JSB Market Research: PharmaPoint: Crohn's Disease - Global Drug Forecast and Market Analysis to 2022

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PharmaPoint: Crohn's Disease - Global Drug Forecast and Market Analysis to 2022 On 8th July 2014

Summary The Crohn's disease (CD) market is currently very dynamic, with novel biologic therapies on the horizon, such as - Takeda's alpha4beta7 inhibitor, Entyvio (vedolizumab) - Johnson & Johnson's (J&J's) interleukin (IL)-12/23 inhibitor, Stelara (ustekinumab) Browse Full Report @ http://www.jsbmarketresearch.com/healthcare-medical/r-PharmaPointCrohns-Disease-Global-Drug-Forecast-and-Market-Analysis-118887 These compounds will challenge the current biologics in an attempt to dislodge the stronghold of the TNF inhibitors, as they aim to tap into the lucrative portion of the CD therapeutics market. If their promising safety and efficacy profiles translate to clinical practice once they enter the market, their launch will be to the detriment of the existing market leaders, Remicade (infliximab) and Humira (adalimumab). The loss of patent protection of the anti-TNF marketed brands will allow for the emergence of biosimilars, such as Hospira's Inflectra (infliximab) a Remicade biosimilar. Patent expiries begin in 2015 for the current market leaders - J&J's Remicade (infliximab) - AbbVie's Humira (adalimumab) Focusing on country dynamics, Canada and the emerging markets of China and India will also play a key role in driving growth in the long term, with each market forecast to post positive Compound Annual Growth Rates (CAGRs) from 2012 to 2022, primarily due to the anticipated strong uptake of Remicade over the forecast period. Exciting times lay ahead for the CD marketplace, as the market events noted above are due to occur against the backdrop of a steadily rising global CD prevalent population. With the clinical Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


unmet need for better diagnostic tools and treatment options for the anti-TNF-refractory population, CD represents an attractive autoimmune disease for drug developers. This, in turn should fuel commercial interest in this subtype of IBD.

Highlights Key Questions Answered - How will the Crohn's disease 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 CD 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 Stelara shape the future treatment landscape? - What are the remaining unmet needs and opportunities for drug developers within the CD market?

Key Findings - The main drivers of growth in the CD market during the coming decade include the anticipated launch of the first non-anti-tumor necrosis factor (TNF) biologics, Entyvio and Stelara; the uptake of infliximab and adalimumab biosimilars; and the increasing prevalent cases of CD. - Companies striving to enter the CD market appear most focused on the anti-TNF refractory population, as this remains the most underserved group. However, competition within this patient segment is set to intensify from 2014 on, following new product launches. Therefore, companies with early-phase products targeting this patient group may struggle to gain a foothold in the future CD market. - The level of unmet need in the CD marketplace is moderate, with clinical unmet needs being the main driver for research into this autoimmune disease. The most pressing clinical unmet need is for reliable disease diagnostic tools, such as biomarkers, as these could aid physicians to tailor their treatment approach. - Although GlobalData forecasts four new product launches (Entyvio, Stelara, vercirnon, and Prochymal [remestemcel-L]) during the 2012-2022 forecast period, growth within the 10 CD healthcare markets covered in this report will largely be driven by the strong uptake of Entyvio and Stelara.

Scope - Overview of CD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


current treatment options. - Annualized CD 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 CD therapeutics markets. - Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of mid-to-late stage pipeline drugs. - Analysis of the current and future market competition in the global CD therapeutics markets. 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 - 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 CD therapeutics markets. - Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CD 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 CD 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.

Other industries we cover: • • • • • • • •

Advertising and Media Automotive and Parts Consumer Goods Healthcare and Medical Finance and Banking Food and Beverages Travel and Tourism Textiles and Clothing

