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PharmaPoint: Irritable Bowel Syndrome - Global Drug Forecast and Market Analysis to 2023

Summary

Irritable Bowel Syndrome (IBS) is a common disorder characterized by abdominal discomfort associated with altered bowel function. Although IBS is not a life-threatening disorder, it has a considerable effect on patients’ quality of life (QOL). In terms of volume, the IBS market is a large, albeit naïve, one, with only a small number of pharmacotherapies indicated for the treatment of the disorder, and it is also characterized by significant unmet needs.

As of October 2014, there were four products indicated for IBS in the 7MM. These include the constipation-predominant IBS (IBS-C) therapies, Sucampo/Takeda/Abbott’s Amitiza (lubiprostone) and Ironwood/Actavis/Almirall/Astellas’ Linzess (linaclotide), and the diarrhea-predominant IBS (IBS-D) therapies, Prometheus’ Lotronex (alosetron) and Astellas’ Irribow (ramosetron). Antidepressants and antibiotics (mainly Salix/Alfa Wassermann/Norgine/Bama-Geve’s Xifaxan [rifaximin]), are also commonly used off-label to treat IBS. GlobalData anticipates that four new therapies have the potential to enter the IBS market during the 2013-2023 forecast period. This includes Furiex’s (Actavis’) eluxadoline and Menarini’s ibodutant for IBS-D, and Synergy’s plecanatide and AstraZeneca/Ardelyx’s tenapanor for IBS-C. In addition, Xifaxan is in development for IBS-D, and has the potential to gain a label expansion for this indication during the forecast period.

Highlights

Key Questions Answered

- What do physicians think about Ironwood/Actavis/Almirall/Astellas’ Linzess and what will be the impact in the IBS market following its launch in 2012 in the US and 2013 in the 5EU region?
- What will be the uptake of Salix/Alfa Wassermann/Norgine/Bama-Geve’s Xifaxan following its anticipated label-expansion for IBS-D and how will it impact the treatment paradigm for IBS?
- What is the significance of late-phase pipeline products for IBS and how will their launch shape the future treatment landscape in IBS?
- What are the significant unmet needs in the IBS market?
- What are the remaining opportunities in the IBS market?

Key Findings

- The IBS market value will be driven by the increasing uptake of Ironwood/Actavis/Almirall/Astellas’ Linzess and its expected launch in all the major European markets and Japan, the anticipated label expansion of Salix/Alfa Wassermann/Norgine/Bama-Geve’s Xifaxan for IBS-D, the potential introduction of four pipeline drugs for the treatment of IBS, and the increasing prevalent cases of IBS.
- The main corporate strategy trend in the IBS market is for companies to enter into partnerships for the successful co-development and co-marketing of products in the different global regions.
- The most pressing unmet need in the IBS market is for the development of drugs with improved efficacy.

Scope

- Overview of IBS, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Annualized IBS therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2013 and forecast for ten years to 2023.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the IBS market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of mid-stage pipeline drugs.
- Analysis of the current and future market competition in the global IBS market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop and design in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global IBS market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global IBS market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global IBS market from 2013-2023.
- Organize sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

