Pharmapoint ulcerative colitis global drug forecast and market analysis to 2022

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PharmaPoint: Ulcerative Colitis - Global Drug Forecast and Market Analysis to 2022 Released On 7th June 2014 During the forecast period from 20122022, the growth of the UC 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: 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 . 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. JSB Market Research Pvt. Ltd.

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Market Model Features An interactive excel forecast model based on primary research interviews and surveys with KOLs and highprescribing physicians is included in this report*. This patient based model provides diagnosis rates, patient segmentation, treatment rates, annual costs of therapy , and indication-specific drug sales for the 10 year forecast period. forecast model is robust, fully transparent, and easy to navigate. Moreover, support data presented in the reports and the complete methodology is outlined in the report and the model.

The our models

*Model only available with site and global license purchases. Buy this report OR Know more : http://www.jsbmarketresearch.com/healthcaremedical/r-PharmaPoint-Ulcerative-Colitis-Global-Drug-Forecast-and-Market-Analysisto-2022-89051 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 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. JSB Market Research Pvt. Ltd.

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Key Questions Answered in this Report 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 Benefits 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 counterstrategies 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. Companies Mentioned J&J AbbVie Takeda Warner Chilcott Salix/Santarus Shire Ferring Pfizer InDeX Pharmaceuticals JSB Market Research Pvt. Ltd.

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Report at a Glance Number of Pages 328 Number of Tables 144 Number of Figures 30 Number of Companies Mentioned 9 Number of Marketed and Pipeline Products Mentioned 14 Number of KOL interviews 9 Major Pipeline Products Mentioned 3 Phase III/Filed products Markets Covered US, France, Germany, Italy, Spain, UK, Japan, Canada, China, India Table of Content: List of Tables Table 1: Ulcerative Colitis: Key Metrics in the 10 Major Pharmaceutical Markets, 2012 - 2022 16 Table 2: Genetic Factors That Confer a Predisposition to UC 30 Table 3: Typical Symptoms of UC 32 Table 4: Strongest Putative Risk Factors for UC 36 Table 5: Prevalence of UC in the US 41 Table 6: Incidence of UC in the 5EU 42 Table 7: Prevalence of UC in the 5EU 43 Table 8: 10MM, Sources of UC Incidence Data Used in the Epidemiological Forecast 50 Table 9: 10MM, Sources of UC Prevalence Data Used in the Epidemiological Forecast 51 Table 10: 10MM, Incident Cases of UC, Ages =10 Years, Both Sexes, N, Select Years, 2012 2022 65 Table 11: 10MM, Incident Cases of UC, By Age, Both Sexes, N (Row %), 2012 67 Table 12: 10MM, Incident Cases of UC, By Sex, Ages =10 Years, N (Row %), 2012 69 Table 13: 10MM, Prevalent Cases of UC, Ages =10 Years, Both Sexes, N, Select Years, 2012 2022 72 Table 14: 10MM, Prevalent Cases of UC, By Age, Both Sexes, N (Row %), 2012 74 Table 15: 10MM, Prevalent Cases of UC, By Sex, Ages =10 Years, N (Row %), 2012 76 Table 16: Truelove and Witts UC Severity Index 83 Table 17: UCDAI 84 Table 18: Treatment Guidelines for UC Used in the 10MM 85 Table 19: Most Commonly Prescribed Drugs for UC by Class in the 10MM, 2013 86 Table 20: UC Management Country Profile US 92 Table 21: UC Management Country Profile France 94 Table 22: UC Management Country Profile Germany 97 Table 23: UC Management Country Profile Italy 100 Table 24: UC Management Country Profile Spain 102 Table 25: UC Management Country Profile UK 105 JSB Market Research Pvt. Ltd.

