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Global Neurodegenerative Drugs Market to 2022 - Growth Driven by an Aging Population, the Approval of Novel Immunomodulators and Neuromodulators, and Strong Uptake of Marketed Anti-Inflammatory Treatments

Published By :

GBI Research

Published Date : Dec 2016

Category :

Pharmaceutical

No. of Pages : 133 Pages

Neurodegenerative disorders are a cluster of conditions that affect the central nervous system. They include both hereditary and sporadic conditions that are characterized by slow, irreversible, progressive dysfunction of the nervous system with the increasing degeneration of neurons, which causes symptoms such as motor impairment, memory loss and declining cognitive ability. Neurodegenerative disorders cannot currently be cured, and treatment is aimed at managing the disease indication in order to reduce the severity of symptoms and slow progression.

The report focuses on five key indications within neurodegenerative disorders: Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, amyotrophic lateral sclerosis and multiple sclerosis. With no curative therapies available, symptomatic medications prescribed off-label are an important part of the treatment paradigm, especially in amyotrophic lateral sclerosis and multiple sclerosis. This indicates the need for extensive R&D within this area.

Immunomodulators are the most effective and most common therapies used in neurodegenerative disorders. This class of compounds has been the most commercially successful in the past decade, particularly in the multiple sclerosis market, with many clinical trials underway for amyotrophic lateral sclerosis. The market for neurodegenerative disorders is largely accounted for by premium products, with generic products holding only a relatively small share. However, some generic products have been able to secure sizable market shares after the patent expiries of leading drugs. Glatopa (a generic version of Copaxone) recently entered the market and is expected to reach sales of $233m within the forecast period.

Although there is a high degree of failure and uncertainty within the R&D of neurodegenerative disorder drugs, the number of drugs in the pipeline is very high, at 1,494. The majority of pipeline products are novel active pharmaceutical ingredients, with only a small proportion of products being either generics or repositioned from other indications. This shows progression in terms of the variety of molecules being developed as therapeutic agents within the neurodegenerative disorders pipeline. The market is expected to grow over the forecast period, which is attributed to the approval of new drugs, as well as the increasing aging population.

Scope

  • Global revenues for the neurodegenerative disorders market are forecast to grow at a compound annual growth rate of 7.42%, from $27.2 billion in 2015 to $45 billion in 2022. Which drugs will achieve blockbuster status and how will the key player companies perform during the forecast period?
  • The neurodegenerative disorders pipeline is large and diverse, and contains 1,494 products. How does the composition of the pipeline compare with that of the existing market?
  • What mechanisms of action and molecule types are being trialed most commonly in pipeline products for the key indications?
  • Which products will contribute most significantly to market growth, and which will achieve blockbuster status?
  • Will the current market leaders retain their dominance over the forecast period, and how is their revenue share set to change?

Reasons to buy

This report will allow you to - 

  • Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis
  • Visualize the composition of the neurodegenerative disorders market across each indication, in terms of dominant molecule types and targets, and key commercial assets and players
  • Analyze the neurodegenerative disorders pipeline and stratify by stage of development, molecule type and molecular target, making use of a granular breakdown across key indications
  • Understand the growth in patient epidemiology and market revenues for the neurodegenerative disorders market, globally and across the key players and product types
  • Stratify the market in terms of the split between generic and premium products, and assess the role of these product types in the treatment of the various neurodegenerative disorders
  • Identify commercial opportunities in the neurodegenerative disorders deals landscape by analyzing trends in licensing and co-development deals

