Developmental and Epileptic Encephalopathies (DEE) - Market Insight, Epidemiology And Market Forecast - 2032

Developmental and Epileptic Encephalopathies (DEE) - Market Insight, Epidemiology And Market Forecast - 2032

DelveInsight's "" Developmental and Epileptic Encephalopathy - Market Insights, Epidemiology, and Market Forecast-2032"" report delivers an in-depth understanding of the DEE, historical and forecasted epidemiology as well as the DEE market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The DEE market report provides current treatment practices, emerging drugs, DEE market share of the individual therapies, current and forecasted DEE market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current DEE treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.

Geography Covered

  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan

  • Study Period: 2019-2032

    Developmental and Epileptic Encephalopathy Disease Understanding and Treatment Algorithm

    Developmental and Epileptic Encephalopathy (DEE) refers to a group of severe epilepsies that are characterized both by seizures, which are often drug-resistant, as well as encephalopathy, which is a term used to describe significant developmental delay or even loss of developmental skills. The syndromes of epileptic encephalopathies with onset in the neonatal period, infancy, and early childhood include early myoclonic encephalopathy, Ohtahara syndrome, West syndrome, Dravet syndrome (severe myoclonic epilepsy in infancy), Lennox–Gastaut syndrome (LGS), Landau–Kleffner syndrome (LKS), Epilepsy with continuous spike-and-waves during slow-wave sleep, Doose Syndrome (myoclonic atonic epilepsy), CDKL5 deficiency disorder (CDD), Tuberous sclerosis complex (TSC), SCN8A-DEE, and KCNQ2-DEE.

    DEE Diagnosis

    The diagnosis of these epileptic encephalopathies begins with an EEG which should include both the sleep and wake states. Moreover, Brain computed tomography (CT) scanning, and more specifically, magnetic resonance imaging (MRI) is also indicated. These should be performed before steroid treatment, which may lead to apparent atrophy on the CT or MRI scan.


    The approach to the treatment of epileptic encephalopathy has some of the general principles and approach to pediatric epilepsy treatment. The most appropriate anti-epileptic treatment is selected based on the type of epilepsy syndrome. Antiseizure medications includes clobazam, vigabatrin, zonisamide, phenobarbital, benzodiazapines, vigabatrin, and others are used for treatment of DEE. Steroids therapies, vagus nerve stimulation, ketogenic diet and epilepsy surgery are also used for management of DEE.

    DEE Epidemiology

    The DEE epidemiology division provides insights about historical and current DEE patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight’s report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

    Key Findings

    The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by, diagnosed prevalent cases of DEE in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan market from 2019 to 2032.

    Country Wise- DEE Epidemiology

    This section provides glimpse of the DEE epidemiology in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
  • The total diagnosed prevalent cases of DEE in the 7MM were 302,897 in 2021, growing at a CAGR of 0.31% during the study period (2019–2032).
  • Epidemiology assessed for the condition showed that the US, in 2021, accounted for approximately 129,437 diagnosed prevalent cases of DEE.
  • Among the EU-5 countries in 2021, Germany had the highest diagnosed prevalent population of DEE with 21,041 cases, followed by France (17,258) and UK (16,381). In contrast, Spain had the lowest cases (11,743) in 2021.
  • Japan accounted for 23,798 diagnosed prevalent DEE cases in 2021.
  • LGS accounted for the highest number of diagnosed prevalent cases in 7MM. 79,396 cases, were observed in 2021 which are expected to increase by 2032.
  • In EU5 countries, the diagnosed prevalent cases of Tuberous sclerosis complex were highest in Germany with 4,651 in 2021.

  • DEE Drug Chapters

    Drug chapter segment of the DEE report encloses the detailed analysis of DEE marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the DEE clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

    Marketed Drugs

    Epidiolex (Cannabidol): Jazz Pharmaceuticals

    Epidiolex (formerly GWP42003-P), also known as Epidyolex in Europe, is the first prescription, plant-derived cannabis oral formulation developed by GW pharmaceuticals. It is a novel class of antiepileptic medications with a different mechanism of action. It has been approved in the US and Europe for the treatment of seizures associated with LGS or Dravet syndrome in patients 2 years of age and older. The drug is the first FDA-approved drug that contains a purified drug substance derived from marijuana, and the active ingredient is cannabidiol (CBD).

    Diacomit (Stiripentol): Biocodex

    Diacomit (stiripentol), an original anti-epileptic drug resulting from Biocodex’s research program, is indicated for treating seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam. In August 2018, the FDA approved Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.

