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JSB Market Research: PharmaPoint:
Ulcerative Colitis - Global Drug Forecast
and Market Analysis to 2022
On 9
th
August 2014

During the forecast period from 2012-2022, the growth of the ulcerative colitis
market will be driven largely by the entry of Johnson & Johnsons (J&Js) Simponi
and Takedas 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.

Overall, major barriers to the growth of the UC market include:

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Remicade and Humira losing patent protection in the mid-forecast
Austerity measures favoring generic prescribing
Biosimilars are predicted to face low uptake due to the lack of regulatory
guidelines in some markets, such as the US
In 2012, GlobalData estimates that the global UC market reached $4.2 billion
across the 10 healthcare markets covered in our forecast: the US, France,
Germany, Italy, Spain, the UK, Japan, Canada, China, and India. By the end of the
forecast period, in 2022, sales across these markets will grow steadily to reach
$6.6 billion, representing a Compound Annual Growth Rate (CAGR) of 4.8% over
the 10-year timeframe.

Highlights

Key Questions Answered

How will the UC market (sales and patient numbers) evolve over the 10-year
forecast period from 2012 to 2022?
Which brands and specific drug classes did physicians select for their UC
patients in 2012 and how do they foresee their prescribing behavior evolving over
the next five years?
How will the launch of late-stage pipeline therapies such as Entyvio and
Kappaproct shape the future treatment landscape?
What are the remaining unmet needs and opportunities for drug developers
within the UC market?

Key Findings

The UC market has predominantly been driven by two TNF blockers, namely
J&Js Remicade and AbbVies Humira. Although these TNF blockers have
monopolized the UC market for almost a decade, the balance is about to be
tipped, with Takedas Entyvio imminently entering the market in 2014 and J&Js
Simponi launching in 2014 as well, stealing market share from Humira and

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Remicade.
Remicade and Humira will also be hit by their respective loss of patent
protection in 2018 (US), 2015 (EU) and 2016 (US), 2018 (EU). Europe has already
approved a biosimilar to Remicade, Celltrions Remsima, which will be marketed
by Hospira under the brand name Inflectra in the EU. Due to lack of regulatory
guidelines and the current debate about indication extrapolation for biosimilars
based on a clinical trial in one indication, initial biosimilar uptake will be low, but
by the end of the forecast period, in 2022 infliximab, adalimumab and golimumab
biosimilars are forecast to become an established part of the UC market.
During the coming decade, Europe is expecting the approval and launch of a UC
colectomy rescue therapy, InDex Pharmaceuticals Kappaproct. Kappaproct is
targeting a small patient population group, but due to the involvement of key
gastroenterologists in the development of this therapy, it will likely be welcomed
for use in this new treatment setting, which has never been addressed before by
a pharmaceutical product. In addition, Pfizers Xeljanz is expected to face low
uptake post its estimated launch in 2017, owing to the controversy surrounding
its rejection by the EMA for its primary indication, rheumatoid arthritis.

Scope

Overview of UC, including epidemiology, etiology, pathophysiology, symptoms,
diagnosis, and current treatment options.
Annualized UC therapeutics market revenue, annual cost of therapy and
treatment usage pattern data from 2012 to 2022.
Key topics covered include strategic competitor assessment, market
characterization, unmet needs, and implications for the UC therapeutics markets.
Pipeline analysis: comprehensive data split across different phases, emerging
novel trends under development, and detailed analysis of late stage pipeline
drugs.
Analysis of the current and future market competition in the global UC
therapeutics markets. Insightful review of the key industry drivers, restraints and
challenges. Each trend is independently researched to provide qualitative analysis
of its implications.

