Published : Dec-2017
No. of Pages : 185
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 9
2 Executive Summary 10
2.1 The IBS Market Expected to Experience Solid Growth from 2016-2026 11
2.2 Companies Leverage Partnerships to Successfully Develop and Commercialize IBS Products 12
2.3 The IBS Market is Characterized by Significant Unmet Needs 14
2.4 Products With Improved Efficacy Will Have Significant Opportunities in the IBS Market 14
2.5 The Potential Introduction of Late-Stage Pipeline Products Will Drive Growth in the IBS Market 14
2.6 What Do Physicians Think 15
3 Introduction 18
3.1 Catalyst 18
3.2 Related Reports 19
3.3 Upcoming Related Reports 19
4 Disease Overview 20
4.1 Etiology and Pathophysiology 20
4.1.1 Etiology 20
4.1.2 Pathophysiology 21
4.2 Classification or Staging Systems 26
4.3 Symptoms 27
4.4 Prognosis 27
4.5 Quality of Life 28
5 Epidemiology 29
5.1 Disease Background 29
5.2 Risk Factors and Comorbidities 30
5.3 Global and Historical Trends 31
5.3.1 US 33
5.3.2 5EU 34
5.3.3 Japan 35
5.4 Forecast Methodology 35
5.4.1 Sources 36
5.4.2 Forecast Assumptions and Methods 40
5.5 Epidemiological Forecast for IBS (2016-2026) 46
5.5.1 Total Prevalent Cases of IBS 46
5.5.2 Diagnosed Prevalent Cases of IBS 47
5.5.3 Age-Specific Diagnosed Prevalent Cases of IBS 48
5.5.4 Sex-Specific Diagnosed Prevalent Cases of IBS 49
5.5.5 Diagnosed Prevalent Cases of IBS by Clinical Subtype 50
5.5.6 Diagnosed Prevalent Cases of IBS Clinical Subtype by Comorbidity 51
5.6 Discussion 52
5.6.1 Epidemiological Forecast Insight 52
5.6.2 Limitations of the Analysis 54
5.6.3 Strengths of the Analysis 55
6 Disease Management 56
6.1 Diagnosis Overview 56
6.2 Treatment Overview 58
6.2.1 Treatment Guidelines 58
6.2.2 Clinical Practice 58
6.3 US 62
6.4 5EU 64
6.5 Japan 65
7 Competitive Assessment 68
7.1 Overview 68
7.2 Product Profiles - Major Brands, IBS-C Therapy 70
7.2.1 Linzess (linaclotide) 70
7.2.2 Amitiza (lubiprostone) 74
7.3 Product Profiles - Major Brands, IBS-D Therapy 77
7.3.1 Xifaxan (rifaximin) 77
7.3.2 Viberzi (eluxadoline) 84
7.3.3 Lotronex (alosetron) 89
7.3.4 Irribow (ramosetron) 92
7.4 Product Profiles - Therapeutic Agents for All IBS Clinical Subtypes 95
7.4.1 Antidepressants 95
7.5 Other Minor Therapeutic Classes 97
7.5.1 OTCs and Non-pharmacological Treatment Options for IBS 97
7.5.2 Off-Label Prescription Treatment Alternatives for IBS 99
8 Unmet Needs and Opportunity Analysis 101
8.1 Overview 101
8.2 More Efficacious Prescription Drugs Indicated for IBS 102
8.2.1 Unmet Need 102
8.2.2 Gap Analysis 103
8.2.3 Opportunity 104
8.3 Novel Therapies for IBS-D Patients 104
8.3.1 Unmet Need 104
8.3.2 Gap Analysis 105
8.3.3 Opportunity 105
8.4 Drugs Specifically Approved for IBS-M Patients 105
8.4.1 Unmet Need 105
8.4.2 Gap Analysis 106
8.4.3 Opportunity 106
8.5 Therapies to Address Abdominal Pain and Bloating Associated with IBS 106
8.5.1 Unmet Need 106
8.5.2 Gap Analysis 107
8.5.3 Opportunity 107
8.6 More Accurate Diagnosis of Appropriate IBS Clinical Subtype 108
8.6.1 Unmet Need 108
8.6.2 Gap Analysis 109
8.6.3 Opportunity 109
9 Pipeline Assessment 110
9.1 Overview 110
9.2 Promising Drugs in Clinical Development 111
9.2.1 Trulance (plecanatide) 112
9.2.2 Tenapanor 117
9.2.3 SYN-010 (oral modified-release lovastatin lactone) 122
9.3 Other Drugs in Development 125
10 Current and Future Players 127
10.1 Overview 127
10.2 Trends in Corporate Strategy 128
10.3 Company Profiles 129
10.3.1 Allergan 129
10.3.2 Astellas 130
10.3.3 Ironwood Pharmaceuticals 131
10.3.4 Takeda 132
10.3.5 Sucampo 133
10.3.6 Sebela Pharmaceuticals 134
10.3.7 Salix 134
10.3.8 Synergy 135
10.3.9 Ardelyx 136
10.3.10 Synthetic Biologics 136
11 Market Outlook 138
11.1 Global Markets 138