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•

SWOT Analysis

Table of Content 2 Introduction 23 2.1 Catalyst 23 2.2 Related Reports 24 2.3 Upcoming Related Reports 24 3 Disease Overview 25 3.1 Etiology and Pathophysiology 25 3.1.1 Etiology 25 3.1.2 Pathophysiology 25 3.2 Symptoms 29 3.3 Prognosis 30 3.4 Quality of Life 31 4 Epidemiology 32 4.1 Risk Factors and Comorbidities 32 4.1.1 Up to 60% of CD patients experience reduced bone density 33 4.1.2 One third of patients with CD suffer from psychiatric illness 33 4.1.3 Arthritis affects 25% of CD Patients 33 4.1.4 Gastrointestinal complications often occur as part of CD 34 4.2 Global Trends 34 4.2.1 US 35 4.2.2 5EU 36 4.2.3 Japan 37 4.2.4 Canada 38 4.2.5 China 38 4.2.6 India 39 4.3 Forecast Methodology 39 4.4 Sources Used 42 4.4.1 US 42 4.4.2 France 42 4.4.3 Germany 43 4.4.4 Italy 43 4.4.5 Spain 44 4.4.6 UK 45 4.4.7 Japan 45 4.4.8 Canada 46 4.4.9 China 46 4.4.10 India 47 4.5 Forecast Assumptions and Methods 47 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


4.5.1 Incident Cases 47 4.5.2 Prevalent Cases 50 4.5.3 Sources Not Used 53 4.6 Epidemiological Forecast for CD 54 4.6.1 Incident Cases of CD 54 4.6.2 Prevalent Cases of CD 59 4.7 Discussion 66 4.8 Limitations of the Analysis 68 4.9 Strengths of the Analysis 68 5 Disease Management 69 5.1 Treatment Overview 70 5.2 US 75 5.2.1 Diagnosis 75 5.2.2 Clinical Practice 75 5.3 France 77 5.3.1 Diagnosis 77 5.3.2 Clinical Practice 78 5.4 Germany 79 5.4.1 Diagnosis 79 5.4.2 Clinical Practice 79 5.5 Italy 81 5.5.1 Diagnosis 81 5.5.2 Clinical Practice 81 5.6 Spain 83 5.6.1 Diagnosis 83 5.6.2 Clinical Practice 83 5.7 UK 85 5.7.1 Diagnosis 85 5.7.2 Clinical Practice 85 5.8 Japan 87 5.8.1 Diagnosis 87 5.8.2 Clinical Practice 87 5.9 Canada 89 5.9.1 Diagnosis 89 5.9.2 Clinical Practice 89 5.10 China 90 5.10.1 Diagnosis 90 5.10.2 Clinical Practice 90 5.11 India 91 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


5.11.1 Diagnosis 91 5.11.2 Clinical Practice 92 6 Competitive Assessment 93 6.1 Overview 93 6.2 Strategic Competitor Assessment 94 6.3 Product Profiles - Major Brands 96 6.3.1 Remicade (infliximab) 96 6.3.2 Humira (adalimumab) 102 6.3.3 Cimzia (certolizumab pegol) 109 6.3.4 Tysabri (natalizumab) 114 6.3.5 Other Marketed Products 120 6.4 Biosimilars 121 6.4.1 Introduction 121 6.4.2 Hospira's Inflectra Versus J&J's Remicade in Key Autoimmune Diseases 122 6.4.3 Biosimilars in the Immunology Community 123 6.4.4 By the Numbers: Biosimilars in Development 123 6.4.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 126 6.4.6 Biosimilars' Forecast 127 7 Opportunity and Unmet Need 129 7.1 Overview 129 7.2 Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach 130 7.3 More Therapies for Anti-TNF-Refractory Patients 131 7.4 Unmet Needs Gap Analysis 132 7.5 Targeted Therapies 133 7.6 Predictive Tools for Early Diagnosis and Treatment 134 8 Pipeline Assessment 135 8.1 Overview 135 8.2 Clinical Trial Mapping 136 8.2.1 Clinical Trials by Country 136 8.3 Clinical Trials by Phase and Trial Status 137 8.4 Promising Drugs in Clinical Development 138 8.4.1 Entyvio (vedolizumab) 140 8.4.2 Stelara (ustekinumab) 152 8.4.3 Vercirnon (formerly GSK1605786) 160 8.4.4 Prochymal (Remestemcel-L) 169 8.5 Other Late-Stage Pipeline Products 175 8.5.1 Cx601 175 8.5.2 RHB-104 (clarithromycin + clofazimine + rifabutin) 178 9 Current and Future Players 182 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


