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PharmaPoint: Irritable Bowel Syndrome - Japan 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.

The key growth drivers for the IBS market in Japan are the anticipated label expansion of Astellas’ Irribow for the treatment of women with IBS-D, and the potential introduction of five additional therapies for IBS during the forecast period. Antidepressants represented the remaining 32% of the market. The anticipated label expansion of Irribow for treating women with IBS-D, and the potential introduction of five new therapies for IBS, is set to change the IBS market dynamics in Japan.

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 Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the Japan from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the Japan Irritable Bowel Syndrome.

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 Japan

Table Of Contents

PharmaPoint: Irritable Bowel Syndrome - Japan 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 Japan 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 Irribow (ramosetron) 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
7.4 Product Profiles - Late-Stage Pipeline, IBS-C 70
7.4.1 Plecanatide 70
7.4.2 Tenapanor (AZD1722, RDX5791) 75
7.5 Other Drugs in Development for IBS 79
8 Market Outlook 80
8.1 Japan 80
8.1.1 Forecast 80
8.1.2 Key Events 83
8.1.3 Drivers and Barriers - Global Issues 83
8.1.4 Drivers and Barriers - Japan 85
9 Appendix 88
9.1 Bibliography 88
9.2 Abbreviations 93
9.3 Methodology 96
9.4 Forecasting Methodology 96
9.4.1 Diagnosed IBS Patients 96
9.4.2 Drugs Included in Each Therapy Type 97
9.4.3 Launch and Patent Expiry Dates 97
9.4.4 General Pricing Assumptions 98
9.4.5 Individual Drug Assumptions 98
9.4.6 Generic Erosion 99
9.4.7 Pricing of Pipeline Agents 99
9.5 Primary Research - KOLs Interviewed for This Report 101
9.6 Primary Research - Prescriber Survey 103
9.7 About the Authors 104
9.7.1 Analyst 104
9.7.2 Therapy Area Director 104
9.7.3 Global Head of Healthcare 105
9.8 About GlobalData 106
9.9 Disclaimer 106

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 Japan Market, 2014† 20
Table 5: IBS Diagnosis and Treatment, Country Profile - Japan 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 - Irribow 40
Table 16: Irribow SWOT Analysis, 2014 42
Table 17: Use of Antidepressants in IBS, SWOT Analysis, 2014 46
Table 18: Summary of Other Therapeutic Classes of Pharmacologics in IBS, 2014 47
Table 19: Unmet Needs and Opportunities in IBS 49
Table 20: Drugs in Late-Stage Clinical Development for IBS, 2014 58
Table 21: Product Profile - Eluxadoline 59
Table 22: Eluxadoline SWOT Analysis, 2014 65
Table 23: Product Profile - Ibodutant 67
Table 24: Ibodutant SWOT Analysis, 2014 70
Table 25: Product Profile - Plecanatide 72
Table 26: Plecanatide SWOT Analysis, 2014 75
Table 27: Product Profile - Tenapanor 76
Table 28: Tenapanor SWOT Analysis, 2014 78
Table 29: Drugs in Early-Stage Clinical Development for IBS, 2014 79
Table 30: Sales Forecasts ($m) for IBS in Japan, 2013-2023 81
Table 31: Key Events Impacting Sales for IBS in Japan, 2013-2023 83
Table 32: Global IBS Market - Drivers and Barriers, 2013-2023 83
Table 33: IBS Market in Japan - Drivers and Barriers, 2013-2023 85
Table 34: Key Launch Dates 97
Table 35: Key Patent Expiries 97
Table 36: High-Prescribing Physicians (Non-KOLs) Surveyed, in Japan 103

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 Plecanatide 74
Figure 7: Clinical and Commercial Positioning of Tenapanor 78
Figure 8: Sales for IBS in Japan by Therapy Type, 2013-2023 82

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