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Amitiza (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.

Amitiza (lubiprostone) is indicated for the treatment of IBS-C in women 18 years of age and older, but only in the US. This product was developed by Sucampo Pharmaceuticals and Takeda, and initially gained approval in the US in 2006 for the treatment of chronic idiopathic constipation (CIC) in adults. In 2008, Amitiza gained a label expansion from the Food and Drug Administration (FDA) for the treatment of IBS-C in women of 18 years of age and older.

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 Amitiza including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Amitiza for the top 2 countries from 2013 to 2023.
- Sales information covered for the US 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 Amitiza performance.
- Obtain sales forecast for Amitiza from 2013-2023 in top 2 countries (the US and Japan).

Table Of Contents

Amitiza (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 Amitiza (lubiprostone) 24
6.1 Overview 24
6.2 Efficacy 26
6.3 Safety 28
6.4 SWOT Analysis 29
6.5 Forecast 30
7 Appendix 31
7.1 Bibliography 31
7.2 Abbreviations 34
7.3 Methodology 36
7.4 Forecasting Methodology 36
7.4.1 Diagnosed IBS Patients 36
7.4.2 General Pricing Assumptions 37
7.4.3 Individual Drug Assumptions 38
7.4.4 Generic Erosion 38
7.5 Primary Research - KOLs Interviewed for This Report 39
7.6 Primary Research - Prescriber Survey 41
7.7 About the Authors 42
7.7.1 Analyst 42
7.7.2 Therapy Area Director 42
7.7.3 Global Head of Healthcare 43
7.8 About GlobalData 44
7.9 Disclaimer 44

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: Product Profile - Amitiza 26
Table 7: Safety of Amitiza - Most Frequently Reported Adverse Events 28
Table 8: Amitiza SWOT Analysis, 2014 29
Table 9: Global IBS Sales Forecasts ($m) for Amitiza, 2013-2023 30
Table 10: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 41

1.2 List of Figures

Figure 1: Summary of Pharmacotherapies Used to Treat IBS 21

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