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PharmaPoint: Ulcerative Colitis - 5EU 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.

France emerged as the highest-grossing UC market in 2012 in GlobalData’s forecast. Germany follows a reference pricing approach for drug reimbursement. Under this system, drugs that are considered to be therapeutically equivalent are clustered together and a reference price is set based on the least expensive drug in the cluster. In 2012, the base year of the forecast period, GlobalData estimated that the size of the UC market in Italy was $138m. This sales figure positions Italy as the lowest-grossing market in the 5EU, with approximately 10% of the total 5EU market value. Austerity measures within Spain led GlobalData to predict that biosimilar uptake will be strong, particularly within the moderate to severe UC patient group, Despite drug pricing pressures and the current global financial crisis, the UK is predicted to be the second-highest growing market for UC in GlobalData’s forecast.

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 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in 5EU from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the 5EU 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 - 5EU Drug Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 13
2.3 Upcoming Related Reports 15
3 Disease Overview 16
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 19
3.2 Symptoms 20
3.2.1 Quality of Life 21
4 Disease Management 22
4.1 Diagnosis and Treatment Overview 22
4.1.1 Diagnosis 22
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 26
4.1.3 Clinical Practice 27
4.2 France 31
4.3 Germany 33
4.4 Italy 35
4.5 Spain 37
4.6 UK 39
5 Competitive Assessment 42
5.1 Overview 42
5.2 Strategic Competitor Assessment 43
5.3 Product Profiles - Major Brands 45
5.3.1 Remicade (infliximab) 45
5.3.2 Humira (adalimumab) 52
5.3.3 Simponi (golimumab) 57
5.3.4 Apriso (mesalamine) 60
5.3.5 Asacol HD (mesalamine) 65
5.3.6 Lialda (mesalamine) 69
5.3.7 Pentasa (mesalamine) 72
5.3.8 Colazal (balsazide disodium) 75
5.3.9 Uceris (budesonide) 78
5.3.10 Other Drug Classes Used in the Treatment of UC 81
5.4 Biosimilars 82
5.4.1 Introduction 82
5.4.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 83
5.4.3 Biosimilars in the Immunology Community 83
5.4.4 By the Numbers: Biosimilars in Development 84
5.4.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 86
6 Opportunity and Unmet Need 88
6.1 Overview 88
6.2 Unmet Needs 89
6.2.1 Curative Therapy for Severe UC Patients 89
6.2.2 Diagnostic Markers for Disease Severity 89
6.2.3 Personalized Therapy 90
6.2.4 A Replacement for Steroids 90
6.2.5 Novel Oral Drug Formulations 91
6.2.6 Preventative Medicine for Lowering the Associated Colorectal Cancer Risk 92
6.2.7 Improved Management of Infectious Adverse Events 92
6.3 Unmet Needs Gap Analysis 93
6.4 Disease Severity and Colorectal Cancer Biomarker-Based Prognostic Tools 94
6.5 Predictors of Medically-Refractory Disease 95
7 Pipeline Assessment 96
7.1 Overview 96
7.2 Promising Drugs in Clinical Development 96
7.2.1 Entyvio (vedolizumab) 98
7.2.2 Xeljanz (tofacitinib) 107
7.2.3 Kappaproct (DIMS 0150) 112
8 Market Outlook 117
8.1 France 117
8.1.1 Forecast 117
8.1.2 Key Events 122
8.1.3 Drivers and Barriers 122
8.2 Germany 125
8.2.1 Forecast 125
8.2.2 Key Events 130
8.2.3 Drivers and Barriers 130
8.3 Italy 132
8.3.1 Forecast 132
8.3.2 Key Events 136
8.3.3 Drivers and Barriers 136
8.4 Spain 138
8.4.1 Forecast 138
8.4.2 Key Events 143
8.4.3 Drivers and Barriers 143
8.5 United Kingdom 145
8.5.1 Forecast 145
8.5.2 Key Events 150
8.5.3 Drivers and Barriers 150
9 Appendix 153
9.1 Bibliography 153
9.2 Abbreviations 158
9.3 Methodology 162
9.4 Forecasting Methodology 162
9.4.1 Diagnosed UC Patients 162
9.4.2 Percent Drug-Treated Patients 163
9.4.3 Drugs Included in Each Therapeutic Class 163
9.4.4 Launch and Patent Expiry Dates 163
9.4.5 General Pricing Assumptions 164
9.4.6 Individual Drug Assumptions 164
9.4.7 Generic Erosion 166
9.4.8 Pricing of Pipeline Agents 167
9.5 Physicians and Specialists Included in This Study 168
9.6 Primary Research - Prescriber Survey 169
9.7 About the Authors 170
9.7.1 Author 170
9.7.2 Global Head of Healthcare 171
9.8 About GlobalData 172
9.9 Disclaimer 172

