
•Overview of Irritable Bowel Syndrome 38
oDiagnosis of IBS 39
oAssessment of Disease Activity in IBS Clinical Trials 40
oClinical Trial Design Guidance—IBS 41
oClinical Guidelines—IBS 43
•Personalized Medicine in Bowel Disorders 44
•Key Questions This Study Will Answer 45
•Market Overview—Segmentation 46
External Challenges: Drivers and Restraints 57
Forecast and Trends 69
Demand Analysis 84
Market Share and Competitive Analysis 87
Inflammatory Bowel Disease Prescription Pharmaceuticals Segment 123
•5-ASA Subsegment Breakdown 127
•Corticosteroid Subsegment Breakdown 138
•TNF Inhibitor Subsegment Breakdown 149
•Non-TNF Biologicals Subsegment Breakdown 160
•Novel Orals Subsegment Breakdown 169
Irritable Bowel Syndrome Prescription Pharmaceuticals Segment 177
The Last Word (Conclusions and Implications) 188
Game-changing Strategies 193
Appendix 195
List of Exhibits
Market Overview —
•Total Bowel Disorders Prescription Pharmaceuticals Market: Estimated Incidence and Prevalence of CD and UC, U.S., 2011 24
•Total Bowel Disorders Prescription Pharmaceuticals Market: Distinguishing Characteristics of CD and UC, U.S., 2011 25
•Total Bowel Disorders Prescription Pharmaceuticals Market: Diagnostic Procedures Used in the Differential Diagnosis of CD and UC, U.S., 2011 26
•Total Bowel Disorders Prescription Pharmaceuticals Market: Severity of Ulcerative Colitis Based on the Truelove and Witts Classification, U.S., 2011 27
•Total Bowel Disorders Prescription Pharmaceuticals Market: Severity of Crohn's Disease Based on the CDAI, U.S., 2011 28
•Total Bowel Disorders Prescription Pharmaceuticals Market: Common Disease Activity Assessment Instruments in Recent Phase 3 UC Trials, U.S., 2011 30
•Total Bowel Disorders Prescription Pharmaceuticals Market: Anatomic Extent of Ulcerative Colitis, U.S., 2011 31, 32
•Total Bowel Disorders Prescription Pharmaceuticals Market: Clinical Guidelines (Mild to Moderate UC), U.S., 2011 33
•Total Bowel Disorders Prescription Pharmaceuticals Market: Clinical Guidelines (Severe UC), U.S., 2011 34
•Total Bowel Disorders Prescription Pharmaceuticals Market: Clinical Guidelines (Mild-Moderate) CD, U.S., 2011 35
•Total Bowel Disorders Prescription Pharmaceuticals Market: Traditional Clinical Guidelines (Moderate-Severe CD), U.S., 2011 36
•Total Bowel Disorders Prescription Pharmaceuticals Market: Modern Clinical Guidelines (Moderate-Severe CD), U.S., 2011 37
•Total Bowel Disorders Prescription Pharmaceuticals Market: Rome III Diagnostic Criteria for IBS, U.S., 2011 39
•Total Bowel Disorders Prescription Pharmaceuticals Market: Examples of PRO Questions Used as Primary Endpoints in Past IBS Clinical Trials, U.S., 2011 40
•Total Bowel Disorders Prescription Pharmaceuticals Market: General Clinical Trial Design Guidance for Sponsors of IBS Clinical Trials, U.S., 2011 41
•Total Bowel Disorders Prescription Pharmaceuticals Market: Clinical Trial Design Recommendations for Sponsors of IBS Clinical Trials, U.S., 2011 42
•Total Bowel Disorders Prescription Pharmaceuticals Market: Market Segmentation, U.S., 2011 46
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBD Market Segmentation, U.S., 2011 47
•Total Irritable Bowel Syndrome Therapeutics Market: IBS Market Segmentation, U.S., 2011 52
•Total Bowel Disorders Prescription Pharmaceuticals Market: Percent Sales Breakdown by Indication, U.S., 2011 55
•Total Bowel Disorders Prescription Pharmaceuticals Market: Percent Sales Breakdown by Drug Class, U.S., 2011 56