11.1.1 Forecast 138
11.1.2 Drivers and Barriers - Global Issues 140
11.2 US 141
11.2.1 Forecast 141
11.2.2 Key Events 143
11.2.3 Drivers and Barriers 143
11.3 5EU 144
11.3.1 Forecast 144
11.3.2 Key Events 146
11.3.3 Drivers and Barriers 146
11.4 Japan 147
11.4.1 Forecast 147
11.4.2 Key Events 149
11.4.3 Drivers and Barriers 149
12 Appendix 151
12.1 Bibliography 151
12.2 Abbreviations 165
12.3 Methodology 168
12.3.1 Forecasting Methodology 168
12.3.2 Diagnosed Patients 168
12.3.3 Percent Drug-Treated Patients 169
12.3.4 Drugs Included In Each Therapeutic Class 169
12.3.5 Launch and Patent Expiry Dates 170
12.3.6 General Pricing Assumptions 171
12.3.7 Individual Drug Assumptions 172
12.3.8 Generic Erosion 174
12.3.9 Pricing of Pipeline Agents 175
12.4 Primary Research - KOLs Interviewed for this Report 176
12.5 Primary Research - Prescriber Survey 180
12.6 About the Authors 181
12.6.1 Analyst 181
12.6.2 Therapy Area Directors 181
12.6.3 Epidemiologists 182
12.6.4 Global Director of Therapy Analysis and Epidemiology 182
12.6.5 Global Head and EVP of Healthcare Operations and Strategy 183
12.7 About GlobalData 184
12.8 Contact Us 184
12.9 Disclaimer 185
1.1 List of Tables
Table 1: Irritable Bowel Syndrome (IBS): Key Metrics in Seven Major Pharmaceutical Markets 10
Table 2: Symptoms of IBS 27
Table 3: Risk Factors and Comorbidities for IBS 30
Table 4: Comparison of the IBS Diagnostic Criteria Used in Epidemiological Studies 32
Table 5: 7MM, Total Prevalent Cases of IBS, Both Sexes, Ages ?18 Years, N, Selected Years from 2016-2026 47
Table 6: 7MM, Diagnosed Prevalent Cases of IBS, Both Sexes, Ages ?18 Years, N, Selected Years from 2016-2026 48
Table 7: 7MM, Diagnosed Prevalent Cases of IBS by Clinical Subtypes, Both Sexes, Ages ?18 Years, N, 2016 51
Table 8: 7MM, Diagnosed Prevalent Cases of IBS Subtypes with Comorbidity, Both Sexes, Ages ?18 Years, N, 2016 52
Table 9: Summary of the Various Diagnostic Criteria Used for the Diagnosis of IBS 57
Table 10: Treatment Guidelines for IBS 58
Table 11: Country Profile - US 63
Table 12: Country Profile - 5EU 65
Table 13: Country Profile - Japan 67
Table 14: Leading Treatments for IBS, 2017 69
Table 15: Product Profile - Linzess 71
Table 16: Efficacy Responder Rates in Linzess' Two Placebo-Controlled IBS-C Trials: At Least Nine Out of 12 Weeks 71
Table 17: Efficacy Responder Rates in Linzess' Two Placebo-Controlled IBS-C Trials: At Least Six Out of 12 Weeks 72
Table 18: Safety of Linzess - Most Frequently Reported AEs 73
Table 19: Linzess SWOT Analysis, 2017 73
Table 20: Product Profile - Amitiza 75
Table 21: Safety of Amitiza - Most Frequently Reported AEs 76
Table 22: Amitiza SWOT Analysis, 2017 76
Table 23: Product Profile - Xifaxan 78
Table 24: Efficacy Analysis of Xifaxan in Target 1 and 2 Trials 79
Table 25: Efficacy Responder Rates in Target 3 Trial in a Given Week for at Least 2 Weeks During Weeks 3 to 6 of the Double-Blind, First Repeat Treatment Phase 80
Table 26: Safety Analysis of Xifaxan in Target 1 and 2 Trials 81
Table 27: Safety Analysis of Xifaxan in Target 3 Trial 82
Table 28: Xifaxan SWOT Analysis, 2017 83
Table 29: Product Profile - Viberzi 85
Table 30: Efficacy Analysis of Viberzi in IBS-3001 and IBS-3002 Trials 86
Table 31: Common AEs of Viberzi 87
Table 32: Viberzi SWOT Analysis, 2017 88
Table 33: Product Profile - Lotronex 90
Table 34: Safety of Lotronex - Most Frequently Reported AEs 91
Table 35: Lotronex SWOT Analysis, 2017 92
Table 36: Product Profile - Irribow 93
Table 37: Irribow SWOT Analysis, 2017 95
Table 38: Antidepressants in IBS, SWOT Analysis, 2017 97
Table 39: Summary of Minor Therapeutic Classes, 2016 98
Table 40: Mechanisms of Action and AEs of Minor Therapeutic Classes, 2016 99