    Fintepla (Fenfluramine): Zogenix (Acquired by UCB)

    Fintepla (formerly known as ZX008) is an oral medication that is a low-dose solution of fenfluramine hydrochloride. It prevents the entry of calcium ions into nerve cells, lowering their over-excitability and reducing seizure episodes. It also activates serotonin receptors, which contributes to the overall antiepileptic action. In April 2022, UCB announced the US FDA approval of Fintepla oral solution CIV for the treatment of seizures associated with LGS in patients two years of age and older.

    Sabril (Vigabatrin): Lundbeck

    Sabril contains the active ingredients of vigabatrin, which is a GABA-aminotransferase inhibitor indicated for the treatment of infantile spasms (a rare disease) and complex partial seizures. The precise mechanism of vigabatrin’s antiseizure effect is unknown, but it is believed to result from its action as an irreversible inhibitor of GABA-T, the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. In August 2009, Lundbeck received FDA approval for the Sabril (vigabatrin) monotherapy for pediatric patients of 1 month to 1 year of age with infantile spasms for whom the potential benefits outweigh the potential risk of vision loss, and as adjunctive (add-on) therapy for adult patients with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss.

    Note: Detailed Current therapies assessment will be provided in the full report of DEE

    DEE Emerging Drugs

    Epygenix’s lead product candidate, EPX-100, is a repurposed antihistamine which was used in the past to treat itchiness. The medication can suppress seizures via modulation of serotonin (5HT) signaling pathways, which is different from its anti-histaminic properties. EPX-100 was a powerful suppressor of spontaneous convulsive behavior and electrographic seizures in zebrafish disease models for Dravet syndrome. EPX-100’s antiepileptic action is not through a histaminergic mechanism of action but acts via modulation of serotonin (5HT) signaling pathways. Currently, the drug is in Phase II trial (NCT04462770) as a single pivotal study to compare the efficacy of EPX-100 against placebo as adjunctive therapy in 60 patients with Dravet Syndrome. Apart from this, EPX-100 is also evaluated as a single pivotal study in the Phase II trial (NCT05066217) as Adjunctive Therapy in Children with LGS. Moreover, the company is also investigating EPX-200 and EPX-300 for Dravet syndrome and LGS. Furthermore, these drugs can progress directly into Phase III trials and pursue approval. In addition to that, EpyGenix expects to start the Phase III trial for EPX-200 and EPX-300 in 1H22.

    XEN496 is a pediatric formulation of ezogabine (retigabine), a neuronal KCNQ (Kv7) potassium channel modulator under development by Xenon Pharmaceuticals as a precision medicine treatment for KCNQ2-related neonatal developmental and epileptic encephalopathy (KCNQ2-DEE). Moreover, a Phase III randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial, called the “EPIK” study, is underway to evaluate the efficacy, safety, and tolerability of XEN496 administered as adjunctive treatment in approximately 40 pediatric patients aged 1 month to less than 6 years with KCNQ2-DEE. Xenon anticipates that the EPIK study (NCT04639310) will be completed in the first half of 2023.

    LP352 (Longboard Pharmaceuticals) is an oral, centrally acting, 5-HT2c superagonist in development for the potential treatment of seizures associated with DEEs such as Dravet syndrome, LGS, tuberous sclerosis complex (TSC), CDKL5 deficiency disorder (CDD), and other epileptic disorders. LP352 is designed to modulate GABA and, as a result, suppress the central hyperexcitability that is characteristic of seizures. LP352 is the only 5-HT2c receptor superagonist being dose-optimized for the refractory epilepsy population.

    STK-001 (Stoke Therapeutics) is an investigational new medicine for the treatment of Dravet syndrome. It is a proprietary antisense oligonucleotide (ASO) and has the potential to be the first disease-modifying therapy to address the genetic cause of Dravet syndrome. The drug is designed to upregulate NaV1.1 protein expression by leveraging the non-mutant copy of the SCN1A gene to restore physiological NaV1.1 levels, thereby reducing both occurrences of seizures and significant non-seizure comorbidities. This RNA-based approach is not gene therapy but rather RNA modulation, as it does not manipulate nor insert genetic deoxyribonucleic acid (DNA).

