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Linzess (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.

Linzess (linaclotide) is indicated for the treatment of IBS-C in adults. This product was initially discovered by Ironwood Pharmaceuticals, and its development and commercialization were supported by a series of licensing agreements with Forest in the US, Almirall in the EU, and Astellas in Japan. As of November 2014, Linzess was in Phase III of development as a potential treatment for IBS-C in Japan, and is therefore not currently available in this market.

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

Table Of Contents

Linzess (Irritable Bowel Syndrome) - Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 8
3 Disease Overview 10
3.1 Etiology and Pathophysiology 10
3.1.1 Etiology 10
3.1.2 Pathophysiology 11
3.2 Classification 11
3.3 Symptoms 12
3.4 Prognosis 13
3.5 Quality of Life 13
4 Disease Management 14
4.1 Diagnosis and Treatment Overview 14
4.1.1 Diagnosis 14
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 16
4.1.3 Clinical Practice 19
5 Competitive Assessment 21
5.1 Overview 21
6 Linzess (linaclotide) 23
6.1 Overview 23
6.2 Efficacy 24
6.3 Safety 28
6.4 SWOT Analysis 29
6.5 Forecast 29
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 12
Table 2: Summary of the Various Diagnostic Criteria Used for the Diagnosis of IBS 15
Table 3: Treatment Guidelines for IBS 17
Table 4: Leading Prescribed Drugs for IBS by Predominant Symptoms in the 7MM, 2014† 18
Table 5: Leading Branded Treatments for IBS, 2014 22
Table 6: Product Profile - Linzess 24
Table 7: Efficacy Responder Rates in Linzess' Two Placebo-Controlled IBS-C Trials: At Least Nine Out of 12 Weeks 26
Table 8: Efficacy Responder Rates in Linzess' Two Placebo-Controlled IBS-C Trials: At Least Six Out of 12 Weeks 27
Table 9: Safety of Linzess - Most Frequently Reported Adverse Events 28
Table 10: Linzess SWOT Analysis, 2014 29
Table 11: Global IBS Sales Forecasts ($m) for Linzess, 2013-2023 30
Table 12: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 41

1.2 List of Figures

Figure 1: Summary of Pharmacotherapies Used to Treat IBS 20

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