Colorectal cancer. Forecast. Catalyst. Contact Us

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1 Colorectal cancer Forecast Catalyst The colon cancer pipeline has grown as pharmaceutical companies are attracted by the high incidence and success experienced by other developers. Cytotoxics remain an integral part of colon cancer treatment, but there are a growing number of targeted therapies on the market and in the pipeline. With key brands expected to come off patent over the forecast period and the approval of new therapies, competition in this lucrative indication is set to intensify. Ref Code: DMKC Publication Date: 22/12/2011 Author: James Wade Contact Us Datamonitor America 52 Vanderbilt Ave, 7th Floor, New York, NY USA t: e: usinfo@datamonitor.com Datamonitor Europe 119 Farringdon Road, London, EC1R 3ER, United Kingdom t: e: eurinfo@datamonitor.com Datamonitor Asia Pacific Level 7 / 120 Sussex Street, Sydney, NSW 2000, Australia t: e: apinfo@datamonitor.com Datamonitor Japan Da Vinci Ginza East 7th Floor, Ginza, Chuo-ku, Tokyo , Japan t: e: jpinfo@datamonitor.com

2 Report downloaded by: smaeda Date of download: 20/08/2014 Reference: DMKC First published: 22/12/2011 About Datamonitor Healthcare Bringing you a clearer, richer and more responsive view of the pharma & healthcare market. Complete market coverage Our independent research and analysis provides extensive coverage of major disease areas, companies and strategic issues, giving you the perspective to identify opportunities and threats arising from shifting market dynamics and the insights to respond with faster, more effective decision-making. Unique expert capabilities With teams located across developed and emerging pharma markets, we are uniquely placed to understand local healthcare trends and provide accurate and reliable recommendations. By working closely with our partners at MedTrack, Citeline, SCRIP Intelligence and Informa Healthcare, 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. Cutting-edge delivery Available through single reports or via subscription to our state-of-the art online intelligence service that features intuitive design and interactive capabilities, our analysis offers the definitive platform to enhance your product management, market assessment and strategic planning. Contact Us For more information about our products or to arrange a demo of the our online service, please contact: getcloser@datamonitorhealthcare.com Disclaimer 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 the our online service, please contact: getcloser@datamonitorhealthcare.com 2

3 TABLE OF CONTENTS 6 EXECUTIVE SUMMARY 7 MARKET DEFINITION 7 Market definition for colon cancer 7 Forecast methodology and assumptions 10 Additional forecast methodology 11 MARKET OVERVIEW AND CONTEXT 11 Cancer therapies included in this report 12 Current and future market dynamics overview 30 FORECAST SUMMARY 30 Molecule dynamics 32 AVASTIN (BEVACIZUMAB) 32 Forecast assumptions 32 Avastin forecast ELOXATIN (OXALIPLATIN) 36 Forecast assumptions 36 Eloxatin forecast ERBITUX (CETUXIMAB) 40 Forecast assumptions 40 Erbitux forecast IMPRIME PGG 44 Forecast assumptions 44 Imprime PGG forecast IRINOTECAN 48 Forecast assumptions 48 Irinotecan forecast RAMUCIRUMAB 52 Forecast assumptions 52 Ramucirumab forecast STIVARGA (REGORAFENIB) 56 Forecast assumptions 56 Stivarga forecast ZALTRAP (AFLIBERCEPT/VEGF-TRAP) 3

4 60 Forecast assumptions 60 Zaltrap forecast BIBLIOGRAPHY 64 Journal papers 64 Websites 66 APPENDIX 66 Forecast methodology LIST OF FIGURES 7 Figure 1: Patient-based forecast methodology for colon cancer 13 Figure 2: Colon cancer market forecast across the US, Japan, and five major EU markets, by country ($m), Figure 3: Colon cancer sales in the US, Japan, and five major EU markets, by class ($m), Figure 4: Estimated approval/launch dates of key colon cancer therapies, Figure 5: Colon cancer market value in the US, by drug class ($m), Figure 6: Colon cancer market value in Japan, by drug class ($m), Figure 7: Colon cancer market value in the five major EU markets, by drug class ($m), Figure 8: Key colon cancer molecule sales, Figure 9: Avastin sales, by country ($m), Figure 10: Eloxatin sales, by country ($m), Figure 11: Erbitux sales, by country ($m), Figure 12: Imprime PGG sales, by country ($m), Figure 13: Irinotecan sales, by country ($m), Figure 14: Ramucirumab sales, by country ($m), Figure 15: Stivarga sales, by country ($m), Figure 16: Zaltrap sales, by country ($m), LIST OF TABLES 7 Table 1: Summary of therapeutic classes in colon cancer by Anatomical Therapeutic Chemical code, Table 2: Patent expiry dates for key marketed brands in colon cancer 9 Table 3: Estimated launch dates for key late-stage pipeline products and marketed brands in colon cancer in the US, Japan, and five major EU markets, Table 4: Drugs included in colon cancer market and product forecasts, Table 5: Colon cancer molecule sales in the US, Japan, and five major EU markets ($m), Table 6: Colon cancer regimen sales in the US, Japan, and five major EU markets ($m), Table 7: Colon cancer regimen patients in the US, Japan, and five major EU markets, Table 8: Colon cancer molecule sales in the US ($m),

