Summary
Epilepsy is a chronic disorder of the brain with substantial morbidity. There are more than 65 million people with epilepsy globally, and this is growing because of the rapidly increasing population. The rising prevalence population in Asia-Pacific (APAC) has driven revenue growth.
The morbidity and mortality associated with epilepsy are considerable. Epilepsy has the greatest impact on quality of life of all the chronic diseases, including diabetes, arthritis, and hypertension. Due to social stigma patients are reluctant to visit physicians. The poor long-term prognosis associated with epilepsy has created a pressing need for improved therapeutic options.
The marketed drug landscape contains hydantoins (phenytoin and fosphenytoin), iminostilbenes (carbamazepine and oxcarbazepine), succinimides (ethosuximide), aliphatic carboxylic acid (valproic acid) benzodiazepines (clonazepam, diazepam, lorazepam and clobazam), phenyltriazine (lamotrigine), cyclic GABA analogues (gabapentin and pregabalin), and newer drugs (levetiracetam, vigabatrin, tiagabine, lacosamide, felbamate, rufinamide, and brivaracetam). However, significant unmet need exists for disease-modifying therapies and targeted therapies.
Drugs currently in Phase III are Cenobamate for refectory epilepsy and ZX-008 (low-dose fenfluramine Hydrochloride) for Lennox-Gastaut syndrome. Epidiolex, an FDA-approved first drug comprising an active ingredient derived from marijuana to treat Lennox-Gastaut syndrome, is in the early stages of development in APAC.
Scope
- The APAC epilepsy market will be valued at $1.7 billion in 2024, growing from $1.4 billion in 2017 at a CAGR of 3.5%.
- How will the approval of Cenobamate for treatment-resistant epilepsy affect the competitive landscape, with no therapy currently available to address this patient subset?
- The epilepsy market is crowded with cheap, generic, “me-too” drugs. What are the main barriers a new therapy faces when entering the epilepsy market?
- The pipeline for epilepsy therapy is not diverse in terms of molecule type and molecular targets.
- How have the late-stage therapies performed in clinical trials?
- The level of unmet need in the epilepsy market is high. Will the pipeline drugs fulfill these unmet needs?
- The market forecasts indicate that India and China will contribute the most to the APAC market.
- How will the annual cost of therapy and market size vary between the five assessed APAC markets?
- How will the growing population affect the market?
- How will the various drivers and barriers influence the market over the forecast period?
- Licensing deals are the most common form of strategic alliance in epilepsy, with total deal values ranging from under $0.1m to over $820m.
- How do deal frequency and value compare between target families and molecule types?
Reasons to buy
This report will enable 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, including a clinical comparison of marketed therapies.
- Visualize the composition of the epilepsy market in terms of the dominant therapies for each patient subset, along with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the market.
- Analyze the epilepsy pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.
- Understand the potential of late-stage therapies with extensive profiles of products that could enter the market over the forecast period, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.
- Predict epilepsy market growth in the five assessed APAC markets, with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as the individual contributions of promising late-stage molecules to market growth.
- Identify commercial opportunities in the epilepsy deals landscape by analyzing trends in licensing and co-development deals.
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1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 8
2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 10
2.3 Disease Classification 11
2.4 Symptoms 13
2.5 Etiology and Pathophysiology 14
2.5.1 Etiology 14
2.5.2 Pathophysiology 15
2.6 Diagnosis 17
2.6.1 Biomarkers 19
2.7 Prognosis 20
2.8 Treatment Guidelines and Options 21
2.8.1 Treatment Options 21
3 Marketed Products 28
3.1 Overview 28
3.1.1 Aptiom/Zebinix (Eslicarbazepine acetate) - BIAL-Portela 29
3.1.2 Banzel/Inovelon (Rufinamide) - Novartis 30
3.1.3 Briviact (Brivaracetam) - UCB 31
3.1.4 Fycompa (perampanel) - Eisai 32
3.1.5 Keppra (levetiracetam) - UCB 34
3.1.6 Lyrica (pregabalin) - Pfizer 36
3.1.7 Vimpat (lacosamide) - UCB 37
3.1.8 Lamictal (lamotrigine) - GSK 39
3.1.9 Epidiolex (Cannabidiol) - GW Pharmaceuticals 40
