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Eluxadoline (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.

Eluxadoline is being developed for the treatment of IBS-D. As of October 2014, it had reached the Phase III stage of development, and also has been granted a Fast-Track designation by the FDA. Furiex Pharmaceuticals initially licensed eluxadoline from Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson [J&J]) for the development of the product. Subsequently, Furiex was fully-acquired by Actavis in July 2014 (Furiex Pharmaceuticals, press release, July 2, 2014).

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 Eluxadoline including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Eluxadoline 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 Eluxadoline performance.
- Obtain sales forecast for Eluxadoline from 2013-2023 in top 7 countries (the US, France, Germany, Italy, Spain, UK and Japan).

Table Of Contents

Eluxadoline (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 Eluxadoline 36
8.1 Overview 36
8.2 Efficacy 37
8.3 Safety 40
8.4 Dosing and Formulation 41
8.5 Potential Clinical and Commercial Positioning 41
8.6 SWOT Analysis 42
8.7 Forecast 42
9 Appendix 44
9.1 Bibliography 44
9.2 Abbreviations 47
9.3 Methodology 49
9.4 Forecasting Methodology 49
9.4.1 Diagnosed IBS Patients 49
9.4.2 General Pricing Assumptions 50
9.4.3 Generic Erosion 51
9.4.4 Pricing of Pipeline Agents 51
9.5 Primary Research - KOLs Interviewed for This Report 52
9.6 Primary Research - Prescriber Survey 54
9.7 About the Authors 55
9.7.1 Analyst 55
9.7.2 Therapy Area Director 55
9.7.3 Global Head of Healthcare 56
9.8 About GlobalData 57
9.9 Disclaimer 57

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 - Eluxadoline 37
Table 9: Eluxadoline SWOT Analysis, 2014 42
Table 10: Global IBS Sales Forecasts ($m) for Eluxadoline, 2013-2023 43
Table 11: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 54

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 Eluxadoline 41

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