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Siponimod (Multiple Sclerosis) - Forecast and Market Analysis to 2022

Published By :


Published Date : Mar 2013

Category :

Therapeutic Area

No. of Pages : 61 Pages

Siponimod (Multiple Sclerosis) Forecast and Market Analysis to 2022


GlobalData has released its new PharmaPoint Drug Evaluation report, “Siponimod (Multiple Sclerosis) Forecast and Market Analysis to 2022”. Multiple sclerosis (MS) is a chronic, inflammatory neurological disorder characterized pathologically by demyelination, axonal transection and neurodegeneration within the central nervous system. With curative therapy still elusive, current disease management is dependent on life-long pharmacotherapy with disease-modifying therapies (DMT). The dominance of first-line injectable DMTs, including the interferon beta (IFNB) agents: Bayer’s Betaseron/Betaferon (IFNB-1b), Biogen’s Avonex (IFNB-1a) and Merck’s Rebif (IFNB-1a), and Teva’s Copaxone (glatiramer acetate), has been a salient feature of the MS therapeutics market. However, the competitive landscape is undergoing significant change with the emergence of oral therapies, several pipeline products with notable efficacies, and looming generics/biosimilars following the patent expiries of key branded products during the forecast period. In addition, the entry of new companies such as Sanofi/Genzyme and F. Hoffmann-La-Roche/Genentech will challenge the position of the established players in the MS marketplace.

Siponimod (BAF-312) is Novartis’ second-generation S1P receptor modulator, which has a mechanism of action similar to Gilenya, but specifically targets receptor subtypes 1 and 5 (S1P1 and S1P5). It is currently initiating Phase III trials of clinical development. Like Gilenya, siponimod retains lymphocytes in the peripheral lymph nodes and inhibits their migration into the CNS, where they are implicated in the immunopathological proceBes of MS. It is believed that the higher specificity of siponimod will significantly reduce the incidence of serious side effects that are aBociated with Gilenya, thus providing an improved overall safety profile. Despite having demonstrated promising results in a Phase II trial as a treatment for RRMS, Novartis has instead decided to evaluate siponimod as an SPMS therapy in the current Phase III trials. Therefore, siponimod can potentially fulfill an important unmet need in MS by providing a much-needed additional treatment option for patients with SPMS.


  • Overview of Multiple Sclerosis, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Siponimod including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Siponimod for the top ten countries from 2012 to 2022.
  • Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China and India

Reasons to buy

  • Understand and capitalize by identifying products that are most likely to ensure a robust return
  • Stay ahead of the competition by understanding the changing competitive landscape for Multiple Sclerosis
  • Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
  • Make more informed busineB decisions from insightful and in-depth analysis of Siponimod performance
  • Obtain sales forecast for Siponimod from 2012-2022 in top ten countries (the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China and India)
Table of Contents

1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 7

2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 9

3 Disease Overview 11
3.1 Etiology and Pathophysiology 11
3.1.1 Etiology 11
3.1.2 Pathophysiology 12
3.1.3 Classification of Multiple Sclerosis 13
3.2 Symptoms 15
3.2.1 Prognosis 16
3.2.2 Quality of Life 17

4 Disease Management 18
4.1 Diagnosis 18
4.2 Treatment Overview 21
4.2.1 Management of Acute Relapse 22
4.2.2 Treatment with Disease-Modifying Therapies 22
4.2.3 Symptomatic Therapies 25

5 Competitive Assessment 26
5.1 Overview 26
5.2 Strategic Competitor Assessment 27

6 Opportunity and Unmet Need 29
6.1 Overview 29
6.2 Unmet Needs 30
6.2.1 Currently Available MS Drugs Only Provide Partial Benefits 30
6.2.2 The High Cost of MS Drugs Could Continue to Price out Patients 31
6.2.3 Safety and Tolerability of Therapy is Undermined by Side Effects 32
6.2.4 Effective Treatments for Progressive MS Are Still Elusive 33
6.2.5 Inconvenient Route of Administration and Frequent Dosing Limits Compliance 34
6.2.6 The Lack of Predictive Biomarkers Delays MS Diagnosis 35
6.3 Unmet Needs Gap Analysis 36
6.4 Opportunities 37
6.4.1 Treatments for Progressive MS 37
6.4.2 Targeting Patients with Clinically Isolated Syndrome 37

7 Pipeline Assessment 38
7.1 Overview 38
7.2 Promising Drugs in Clinical Development 40

8 Siponimod (BAF-312) 42
8.1 Overview 42
8.2 Efficacy 43
8.3 Safety 44
8.4 Dosing and Formulation 44
8.5 Potential Clinical Positioning 45
8.6 Potential Commercial Positioning 45
8.7 Pricing and Reimbursement 45
8.8 SWOT Analysis 46
8.9 Forecast 47

9 Appendix 48
9.1 Bibliography 48
9.2 Abbreviations 52
9.3 Methodology 54
9.4 Forecasting Methodology 54
9.4.1 Diagnosed MS patients 54
9.4.2 Percent Drug-Treated Patients 55
9.4.3 General Pricing Assumptions 55
9.4.4 Generic Erosion 56
9.4.5 Pricing of Pipeline agents 56
9.5 Physicians and Specialists Included in This Report 57
9.6 Primary Research Prescriber Survey 58
9.7 About the Authors 59
9.7.1 Analysts 59
9.7.2 Global Head of Healthcare 60
9.8 About GlobalData 61
9.9 Contact Us 61
9.10 Disclaimer 61

List of Table

Table 1: Common Presenting Symptoms of Multiple Sclerosis 15
Table 2: Factors That Can Affect Prognosis in Multiple Sclerosis 16
Table 3: Revised 2010 McDonald Criteria for the Diagnosis of Multiple Sclerosis 19
Table 4: Treatment Guidelines for Multiple Sclerosis 21
Table 5: Top Three Disease-Modifying Therapies Prescribed for Multiple Sclerosis by Market 23
Table 6: Pharmacotherapy for Common Multiple Sclerosis Symptoms 25
Table 7: Disease-Modifying Drugs for the Treatment of Multiple Sclerosis, 2012 28
Table 8: Overall Unmet Needs Current Level of Attainment 29
Table 9: Clinical Unmet Needs Gap Analysis, 2012 36
Table 10: Multiple Sclerosis Phase Pipeline, 2012 40
Table 11: Comparison of Therapeutic Classes in Development for Multiple Sclerosis, 2012 41
Table 12: Product Profile Siponimod 43
Table 13: Siponimod SWOT Analysis, 2012 46
Table 14: Global Sales Forecasts ($m) for Siponimod, 20122022 47
Table 15: Physicians Surveyed, By Country 58

List of Chart

Figure 1: Accrual of Disability in the Four Subtypes of Multiple Sclerosis 14
Figure 2: Expanded Disability Status Scale (EDSS) 20
Figure 3: Current Algorithm for the Treatment of MS with Disease-Modifying Therapies 24
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in Multiple Sclerosis, 20122022 40

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