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Ulcerative Colitis: Global Drug Forecast and Market Analysis to 2026

  • Published Date: 26 Jun 2018
  • Number of Pages: 272
  • Category: Pharmaceuticals
  • Country: Global
Ulcerative Colitis: Global Drug Forecast and Market Analysis to 2026

Summary

Inflammatory bowel disease (IBD) refers to two chronic autoimmune diseases that cause intestinal inflammation: Crohns disease (CD) and ulcerative colitis (UC). In UC, chronic inflammation affects the colon or large intestines, which are synonymous terms. UC usually manifests initially in the terminal part of the colon, the rectum, and is termed ulcerative proctitis. It can extend to the entire left part of the colon (left-sided proctitis) or the entire colon (pancolitis).

GlobalData estimates the 2016 sales for the UC market at approximately $5.4 billion across the 7MM, encompassing the US, the five major European Union countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. Over the course of the 10-year forecast period, the UC market is expected to grow at a Compound Annual Growth Rate (CAGR) of 2.5% across the 7MM. Each of the 7MM are anticipated to grow, recording CAGRs of 2.7%, 1.2%, and 4.3% across the US, 5EU, and Japan, respectively. At the end of 2026, the US will account for 80.4% of sales across the 7MM, while the 5EU and Japan, will account for around 16.1% and 3.4% of sales, respectively. The higher sales numbers for the US can be attributed to the higher prices of pharmaceuticals and the greater diagnosed prevalence of UC in the region, as well as the high annual cost of therapy (ACOT) of J&Js Stelara and the anticipated ACOT of AbbVies risankizumab and Eli Lillys mirikizumab in the US market.

Key Questions Answered

- How will the UC market landscape in the 7MM (US, France, Germany, Italy, Spain, UK , and Japan) change from 2016-2026?
- What are the most promising late-stage pipeline drugs in UC?
- How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another, and against existing treatment options?
- What are the greatest unmet needs in UC? Will the pipeline drugs fulfil these needs of the market?
- What are the largest opportunities in the UC landscape?

Scope

- Overview of UC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
- Topline UC market revenue from 2016-2026. ACOT and major pipeline product sales in this forecast period are included.
- Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting UC therapeutics sales in the 7MM.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
- Analysis of the current and future market competition in the global UC therapeutics market. Insightful review of the key industry drivers, restraints, and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global UC therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the UC therapeutics market 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.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.
Publisher Name : GlobalData
1.1 List of Tables 4
1.2 List of Figures 7
2 Ulcerative Colitis: Executive Summary 9
2.1 Moderate Growth is Expected for UC Market from 2016-2026 10
2.2 R&D and Corporate Strategies 11
2.3 Current and Pipeline Products Partially Address Unmet Needs 13
2.4 Opportunities for Managing Severe to Fulminant Patients Remain 14
2.5 Oral Therapies and Biosimilars to Drive Growth in UC Market 14
2.6 What Do Physicians Think? 15
3 Introduction 18
3.1 Catalyst 18
3.2 Related Reports 18
3.3 Upcoming Related Reports 19
4 Disease Overview 20
4.1 Etiology and Pathophysiology 20
4.2 Classification or Staging Systems 24
4.3 Symptoms 26
4.4 Quality of Life 26
5 Epidemiology 28
5.1 Disease Background 28
5.2 Risk Factors and Comorbidities 29
5.3 Global and Historical Trends 30
5.4 Forecast Methodology 32
5.5 Epidemiological Forecast for UC (2016-2026) 60
5.6 Discussion 76
6 Disease Management 79
6.1 Diagnosis Overview 79
6.2 Treatment Overview 80
6.3 Treatment Guidelines and Leading Prescribed Drugs 80
6.4 US 83
6.5 5EU 85
6.6 Japan 86
7 Competitive Assessment 88
7.1 Overview 88
7.2 5-ASAs 90
7.3 Steroids 94
7.4 Thiopurines 97
7.5 Other Immunomodulators 101
7.6 Remicade 105
7.7 Humira 110
7.8 Simponi 115
7.9 Entyvio 119
7.10 Xeljanz 124
7.11 Biosimilar Assessment 129
7.12 Infliximab Biosimilars 133
7.13 Adalimumab Biosimilars 138
8 Unmet Needs and Opportunity Assessment 142
8.1 Overview 142
8.2 Lack of Safe and Efficacious Treatment Alternatives 143
8.3 Need for Novel Oral Therapies 146
8.4 Improved Medical Management for Severe to Fulminant Patients 147
8.5 Cost of Therapy 149
9 Pipeline Assessment 151
9.1 Overview 151
9.2 Promising Drugs in Clinical Development 152
9.3 Stelara 153
9.4 Etrolizumab 158
9.5 Ozanimod Hydrochloride 162
9.6 Carotegrast (AJM300) 167
9.7 SHP-647 170
9.8 Upadacitinib Tartrate 175
9.9 Filgotinib 178
9.10 Kappaproct 182
9.11 Risankizumab 186
9.12 Mirikizumab 190
9.13 Other Drugs in Development 193
10 Current and Future Players 194
10.1 Overview 194
10.2 Trends in Corporate Strategy 197
10.3 Johnson & Johnson 198
10.4 AbbVie 200
10.5 Takeda Pharmaceuticals 202
10.6 Pfizer 204
10.7 Roche 206
10.8 InDex Pharmaceuticals 207
10.9 Celgene Corporation 209
10.10 EA Pharma 211
10.11 Galapagos 212
10.12 Eli Lilly 213
10.13 Shire 214
11 Market Outlook 216
11.1 Global Markets 216
11.2 US 219
11.3 5EU 222
11.4 Japan 226
12 Appendix 229
12.1 Bibliography 229
12.2 Abbreviations 248
12.3 Methodology 252
12.4 Primary Research - KOLs Interviewed for This Report 259
12.5 Primary Research - Prescriber Survey 261
12.6 About the Authors 262
12.7 About GlobalData 265
12.8 Contact Us 265
12.9 Disclaimer 266