External Challenges: Drivers and Restraints—Total Bowel Disorders Prescription Pharmaceuticals Market —
•Total Bowel Disorders Prescription Pharmaceuticals Market: Key Market Drivers and Restraints, U.S., 2012–2017 58
•Total Bowel Disorders Prescription Pharmaceuticals Market: Potential Revenue per Patient for Lifelong IBD Therapy Diagnosed in a Young Patient, U.S., 2011 62
•Total Bowel Disorders Prescription Pharmaceuticals Market: Selected Drugs Discontinued for Irritable Bowel Syndrome, U.S., 2011 65
•Total Bowel Disorders Prescription Pharmaceuticals Market: Selected Drugs Discontinued for Inflammatory Bowel Disease, U.S., 2011 66
Forecasts and Trends—Total Bowel Disorders Prescription Pharmaceuticals Market —
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBD Prevalence and Treated Patient Forecast, U.S., 2009-2017 74
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBD Prevalence by Indication, U.S., 2009-2017 75
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBS Prevalence by Disease Severity and Forecast, U.S., 2009-2017 76-77
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBS Prevalence by Indication and Forecast, U.S., 2009-2017 78
•Total Bowel Disorders Prescription Pharmaceuticals Market: Range of Reported Disease Prevalence Estimates, U.S., 2011 79
Forecasts and Trends—Total Bowel Disorders Prescription Pharmaceuticals Market —
•Total Bowel Disorders Prescription Pharmaceuticals Market: Average Annual Cost of Therapy, U.S., 2009-2017 80
•Total Bowel Disorders Prescription Pharmaceuticals Market: Revenue Forecast, U.S., 2009-2017 82
Demand Analysis—Total Bowel Disorders Prescription Pharmaceuticals Market —
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBD Market Penetration, U.S., 2011 85
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBS Market Penetration, U.S., 2011 86
Market Share and Competitive Analysis—Total Bowel Disorders Prescription Pharmaceuticals Market —
•Total Bowel Disorders Prescription Pharmaceuticals Market: Percent of Sales, U.S., 2011 88
•Total Bowel Disorders Prescription Pharmaceuticals Market: Absolute Market Share Trend, U.S., 2009-2011 89
•Total Bowel Disorders Prescription Pharmaceuticals Market: Percent Market Share Trend, U.S., 2009-2011 90
•Total Bowel Disorders Prescription Pharmaceuticals Market: Company Market Share Analysis of Top Four Participants, U.S., 2011 91
•Total Bowel Disorders Prescription Pharmaceuticals Market: Competitive Structure, U.S., 2011 92
•Total Bowel Disorders Prescription Pharmaceuticals Market: Timeline of Key Events, U.S., 2011 94
•Total Bowel Disorders Prescription Pharmaceuticals Market: Comparative Product Profiles of Promising Late-stage Candidates, U.S., 2011 95
Market Share and Competitive Analysis—Total Bowel Disorders Prescription Pharmaceuticals Market —
•Total Bowel Disorders Prescription Pharmaceuticals Market: Comparative Remission Rates in CD of Selected Marketed and Late-stage Drugs, U.S., 2011 96-97
•Total Bowel Disorders Prescription Pharmaceuticals Market: Comparative Remission Rates in UC of Selected Marketed and Late-stage Drugs, U.S., 2011 98-99
•Total Bowel Disorders Prescription Pharmaceuticals Market: Number of Drugs per Class by Stage of Development—Oral and Injectable Therapies for IBD, U.S., 2011 101
•Total Bowel Disorders Prescription Pharmaceuticals Market: Number of Drugs per Class by Stage of Development—Topical Therapies for IBD, U.S., 2011 102
•Total Bowel Disorders Prescription Pharmaceuticals Market: Number of IBD Drugs per Class by Stage of Development, U.S., 2011 103
