1 Table of Contents
1 Table of Contents 10
1.1 List of Tables 16
1.2 List of Figures 23
2 Introduction 25
2.1 Catalyst 25
2.2 Related Reports 26
2.3 Upcoming Related Reports 26
3 Disease Overview 27
3.1 Etiology and Pathophysiology 27
3.1.1 Etiology 27
3.1.2 Pathophysiology 31
3.2 Classification or Staging Systems 33
3.3 Symptoms 36
3.4 Quality of Life 36
4 Epidemiology 38
4.1 Disease Background 38
4.2 Risk Factors and Comorbidities 39
4.3 Global Trends 40
4.3.1 Incidence 41
4.3.2 Prevalence 44
4.4 Forecast Methodology 47
4.4.1 Sources Used 47
4.4.2 Forecast Assumptions and Methods 58
4.4.3 Sources Not Used 76
4.5 Epidemiological Forecast for UC (2015-2025) 77
4.5.1 Diagnosed Incident Cases of UC 77
4.5.2 Diagnosed Prevalent Cases of UC 85
4.5.3 Undiagnosed Prevalent Cases of UC 96
4.5.4 Total Prevalent Cases of UC 103
4.5.5 Diagnosed Incident Cases of IC 109
4.5.6 Diagnosed Prevalent Cases of IC 111
4.6 Discussion 112
4.6.1 Epidemiological Forecast Insight 112
4.6.2 Limitations of the Analysis 113
4.6.3 Strengths of the Analysis 114
4.6.4 Strengths of the Analysis 115
5 Disease Management 116
5.1 Diagnosis and Treatment Overview 116
5.1.1 Diagnosis 116
5.1.2 Treatment Guidelines and Leading Prescribed Drugs 121
5.1.3 Clinical Practice 123
5.2 US 129
5.3 5EU 131
5.4 Japan 135
6 Competitive Assessment 138
6.1 Overview 138
6.2 Product Profiles - Ulcerative Colitis 140
6.2.1 5-ASAs 140
6.2.2 Steroids 145
6.2.3 Thiopurines 150
6.2.4 Other Immunomodulators 154
6.2.5 Anti-TNFα drugs (Remicade, Humira, Simponi) 157
6.2.6 Anti-integrins (Entyvio) 174
6.2.7 Biosimilars 180
7 Unmet Needs Assessment and Opportunity Analysis 185
7.1 Overview 185
7.2 Inadequacy of current anti-TNF- α drug treatment 186
7.2.1 Unmet need 186
7.2.2 Gap Analysis 187
7.2.3 Opportunity 188
7.3 Patient Adherence 188
7.3.1 Unmet Need 188
7.3.2 Gap Analysis 189
7.3.3 Opportunity 189
7.4 Lack of safe, efficacious and less costly treatment alternatives 190
7.4.1 Unmet Need 190
7.4.2 Gap Analysis 191
7.4.3 Opportunity 192
7.5 Need for novel oral therapies 192
7.5.1 Unmet Need 192
7.5.2 Gap Analysis 192
7.5.3 Opportunity 193
7.6 Preventative Medicine for Lowering the Associated Colorectal Cancer Risk 193
7.6.1 Unmet Need 193
7.6.2 Gap Analysis 194
7.6.3 Opportunity 194
8 Pipeline Assessment 195
8.1 Overview 195
8.2 Promising Drugs in Clinical Development 196
8.2.1 Ustekinumab (Stelara, Suterara, CNTO-1275) 197
8.2.2 Etrolizumab 202
8.2.3 LT-02 (phosphatidylcholine) 207
8.2.4 Kappaproct 213
8.2.5 Xeljanz (Tofacitinib, Cp-690,550) 219
8.2.6 Ozanimod hydrochloride 226
8.2.7 Carotegrast (AJM300) 230
8.2.8 Mesalamine (TP-05) 235
8.2.9 AJG511 238
8.3 Biosimilars 242
8.3.1 Overview 242
8.3.2 Infliximab biosimilars 244
8.3.3 Adalimumab biosimilars 247
8.3.4 Forecast 251
9 Current and Future Players 252
9.1 Overview 252
9.2 Trends in Corporate Strategy 253
9.3 Company Profiles 254
9.3.1 Johnson & Johnson (J&J) 254
9.3.2 AbbVie 256
9.3.3 Takeda Pharmaceuticals 257
9.3.4 Salix Pharmaceuticals 258
9.3.5 Pfizer Inc. 259
9.3.6 F. Hoffmann-La Roche Ltd. 261
9.3.7 InDex Pharmaceuticals 262
9.3.8 Lipid Therapeutics GmbH 263
9.3.9 Celgene Corporation 264
9.3.10 EA Pharma 265
9.3.11 Ferring International 266
9.3.12 Tillotts Pharma 268
10 Market Outlook 270
10.1 Global Markets 270
10.1.1 Forecast 270
10.1.2 Drivers and Barriers - Global Issues 273
10.2 US 276
10.2.1 Forecast 276
10.2.2 Key Events 277
10.2.3 Drivers and Barriers 278
10.3 France 279