PharmaPoint: Irritable Bowel Syndrome - Global Drug Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 20
2.1 Catalyst 20
2.2 Related Reports 20
3 Disease Overview 21
3.1 Etiology and Pathophysiology 21
3.1.1 Etiology 21
3.1.2 Pathophysiology 22
3.2 Classification 22
3.3 Symptoms 23
3.4 Prognosis 23
3.5 Quality of Life 24
4 Epidemiology 25
4.1 Disease Background 25
4.2 Risk Factors and Comorbidities 26
4.3 Global Trends 27
4.3.1 US 29
4.3.2 5EU 31
4.3.3 Japan 31
4.4 Forecast Methodology 32
4.4.1 Sources Used 32
4.4.2 Sources Not Used 38
4.4.3 Forecast Assumptions and Methods - Total Prevalent Cases of IBS 39
4.4.4 Forecast Assumptions and Methods - IBS Subtype Segmentations 42
4.5 Epidemiological Forecast for IBS (2013-2023) 44
4.5.1 Total Prevalent Cases of IBS 44
4.5.2 Age-Specific Total Prevalent Cases of IBS 46
4.5.3 Sex-Specific Total Prevalent Cases of IBS 48
4.5.4 Age-Standardized Total Prevalence of IBS 50
4.5.5 Total Prevalent Cases of IBS by Clinical Subtype 51
4.6 Discussion 53
4.6.1 Epidemiological Forecast Insight 53
4.6.2 Limitations of the Analysis 54
4.6.3 Strengths of the Analysis 56
5 Disease Management 57
5.1 Diagnosis and Treatment Overview 57
5.1.1 Diagnosis 57
5.1.2 Treatment Guidelines and Leading Prescribed Drugs 59
5.1.3 Clinical Practice 62
5.2 US 64
5.3 France 66
5.4 Germany 68
5.5 Italy 70
5.6 Spain 72
5.7 UK 74
5.8 Japan 76
6 Competitive Assessment 78
6.1 Overview 78
6.2 Product Profiles - Major Brands, IBS-C 79
6.2.1 Amitiza (lubiprostone) 79
6.2.2 Linzess (linaclotide) 85
6.3 Product Profiles - Major Brands, IBS-D 93
6.3.1 Lotronex (alosetron) 93
6.3.2 Irribow (ramosetron) 98
6.4 Product Profiles - Major Brands, Other 103
6.4.1 Antidepressants 103
6.5 Other Therapeutic Classes 108
7 Unmet Need and Opportunity 110
7.1 Overview 110
7.2 More Effective Pharmacotherapies 111
7.2.1 Unmet Need 111
7.2.2 Gap Analysis 112
7.2.3 Opportunity 113
7.3 Therapies for the IBS-D Subtype 113
7.3.1 Unmet Need 113
7.3.2 Gap Analysis 114
7.3.3 Opportunity 114
7.4 Therapies for the IBS-M Subtype 114
7.4.1 Unmet Need 114
7.4.2 Gap Analysis 115
7.4.3 Opportunity 115
7.5 Therapies to Address Abdominal Pain and Bloating Symptoms 115
7.5.1 Unmet Need 115
7.5.2 Gap Analysis 116
7.5.3 Opportunity 116
7.6 Improved Diagnosis Rate for IBS 117
7.6.1 Unmet Need 117
7.6.2 Gap Analysis 117
7.6.3 Opportunity 117
8 Pipeline Assessment 119
8.1 Overview 119
8.2 Clinical Trial Mapping 119
8.2.1 Clinical Trials by Therapy Type 119
8.3 Promising Drugs in Clinical Development 120
8.4 Product Profiles - Late-Stage Pipeline, IBS-D 123
8.4.1 Eluxadoline 123
8.4.2 Ibodutant (MEN-15596) 130
8.4.3 Xifaxan (rifaximin) 136
8.5 Product Profiles - Late-Stage Pipeline, IBS-C 145
8.5.1 Plecanatide 145
8.5.2 Tenapanor (AZD1722, RDX5791) 151
8.6 Other Drugs in Development for IBS 156
9 Current and Future Players 157
9.1 Overview 157
9.2 Trends in Corporate Strategy 159
9.3 Company Profiles 160
9.3.1 Actavis 160
9.3.2 Astellas 162
9.3.3 Almirall 165
9.3.4 Ironwood 166
9.3.5 Takeda 169
9.3.6 Sucampo 171
9.3.7 Prometheus 173
9.3.8 Salix 175
9.3.9 Menarini 177
9.3.10 Synergy 179
9.3.11 AstraZeneca 181
10 Market Outlook 183
10.1 Global Markets 183
10.1.1 Forecast 183
10.1.2 Drivers and Barriers - Global Issues 187
10.2 US 188
10.2.1 Forecast 188
10.2.2 Key Events 192
10.2.3 Drivers and Barriers 192
10.3 France 194
10.3.1 Forecast 194
10.3.2 Key Events 198
10.3.3 Drivers and Barriers 198
10.4 Germany 200
10.4.1 Forecast 200
10.4.2 Key Events 204
10.4.3 Drivers and Barriers 204
10.5 Italy 206
10.5.1 Forecast 206
10.5.2 Key Events 210
10.5.3 Drivers and Barriers 210
10.6 Spain 212
10.6.1 Forecast 212
10.6.2 Key Events 215
10.6.3 Drivers and Barriers 215
10.7 UK 217
10.7.1 Forecast 217
10.7.2 Key Events 221
10.7.3 Drivers and Barriers 221
10.8 Japan 223
10.8.1 Forecast 223
10.8.2 Key Events 227
10.8.3 Drivers and Barriers 227
11 Appendix 230
11.1 Bibliography 230
11.2 Abbreviations 240
11.3 Methodology 243
11.4 Forecasting Methodology 243
11.4.1 Diagnosed IBS Patients 243
11.4.2 Drugs Included in Each Therapy Type 244
11.4.3 Launch and Patent Expiry Dates 244
11.4.4 General Pricing Assumptions 245
11.4.5 Individual Drug Assumptions 246
11.4.6 Generic Erosion 247
11.4.7 Pricing of Pipeline Agents 247
11.5 Primary Research - KOLs Interviewed for This Report 248
11.6 Primary Research - Prescriber Survey 250
11.7 About the Authors 251
11.7.1 Analyst 251
11.7.2 Therapy Area Director 251
11.7.3 Epidemiologist 252
11.7.4 Global Head of Healthcare 253
11.8 About GlobalData 254
11.9 Disclaimer 254