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Reasons to buy

Develop and design in-licensing and out-licensing strategies through a review of
pipeline products and technologies, and by identifying the companies with the
most robust pipeline. Additionally a list of acquisition targets included in the
pipeline product company list.
Develop business strategies by understanding the trends shaping and driving
the global UC therapeutics markets.
Drive revenues by understanding the key trends, innovative products and
technologies, market segments, and companies likely to impact the global UC
therapeutics markets in the future.
Formulate effective sales and marketing strategies by understanding the
competitive landscape and by analyzing the performance of various competitors.
Identify emerging players with potentially strong product portfolios and create
effective counter-strategies to gain a competitive advantage.
Track drug sales in the global UC therapeutics markets from 2012-2022.
Organize sales and marketing efforts by identifying the market categories and
segments that present maximum opportunities for consolidations, investments
and strategic partnerships.

Table of Contents:
1.1 List of Tables
1.2 List of Figures

2 Introduction 25
2.1 Catalyst 25
2.2 Related Reports 25

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2.3 Upcoming Related Reports 25

3 Disease Overview 26
3.1 Etiology and Pathophysiology 26
3.1.1 Etiology 26
3.1.2 Pathophysiology 29
3.2 Symptoms 30
3.2.1 Quality of Life 31

4 Epidemiology 32
4.1 Disease Background 32
4.2 Risk Factors and Comorbidities 33
4.2.1 Being Caucasian and Jewish can increase the risk of UC by almost 37 times
34
4.2.2 A family history of UC in first-degree relatives can increase the risk of the
disease by almost three-fold 34
4.2.3 Current smokers have a lower risk of developing UC than former smokers or
never smokers 35
4.3 Global Trends 36
4.3.1 US 37

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4.3.2 5EU 39
4.3.3 Japan 42
4.3.4 Canada 44
4.3.5 China 45
4.3.6 India 47
4.4 Forecast Methodology 48
4.4.1 Sources Used 50
4.4.2 Sources Not Used 56
4.4.3 Forecast Assumptions and Methods 57
4.5 Epidemiological Forecast of UC (2012-2022) 63
4.5.1 Incident Cases of UC 63
4.5.2 Age-Specific Incident Cases of UC 65
4.5.3 Sex-Specific Incident Cases of UC 66
4.5.4 Age-Standardized Incidence Rates 69
4.6 Epidemiological Forecast for UC Prevalent Cases (2012-2022) 70
4.6.1 Prevalent Cases of UC 70
4.6.2 Age-Specific Prevalent Cases of UC 72
4.6.3 Sex-Specific Prevalent Cases of UC 74
4.6.4 Age-Standardized Prevalence Rate of UC in All Markets 76

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4.7 Discussion 77
4.7.1 Epidemiological Forecast Insight 77
4.7.2 Limitations of the Analysis 78
4.7.3 Strengths of the Analysis 79

5 Disease Management 80
5.1 Diagnosis and Treatment Overview 80
5.1.1 Diagnosis 80
5.1.2 Treatment Guidelines and Leading Prescribed Drugs 84
5.1.3 Clinical Practice 85
5.2 US 89
5.3 France 92
5.4 Germany 94
5.5 Italy 96
5.6 Spain 98
5.7 UK 100
5.8 Japan 102
5.9 Canada 104
5.10 China 106

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5.11 India 108

6 Competitive Assessment 110
6.1 Overview 110
6.2 Strategic Competitor Assessment 111
6.3 Product Profiles - Major Brands 113
6.3.1 Remicade (infliximab) 113
6.3.2 Humira (adalimumab) 121
6.3.3 Simponi (golimumab) 127
6.3.4 Apriso (mesalamine) 131
6.3.5 Asacol HD (mesalamine) 137
6.3.6 Lialda (mesalamine) 142
6.3.7 Pentasa (mesalamine) 146
6.3.8 Colazal (balsazide disodium) 150
6.3.9 Giazo (balsalazide disodium) 154
6.3.10 sfRowasa (mesalamine) 158
6.3.11 Uceris (budesonide) 161
6.3.12 Other Drug Classes Used in the Treatment of UC 165
6.4 Biosimilars 166