Table of Contents

1 Table of Contents

1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 7

2 Introduction 10
2.1 Therapy Area Introduction 10
2.1.1 Alzheimer’s Disease 10
2.1.2 Parkinson’s Disease 11
2.1.3 Huntington’s Disease 11
2.1.4 Amyotrophic Lateral Sclerosis 12
2.1.5 Multiple Sclerosis 13
2.2 Symptoms 14
2.3 Etiology and Pathophysiology 15
2.3.1 Pathophysiology 18
2.4 Epidemiology Patterns: Prevalence, Patient Segmentation, and Diagnostic and Treatment Usage Rates 22
2.4.1 Alzheimer’s Disease 23
2.4.2 Parkinson’s Disease 24
2.4.3 Huntington’s Disease 25
2.4.4 Amyotrophic Lateral Sclerosis 26
2.4.5 Multiple Sclerosis 27
2.5 Co-morbidities and Complications 28
2.6 Treatment 29
2.6.1 Alzheimer’s Disease 29
2.6.2 Parkinson’s Disease 30
2.6.3 Huntington’s Disease 33
2.6.4 Amyotrophic Lateral Sclerosis 33
2.6.5 Multiple Sclerosis 33

3 Key Marketed Products 35
3.1 Overview 35
3.2 Tecfidera (dimethyl fumarate) - Biogen 35
3.3 Copaxone (glatiramer acetate) - Teva 37
3.4 Tysabri (natalizumab) - Biogen 39
3.5 Gilenya (fingolimod hydrochloride) - Novartis 41
3.6 Avonex (interferon beta-1a) - Biogen 43
3.7 Plegridy (peginterferon beta-1a) - Biogen 44
3.8 Namenda/Memary/Ebixa/Axura/Namenda XR (memantine hydrochloride/memantine hydrochloride ER) - Merz Pharma/Lundbeck/Forest/Daiichi Sankyo 46
3.9 Nuplazid (pimavanserin tartrate) - Acadia 48

4 Pipeline Landscape Assessment 50
4.1 Pipeline Development Landscape 50
4.2 Molecular Targets in the Pipeline 53
4.3 Clinical Trials 55
4.3.1 Failure Rate 55
4.3.2 Clinical Trial Duration 59
4.3.3 Clinical Trial Size 63
4.3.4 Aggregate Clinical Program Size 67
4.4 Assessment of Key Pipeline Products 70
4.4.1 Ocrelizumab - Roche 70
4.4.2 Ozanimod - Celgene 72
4.4.3 Solanezumab - Eli Lilly 73
4.4.4 Crenezumab - Roche 74
4.4.5 Tirasemtiv - Cytokinetics 76
4.4.6 CVT-301 (Levodopa) - Acorda Therapeutics 78
4.5 5.5 Conclusion 79

5 Multi-scenario Market Forecast to 2022 80
5.1 Overall Market Size 80
5.2 Generic Penetration 82
5.3 Revenue Forecast by Molecular Target 82
5.3.1 Immunomodulators (interferon receptor/S1PR1/MHC II/IL-2 receptor/cells expressing B lymphocyte antigen CD20/glucocorticoid receptor) 83
5.3.2 Neuromodulators (acetylcholinesterase/dopamine receptor/5HTA receptor) 83
5.3.3 Amyloid Inhibitors (Amyloid Beta Inhibitors) 84
5.3.4 APP inhibitors (BACE) 85

6 Company Analysis and Positioning 86
6.1 Revenue and Market Share Analysis by Company 87
6.1.1 Biogen - Will the Patent Expiration of Tysabri Cause a Loss in Market Size? 92
6.1.2 Novartis - Gradual Decline in Revenue due to Gilenya Patent Expiration 93
6.1.3 Roche - Approval of Ocrelizumab to Drive Market Size 94
6.1.4 Sanofi - Aubagio and Lemtrada to Become Blockbuster Drugs 95
6.1.5 Teva - Gradual Decline in Revenue due to Patent Expiration of Products 96
6.1.6 Acadia - Newly Approved Nuplazid Expected to Achieve Blockbuster Status in Forecast Period 97
6.1.7 AbbVie - Pipeline Product Approval to Significantly Increase CAGR 98
6.1.8 Eli Lilly - Solanezumab to Achieve Blockbuster Status following its Approval 99
6.1.9 Celgene - Its First Product in Neurodegenerative Disorder Market to Reach Blockbuster Status in Forecast Period 100
6.1.10 Lundbeck - Approval of Idalopirdine to Offset Loss in Revenue Caused by Patent Expiration of Azilect 101
6.2 Company Landscape 102
6.3 Marketed and Pipeline Portfolio Analysis 103

