Multiple Sclerosis. Global Drug Forecast and Market Analysis to 2022 Event-Driven Update. GDHC34PIDR / Published April 2013

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1 Multiple Sclerosis Global Drug Forecast and Market Analysis to 2022 Event-Driven Update GDHC34PIDR / Published April 2013

2 Executive Summary The table below presents the key metrics for multiple sclerosis (MS) in the seven major pharmaceutical markets. Multiple Sclerosis: Key Metrics in the Seven Major Pharmaceutical Markets 2012 Epidemiology Diagnosed Prevalence Population 7MM Diagnosed Prevalence Population Global 2012 Market Sales US 5EU Japan Total 7MM Total Global* Pipeline Assessment 0.68 million 0.84 million $8.10bn $2.49bn $0.13bn $10.72bn $12.60bn Number of drugs in Phase II III 45 Number of first-in-class drugs in late-stage pipeline 6 Most Promising Pipeline Drugs Tecfidera (dimethyl fumarate [Biogen Idec.]) Ocrelizumab (RG1594 [Roche/Genentech/Biogen]) Daclizumab (Abbott/Biogen) Lemtrada (alemtuzumab [Sanofi/Genzyme/Bayer]) Siponimod (BAF-312 [Novartis]) Key events ( ) Avonex patent expiry in Europe in 2012 Global launch of Tecfidera in 2013 Copaxone patent expiry in the US in 2014 Launch of ocrelizumab in the US in 2016 Gilenya patent expiry/loss of data exclusivity in the US in Market Sales US 5EU Japan Total 7MM 2022 Sales $3.87bn $1.31bn $1.11bn $0.81bn $0.83bn Level of Impact $9.69bn $3.41bn $0.12bn $13.22bn Continuous Growth in the Multiple Sclerosis Market is Expected from GlobalData estimates the 2012 disease-modifying therapy (DMT) sales for multiple sclerosis to be approximately $12.6 billion across the 10 markets 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 $15.73 billion, with a Compound Annual Growth Rate (CAGR) of 2.25%. 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 forecast period will include: The launch of efficacious pipeline products with convenient oral formulations or less frequent dosing, in addition to DMTs that target the progressive MS subtypes, which are expected to demand higher prices than conventional therapies The push by the physician base for the swift diagnosis of the disease, and the earlier initiation of therapy in patients with clinically isolated syndrome (CIS) and early MS will drive up overall treatment rates Increasing access to MS pharmacotherapies in the key emerging markets of India and China Total Global* $15.73bn 7 MM = US, France, Germany, Italy, Spain, UK, Japan; 5EU = France, Germany, Italy, Spain, UK *For the purposes of this report, Global = US, France, Germany, Italy, Spain, UK, Japan, Canada, China, India Source: GlobalData Page 2 GDHC34PIDR / Published APR 2013

3 Executive Summary Major barriers to the growth of the MS market will include: Patent expiries of market-leading branded products throughout the forecast period will significantly expose sales to generic erosion and will result in market contraction. 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. 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 figure below 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, % 19.8% 0.8% 21.7% 14.8% 15.8% 0.1% 0.1% 64.3% 61.6% 2012 Total: $12.6 bn US 5EU Japan Canada China and India 2022 Total: $15.7 bn US 5EU Japan Canada China and India Source: GlobalData Page 3 GDHC34PIDR / Published APR 2013

4 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 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. The figure below provides an analysis of the company portfolio gap in MS for the forecast period. Company Portfolio Gap Analysis in Multiple Sclerosis, 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 GDHC34PIDR / Published APR 2013