10.3.1 Forecast 279
10.3.2 Key Events 282
10.3.3 Drivers and Barriers 282
10.4 Germany 283
10.4.1 Forecast 283
10.4.2 Key Events 286
10.4.3 Drivers and Barriers 286
10.5 Italy 288
10.5.1 Forecast 288
10.5.2 Key Events 290
10.5.3 Drivers and Barriers 290
10.6 Spain 291
10.6.1 Forecast 291
10.6.2 Key Events 294
10.6.3 Drivers and Barriers 294
10.7 United Kingdom 295
10.7.1 Forecast 295
10.7.2 Key Events 298
10.7.3 Drivers and Barriers 298
10.8 Japan 299
10.8.1 Forecast 299
10.8.2 Key Events 302
10.8.3 Drivers and Barriers 302
11 Appendix 305
11.1 Bibliography 305
11.2 Abbreviations 322
11.3 Methodology 327
11.4 Forecasting Methodology 327
11.4.1 Diagnosed Prevalent Patients 327
11.4.2 Percent Drug-Treated Patients 328
11.4.3 Drugs Included in Each Therapeutic Class 328
11.4.4 Launch and Patent Expiry Dates 329
11.4.5 General Pricing Assumptions 329
11.4.6 Individual Drug Assumptions 330
11.4.7 Generic Erosion 335
11.4.8 Pricing of Pipeline Agents 336
11.5 Primary Research - KOLs Interviewed for this Report 337
11.6 Primary Research - Prescriber Survey 339
11.7 About the Authors 340
11.7.1 Analyst 340
11.7.2 Analyst 340
11.7.3 Reviewer 340
11.7.4 Therapy Area Director 341
11.7.5 Epidemiologist 341
11.7.6 Managing Epidemiologist 342
11.7.7 Global Director of Therapy Analysis and Epidemiology 343
11.8 About GlobalData 344
11.9 Disclaimer 344

1.1 List of Tables
Table 1: Genetic factors implicated in UC causation 31
Table 2: Truelove and Witts categorization of disease severity and clinical parameters 34
Table 3: Pediatric Ulcerative Colitis Activity Index 35
Table 4: Typical Symptoms of UC 36
Table 5: Risk Factors and Comorbidities for UC and IBD 39
Table 6: Incidence of UC in the 5EU 43
Table 7: Prevalence of UC in Italy, Spain, and the UK 46
Table 8: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of UC 48
Table 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of UC 49
Table 10: 7MM, Sources Used to Forecast Undiagnosed Prevalent Cases of UC 50
Table 11: 7MM, Sources Used to Forecast the Total Prevalent Cases of UC 51
Table 12: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of UC by Stage at Diagnosis 52
Table 13: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Incident/Prevalent Cases of UC by Severity 53
Table 14: 7MM, Sources of Epidemiological Data used to Forecast Mortality Due to CRC and TMC Among the Diagnosed Prevalent Cases of UC 54
Table 15: 7MM, Sources Used to Forecast Autoimmune Comorbidities Among the Diagnosed Prevalent Cases of UC 55
Table 16: 7MM, Sources Used to Forecast UC Cases Requiring Colectomy Among the Diagnosed Prevalent Cases of UC Due to Failure of Medical Management 56
Table 17: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of IC 57
Table 18: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of IC 58
Table 19: 7MM, Sources Not Used in Epidemiological Analysis of UC 76
Table 20: 7MM, Diagnosed Incident Cases of UC, Both Sexes, All Ages, N, Selected Years 2015-2025 77
Table 21: 7MM, Age-Specific Diagnosed Incident Cases of UC, Both Sexes, N (Row %), 2015 79
Table 22: 7MM, Sex-Specific Diagnosed Incident Cases of UC, All Ages, N (Row %), 2015 81
Table 23: 7MM, Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, Selected Years, 2015-2025 86
Table 24: 7MM, Age-Specific Diagnosed Prevalent Cases of UC, Both Sexes, N (Row %), 2015 88
Table 25: 7MM, Sex-Specific Diagnosed Prevalent Cases of UC, All Ages, N (Row %), 2015 90
