PUBLISHER: DelveInsight | PRODUCT CODE: 1415495
PUBLISHER: DelveInsight | PRODUCT CODE: 1415495
DelveInsight's "Epilepsy - Market Insights, Epidemiology, and Market Forecast - 2032" report delivers an in-depth understanding of Epilepsy, historical and forecasted epidemiology, as well as the Epilepsy market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The Epilepsy market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Epilepsy market size from 2019 to 2032. The report also covers Epilepsy treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2019-2032.
The World Health Organization (WHO) describes epilepsy as a chronic, non-communicable brain disorder that affects individuals of all ages and contributes to a burden worldwide. It is a neurological disorder characterized by recurrent, unprovoked seizures. A seizure is a sudden, uncontrolled electrical disturbance in the brain that can manifest in various ways, such as convulsions, altered consciousness, unusual sensations, or behaviors.
Epilepsy is diagnosed using a combination of clinical examination, physical examination, and various diagnostic tests such as imaging analysis (magnetic resonance imaging (MRI), CT scan), electroencephalogram (EEG), blood tests, and others. Electrical activity and structural abnormalities in the brain can be measured using brain scans such as magnetic resonance imaging (MRI), electroencephalogram, or computed tomography. Blood tests are performed to check for the underlying conditions causing epilepsy.
The management of epilepsy involves a comprehensive approach aimed at controlling seizures, improving the individual's quality of life, and addressing any associated issues, but none of them is curative. It includes the pharmacological, nonpharmacological (ketogenic diet), and medical device approaches (vagus nerve stimulation [VNS], deep brain stimulation).
Medications are the early treatment choice for almost all patients with multiple seizures. Some patients who only have a single seizure and whose tests do not indicate a high likelihood of seizure recurrence may not need medications. The medications treat the symptoms of epilepsy (seizures) rather than curing the underlying condition. They are highly effective and completely control seizures in most patients (approximately 70%). The drugs prevent seizures from starting by reducing the tendency of brain cells to send excessive and confused electrical signals. The 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.
As the market is derived using a patient-based model, the epilepsy epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of epilepsy, gender-specific cases of epilepsy, diagnosed prevalent cases of epilepsy based on seizure type, and diagnosed cases of other types of epilepsies and associated diseases in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.
According to estimates based on DelveInsight's epidemiology model, epilepsy exhibits a female preponderance than males in EU4 and the UK. Of the total cases, nearly 47% were males and 53% were females.
The drug chapter segment of the Epilepsy report encloses a detailed analysis of Epilepsy-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the Epilepsy 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.
EPIDIOLEX/EPIDYOLEX (cannabidiol), an oral solution, is a clear, colorless-to-yellow liquid containing cannabidiol at 100 mg/mL concentration. Cannabidiol, the active ingredient in EPIDIOLEX, is a cannabinoid that naturally occurs in the Cannabis sativa L. plant. Inactive ingredients include dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose. EPIDIOLEX contains no ingredient made from a gluten-containing grain
EPIDIOLEX is approved for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. Jazz Pharmaceuticals had initiated a Phase III trial to treat children and adolescents living with developmental and epileptic encephalopathy; however, the trial was terminated due to a business decision. The Japanese unit of Jazz Pharmaceuticals has started a Phase III trial of the drug for epilepsy in Japan.
EPIDIOLEX is to be administered orally. The recommended starting dosage is 2.5 mg/kg taken twice daily (5 mg/kg/day). After 1 week, the dosage can be increased to a maintenance dosage of 5 mg/kg twice daily (10 mg/kg/day).
XEN1101 is a novel, orally administered, potent, selective KCNQ2/3 (Kv7.2/7.3) potassium channel opener being developed to treat focal onset seizures and primary generalized tonic-clonic seizures (PGTCS). It acts as a neuronal Kv7 voltage-gated potassium channel opener and has been developed to stabilize nerve cells, control action potential burst firing, and reduce brain hyperexcitability as a seizure treatment.
The Kv7 potassium channel mechanism has been clinically validated with ezogabine. The FDA approved this earlier generation Kv7 modulator as an adjunctive treatment for adults with focal seizures with or without secondary generalization. XEN1101's unique composition is chemically designed to improve the potency, selectivity, and pharmacokinetics of ezogabine and is not expected to have ezogabine's composition-specific tissue pigmentation effects.
The drug is currently investigated in multiple Phase III clinical trials to treat patients with focal-onset and primary generalized tonic-clonic seizures. The drug is also being developed for major depressive disorder.
Note: Further emerging therapies and their detailed assessment will be provided in the final report.
Epilepsy, as a chronic, non-communicable disease of the brain, affects people of all ages and contributes significantly to the global disease burden. It is a neurological disorder characterized by recurrent, unprovoked seizures. A seizure occurs when the brain has sudden and abnormal electrical activity. These abnormal electrical discharges may cause changes in behavior, consciousness, sensation, or a combination of these factors. Treatment involves pharmacologic (use of anti-epileptic drugs), nonpharmacologic (such as exercise, ketogenic diet), and medical device approaches. Anti-epileptic medications (AEDs) are the most widely prescribed class of medication for epilepsy; however, they do not treat the condition; instead, they alter the chemical balance in the brain to prevent seizures. Several AEDs with different modes of action, some possessing more than one, are available in the market and prescribed as monotherapy or adjunctive therapy in different lines of treatment.