1.1 List of Tables

Table 1: Genetic Factors That Confer a Predisposition to UC 18
Table 2: Typical Symptoms of UC 20
Table 3: Truelove and Witts UC Severity Index 24
Table 4: UCDAI 25
Table 5: Treatment Guidelines for UC Used in the 10MM 26
Table 6: Most Commonly Prescribed Drugs for UC by Class in the 10MM, 2013 27
Table 7: UC Management Country Profile - France 32
Table 8: UC Management Country Profile - Germany 34
Table 9: UC Management Country Profile - Italy 36
Table 10: UC Management Country Profile - Spain 38
Table 11: UC Management Country Profile - UK 41
Table 12: Leading Treatments for UC, 2014 44
Table 13: Product Profile - Remicade 47
Table 14: Remicade SWOT Analysis, 2014 51
Table 15: Product Profile - Humira 53
Table 16: Humira Efficacy in the ULTRA 2 Trial 54
Table 17: Product Efficacy Comparison - Humira vs. Remicade 54
Table 18: Humira SWOT Analysis, 2014 56
Table 19: Product Profile - Simponi 58
Table 20: Simponi SWOT Analysis, 2014 60
Table 21: Product Profile - Apriso 62
Table 22: Apriso SWOT Analysis, 2014 64
Table 23: Product Profile - Asacol HD 66
Table 24: Asacol HD SWOT Analysis, 2014 69
Table 25: Product Profile - Lialda 70
Table 26: Lialda SWOT Analysis, 2014 72
Table 27: Product Profile - Pentasa 73
Table 28: Pentasa SWOT Analysis, 2014 75
Table 29: Product Profile - Colazal 76
Table 30: Colazal SWOT Analysis, 2014 78
Table 31: Product Profile - Uceris 79
Table 32: Uceris SWOT Analysis, 2014 81
Table 33: Summary of Other Immunomodulators for UC, 2013 82
Table 34: Biosimilars Pipeline, 2013 85
Table 35: Overall Unmet Needs - Current Level of Attainment 88
Table 36: Corticosteroid Long-Term Side Effects 91
Table 37: Clinical Unmet Needs in UC - Gap Analysis, 2013 94
Table 38: Prognostic Markers in UC 95
Table 39: UC - Pre-Registration and Phase III Pipeline, 2014 96
Table 40: Comparison of Therapeutic Classes in Development for UC, 2014 97
Table 41: Product Profile - Entyvio 100
Table 42: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Induction of Remission in UC 101
Table 43: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Maintenance of Remission in UC 102
Table 44: Most Common Adverse Events with Vedolizumab in the GEMINI I Study 103
Table 45: Entyvio SWOT Analysis, 2014 106
Table 46: Product Profile - Xeljanz 107
Table 47: Results of Phase IIa Trial of Xeljanz in the Induction of Remission in UC 108
Table 48: Most Common Adverse Events in the Phase IIa Trial of Xeljanz 110
Table 49: Xeljanz SWOT Analysis, 2014 112
Table 50: Product Profile - Kappaproct 113
Table 51: Results of Phase IIb Trial of Kappaproct in the Induction of Remission in UC 114
Table 52: Kappaproct SWOT Analysis, 2014 116
Table 53: Sales Forecasts ($m) for UC in France, 2012-2022 119
Table 54: Key Events Impacting Sales for UC in France, 2012-2022 122
Table 55: UC Market in France - Drivers and Barriers, 2012-2022 122
Table 56: Sales Forecasts ($m) for UC in Germany, 2012-2022 127
Table 57: Key Events Impacting Sales for UC in Germany, 2012-2022 130
Table 58: UC Market in Germany - Drivers and Barriers, 2012-2022 130
Table 59: Sales Forecasts ($) for UC in Italy, 2012-2022 134
Table 60: Key Events Impacting Sales for UC in Italy, 2012-2022 136
Table 61: UC Market in Italy - Drivers and Barriers, 2012-2022 136
Table 62: Sales Forecasts ($m) for UC in Spain, 2012-2022 140
Table 63: Key Events Impacting Sales for UC in Spain, 2012-2022 143
Table 64: UC Market in Spain - Drivers and Barriers, 2012-2022 143
Table 65: Sales Forecasts ($m) for UC in the UK, 2012-2022 147
Table 66: Key Events Impacting Sales for UC in the UK, 2012-2022 150
Table 67: UC Market in the UK - Drivers and Barriers, 2012-2022 150
Table 68: Key launches for Ulcerative Colitis , 2012-2022 163
Table 69: Key Patent Expiries 164
Table 70: Annual Cost of Therapy for 5-ASAs ($) 166
Table 71: Physicians Surveyed, 5EU 169

1.2 List of Figures

Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC 20
Figure 2: UC Disease Management Flowchart 30
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents UC, 2012-2022 97
Figure 4: Sales for UC in France by Drug Class, 2012-2022 121
Figure 5: Sales for UC in Germany by Drug Class, 2012-2022 129
Figure 6: Sales for UC in Italy by Drug Class, 2012-2022 135
Figure 7: Sales for UC in Spain by Drug Class, 2012-2022 142
Figure 8: Sales for UC in the UK by Drug Class, 2012-2022 149

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