Table 26: 7MM, Undiagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, Select Years, 2015-2025 97
Table 27: 7MM, Age-Specific Undiagnosed Prevalent Cases of UC, Both Sexes, N (Row %), 2015 99
Table 28: 7MM, Sex-Specific Undiagnosed Prevalent Cases of UC, All Ages, N (Row %), 2015 101
Table 29: 7MM, Total Prevalent Cases of UC, Both Sexes, All Ages, N, Selected Years, 2015-2025 104
Table 30: 7MM, Age-Specific Total Prevalent Cases of UC, Both Sexes, N (Row %), 2015 105
Table 31: 7MM, Sex-Specific Total Prevalent Cases of UC, All Ages, N (Row %), 2015 107
Table 32: 7MM, Diagnosed Incident Cases of IC, Both Sexes, All Ages, N, Selected Years, 2015-2025 110
Table 33: 7MM, Diagnosed Prevalent Cases of IC, Both Sexes, All Ages, N, Selected Years, 2015-2025 111
Table 34: Diagnostic features of UC 117
Table 35: Truelove and Witts categorization of disease severity and clinical parameters 118
Table 36: UCDAI 119
Table 37: Pediatric Ulcerative Colitis Activity Index 120
Table 38: Treatment Guidelines for Ulcerative Colitis 121
Table 39: Most Prescribed Drugs for Ulcerative Colitis by Class in the Global Markets, 2015 122
Table 40: Different 5-ASAs used for managing UC 125
Table 41: Different corticosteroids used for managing UC 126
Table 42: Country Profile - US 130
Table 43: Region Profile - 5EU 132
Table 44: Country Profile - Japan 136
Table 45: Leading Treatments for UC, 2015 139
Table 46: Product Profile - Lialda 142
Table 47: Efficacy of different drugs in 5-ASA class in inducing remission in UC patients 143
Table 48: Efficacy of different drugs in 5-ASA class in preventing disease relapse in UC patients 143
Table 49: Percentage of patients experiencing adverse events with 5-ASAs 144
Table 50: 5-ASA SWOT Analysis, 2015 144
Table 51: Product Profile -Steroids 147
Table 52: Efficacy of Uceris 148
Table 53: Safety of Uceris 149
Table 54: Uceris SWOT Analysis, 2016 149
Table 55: Product Profile -Azathioprine 151
Table 56: Percentage of patients experiencing adverse events with AZA and 6-MP therapy 153
Table 57: Azathioprine SWOT Analysis, 2015 153
Table 58: Product Profile -MTX 155
Table 59: MTX SWOT Analysis, 2015 157
Table 60: Product Profile -Remicade 160
Table 61: Efficacy data for ACT 1 and ACT 2 trials 161
Table 62: Safety of Remicade 163
Table 63: SWOT Analysis, Remicade 2016 164
Table 64: Product Profile -Humira 166
Table 65: Efficacy of Humira - Primary and Secondary Endpoints-ULTRA 2 Phase III Program 167
Table 66: SWOT Analysis, Humira 2016 168
Table 67: Product Profile -Simponi 170
Table 68: Efficacy of Simponi 171
Table 69: Safety of Simponi 172
Table 70: Simponi SWOT Analysis, 2016 173
Table 71: Product Profile - Entyvio 176
Table 72: Efficacy of Entyvio 177
Table 73: Efficacy of Entyvio 177
Table 74: Safety of Entyvio 178
Table 75: Entyvio SWOT Analysis 179
Table 76: Infliximab Biosimilars for UC Treatment 181
Table 77: Product Profile -Infliximab biosimilar 181
Table 78: Percentage of patients experiencing adverse events with infliximab biosimilars 183
Table 79: Biosimilars SWOT Analysis, 2015 184
Table 80: Unmet Need and Opportunity in UC, 2015 185
Table 81: Late stage development drugs for UC, 2015-2025 196
Table 82: Product Profile - Ustekinumab 198
Table 83: Ustekinumab SWOT Analysis, 2015 201
Table 84: Product Profile - Etrolizumab 203
Table 85: Efficacy of Etrolizumab 204
Table 86:Safety of Etrolizumab 205
Table 87 : Pipeline Drug Etrolizumab SWOT Analysis, 2016 206
Table 88: Product Profile - LT-02 209
