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Report Title

Epilepsy Therapeutics in Asia-Pacific Markets to 2024 - Uptake of Novel Therapies and Rising Awareness is Expected to Drive the Market Growth

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Epilepsy Therapeutics in Asia-Pacific Markets to 2024 - Uptake of Novel Therapies and Rising Awareness is Expected to Drive the Market Growth


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Epilepsy Therapeutics in Asia-Pacific Markets to 2024 - Uptake of Novel Therapies and Rising Awareness is Expected to Drive the Market Growth

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Epilepsy Therapeutics in Asia-Pacific Markets to 2024 - Uptake of Novel Therapies and Rising Awareness is Expected to Drive the Market Growth



Executive Summary

Epilepsy Therapeutics in Asia-Pacific Markets to 2024-Uptake of Novel Therapies and Rising Awareness is Expected to Drive the Market Growth

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 USD 1.7 billion in 2024, growing from USD 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 USD 0.1m to over USD 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.

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

To know more information on Purchase by Section, please send a mail to sales@kenresearch.com

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 (USD m), 2020-2024 50

Figure 10: Epilepsy Therapeutics Market, APAC, Cenobamate Forecast (USD 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 (USD 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 (USD ), 2017-2024 69

Figure 27: Epilepsy Therapeutics Market, India, Market Size (USD 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 (USD ), 2017-2024 72

Figure 30: Epilepsy Therapeutics Market, China, Market Size (USD 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 (USD ), 2017-2024 75

Figure 33: Epilepsy Therapeutics Market, Australia, Market Size (USD 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 (USD ), 2017-2024 78

Figure 36: Epilepsy Therapeutics Market, South Korea, Market Size (USD 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 (USD ), 2017-2024 81

Figure 39: Epilepsy Therapeutics Market, Japan, Market Size (USD 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 (USD ), 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

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 USD 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

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