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Ibodutant (Irritable Bowel Syndrome) - 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.

Ibodutant is being developed by Menarini for the treatment of women with IBS-D. The Phase III program for ibodutant was initiated in Q1 2014 with two Phase III clinical trials, a 12-week study and a 52-week study, both of which were designed to evaluate the efficacy and safety of this product (Menarini, NCT02107196; Menarini, NCT02120027).

Scope

- Overview of IBS, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Ibodutant including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Ibodutant for the top 7 countries from 2013 to 2023.
- Sales information covered for the US, France, Germany, Italy, Spain, UK and Japan.

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 IBS.
- 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 Ibodutant performance.
- Obtain sales forecast for Ibodutant from 2013-2023 in top 7 countries (the US, France, Germany, Italy, Spain, UK and Japan).

Table Of Contents

Ibodutant (Irritable Bowel Syndrome) - Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 9
3 Disease Overview 11
3.1 Etiology and Pathophysiology 11
3.1.1 Etiology 11
3.1.2 Pathophysiology 12
3.2 Classification 12
3.3 Symptoms 13
3.4 Prognosis 14
3.5 Quality of Life 14
4 Disease Management 15
4.1 Diagnosis and Treatment Overview 15
4.1.1 Diagnosis 15
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 17
4.1.3 Clinical Practice 20
5 Competitive Assessment 22
5.1 Overview 22
6 Unmet Need and Opportunity 24
6.1 Overview 24
6.2 More Effective Pharmacotherapies 25
6.2.1 Unmet Need 25
6.2.2 Gap Analysis 26
6.2.3 Opportunity 27
6.3 Therapies for the IBS-D Subtype 27
6.3.1 Unmet Need 27
6.3.2 Gap Analysis 28
6.3.3 Opportunity 28
6.4 Therapies for the IBS-M Subtype 28
6.4.1 Unmet Need 28
6.4.2 Gap Analysis 29
6.4.3 Opportunity 29
6.5 Therapies to Address Abdominal Pain and Bloating Symptoms 29
6.5.1 Unmet Need 29
6.5.2 Gap Analysis 30
6.5.3 Opportunity 30
6.6 Improved Diagnosis Rate for IBS 31
6.6.1 Unmet Need 31
6.6.2 Gap Analysis 31
6.6.3 Opportunity 31
7 Pipeline Assessment 33
7.1 Overview 33
7.2 Promising Drugs in Clinical Development 33
8 Ibodutant (MEN-15596) 36
8.1 Overview 36
8.2 Efficacy 37
8.3 Safety 38
8.4 Dosing and Formulation 38
8.5 Potential Clinical and Commercial Positioning 39
8.6 SWOT Analysis 40
8.7 Forecast 40
9 Appendix 42
9.1 Bibliography 42
9.2 Abbreviations 45
9.3 Methodology 47
9.4 Forecasting Methodology 47
9.4.1 Diagnosed IBS Patients 47
9.4.2 General Pricing Assumptions 48
9.4.3 Generic Erosion 49
9.4.4 Pricing of Pipeline Agents 49
9.5 Primary Research - KOLs Interviewed for This Report 50
9.6 Primary Research - Prescriber Survey 52
9.7 About the Authors 53
9.7.1 Analyst 53
9.7.2 Therapy Area Director 53
9.7.3 Global Head of Healthcare 54
9.8 About GlobalData 55
9.9 Disclaimer 55

1.1 List of Tables

Table 1: Common Symptoms of IBS 13
Table 2: Summary of the Various Diagnostic Criteria Used for the Diagnosis of IBS 16
Table 3: Treatment Guidelines for IBS 18
Table 4: Leading Prescribed Drugs for IBS by Predominant Symptoms in the 7MM, 2014† 19
Table 5: Leading Branded Treatments for IBS, 2014 23
Table 6: Unmet Needs and Opportunities in IBS 25
Table 7: Drugs in Late-Stage Clinical Development for IBS, 2014 35
Table 8: Product Profile - Ibodutant 37
Table 9: Ibodutant SWOT Analysis, 2014 40
Table 10: Global IBS Sales Forecasts ($m) for Ibodutant, 2013-2023 41
Table 11: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 52

1.2 List of Figures

Figure 1: Summary of Pharmacotherapies Used to Treat IBS 21
Figure 2: IBS - Phase IIb-III Pipeline, October 2014 34
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in IBS, 2013-2023 34
Figure 4: Clinical and Commercial Positioning of Ibodutant 39

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