7 Strategic Consolidations 105
7.1 Licensing Deals 105
7.1.1 Deals by Region, Year and Value 105
7.1.2 Deals by Stage of Development and Value 107
7.1.3 Deals by Molecule Type, Mechanism of Action and Value 108
7.1.4 Table for Licensing Deals Valued above $100m 110
7.2 Co-development Deals 113
7.2.1 Deals by Region, Year and Value 113
7.2.2 Deals by Stage of Development and Value 115
7.2.3 Deals by Molecule Type, Mechanism of Action and Value 116
7.2.4 Table for Co-development Deals Valued above $100m 118

8 Appendix 120
8.1 References 120
8.2 Abbreviations 130
8.3 Disease List 131
8.4 Methodology 131
8.4.1 Coverage 131
8.4.2 Secondary Research 132
8.4.3 Market Size and Revenue Forecasts 132
8.4.4 Pipeline Analysis 132
8.4.5 Competitive Landscape 133
8.5 Contact Us 133
8.6 Disclaimer 133

List of Table


Table 1: Neurodegenerative Disorders Therapeutics Market, Symptoms of AD, PD, HD, ALS and MS, 2016 14
Table 2: Neurodegenerative Disorders Therapeutics Market, Etiology of AD, PD, HD, ALS and MS, 2016 16
Table 3: Neurodegenerative Disorders , Global, Epidemiology of Neurodegenerative Disorders, 2016 23
Table 4: Neurodegenerative Disorders Therapeutics Market, Comorbidities Associated with AD, PD, HD, ALS and MS, 2016 29
Table 5: Neurodegenerative Disorders Therapeutics Market, Treatment Options Available for Parkinson’s Disease, 2016 31
Table 6: Neurodegenerative Disorder Therapeutics Market, Global, Approved Indications for Tecfidera, 2016 36
Table 7: Neurodegenerative Disorder Therapeutics Market, Global, Approved Indications for Copaxone, 2016 38
Table 8: Neurodegenerative Disorder Therapeutics Market, Global, Approved Indications for Tysabri, 2016 40
Table 9: Neurodegenerative Disorder Therapeutics Market, Global, Approved Indications for Gilenya, 2016 41
Table 10: Neurodegenerative Disorder Therapeutics Market, Global, Approved Indications for Avonex, 2016 43
Table 11: Neurodegenerative Disorder Therapeutics Market, Global, Approved Indications for Plegridy, 2016 45
Table 12: Neurodegenerative Disorder Therapeutics Market, Global, Approved Indications for Namenda/Namenda XR, 2016 47
Table 13: Neurodegenerative Disorder Therapeutics Market, Global, Approved Indications for Nuplazid, 2016 48
Table 14: Neurodegenerative Disorders, Global, Annual Revenue for key Products ($bn), 2015-2022 81
Table 15: Neurodegenerative Disorders, Global, Revenue by Company, 2015-2022 88
Table 16: Neurodegenerative Disorders, Global, Licensing Deals Valued above $100m, 2006-2016 110
Table 17: Neurodegenerative Disorders, Global, Co-development Deals Valued above $100m, 2006-2016 118

