Dravet Syndrome Market Outlook 2034 - Competitive Landscape, Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

The Dravet Syndrome Treatment Market is witnessing rapid evolution, driven by emerging therapies, regulatory approvals, and increasing disease awareness. Leading companies in this space include Takeda, Eisai, Stoke Therapeutics, EpyGenix Therapeutics, Marinus Pharmaceuticals, Zogenix International Ltd., Jazz Pharmaceuticals, Ovid Therapeutics, Longboard Pharmaceuticals, among others.

DelveInsight's report, "Dravet Syndrome Market Insights, Epidemiology, and Market Forecast 2034," provides a comprehensive understanding of Dravet Syndrome, detailing historical trends, current epidemiology, and market forecasts. The report covers key markets including the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan, providing insights into current treatment paradigms, emerging drugs, market share of individual therapies, and the overall market size from 2020 to 2034.
This extensive report also addresses the Dravet Syndrome treatment algorithms, unmet medical needs, market drivers and barriers, as well as potential opportunities, helping stakeholders evaluate the underlying growth potential in this therapeutic area.

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Key Dravet Syndrome Market Insights and Developments
• The Dravet Syndrome market is projected to grow at a substantial CAGR during the forecast period (2020-2034).
• In August 2025, Biogen Inc. (Nasdaq: BIIB) and Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine, today announced presentations of new clinical data from studies of zorevunersen at the 36th International Epilepsy Congress (IEC), taking place August 30 - September 3, 2025 in Lisbon, Portugal. Zorevunersen, an investigational antisense oligonucleotide, is being evaluated as a potential disease-modifying medicine for the treatment of Dravet syndrome in the global pivotal EMPEROR Phase 3 study.
• In January 2025, Stoke Therapeutics, Inc. (Nasdaq: STOK) reached agreements with global regulatory authorities on the Phase 3 EMPEROR study, evaluating zorevunersen as a potential first disease-modifying therapy for Dravet Syndrome.
• In December 2024, Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for relutrigine in Dravet syndrome.
• The FDA awarded rare pediatric disease designation to relutrigine (Praxis Precision Medicines) in January 2025, aimed at reducing seizures in children with epileptic disorders including Dravet Syndrome.
• In December 2024, zorevunersen received Breakthrough Therapy Designation from the FDA for Dravet Syndrome patients with confirmed SCN1A gene mutations not associated with gain-of-function.
• In February 2024, Encoded Therapeutics' ETX101 gene therapy received FDA Investigational New Drug (IND) approval to start clinical trials in the US and Clinical Trial Approval (CTA) in Australia. ETX101 uses AAV9-mediated gene regulation to enhance SCN1A gene expression in GABAergic inhibitory neurons, targeting the root cause of Dravet Syndrome. The ENDEAVOR Phase I/II trial is planned for children aged six months to under three years.

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Dravet Syndrome Epidemiology Highlights
• According to the Dravet Syndrome Foundation (2022), the prevalence of Dravet Syndrome is 1:15,700 infants, with approximately 80% exhibiting SCN1A mutations, indicating a higher prevalence than previously estimated.
• In France, the total diagnosed cases were 1,050 in 2022, with a rising trend projected by 2032.
• In the UK, around 1,000 cases were treated in 2022, expected to increase over the next decade.
• Epidemiological analysis indicates a slightly higher prevalence in males compared to females.

Dravet Syndrome Marketed Drugs and Pipeline Therapies
The market features a mix of established therapies and late-stage pipeline candidates, including:
• TAK-935 (soticlestat) - Takeda
• BELVIQ (lorcaserin) - Eisai
• STK-001 - Stoke Therapeutics
• EPX-100 (Clemizole HCl) - EpyGenix Therapeutics
• Ganaxolone - Marinus Pharmaceuticals
• ZX008 (Fenfluramine Hydrochloride) - Zogenix International Ltd.
• GWP42003-P - Jazz Pharmaceuticals
• LP352 - Longboard Pharmaceuticals
FINTEPLA and EPIDIOLEX are key market performers, with net sales of $75 million and $463.6 million (2021), respectively. Several pipeline drugs, including lorcaserin and TAK-935, are showing significant promise in late-stage clinical trials.