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6.4.1 Introduction 166
6.4.2 Hospiras Inflectra Versus J&Js Remicade in Key Autoimmune Diseases 167
6.4.3 Biosimilars in the Immunology Community 167
6.4.4 By the Numbers: Biosimilars in Development 168
6.4.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical
Industry 170
6.4.6 Biosimilars Forecast 171

7 Opportunity and Unmet Need 173
7.1 Overview 173
7.2 Unmet Needs 174
7.2.1 Curative Therapy for Severe UC Patients 174
7.2.2 Diagnostic Markers for Disease Severity 174
7.2.3 Personalized Therapy 175
7.2.4 A Replacement for Steroids 175
7.2.5 Novel Oral Drug Formulations 176
7.2.6 Preventative Medicine for Lowering the Associated Colorectal Cancer Risk
177
7.2.7 Improved Management of Infectious Adverse Events 177
7.3 Unmet Needs Gap Analysis 178

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7.4 Disease Severity and Colorectal Cancer Biomarker-Based Prognostic Tools 179
7.5 Predictors of Medically-Refractory Disease 180

8 Pipeline Assessment 181
8.1 Overview 181
8.2 Clinical Trial Mapping 181
8.2.1 Clinical Trials by Country 181
8.3 Clinical Trials by Phase and Trial Status 182
8.4 Promising Drugs in Clinical Development 183
8.4.1 Entyvio (vedolizumab) 185
8.4.2 Xeljanz (tofacitinib) 195
8.4.3 Kappaproct (DIMS 0150) 202

9 Current and Future Players 208
9.1 Overview 208
9.2 Trends in Corporate Strategy 211
9.3 Company Profiles 212
9.3.1 Johnson & Johnson 212
9.3.2 AbbVie 214

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9.3.3 Takeda Pharmaceuticals 216
9.3.4 Warner Chilcott 218
9.3.5 Salix Pharmaceuticals/Santarus 220
9.3.6 Shire Pharmaceuticals 222
9.3.7 Ferring Pharmaceuticals 224
9.3.8 Pfizer 225
9.3.9 InDeX Pharmaceuticals 227

10 Market Outlook 230
10.1 Global Markets 230
10.1.1 Forecast 230
10.1.2 Drivers and Barriers - Global Issues 235
10.2 United States 239
10.2.1 Forecast 239
10.2.2 Key Events 243
10.2.3 Drivers and Barriers 243
10.3 France 246
10.3.1 Forecast 246

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10.4 Germany 253
10.4.1 Forecast 253
10.5 Italy 259
10.5.1 Forecast 259
10.6 Spain 265
10.6.1 Forecast 265
10.7 United Kingdom 271
10.7.1 Forecast 271
10.8 Japan 277
10.8.1 Forecast 277

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10.9 Canada 284
10.9.1 Forecast 284
10.10 China 289
10.10.1 Forecast 289
10.11 India 294
10.11.1 Forecast 294

11 Appendix 300
11.1 Bibliography 300
11.2 Abbreviations 311
11.3 Methodology 316

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11.4 Forecasting Methodology 316
11.4.1 Diagnosed UC Patients 316
11.4.2 Percent Drug-Treated Patients 317
11.4.3 Drugs Included in Each Therapeutic Class 317
11.4.4 Launch and Patent Expiry Dates 317
11.4.5 General Pricing Assumptions 318
11.4.6 Individual Drug Assumptions 319
11.4.7 Generic Erosion 321
11.4.8 Pricing of Pipeline Agents 321
11.5 Physicians and Specialists Included in This Study 322
11.6 Primary Research - Prescriber Survey 324
11.7 About the Authors 325
11.7.1 Author 325
11.7.2 Epidemiologist 326
11.7.3 Global Head of Healthcare 326
11.8 About GlobalData 327
11.9 Disclaimer 327