Table 89: Efficacy Analysis for LT-02 210
Table 90: Efficacy Analysis for Different Doses of LT-02 211
Table 91: LT-02 SWOT Analysis, 2015 212
Table 92: Product Profile - Kappaproct 215
Table 93: Safety of Kappaproct 217
Table 94: Kappaproct SWOT Analysis, 2016 218
Table 95: Product Profile - Xeljanz 221
Table 96: Patient reported outcomes for Xeljanz compared to placebo 222
Table 97: Mean change from baseline in partial Mayo score in Xeljanz and placebo groups 222
Table 98: Mean change from baseline in partial Mayo score in Xeljanz and placebo groups 223
Table 99: Rates of various adverse events experienced in Xeljanz and placebo groups 223
Table 100: Xeljanz SWOT Analysis, 2015 225
Table 101: Product Profile - Ozanimod hydrochloride 227
Table 102: Efficacy analysis of Ozanimod 228
Table 103: Safety of Ozanimod 228
Table 104: Pipeline Drug Ozanimod SWOT Analysis, 2015 230
Table 105: Product Profile - Carotegrast 232
Table 106: Efficacy analysis in carotegrast and placebo groups 232
Table 107: Safety analysis of carotegrast 233
Table 108: Carotegrast SWOT Analysis, 2015 234
Table 109: Product Profile - Mesalamine (TP-05) 236
Table 110: Pipeline Drug TP-05 SWOT Analysis, 2016 238
Table 111: Product Profile - AJG511 239
Table 112: Efficacy analysis of AJG511 240
Table 113: Carotegrast SWOT Analysis, 2015 242
Table 114: Product Profile - Infliximab biosimilars 245
Table 115: Infliximab biosimilars SWOT Analysis, 2015 247
Table 116: Product Profile - Amjevita 249
Table 117: Amjevita SWOT Analysis, 2016 251
Table 118: Key Companies in the Ulcerative Colitis Market in the 7MM, 2015 252
Table 119: J&J’s UC Portfolio Assessment, 2015 255
Table 120: AbbVie’s UC Portfolio Assessment, 2015 257
Table 121: Takeda’s UC Portfolio Assessment, 2015 258
Table 122: Salix Pharmaceuticals’ UC Portfolio Assessment, 2015 259
Table 123: Pfizer’s UC Portfolio Assessment, 2015 261
Table 124: Roches UC Portfolio Assessment, 2015 262
Table 125: InDex Pharmaceutical’s UC Portfolio Assessment, 2015 263
Table 126: Lipid Therapeutics’ UC Portfolio Assessment, 2015 264
Table 127: Celgene’s UC Portfolio Assessment, 2015 265
Table 128: EA Pharma’s UC Portfolio Assessment, 2015 266
Table 129: Ferring Pharmaceuticals’ UC Portfolio Assessment, 2015 268
Table 130: Tillotts Pharma’s UC Portfolio Assessment, 2015 269
Table 131:Ulcerative Colitis Market - Global Drivers and Barriers, 2015‒2025 273
Table 132: Key Events Impacting Sales for Ulcerative Colitis in the US, 2015-2025 278
Table 133: Ulcerative Colitis Market - Drivers and Barriers in the US, 2015‒2025 278
Table 134: Key Events Impacting Sales for Ulcerative Colitis in France, 2015-2025 282
Table 135: Ulcerative Colitis Market - Drivers and Barriers in France, 2015‒2025 282
Table 136: Key Events Impacting Sales for Ulcerative Colitis in Germany, 2015-2025 286
Table 137: Ulcerative Colitis Market - Drivers and Barriers in Germany, 2015‒2025 286
Table 138: Key Events Impacting Sales for Ulcerative Colitis in Italy, 2015-2025 290
Table 139: Ulcerative Colitis Market - Drivers and Barriers in Italy, 2015‒2025 290
Table 140: Key Events Impacting Sales for Ulcerative Colitis in Spain, 2015-2025 294
Table 141: Ulcerative Colitis Market - Drivers and Barriers in Spain, 2015‒2025 294
Table 142: Key Events Impacting Sales for Ulcerative Colitis in the UK, 2015-2025 298
Table 143: Ulcerative Colitis Market - Drivers and Barriers in UK, 2015‒2025 298