List Of Tables


Table 1: Ulcerative Colitis: Key Metrics in the 7MM 15
Table 2: Truelove and Witts Categorization of Disease Severity and Clinical Parameters 30
Table 3: Montreal Classification for the Distribution of UC 31
Table 4: Typical Symptoms of UC 32
Table 5: Risk Factors and Comorbidities for UC and IBD 35
Table 6: Truelove and Witts Categorization of Disease Severity and Clinical Parameters 85
Table 7: Different Guidelines Used for Managing UC 87
Table 8: Country Profile - US 90
Table 9: Country Profile - 5EU 92
Table 10: Country Profile - Japan 93
Table 11: Leading Treatments for UC, 2017 96
Table 12: Product Profile - Pentasa 97
Table 13: Efficacy of Different Drugs in the 5-ASA Class in Inducing Remission in UC Patients 98
Table 14: Efficacy of Different Drugs in the 5-ASA Class in Preventing Disease Relapse in UC Patients 98
Table 15: Percentage of Patients Experiencing AEs with 5-ASAs 99
Table 16: 5-ASA SWOT Analysis, 2018 99
Table 17: Product Profile - Uceris 101
Table 18: Efficacy of Uceris 102
Table 19: Uceris SWOT Analysis, 2018 103
Table 20: Product Profile - AZA 104
Table 21: Percentage of Patients Experiencing AEs with AZA and 6-MP Therapy 106
Table 22: AZA SWOT Analysis, 2018 106
Table 23: Product Profile - MTX 108
Table 24: MTX SWOT Analysis, 2018 110
Table 25: Product Profile - Remicade 112
Table 26: Efficacy Data for the ACT 1 and ACT 2 Trials 113
Table 27: Safety of Remicade 115
Table 28: Remicade SWOT Analysis, 2018 115
Table 29: Product Profile - Humira 118
Table 30: Efficacy of Humira - Primary and Secondary 119
Table 31: Humira SWOT Analysis, 2018 120
Table 32: Product Profile - Simponi 122
Table 33: Efficacy of Simponi 123
Table 34: Safety of Simponi 124
Table 35: Simponi SWOT Analysis, 2018 124
Table 36: Product Profile - Entyvio 126
Table 37: Efficacy of Entyvio 127
Table 38: Efficacy of Entyvio 128
Table 39: Safety of Entyvio 129
Table 40: Entyvio SWOT Analysis, 2018 129
Table 41: Product Profile - Xeljanz 132
Table 42: Mean change in Mayo score from OCTAVE Sustain 133
Table 43: Safety analysis from OCTAVE Induction 1 and 2 Trials 133
Table 44: Rates of various AEs from OCTAVE Induction 1 and 2 133
Table 45: Xeljanz SWOT Analysis, 2018 134
Table 46: Marketed and Pipeline Biosimilars for UC, 2018 136
Table 47: Average price of Remicade discount accross the 7MM 137
Table 48: Product Profile - Inflectra/Remsima 141
Table 49: Infliximab Biosimilars SWOT Analysis, 2018 143
Table 50: Product Profile - Amjevita 145
Table 51: Adalimumab Biosimilars SWOT Analysis, 2018 146
Table 52: Unmet Need and Opportunity in UC, 2017 149
Table 53: Product Profile - Stelara 160
Table 54: Stelara SWOT Analysis, 2018 163
Table 55: Product Profile - Etrolizumab 165
Table 56: Efficacy Data for Etrolizumab 166
Table 57: Etrolizumab SWOT Analysis, 2018 167
Table 58: Product Profile - Ozanimod Hydrochloride 169
Table 59: Efficacy Analysis of Ozanimod Hydrochloride from the Phase II TOUCHSTONE Trial 170