List of Tables

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Table 1: Genetic Factors That Confer a Predisposition to UC 28
Table 2: Typical Symptoms of UC 30
Table 3: Strongest Putative Risk Factors for UC 34
Table 4: Prevalence of UC in the US 39
Table 5: Incidence of UC in the 5EU 40
Table 6: Prevalence of UC in the 5EU 41
Table 7: 10MM, Sources of UC Incidence Data Used in the Epidemiological
Forecast 48
Table 8: 10MM, Sources of UC Prevalence Data Used in the Epidemiological
Forecast 49
Table 9: 10MM, Incident Cases of UC, Ages ?10 Years, Both Sexes, N, Select Years,
2012-2022 64
Table 10: 10MM, Incident Cases of UC, By Age, Both Sexes, N (Row %), 2012 65
Table 11: 10MM, Incident Cases of UC, By Sex, Ages ?10 Years, N (Row %), 2012
67
Table 12: 10MM, Prevalent Cases of UC, Ages ?10 Years, Both Sexes, N, Select
Years, 2012-2022 71
Table 13: 10MM, Prevalent Cases of UC, By Age, Both Sexes, N (Row %), 2012 73
Table 14: 10MM, Prevalent Cases of UC, By Sex, Ages ?10 Years, N (Row %), 2012
75
Table 15: Truelove and Witts UC Severity Index 82

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Table 16: UCDAI 83
Table 17: Treatment Guidelines for UC Used in the 10MM 84
Table 18: Most Commonly Prescribed Drugs for UC by Class in the 10MM, 2013 85
Table 19: UC Management Country Profile - US 91
Table 20: UC Management Country Profile - France 93
Table 21: UC Management Country Profile - Germany 95
Table 22: UC Management Country Profile - Italy 97
Table 23: UC Management Country Profile - Spain 98
Table 24: UC Management Country Profile - UK 101
Table 25: UC Management Country Profile - Japan 103
Table 26: Country Profile - Canada 105
Table 27: UC Management Country Profile - China 107
Table 28: UC Management Country Profile - India 109
Table 29: Leading Treatments for UC, 2014 112
Table 30: Product Profile - Remicade 115
Table 31: Remicade SWOT Analysis, 2014 119
Table 32: Global Sales Forecasts ($m) for Remicade, 2012-2022 120
Table 33: Product Profile - Humira 122
Table 34: Humira Efficacy in the ULTRA 2 Trial 123

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Table 35: Product Efficacy Comparison - Humira vs. Remicade 123
Table 36: Humira SWOT Analysis, 2014 125
Table 37: Global Sales Forecasts ($m) for Humira, 2012-2022 126
Table 38: Product Profile - Simponi 128
Table 39: Simponi SWOT Analysis, 2014 130
Table 40: Global Sales Forecasts ($m) for Simponi, 2012-2022 131
Table 41: Product Profile - Apriso 133
Table 42: Apriso SWOT Analysis, 2014 135
Table 43: Global Sales Forecasts ($m) for Apriso, 2012-2022 136
Table 44: Product Profile - Asacol HD 138
Table 45: Asacol HD SWOT Analysis, 2014 141
Table 46: Global Sales Forecasts ($m) for Asacol HD, 2012-2022 142
Table 47: Product Profile - Lialda 143
Table 48: Lialda SWOT Analysis, 2014 145
Table 49: Global Sales Forecasts ($m) for Lialda, 2012-2022 146
Table 50: Product Profile - Pentasa 147
Table 51: Pentasa SWOT Analysis, 2014 149
Table 52: Global Sales Forecasts ($m) for Pentasa, 2012-2022 150
Table 53: Product Profile - Colazal 151