3.1.10 Older Generation AEDs 41
3.2 Comparative Efficacy and Safety of Marketed Product 42
4 Pipeline Analysis 44
4.1 Overview 44
4.2 Pipeline Distribution by Stage of Development, Molecule Type, Route of Administration and Program Type 44
4.3 Pipeline Distribution by Molecular Target 45
4.4 Promising Pipeline Candidates 48
4.4.1 Fintepla (low-dose fenfluramine Hydrochloride/ZX-008) - Zogenix 48
4.4.2 Cenobamate (YKP3089) - SK Biopharmaceuticals 50
4.5 Comparative Efficacy and Safety of Pipeline Products 52
4.6 Product Competitiveness Framework 53
5 Clinical Trial Analysis 54
5.1 Failure Rate 54
5.1.1 Overall Failure Rate 54
5.1.2 Failure Rate by Phase and Molecule Type 55
5.1.3 Failure Rate by Phase and Molecular Target 55
5.2 Clinical Trial Size 56
5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 56
5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 57
5.2.3 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 58
5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 59
5.3 Clinical Trial Duration 60
5.3.1 Clinical Trial Duration by Molecule Type 60
5.3.2 Clinical Trial Duration by Molecular Target 61
5.4 Competitive Clinical Trials Metrics Analysis 62
6 Multi-scenario Forecast 64
6.1 Geographical Markets 64
6.2 Asia-Pacific Market 65
6.3 India 66
6.3.1 Treatment Usage Patterns 66
6.3.2 Annual Cost of Therapy 68
6.3.3 Market Size 69
6.4 China 70
6.4.1 Treatment Usage Patterns 70
6.4.2 Annual Cost of Therapy 71
6.4.3 Market Size 72
6.5 Australia 73
6.5.1 Treatment Usage Patterns 73
6.5.2 Annual Cost of Therapy 74
6.5.3 Market Size 75
6.6 South Korea 76
6.6.1 Treatment Usage Patterns 76
6.6.2 Annual Cost of Therapy 77
6.6.3 Market Size 78
6.7 Japan 79
6.7.1 Treatment Usage Patterns 79
6.7.2 Annual Cost of Therapy 80
6.7.3 Market Size 82
7 Drivers and Barriers 83
7.1 Drivers 83
7.1.1 Improved Economy and Affordability Boost the Market 83
7.1.2 Promising Pipeline Products that Target Unmet Needs for Epilepsy 83
7.1.3 Government-Sponsored Increased Awareness and Access to Healthcare will Improve Epilepsy Treatment 83
7.2 Barriers 84
7.2.1 Social Stigma and Lack Awareness to Hamper Low Diagnosis and Treatment Rates 84
7.2.2 Impending Patent Cliffs and Generic Erosion 84
7.2.3 Lack of Strong Patent Protection or Intellectual Property Rights. 84
8 Deals and Strategic Consolidations 85
8.1 Licensing Deals 85
8.1.1 Deals by Region and Value 85
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 86
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 87
8.2 Key Licensing Deals 90
8.3 Co-development Deals 91
8.3.1 Deals by Region and Value 91
8.3.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 92
8.3.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 93
8.4 Key Co-development Deals 96
9 Appendix 98
9.1 All Pipeline Drugs by Stage of Development 98
9.1.1 Discovery 98
9.1.2 Preclinical 99
9.1.3 IND/CTA-filed 103
9.1.4 Phase I 103
9.1.5 Phase II 104
9.1.6 Phase III 105
9.1.7 Pre-registration 106
9.2 Summary of Multi-scenario Market Forecasts to 2024 107
9.2.1 Asia-Pacific 107
9.2.2 India 107
9.2.3 China 107
9.2.4 Australia 108
9.2.5 South Korea 108
9.2.6 Japan 109
9.3 Bibliography 109
9.4 Abbreviations 114
9.5 Research Methodology 116
9.5.1 Secondary Research 117
9.5.2 Marketed Product Profiles 117
9.5.3 Late-Stage Pipeline Candidates 117
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 117
9.5.5 Product Competitiveness Framework 118
9.5.6 Pipeline Analysis 118
9.5.7 Forecasting Model 119
9.5.8 Deals Data Analysis 119
9.6 Contact Us 120
9.7 Disclaimer 120
1.1 List of Tables
Table 1: Epilepsy Therapeutics, Global, Types of Seizures, 2017 12
Table 2: Causes of Epilepsy According to Age 14
Table 3: Examples of Biomarkers Needed in Different Epilepsy Indications 20
Table 4: AED Options by Seizure Type 22
Table 5: Epilepsy Therapeutics Market, Global, Licensing Deals Valued Above $10m, 2007-2018 91
Table 6: Epilepsy Therapeutics Market, Global, Co-development Deals, 2007-2018 97
Table 7: Epilepsy Therapeutics Market, Global, All Pipeline Products, Discovery, 2018 98
Table 8: Epilepsy Therapeutics Market, Global, All Pipeline Products, Preclinical, 2018 99
Table 9: Epilepsy Therapeutics Market, Global, All Pipeline Products, IND/CTA-filed, 2018 103
Table 10: Epilepsy Therapeutics Market, Global, All Pipeline Products, Phase I, 2018 103
Table 11: Epilepsy Therapeutics Market, Global, All Pipeline Products, Phase II, 2018 104
Table 12: Epilepsy Therapeutics Market, Global, All Pipeline Products, Phase III, 2018 105
Table 13: Epilepsy Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2018 106
Table 14: Epilepsy Therapeutics Market, Asia-Pacific, Market Forecast, 2017-2024 107
