1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

5. SWOT Analysis

6. Epidemiology and Market Methodology

7. Developmental and Epileptic Encephalopathy (DEE) Market Overview at a Glance
7.1. Market Share (%) Distribution by Therapies in 2021
7.2. Market Share (%) Distribution by Therapies in 2032

8. Disease Background and Overview
8.1. West Syndrome
8.1.1. Clinical Manifestations
8.1.2. Etiology
8.1.3. Pathophysiology
8.1.4. Diagnosis
8.1.5. Differential Diagnosis
8.2. Dravet Syndrome
8.2.1. First Period of Mainly Febrile Convulsions
8.2.2. Second Relentlessly Aggressive Period
8.2.3. Third Static Period of Regression
8.2.4. Etiology
8.2.5. Diagnosis
8.2.6. Differential Diagnosis
8.3. Lennox-Gastaut Syndrome
8.3.1. Etiology
8.3.2. Pathophysiology
8.3.3. Diagnosis
8.3.4. Differential Diagnosis
8.4. Landau-Kleffner Syndrome (LKS) (Acquired Epileptic Aphasia)
8.4.1. Etiology
8.4.2. Pathophysiology
8.4.3. Diagnosis
8.4.4. Differential Diagnosis
8.5. Epilepsy with Continuous Spike-and-Waves during Slow-Wave Sleep
8.5.1. Etiology
8.5.2. Pathophysiology
8.5.3. Diagnostic Procedures
8.5.4. Differential Diagnosis
8.6. Doose Syndrome (myoclonic atonic epilepsy)
8.6.1. Causes
8.6.2. Clinical features
8.6.3. Diagnosis
8.6.4. Differential diagnosis
8.7. CDKL5 deficiency disorder (CDD)
8.7.1. Signs and Symptoms
8.7.2. Causes
8.7.3. Diagnosis
8.7.4. Differential Diagnosis
8.8. Tuberous sclerosis complex (TSC)
8.8.1. Sign and Symptoms
8.8.2. Cause
8.8.3. Diagnosis
8.9. Genetic Epilepsy
8.9.1. SCN8A-DEE
8.9.2. KCNQ2-DEE
8.10. Biomarkers of epileptic encephalopathies
8.10.1. Neuroinflammation and Oxidative Stress
8.10.2. MicroRNA as the Novel Diagnostic Tools for Epilepsy
8.10.3. The Role of the Complement System in Epilepsy
8.10.4. Role of Cytokines in Epileptogenesis
8.10.5. Proteins and Amino Acids Role in Epilepsy

9. Treatment of DEE
9.1. Antiseizure medications
9.1.1. Clobazam (CLB)
9.1.2. Vigabatrin
9.1.3. Topiramate
9.1.4. Levetiracetam
9.1.5. Zonisamide
9.1.6. Phenobarbital
9.1.7. Cannabidiol
9.1.8. Stiripentol
9.1.9. Ethosuximide
9.1.10. Carbamazepine
9.1.11. Lamotrigine
9.1.12. Benzodiazapines (BZDs)
9.1.13. Succinimides
9.1.14. Valproic acid
9.1.15. Rufinamide
9.1.16. Vigabatrin
9.1.17. Felbamate
9.2. Steroid therapy
9.2.1. Prednisolone
9.2.2. ACTH (Adrenocorticotropic Hormone)
9.3. Other Therapies
9.3.1. Vagus Nerve Stimulation
9.3.2. Ketogenic diet
9.4. Epilepsy surgery
9.5. Treatment Algorithm

10. Treatment Guidelines
10.1. Guidelines for Management of Developmental and Epileptic Encephalopathy (National Institute for Health and Care Excellence, 2021)
10.2. Practice Guideline Update: Efficacy and Tolerability of new AEDs I: Treatment of new-onset epilepsy
10.3. Practice Guideline Update: Efficacy and Tolerability of the New AEDs II: Treatment-resistant Epilepsy
10.4. Recommendations for the management of infantile seizures: Task Force Report for the ILAE Commission of Pediatrics

11. Epidemiology and Patient Population of 7MM
11.1. Key Findings
11.2. Assumptions and Rationale
11.2.1. Dravet Syndrome
11.2.2. Lennox-Gastaut Syndrome
11.2.3. Ohtahara Syndrome
11.2.4. West Syndrome
11.2.5. Landau-Kleffner Syndrome
11.2.6. Tuberous Sclerosis Complex
11.2.7. CDKL5 deficiency disorder
11.2.8. Others
11.3. Diagnosed Prevalent Population of DEE in 7MM
11.4. The United States
11.4.1. Diagnosed Prevalent Population of DEE in the United States
11.5. EU5
11.5.1. Diagnosed Prevalence of DEE in EU5
11.6. Japan
11.6.1. Diagnosed Prevalent Population of DEE in Japan