    Soticlestat (OV935/TAK-935) (Takeda/Ovid Therapeutics) is a potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H), with the potential to reduce seizure susceptibility and improve seizure control. CH24H is predominantly expressed in the brain, where it plays a central role in cholesterol homeostasis. CH24H converts cholesterol to 24-hydroxycholesterol (24HC), exiting the brain into the blood plasma circulation. Glutamate is one of the main neurotransmitters in the brain and can play a role in initiating and spreading seizure activity. Recent literature indicates CH24H is involved in the over-activation of the glutamatergic pathway through modulation of the NMDA channel, implying its potential role in central nervous system diseases such as epilepsy. Ovid and Takeda believe that OV935’s novel mechanism of action may potentially treat rare epilepsies by inhibiting CH24H from decreasing 24HC levels, effectively decreasing glutamate hyperactivity. The company is currently conducting multiple Phase III clinical developmental trials of soticlestat as adjunctive therapy in pediatric and adult patients suffering from LGS and Dravet Syndrome and is anticipating potential approval of soticlestat for these indications in 2023.

    Note: Detailed emerging therapies assessment will be provided in the final report.

    DEE Market Outlook

    Currently, the commonly used treatment therapy is antiepileptic medications. The early treatment choice for almost all patients with multiple seizures is AEDs. The medications treat the symptoms of epilepsy (the seizures) and are highly effective and completely control seizures in the majority (70%) of cases. The drugs prevent seizures from starting by reducing brain cells’ tendency to send excessive and confused electrical signals. Choice of medication depends on a variety of factors, some of which include the type of seizure and type of epilepsy, the likely side effects of the medication, other medical conditions the patient may have, potential interactions with the patient’s other medications, age, gender and cost of the medication. Anticonvulsant therapy is also considered after two unprovoked epileptic seizures. The medication prescribed by the medical practitioner could be monotherapy or a combinational therapy, including two or more products as a medication.

    Out of the above-mentioned syndromes of epileptic encephalopathies, infants are majorly affected by LGS and Dravet Syndrome. The three main forms of treatment for LGS and Dravet Syndrome are antiepileptic drugs (AEDs), dietary therapy (typically the ketogenic diet), or device/surgery (VNS therapy or corpus callosotomy). Valproate (Valproic acid) is one of the most useful initial medications of choice to control absence seizures, tonic-clonic seizures (grand mal), complex partial seizures, juvenile myoclonic epilepsy, and the seizures associated with LGS. Valproate is considered the first line of therapy for LGS as it is effective against a wide spectrum of seizures. The drug is administered as a monotherapy, and if ineffective, another drug such as lamotrigine, topiramate rufinamide, or clobazam may be added. It also has significant side effects ranging from tremors to reduction in platelet count and function as well as hyperammonemia.

    The US FDA has approved several drugs for the treatment of LGS and Dravet Syndrome, including different classes such as Sodium Channel Modulators, Gamma-Aminobutyric Acid (GABA) Receptor Modulator, Calcium Channel Blockers, Receptor Blockers, and a few other categories. Several AEDs currently available in the market consist of Fintepla, Epidiolex, Topamax, Banzel, Lamictal, Felbatol, Onfi, Klonopin, Diacomit, Sabril, and others.

    While Neurocrine Biosciences (NBI-921352, NBI-827104), Takeda (Soticlestat), SK Life Science (Carisbamate), Epygenix (EPX-100, EPX-200, and EPX-300), Xenon Pharmaceuticals (XEN496), Praxis Precision Medicines (PRAX-562), Stoke Pharmaceutics (STK-001), BioPharm Solutions (JBPOS0101), and others are evaluating their lead candidates in different stages of clinical development, respectively. These companies aim to investigate their products for the treatment of DEE, including LGS, DS, CDD, EE-CSWS, and various others. With several potential therapies being investigated for the management of DEE, it is safe to predict that the treatment space will experience a significant impact during the forecast period of 2022–2032. According to DelveInsight, DEE market in 7MM is expected to witness a major change in the study period 2019-2032.

    Key Findings
  • The market size of DEE in the 7MM is expected to rise from USD 957 million in 2019 at a CAGR of 15.5% during the study period (2019–2032).
  • The potential therapies expected to be launched in the forecast period include XEN496, Carisbamate, TAK-935, EPX-100, and others. The launch of these therapies may increase market size in the coming years.
  • The United States accounts for the largest market size of DEE compared to EU5 (Germany, the United Kingdom, Italy, France, and Spain) and Japan.
  • In the United States, the market size of DEE is anticipated to rise from USD 1,030 million in 2021 during the forecast period.
  • Among the EU5 countries, Germany had the largest market size (USD 71.8 million) in 2021, while Spain had the smallest with USD 44.7 million.
  • In 2021, Japan accounted for a market size of USD 53.4 million.