5 Executive Summary The MS Market is Still Littered with Unmet Needs While the last two decades have brought many important advances in the management of MS with the FDA approval of nine DMTs, there still remain significant unmet needs in the market. There are no curative therapies for MS, and most existing DMTs are only partially effective in preventing relapses, with limited impact on the accrual of disability. There are also insufficient options for patients with progressive forms of MS. The current use of escalation therapy with drugs like Tysabri can provide an improved efficacy over the standard first-line treatments, but they are associated with a higher risk of serious side effects. While Gilenya and the recently approved Aubagio and Tecfidera (dimethyl fumarate; Biogen Idec) offer added convenience with their oral formulations, the established first-line treatments are injectables, which can hinder patient adherence. The unmet needs that remain drive the research for better MS DMTs. Several oral pipeline products that target the need for more convenient routes of administration will emerge onto the market by midforecast or even earlier, including Tecfidera, which was recently launched in the US, and laquinimod. These agents will compete with Gilenya and Aubagio for patient share. Other agents, such as ocrelizumab, aim to provide high efficacy for patients who require escalation therapy, but do not carry the risk of progressive multifocal leukoencephalopathy (PML) that is associated with Tysabri use. A Crowded Relapsing-Remitting MS Market Leaves Opportunities to Target Progressive MS Patient Populations Most of the late-stage pipeline products due to emerge during the forecast period are geared towards treating patients with relapsing-remitting multiple sclerosis (RRMS), which leaves the population of patients with SPMS or PPMS largely devoid of treatment options in comparison. Therefore, while the RRMS market is becoming overcrowded, competition for market share in the progressive MS segment is considerably less fierce, even with the anticipated arrival of agents such as Novartis siponimod (BAF-312) for these subtypes by late-forecast. In addition, the conventional MS DMTs, including those in the pipeline, are mainly directed at the inflammatory and systemic origins of the disease, but have largely insufficient impact on the underlying neuro - deterioration process. DMTs that have strong neuroprotective properties and can halt the progression of the disease are still very much elusive. This is a prime need, which if addressed, will greatly impact the market both from a clinical and commercial prospective. Such a drug will achieve unparalleled success not only in the treatment of progressive MS, but also in the early stages of the disease. Page 5 GDHC34PIDR / Published APR 2013

6 Executive Summary Newer Drugs Dominate the Pipeline with Improved Efficacy and More Convenient Administration The anticipated emergence of several promising pipeline DMTs will threaten the stronghold of the established MS therapies. Current research and development (R&D) efforts will deliver newer pharmaceuticals touting improved efficacy in reducing the risk of relapses or delaying the accumulation of permanent disability, novel mechanisms of action, and more convenient administration through oral formulations or infrequent dosing. Tecfidera, which received Food and Drug Administration (FDA) approval on March 27, 2013, is hotly anticipated to be the next mega-blockbuster treatment for MS, owing to its first-in-class mechanism of action, attractive oral route of administration, and strong efficacy and safety data in clinical trials, which will position the drug as a firstline therapy. Tecfidera will provide the stiffest competition to the conventional first-line injectable DMTs and is expected to overtake Copaxone s position as the best-selling MS drug, with predicted global sales reaching $3.2 billion by In the progressive MS market, siponimod is projected to generate the highest sales within the forecast period, given its likely premium pricing, oral formulation, and promising results from previous clinical trials, thus outcompeting masitinib (AB1010; AB Science), while Tcelna arrives late onto the market. As a me-too product, siponimod has a higher specificity with regard to mechanism of action than Gilenya, with the potential for improved safety without sacrificing efficacy. GlobalData predicts global end-of-forecast sales of $830m for siponimod in The figure below provides a competitive assessment of the late-stage pipeline agents in development for MS for the forecast period. Competitive Assessment of Late-Stage Pipeline Agents in Multiple Sclerosis, The launch of ocrelizumab in mid-forecast will threaten the sales of Tysabri as the current treatment of choice for escalation therapy. Ocrelizumab will achieve strong market penetration due to its lowfrequency dosing, lack of established risk of developing PML, and similarities to Rituxan (rituximab), a drug commonly prescribed off label for MS. Given its strong product characteristics, GlobalData projects global ocrelizumab end-offorecast sales of $1.3 billion in 2022, narrowly edging out Lemtrada (alemtuzumab; Sanofi/Genzyme/Bayer) and daclizumab (Abbott/Biogen), which are also strong candidates for escalation therapy. Source: GlobalData Page 6 GDHC34PIDR / Published APR 2013

