Multiple Sclerosis. Current and Future Players. GDHC1009FPR/ Published March 2013

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1 Multiple Sclerosis Current and Future Players GDHC1009FPR/ Published March 2013

2 Executive Summary Moderate Growth in the Multiple Sclerosis Market is Expected from GlobalData estimates the 2012 disease-modifying therapy (DMT) sales for multiple sclerosis (MS) to be approximately $12.6 billion across the 10 markets Increased pressure for cost-effectiveness will result in reimbursement challenges and price cuts, while governments undergoing financial austerity measures are likely to promote the use of generic drugs over branded products. covered in this forecast: US, France, Germany, Italy, Spain, UK, Japan, Canada, China, and India. By the end of the forecast period, sales will grow to $13.6 billion, with a Compound Annual Growth Rate (CAGR) of 0.7%. The majority of sales will come from the US, which represents more than 60% of the market, especially as financial austerity measures remain a primary barrier to growth in other countries. Major drivers to the growth of the MS market over the The increasingly crowded MS marketplace will make it more difficult for newer DMTs to differentiate themselves from the established agents and achieve significant individual patient share. The below figure illustrates the global MS sales for the seven major markets (US, 5EU, Japan), Canada, China, and India during the forecast period. Global Sales for Multiple Sclerosis by Region, forecast period will include: 14.7% 0.1% 2012 Total: $12.6 bn The launch of efficacious pipeline products with convenient oral formulations or less frequent dosing, in addition to DMTs that target the progressive MS 1.1% US 5EU subtypes, which are expected to demand higher prices than conventional therapies 19.8% Japan Canada China and India The push by the physician base for the swift diagnosis of the disease, and the earlier initiation of 64.3% therapy in patients with clinically isolated syndrome (CIS) and early MS will drive up overall treatment 15.2% 0.1% 2022 Total: $13.6 bn rates Increasing access to MS pharmacotherapies in the key emerging markets of India and China 0.9% US 5EU Japan Major barriers to the growth of the MS market will Canada China and India include: 21.2% 62.5% Patent expiries of market-leading branded products throughout the forecast period will significantly expose sales to generic erosion and will result in Source: GlobalData market contraction. Page 2 GDHC1009FPR / Published MAR 2013

3 Executive Summary Established Players are Investing Heavily to Maintain Their Presence in the Increasingly Competitive MS Market The MS market has historically been dominated by four players: Biogen Idec, Merck Serono (EMD Serono in the US), Teva, and Bayer HealthCare. These companies have been the leading competitors globally since 1993, beginning with the successful launch of Bayer s Betaseron/Betaferon (interferon beta-1b), followed soon after by Biogen s Avonex (interferon beta-1a), Teva s Copaxone (glatiramer acetate), and Merck s Rebif (interferon beta-1a). These established first-line therapies have shaped the treatment paradigm and now generate the majority of global sales. However, the MS market has become increasingly competitive with the emergence of oral therapies, several pipeline products with notable efficacies, and looming biosimilars following the patent expiries of key branded products. Therefore, the established players are due to face major challenges in maintaining their position in the MS marketplace, especially as new challengers enter the competitive landscape. In an attempt to gain market share, companies are generally looking to expand the coverage of their current products to increase the treated-patient population, and are targeting alternative disease subtypes where the competition is less fierce. For example, Biogen is investigating Tysabri (natalizumab) for the treatment of secondary-progressive multiple sclerosis (SPMS), while Novartis Gilenya (fingolimod) is being evaluated for primary-progressive multiple sclerosis (PPMS). Another common strategy is to seek approval or brand extensions based on combination therapies. Sanofi s/genzyme s Aubagio (teriflunomide) and Teva s/active Biotech s laquinimod (ABR ) are already being evaluated as possible adjuvant therapies, which if successful, would allow these drugs to generate uptake, even if more efficacious treatment options are available. Other corporate trends include entering partnerships in a bid for companies to broaden their pipeline portfolio or to build important experience in target markets. Of particular strategic importance is the recent collaborative agreement between Merck and Opexa Therapeutics for the development and commercialization of Tcelna (imilecleucel-t), a novel first-in-class MS vaccine. In addition, Teva s acquisition of Taiyo Pharmaceutical Industry in 2011 will boost the company s presence in Japan, with significant opportunity for Teva to extend its MS franchise in the region. Companies that have had no historical involvement in the MS market have also formed collaborations with established players to gain a vital foothold: for example, Sanofi s previous partnership with Teva for the distribution of Copaxone, and Roche/Genentech s collaboration with Biogen in the development of its late-stage product, ocrelizumab (RG1594). Page 3 GDHC1009FPR / Published MAR 2013

