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PharmaPoint: Ulcerative Colitis - Japan Drug Forecast and Market Analysis to 2022

Summary

During the forecast period from 2012-2022, the growth of the UC market will be driven largely by the entry of Johnson & Johnson’s (J&J’s) Simponi and Takeda’s Entyvio, which will lead to an increase in the overall number of patients being treated with biologics in the US, 5EU, Japan, and Canada. Another key event affecting the UC market is the anticipated launch of biosimilars, given that the patent expiry of the UC blockbusters, Remicade and Humira are set to expire in the US in 2018 and 2016, respectively.

GlobalData valued the UC market in Japan at $64m in 2012. By 2022, this figure is expected to rise to $173m, with a CAGR of 10.5% over the 10-year time period. Growth within this market will stem from the increasing number of prevalent cases of UC, as well as the continued uptake of the anti-TNF brand, Remicade. UC is considered a western disease in Japan, and it has been observed that with the westernization of Eastern cultures — namely, their culinary habits — UC is on the rise.

Scope

- Overview of Ulcerative Colitis 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 Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Japan from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the Japan Ulcerative Colitis market.

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 Ulcerative Colitis.
- 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 2012-2022 in Ulcerative Colitis.

Table Of Contents

PharmaPoint: Ulcerative Colitis - Japan Drug Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 11
2.3 Upcoming Related Reports 13
3 Disease Overview 14
3.1 Etiology and Pathophysiology 14
3.1.1 Etiology 14
3.1.2 Pathophysiology 16
3.2 Symptoms 18
3.2.1 Quality of Life 18
4 Disease Management 20
4.1 Diagnosis and Treatment Overview 20
4.1.1 Diagnosis 20
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 23
4.1.3 Clinical Practice 25
4.2 Japan 29
5 Competitive Assessment 31
5.1 Overview 31
5.2 Strategic Competitor Assessment 32
5.3 Product Profiles - Major Brands 33
5.3.1 Remicade (infliximab) 33
5.3.2 Humira (adalimumab) 40
5.3.3 Simponi (golimumab) 45
5.3.4 Asacol HD (mesalamine) 48
5.3.5 Lialda (mesalamine) 52
5.3.6 Pentasa (mesalamine) 55
5.3.7 Other Drug Classes Used in the Treatment of UC 58
5.4 Biosimilars 59
5.4.1 Introduction 59
5.4.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 60
5.4.3 Biosimilars in the Immunology Community 60
5.4.4 By the Numbers: Biosimilars in Development 61
5.4.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 63
5.4.6 Biosimilars' Forecast 64
6 Opportunity and Unmet Need 66
6.1 Overview 66
6.2 Unmet Needs 67
6.2.1 Curative Therapy for Severe UC Patients 67
6.2.2 Diagnostic Markers for Disease Severity 67
6.2.3 Personalized Therapy 68
6.2.4 A Replacement for Steroids 68
6.2.5 Novel Oral Drug Formulations 69
6.2.6 Preventative Medicine for Lowering the Associated Colorectal Cancer Risk 70
6.2.7 Improved Management of Infectious Adverse Events 70
6.3 Unmet Needs Gap Analysis 71
6.4 Disease Severity and Colorectal Cancer Biomarker-Based Prognostic Tools 72
6.5 Predictors of Medically-Refractory Disease 73
7 Pipeline Assessment 74
7.1 Overview 74
7.2 Promising Drugs in Clinical Development 74
7.2.1 Entyvio (vedolizumab) 76
7.2.2 Xeljanz (tofacitinib) 84
8 Market Outlook 90
8.1 Japan 90
8.1.1 Forecast 90
8.1.2 Key Events 94
8.1.3 Drivers and Barriers 94
9 Appendix 97
9.1 Bibliography 97
9.2 Abbreviations 101
9.3 Methodology 105
9.4 Forecasting Methodology 105
9.4.1 Diagnosed UC Patients 105
9.4.2 Percent Drug-Treated Patients 106
9.4.3 Drugs Included in Each Therapeutic Class 106
9.4.4 Launch and Patent Expiry Dates 106
9.4.5 General Pricing Assumptions 107
9.4.6 Individual Drug Assumptions 107
9.4.7 Generic Erosion 109
9.4.8 Pricing of Pipeline Agents 110
9.5 Physicians and Specialists Included in This Study 110
9.6 Primary Research - Prescriber Survey 112
9.7 About the Authors 113
9.7.1 Author 113
9.7.2 Global Head of Healthcare 114
9.8 About GlobalData 115
9.9 Disclaimer 115