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Dravet Syndrome Overview
Dravet Syndrome is a rare and severe epilepsy disorder typically manifesting in infancy. Seizures are often triggered by fever or illness and may include myoclonic, focal, and generalized tonic-clonic seizures. Most cases are associated with SCN1A gene mutations, causing dysfunctional sodium channels in the brain.
Diagnosis relies on genetic testing and clinical evaluation, while treatment typically involves antiepileptic medications such as stiripentol, and fenfluramine, often used in combination. Effective disease management also requires seizure first-aid training, avoidance of triggers, and individualized care plans. Research is increasingly focused on gene therapy and precision medicine to target the underlying genetic cause. Early intervention and comprehensive care can significantly improve quality of life, supported by healthcare professionals, caregivers, and advocacy groups.

Dravet Syndrome Epidemiology
Dravet Syndrome is a rare epilepsy disorder, affecting approximately 1 in 15,700 individuals in the US, with 80-90% carrying an SCN1A mutation, representing about 0.17% of all epilepsy cases. Recent US studies suggest the condition may be twice as common as previously thought. Incidence rates vary internationally, with Spain reporting 1.1 cases per million in pediatric patients and 0.5 per million in adults. Country-specific estimates for 2022 include around 21,760 cases in the US, 1,050 in France, 1,000 in the UK, and 2,800 in Japan.

Dravet Syndrome Epidemiology Segmentation
The report provides detailed analysis for 7 major markets (7MM) from 2020-2034, covering:
• Gender-specific Diagnosed Prevalent Cases of Dravet Syndrome in the 7MM
• Treated Cases of Dravet Syndrome in the 7MM
• Total Prevalent Cases of Dravet Syndrome in the 7MM
• Total Diagnosed Prevalent Cases of Dravet Syndrome in the 7MM
• Mutation-specific Diagnosed Prevalent Cases of Open-angle Dravet Syndrome in the 7MM
• Age-specific Diagnosed Prevalent Cases of Dravet Syndrome in the 7MM

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Dravet Syndrome Therapeutic Uptake and Pipeline Development
The report examines the adoption rate of newly launched therapies, patient uptake by drug and therapy, and sales performance. It also provides insights into pipeline development activities, including collaborations, mergers, licensing agreements, and patent updates for emerging therapies.

Dravet Syndrome Market Drivers:
• Regulatory Approvals: Recent approvals of therapies like Epidiolex (cannabidiol) and Fintepla (fenfluramine) have expanded treatment options, contributing to market growth.
• Advancements in Diagnostics: Improvements in genetic testing and imaging technologies have enhanced early detection, facilitating timely interventions and supporting clinical trials.
• Pipeline Developments: Emerging therapies, such as zorevunersen and soticlestat, are progressing through clinical trials, with some receiving expedited designations from regulatory agencies.
• Increasing Awareness: Rising awareness among healthcare professionals and the public has led to better diagnosis and management of Dravet syndrome, positively impacting market dynamics.

Dravet Syndrome Market Barriers:
• Adverse Effects of Treatments: Some approved therapies are associated with side effects like drowsiness, agitation, and impaired coordination, which may limit their suitability for certain patients.
• Delayed Diagnosis: Late diagnosis can lead to worsened outcomes, including increased risk of status epilepticus and cognitive decline, complicating treatment efforts.
• High Treatment Costs: The expense of therapies and diagnostic procedures can be prohibitive, especially in regions with limited healthcare resources.
• Regulatory Challenges: Navigating the complex regulatory pathways for new treatments can delay market entry and availability of novel therapies.
Despite these challenges, the Dravet syndrome market is poised for continued growth, driven by ongoing research, regulatory advancements, and a commitment to addressing unmet medical needs.

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Scope of the Dravet Syndrome Market Report
• Study Period: 2020 - 2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Dravet Syndrome Therapies: TAK-935 (soticlestat), BELVIQ (lorcaserin), STK-001, ganaxolone, EPX-100 (Clemizole HCl), STK-001, ZX008 (Fenfluramine Hydrochloride), GWP42003-P, Soticlestat, LP352, and others
• Dravet Syndrome Therapeutic Assessment: Dravet Syndrome current marketed and Dravet Syndrome emerging therapies
• Dravet Syndrome Market Dynamics: Dravet Syndrome market drivers and Dravet Syndrome market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Dravet Syndrome Unmet Needs, KOL's views, Analyst's views, Dravet Syndrome Market Access and Reimbursement

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.