List of Chart


Figure 1: Neurodegenerative Disorders, Seven Major Markets, Epidemiology Patterns for Alzheimer’s Disease (‘000), 2015-2022 24
Figure 2: Neurodegenerative Disorders, Seven Major Markets, Epidemiology Patterns for Parkinson’s Disease (‘000), 2015-2022 25
Figure 3: Neurodegenerative disorders, Seven Major Markets, Epidemiology Patterns for Huntington’s Disease (‘000), 2015-2022 26
Figure 4: Neurodegenerative Disorders, Seven Major Markets, Epidemiology Patterns for Amyotrophic Lateral Sclerosis (‘000), 2015-2022 27
Figure 5: Neurodegenerative disorders, Seven Major Markets, Epidemiology Patterns for Multiple Sclerosis (‘000), 2015-2022 28
Figure 6: Neurodegenerative Disorders, Global, Key Marketed Products and Approved Indications, 2016 35
Figure 7: Neurodegenerative Disorder Therapeutics Market, Global, Annual Revenue for Tecfidera ($bn), 2013-2022 37
Figure 8: Neurodegenerative Disorder Therapeutics Market, Global, Annual Revenue for Copaxone ($bn), 2006-2022 39
Figure 9: Neurodegenerative Disorder Therapeutics Market, Global, Annual Revenue for Tysabri ($bn), 2006-2022 41
Figure 10: Neurodegenerative Disorder Therapeutics Market, Global, Annual Revenue for Gilenya ($bn), 2011-2022 43
Figure 11: Neurodegenerative Disorder Therapeutics Market, Global, Annual Revenue for Avonex ($bn), 2006-2022 44
Figure 12: Neurodegenerative Disorder Therapeutics Market, Global, Annual Revenue for Plegridy ($bn), 2014-2022 46
Figure 13: Neurodegenerative Disorder Therapeutics Market, Global, Annual Revenue for Namenda/Namenda XR ($bn), 2006-2022 47
Figure 14: Neurodegenerative Disorder Therapeutics Market, Global, Annual Revenue for Nuplazid ($bn), 2016-2022 49
Figure 15: Neurodegenerative Disorders Therapeutics Market, Global, Pipeline for Neurodegenerative Disorder by Stage of Development, Molecule Type and Program Type, 2016 51
Figure 16: Breakdown of Biologics in Neurodegenerative Disorders Pipeline, 2016 51
Figure 17: Neurodegenerative Disorders Therapeutics Market, Global, Pipeline for Key Neurodegenerative Disorder Indications by Stage of Development, 2016 52
Figure 18: Neurodegenerative Disorders Therapeutics Market, Pipeline by Mechanism of Action (%), 2016 53
Figure 19: Neurodegenerative Disorders Therapeutics Market, Global, Pipeline for Key Neurodegenerative Disorder Indications by Mechanism of Action, 2016 54
Figure 20: Neurodegenerative Disorders Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development (%), 2006-2016 55
Figure 21: Neurodegenerative Disorder Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Indication (%), 2006-2016 56
Figure 22: Neurodegenerative Disorders Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecule Type (%), 2006-2016 57
Figure 23: Neurodegenerative Disorders Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecular Target (%), 2006-2016 58
Figure 24: Neurodegenerative Disorders Therapeutics Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2016 59
Figure 25: Neurodegenerative Disorder Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006-2016 60
Figure 26: Neurodegenerative Disorders Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2016 61
Figure 27: Neurodegenerative Disorder Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2016 62
Figure 28: Neurodegenerative Disorder Therapeutics Market, Global, Clinical Trial Size by Stage of Development (patients), 2006-2016 63
Figure 29: Neurodegenerative disorder Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006-2015 64
Figure 30: Neurodegenerative Disorder Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 2006-2016 65
Figure 31: Neurodegenerative Disorder Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 2006-2016 66
Figure 32: Neurodegenerative Disorder Therapeutics Market, Global, Clinical Program Size by Stage of Development (patients), 2006-2016 67
Figure 33: Neurodegenerative Disorder Therapeutics Market, Global, Clinical Program Size by Stage of Development and Indication (participants), 2006-2016 68