Table 41: Product Profile - Trulance 113
Table 42: Trulance SWOT Analysis, 2017 116
Table 43: Product Profile - Tenapanor 117
Table 44: T3MPO-1 Trial-Tenapanor 6 of 12 Week Treatment Results 118
Table 45: T3MPO-2 Trial-Tenapanor 6 of 12 Week Treatment Results 119
Table 46: Tenapanor SWOT Analysis, 2017 121
Table 47: Product Profile - SYN-010 122
Table 48: SYN-010 SWOT Analysis, 2017 125
Table 49: Other Drugs in Development for IBS, 2017 126
Table 50: Key Companies in the IBS Market in the 7MM, 2017 127
Table 51: Allergan's IBS Portfolio Assessment, 2017 130
Table 52: Astellas' IBS Portfolio Assessment, 2017 131
Table 53: Ironwood's IBS Portfolio Assessment, 2017 132
Table 54: Takeda's IBS Portfolio Assessment, 2017 133
Table 55: Sucampo's IBS Portfolio Assessment, 2017 134
Table 56: Prometheus/Sebela Ireland's IBS Portfolio Assessment, 2017 134
Table 57: Salix's IBS Portfolio Assessment, 2017 135
Table 58: Synergy's IBS Portfolio Assessment, 2017 136
Table 59: Ardelyx's IBS Portfolio Assessment, 2017 136
Table 60: Synthetic Biologics' IBS Portfolio Assessment, 2017 137
Table 61: IBS - Global Drivers and Barriers, 2016-2026 141
Table 62: Key Events Impacting Sales for IBS in the US, 2016-2026 143
Table 63: IBS - US Drivers and Barriers, 2016-2026 144
Table 64: Key Events Impacting Sales for IBS in the 5EU, 2016-2026 146
Table 65: IBS - 5EU Drivers and Barriers, 2016-2026 147
Table 66: Key Events Impacting Sales for IBS in Japan, 2016-2026 149
Table 67: IBS - Japan Drivers and Barriers, 2016-2026 150
Table 68: Key Historical and Projected Launch Dates for IBS 170
Table 69: Key Patent Expiry Dates for IBS 170
Table 70: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 180
1.2 List of Figures
Figure 1: Global (7MM) Sales for IBS by Region, 2016 and 2026 12
Figure 2: Analysis of the Company Portfolio Gap in IBS During the Forecast Period 13
Figure 3: Competitive Assessment of the Late-Stage Pipeline Products Under Development for IBS 15
Figure 4: IBS Pathophysiology 21
Figure 5: 7MM, Age-Standardized Diagnosed Prevalence of IBS, Ages ?18 Years, 2016 33
Figure 6: 7MM, Sources Used and Not Used, Total Prevalent Cases of IBS 36
Figure 7: 7MM, Sources Used, Diagnosed Prevalent Cases of IBS 37
Figure 8: 7MM, Sources Used, Diagnosed Prevalent Cases of IBS Clinical Subtypes 38
Figure 9: 7MM, Sources Used, Diagnosed Prevalent Cases of IBS With Comorbidity 39
Figure 10: 7MM, Age-Specific Diagnosed Prevalent Cases of IBS, Both Sexes, Ages ?18 Years, N, 2016 49
Figure 11: 7MM, Sex-Specific Diagnosed Prevalent Cases of IBS, Both Sexes, Ages ?18 Years, N, 2016 50
Figure 12: Unmet Need and Opportunity in IBS, 2017 102
Figure 13: Bullseye Diagram of Products in Clinical Development for IBS, 2017 110
Figure 14: Key Phase II/III Trials for Promising Pipeline Agents for IBS, 7MM, 2016-2026 111
Figure 15: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of IBS in the Forecast Period 112
Figure 16: Clinical and Commercial Positioning of Trulance 115
Figure 17: Clinical and Commercial Positioning of Tenapanor 120
Figure 18: Clinical and Commercial Positioning of SYN-010 124
Figure 19: Analysis of the Company Portfolio Gap in IBS During the Forecast Period 128
Figure 20: Global (7MM) Sales for IBS by Region, 2016 and 2026 139
Figure 21: Global (7MM) Sales for IBS by Drug, 2016 and 2026 140
Figure 22: Sales for IBS in the US, 2016 and 2026 142
Figure 23: Sales for IBS in the US by clinical subtype, 2016-2026 143
Figure 24: Sales for IBS in the 5EU, 2016 and 2026 145
Figure 25: Sales for IBS in the 5EU by clinical subtype, 2016-2026 146
Figure 26: Sales for IBS in Japan, 2016 and 2026 148
Figure 27: Sales for IBS in Japan by clinical subtype, 2016-2026 149