5 23 Table 9: Colon cancer molecule sales in Japan ($m), Table 10: Colon cancer molecule sales in the five major EU markets ($m), Table 11: Avastin sales, by country ($m), Table 12: Avastin patients, by country, Table 13: Eloxatin sales, by country ($m), Table 14: Eloxatin patients, by country, Table 15: Erbitux sales, by country ($m), Table 16: Erbitux patients, by country, Table 17: Imprime PGG sales, by country ($m), Table 18: Imprime PGG patients, by country, Table 19: Irinotecan sales, by country ($m), Table 20: Irinotecan patients, by country, Table 21: Ramucirumab sales, by country ($m), Table 22: Ramucirumab patients, by country, Table 23: Stivarga sales, by country ($m), Table 24: Stivarga patients, by country, Table 25: Zaltrap sales, by country ($m), Table 26: Zaltrap patients, by country,

6 Table 2: Patent expiry dates for key marketed brands in colon cancer Brand Molecule US Japan 5EU n/a 5-fluorouracil Expired Expired Expired Avastin Bevacizumab July 2019 April 2018 December 2019 Xeloda Capecitabine December 2013 December 2018 December 2013 Erbitux Cetuximab May 2019 June 2016 June 2016 Camptosar Irinotecan Expired Expired Expired Eloxatin Oxaliplatin Expired* Expired Expired Vectibix Panitumumab April 2018 May 2018 May 2018 Tegafur-gimeracil-oxonic n/a n/a TS-1 acid Expired UFT Tegafur-uracil n/a September 2016 n/a 5EU = five major EU markets (France, Germany, Italy, Spain, and the UK) Source: FDA Orange Book; MedTRACK, December 2011, Copyright Datamonitor NEW PRODUCT LAUNCHES The table below shows the estimated launch dates for key colon cancer late-stage pipeline drugs across the US, Japan, and five major EU markets over

7 of , demonstrating a compound annual growth rate (CAGR) of 1.18%. This relatively slow growth is a consequence of a combination of market saturation and patent expiries of key brands, such as Eloxatin (oxaliplatin; Sanofi), Avastin (bevacizumab; Genentech/Roche/Chugai), and Erbitux (cetuximab; Eli Lilly/Bristol-Myers Squibb/Merck KGaA). The figure below shows Datamonitor s forecast of colon cancer sales in the US, Japan, and five major EU markets over , by country. Figure 2: Colon cancer market forecast across the US, Japan, and five major EU markets, by country ($m), Source: Datamonitor The value of the colon cancer market in the US, Japan, and five major EU markets will be significantly impacted by the patent expiry of Eloxatin in the US, as well as market entry of biosimilar versions of Avastin and Erbitux. Ongoing patent litigation meant that Sanofi only managed to prevent generic versions of Eloxatin from entering the US market up until August 2012 (Sanofi press release, 2010). Eloxatin s patent has expired in the US, EU, and Japan where entry of generics will significantly reduce the price of the molecule and therefore its sales value. The introduction of biosimilar versions of Avastin and Erbitux towards the end of the forecast period will also act to suppress the overall commercial value of the colon cancer market, but will have less of an impact than generic erosion of small molecules. MARKET ENTRY OF NEW DRUGS WILL HELP MAINTAIN THE VALUE OF THE COLON CANCER 13

8 development toward more expensive targeted therapies rather than a shift away from treatment with cytotoxic therapies. As a result, the cytotoxic class in colon cancer is predominately made up of drugs which have lost market exclusivity, resulting in a generic market. Furthermore, the market entry of generic Eloxatin in the US will result in a significant drop in commercial value of the cytotoxic class between 2012 and The figure below shows colon cancer sales by class across the US, Japan, and five major EU markets over Figure 3: Colon cancer sales in the US, Japan, and five major EU markets, by class ($m), Source: Datamonitor The drugs currently in late-stage development for colon cancer are all targeted therapies. The growing trend toward targeted therapy development has not resulted in a decrease in cytotoxic use as it is common for physicians to administer targeted therapies in combination with a cytotoxic therapy "backbone. Therefore the drugs in development in combination with cytotoxic regimens will not have an impact on the number of patients receiving chemotherapy. To date, combinations of targeted therapies without cytotoxics have not proven successful, and must demonstrate significant improvements in efficacy to warrant the additional costs incurred. Even so, if approved, new combination therapies may struggle to achieve uptake in an ever more cost-conservative market. In the future, an improved understanding of the heterogeneity of colon cancer tumors and evolution of 16

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