Report Detail

Global Neurodegenerative Diseases Drugs Market to 2023 - MS Set to Dominate with Tecfidera and Ocrevus, as Disease-Modifying Pipeline Therapies for Alzheimer’s Disease and SMA Show Clinical and Commercial Potential

1 Table of Contents

    1 Table of Contents 5

    • 1.1 List of Tables 7
    • 1.2 List of Figures 8

    2 Introduction 13

    • 2.1 Therapy Area Introduction 13
      • 2.1.1 Alzheimer’s Disease 13
      • 2.1.2 Parkinson’s Disease 14
      • 2.1.3 Multiple Sclerosis 15
      • 2.1.4 Huntington’s Disease 15
      • 2.1.5 Amyotrophic Lateral Sclerosis 16
    • 2.2 Symptoms 17
    • 2.3 Diagnosis 18
      • 2.3.1 Alzheimer’s Disease 18
      • 2.3.2 Parkinson’s Disease 19
      • 2.3.3 Multiple Sclerosis 20
      • 2.3.4 Huntington’s Disease 21
      • 2.3.5 Amyotrophic Lateral Sclerosis 21
    • 2.4 Etiology and Pathophysiology 22
      • 2.4.1 Alzheimer’s Disease 22
      • 2.4.2 Parkinson’s Disease 24
      • 2.4.3 Multiple Sclerosis 26
      • 2.4.4 Huntington’s Disease 27
      • 2.4.5 Amyotrophic Lateral Sclerosis 28
    • 2.5 Epidemiology 29
      • 2.5.1 Alzheimer’s Disease 29
      • 2.5.2 Parkinson’s Disease 30
      • 2.5.3 Multiple Sclerosis 32
      • 2.5.4 Huntington’s Disease 33
      • 2.5.5 Amyotrophic Lateral Sclerosis 34
    • 2.6 Prognosis and Disease Staging 35
      • 2.6.1 Alzheimer’s Disease 35
      • 2.6.2 Parkinson’s Disease 36
      • 2.6.3 Multiple Sclerosis 39
      • 2.6.4 Huntington’s Disease 40
      • 2.6.5 Amyotrophic Lateral Sclerosis 41
    • 2.7 Treatment 42
      • 2.7.1 Alzheimer’s Disease 43
      • 2.7.2 Parkinson’s Disease 43
      • 2.7.3 Multiple Sclerosis 46
      • 2.7.4 Huntington’s Disease 47
      • 2.7.5 Amyotrophic Lateral Sclerosis 47

    3 Key Marketed Products 49

    • 3.1 Overview 49
    • 3.2 Current and Future Trends in the MS Market 50
    • 3.3 Copaxone (glatiramer acetate) - Teva 51
    • 3.4 Tecfidera (dimethyl fumarate) - Biogen 53
    • 3.5 Gilenya (fingolimod) - Novartis 55
    • 3.6 Avonex (Interferon beta-1a) - Biogen 57
    • 3.7 Tysabri (natalizumab) - Biogen 58
    • 3.8 Ocrevus (ocrelizumab) - F. Hoffmann-La Roche Ltd. 60
    • 3.9 Namenda/Ebixa/Axura/Abixa Memary (memantine hydrochloride) - Merz/Lundbeck/Forest/Daiichi/ Sankyo 62
    • 3.10 Aricept (donepezil) - Eisai/Pfizer 64
    • 3.11 Azilect (rasagiline mesylate) -Teva 66
    • 3.12 Neupro (rotigotine) - UCB 67
    • 3.13 Radicut (edaravone) - Mitsubishi Tanabe Pharma Corp 69
    • 3.14 Xenazine (tetrabenazine) - Valeant Pharmaceuticals International Inc. 70
    • 3.15 Spinraza (nusinersen) - Biogen 72

