JSB Market Research: PharmaPoint: Ulcerative Colitis - Global Drug Forecast and Market Analysis to 2022

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 


7.2 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 


8.2 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 


9.2 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 


10.2.2 Key Events 243 

10.2.3 Drivers and Barriers 243 

10.3 France 246 




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10.4 Germany 253 




10.5 Italy 259 




10.6 Spain 265 




10.7 United Kingdom 271 




10.8 Japan 277 



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10.9 Canada 284 




10.10 China 289 


10.10.2 Key Events 291 


10.11 India 294 


10.11.2 Key Events 296 


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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