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PharmaPoint: Ulcerative Colitis - US 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 estimates that by the end of the forecast period the UC market in the US will grow to approximately $3.5 billion. While the prevalence of the disease in the US will plateau during the course of the 10-year forecast period from 2012-2022, the overall patient numbers are on the rise because of the country’s growing population and increasing life expectancy. This market would grow even more if Remicade and Humira were not set to lose their patent protection in 2018. Biosimilars are expected to eventually take two thirds of their branded drugs’ sales in the US.

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 the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the US 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 - US 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 17
3.2 Symptoms 18
3.2.1 Quality of Life 19
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 24
4.1.3 Clinical Practice 25
4.2 US 29
5 Competitive Assessment 32
5.1 Overview 32
5.2 Strategic Competitor Assessment 33
5.3 Product Profiles - Major Brands 35
5.3.1 Remicade (infliximab) 35
5.3.2 Humira (adalimumab) 42
5.3.3 Simponi (golimumab) 47
5.3.4 Apriso (mesalamine) 50
5.3.5 Asacol HD (mesalamine) 55
5.3.6 Lialda (mesalamine) 59
5.3.7 Pentasa (mesalamine) 62
5.3.8 Colazal (balsazide disodium) 65
5.3.9 Giazo (balsalazide disodium) 68
5.3.10 sfRowasa (mesalamine) 71
5.3.11 Uceris (budesonide) 73
5.3.12 Other Drug Classes Used in the Treatment of UC 76
5.4 Biosimilars 77
5.4.1 Introduction 77
5.4.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 78
5.4.3 Biosimilars in the Immunology Community 78
5.4.4 By the Numbers: Biosimilars in Development 79
5.4.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 81
6 Opportunity and Unmet Need 83
6.1 Overview 83
6.2 Unmet Needs 84
6.2.1 Curative Therapy for Severe UC Patients 84
6.2.2 Diagnostic Markers for Disease Severity 84
6.2.3 Personalized Therapy 85
6.2.4 A Replacement for Steroids 85
6.2.5 Novel Oral Drug Formulations 86
6.2.6 Preventative Medicine for Lowering the Associated Colorectal Cancer Risk 87
6.2.7 Improved Management of Infectious Adverse Events 87
6.3 Unmet Needs Gap Analysis 88
6.4 Disease Severity and Colorectal Cancer Biomarker-Based Prognostic Tools 89
6.5 Predictors of Medically-Refractory Disease 90
7 Pipeline Assessment 91
7.1 Overview 91
7.2 Promising Drugs in Clinical Development 91
7.2.1 Entyvio (vedolizumab) 93
7.2.2 Xeljanz (tofacitinib) 102
8 Market Outlook 108
8.1 United States 108
8.1.1 Forecast 108
8.1.2 Key Events 113
8.1.3 Drivers and Barriers 113
9 Appendix 116
9.1 Bibliography 116
9.2 Abbreviations 120
9.3 Methodology 124
9.4 Forecasting Methodology 124
9.4.1 Diagnosed UC Patients 124
9.4.2 Percent Drug-Treated Patients 125
9.4.3 Drugs Included in Each Therapeutic Class 125
9.4.4 Launch and Patent Expiry Dates 125
9.4.5 General Pricing Assumptions 126
9.4.6 Individual Drug Assumptions 126
9.4.7 Generic Erosion 128
9.4.8 Pricing of Pipeline Agents 128
9.5 Physicians and Specialists Included in This Study 129
9.6 Primary Research - Prescriber Survey 130
9.7 About the Authors 131
9.7.1 Author 131
9.7.2 Global Head of Healthcare 132
9.8 About GlobalData 133
9.9 Disclaimer 133

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 - US 31
Table 8: Leading Treatments for UC, 2014 34
Table 9: Product Profile - Remicade 37
Table 10: Remicade SWOT Analysis, 2014 41
Table 11: Product Profile - Humira 43
Table 12: Humira Efficacy in the ULTRA 2 Trial 44
Table 13: Product Efficacy Comparison - Humira vs. Remicade 44
Table 14: Humira SWOT Analysis, 2014 46
Table 15: Product Profile - Simponi 48
Table 16: Simponi SWOT Analysis, 2014 50
Table 17: Product Profile - Apriso 52
Table 18: Apriso SWOT Analysis, 2014 54
Table 19: Product Profile - Asacol HD 56
Table 20: Asacol HD SWOT Analysis, 2014 59
Table 21: Product Profile - Lialda 60
Table 22: Lialda SWOT Analysis, 2014 62
Table 23: Product Profile - Pentasa 63
Table 24: Pentasa SWOT Analysis, 2014 65
Table 25: Product Profile - Colazal 66
Table 26: Colazal SWOT Analysis, 2014 68
Table 27: Product Profile - Giazo 69
Table 28: Giazo SWOT Analysis, 2014 71
Table 29: Product Profile - sfRowasa 72
Table 30: sfRowasa SWOT Analysis, 2014 73
Table 31: Product Profile - Uceris 74
Table 32: Uceris SWOT Analysis, 2014 76
Table 33: Summary of Other Immunomodulators for UC, 2013 77
Table 34: Biosimilars Pipeline, 2013 80
Table 35: Overall Unmet Needs - Current Level of Attainment 83
Table 36: Corticosteroid Long-Term Side Effects 86
Table 37: Clinical Unmet Needs in UC - Gap Analysis, 2013 89
Table 38: Prognostic Markers in UC 90
Table 39: UC - Pre-Registration and Phase III Pipeline, 2014 91
Table 40: Comparison of Therapeutic Classes in Development for UC, 2014 92
Table 41: Product Profile - Entyvio 95
Table 42: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Induction of Remission in UC 96
Table 43: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Maintenance of Remission in UC 97
Table 44: Most Common Adverse Events with Vedolizumab in the GEMINI I Study 98
Table 45: Entyvio SWOT Analysis, 2014 101
Table 46: Product Profile - Xeljanz 102
Table 47: Results of Phase IIa Trial of Xeljanz in the Induction of Remission in UC 103
Table 48: Most Common Adverse Events in the Phase IIa Trial of Xeljanz 105
Table 49: Xeljanz SWOT Analysis, 2014 107
Table 50: Sales Forecasts ($m) for UC in the US, 2012-2022 110
Table 51: Key Events Impacting Sales for UC in the US, 2012-2022 113
Table 52: UC Market in the US - Drivers and Barriers, 2012-2022 113
Table 53: Key launches for Ulcerative Colitis , 2012-2022 125
Table 54: Key Patent Expiries 126
Table 55: Annual Cost of Therapy for 5-ASAs ($) 128
Table 56: Physicians Surveyed, By Country 130

1.2 List of Figures

Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC 18
Figure 2: UC Disease Management Flowchart 28
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents UC, 2012-2022 92
Figure 4: Sales for UC in the US by Drug Class, 2012-2022 112

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