Table 144: Key Events Impacting Sales for Ulcerative Colitis in Japan, 2015-2025 302
Table 145: Ulcerative Colitis Market - Drivers and Barriers in Japan, 2015‒2025 302
Table 146: Key Projected Launch Dates for UC 329
Table 147: Key Historical and Projected Patent Expiry Dates for UC 329
Table 148: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 339

1.2 List of Figures
Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC 32
Figure 2: 7MM, Diagnosed Incident Cases of UC, Both Sexes, All Ages, Selected Years, 2015-2025 78
Figure 3: 7MM, Age-Specific Diagnosed Incident Cases of UC, Both Sexes, All Ages, N, 2015 80
Figure 4: 7MM, Sex-Specific Diagnosed Incident Cases of UC, All Ages, N, 2015 82
Figure 5: 7MM, Age-Standardized Diagnosed Incidence of UC (Cases per 100,000 Population), All Ages, Both Sexes, N, 2015 83
Figure 6: 7MM, Diagnosed Incident Cases of UC Segmented by Stage at Diagnosis, Both Sexes, All Ages, N, 2015 84
Figure 7: 7MM, Diagnosed Incident Cases of UC Segmented by Severity, Both Sexes, All ages, N, 2015 85
Figure 8: 7MM, Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, Selected Years, 2015-2025 86
Figure 9: 7MM, Age-Specific Diagnosed Prevalent Cases of UC, Both Sexes, N, 2015 89
Figure 10: 7MM, Sex-Specific Diagnosed Prevalent Cases of UC, All Ages, N, 2015 91
Figure 11:7MM, Age-Standardized Diagnosed Prevalence of UC, All Ages, Both Sexes, %, 2015 92
Figure 12: 7MM, Diagnosed Prevalent Cases of UC Segmented by Severity, Both Cases, All Ages, N, 2015 93
Figure 13: 7MM, Mortality Due to Complications Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2015 94
Figure 14: 7MM, Colectomy Due to Failure of Medical Management Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2015 95
Figure 15: 7MM. Comorbidities Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2015 96
Figure 16: 7MM, Undiagnosed Prevalent Cases of UC, Both Sexes, All Ages, Selected Years, N, 2015-2025 98
Figure 17: 7MM, Age-Specific Undiagnosed Prevalent Cases of UC, Both Sexes, N, 2015 100
Figure 18: 7MM, Sex-Specific Undiagnosed Prevalent Cases of UC, All Ages, N, 2015 102
Figure 19: 7MM, Age-Standardized Undiagnosed Prevalence of UC, All Ages, Both Sexes, %, 2015 103
Figure 20: 7MM, Total Prevalent Cases of UC, Both Sexes, All Ages, Selected Years, N, 2015-2025 104
Figure 21: 7MM, Age-Specific Total Prevalent Cases of UC, Both Sexes, N, 2015 106
Figure 22: 7MM, Sex-Specific Total Prevalent Cases of UC, All Ages, N, 2015 108
Figure 23: 7MM, Age-Standardized Total Prevalence of UC, All Ages, Both Sexes, %, 2015 109
Figure 24: 7MM, Diagnosed Incident Cases of IC, Both Sexes, All Ages, Selected Years, N, 2015-2025 110
Figure 25: 7MM, Diagnosed Prevalent Cases of IC, Both Sexes, All Ages, Selected Years, N, 2015-2025 112
Figure 26 : Ulcerative Colitis Treatment Algorithm 129
Figure 27: Global Sales for Ulcerative Colitis by Drug Class, 2015 and 2025 272
Figure 28: Sales for Ulcerative Colitis by Drug Class in the US, 2015 and 2025 277
Figure 29: Sales for Ulcerative Colitis by Drug Class in France, 2015 and 2025 281
Figure 30: Sales for Ulcerative Colitis by Drug Class in Germany, 2015 and 2025 285
Figure 31: Sales for Ulcerative Colitis by Drug Class in Italy, 2015 and 2025 289
Figure 32: Sales for Ulcerative Colitis by Drug Class in Spain, 2015 and 2025 293
Figure 33: Sales for Ulcerative Colitis by Drug Class in the UK, 2015 and 2025 297
Figure 34: Sales for Ulcerative Colitis by Drug Class in Japan, 2015 and 2025 301