7 Executive Summary What Do the Physicians Think? Our experts believe that the most promising DMTs are Biogen s Tecfidera, which was recently launched in the US, and Roche s/genentech s/biogen s ocrelizumab. Higher efficacy generally comes with higher risks. The only drug which has not followed this pattern is BG-12 [Tecfidera] that has a high efficacy, but there haven t been very many associated infections. So far, the BG-12 [Tecfidera] profile has been quite safe, so I would expect it will come out as a first-line drug. [EU] Key Opinion Leader, November 2012 I think ocrelizumab will have a big impact. It is essentially the same drug as rituximab, which we have a lot of experience with, but is more humanized. Like rituximab, it looks to be well-tolerated and doesn t need to be taken very often because of its long-lasting effect. [US] Key Opinion Leader, November 2012 The launch of oral MS DMTs is expected to progressively diminish the role of the injectable firstline therapies through the forecast period. If we just focus on the interferons and glatiramer acetate [Copaxone], I would say the main downfall of them is that they are injectable agents, as a lot of patients don t like injecting themselves. Plus, they also have to be administered quite frequently, so people might find them quite disruptive. Oral DMTs are highly desired by patients, as they are much more convenient, and fortunately, there are several in the pipeline. I expect the role of the first-line injectable drugs will diminish over time, as more patients will prefer the oral drugs. Physicians interviewed in this report have highlighted the current challenges in diagnosing MS, which can negatively impact the treatment of patients. I would say the biggest challenge in diagnosing MS is differential diagnosis. Without a definitive test, ruling out that your patient may have something else is difficult, and there are a lot of conditions that share the same features as MS, like neuromyelitis optica. So, do you wait and delay starting your patient on treatment while you monitor progress? Or, do you risk giving the wrong treatment to your patient? That is the problem we currently face. [EU] Key Opinion Leader, November 2012 Key Opinion Leaders (KOLs) interviewed for this report are in agreement that the proportion of patients with SPMS will progressively decrease over time as more efficacious DMTs become available for patients with RRMS, as well as the earlier initiation of treatment in patients. In the next few years, there will be many strong diseasemodifying drugs that will become available for patients. I really do expect, and I think we are already starting to see this trend, is that the overall population of secondaryprogressive patients will drop over time as therapies become more effective in stopping patients from progressing to this subtype, [US] Key Opinion Leader, November 2012 As more patients are started on treatment early in MS, we will see fewer patients with secondary-progressive MS in the future, [EU] Key Opinion Leader, October 2012 [US] Key Opinion Leader, November 2012 Page 7 GDHC34PIDR / Published APR 2013

8 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Catalyst Upcoming Related Reports Disease Overview Etiology and Pathophysiology Etiology Pathophysiology Classification of Multiple Sclerosis Symptoms Prognosis Quality of Life Epidemiology Risk Factors Family members of MS patients have a 1 5% risk of developing MS Women are twice as likely to develop MS, but men have a worse prognosis Caucasians have a higher risk of MS than any other race/ethnicity Protective effect of vitamin D on MS may relate to latitude and month of birth Timing of environmental exposures affects MS risk Exposure to smoking may increase MS risk and worsen prognosis Comorbidities Autoimmune diseases may be comorbidities of MS Mental comorbidities are found in up to 60% of MS patients and may affect relapse rates Global Trends North America Page 8 GDHC34PIDR / Published APR 2013

9 4.3.2 Europe Asia Forecast Methodology Sources Used Forecast Assumptions and Methods Sources Not Used Epidemiology Forecast for Multiple Sclerosis Total Prevalent Cases of Multiple Sclerosis Age-Specific Prevalent Cases of Multiple Sclerosis Gender-Specific Prevalent Cases of Multiple Sclerosis Total Incident Cases of Multiple Sclerosis Age-Specific Incident Cases of Multiple Sclerosis Gender-Specific Incident Cases of Multiple Sclerosis Multiple Sclerosis Subtypes Discussion Conclusions on Epidemiological Trends Limitations of the Analysis Strengths of the Analysis Disease Management Diagnosis Treatment Overview Management of Acute Relapse Treatment with Disease-Modifying Therapies Symptomatic Therapies US Diagnosis Clinical Practice France Page 9 GDHC34PIDR / Published APR 2013

10 5.4.1 Diagnosis Clinical Practice Germany Diagnosis Clinical Practice Italy Diagnosis Clinical Practice Spain Diagnosis Clinical Practice UK Diagnosis Clinical Practice Japan Diagnosis Clinical Practice Canada Diagnosis Clinical Practice China Diagnosis Clinical Practice India Diagnosis Clinical Practice Competitive Assessment Overview Page 10 GDHC34PIDR / Published APR 2013

11 6.2 Strategic Competitor Assessment Product Profiles Major Brands Betaseron/Betaferon (interferon beta-1b) Avonex (interferon beta-1a) Rebif (interferon beta-1a) Copaxone (glatiramer acetate; copolymer-1) Tysabri (natalizumab) Gilenya/Imusera (fingolimod; FTY720) Aubagio (teriflunomide) Other Disease Modifying Therapies Opportunity and Unmet Need Overview Unmet Needs Currently Available MS Drugs Only Provide Partial Benefits The High Cost of MS Drugs Could Continue to Price out Patients Safety and Tolerability of Therapy is Undermined by Side Effects Effective Treatments for Progressive MS Are Still Elusive Inconvenient Route of Administration and Frequent Dosing Limits Compliance The Lack of Predictive Biomarkers Delays MS Diagnosis Unmet Needs Gap Analysis Opportunities Treatments for Progressive MS Targeting Patients with Clinically Isolated Syndrome Pipeline Assessment Overview Clinical Trial Mapping Clinical Trials by Country Clinical Trials by Phase and Trial Status Page 11 GDHC34PIDR / Published APR 2013