Commonly, initial or first-line treatment with AED monotherapy is recommended for new-onset epilepsy, with subsequent substitution with another AED monotherapy; however, if results are not satisfactory, AED polytherapy or combination therapy is adopted. Further, even after mono and combination therapy in the first line, treatment failure, known as drug-resistant epilepsy, still occurs in epilepsy patients. These patients are further recommended a second-line therapy, where AEDs are usually used as substitution therapy (mono or combination) to control seizures, although international consensus and clarity for the AEDs used in second-line is not available yet. If seizures continue, a third-line therapy is instituted using intravenous sedation (therapeutic coma). Propofol and midazolam are the most commonly used agents, partly because of their short half-life.
The current first-line therapy for epilepsy involves AEDs with following mechanism of action: GABA enhancers/inhibitors (vigabatrin, gabapentin, benzodiazepines, phenobarbital, clonazepam, clobazam, cenobamate, etc.), calcium channel blockers (topiramate, valproate, ethosuximide, etc.), sodium channel blockers (phenytoin, carbamazepine, oxcarbazepine, zonisamide, lamotrigine, etc.) AMPA receptor antagonist (perampanel and topiramate), and SV2a vesicle inhibition (levetiracetam and brivaracetam).
AEDs that are frequently prescribed include lamotrigine, sodium valproate, carbamazepine, levetiracetam, topiramate, and others. Several US FDA-approved medications such as EPIDIOLEX, XCOPRI (cenobamate), FINTEPLA (fenfluramine hydrochloride), NAYZILAM (midazolam) (nasal spray), and others are also being used to treat seizures associated with epilepsy. Few people are also observed with refractory epilepsy (intractable), i.e., seizures that are not controlled by medications. In addition, vagus nerve stimulation (VNS) devices are inserted beneath the skin to activate the vagus nerve and lessen seizures.
Epilepsy is a disorder of the brain characterized by repeated seizures. A seizure is defined as a sudden alteration of behavior due to a temporary change in the brain's electrical functioning. Usually, the brain continuously generates tiny electrical impulses in an orderly pattern. The epilepsies have many possible causes, and there are several types of seizures. Anything that disturbs the normal neuron activity pattern-from illness to brain damage to abnormal brain development-can lead to seizures. In patients with seizures, the normal electrical pattern is disrupted by sudden and synchronized bursts of electrical energy that may briefly affect their consciousness, movements, or sensations.
The treatment paradigm of epilepsy or its management strategies involves three main categories, i.e., pharmacotherapy, surgery, and alternative treatment strategies, including neurostimulation, ketogenic diet, and lifestyle changes. Medical professionals decide the treatment line according to the patient's condition and the severity of the case.
The current market segmentation is based on the lines of therapies prescribed and is further sub-segment based on the mechanism of action and their usage as a combo or monotherapy. Additionally, the different epileptic syndromes and associated diseases have also been considered to represent the epilepsy market. First-line therapies (GABA enhancers/Inhibitors, calcium channel blockers, sodium channel blockers, AMPA receptor antagonist, SV2a vesicle inhibition, other mono or combo therapies), second-line (mono AEDs and mono or combo AEDs), mono or adjunctive therapies (EPIDIOLEX/EPIDYOLEX [cannabidiol], FINTEPLA [fenfluramine], DIACOMIT [stiripentol], AFINITOR DISPERZ/VOTUBIA [everolimus], ZTALMY [ganaxolone], TROKENDI XR [topiramate], BANZEL [rufinamide], SYMPAZAN [clobazam]) are the major segmentation covered in the forecast model.
Several key players are evaluating their lead candidates in different stages of clinical development including FINTEPLA (fenfluramine), LIBERVANT (diazepam buccal film), XEN1101, ZTALMY (ganaxolone), XCOPRI/ONTOZRY (cenobamate), lorcaserin (E2023), BHV-7000 (KB-3061), STACCATO alprazolam (benzodiazepine), and others. They aim to investigate their products to treat epilepsy and their types of associated conditions.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032. For example, Marinus Pharmaceuticals, Ovid Therapeutics, and Orion's ZTALMY (ganaxolone), a neuroactive steroid GABAA receptor modulator with a slow-medium uptake, will enter the US market in 2025. On the contrary, UCB and Nippon Shinyaku's FINTEPLA (fenfluramine), which also enters in 2025, and is being investigated for CDKL5 deficiency disorder will grow in the market with fast uptake.
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Epilepsy.
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on Epilepsy evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the American Association of Neurological Surgeons, Johns Hopkins University School of Medicine, Charite University Medicine Berlin, Italian College of General Practitioners, University of Leicester, and the Kanagawa Children's Medical Center were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Epilepsy market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
According to our primary research analysis, several AEDs with different modes of action, some possessing more than one, are available in the market and prescribed as monotherapy or adjunctive therapy in different lines of treatment. The specific treatment plan is tailored to each individual based on factors such as the type of seizures, their frequency, the person's age, overall health, and any underlying causes.
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in Epilepsy trials, efficacy scores are according to seizure response rate, reduction in seizure frequency, reduction in drop seizure, seizure cessation, and others.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers' concerns about budget impact. The high cost of rare disease drugs usually has a limited effect on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently.
The reimbursement challenges related to medical care and treatment for individuals with Epilepsy can be significant as it often requires specialized medical attention, covering the costs of diagnosis, treatment, and ongoing care. Health insurance plans may not fully cover limited coverage of some medical treatments, therapies, and devices specific to Epilepsy. This can result in high out-of-pocket expenses for families seeking the best care for their loved ones. Moreover, it requires specialized care from healthcare providers with expertise. Finding and accessing such specialists may be challenging, and the associated costs may not always be fully reimbursed by insurance.
The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.