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PharmaPoint: Irritable Bowel Syndrome - US 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.

GlobalData estimated that prescription drug sales for IBS in the US were approximately $480.1m in 2013. The key growth drivers for the IBS market in the US are the anticipated increasing uptake of Ironwood/Actavis/Almirall/Astellas’ Linzess, the potential label expansion of Salix/Alfa Wassermann/Norgine/Bama-Geve’s Xifaxan for IBS-D, the potential introduction of four additional therapies, and the increasing prevalent cases of IBS during the forecast period.

Scope

- Overview of Irritable Bowel Syndrome including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the US Irritable Bowel Syndrome market.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for Irritable Bowel Syndrome
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of drug performance
- Obtain sales forecast for drugs from 2013-2023 in the US

Table Of Contents

PharmaPoint: Irritable Bowel Syndrome - US Drug Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 11
3 Disease Overview 13
3.1 Etiology and Pathophysiology 13
3.1.1 Etiology 13
3.1.2 Pathophysiology 14
3.2 Classification 14
3.3 Symptoms 15
3.4 Prognosis 16
3.5 Quality of Life 16
4 Disease Management 17
4.1 Diagnosis and Treatment Overview 17
4.1.1 Diagnosis 17
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 20
4.1.3 Clinical Practice 21
4.2 US 23
5 Competitive Assessment 25
5.1 Overview 25
5.2 Product Profiles - Major Brands, IBS-C 26
5.2.1 Amitiza (lubiprostone) 26
5.2.2 Linzess (linaclotide) 31
5.3 Product Profiles - Major Brands, IBS-D 38
5.3.1 Lotronex (alosetron) 38
5.4 Product Profiles - Major Brands, Other 42
5.4.1 Antidepressants 42
5.5 Other Therapeutic Classes 46
6 Unmet Need and Opportunity 48
6.1 Overview 48
6.2 More Effective Pharmacotherapies 49
6.2.1 Unmet Need 49
6.2.2 Gap Analysis 50
6.2.3 Opportunity 51
6.3 Therapies for the IBS-D Subtype 51
6.3.1 Unmet Need 51
6.3.2 Gap Analysis 52
6.3.3 Opportunity 52
6.4 Therapies for the IBS-M Subtype 52
6.4.1 Unmet Need 52
6.4.2 Gap Analysis 53
6.4.3 Opportunity 53
6.5 Therapies to Address Abdominal Pain and Bloating Symptoms 53
6.5.1 Unmet Need 53
6.5.2 Gap Analysis 54
6.5.3 Opportunity 54
6.6 Improved Diagnosis Rate for IBS 54
6.6.1 Unmet Need 54
6.6.2 Gap Analysis 55
6.6.3 Opportunity 55
7 Pipeline Assessment 56
7.1 Overview 56
7.2 Promising Drugs in Clinical Development 56
7.3 Product Profiles - Late-Stage Pipeline, IBS-D 58
7.3.1 Eluxadoline 58
7.3.2 Ibodutant (MEN-15596) 65
7.3.3 Xifaxan (rifaximin) 70
7.4 Product Profiles - Late-Stage Pipeline, IBS-C 78
7.4.1 Plecanatide 78
7.4.2 Tenapanor (AZD1722, RDX5791) 83
7.5 Other Drugs in Development for IBS 87
8 Market Outlook 88
8.1 US 88
8.1.1 Forecast 88
8.1.2 Key Events 92
8.1.3 Drivers and Barriers - Global Issues 92
8.1.4 Drivers and Barriers - US 94
9 Appendix 97
9.1 Bibliography 97
9.2 Abbreviations 102
9.3 Methodology 105
9.4 Forecasting Methodology 105
9.4.1 Diagnosed IBS Patients 105
9.4.2 Drugs Included in Each Therapy Type 106
9.4.3 Launch and Patent Expiry Dates 106
9.4.4 General Pricing Assumptions 107
9.4.5 Individual Drug Assumptions 107
9.4.6 Generic Erosion 108
9.4.7 Pricing of Pipeline Agents 108
9.5 Primary Research - KOLs Interviewed for This Report 110
9.6 Primary Research - Prescriber Survey 112
9.7 About the Authors 113
9.7.1 Analyst 113
9.7.2 Therapy Area Director 113
9.7.3 Global Head of Healthcare 114
9.8 About GlobalData 115
9.9 Disclaimer 115