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Table 26: UC Management Country Profile Japan 107 Table 27: Country Profile Canada 110 Table 28: UC Management Country Profile China 112 Table 29: UC Management Country Profile India 115 Table 30: Leading Treatments for UC, 2014 118 Table 31: Product Profile Remicade 121 Table 32: Remicade SWOT Analysis, 2014 125 Table 33: Global Sales Forecasts ($m) for Remicade, 2012 - 2022 126 Table 34: Product Profile Humira 128 Table 35: Humira Efficacy in the ULTRA 2 Trial 129 Table 36: Product Efficacy Comparison Humira vs. Remicade 129 Table 37: Humira SWOT Analysis, 2014 131 Table 38: Global Sales Forecasts ($m) for Humira, 2012 - 2022 132 Table 39: Product Profile Simponi 134 Table 40: Simponi SWOT Analysis, 2014 136 Table 41: Global Sales Forecasts ($m) for Simponi, 2012 - 2022 137 Table 42: Product Profile Apriso 139 Table 43: Apriso SWOT Analysis, 2014 141 Table 44: Global Sales Forecasts ($m) for Apriso, 2012 - 2022 142 Table 45: Product Profile Asacol HD 144 Table 46: Asacol HD SWOT Analysis, 2014 147 Table 47: Global Sales Forecasts ($m) for Asacol HD, 2012 - 2022 148 Table 48: Product Profile Lialda 149 Table 49: Lialda SWOT Analysis, 2014 151 Table 50: Global Sales Forecasts ($m) for Lialda, 2012 - 2022 152 Table 51: Product Profile Pentasa 153 Table 52: Pentasa SWOT Analysis, 2014 155 Table 53: Global Sales Forecasts ($m) for Pentasa, 2012 - 2022 156 Table 54: Product Profile Colazal 157 Table 55: Colazal SWOT Analysis, 2014 159 Table 56: Global Sales Forecasts ($m) for Colazal, 2012 - 2022 160 Table 57: Product Profile Giazo 161 Table 58: Giazo SWOT Analysis, 2014 163 Table 59: Global Sales Forecasts ($m) for Giazo, 2012 - 2022 164 Table 60: Product Profile sfRowasa 165 Table 61: sfRowasa SWOT Analysis, 2014 166 Table 62: Global Sales Forecasts ($m) for sfRowasa, 2012 - 2022 167 Table 63: Product Profile Uceris 168 Table 64: Uceris SWOT Analysis, 2014 170 Table 65: Global Sales Forecasts ($m) for Uceris, 2012 - 2022 171 Table 66: Summary of Other Immunomodulators for UC, 2013 172 JSB Market Research Pvt. Ltd.

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Table 67: Biosimilars Pipeline, 2013 174 Table 68: Global Sales Forecasts ($m) for Infliximab Biosimilars, 2012 - 2022 177 Table 69: Global Sales Forecasts ($m) for Adalimumab Biosimilars, 2012 - 2022 177 Table 70: Global Sales Forecasts ($m) for Golimumab Biosimilars, 2012 - 2022 178 Table 71: Overall Unmet Needs Current Level of Attainment 179 Table 72: Corticosteroid Long-Term Side Effects 182 Table 73: Clinical Unmet Needs in UC Gap Analysis, 2013 185 Table 74: Prognostic Markers in UC 186 Table 75: UC Clinical Trials by Phase and Status, 2014 189 Table 76: UC Pre-Registration and Phase III Pipeline, 2014 189 Table 77: Comparison of Therapeutic Classes in Development for UC, 2014 190 Table 78: Product Profile Entyvio 193 Table 79: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Induction of Remission in UC 194 Table 80: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Maintenance of Remission in UC 195 Table 81: Most Common Adverse Events with Vedolizumab in the GEMINI I Study 196 Table 82: Entyvio SWOT Analysis, 2014 199 Table 83: Global Sales Forecasts ($m) for Entyvio, 2012 - 2022 201 Table 84: Product Profile Xeljanz 202 Table 85: Results of Phase IIa Trial of Xeljanz in the Induction of Remission in UC 203 Table 86: Most Common Adverse Events in the Phase IIa Trial of Xeljanz 205 Table 87: Xeljanz SWOT Analysis, 2014 207 Table 88: Global Sales Forecasts ($m) for Xeljanz, 2012 - 2022 208 Table 89: Product Profile Kappaproct 209 Table 90: Results of Phase IIb Trial of Kappaproct in the Induction of Remission in UC 210 Table 91: Kappaproct SWOT Analysis, 2014 212 Table 92: Global Sales Forecasts ($m) for Kappaproct, 2012 - 2022 213 Table 93: Key Companies in the UC Market, 2012 - 2022 215 Table 94: J&Js UC Portfolio Assessment, 2014 221 Table 95: J&Js SWOT Analysis in UC, 2014 222 Table 96: AbbVies UC Portfolio Assessment, 2014 223 Table 97: AbbVies UC SWOT Analysis, 2014 224 Table 98: Takeda Pharmaceuticals UC Portfolio Assessment, 2014 225 List of Figures Figure 1: Global UC Sales by Region, 2012 - 2022 19 Figure 2: Company Portfolio Gap Analysis in UC, 2012 - 2022 22 Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in UC, 2012 - 2022 25 Figure 4: Cellular Mechanisms Involved in the Pathogenesis of UC 32 JSB Market Research Pvt. Ltd.

