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Crohn's Disease Disease Coverage Crohn's disease Disease Coverage Ref Code: DMKC5415 Authors: Dominique Fontanilla, Christina Vasiliou, Nicola Sawalhi-Leckenby, Astrid Kurniawan www.datamonitorhealthcare.com Disease Coverage | Crohn's disease 2 ABOUT DATAMONITOR HEALTHCARE Bringing you a clearer, richer, and more responsive view of the pharma and healthcare market. COMPLETE MARKET COVERAGE CUTTING-EDGE DELIVERY Our independent research and analysis provides extensive Available through single reports or via subscription to our state- coverage of major disease areas, companies, and strategic of-the-art online intelligence service that features intuitive issues, giving you the perspective to identify opportunities and design and interactive capabilities, our analysis offers the threats arising from shifting market dynamics and the insights to definitive platform to enhance your product management, respond with faster, more effective decision-making. market assessment, and strategic planning. UNIQUE EXPERT CAPABILITIES CONTACT US With teams located across developed and emerging pharma For more information about our products or to arrange markets, we are uniquely placed to understand local healthcare a demo of our online service, please contact: trends and provide accurate and reliable recommendations. [email protected] Our experts are able to share data and resources to produce the most authoritative and robust market intelligence. With over 700 clients across the pharma and biotech industries, we are relied upon to provide strategic guidance, not only through published analysis, but also tailored support solutions. All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, Datamonitor Healthcare. The facts of this report are believed to be correct at the time of publication but cannot be guaranteed. Please note that the findings, conclusions and recommendations that Datamonitor Healthcare delivers will be based on information gathered in good faith from both primary and secondary sources, whose accuracy we are not always in a position to guarantee. As such, Datamonitor Healthcare can accept no liability whatsoever for actions taken based on any information that may subsequently prove to be incorrect. For more information about our products or to arrange a demonstration of our online service, please contact: [email protected] © Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed Disease Coverage | Crohn's disease 3 CONTENTS 14 FORECAST: CROHN’S DISEASE (Published on 02 August 2018) 14 OVERVIEW 16 RECENT FORECAST UPDATES 17 MARKET DYNAMICS 23 FORECAST AND FUTURE TRENDS 33 MARKET DEFINITION AND METHODOLOGY 40 PRIMARY RESEARCH METHODOLOGY 43 BIBLIOGRAPHY 45 PRODUCT PROFILE: ALOFISEL 61 PRODUCT PROFILE: CIMZIA 75 PRODUCT PROFILE: ENTYVIO 92 PRODUCT PROFILE: HUMIRA 112 PRODUCT PROFILE: REMICADE 128 PRODUCT PROFILE: STELARA 142 PRODUCT PROFILE: TYSABRI 153 PRODUCT PROFILE (LATE STAGE): ETROLIZUMAB 166 PRODUCT PROFILE (LATE STAGE): FILGOTINIB 179 PRODUCT PROFILE (LATE STAGE): OZANIMOD 191 PRODUCT PROFILE (LATE STAGE): RISANKIZUMAB 205 PRODUCT PROFILE (LATE STAGE): UPADACITINIB 218 TREATMENT: CROHN’S DISEASE (Published on 07 August 2017) 218 OVERVIEW 219 EXECUTIVE SUMMARY 220 PRIMARY RESEARCH METHODOLOGY 222 PATIENT SEGMENTATION 225 CURRENT TREATMENT OPTIONS 234 PRESCRIBING TRENDS 252 COMPLIANCE 255 UNMET NEEDS IN CROHN’S DISEASE 259 PRESCRIBING INFLUENCES 263 IMPACT OF BIOSIMILARS © Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed Disease Coverage | Crohn's disease 4 271 EPIDEMIOLOGY: CROHN’S DISEASE (Published on 15 May 2018) 271 OVERVIEW 272 DISEASE BACKGROUND 276 METHODOLOGY 286 FORECAST 291 BIBLIOGRAPHY 294 APPENDIX: ADDITIONAL SOURCES 295 MARKETED DRUGS: CROHN'S DISEASE (Published on 02 August 2018) 295 OVERVIEW 297 PRODUCT OVERVIEW 298 PRODUCT PROFILE: ALOFISEL 314 PRODUCT PROFILE: CIMZIA 328 PRODUCT PROFILE: ENTYVIO 345 PRODUCT PROFILE: HUMIRA 365 PRODUCT PROFILE: REMICADE 381 PRODUCT PROFILE: STELARA 395 PRODUCT PROFILE: TYSABRI 406 CROHN'S DISEASE AND ULCERATIVE COLITIS PRICING AND REIMBURSEMENT (Published on 16 March 2018) 406 OVERVIEW 407 EXECUTIVE SUMMARY 408 REGULATORY LABELS 417 GLOBAL ACCESS LEVERS 428 EVIDENCE AND VALUE 434 ACCESS TO RECENTLY APPROVED AND PIPELINE PRODUCTS 460 PRICING 464 US 496 JAPAN 498 BIOSIMILAR TNF-ALPHA INHIBITORS IN THE FIVE MAJOR EU MARKETS 511 FRANCE 554 GERMANY 566 ITALY 577 SPAIN 587 UK 608 METHODOLOGY © Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed Disease Coverage | Crohn's disease 5 611 PIPELINE: CROHN’S DISEASE (Published on 02 August 2018) 611 OVERVIEW 612 CLINICAL