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Table 54: Colazal SWOT Analysis, 2014 153
Table 55: Global Sales Forecasts ($m) for Colazal, 2012-2022 154
Table 56: Product Profile - Giazo 155
Table 57: Giazo SWOT Analysis, 2014 157
Table 58: Global Sales Forecasts ($m) for Giazo, 2012-2022 158
Table 59: Product Profile - sfRowasa 159
Table 60: sfRowasa SWOT Analysis, 2014 160
Table 61: Global Sales Forecasts ($m) for sfRowasa, 2012-2022 161
Table 62: Product Profile - Uceris 162
Table 63: Uceris SWOT Analysis, 2014 164
Table 64: Global Sales Forecasts ($m) for Uceris, 2012-2022 165
Table 65: Summary
of Other Immunomodulators for UC, 2013 166
Table 66: Biosimilars Pipeline, 2013 168
Table 67: Global Sales Forecasts ($m) for Infliximab Biosimilars, 2012-2022 171
Table 68: Global Sales Forecasts ($m) for Adalimumab Biosimilars, 2012-2022 171
Table 69: Global Sales Forecasts ($m) for Golimumab Biosimilars, 2012-2022 172
Table 70: Overall Unmet Needs - Current Level of Attainment 173
Table 71: Corticosteroid Long-Term Side Effects 176

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Table 72: Clinical Unmet Needs in UC - Gap Analysis, 2013 179
Table 73: Prognostic Markers in UC 180
Table 74: UC - Clinical Trials by Phase and Status, 2014 183
Table 75: UC - Pre-Registration and Phase III Pipeline, 2014 183
Table 76: Comparison of Therapeutic Classes in Development for UC, 2014 184
Table 77: Product Profile - Entyvio 187
Table 78: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Induction of
Remission in UC 188
Table 79: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the
Maintenance of Remission in UC 189
Table 80: Most Common Adverse Events with Vedolizumab in the GEMINI I Study
190
Table 81: Entyvio SWOT Analysis, 2014 193
Table 82: Global Sales Forecasts ($m) for Entyvio, 2012-2022 195
Table 83: Product Profile - Xeljanz 196
Table 84: Results of Phase IIa Trial of Xeljanz in the Induction of Remission in UC
197
Table 85: Most Common Adverse Events in the Phase IIa Trial of Xeljanz 199
Table 86: Xeljanz SWOT Analysis, 2014 201
Table 87: Global Sales Forecasts ($m) for Xeljanz, 2012-2022 202
Table 88: Product Profile - Kappaproct 203

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Table 89: Results of Phase IIb Trial of Kappaproct in the Induction of Remission in
UC 204
Table 90: Kappaproct SWOT Analysis, 2014 206
Table 91: Global Sales Forecasts ($m) for Kappaproct, 2012-2022 207
Table 92: Key Companies in the UC Market, 2012-2022 209
Table 93: J&Js UC Portfolio Assessment, 2014 213
Table 94: J&Js SWOT Analysis in UC, 2014 214
Table 95: AbbVies UC Portfolio Assessment, 2014 215
Table 96: AbbVies UC SWOT Analysis, 2014 216
Table 97: Takeda Pharmaceuticals UC Portfolio Assessment, 2014 217
Table 98: Takedas UC SWOT Analysis, 2014 218
Table 99: Warner Chilcotts UC Portfolio Assessment, 2014 219
Table 100: Warner Chilcotts UC SWOT Analysis, 2014 220
Table 101: Salix Pharmaceuticals/Santarus UC Portfolio Assessment, 2013 221
Table 102: Salix Pharmaceuticals/Santarus UC SWOT Analysis, 2014 222
Table 103: Shire Pharmaceuticals UC Portfolio Assessment, 2014 223
Table 104: Shire Pharmaceuticals UC SWOT Analysis, 2014 223
Table 105: Ferring Pharmaceuticals UC Portfolio Assessment, 2013 224
Table 106: Ferring Pharmaceuticals UC SWOT Analysis, 2014 225