1.1 List of Tables

Table 1: Common Symptoms of IBS 23
Table 2: Risk Factors and Comorbidities for IBS 26
Table 3: Comparison of the IBS Diagnostic Criteria Used in Epidemiological Studies 29
Table 4: Total Prevalence (%) of IBS in the 7MM, as Reported in Epidemiological Studies 29
Table 5: Total Prevalence (%) of IBS in the US, as Reported in Epidemiological Studies 30
Table 6: 7MM, Sources of Total Prevalence Data Used to Forecast the Total Prevalent Cases of IBS 32
Table 7: 7MM, Sources of IBS Subtype Data Used to Forecast the Total Prevalent Cases of IBS by Subtype 33
Table 8: 7MM, Total Prevalent Cases of IBS, Ages ?10 Years, Both Sexes, N, Selected Years 2013-2023 45
Table 9: 7MM, Age-Specific Total Prevalent Cases of IBS, Both Sexes, N (Row %), 2013 47
Table 10: 7MM, Sex-Specific Prevalent Cases of IBS, Ages ?10 Years, N (Row %), 2013 49
Table 11: 7MM Total Prevalent Cases of IBS, N (%), by Clinical Subtype, Both Sexes, Ages ?10 Years, 2013 52
Table 12: Summary of the Various Diagnostic Criteria Used for the Diagnosis of IBS 58
Table 13: Treatment Guidelines for IBS 60
Table 14: Leading Prescribed Drugs for IBS by Predominant Symptoms in the 7MM, 2014† 61
Table 15: IBS Diagnosis and Treatment Country Profile - US 65
Table 16: IBS Diagnosis and Treatment, Country Profile - France 67
Table 17: IBS Diagnosis and Treatment, Country Profile - Germany 69
Table 18: IBS Diagnosis and Treatment, Country Profile - Italy 71
Table 19: IBS Diagnosis and Treatment, Country Profile - Spain 73
Table 20: IBS Diagnosis and Treatment, Country Profile - UK 75
Table 21: IBS Diagnosis and Treatment, Country Profile - Japan 77
Table 22: Leading Branded Treatments for IBS, 2014 79
Table 23: Product Profile - Amitiza 81
Table 24: Safety of Amitiza - Most Frequently Reported Adverse Events 83
Table 25: Amitiza SWOT Analysis, 2014 84
Table 26: Global IBS Sales Forecasts ($m) for Amitiza, 2013-2023 85
Table 27: Product Profile - Linzess 87
Table 28: Efficacy Responder Rates in Linzess' Two Placebo-Controlled IBS-C Trials: At Least Nine Out of 12 Weeks 89
Table 29: Efficacy Responder Rates in Linzess' Two Placebo-Controlled IBS-C Trials: At Least Six Out of 12 Weeks 89
Table 30: Safety of Linzess - Most Frequently Reported Adverse Events 91
Table 31: Linzess SWOT Analysis, 2014 92
Table 32: Global IBS Sales Forecasts ($m) for Linzess, 2013-2023 93
Table 33: Product Profile - Lotronex 95
Table 34: Safety of Lotronex - Most Frequently Reported Adverse Events 96
Table 35: Lotronex SWOT Analysis, 2014 97
Table 36: Global IBS Sales Forecasts ($m) for Lotronex, 2013-2023 98
Table 37: Product Profile - Irribow 100
Table 38: Irribow SWOT Analysis, 2014 102
Table 39: Global IBS Sales Forecasts ($m) for Irribow, 2013-2023 103
Table 40: Use of Antidepressants in IBS, SWOT Analysis, 2014 107
Table 41: Global IBS Sales Forecasts ($m) for Antidepressants, 2013-2023 108
Table 42: Summary of Other Therapeutic Classes of Pharmacologics in IBS, 2014 109
Table 43: Unmet Needs and Opportunities in IBS 111
Table 44: Drugs in Late-Stage Clinical Development for IBS, 2014 122
Table 45: Product Profile - Eluxadoline 124
Table 46: Eluxadoline SWOT Analysis, 2014 129