Table 15: Epilepsy Therapeutics Market, India, Market Forecast, 2017-2024 107
Table 16: Epilepsy Therapeutics Market, China, Market Forecast, 2017-2024 107
Table 17: Epilepsy Therapeutics Market, Australia, Market Forecast, 2017-2024 108
Table 18: Epilepsy Therapeutics Market, South Korea, Market Forecast, 2017-2024 108
Table 19: Epilepsy Therapeutics Market, Japan, Market Forecast, 2017-2024 109
1.2 List of Figures
Figure 1: Epilepsy Therapeutics Market, Patient Distribution in APAC 10
Figure 2: Summary of the Pathophysiology of Seizures by Net Increased Neuronal Excitation 16
Figure 3: Algorithm for investigation of patient presenting with seizure 18
Figure 4: Algorithm for Choice of AED for New-Onset Epilepsy Patients 26
Figure 5: Treatment Algorithm for Status Epilepticus in Australia 27
Figure 6: Epilepsy Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products 43
Figure 7: Pipeline for Epilepsy Therapeutics, Global, 2018 45
Figure 8: Pipeline for Epilepsy Therapeutics by Molecular Target, Global, 2018 47
Figure 9: Epilepsy Therapeutics Market, APAC, ZX008 Forecast ($m), 2020-2024 50
Figure 10: Epilepsy Therapeutics Market, APAC, Cenobamate Forecast ($m), 2020-2024 51
Figure 11: Epilepsy Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products 52
Figure 12: Epilepsy Therapeutics Market, Competitor Matrix for Epilepsy Marketed and Pipeline Products 53
Figure 13: Epilepsy Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2007-2017 55
Figure 14: Epilepsy Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2007-2017 56
Figure 15: Epilepsy Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2007-2017 57
Figure 16: Epilepsy Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2007-2017 58
Figure 17: Epilepsy Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2007-2017 59
Figure 18: Epilepsy Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2007-2017 60
Figure 19: Epilepsy Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2007-2017 61
Figure 20: Epilepsy Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2007-2017 62
Figure 21: Epilepsy Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 62
Figure 22: Epilepsy Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 63
Figure 23: Epilepsy Therapeutics Market, Asia-Pacific, Treatment Patterns (million), 2017-2024 65
Figure 24: Epilepsy Therapeutics Market, APAC, Market Size ($m), 2017-2024 66
Figure 25: Epilepsy Therapeutics Market, India, Treatment Patterns (million), 2017-2024 67
Figure 26: Epilepsy Therapeutics Market, India, Annual Cost of Therapy ($), 2017-2024 69
Figure 27: Epilepsy Therapeutics Market, India, Market Size ($m), 2017-2024 70
Figure 28: Epilepsy Therapeutics Market, China, Treatment Patterns (million), 2017-2024 71
Figure 29: Epilepsy Therapeutics Market, China, Annual Cost of Therapy ($), 2017-2024 72
Figure 30: Epilepsy Therapeutics Market, China, Market Size ($m), 2017-2024 73
Figure 31: Epilepsy Therapeutics Market, Australia, Treatment Patterns (‘000), 2017-2024 74
Figure 32: Epilepsy Therapeutics Market, Australia, Annual Cost of Therapy ($), 2017-2024 75
Figure 33: Epilepsy Therapeutics Market, Australia, Market Size ($m), 2017-2024 76
Figure 34: Epilepsy Therapeutics Market, South Korea, Treatment Patterns (‘000), 2017-2024 77
Figure 35: Epilepsy Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2017-2024 78
Figure 36: Epilepsy Therapeutics Market, South Korea, Market Size ($m), 2017-2024 79
Figure 37: Epilepsy Therapeutics Market, Japan, Treatment Patterns (000), 2017-2024 80
Figure 38: Epilepsy Therapeutics Market, Japan, Annual Cost of Therapy ($), 2017-2024 81
Figure 39: Epilepsy Therapeutics Market, Japan, Market Size ($m), 2017-2024 82
Figure 40: Epilepsy Therapeutics Market, Global, Licensing Deals By Region And Value, 2007-2018 86
Figure 41: Epilepsy Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2007-2018 87
Figure 42: Epilepsy Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2018 88
Figure 43: Epilepsy Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2007-2018 89
Figure 44: Epilepsy Therapeutics Market, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2007-2018 90
Figure 45: Epilepsy Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2007-2018 92
Figure 46: Epilepsy Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2008-2018 93
Figure 47: Epilepsy Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2018 94
Figure 48: Epilepsy Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2007-2018 95
Figure 49: Epilepsy Therapeutics Market, Global, Co-development Deals by Molecular Target, 2007-2018 95