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Table 107: Pfizers UC Portfolio Assessment, 2014 226
Table 108: Pfizers UC SWOT Analysis, 2014 227
Table 109: InDeX Pharmaceuticals UC Portfolio Assessment, 2013 228
Table 110: InDeX Pharmaceuticals UC SWOT Analysis, 2014 229
Table 111: Global Sales Forecasts ($m) for UC, 2012-2022 232
Table 112: Global UC Market - Drivers and Barriers, 2012-2022 235
Table 113: Sales Forecasts ($m) for UC in the US, 2012-2022 241
Table 114: Key Events Impacting Sales for UC in the US, 2012-2022 243
Table 115: UC Market in the US - Drivers and Barriers, 2012-2022 243
Table 116: Sales Forecasts ($m) for UC in France, 2012-2022 247
Table 117: Key Events Impacting Sales for UC in France, 2012-2022 250
Table 118: UC Market in France - Drivers and Barriers, 2012-2022 250
Table 119: Sales Forecasts ($m) for UC in Germany, 2012-2022 255
Table 120: Key Events Impacting Sales for UC in Germany, 2012-2022 257
Table 121: UC Market in Germany - Drivers and Barriers, 2012-2022 257
Table 122: Sales Forecasts ($) for UC in Italy, 2012-2022 261
Table 123: Key Events Impacting Sales for UC in Italy, 2012-2022 263
Table 124: UC Market in Italy - Drivers and Barriers, 2012-2022 263
Table 125: Sales Forecast

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List of Figures
Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC 30
Figure 2: Olmsted Country, Minnesota, US, Age- and Sex-Adjusted Incidence of
UC, Cases per 100,000 Population, 1940-2000 38
Figure 3: Canada, Incidence and Prevalence of UC, Cases per 100,000 Population,
1990-2001 44
Figure 4: Hong Kong, China, Crude Incidence and Prevalence of UC, Cases per
100,000 Population, 1997-2006 46
Figure 5: 10MM, Incident Cases of UC, Ages ? 10 Years, Both Sexes, N, 2012-2022
64
Figure 6: 10MM, Incident Cases of UC, By Age, Both Sexes, N, 2012 66
Figure 7: 10MM, Incident Cases of UC, By Sex, Ages ?10 Years, N, 2012 68
Figure 8: 10MM, Age-Standardized Incidence of UC, Ages ?10 Years, Both Sexes,
Cases per 100,000 Population, 2012 69
Figure 9: 10MM, Prevalent Cases of UC, Ages ?10 Years, Both Sexes, N, 2012-2022
72
Figure 10: 10MM, Prevalent Cases of UC, By Sex, Ages ? 10 Years, N, 2012 74
Figure 11: 10MM, Prevalent Cases of UC, By Sex, Ages ?10 Years, N, 2012 76
Figure 12: 10MM, Age-Standardized Prevalence of UC, Ages ?10 Years, Both
Sexes, %, 2012 77
Figure 13: UC Disease Management Flowchart 88

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Figure 14: UC Therapeutics - Clinical Trials by Country, 2014 182
Figure 15: Competitive Assessment of Late-Stage Pipeline Agents UC, 2012-2022
184
Figure 16: Company Portfolio Gap Analysis in UC, 2012-2022 210
Figure 17: Global Sales for UC by Region, 2012 (Total: $m)-2022 (Total: $m) 234
Figure 18: Sales for UC in the US by Drug Class, 2012-2022 242
Figure 19: Sales for UC in France by Drug Class, 2012-2022 249
Figure 20: Sales for UC in Germany by Drug Class, 2012-2022 256
Figure 21: Sales for UC in Italy by Drug Class, 2012-2022 262
Figure 22: Sales for UC in Spain by Drug Class, 2012-2022 268
Figure 23: Sales for UC in the UK by Drug Class, 2012-2022 274
Figure 24: Sales for UC in Japan by Drug Class, 2012-2022 280
Figure 25: Sales for UC in Canada by Drug Class, 2012-2022 286
Figure 26: Sales for UC in China by Drug Class, 2012-2022 291
Figure 27: Sales for UC in India by Drug Class, 2012-2022 296

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To know more on PharmaPoint: Ulcerative Colitis - Global Drug Forecast and
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Forecast-and-Market-Analysis-114234

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