1.1 List of Tables

Table 1: Genetic Factors That Confer a Predisposition to UC 16
Table 2: Typical Symptoms of UC 18
Table 3: Truelove and Witts UC Severity Index 22
Table 4: UCDAI 23
Table 5: Treatment Guidelines for UC Used in the 10MM 24
Table 6: Most Commonly Prescribed Drugs for UC by Class in the 10MM, 2013 25
Table 7: UC Management Country Profile - Japan 30
Table 8: Leading Treatments for UC, 2014 33
Table 9: Product Profile - Remicade 35
Table 10: Remicade SWOT Analysis, 2014 39
Table 11: Product Profile - Humira 41
Table 12: Humira Efficacy in the ULTRA 2 Trial 42
Table 13: Product Efficacy Comparison - Humira vs. Remicade 42
Table 14: Humira SWOT Analysis, 2014 44
Table 15: Product Profile - Simponi 46
Table 16: Simponi SWOT Analysis, 2014 48
Table 17: Product Profile - Asacol HD 49
Table 18: Asacol HD SWOT Analysis, 2014 52
Table 19: Product Profile - Lialda 53
Table 20: Lialda SWOT Analysis, 2014 55
Table 21: Product Profile - Pentasa 56
Table 22: Pentasa SWOT Analysis, 2014 58
Table 23: Summary of Other Immunomodulators for UC, 2013 59
Table 24: Biosimilars Pipeline, 2013 61
Table 25: Global Sales Forecasts ($m) for Infliximab Biosimilars, 2012-2022 64
Table 26: Global Sales Forecasts ($m) for Adalimumab Biosimilars, 2012-2022 64
Table 27: Global Sales Forecasts ($m) for Golimumab Biosimilars, 2012-2022 65
Table 28: Overall Unmet Needs - Current Level of Attainment 66
Table 29: Corticosteroid Long-Term Side Effects 69
Table 30: Clinical Unmet Needs in UC - Gap Analysis, 2013 72
Table 31: Prognostic Markers in UC 73
Table 32: UC - Pre-Registration and Phase III Pipeline, 2014 74
Table 33: Comparison of Therapeutic Classes in Development for UC, 2014 75
Table 34: Product Profile - Entyvio 78
Table 35: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Induction of Remission in UC 79
Table 36: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Maintenance of Remission in UC 79
Table 37: Most Common Adverse Events with Vedolizumab in the GEMINI I Study 81
Table 38: Entyvio SWOT Analysis, 2014 84
Table 39: Product Profile - Xeljanz 85
Table 40: Results of Phase IIa Trial of Xeljanz in the Induction of Remission in UC 86
Table 41: Most Common Adverse Events in the Phase IIa Trial of Xeljanz 88
Table 42: Xeljanz SWOT Analysis, 2014 89
Table 43: Sales Forecasts ($) for UC in Japan, 2012-2022 91
Table 44: Key Events Impacting Sales for UC in Japan, 2012-2022 94
Table 45: UC Market in Japan - Drivers and Barriers, 2012-2022 94
Table 46: Key launches for Ulcerative Colitis , 2012-2022 106
Table 47: Key Patent Expiries 107
Table 48: Annual Cost of Therapy for 5-ASAs ($) 109
Table 49: Physicians Surveyed, By Country 112

1.2 List of Figures

Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC 17
Figure 2: UC Disease Management Flowchart 28
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents UC, 2012-2022 75
Figure 4: Sales for UC in Japan by Drug Class, 2012-2022 93

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