  • The United States Market Outlook

    The total market size of DEE in the United States is expected to increase with a CAGR of 15.48% in the study period (2019–2032).

    EU-5 Countries: Market Outlook

    The total market size of DEE in EU5 is expected to increase with a CAGR of 16.4% in the study period (2019–2032).

    Japan Market Outlook

    The total market size of DEE in the Japan is expected to increase with a CAGR of 11.79% in the study period (2019–2032).

    Analyst Commentary
  • The pipeline of DEE is very robust, many potential therapies are being investigated for the treatment of DEE, and it is safe to predict that the treatment space will experience a significant impact on the market during the forecast period.
  • The expected introduction of emerging therapies with improved seizure control, more awareness initiatives programs, and further improvement in the diagnosis rate, are likely to boost the growth of the DEE market in the 7MM. Aside from that, the market size of DEE may flourish due to increased research and development, label-expansion of approved therapies into other epilepsy in this field.
  • Given the possibility of label expansion and the benefits of orphan pricing, as well as the lack of competition that is crucial for competitive positioning in rare illnesses, DEE might be a high-revenue category of severe epilepsies. In fiscal year 2020, Epidiolex, for example, made about half a billion dollars. Epidiolex and Fintepla are also predicted to generate billions in sales revenue by 2032 in the 7MM owing to their label-expansion, robust uptake, and better clinical profile.
  • Recently, Fintepla oral solution CIV had been approved by the US FDA for the treatment of seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. With this approval fintepla will experience a significant impact on the market during the forecast period.
  • The market growth of DEE may offset by failures and/or discontinuation of the emerging therapies, unaffordable pricing, market access and reimbursement issues, and a scarcity of healthcare specialists.

  • DEE Drugs Uptake

    This section focusses on the rate of uptake of the potential drugs recently launched in the DEE market or expected to get launched in the market during the study period 2019-2032. The analysis covers DEE market uptake by drugs; patient uptake by therapies; and sales of each drug. For example-

    Soticlestat (Takeda/Ovid Therapeutics), is a potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H), with the potential to reduce seizure susceptibility and improve seizure control The company is currently conducting multiple Phase III clinical developmental trials of soticlestat as adjunctive therapy in pediatric and adult patients suffering from LGS and Dravet It expected to first launch in USA (2023) followed by Germany, UK (2024), France, Italy, Spain (2025), and Japan (2025). As per our analysis, Soticlestat drug uptake in 7MM is expected to be fast and with an estimated peak share to be 13% for Dravet syndrome and 14% for LGS in 7MM.

    Note: Detailed emerging therapies assessment will be provided in the final report.

    DEE Pipeline Development Activities

    The report provides insights into different therapeutic candidates in Phase II and Phase III stage. It also analyses DEE key players involved in developing targeted therapeutics.

    Pipeline Development Activities

    The report covers the detailed information of collaborations, acquisition and merger, licensing, patent details and other information for DEE emerging therapies.

    Reimbursement Scenario in DEE

    LGS is a severe and treatment-resistant epilepsy syndrome for which the burden of illness remains poorly understood. According to a study, the average total costs PPPY (services + drugs) were significantly higher for the cohort with LGS vs. controls: USD 65,026 (SD USD 34,324) vs. USD 2442 (SD USD 10,670) for commercial-insured and USD 63,930 (SD USD 45,761) vs. USD 3849 (SD USD 13849) for Medicaid-insured patients. Annual costs for services were 17–20 times higher for patients with possible LGS than for matched controls. Similarly, annual costs for drugs were 16–38 times higher for patients with possible LGS compared with matched controls. Differences in total costs between commercial and Medicaid claims were insignificant, and patients covered under Medicaid insurance averaged ≈USD 1400 more in healthcare services and ≈USD 2500 less in drugs. The majority of individuals with LGS experience lifelong cognitive and behavioral problems, with intractable seizures persisting into adulthood in 80–90% of patients.

    According to a study, the medical cost to the NHS in 1992/1993 of newly diagnosed epilepsy in the first year of diagnosis was calculated as GBP 18 million, and the total annual cost of established epilepsy was estimated at GBP 2 billion (direct and indirect costs), over 69% of which was due to indirect costs (unemployment and excess mortality). Moreover, One of the latest studies in the literature estimated that the costs of prescribing costs in the community have risen threefold in the last 10 years, from GBP 26 million to GBP 86 million, a yearly increase five times the rate of inflation.