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Figure 5: Olmsted Country, Minnesota, US, Age- and Sex-Adjusted Incidence of UC, Cases per 100,000 Population, 19402000 40 Figure 6: Canada, Incidence and Prevalence of UC, Cases per 100,000 Population, 19902001 46 Figure 7: Hong Kong, China, Crude Incidence and Prevalence of UC, Cases per 100,000 Population, 19972006 48 Figure 8: 10MM, Incident Cases of UC, Ages = 10 Years, Both Sexes, N, 2012 - 2022 66 Figure 9: 10MM, Incident Cases of UC, By Age, Both Sexes, N, 2012 68 Figure 10: 10MM, Incident Cases of UC, By Sex, Ages =10 Years, N, 2012 70 Figure 11: 10MM, Age-Standardized Incidence of UC, Ages =10 Years, Both Sexes, Cases per 100,000 Population, 2012 71 Figure 12: 10MM, Prevalent Cases of UC, Ages =10 Years, Both Sexes, N, 2012 - 2022 73 Figure 13: 10MM, Prevalent Cases of UC, By Sex, Ages = 10 Years, N, 2012 75 Figure 14: 10MM, Prevalent Cases of UC, By Sex, Ages =10 Years, N, 2012 77 Figure 15: 10MM, Age-Standardized Prevalence of UC, Ages =10 Years, Both Sexes, %, 2012 78 Figure 16: UC Disease Management Flowchart 89 Figure 17: UC Therapeutics Clinical Trials by Country, 2014 188 Figure 18: Competitive Assessment of Late-Stage Pipeline Agents UC, 2012 - 2022 190 Figure 19: Company Portfolio Gap Analysis in UC, 2012 - 2022 217 Figure 20: Global Sales for UC by Region, 2012 (Total: $m)2022 (Total: $m) 242 Figure 21: Sales for UC in the US by Drug Class, 2012 - 2022 250 Figure 22: Sales for UC in France by Drug Class, 2012 - 2022 257 Figure 23: Sales for UC in Germany by Drug Class, 2012 - 2022 264 Figure 24: Sales for UC in Italy by Drug Class, 2012 - 2022 270 Figure 25: Sales for UC in Spain by Drug Class, 2012 - 2022 276 Figure 26: Sales for UC in the UK by Drug Class, 2012 - 2022 282 Figure 27: Sales for UC in Japan by Drug Class, 2012 - 2022 288 Figure 28: Sales for UC in Canada by Drug Class, 2012 - 2022 295 Figure 29: Sales for UC in China by Drug Class, 2012 - 2022 299 Figure 30: Sales for UC in India by Drug Class, 2012 - 2022 304

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