    4 Pipeline Landscape Assessment 75

    • 4.1 Overview 75
    • 4.2 Pipeline Development Landscape 76
      • 4.2.1 Neurodegenerative Disease Overall 76
      • 4.2.2 Key Neurodegenerative Disease Indications 77
    • 4.3 Molecular Targets in the Pipeline 80
      • 4.3.1 Neurodegenerative Disease Overall 80
      • 4.3.2 Key Neurodegenerative Disease Indications 83
    • 4.4 Clinical Trials 85
      • 4.4.1 Failure Rate by Stage of Development, Indication, Molecule Type and Molecular Target 85
      • 4.4.2 Clinical Trial Duration by Stage of Development, Indication, Molecular Type and Molecular Target 88
      • 4.4.3 Clinical Trial Size by Stage of Development, Indication, Molecule Type and Molecular Target 92
      • 4.4.4 Aggregate Clinical Program Size by Stage of Development, Indication, Molecular Type and Molecular Target 95
    • 4.5 Assessment of Key Pipeline Products 98
      • 4.5.1 Aducanumab - Biogen/Eisai 98
      • 4.5.2 Azeliragon - vTv Therapeutics 100
      • 4.5.3 ChariSMA - AveXis 101
      • 4.5.4 Omaveloxolone - Reata Pharmaceuticals 102
      • 4.5.5 Siponimod - Novartis 104
      • 4.5.6 Ozanimod - Celgene 105
      • 4.5.7 Elenbecestat - Eisai 106
      • 4.5.8 BAN-2401 - Sage Therapeutics 107
      • 4.5.9 IONIS-HTTRx 108
    • 4.6 Conclusion 110

    5 Multi-scenario Market Forecast to 2023 111

    • 5.1 Overall Market Size 111
    • 5.2 Generic Penetration 113
    • 5.3 Revenue Forecast by Molecular Target 115
      • 5.3.1 Neuromodulators 115
      • 5.3.2 Immunomodulators 116
      • 5.3.3 Stress-related Targets 116
      • 5.3.4 Protein Misfolding Targets 117
      • 5.3.5 Neuroprotectants 118

    6 Company Analysis and Positioning 119

    • 6.1 Revenue and Market Share Analysis by Company 122
      • 6.1.1 Biogen - Aducanumab and Tecfidera Cement Biogen as the Market Leader 128
      • 6.1.2 Roche - Increasing Sales of Ocrevus to Drive Market Size 130
      • 6.1.3 Novartis - Gradual Decline in Revenue due to Gilenya Patent Expiration Offset by Large Pipeline 131
      • 6.1.4 Teva - Gradual Decline in Revenue due to Patent Expiration of Premium Product Copaxone 133
      • 6.1.5 Eisai - Elenbecestat and BAN-2401 Driving New Market Growth for Eisai 134
      • 6.1.6 Sanofi - Aubagio and Lemtrada on Course for Blockbuster Status in 2023 135
    • 6.2 Company Landscape 136
    • 6.3 Marketed and Pipeline Portfolio Analysis 137
      • 6.3.1 Conclusion 139

    7 Strategic Consolidations 140

    • 7.1 Licensing Deals 140
      • 7.1.1 Deals by Region, Year and Value 140
      • 7.1.2 Deals by Indication 142
      • 7.1.3 Deals by Stage of Development and Value 143
      • 7.1.4 Deals by Molecule Type and Molecular Target 144
      • 7.1.5 Table for Licensing Deals Valued Above $100m 145
    • 7.2 Co-development Deals 148
      • 7.2.1 Deals by Region, Year and Value 148
      • 7.2.2 Deals by Indication 149
      • 7.2.3 Deals by Stage of Development and Value 150
      • 7.2.4 Deals by Molecule Type, Mechanism of Action and Value 151
      • 7.2.5 Table for Co-development Deals Valued Above $100m 152

    8 Appendix 154

    • 8.1 Bibliography 154
    • 8.2 All Pipeline Drugs by Phase 170
      • 8.2.1 Discovery 170
      • 8.2.2 Preclinical 174
      • 8.2.3 IND/CTA-Filed/Phase 0 188
      • 8.2.4 Phase I 189
      • 8.2.5 Phase II 191
      • 8.2.6 Phase III 193
      • 8.2.7 Pre-registration 193
    • 8.3 Abbreviations 194
    • 8.4 Disease List 196
      • 8.4.1 Alzheimer’s disease 196
      • 8.4.2 Parkinson’s disease 196
      • 8.4.3 Multiple sclerosis 196
      • 8.4.4 Amyotrophic lateral sclerosis 196
      • 8.4.5 Huntington’s disease 196
      • 8.4.6 Other 196
    • 8.5 Methodology 197
      • 8.5.1 Coverage 197
      • 8.5.2 Secondary Research 197
      • 8.5.3 Market Size and Revenue Forecasts 198
      • 8.5.4 Pipeline Analysis 198
      • 8.5.5 Competitive Landscape 198
    • 8.6 Contact Us 199