12 8.4 Promising Drugs in Clinical Development Tecfidera (dimethyl fumarate) Lemtrada (alemtuzumab) Laquinimod (ABR ) Daclizumab High-Yield Process (HYP) Ocrelizumab (RG1594) Siponimod (BAF-312) NU-100 (interferon beta-1b) Masitinib (AB-1010) Tcelna (imilecleucel-t) 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 Market Outlook Global Markets Forecast Drivers and Barriers Global Issues United States Forecast Page 12 GDHC34PIDR / Published APR 2013

13 Key Events Drivers and Barriers France Forecast Key Events Drivers and Barriers Germany Forecast Key Events Drivers and Barriers Italy Forecast Key Events Drivers and Barriers Spain Forecast Key Events Drivers and Barriers United Kingdom Forecast Key Events Drivers and Barriers Japan Forecast Key Events Drivers and Barriers Canada Forecast Page 13 GDHC34PIDR / Published APR 2013

14 Key Events Drivers and Barriers China Forecast Key Events Drivers and Barriers India Forecast Key Events Drivers and Barriers Appendix Bibliography Abbreviations Methodology 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 Epidemiologists Page 14 GDHC34PIDR / Published APR 2013

15 Global Head of Healthcare About GlobalData Contact Us Disclaimer Page 15 GDHC34PIDR / Published APR 2013

16 1.1 List of Tables Table 1: Common Presenting Symptoms of Multiple Sclerosis Table 2: Factors That Can Affect Prognosis in Multiple Sclerosis Table 3: Sources of Prevalence and Incidence Data Used in the Epidemiology Forecast Table 4: 10 Markets, Prevalent Cases of Multiple Sclerosis, Ages 20, Male and Female, N, Select Table 5: Table 6: 10 Markets, Prevalent Cases of Multiple Sclerosis, By Age*, Male and Female, N (Row %), Major Markets, Prevalent Cases of Multiple Sclerosis, Ages 20, By Gender, N (Row %), Table 7: 10 Markets, Incident Cases of Multiple Sclerosis, Ages 20, Male and Female, N, Select Years, Table 8: 10 Markets, Incident Cases of Multiple Sclerosis, By Age*, Male and Female, N (Row %), Table 9: 10 Major Markets, Incident Cases of Multiple Sclerosis, By Gender, N (Row %), Table 10: Revised 2010 McDonald Criteria for the Diagnosis of Multiple Sclerosis Table 11: Treatment Guidelines for Multiple Sclerosis Table 12: Top Three Disease-Modifying Therapies Prescribed for Multiple Sclerosis by Market Table 13: Pharmacotherapy for Common Multiple Sclerosis Symptoms Table 14: Disease-Modifying Drugs for the Treatment of Multiple Sclerosis, Table 15: Product Profile Betaseron Table 16: Betaseron/Betaferon SWOT Analysis, Table 17: Global Sales Forecasts ($m) for Betaseron/Betaferon, Table 18: Product Profile Avonex Table 19: Avonex SWOT Analysis, Table 20: Global Sales Forecasts ($m) for Avonex, Table 21: Product Profile Rebif Page 16 GDHC34PIDR / Published APR 2013

