Amyotrophic Lateral Sclerosis – Analysis and Market Forecasts to 2019

Amyotrophic Lateral Sclerosis – Analysis and Market Forecasts to 2019

Table of Contents

1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 6

2 Introduction 
2.1 Catalyst 7

3 Disease Overview 
3.1 Motor Neuron Disease 8
3.2 Etiology and Pathophysiology 9
3.2.1 Etiology 9
3.2.2 Common Hypotheses for the Pathogenesis of Amyotrophic Lateral Sclerosis 10
3.2.3 Therapeutic Strategies Based on Pathophysiology 12
3.2.4 Risk Factors 12
3.2.5 Quality of Life 13
3.2.6 Prognosis 13
3.3 Epidemiology 14
3.3.1 Prevalence 14
3.4 Symptoms 16
3.5 Diagnosis and Referral 16
3.5.1 Physical Examination 17
3.5.2 Diagnostic Tests 18
3.5.3 Emerging Diagnostic Tests 19
3.6 Treatment Guidelines 19
3.7 Disease Management 20
3.7.1 Pharmacological Treatment 20
3.7.2 Supportive Care 22

4 Competitive Assessment 
4.1 Overview 24
4.2 Strategic Competitor Assessment 24
4.3 Product Profiles – Major Brands 25
4.3.1 Rilutek (riluzole) 25

5 Opportunity and Unmet Need 
5.1 Overview 28
5.2 Low Awareness 29
5.3 Disease-Modifying Drugs 29
5.4 High Cost of Therapy 30

6 Pipeline Assessment 
6.1 Overview 31
6.2 Strategic Pipeline Assessment 31
6.3 Pipeline by Phases of Development 32
6.3.1 Phase III Pipeline 32
6.3.2 Phase II/III Pipeline 33
6.3.3 Phase II Pipeline 33
6.3.4 Phase I/II Pipeline 33
6.3.5 Phase I Pipeline 34
6.3.6 Preclinical and Discovery Pipeline 34
6.3.7 Status Unknown 34
6.4 Pipeline by Mechanism of Action 35
6.5 Technology Trends Analytic Framework 37
6.6 Promising Drugs in Clinical Development 38
6.6.1 ALS-02 39
6.6.2 Radicut (edaravone) 41

7 Clinical Trials Mapping 
7.1 Clinical Trials by Region/Country (US, 5EU and Japan) 43
7.2 Clinical Trials by Phase 43
7.3 Clinical Trials by Trial Status 44
7.4 Prominent Sponsors 44

8 Current and Future Players 
8.1 Overview 46
8.2 Trends in Corporate Strategy 46
8.3 Company Profiles 47
8.3.1 Sanofi 47
8.3.2 Avicena 48
8.3.3 Biogen 49
8.3.4 Mitsubishi Tanabe Pharma 51
8.3.5 Other Companies in the Amyotrophic Lateral Sclerosis Therapeutics Market 52

9 Licensing and Partnership Deals 
9.1 Key Deals and Alliances 53

10 Market Outlook 
10.1 Seven Major Markets Overview 54
10.2 Regional Analysis 57
10.2.1 United States 57
10.2.2 France 58
10.2.3 Germany 59
10.2.4 Italy 59
10.2.5 Spain 60
10.2.6 United Kingdom 60
10.2.7 Japan 61
10.3 Key Events 61
10.4 Drivers and Barriers 62
10.4.1 Drivers for the Amyotrophic Lateral Sclerosis Market 62
10.4.2 Barriers for the Amyotrophic Lateral Sclerosis Market 63

11 Appendix 
11.1 Bibliography 64
11.2 Abbreviations 68
11.3 Methodology 70
11.3.1 Coverage 70
11.3.2 Secondary Research 70
11.3.3 Forecasting 71
11.3.4 Expert Panel Validation 73
11.4 Physicians and Specialists Included in this Study 74
11.5 About GlobalData 75
11.6 Contact Us 75
11.7 Disclaimer 75