12. Marketed Drugs
12.1. Key Competitor
12.2. Epidiolex (Cannabidiol): Jazz Pharmaceuticals
12.2.1. Product Description
12.2.2. Regulatory Milestones
12.2.3. Other Developmental Activities
12.2.4. Current Pipeline Activity
12.2.5. Safety and Efficacy
12.2.6. Product Profile
12.3. Diacomit (stiripentol): Biocodex
12.3.1. Product Description
12.3.2. Regulatory Milestones
12.3.3. Other Developmental Activities
12.3.4. Safety and Efficacy
12.3.5. Product Profile
12.4. Fintepla (Fenfluramine): Zogenix (Acquired by UCB)
12.4.1. Product Description
12.4.2. Regulatory Milestone
12.4.3. Other Developmental Activities
12.4.4. Current Pipeline Activity
12.4.5. Safety and Efficacy
12.4.6. Product Profile
12.5. Sabril (Vigabatrin): Lundbeck
12.5.1. Product Description
12.5.2. Regulatory Milestones
12.5.3. Other Developmental Activities
12.5.4. Safety and Efficacy
12.5.5. Product Profile
12.6. Ztalmy (Ganaxolone): Marinus Pharmaceuticals
12.6.1. Product Description
12.6.2. Regulatory Milestones
12.6.3. Other Developmental Activities
12.6.4. Safety and Efficacy
12.6.5. Product Profile
12.7. Afinitor Disperz/ Votubia (Everolimus): Novartis
12.7.1. Product Description
12.7.2. Regulatory Milestones
12.7.3. Other Developmental Activities
12.7.4. Safety and Efficacy
12.7.5. Product Profile
12.8. Sympazan (Clobazam): Aquestive Therapeutics
12.8.1. Product Description
12.8.2. Regulatory Milestones
12.8.3. Other Developmental Activities
12.8.4. Safety and Efficacy
12.8.5. Product Profile
12.9. Trokendi XR (Topiramate): Supernus Pharmaceuticals
12.9.1. Product Description
12.9.2. Regulatory Milestones
12.9.3. Other Developmental Activities
12.9.4. Safety and Efficacy
12.9.5. Product Profile
12.10. Onfi (Clobazam): Lundbeck
12.10.1. Product Description
12.10.2. Regulatory Milestones
12.10.3. Other Developmental Activities
12.10.4. Safety and Efficacy
12.10.5. Product Profile
12.11. Banzel (Rufinamide): Eisai Pharmaceuticals
12.11.1. Product Description
12.11.2. Regulatory Milestones
12.11.3. Other Developmental Activities
12.11.4. Safety and Efficacy
12.11.5. Product Profile
12.12. Lamictal (Lamotrigine): GlaxoSmithKline
12.12.1. Product Description
12.12.2. Regulatory Milestones
12.12.3. Safety and Efficacy
12.12.4. Product Profile
12.13. Felbatol (Felbamate): Meda Pharmaceuticals
12.13.1. Product Description
12.13.2. Other Developmental Activities
12.13.3. Safety and Efficacy
12.13.4. Product Profile
12.14. Klonopin (Clonazepam): Roche
12.14.1. Product Description
12.14.2. Regulatory Milestones
12.14.3. Product Profile
12.15. H.P. Acthar Gel: Questcor Pharmaceuticals/Mallinckrodt Pharmaceuticals
12.15.1. Product Description
12.15.2. Regulatory Milestones
12.15.3. Other Development Activities
12.15.4. Safety and Efficacy
12.15.5. Product Profile