9.1 Overview 182 9.2 Trends in Corporate Strategy 184 9.3 Company Profiles 187 9.3.1 Johnson & Johnson 187 9.3.2 AbbVie 189 9.3.3 UCB 191 9.3.4 Biogen Idec 192 9.3.5 Takeda 194 9.3.6 ChemoCentryx 196 10 Market Outlook 198 10.1 Global Markets 198 10.1.1 Forecast 198 10.1.2 Drivers and Barriers - Global Issues 202 10.2 US 207 10.2.1 Forecast 207 10.2.2 Key Events 210 10.2.3 Drivers and Barriers 210 10.3 France 214 10.3.1 Forecast 214 10.3.2 Key Events 218 10.3.3 Drivers and Barriers 218 10.4 Germany 221 10.4.1 Forecast 221 10.4.2 Key Events 225 10.4.3 Drivers and Barriers 225 10.5 Italy 228 10.5.1 Forecast 228 10.5.2 Key Events 232 10.5.3 Drivers and Barriers 232 10.6 Spain 235 10.6.1 Forecast 235 10.6.2 Key Events 239 10.6.3 Drivers and Barriers 239 10.7 UK 242 10.7.1 Forecast 242 10.7.2 Key Events 246 10.7.3 Drivers and Barriers 246 10.8 Japan 249 10.8.1 Forecast 249 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


10.8.2 Key Events 253 10.8.3 Drivers and Barriers 253 10.9 Canada 257 10.9.1 Forecast 257 10.9.2 Key Events 261 10.9.3 Drivers and Barriers 261 10.10 China 263 10.10.1 Forecast 263 10.10.2 Key Events 266 10.10.3 Drivers and Barriers 266 10.11 India 268 10.11.1 Forecast 268 10.11.2 Key Events 271 10.11.3 Drivers and Barriers 271 11 Appendix 274 11.1 Bibliography 274 11.2 Abbreviations 287 11.3 Methodology 291 11.4 Forecasting Methodology 291 11.4.1 Diagnosed CD Patients 291 11.4.2 Percent Drug-Treated Patients 292 11.4.3 Drugs Included in Each Therapeutic Class 292 11.4.4 Launch and Patent Expiry Dates 292 11.4.5 General Pricing Assumptions 293 11.4.6 Individual Drug Assumptions 294 11.4.7 Generic Erosion 297 11.4.8 Pricing of Pipeline agents 298 11.5 Physicians and Specialists Included in This Study 299 11.6 Primary Research - Prescriber Survey 301 11.7 About the Authors 302 11.7.1 Author/Reviewer 302 11.7.2 Epidemiologist 302 11.7.3 Global Head of Healthcare 303 11.8 About GlobalData 304 11.9 Disclaimer 304

List of Tables Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


Table 1: Symptoms of CD 30 Table 2: Comorbidities for CD 32 Table 3: Sources of Incidence Data Used in This Analysis 40 Table 4: Sources of Prevalence Data Used in This Analysis 41 Table 5: All Markets, Incident Cases of CD, Ages ?10 Years, Men and Women, N, 2012-2022 54 Table 6: All Markets, Incident Cases of CD, by Age, Men and Women, N (Row Total), 2012 56 Table 7: All Markets, Incident Cases of CD, by Sex, Ages ?10 Years, N (%), 2012 57 Table 8: All Markets, Prevalent Cases of CD, Ages ?10 Years, Men and Women, N, 2012-2022 60 Table 9: All Markets, Prevalent Cases of CD, by Age, Men and Women, N, 2012 62 Table 10: All Markets, Prevalent Cases of CD, by Sex, Ages ?10 Years, N (%), 2012 64 Table 11: Treatment Guidelines for CD 71 Table 12: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 2013 73 Table 13: Leading Branded Drugs Used to Treat CD 95 Table 14: Product Profile - Remicade 97 Table 15: Remicade SWOT Analysis, 2013 100 Table 16: Global Sales Forecasts ($) for Remicade, 2012-2022 102 Table 17: Product Profile - Humira 104 Table 18: Humira SWOT Analysis, 2013 107 Table 19: Global Sales Forecasts ($) for Humira, 2012-2022 109 Table 20: Product Profile - Cimzia 110 Table 21: Cimzia SWOT Analysis, 2013 112 Table 22: Global Sales Forecasts ($) for Cimzia, 2012-2022 114 Table 23: Product Profile - Tysabri 115 Table 24: Tysabri SWOT Analysis, 2013 118 Table 25: Global Sales Forecasts ($) for Tysabri, 2012-2022 120 Table 26: Summary of the Minor Therapeutic Classes in CD, 2013 121 Table 27: Biosimilars Pipeline, 2013 124 Table 28: Global Sales Forecasts ($) for Infliximab Biosimilars, 2012-2022 127 Table 29: Global Sales Forecasts ($) for Adalimumab Biosimilars, 2012-2022 127 Table 30: Global Sales Forecasts ($) for Certolizumab pegol Biosimilars, 2012-2022 128 Table 31: Overall Unmet Needs in CD - Current Level of Attainment 130 Table 32: Clinical Unmet Needs in CD - Gap Analysis, 2013 133 Table 33: CD - Clinical Trials by Phase and Status, 2013 137 Table 34: Promising Drugs in Clinical Development for CD - Pipeline Phase, 2013 138 Table 35: Comparison of Therapeutic Classes in Development for CD, 2013 139 Table 36: Product Profile - Entyvio 141 Table 37: Efficacy of Entyvio in GEMINI II Studies of CD 142 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