Table 47: Global IBS Sales Forecasts ($m) for Eluxadoline, 2013-2023 130
Table 48: Product Profile - Ibodutant 132
Table 49: Ibodutant SWOT Analysis, 2014 135
Table 50: Global IBS Sales Forecasts ($m) for Ibodutant, 2013-2023 136
Table 51: Product Profile - Xifaxan 139
Table 52: Safety of Xifaxan - Most Frequently Reported Adverse Events 142
Table 53: Xifaxan SWOT Analysis, 2014 144
Table 54: Global IBS Sales Forecasts ($m) for Xifaxan, 2013-2023 145
Table 55: Product Profile - Plecanatide 147
Table 56: Plecanatide SWOT Analysis, 2014 150
Table 57: Global IBS Sales Forecasts ($m) for Plecanatide, 2013-2023 151
Table 58: Product Profile - Tenapanor 152
Table 59: Tenapanor SWOT Analysis, 2014 154
Table 60: Global IBS Sales Forecasts ($m) for Tenapanor, 2013-2023 155
Table 61: Drugs in Early-Stage Clinical Development for IBS, 2014 156
Table 62: Key Companies in the IBS Market in the 7MM, 2014 158
Table 63: Actavis' IBS Portfolio Assessment, 2014 161
Table 64: Astellas' IBS Portfolio Assessment, 2014 163
Table 65: Almirall's IBS Portfolio Assessment, 2014 165
Table 66: Ironwood's IBS Portfolio Assessment, 2014 167
Table 67: Takeda's IBS Portfolio Assessment, 2014 169
Table 68: Sucampo's IBS Portfolio Assessment, 2014 171
Table 69: Prometheus' IBS Portfolio Assessment, 2014 173
Table 70: Salix's IBS Portfolio Assessment, 2014 175
Table 71: Menarini's IBS Portfolio Assessment, 2014 177
Table 72: Synergy's IBS Portfolio Assessment, 2014 179
Table 73: AstraZeneca's IBS Portfolio Assessment, 2014 181
Table 74: Global Sales Forecasts ($m) for IBS, 2013-2023 185
Table 75: Global IBS Market - Drivers and Barriers, 2013-2023 187
Table 76: Sales Forecasts ($m) for IBS in the US, 2013-2023 190
Table 77: Key Events Impacting Sales for IBS in the US, 2013-2023 192
Table 78: IBS Market in the US - Drivers and Barriers, 2013-2023 192
Table 79: Sales Forecasts ($m) for IBS in France, 2013-2023 196
Table 80: Key Events Impacting Sales for IBS in France, 2013-2023 198
Table 81: IBS Market in France - Drivers and Barriers, 2013-2023 198
Table 82: Sales Forecasts ($m) for IBS in Germany, 2013-2023 202
Table 83: Key Events Impacting Sales for IBS in Germany, 2013-2023 204
Table 84: IBS Market in Germany - Drivers and Barriers, 2013-2023 204
Table 85: Sales Forecasts ($m) for IBS in Italy, 2013-2023 208
Table 86: Key Events Impacting Sales for IBS in Italy, 2013-2023 210
Table 87: IBS Market in Italy - Drivers and Barriers, 2013-2023 210
Table 88: Sales Forecasts ($m) for IBS in Spain, 2013-2023 213
Table 89: Key Events Impacting Sales for IBS in Spain, 2013-2023 215
Table 90: IBS Market in Spain - Drivers and Barriers, 2013-2023 215
Table 91: Sales Forecasts ($m) for IBS in the UK, 2013-2023 219
Table 92: Key Events Impacting Sales for IBS in the UK, 2013-2023 221
Table 93: IBS Market in the UK - Drivers and Barriers, 2013-2023 221
Table 94: Sales Forecasts ($m) for IBS in Japan, 2013-2023 225
Table 95: Key Events Impacting Sales for IBS in Japan, 2013-2023 227
Table 96: IBS Market in Japan - Drivers and Barriers, 2013-2023 227
Table 97: Key Launch Dates 244
Table 98: Key Patent Expiries 244
Table 99: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 250