13. Emerging Drugs
13.1. Key Competitors
13.2. XEN496: Xenon Pharmaceuticals
13.2.1. Product Description
13.2.2. Other Developmental Activities
13.2.3. Clinical Development
13.3. Soticlestat: Takeda/Ovid Therapeutics
13.3.1. Product Description
13.3.2. Other Developmental Activities
13.3.3. Clinical Development
13.3.4. Safety and Efficacy
13.4. Carisbamate: SK Life Science
13.4.1. Product Description
13.4.2. Other Developmental Activities
13.4.3. Clinical Development
13.5. EPX-100 (Clemizole HCl): Epygenix
13.5.1. Product Description
13.5.2. Other Developmental Activities
13.5.3. Clinical Development
13.5.4. Safety and Efficacy
13.6. NBI-921352: Neurocrine Biosciences
13.6.1. Product Description
13.6.2. Other Developmental Activities
13.6.3. Clinical Development
13.6.4. Safety and Efficacy
13.7. STK-001: Stoke Therapeutics
13.7.1. Product Description
13.7.2. Other Developmental Activities
13.7.3. Clinical Development
13.7.4. Safety and Efficacy
13.8. NBI-827104: Neurocrine Biosciences
13.8.1. Product Description
13.8.2. Other Developmental Activities
13.8.3. Clinical Development
13.8.4. Safety and Efficacy
13.9. JBPOS0101: BioPharm Solutions
13.9.1. Product Description
13.9.2. Other Development Activities
13.9.3. Clinical Development
13.10. PRAX-562: Praxis Precision Medicines
13.10.1. Product Description
13.10.2. Other Developmental Activities
13.10.3. Clinical Development
13.10.4. Safety and Efficacy
13.11. EPX-200 (Lorcaserin): Epygenix
13.11.1. Product Description
13.11.2. Other Developmental Activities
13.12. EPX-300: Epygenix
13.12.1. Product Description
13.12.2. Other Developmental Activities
13.13. LP352: Longboard Pharmaceuticals
13.13.1. Product Description
13.13.2. Other Developmental Activities
13.13.3. Safety and Efficacy

14. Developmental and Epileptic Encephalopathy (DEE): 7MM Market Analysis
14.1. Key Findings
14.2. Market Outlook
14.3. Key Market Forecast Assumptions
14.4. Attribute Analysis
14.5. Total Market Size of DEE in the 7MM
14.6. Market Size of DEE by Current and Emerging Therapies in the 7MM
14.7. United States Market Size
14.7.1. Total Market Size of DEE in the United States
14.7.2. Market Size of DEE by Current and Emerging Therapies in the United States
14.8. EU-5 Market Size
14.8.1. Total Market size of DEE in Europe
14.8.2. Market Size of DEE by Current and Emerging Therapies in Europe
14.9. Japan
14.9.1. Total Market size of DEE in Japan
14.9.2. Market Size of DEE by Current and Emerging Therapies in Japan

15. Market Drivers

16. Market Barriers

17. Unmet Needs

18. Market Access and Reimbursement
18.1. Fintepla (Fenfluramine) Reimbursement
18.2. Epidiolex Reimbursement
18.3. Diacomit Reimbursement
18.4. Topamax Reimbursement
18.5. Banzel Reimbursement
18.6. Onfi Reimbursement
18.7. Fycompa Reimbursement
18.8. Ganaxolone Reimbursement
18.9. GSK Reimbursement Support Services
18.10. American Academy of Neurology (AAN) and American Epilepsy Society (AES) “Practice guideline update: Efficacy and tolerability of the new anti-epileptic drugs: Treatment of new-onset epilepsy”
18.11. Everolimus