Table 38: Entyvio SWOT Analysis, 2013 150 Table 39: Global Sales Forecasts ($) for Entyvio, 2012-2022 152 Table 40: Product Profile - Stelara 153 Table 41: Comparison of Stelara's Phase IIb CERTIFI trial Efficacy Data Versus Tysabri's Phase III Efficacy Data in Anti-TNF Refractory CD Patients 155 Table 42: Stelara SWOT Analysis, 2013 158 Table 43: Global Sales Forecasts ($) for Stelara, 2012-2022 160 Table 44: Product Profile - Vercirnon 162 Table 45: Vercirnon SWOT Analysis, 2013 167 Table 46: Global Sales Forecasts ($) for Vercirnon, 2012-2022 168 Table 47: Product Profile - Prochymal 170 Table 48: Prochymal SWOT Analysis, 2013 173 Table 49: Global Sales Forecasts ($) for Prochymal, 2012-2022 175 Table 50: Product Profile - Cx601 176 Table 51: Cx601 SWOT Analysis, 2013 177 Table 52: Product Profile - RHB-104 179 Table 53: RHB-104 SWOT Analysis, 2013 181 Table 54: Key Companies in the CD Market, 2013 183 Table 55: J&J's CD Portfolio Assessment, 2013 188 Table 56: J&J's CD SWOT Analysis, 2013 188 Table 57: AbbVie's CD Portfolio Assessment, 2013 190 Table 58: Abbott/AbbVie's CD SWOT Analysis, 2013 190 Table 59: UCB's CD Portfolio Assessment, 2013 191 Table 60: UCB's CD SWOT Analysis, 2013 192 Table 61: Biogen Idec's CD Portfolio Assessment, 2013 193 Table 62: Biogen Idec's CD SWOT Analysis, 2013 194 Table 63: Takeda's CD Portfolio Assessment, 2013 195 Table 64: Takeda's CD SWOT Analysis, 2013 195 Table 65: ChemoCentryx's CD Portfolio Assessment, 2013 196 Table 66: ChemoCentryx's CD SWOT Analysis, 2013 197 Table 67: Global Sales Forecasts ($) for CD, 2012-2022 200 Table 68: Global CD Market - Drivers and Barriers, 2012-2022 202 Table 69: Sales Forecasts ($) for CD in the United States, 2012-2022 208 Table 70: Key Events Impacting Sales for CD in the US, 2012-2022 210 Table 71: CD Market in the US - Drivers and Barriers, 2012-2022 210 Table 72: Sales Forecasts ($) for CD in France, 2012-2022 216 Table 73: Key Events Impacting Sales for CD in France, 2012-2022 218 Table 74: CD Market in France - Drivers and Barriers, 2012-2022 218 Table 75: Sales Forecasts ($) for CD in Germany, 2012-2022 223 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