1.2 List of Figures

Figure 1: 7MM, Total Prevalent Cases of IBS Ages ?10 Years, Both Sexes, N, 2013-2023 45
Figure 2: 7MM, Age-Specific Total Prevalent Cases of IBS, Both Sexes, N, 2013 48
Figure 3: 7MM, Sex-Specific Total Prevalent Cases of IBS, Ages ?10 Years, N, 2013 49
Figure 4: 7MM, Age-Standardized Total Prevalence of IBS (%), Ages ?10 Years, by Sex, 2013 51
Figure 5: 7MM Total Prevalent Cases of IBS (%), by Clinical Subtype, Both Sexes, Ages ?10 Years, 2013 53
Figure 6: Summary of Pharmacotherapies Used to Treat IBS 63
Figure 7: IBS Therapeutics - Clinical Trials by Therapy Type and Development Stage, October 2014 120
Figure 8: IBS - Phase IIb-III Pipeline, October 2014 121
Figure 9: Competitive Assessment of Late-Stage Pipeline Agents in IBS, 2013-2023 122
Figure 10: Clinical and Commercial Positioning of Eluxadoline 128
Figure 11: Clinical and Commercial Positioning of Ibodutant 134
Figure 12: Clinical and Commercial Positioning of Xifaxan 143
Figure 13: Clinical and Commercial Positioning of Plecanatide 149
Figure 14: Clinical and Commercial Positioning of Tenapanor 154
Figure 15: Company Portfolio Gap Analysis in IBS, 2013-2023 159
Figure 16: Actavis' SWOT Analysis in IBS, 2013-2023 162
Figure 17: Astellas' SWOT Analysis in IBS, 2013-2023 164
Figure 18: Almirall's SWOT Analysis in IBS, 2013-2023 166
Figure 19: Ironwood's SWOT Analysis in IBS, 2013-2023 168
Figure 20: Takeda's SWOT Analysis in IBS, 2013-2023 170
Figure 21: Sucampo's SWOT Analysis in IBS, 2013-2023 172
Figure 22: Prometheus' SWOT Analysis in IBS, 2013-2023 174
Figure 23: Salix's SWOT Analysis in IBS, 2013-2023 176
Figure 24: Menarini's SWOT Analysis in IBS, 2013-2023 178
Figure 25: Synergy's SWOT Analysis in IBS, 2013-2023 180
Figure 26: AstraZeneca's SWOT Analysis in IBS, 2013-2023 182
Figure 27: Global Sales for IBS by Region, 2013-2023 186
Figure 28: Sales for IBS in the US by Therapy Type, 2013-2023 191
Figure 29: Sales for IBS in France by Therapy Type, 2013-2023 197
Figure 30: Sales for IBS in Germany by Therapy Type, 2013-2023 203
Figure 31: Sales for IBS in Italy by Therapy Type, 2013-2023 209
Figure 32: Sales for IBS in Spain by Therapy Type, 2013-2023 214
Figure 33: Sales for IBS in the UK by Therapy Type, 2013-2023 220
Figure 34: Sales for IBS in Japan by Therapy Type, 2013-2023 226

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