List of Tables

Table 1: Incidence of ALS in the 7MM and the World 14
Table 2: Key Opinion Leader Insights, Prevalence of Amyotrophic Lateral Sclerosis 14
Table 3: Total Prevalence of Amyotrophic Lateral Sclerosis in the Major Markets, 2011–2019 15
Table 4: Key Opinion Leader Insights, Diagnosis of Amyotrophic Lateral Sclerosis 16
Table 5: EI Escorial Criteria for Diagnosing Amyotrophic Lateral Sclerosis 18
Table 6: Treatment Guidelines for Amyotrophic Lateral Sclerosis 19
Table 7: Key Opinion Leader Insights, Treatment of Amyotrophic Lateral Sclerosis 20
Table 8: Commonly Used Medications for Symptomatic Amyotrophic Lateral Sclerosis Treatment 21
Table 9: Key Opinion Leader Insights, Limitations with the Currently Available Treatment Options for Amyotrophic Lateral Sclerosis 24
Table 10: Leading Treatments for Amyotrophic Lateral Sclerosis, 2012 24
Table 11: Product Profile – Rilutek 25
Table 12: Adverse Events Occurring in Placebo-Controlled Clinical Trials 26
Table 13: Rilutek SWOT Analysis, 2012 27
Table 14: Summary of Minor Drug Classes, 2012 27
Table 15: Key Opinion Leader Insights, Current Unmet Need for Amyotrophic Lateral Sclerosis 28
Table 16: Overall Unmet Needs – Current Level of Attainment 28
Table 17: Key Opinion Leader Insights, Research for Future Treatment Options for Amyotrophic Lateral Sclerosis 32
Table 18: Amyotrophic Lateral Sclerosis – Phase III Pipeline, 2012 32
Table 19: Amyotrophic Lateral Sclerosis – Phase II/III Pipeline, 2012 33
Table 20: Amyotrophic Lateral Sclerosis – Phase II Pipeline, 2012 33
Table 21: Amyotrophic Lateral Sclerosis – Phase I/II Pipeline, 2012 33
Table 22: Amyotrophic Lateral Sclerosis – Phase I Pipeline, 2012 34
Table 23: Amyotrophic Lateral Sclerosis – Pipeline Molecules Status Unknown, 2012 34
Table 24: Comparison of Mechanism of Action in Development for Amyotrophic Lateral Sclerosis, 2012 36
Table 25: Key Opinion Leader Insights, Promising Drugs in Amyotrophic Lateral Sclerosis 38
Table 26: Amyotrophic Lateral Sclerosis – Promising Drugs in Clinical Development 39
Table 27: Product Profile – ALS-02 39
Table 28: ALS-02 SWOT Analysis, 2012 40
Table 29: Product Profile – Radicut (edaravone) 41
Table 30: Radicut (edaravone) SWOT Analysis, 2012 42
Table 31: Amyotrophic Lateral Sclerosis, Clinical Trials by Phase, 2012 43
Table 32: Amyotrophic Lateral Sclerosis, Clinical Trials by Status of Development, 2012 44
Table 33: Amyotrophic Lateral Sclerosis, Overall Sponsor Mix, 2012 44
Table 34: Key Companies in the Amyotrophic Lateral Sclerosis Market, 2019 46
Table 35: Sanofi’s Amyotrophic Lateral Sclerosis Portfolio Assessment, 2012 47
Table 36: Sanofi’s Amyotrophic Lateral Sclerosis Portfolio SWOT Analysis, 2012 48
Table 37: Avicena’s Amyotrophic Lateral Sclerosis Portfolio Assessment, 2012 48
Table 38: Avicena’s Amyotrophic Lateral Sclerosis Portfolio SWOT Analysis, 2012 49
Table 39: Biogen’s Amyotrophic Lateral Sclerosis Portfolio Assessment, 2012 50
Table 40: Biogen’s Amyotrophic Lateral Sclerosis Portfolio SWOT Analysis, 2012 50
Table 41: Mitsubishi Tanabe Pharma’s Amyotrophic Lateral Sclerosis Portfolio Assessment, 2012 51
Table 42: Mitsubishi Tanabe Pharma’s Amyotrophic Lateral Sclerosis Portfolio SWOT Analysis, 2012 51
Table 43: Portfolio Assessment – Other Leading Players in the Amyotrophic Lateral Sclerosis Market, 2012 52
Table 44: Strategic Deals and Alliances for Amyotrophic Lateral Sclerosis 53
Table 45: Sales Forecasts ($) for Amyotrophic Lateral Sclerosis in the Seven Major Markets, 2011–2019 55
Table 46: Sales Forecasts ($) for Amyotrophic Lateral Sclerosis in the United States, 2011–2019 57
Table 47: Sales Forecasts ($) for Amyotrophic Lateral Sclerosis in France, 2011–2019 58
Table 48: Sales Forecasts ($) for Amyotrophic Lateral Sclerosis in Germany, 2011–2019 59
Table 49: Sales Forecasts ($) for Amyotrophic Lateral Sclerosis in Italy, 2011–2019 59
Table 50: Sales Forecasts ($) for Amyotrophic Lateral Sclerosis in Spain, 2011–2019 60
Table 51: Sales Forecasts ($) for Amyotrophic Lateral Sclerosis in the United Kingdom, 2011–2019 60
Table 52: Sales Forecasts ($) for Amyotrophic Lateral Sclerosis in Japan, 2011–2019 61
Table 53: Key Events Impacting Sales for Amyotrophic Lateral Sclerosis, 2012 61
Table 54: Amyotrophic Lateral Sclerosis Therapeutics Market – Drivers and Barriers, 2012 62

List of Figures

Figure 1: Motor Neuron Disease 8
Figure 2: Common Hypothesis for the Pathogenesis of Amyotrophic Lateral Sclerosis 10
Figure 3: Referral Pathway for Amyotrophic Lateral Sclerosis Patients 17
Figure 4: Nutritional Management Algorithm 22
Figure 5: Respiratory Management Algorithm 23
Figure 6: Opportunity and Clinical Unmet Need in Amyotrophic Lateral Sclerosis, 2012 29
Figure 7: Amyotrophic Lateral Sclerosis – Pipeline by Mechanism of Action, 2012 35
Figure 8: Technology Trends Analytics Framework for Amyotrophic Lateral Sclerosis Pipeline, 2012 37
Figure 9: Technology Trends Analytics Framework – Unmet Need Gap Analysis, 2012 38
Figure 10: Amyotrophic Lateral Sclerosis, Clinical Trials by Country, 2012 43
Figure 11: Amyotrophic Lateral Sclerosis – Leading Companies Participating in Clinical Trials, 2012 45
Figure 12: Sales Forecasts ($) for Amyotrophic Lateral Sclerosis in the Seven Major Markets, 2011–2019 55
Figure 13: Seven Major Market Sales for Amyotrophic Lateral Sclerosis by Region, 2011–2019 56
Figure 14: GlobalData Market Forecasting Model 73

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