Figure 34: Neurodegenerative Disorder Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecule Type (participants), 2006-2015 69
Figure 35: Neurodegenerative Disorder Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecular Target (participants), 2006-2016 70
Figure 36: Neurodegenerative Disorders, Global, Annual Revenue for Ocrelizumab ($bn), 2016-2022 71
Figure 37: Neurodegenerative Disorders, Global, Annual Revenue for Ozanimod ($bn), 2018-2022 73
Figure 38: Neurodegenerative Disorders, Global, Annual Revenue for Solanezumab ($bn), 2017-2022 74
Figure 39: Neurodegenerative Disorders, Global, Annual Revenue for Crenezumab ($m), 2017-2022 76
Figure 40: Neurodegenerative Disorders, Global, Annual Revenue for Tirasemtiv ($m), 2019-2022 77
Figure 41: Neurodegenerative Disorders, Global, Annual Revenue for CVT-301 ($m), 2018-2022 78
Figure 42: Neurodegenerative Disorder Therapeutics Market, Global, Market Size ($bn), 2015-2022 80
Figure 43: Neurodegenerative Disorders, Global, Annual Revenue for Key Products ($m), 2014-2022 82
Figure 44: Neurodegenerative Disorders, Global, Annual Revenue for Immunomodulators ($bn), 2015-2022 83
Figure 45: Neurodegenerative Disorders, Global, Annual Revenue for Neuromodulators ($bn), 2015-2022 84
Figure 46: Neurodegenerative Disorders, Global, Annual Revenue for Amyloid Inhibitors ($bn), 2015-2022 84
Figure 47: Neurodegenerative Disorders, Global, Annual Revenue for APP inhibitors ($m), 2015-2022 85
Figure 48: Neurodegenerative Disorders Therapeutics Market, Global, Cluster by Growth and Market Share, 2015-2022 86
Figure 49: Neurodegenerative Disorders, Global, Market Share by Company (%), 2015-2022 89
Figure 50: Neurodegenerative Disorders, Global, Companies by Compound Annual Growth Rate (%), 2014-2022 90
Figure 51: Neurodegenerative Disorders, Global, Revenue by Product Type, 2015-2022 91
Figure 52: Neurodegenerative Disorders, Global, Biogen Annual Revenue ($bn), 2015-2022 92
Figure 53: Neurodegenerative Disorders, Global, Novartis Annual Revenue ($bn), 2015-2022 93
Figure 54: Neurodegenerative Disorders, Global, Roche Annual Revenue ($bn), 2015-2022 94
Figure 55: Neurodegenerative Disorders, Global, Sanofi Annual Revenue ($bn), 2015-2022 95
Figure 56: Neurodegenerative Disorders, Global, Teva Annual Revenue ($bn), 2015-2022 96
Figure 57: Neurodegenerative Disorders, Global, Acadia Annual Revenue ($bn), 2015-2022 97
Figure 58: Neurodegenerative Disorders, Global, AbbVie Annual Revenue ($m), 2015-2022 98
Figure 59: Neurodegenerative Disorders, Global, Eli Lilly Annual Revenue ($m), 2015-2022 99
Figure 60: Neurodegenerative Disorders, Global, Celgene Annual Revenue ($m), 2015-2022 100
Figure 61: Neurodegenerative Disorders, Global, Lundbeck Annual Revenue ($m), 2015-2022 101
Figure 62: Neurodegenerative Disorders, Global, Companies by Type, 2016 102
Figure 63: Neurodegenerative Disorders, Global, High-Activity and Late-Stage Pipeline Developers by Level of Neurodegenerative Disorders, 2016 103
Figure 64: Neurodegenerative Disorders, Global, Proportion of Total Company Revenue Attributed to Neurodegenerative Disorders, 2015-2022 104
Figure 65: Neurodegenerative Disorders, Global, Licensing Deals, 2006-2016 106
Figure 66: Neurodegenerative Disorders, Global, Licensing Deals by Indication and Value, 2006-2016 107
Figure 67: Neurodegenerative Disorders, Global, Licensing Deals, 2006-2016 108
Figure 68: Neurodegenerative Disorders, Global, Licensing Deals by Molecule Type and Mechanism of Action, 2006-2016 109
Figure 69: Neurodegenerative Disorders, Global, Co-development Deals, 2006-2016 114
Figure 70: Neurodegenerative Disorders, Global, Co-development Deals by Indication and Value, 2006-2016 115
Figure 71: Neurodegenerative Disorders, Global, Co-development Deals, 2006-2016 116
Figure 72: Neurodegenerative Disorders, Global, Co-development Deals by Molecule Type and Mechanism of Action, 2006-2016 117

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