Table 76: Key Events Impacting Sales for CD in Germany, 2012-2022 225 Table 77: CD Market in Germany - Drivers and Barriers, 2012-2022 225 Table 78: Sales Forecasts ($) for CD in Italy, 2012-2022 230 Table 79: Key Events Impacting Sales for CD in Italy, 2012-2022 232 Table 80: CD Market in Italy - Drivers and Barriers, 2012-2022 232 Table 81: Sales Forecasts ($) for CD in Spain, 2012-2022 237 Table 82: Key Events Impacting Sales for CD in Spain, 2012-2022 239 Table 83: CD Market in Spain - Drivers and Barriers, 2012-2022 239 Table 84: Sales Forecasts ($) for CD in the UK, 2012-2022 244 Table 85: Key Events Impacting Sales for CD in the UK, 2012-2022 246 Table 86: CD Market in the UK - Drivers and Barriers, 2012-2022 246 Table 87: Sales Forecasts ($) for CD in Japan, 2012-2022 251 Table 88: Key Events Impacting Sales for CD in Japan, 2012-2022 253 Table 89: CD Market in Japan - Drivers and Barriers, 2012-2022 253 Table 90: Sales Forecasts ($) for CD in Canada, 2012-2022 259 Table 91: Key Events Impacting Sales for CD in Canada, 2012-2022 261 Table 92: CD Market in Canada - Drivers and Barriers, 2012-2022 261 Table 93: Sales Forecasts ($) for CD in China, 2012-2022 264 Table 94: Key Events Impacting Sales for CD in China, 2012-2022 266 Table 95: CD Market in China - Drivers and Barriers, 2012-2022 266 Table 96: Sales Forecasts ($) for CD in India, 2012-2022 269 Table 97: Key Events Impacting Sales for CD in India, 2012-2022 271 Table 98: CD Market in India - Drivers and Barriers, 2012-2022 271 Table 99: Key Launch Dates 292 Table 100: Key Patent Expiries 293 Table 101: Physicians Surveyed, By Country 30

List of Figures Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right) 26 Figure 2: Potential Biologic Drug Targets for CD 29 Figure 3: All Markets, Incident Cases of CD, Ages ?10 Years, Men and Women, N, 2012-2022 55 Figure 4: All Markets, Incident Cases of CD, by Age, Men and Women, N, 2012 56 Figure 5: All Markets, Incident Cases of CD, by Sex, Ages ?10 Years, N, 2012 58 Figure 6: All Markets, Age-Standardized Incidence Rate of CD, Ages ?10 Years, Men and Women, 2012 59 Figure 7: All Markets, Prevalent Cases of CD, Ages ?10 Years, Men and Women, N, 2012-2022 61 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


Figure 8: All Markets, Prevalent Cases of CD, by Age, Men and Women, N, 2012 63 Figure 9: All Markets, Prevalent Cases of CD, by Sex, Ages ?10 Years, N, 2012 65 Figure 10: All Markets, Age-Standardized Prevalence of CD, Ages ?10 Years, Men and Women, 2012 66 Figure 11: Patient Care Path for CD 72 Figure 12: CD Therapeutics - Clinical Trials by Country, 2013 136 Figure 13: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012-2022 139 Figure 14: Company Portfolio Gap Analysis in CD, 2012-2022 186 Figure 15: Global Sales for CD by Region, 2012-2022 201 Figure 16: Sales for CD in the US by Drug Class, 2012-2022 209 Figure 17: Sales for CD in France by Drug Class, 2012-2022 217 Figure 18: Sales for CD in Germany by Drug Class, 2012-2022 224 Figure 19: Sales for CD in Italy by Drug Class, 2012-2022 231 Figure 20: Sales for CD in Spain by Drug Class, 2012-2022 238 Figure 21: Sales for CD in the UK by Drug Class, 2012-2022 245 Figure 22: Sales for CD in Japan by Drug Class, 2012-2022 252 Figure 23: Sales for CD in Canada by Drug Class, 2012-2022 260 Figure 24: Sales for CD in China by Drug Class, 2012-2022 265 Figure 25: Sales for CD in India by Drug Class, 2012-2022 270

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regular updates of the market though newsletters. Our reports are a well-researched work of market researchers with an extensive knowledge and a good level of market experience. To know more on PharmaPoint: Crohn's Disease - Global Drug Forecast and Market Analysis to 2022 http://www.jsbmarketresearch.com/healthcare-medical/r-PharmaPoint-Crohns-DiseaseGlobal-Drug-Forecast-and-Market-Analysis-118887

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