    Global Neurodegenerative Diseases Drugs Market to 2023 - MS Set to Dominate with Tecfidera and Ocrevus, as Disease-Modifying Pipeline Therapies for Alzheimer’s Disease and SMA Show Clinical and Commercial Potential

    Summary

    Neurodegenerative diseases are becoming increasingly prevalent due to an aging population, but this diverse therapy area remains largely untreatable with current therapies.

    Neurodegenerative diseases are characterized by neuronal death within the brain and/or central nervous system (CNS), leading to progressive decline in functional neurological capacities.

    It has a devastating effect on quality of life and independence, often requiring full-time care during the later disease stages. Conditions within the therapy area are diverse and exhibit specific pathophysiologies and etiologies, while affecting people of all ages.

    This report examines the entire neurodegenerative disease therapy area, with a particular focus on the five most prevalent neurodegenerative disorders: Alzheimer’s disease (AD), Parkinson’s disease (PD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and Huntington’s disease (HD).

    AD and PD represent the most pressing challenges within the disease cluster, due to rapidly increasing prevalence driven by aging populations. Both AD and PD remain ineffectively treated despite substantial investment into R&D by pharmaceutical companies, due to high clinical trial failure rates.

    MS, the autoimmune disease of the CNS, contrasts with the rest of this cluster, as it affects a different population demographic and has a lucrative pharmacological market following breakthrough success in the past decade. Recent approvals for Ocrevus and Tecfidera are expected to sustain the market in the near future.

    Scope

    - Unmet need is extremely high in AD, PD, ALS and HD, but MS and spinal muscular atrophy (SMA) show continued promise in the development of effective therapies
    - What are the most important etiological risk factors and pathophysiological processes implicated in AD, PD, MS, ALS and HD?
    - What is the current treatment algorithm?
    - How effective are current therapies for these indications and how does this impact prognosis?
    - The neurodegenerative disease pipeline is large. Does the current pipeline innovation hold the potential to change the market over the forecast period?
    - Which molecule types and molecular targets are most prominent across the five key indications?
    - What is the risk of a neurodegenerative drug failing to make the market?
    - What is the risk of a drug failing at a specific phase, molecular target class and indication?
    - The neurodegenerative disease market landscape is forecast to undergo a period of substantial change following key approvals, patent expiries and acquisitions.
    - What strategies have these companies adopted to achieve market growth?
    - Which of the leading companies will have the highest market share by 2023?
    - Which pipeline products are forecast to achieve the highest revenues on the market by 2023?
    - The deals landscape is active and dominated by immunomodulator products
    - Which indications attract the highest deal values?
    - How has deal activity fluctuated over the past decade?
    - How do deal frequency and value compare between target families and molecule types?

    Reasons to buy

    - Appreciate the current clinical and commercial landscapes by considering disease symptoms, pathogenesis, etiology, co-morbidities and complications, epidemiology, diagnosis, prognosis and treatment options.
    - Identify leading products and key unmet needs within the market.
    - Recognize innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target. This review also provides a detailed look at clinical trials, providing an insight into the risk associated with bringing neurodegenerative disease drugs to market.
    - Predict growth in market size, with in-depth market forecasting from 2016 to 2023. The forecast will provide an understanding of how epidemiology trends, new drug entries and new drug patent expirations will influence market value.
    - Identify the key pipeline products, with a particular focus on those due to be brought to the market in the near future, including sales forecasts for these products.
    - Identify the leading companies in the market, in terms of market share and growth. Company analysis determines how dependent the key companies are on revenues derived from the neurodegenerative market. In addition, analysis determines the primary factors that will drive market growth for the key companies in the market.
    - Consider the licensing and co-development deal landscape for neurodegenerative disease drugs.



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