Table 60: Summary of the AEs Associated with Ozanimod Use in the TOUCHSTONE Phase ll Trial. 170
Table 61: Ozanimod SWOT Analysis, 2018 172
Table 62: Product Profile - Carotegrast 174
Table 63: Efficacy Analysis of Carotegrast 174
Table 64: AEs Seen in Patients Treated with Carotegrast and Placebo 175
Table 65: Carotegrast SWOT Analysis, 2018 176
Table 66: Product Profile - SHP-647 178
Table 67: SHP-647 - Remission, Response, and Mucosal Healing Rates at Week 12 with Local Endoscopy Readings 178
Table 68: SHP-647 SWOT Analysis, 2018 180
Table 69: Product Profile - Upadacitinib 182
Table 70: Upadacitinib SWOT Analysis, 2018 184
Table 71: Product Profile - Filgotinib 186
Table 72: Filgotinib SWOT Analysis, 2018 188
Table 73: Product Profile - Kappaproct 190
Table 74: Safety Data for Kappaproct 191
Table 75: Kappaproct SWOT Analysis, 2018 192
Table 76: Product Profile - Risankizumab 193
Table 77: Phase II Safety Data for Risankizumab in CD 194
Table 78: Risankizumab SWOT Analysis, 2018 195
Table 79: Product Profile - Mirikizumab 196
Table 80: Mirikizumab SWOT Analysis, 2018 198
Table 81: Drugs in Development for UC, 2018 199
Table 82: 7MM, Key Companies in the UC Market, 2018 200
Table 83: J&Js Disease Portfolio Assessment, 2018 205
Table 84: J&J SWOT Analysis, 2018 206
Table 85: AbbVies Disease Portfolio Assessment, 2018 207
Table 86: AbbVies SWOT Analysis, 2018 208
Table 87: Takedas Disease Portfolio Assessment, 2018 209
Table 88: Takedas SWOT Analysis, 2018 210
Table 89: Pfizers Disease Portfolio Assessment, 2018 211
Table 90: Pfizer SWOT Analysis, 2018 212
Table 91: Roches Disease Portfolio Assessment, 2018 213
Table 92: Roche SWOT Analysis, 2018 213
Table 93: InDexs Disease Portfolio Assessment, 2018 214
Table 94: InDex SWOT Analysis, 2018 215
Table 95: Celgenes Disease Portfolio Assessment, 2018 216
Table 96: Celgene SWOT Analysis, 2018 216
Table 97: EA Pharmas Disease Portfolio Assessment, 2018 217
Table 98: EA Pharma SWOT Analysis, 2018 218
Table 99: Galapagos Disease Portfolio Assessment, 2018 219
Table 100: Galapagos SWOT Analysis, 2018 219
Table 101: Eli Lillys Disease Portfolio Assessment, 2018 220
Table 102: Eli Lilly SWOT Analysis, 2018 220
Table 103: Shires Disease Portfolio Assessment, 2018 221
Table 104: Shire SWOT Analysis, 2018 221
Table 105: UC Market - Global Drivers and Barriers, 2016-2026 224
Table 106: Key Events Impacting Sales for UC in the US, 2016-2026 228
Table 107: UC Market - Global Drivers and Barriers in the US, 2016-2026 228
Table 108: Key Events Impacting Sales for UC in the 5EU, 2016-2026 231
Table 109: UC Market - Global Drivers and Barriers in the 5EU, 2016-2026 232
Table 110: Key Events Impacting Sales for UC in Japan, 2016-2026 234
Table 111: UC Market - Global Drivers and Barriers in Japan, 2016-2026 234
Table 112: Key Historical and Projected Launch Dates for UC 260
Table 113: Key Historical and Projected Patent Expiry Dates for UC 260
Table 114: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 267

