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PharmaPoint: Ulcerative Colitis - Canada 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.

There are three UC-approved biologics in Canada, which are the TNF inhibitors, Remicade, Humira and Simponi. Remicade has the larger potential patient pool, as it was approved for use in UC patients long before Humira (in 2013), which was only approved for UC in 2013. It can also be used either alone or in combination with conventional therapy. This, together with its high annual cost of therapy, means that Remicade experiences strong uptake in the Canadian UC market, which positions it as the market-leading therapy.

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 Canada including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Canada from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the Canada 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 - Canada 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 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 23
4.1.3 Clinical Practice 25
4.2 Canada 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 Uceris (budesonide) 58
5.3.8 Other Drug Classes Used in the Treatment of UC 61
5.4 Biosimilars 62
5.4.1 Introduction 62
5.4.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 63
5.4.3 Biosimilars in the Immunology Community 63
5.4.4 By the Numbers: Biosimilars in Development 64
5.4.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 67
6 Opportunity and Unmet Need 68
6.1 Overview 68
6.2 Unmet Needs 69
6.2.1 Curative Therapy for Severe UC Patients 69
6.2.2 Diagnostic Markers for Disease Severity 69
6.2.3 Personalized Therapy 69
6.2.4 A Replacement for Steroids 70
6.2.5 Novel Oral Drug Formulations 71
6.2.6 Preventative Medicine for Lowering the Associated Colorectal Cancer Risk 72
6.2.7 Improved Management of Infectious Adverse Events 72
6.3 Unmet Needs Gap Analysis 73
6.4 Disease Severity and Colorectal Cancer Biomarker-Based Prognostic Tools 74
6.5 Predictors of Medically-Refractory Disease 75
7 Pipeline Assessment 76
7.1 Overview 76
7.2 Promising Drugs in Clinical Development 76
7.2.1 Entyvio (vedolizumab) 78
7.2.2 Xeljanz (tofacitinib) 87
8 Market Outlook 93
8.1 Canada 93
8.1.1 Forecast 93
8.1.2 Key Events 97
8.1.3 Drivers and Barriers 97
9 Appendix 99
9.1 Bibliography 99
9.2 Abbreviations 103
9.3 Methodology 107
9.4 Forecasting Methodology 107
9.4.1 Diagnosed UC Patients 107
9.4.2 Percent Drug-Treated Patients 108
9.4.3 Drugs Included in Each Therapeutic Class 108
9.4.4 Launch and Patent Expiry Dates 108
9.4.5 General Pricing Assumptions 109
9.4.6 Individual Drug Assumptions 109
9.4.7 Generic Erosion 111
9.4.8 Pricing of Pipeline Agents 111
9.5 Physicians and Specialists Included in This Study 112
9.6 Primary Research - Prescriber Survey 114
9.7 About the Authors 115
9.7.1 Author 115
9.7.2 Global Head of Healthcare 116
9.8 About GlobalData 117
9.9 Disclaimer 117

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: Country Profile - Canada 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: Product Profile - Uceris 59
Table 24: Uceris SWOT Analysis, 2014 61
Table 25: Summary of Other Immunomodulators for UC, 2013 62
Table 26: Biosimilars Pipeline, 2013 65
Table 27: Overall Unmet Needs - Current Level of Attainment 68
Table 28: Corticosteroid Long-Term Side Effects 71
Table 29: Clinical Unmet Needs in UC - Gap Analysis, 2013 74
Table 30: Prognostic Markers in UC 75
Table 31: UC - Pre-Registration and Phase III Pipeline, 2014 76
Table 32: Comparison of Therapeutic Classes in Development for UC, 2014 77
Table 33: Product Profile - Entyvio 80
Table 34: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Induction of Remission in UC 81
Table 35: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Maintenance of Remission in UC 82
Table 36: Most Common Adverse Events with Vedolizumab in the GEMINI I Study 83
Table 37: Entyvio SWOT Analysis, 2014 86
Table 38: Product Profile - Xeljanz 87
Table 39: Results of Phase IIa Trial of Xeljanz in the Induction of Remission in UC 88
Table 40: Most Common Adverse Events in the Phase IIa Trial of Xeljanz 90
Table 41: Xeljanz SWOT Analysis, 2014 92
Table 42: Sales Forecasts ($m) for UC in Canada, 2012-2022 94
Table 43: Key Events Impacting Sales for UC in Canada, 2012-2022 97
Table 44: UC Market in Canada - Drivers and Barriers, 2012-2022 97
Table 45: Key launches for Ulcerative Colitis , 2012-2022 108
Table 46: Key Patent Expiries 109
Table 47: Annual Cost of Therapy for 5-ASAs ($) 111
Table 48: Physicians Surveyed, By Country 114

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 77
Figure 4: Sales for UC in Canada by Drug Class, 2012-2022 96

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