17 Table 22: Rebif SWOT Analysis, Table 23: Global Sales Forecasts ($m) for Rebif, Table 24: Product Profile Copaxone Table 25: Copaxone SWOT Analysis, Table 26: Global Sales Forecasts ($m) for Copaxone, Table 27: Product Profile Tysabri Table 28: Tysabri SWOT Analysis, Table 29: Global Sales Forecasts ($m) for Tysabri, Table 30: Product Profile Gilenya Table 31: Gilenya SWOT Analysis, Table 32: Global Sales Forecasts ($m) for Gilenya/Imusera, Table 33: Product Profile Aubagio Table 34: Aubagio SWOT Analysis, Table 35: Global Sales Forecasts ($m) for Aubagio, Table 36: Summary of Alternative MS DMTs, Table 37: Overall Unmet Needs Current Level of Attainment Table 38: Clinical Unmet Needs Gap Analysis, Table 39: Multiple Sclerosis Clinical Trials by Phase and Status, Table 40: Multiple Sclerosis Phase IIb/III Pipeline, Table 41: Comparison of Therapeutic Classes in Development for Multiple Sclerosis, Table 42: Product Profile Tecfidera Table 43: Tecfidera SWOT Analysis, Table 44: Global Sales Forecasts ($m) for Tecfidera, Table 45: Product Profile Lemtrada Table 46: Lemtrada SWOT Analysis, Table 47: Global Sales Forecasts ($m) for Lemtrada, Table 48: Product Profile Laquinimod Table 49: Laquinimod SWOT Analysis, Page 17 GDHC34PIDR / Published APR 2013

18 Table 50: Global Sales Forecasts ($m) for Laquinimod, Table 51: Product Profile Daclizumab High-Yield Process Table 52: Daclizumab SWOT Analysis, Table 53: Global Sales Forecasts ($m) for Daclizumab, Table 54: Product Profile Ocrelizumab Table 55: Ocrelizumab SWOT Analysis, Table 56: Global Sales Forecasts ($m) for Ocrelizumab, Table 57: Product Profile Siponimod Table 58: Siponimod SWOT Analysis, Table 59: Global Sales Forecasts ($m) for Siponimod, Table 60: Product Profile NU Table 61: NU-100 SWOT Analysis, Table 62: Global Sales Forecasts ($m) for NU-100, Table 63: Product Profile Masitinib Table 64: Masitinib SWOT Analysis, Table 65: Global Sales Forecasts ($m) for Masitinib, Table 66: Product Profile Tcelna Table 67: Tcelna SWOT Analysis, Table 68: Global Sales Forecasts ($m) for Tcelna, Table 69: Key Companies in the Multiple Sclerosis Market, Table 70: Biogen s Multiple Sclerosis Portfolio Assessment, Table 71: Biogen SWOT Analysis, Table 72: Teva s Multiple Sclerosis Portfolio Assessment, Table 73: Teva SWOT Analysis, Table 74: Merck s Multiple Sclerosis Portfolio Assessment, Table 75: Merck SWOT Analysis, Table 76: Sanofi s Multiple Sclerosis Portfolio Assessment, Table 77: Sanofi SWOT Analysis, Page 18 GDHC34PIDR / Published APR 2013

19 Table 78: Bayer s Multiple Sclerosis Portfolio Assessment, Table 79: Bayer SWOT Analysis, Table 80: Novartis Multiple Sclerosis Portfolio Assessment, Table 81: Novartis SWOT Analysis, Table 82: Roche s Multiple Sclerosis Portfolio Assessment, Table 83: Roche SWOT Analysis, Table 84: GlaxoSmithKiline s Multiple Sclerosis Portfolio Assessment, Table 85: GlaxoSmithKline SWOT Analysis, Table 86: Global Sales Forecasts ($m) for Multiple Sclerosis, Table 87: Global Multiple Sclerosis Market Drivers and Barriers, Table 88: Sales Forecasts ($m) for Multiple Sclerosis in the United States, Table 89: Key Events Impacting Sales for Multiple Sclerosis the United States, Table 90: Multiple Sclerosis Market in the United States Drivers and Barriers, Table 91: Sales Forecasts ($m) for Multiple Sclerosis in France, Table 92: Key Events Impacting Sales for Multiple Sclerosis in France, Table 93: Multiple Sclerosis Market in France Drivers and Barriers, Table 94: Sales Forecasts ($m) for Multiple Sclerosis in Germany, Table 95: Key Events Impacting Sales for Multiple Sclerosis in Germany, Table 96: Multiple Sclerosis Market in Germany Drivers and Barriers, Table 97: Sales Forecasts ($m) for Multiple Sclerosis in Italy, Table 98: Key Events Impacting Sales for Multiple Sclerosis in Italy, Table 99: Multiple Sclerosis Market in Italy Drivers and Barriers, Table 100: Sales Forecasts ($m) for Multiple Sclerosis in Spain, Table 101: Key Events Impacting Sales for Multiple Sclerosis in Spain, Table 102: Multiple Sclerosis Market in Spain Drivers and Barriers, Table 103: Sales Forecasts ($m) for Multiple Sclerosis in the United Kingdom, Table 104: Key Events Impacting Sales for Multiple Sclerosis in the United Kingdom, Page 19 GDHC34PIDR / Published APR 2013