PIPELINE OVERVIEW 613 ADDITIONAL PHARMA INTELLIGENCE PIPELINE RESOURCES 614 PRODUCT PROFILE (LATE STAGE): ETROLIZUMAB 627 PRODUCT PROFILE (LATE STAGE): FILGOTINIB 640 PRODUCT PROFILE (LATE STAGE): OZANIMOD 652 PRODUCT PROFILE (LATE STAGE): RISANKIZUMAB 666 PRODUCT PROFILE (LATE STAGE): UPADACITINIB © Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed Disease Coverage | Crohn's disease 6 LIST OF FIGURES 17 Figure 1: Crohn’s disease – current and future market dynamics analysis 18 Figure 2: Datamonitor Healthcare’s assessment summary of key marketed and pipeline drugs for Crohn’s disease 23 Figure 3: Crohn’s disease sales across the US, Japan, and five major EU markets, by country, 2016–25 24 Figure 4: Crohn’s disease sales across the US, Japan, and five major EU markets, by class, 2016–25 25 Figure 5: Sales of Humira, Remicade, and their biosimilar versions across the US, Japan, and five major EU markets, 2016–25 27 Figure 6: Sales of Stelara, key branded anti-TNFs, and Entyvio across the US, Japan, and five major EU markets, by drug, 2016–25 30 Figure 7: Sales of filgotinib and upadacitinib across the US, Japan, and five major EU markets, by drug, 2016–25 31 Figure 8: Sales of risankizumab versus pipeline agents in the US, Japan, and five major EU markets, by drug, 2016–25 35 Figure 9: Datamonitor Healthcare’s Crohn’s disease forecast methodology 38 Figure 10: Price sources and calculations, by country 53 Figure 11: Alofisel for Crohn’s disease – SWOT analysis 54 Figure 12: Datamonitor Healthcare’s drug assessment summary of Alofisel in Crohn’s disease 55 Figure 13: Datamonitor Healthcare’s drug assessment summary of Alofisel in Crohn’s disease 58 Figure 14: Alofisel sales for Crohn’s disease across the US, Japan, and five major EU markets, by country, 2016–25 68 Figure 15: Cimzia for Crohn’s disease – SWOT analysis 69 Figure 16: Datamonitor Healthcare’s drug assessment summary of Cimzia in Crohn’s disease 70 Figure 17: Datamonitor Healthcare’s drug assessment summary of Cimzia in Crohn’s disease 72 Figure 18: Cimzia sales for Crohn’s disease across the US, Japan, and Spain, by country, 2016–25 83 Figure 19: Entyvio for Crohn’s disease – SWOT analysis 84 Figure 20: Datamonitor Healthcare’s drug assessment summary of Entyvio in Crohn’s disease 85 Figure 21: Datamonitor Healthcare’s drug assessment summary of Entyvio in Crohn’s disease 89 Figure 22: Entyvio sales for Crohn’s disease across the US, Japan, and five major EU markets, by country, 2016–25 102 Figure 23: Humira for Crohn’s disease – SWOT analysis 103 Figure 24: Datamonitor Healthcare’s drug assessment summary of Humira in Crohn’s disease 104 Figure 25: Datamonitor Healthcare’s drug assessment summary of Humira in Crohn’s disease 108 Figure 26: Humira sales for Crohn’s disease across the US, Japan, and five major EU markets, by country, 2016–25 119 Figure 27: Remicade for Crohn’s disease – SWOT analysis 120 Figure 28: Datamonitor Healthcare’s drug assessment summary of Remicade in Crohn’s disease 121 Figure 29: Datamonitor Healthcare’s drug assessment summary of Remicade in Crohn’s disease 124 Figure 30: Remicade sales for Crohn’s disease across the US, Japan, and five major EU markets, by country, 2016–25 134 Figure 31: Stelara for Crohn’s disease – SWOT analysis 135 Figure 32: Datamonitor Healthcare’s drug assessment summary of Stelara in Crohn’s disease 136 Figure 33: Datamonitor Healthcare’s drug assessment summary of Stelara in Crohn’s disease 139 Figure 34: Stelara sales for Crohn’s disease across the US, Japan, and five major EU markets, by country, 2016–25 146 Figure 35: Tysabri for Crohn’s disease – SWOT analysis © Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed Disease Coverage | Crohn's disease 7 147 Figure 36: Datamonitor Healthcare’s drug assessment summary of Tysabri in Crohn’s disease 148 Figure 37: Datamonitor Healthcare’s drug assessment summary of Tysabri in Crohn’s disease 150 Figure 38: Tysabri sales for Crohn’s disease in the US, 2016–25 159 Figure 39: Etrolizumab for Crohn’s disease – SWOT analysis 160 Figure 40: Datamonitor Healthcare’s drug assessment summary of etrolizumab in Crohn’s disease 161 Figure 41: Datamonitor Healthcare’s drug assessment summary of etrolizumab in Crohn’s disease 163 Figure 42: Etrolizumab sales for Crohn’s disease across the US and five major EU markets, by country, 2016–25 172 Figure 43: Filgotinib for Crohn’s disease – SWOT analysis 173 Figure 44: Datamonitor Healthcare’s drug assessment summary of filgotinib in Crohn’s disease 174 Figure 45: Datamonitor Healthcare’s drug assessment summary of filgotinib
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