List Of Figures


Figure 1: Global Sales Forecast by Country for UC, 2016 and 2026 17
Figure 2: Company Portfolio Gap Analysis in UC, 2016-2026 19
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of UC, 2016-2026 21
Figure 4: Cellular Mechanisms Involved in the Pathogenesis of UC 29
Figure 5: Types of UC 31
Figure 6: 7MM, Age-Standardized Diagnosed Incidence of UC (Cases per 100,000 Population), All Ages, Both Sexes, N, 2016 37
Figure 7: 7MM, Age-Standardized Diagnosed Prevalence of UC (%), All Ages, Both Sexes, N, 2016 38
Figure 8: 7MM, Sources Used, Diagnosed Incident Cases of UC 39
Figure 9: 7MM, Sources Used, Diagnosed Prevalent Cases of UC 40
Figure 10: 7MM, Sources Used, Undiagnosed Prevalent Cases of UC 41
Figure 11: 7MM, Sources Used, Total Prevalent Cases of UC 42
Figure 12: 7MM, Sources Used, Diagnosed Incident Cases of UC by Stage at Diagnosis 43
Figure 13: 7MM, Sources Used, Diagnosed Incident Cases of UC by Severity 44
Figure 14: 7MM, Sources Used, Diagnosed Prevalent Cases of UC by Severity 45
Figure 15: 7MM, Sources Used, Mortality Due to CRC and TMC Among the Diagnosed Prevalent Cases of UC 45
Figure 16: 7MM, Sources Used, UC Cases Requiring Colectomy Among the Diagnosed Prevalent Cases of UC Due to Failure of Medical Management 46
Figure 17: 7MM, Sources Used, Diagnosed Incident Cases of IC 47
Figure 18: 7MM, Sources Used, Diagnosed Prevalent Cases of IC 48
Figure 19: Diagnosed Incident Cases of UC, 7MM, Men and Women, All Ages, 2016 66
Figure 20: 7MM, Age-Specific Diagnosed Incident Cases of UC, Both Sexes, N, 2016 67
Figure 21: 7MM, Sex-Specific Diagnosed Incident Cases of UC, All Ages, N, 2016 68
Figure 22: 7MM, Diagnosed Incident Cases of UC Segmented by Stage at Diagnosis, Both Sexes, All Ages, N, 2016 69
Figure 23: 7MM, Diagnosed Incident Cases of UC Segmented by Severity, Both Sexes, All ages, N, 2016 70
Figure 24: Diagnosed Prevalent Cases of UC, 7MM, Men and Women, All Ages, 2016 71
Figure 25: 7MM, Age-Specific Diagnosed Prevalent Cases of UC, Both Sexes, N, 2016 72
Figure 26: 7MM, Sex-Specific Diagnosed Prevalent Cases of UC, All Ages, N, 2016 73
Figure 27: 7MM, Diagnosed Prevalent Cases of UC by Severity, Both Sexes, 18 Years, N, 2016 74
Figure 28: 7MM, Mortality Due to Complications Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2016 75
Figure 29: 7MM, Colectomy Due to Failure of Medical Management Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2016 76
Figure 30: 7MM, Comorbidities Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2016 77
Figure 31: Undiagnosed Prevalent Cases of UC, 7MM, Men and Women, All Ages, 2016 78
Figure 32: Total Prevalent Cases of UC, 7MM, Men and Women, All Ages, 2016 79
Figure 33: Diagnosed Incident Cases of IC, 7MM, Men and Women, All Ages, 2016 80
Figure 34: Diagnosed Prevalent Cases of IC, 7MM, Men and Women, All Ages, 2016 81
Figure 35: UC Treatment Algorithm 89
Figure 36: Unmet Need and Opportunity in UC, 2018 148
Figure 37: Overview of the Development Pipeline in UC 157
Figure 38: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for UC in the 7MM During the Forecast Period 158
Figure 39: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of UC During the Forecast Period 159
Figure 40: Global Sales of Branded Products for UC by Company in 2016 and 2026 202
Figure 41: Company Portfolio Gap Analysis in UC During the Forecast Period 203
Figure 42: Global (7MM) Sales Forecast by Country for UC, 2016 and 2026 224
Figure 43: Sales Forecast by Class for UC in the US, 2016 and 2026 227

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