4 Executive Summary Below figure provides an analysis of the company portfolio gap in MS for the forecast period. Company Portfolio Gap Analysis in MS, Source: GlobalData Current Players: Currently marketed products and no products in Phase III Current and Future Players: Marketed products and products in Phase III Future Players: No marketed products but products in Phase III Page 4 GDHC1009FPR / Published MAR 2013

5 Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Catalyst Related Reports Upcoming Related Reports Market Outlook Global Markets Forecast Drivers and Barriers Global Issues Current and Future Players Overview Trends in Corporate Strategy Company Profiles Biogen Idec Teva Pharmaceutical Industries Merck Serono (EMD Serono) Sanofi Bayer HealthCare Pharmaceuticals Novartis International Hoffmann-La Roche GlaxoSmithKline Appendix Bibliography Abbreviations Methodology Page 5 GDHC1009FPR / Published MAR 2013

6 Table of Contents 5.4 Forecasting Methodology Diagnosed MS patients Percent Drug-Treated Patients Drugs Included in Each Therapeutic Class Launch and Patent Expiry Dates General Pricing Assumptions Individual Drug Assumptions Generic Erosion Pricing of Pipeline agents Physicians and Specialists Included in This Report Primary Research Prescriber Survey About the Authors Analysts Global Head of Healthcare About GlobalData Contact Us Disclaimer Page 6 GDHC1009FPR / Published MAR 2013

7 Table of Contents 1.1 List of Tables Table 1: Global Sales Forecasts ($m) for Multiple Sclerosis, Table 2: Global Multiple Sclerosis Market Drivers and Barriers, Table 3: Key Companies in the Multiple Sclerosis Market, Table 4: Biogen s Multiple Sclerosis Portfolio Assessment, Table 5: Biogen SWOT Analysis, Table 6: Teva s Multiple Sclerosis Portfolio Assessment, Table 7: Teva SWOT Analysis, Table 8: Merck s Multiple Sclerosis Portfolio Assessment, Table 9: Merck SWOT Analysis, Table 10: Sanofi s Multiple Sclerosis Portfolio Assessment, Table 11: Sanofi SWOT Analysis, Table 12: Bayer s Multiple Sclerosis Portfolio Assessment, Table 13: Bayer SWOT Analysis, Table 14: Novartis Multiple Sclerosis Portfolio Assessment, Table 15: Novartis SWOT Analysis, Table 16: Roche s Multiple Sclerosis Portfolio Assessment, Table 17: Roche SWOT Analysis, Table 18: GlaxoSmithKiline s Multiple Sclerosis Portfolio Assessment, Table 19: GlaxoSmithKline SWOT Analysis, Table 20: Key Launch Dates Table 21: Key Patent Expiries Table 22: Physicians Surveyed, By Country Page 7 GDHC1009FPR / Published MAR 2013

8 Table of Contents 1.2 List of Figures Figure 1: Global Market Sales for Multiple Sclerosis by Region, Figure 2: Company Portfolio Gap Analysis in Multiple Sclerosis, Page 8 GDHC1009FPR / Published MAR 2013

9 Introduction 2 Introduction 2.1 Catalyst The Multiple Sclerosis (MS) therapeutics market is set to enter an exciting phase, with an upsurge of available treatment options and several promising late-stage pipeline products offering diverse mechanisms of action. The arrival of novel oral disease-modifying therapies (DMT) fulfills a significant unmet need in the treatment of MS by providing patients with a more convenient route of administration. Novartis s Gilenya (fingolimod), the first available oral MS drug, and the recently approved Aubagio (teriflunomide; Sanofi/Genzyme) are threatening the stronghold of the currently established injectable therapies, including Teva s Copaxone (glatiramer acetate) and the interferon beta (IFNβ) agents. However, the safety concerns of Gilenya and the modest efficacy of Aubagio are key stumbling blocks in their attempts to make a significant impact in the rapidly growing MS market. The current MS pipeline is very robust, with numerous promising DMTs set to enter the market within the forecast period. Biogen Idec s BG-12 (dimethyl fumarate) demonstrated an impressive efficacy and safety profile in clinical trials prior to its expected launch in 2013, and anticipation is high that it could become the next mega-blockbuster oral treatment for MS. In addition, agents such as Sanofi/Genzyme s Lemtrada (alemtuzumab) will provide stiff competition for Biogen s Tysabri (natalizumab) and challenge its position as the escalating therapy of choice when first-line treatment options have failed. With the market becoming increasingly competitive, the established players are investing heavily to bolster their MS portfolios and are entering into key collaborations with innovative biotech companies. The most recent is Merck (EMD) Serono s agreement with Opexa Therapeutics for the development and commercialization of Tcelna (imilecleucel-t), a novel first-in-class MS vaccine that is making important strides through the phases of clinical development. There are several drivers for growth in the MS market. Initiating early DMT treatment in patients with clinically isolated syndrome (CIS) will delay the onset of clinically-definite MS and increase the overall treated patient population. However, the challenges of the MS industry include an increasingly crowded marketplace, making it more difficult for drugs to distinguish themselves, whereas a natural conservatism among neurologists will also delay the uptake of new drugs trying to gain market entry. Furthermore, the impending patent expiry of current leading DMTs, such as Copaxone, will pave the way for the entry of generics and biosimilars, forcing pharmaceutical companies to derive alternative strategies to offset potential losses in sales. Page 9 GDHC1009FPR / Published MAR 2013