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBD Marketed Product Analysis, U.S., 2011 104-107
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBD Late-stage Product Analysis, U.S., 2011 108-109
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBD Pipeline Analysis, U.S., 2011 110-117
•Total Bowel Disorders Prescription Pharmaceuticals Market: Number of IBS Drugs per Class by Stage of Development, U.S., 2011 118
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBS Marketed Product Analysis, U.S., 2011 119
Market Share and Competitive Analysis—Total Bowel Disorders Prescription Pharmaceuticals Market —
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBS Late-stage Product Analysis, U.S., 2011 120
•Total Bowel Disorders Prescription Pharmaceuticals Market: IBS Pipeline Analysis, U.S., 2011 121-122
Inflammatory Bowel Disease Prescription Pharmaceuticals Segment
•Inflammatory Bowel Disease Prescription Pharmaceuticals Market: Percent Sales Breakdown by Drug Class, U.S., 2011 126
•Inflammatory Bowel Disease Prescription Pharmaceuticals Market: Percent Patient Share Breakdown by Drug Class, U.S., 2011 126 5-ASA Subsegment Breakdown —
•5-ASA Subsegment Percent Sales Breakdown, U.S., 2011 128
•5-ASA Subsegment: Treated Patient Forecast, U.S., 2009-2017 130
•5-ASA Subsegment: Average Annual Cost of Therapy, U.S., 2009-2017 132
•5-ASA Subsegment: Revenue Forecast, U.S., 2009-2017 134
•5-ASA Subsegment: Percent of Sales, U.S., 2011 136
•5-ASA Subsegment: Company Market Share Analysis of Top Two Participants, U.S., 2011 137
Corticosteroid Subsegment Breakdown —
•Corticosteroid Subsegment Percent Sales Breakdown, U.S., 2011 139
•Corticosteroid Subsegment: Treated Patient Forecast, U.S., 2009-2017 141
•Corticosteroid Subsegment: Average Annual Cost of Therapy, U.S., 2009-2017 143
•Corticosteroid Subsegment: Revenue Forecast, U.S., 2009-2017 145
•Corticosteroid Subsegment: Percent of Sales, U.S., 2011 147
•Corticosteroid Subsegment: Company Market Share Analysis of Participants, U.S., 2011 148
TNF Inhibitor Subsegment Breakdown —
•TNF Inhibitor Subsegment: Percent Sales Breakdown, U.S., 2011 150
•TNF Inhibitor Subsegment: Treated Patient Forecast, U.S., 2009-2017 152
•TNF Inhibitor Subsegment: Average Annual Cost of Therapy, U.S., 2009-2017 154
•TNF Inhibitor Subsegment: Revenue Forecast, U.S., 2009-2017 156
•TNF Inhibitor Subsegment: Percent of Sales, U.S., 2011 158
•TNF Inhibitor Subsegment: Company Market Share Analysis of Participants, U.S., 2011 159
Non-TNF Biologicals Subsegment Breakdown —
•Non-TNF Biologicals Subsegment: Percent Sales Breakdown, U.S., 2011 161
•Non-TNF Biologicals Subsegment: Treated Patient Forecast, U.S., 2009-2017 163
•Non-TNF Biologicals Subsegment: Average Annual Cost of Therapy, U.S., 2009-2017 165
•Non-TNF Biologicals Subsegment: Revenue Forecast, U.S., 2009-2017 167
Novel Orals Subsegment Breakdown —
•Novel Orals Subsegment: Percent Sales Breakdown, U.S., 2011 170
•Novel Orals Subsegment: Percent Sales Breakdown, U.S., 2017 170
•Novel Orals Subsegment: Treated Patient Forecast, U.S., 2009-2017 171
•Novel Orals Subsegment: Average Annual Cost of Therapy, U.S., 2009-2017 173
•Novel Orals Subsegment: Revenue Forecast, U.S., 2009-2017 175
Irritable Bowel Syndrome Segment Breakdown —
•IBS Segment: Percent Sales Breakdown, U.S., 2011 180
•IBS Segment: Treated Patient Forecast, U.S., 2009-2017 182
•IBS Segment: Average Annual Cost of Therapy, U.S., 2009-2017 184
•IBS Segment: Revenue Forecast, U.S., 2009-2017 186