19. Appendix
19.1. Bibliography
19.2. Report Methodology

20. DelveInsight Capabilities

21. Disclaimer

22. About DelveInsight

List of Tables
Table 1: Summary of DEE Market, and Epidemiology (2019-2032)
Table 2: Key Events
Table 3: Main differences between atypical and typical absence seizures
Table 4: Nonepileptic and epileptic conditions to differentiate from LGS
Table 5: Landau-Kleffner syndrome versus ECSWS
Table 6: Molecular Genetic Testing Used in SCN8A-Related Encephalopathy with Epilepsy
Table 7: Summary of cytokines and their main role in epileptogenesis.
Table 8: Recommendations for monotherapy in adults with new-onset epilepsy with focal epilepsy or unclassified tonic- clonic seizures
Table 9: Monotherapy in children with new-onset epilepsy with either focal epilepsy or unclassified GTC seizures
Table 10: Monotherapy in adults and children with new-onset GE or unclassified GTC seizures
Table 11: Recommendation for childhood absence epilepsy
Table 12: For adult patients with TR focal epilepsy, are these AEDs effective as adjunctive therapy
Table 13: For adult patients with TR focal epilepsy, are these AEDS effective in reducing seizure f
Table 14: For adult and pediatric patients with TR generalized epilepsy (GE), are these AEDs effect
Table 15: For adult and pediatric patients with LGS, are these AEDs effective as adjunctive therapy
Table 16: For pediatric patients with TR focal epilepsy, are these AEDs effective as adjunctive the
Table 17: Summary of published studies addressing AED treatment for infants with seizures
Table 18: Total diagnosed Prevalent Population of DEE in the 7MM (2019-2032)
Table 19: Diagnosed Prevalent Population of DEE in the United States (2019-2032)
Table 20: Diagnosed Prevalence of DEE in EU5 (2019-2032)
Table 21: Diagnosed Prevalent Population of DEE in Japan (2019-2032)
Table 22: Comparison of marketed drugs for DEE
Table 23: Epidiolex, Clinical Trial Description, 2022
Table 24: Fintepla, Clinical Trial Description, 2022
Table 25: Key Cross of Emerging Therapies
Table 26: XEN496, Clinical Trial Description, 2022
Table 27: Soticlestat, Clinical Trial Description, 2022
Table 28: Carisbamate, Clinical Trial Description, 2022
Table 29: EPX-100 (Clemizole HCl), Clinical Trial Description, 2022
Table 30: NBI-921352 (XEN901), Clinical Trial Description, 2022
Table 31: STK-001, Clinical Trial Description, 2022
Table 32: NBI-827104 (ACT-709478), Clinical Trial Description, 2022
Table 33: JBPOS0101, Clinical Trial Description, 2022
Table 34: PRAX-562, Clinical Trial Description, 2022
Table 35: Key Market Forecast Assumptions for Soticlesat
Table 36: Key Market Forecast Assumptions for NBI-921352 (XEN901)
Table 37: Key Market Forecast Assumptions for NBI- 827104
Table 38: Key Market Forecast Assumptions for PRAX-562
Table 39: Key Market Forecast Assumptions for Carisbamate
Table 40: Key Market Forecast Assumptions for EPX-100
Table 41: Key Market Forecast Assumptions for EPX-200
Table 42: Key Market Forecast Assumptions for EPX-300
Table 43: Key Market Forecast Assumptions for XEN496
Table 44: Key Market Forecast Assumptions for LP352
Table 45: Key Market Forecast Assumptions for STK-001
Table 46: Key Market Forecast Assumptions for JBPOS0101
Table 47: Attribute analysis of emerging drugs
Table 48: Market Size of DEE in the 7MM in USD million (2019-2032)
Table 49: Market Size of DEE by Current and Emerging Therapies in the 7MM, in USD million (2019-2032)
Table 50: Market Size of DEE in the US, USD million (2019-2032)
Table 51: Market Size of DEE by Current and Emerging Therapies in the US, in USD million (2019-2032
Table 52: EU5 Market Size of DEE in USD million (2019-2032)
Table 53: Market Size of DEE by Current and Emerging Therapies in EU5, in USD million (2019-2032)
Table 54: Market Size of DEE in Japan, USD million (2019-2032)
Table 55: Market Size of DEE by Current and Emerging Therapies in the 7MM, in USD million (2019-2032)
Table 56: Drugs in France
Table 57: Treatment Recommendations of Fintepla
Table 58: Treatment Recommendations by AAN and AES

List of Figures
Figure 1: Neonatal Seizure and epilepsy Classification
Figure 2: The spectrum of SCN1A Disorders
Figure 3: Oxidative stress and hypoxia as the key players of epileptogenesis
Figure 4: Potential mechanisms occurring during epileptogenesis and their correlations with one another.
Figure 5: Treatment algorithm
Figure 6: Total diagnosed Prevalent Population of DEE in the 7MM (2019-2032)
Figure 7: Diagnosed Prevalence of DEE in the United States (2019-2032)
Figure 8: Diagnosed Prevalence of DEE in EU5 (2019-2032)
Figure 9: Diagnosed Prevalence of DEE in Japan (2019-2032)
Figure 10: Upcoming launches in the US
Figure 11: Market Size of DEE in the 7MM in USD million (2019-2032)
Figure 12: Market Size of DEE by Current and Emerging Therapies in the 7MM, in USD million (2019-2032)
Figure 13: Market Size of DEE in the US, USD millions (2019-2032)
Figure 14: Market Size of DEE by Current and Emerging Therapies in the US, USD million (2019-2032)
Figure 15: Market Size of DEE in EU5, USD million (2019-2032)
Figure 16: EU5 Market Size of DEE by Current and Emerging Therapies, in USD million (2019-2032)
Figure 17: Market Size of DEE in Japan, USD million (2019-2032)
Figure 18: Market Size of DEE by Current and Emerging Therapies in Japan, USD million (2019-2032)

Key Companies
Jazz Pharmaceuticals
Biocodex
Zogenix (Acquired by UCB)
Lundbeck
Marinus Pharmaceuticals
Novartis
Aquestive Therapeutics
Supernus Pharmaceuticals
Lundbeck
Eisai Pharmaceuticals
GlaxoSmithKline
Meda Pharmaceuticals
Roche
Questcor Pharmaceuticals/Mallinckrodt Pharmaceuticals
Xenon Pharmaceuticals
Takeda/Ovid Therapeutics
SK Life Science
Epygenix
Neurocrine Biosciences
Stoke Therapeutics
Neurocrine Biosciences
BioPharm Solutions
Praxis Precision Medicines
Epygenix
Epygenix
Longboard Pharmaceuticals