1.1 List of Tables

Table 1: Common Symptoms of IBS 15
Table 2: Summary of the Various Diagnostic Criteria Used for the Diagnosis of IBS 18
Table 3: Treatment Guidelines for IBS 20
Table 4: Leading Prescribed Drugs for IBS by Predominant Symptoms in the US Market, 2014† 20
Table 5: IBS Diagnosis and Treatment Country Profile - US 24
Table 6: Leading Branded Treatments for IBS, 2014 26
Table 7: Product Profile - Amitiza 28
Table 8: Safety of Amitiza - Most Frequently Reported Adverse Events 30
Table 9: Amitiza SWOT Analysis, 2014 31
Table 10: Product Profile - Linzess 33
Table 11: Efficacy Responder Rates in Linzess' Two Placebo-Controlled IBS-C Trials: At Least Nine Out of 12 Weeks 35
Table 12: Efficacy Responder Rates in Linzess' Two Placebo-Controlled IBS-C Trials: At Least Six Out of 12 Weeks 35
Table 13: Safety of Linzess - Most Frequently Reported Adverse Events 37
Table 14: Linzess SWOT Analysis, 2014 38
Table 15: Product Profile - Lotronex 40
Table 16: Safety of Lotronex - Most Frequently Reported Adverse Events 41
Table 17: Lotronex SWOT Analysis, 2014 42
Table 18: Use of Antidepressants in IBS, SWOT Analysis, 2014 46
Table 19: Summary of Other Therapeutic Classes of Pharmacologics in IBS, 2014 47
Table 20: Unmet Needs and Opportunities in IBS 49
Table 21: Drugs in Late-Stage Clinical Development for IBS, 2014 58
Table 22: Product Profile - Eluxadoline 59
Table 23: Eluxadoline SWOT Analysis, 2014 65
Table 24: Product Profile - Ibodutant 67
Table 25: Ibodutant SWOT Analysis, 2014 70
Table 26: Product Profile - Xifaxan 73
Table 27: Safety of Xifaxan - Most Frequently Reported Adverse Events 76
Table 28: Xifaxan SWOT Analysis, 2014 78
Table 29: Product Profile - Plecanatide 80
Table 30: Plecanatide SWOT Analysis, 2014 83
Table 31: Product Profile - Tenapanor 84
Table 32: Tenapanor SWOT Analysis, 2014 86
Table 33: Drugs in Early-Stage Clinical Development for IBS, 2014 87
Table 34: Sales Forecasts ($m) for IBS in the US, 2013-2023 90
Table 35: Key Events Impacting Sales for IBS in the US, 2013-2023 92
Table 36: Global IBS Market - Drivers and Barriers, 2013-2023 92
Table 37: IBS Market in the US - Drivers and Barriers, 2013-2023 94
Table 38: Key Launch Dates 106
Table 39: Key Patent Expiries 106
Table 40: High-Prescribing Physicians (Non-KOLs) Surveyed, in the US 112

1.2 List of Figures

Figure 1: Summary of Pharmacotherapies Used to Treat IBS 22
Figure 2: IBS - Phase IIb-III Pipeline, October 2014 57
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in IBS, 2013-2023 57
Figure 4: Clinical and Commercial Positioning of Eluxadoline 64
Figure 5: Clinical and Commercial Positioning of Ibodutant 69
Figure 6: Clinical and Commercial Positioning of Xifaxan 77
Figure 7: Clinical and Commercial Positioning of Plecanatide 82
Figure 8: Clinical and Commercial Positioning of Tenapanor 86
Figure 9: Sales for IBS in the US by Therapy Type, 2013-2023 91

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