10 Introduction 2.2 Related Reports GlobalData (2013). Multiple Sclerosis US Drug Forecast and Market Analysis to GDHC1072CFR GlobalData (2013). Multiple Sclerosis France Drug Forecast and Market Analysis to GDHC1073CFR GlobalData (2013). Multiple Sclerosis Germany Drug Forecast and Market Analysis to GDHC1074CFR GlobalData (2013). Multiple Sclerosis Italy Drug Forecast and Market Analysis to GDHC1075CFR GlobalData (2013). Multiple Sclerosis Spain Drug Forecast and Market Analysis to GDHC1076CFR GlobalData (2013). Multiple Sclerosis UK Drug Forecast and Market Analysis to GDHC1077CFR GlobalData (2013). Multiple Sclerosis Japan Drug Forecast and Market Analysis to GDHC1078CFR GlobalData (2013). Multiple Sclerosis India Drug Forecast and Market Analysis to GDHC1079CFR GlobalData (2013). Multiple Sclerosis China Drug Forecast and Market Analysis to GDHC1080CFR GlobalData (2013). Multiple Sclerosis Canada Drug Forecast and Market Analysis to GDHC1081CFR GlobalData (2013). Betaseron/Betaferon (Multiple Sclerosis) Forecast and Market Analysis to GDHC1112DFR GlobalData (2013). Avonex (Multiple Sclerosis) Forecast and Market Analysis to GDHC1113DFR GlobalData (2013). Copaxone (Multiple Sclerosis) Forecast and Market Analysis to GDHC1114DFR GlobalData (2013). Rebif (Multiple Sclerosis) Forecast and Market Analysis to GDHC1115DFR Page 10 GDHC1009FPR / Published MAR 2013

11 Introduction GlobalData (2013). Tysabri (Multiple Sclerosis) Forecast and Market Analysis to GDHC1116DFR GlobalData (2013). Gilenya/Imusera (Multiple Sclerosis) Forecast and Market Analysis to GDHC1117DFR GlobalData (2013). Aubagio (Multiple Sclerosis) Forecast and Market Analysis to GDHC1118DFR GlobalData (2013). BG-12 (Multiple Sclerosis) Forecast and Market Analysis to GDHC1119DFR GlobalData (2013). Lemtrada (Multiple Sclerosis) Forecast and Market Analysis to GDHC1120DFR GlobalData (2013). Laquinimod (Multiple Sclerosis) Forecast and Market Analysis TO GDHC1121DFR GlobalData (2013). Ocrelizumab (Multiple Sclerosis) Forecast and Market Analysis TO GDHC1122DFR GlobalData (2013). Daclizumab (Multiple Sclerosis) Forecast and Market Analysis TO GDHC1123DFR GlobalData (2013). Masitinib (Multiple Sclerosis) Forecast and Market Analysis TO GDHC1124DFR GlobalData (2013). Siponimod (Multiple Sclerosis) Forecast and Market Analysis TO GDHC1125DFR GlobalData (2013). NU-100 (Multiple Sclerosis) Forecast and Market Analysis TO GDHC1126DFR GlobalData (2013). Tcelna (Multiple Sclerosis) Forecast and Market Analysis TO GDHC1127DFR Page 11 GDHC1009FPR / Published MAR 2013

12 Appendix 5.8 About GlobalData GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, London, India, and Singapore 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, GlobalData. Page 59 GDHC1009FPR / Published MAR 2013

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