20 Table 105: Multiple Sclerosis Market in the United Kingdom Drivers and Barriers, Table 106: Sales Forecasts ($m) for Multiple Sclerosis in Japan, Table 107: Key Events Impacting Sales for Multiple Sclerosis in Japan, Table 108: Multiple Sclerosis Market in Japan Drivers and Barriers, Table 109: Sales Forecasts ($m) for Multiple Sclerosis in Canada, Table 110: Key Events Impacting Sales for Multiple Sclerosis in Canada, Table 111: Multiple Sclerosis Market in Canada Drivers and Barriers, Table 112: Sales Forecasts ($m) for Multiple Sclerosis in China, Table 113: Key Events Impacting Sales for Multiple Sclerosis in China, Table 114: Multiple Sclerosis Market in China Drivers and Barriers, Table 115: Sales Forecasts ($m) for Multiple Sclerosis in India, Table 116: Key Events Impacting Sales for Multiple Sclerosis in India, Table 117: Multiple Sclerosis Market in India Drivers and Barriers, Table 118: Key Launch Dates Table 119: Key Patent Expiries Table 120: Physicians Surveyed, By Country Page 20 GDHC34PIDR / Published APR 2013

21 1.2 List of Figures Figure 1: Accrual of Disability in the Four Subtypes of Multiple Sclerosis Figure 2: 10 Markets, Prevalent Cases of Multiple Sclerosis, Ages 20, Male and Female, N, Select Figure 3: 10 Markets, Prevalent Cases of Multiple Sclerosis, By Age*, Male and Female, N, Figure 4: 10 Markets, Prevalent Cases of Multiple Sclerosis, Ages 20, By Gender, N, Figure 5: 10 Markets, Incident Cases of Multiple Sclerosis, Ages 20, Male and Female, N, Select Years, Figure 6: 10 Markets, Incident Cases of Multiple Sclerosis, By Age*, Male and Female, N, Figure 7: 10 Markets, Incident Cases of Multiple Sclerosis, By Gender, N, Figure 8: 10 Markets, Multiple Sclerosis Subtypes in Prevalent Cases, %*, Figure 9: Expanded Disability Status Scale (EDSS) Figure 10: Current Algorithm for the Treatment of MS with Disease-Modifying Therapies Figure 11: Multiple Sclerosis Therapeutics Clinical Trials by Country, Figure 12: Competitive Assessment of Late-Stage Pipeline Agents in Multiple Sclerosis, Figure 13: Company Portfolio Gap Analysis in Multiple Sclerosis, Figure 14: Global Market Sales for Multiple Sclerosis by Region, Figure 15: Sales for Multiple Sclerosis in the United States by Drug Class, Figure 16: Sales for Multiple Sclerosis in France by Drug Class, Figure 17: Sales for Multiple Sclerosis in Germany by Drug Class, Figure 18: Sales for Multiple Sclerosis in Italy by Drug Class, Figure 19: Sales for Multiple Sclerosis in Spain by Drug Class, Figure 20: Sales for Multiple Sclerosis in the United Kingdom by Drug Class, Figure 21: Sales for Multiple Sclerosis in Japan by Drug Class, Figure 22: Sales for Multiple Sclerosis in Canada by Drug Class, Page 21 GDHC34PIDR / Published APR 2013

22 Figure 23: Sales for Multiple Sclerosis in China by Drug Class, Figure 24: Sales for Multiple Sclerosis in India by Drug Class, Page 22 GDHC34PIDR / Published APR 2013

23 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 (DMTs) 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 Tecfidera (dimethyl fumarate; formerly BG-12) demonstrated an impressive efficacy and safety profile in clinical trials prior to its recent approval by the Food and Drug Administration (FDA) on March 27, 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 23 GDHC34PIDR / Published APR 2013

24 Introduction 2.2 Upcoming Related Reports GlobalData (2013). PharmaPoint: Migraine Global Drug Forecast and Market Analysis to 2022, May, GlobalData (2013). PharmaPoint: Fibromyalgia Global Drug Forecast and Market Analysis to 2022, July, GlobalData (2013). PharmaPoint: Neuropathic Pain Global Drug Forecast and Market Analysis to 2022, July, Page 24 GDHC34PIDR / Published APR 2013

25 Appendix 11.8 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 342 GDHC34PIDR / Published APR 2013

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