    Co-pay Assistance Program

    Through this program, families can pay as little as USD 0 co-pays for Fintepla and associated echocardiograms. The company’s commitment to the patient is that they would not have to pay any more than USD 25 in out-of-pocket co-pays for Fintepla. The Co-pay Assistance Program is not health insurance and is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other government healthcare programs.

    Topamax Savings Program

    This program is only available to individuals’ age 2 or older using commercial or private health insurance for their Janssen medication, including plans available through state and federal healthcare exchanges. The Eligible patients have to pay an initial USD 4 per fill at participating retail pharmacies and receive up to USD 150 off their out-of-pocket prescription costs, with a maximum program benefit of USD 1,800 or 12 fills per calendar year, whichever comes first. This program is not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change.

    KOL- Views

    To keep up with current market trends, we take KOLs and SME's opinion working in DEE domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders are Head, Neuroscience Therapeutic Area Unit at Takeda; Chief Medical Officer of Praxis; President, and others. Their opinion helps to understand and validate current and emerging therapies treatment patterns or DEE market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

    Competitive Intelligence Analysis

    We perform Competitive and Market Intelligence analysis of the DEE Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

    Scope of the Report
  • The report covers the descriptive overview of DEE, explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
  • Comprehensive insight has been provided into the DEE epidemiology and treatment in the 7MM
  • Additionally, an all-inclusive account of both the current and emerging therapies for DEE are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
  • A detailed review of DEE market; historical and forecasted is included in the report, covering drug outreach in the 7MM
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the global DEE market

  • Report Highlights
  • In the coming years, DEE market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
  • The companies and academics are working to assess challenges and seek opportunities that could influence DEE R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
  • Major players are involved in developing therapies for DEE. Launch of emerging therapies will significantly impact the DEE market
  • A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for DEE
  • Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

  • DEE Report Insights
  • Patient Population
  • Therapeutic Approaches
  • DEE Pipeline Analysis
  • DEE Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies

  • DEE Report Key Strengths
  • 11 Years Forecast
  • 7MM Coverage
  • DEE Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake

  • DEE Report Assessment
  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Market Drivers and Barriers

  • Key Questions

    Market Insights:
  • What was the DEE drug class share (%) distribution in 2019 and how it would look like in 2032?
  • What would be the DEE total market size as well as market size by therapies across the 7MM during the forecast period (2019-2032)?
  • What are the key findings pertaining to the market across 7MM and which country will have the largest DEE market size during the forecast period (2019-2032)?
  • At what CAGR, the DEE market is expected to grow in 7MM during the forecast period (2019-2032)?
  • What would be the DEE market outlook across the 7MM during the forecast period (2019-2032)?
  • What would be the DEE market growth till 2032, and what will be the resultant market Size in the year 2032?
  • How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?

  • Epidemiology Insights:
  • What is the disease risk, burden and regional/ethnic differences of the DEE?
  • What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What is the historical DEE patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What would be the forecasted patient pool of DEE in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • Where will be the growth opportunities in the 7MM with respect to the patient population pertaining to DEE?
  • Out of all 7MM countries, which country would have the highest prevalent population of DEE during the forecast period (2019-2032)?
  • At what CAGR the patient population is expected to grow in 7MM during the forecast period (2019-2032)?

  • Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
  • What are the current options for the DEE treatment in addition to the approved therapies?
  • What are the current treatment guidelines for the treatment of DEE in the USA, Europe, and Japan?
  • What are the DEE marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
  • How many companies are developing therapies for the treatment of DEE?
  • How many therapies are in-development by each company for DEE treatment?
  • How many are emerging therapies in mid-stage, and late stage of development for DEE treatment?
  • What are the key collaborations (Industry - Industry, Industry - Academia), Mergers and acquisitions, licensing activities related to the DEE therapies?
  • What are the recent novel therapies, targets, mechanisms of action and technologies being developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for DEE and their status?
  • What are the current challenges faced in drug development?
  • What are the key designations that have been granted for the emerging therapies for DEE?
  • What are the global historical and forecasted market of DEE?

  • Reasons to buy
  • The report will help in developing business strategies by understanding trends shaping and driving the DEE market
  • To understand the future market competition in the DEE market and Insightful review of the key market drivers and barriers
  • Organize sales and marketing efforts by identifying the best opportunities for DEE in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
  • Organize sales and marketing efforts by identifying the best opportunities for DEE market
  • To understand the future market competition in the DEE market

  • 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

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