Dravet Syndrome (DS) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Dravet Syndrome (DS) Market Outlook

Thelansis’s “Dravet Syndrome (DS) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Dravet Syndrome treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Dravet Syndrome (DS) Overview

Dravet syndrome, also known as Severe Myoclonic Epilepsy of Infancy (SMEI), is a rare and fatal form of epilepsy that typically starts during childhood. Initial seizures are often prolonged, and other types develop in the second year of life. It is characterized by frequent, prolonged seizures that are often triggered by high body temperature (hyperthermia). Additionally, it presents with developmental delay, sleep disturbances, ataxia, hypotonia, speech problems, and other health issues. Approximately 85% of cases result from a mutation or deletion in the SCN1A gene (located at 2q24.3), which encodes a voltage-gated sodium channel. Most of these mutations are not inherited but may be part of a familial spectrum of genetic epilepsy known as febrile seizures-plus (GEFS+) in 5-10% of cases. About 5% of female cases might be attributed to mutations in the PCDH19 gene (located at Xq22.1). The cause is unknown in around 10% of cases. In about 3% of initially negative cases, somatic mosaic deletions or mutations in SCN1A can be found. Diagnosis relies on clinical and electroencephalographic (EEG) findings. Initially, the EEG is usually normal, but later, it shows spikes or poly-spike waves with a background slowing and multifocal discharges. Brain magnetic resonance imaging typically appears normal. The presence of SCN1A pathogenic variants can confirm the diagnosis of Dravet syndrome. It's important to differentiate Dravet syndrome from myoclonic atonic epilepsy. The primary goal of treatment is to reduce seizure frequency and prevent status epilepticus (SE). Early in the disease, valproate, clobazam, stiripentol, and bromide may help control febrile seizures. Stiripentol, when used in combination with valproate and clobazam, may effectively reduce seizure duration and frequency. Adjunctive therapies like the ketogenic diet, topiramate, levetiracetam, and cannabidiol in combination with clobazam may also provide significant efficacy. Seizure frequency may decrease in adulthood, but seizures often remain resistant to treatment. Cognitive impairment is common, ranging from moderate to severe, and intractable epilepsy persists into adulthood. Children with Dravet syndrome experience progressive cognitive decline after initial language and visual function impairments. Approximately 86% of patients have intellectual deficiency, and 31% may develop autism spectrum disorder. Preventing convulsive status epilepticus in children may improve long-term outcomes.

• Dravet syndrome is a rare genetic disorder affecting approximately 1 in every 20,000–40,000 births in the US. Approximately 3% to 8% of children who experience their first seizure before 12 months may develop Dravet syndrome.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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