ANTIEPILEPTIC DRUGS MARKET ANALYSIS

Global Antiepileptic Drugs Market is estimated to be valued at US$ 7.01 billion in 2023, and is expected to reach US$ 8.81 billion by 2030, exhibiting a Compounded Annual Growth Rate (CAGR) of 3.3% during the forecast period (2023-2030).

Analysts’ Views on the Global Antiepileptic Drugs Market:

Anti-epileptic drugs are also known as antiseizure medications since they aid in the treatment and prevention of seizures. Anti-epileptic drugs  are commonly classified into two types: broad-spectrum antiseizure medications and narrow-spectrum antiseizure medications. Broad spectrum antiseizure medications treat a wide range of seizure types, whereas narrow spectrum antiseizure medications primarily treat focal or partial seizures. Growing prevalence of epilepsey is anticipated to drive the marketgrowth over the forecast period. According to an article published by the World Health Organization (WHO) on February 09, 2023, 5 million people are diagnosed globally with epilepsy every year. Epilepsy is esimated to affect 49 persons out of every 100,000 in high-income countries every year.

Figure 1. Global Antiepileptic Drugs Market Share (%), By Generation, 2023

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Global Antiepileptic Drugs Market - Drivers

• Increasing inorganic growth strategies: Increasing number of inorganic growth strategies such as collaboration  the key market players is anticipated to drive the market growth over the forecast period. For instance, in May 2021, Epilepsy Foundation, a U.S.-based non-profit national foundation, collaborated with Eisai Inc., a Japan-based pharmaceutical company, to develop the Epilepsy Digital Experience Navigator (EDEN), a platform designed to empower people with epilepsy, their caregivers, and clinicians, to use data to better understand, and improve the epilepsy journey.
• Approvals of new drugs by regulatory authorities: Key market players are engaged in receiving approvals from regulatory authorities, and this is expected to drive the global antiepileptic drugs market growth over the forecast period. For instance, in March 2022, UCB S.A, a global biopharmaceutical firm, announced that the U.S. Food and Drug Administration (FDA) had approved FINTEPLA (fenfluramine) oral solution CIV for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients of two years of age and older. LGS is a severe childhood-onset developmental and epileptic encephalopathy (DEE) marked by drug-refractory seizures, substantial morbidity, and significant impairment of neurodevelopmental, cognitive, and motor functioning.

Figure 2. Global Antiepileptic Drugs Market Share (%), By Region, 2023

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Global Antiepileptic Drugs Market- Regional Analysis

Among region, North America is estimated to hold a dominant position in the global antiepileptic drugs market over the forecast period. North America is estimated to hold 37.7% of the market share in 2023. North America antiepileptic drugs market is expected to witness significant growth in the near future, owing to approval of new drugs in the market. For instance, in August 2021, UCB S.A, a global pharmaceutical firm, announced that the U.S. FDA had approved an extended indication for BRIVIACT (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in infants as young as one month old. This is the first time that the IV formulation of BRIVIACT will be available for pediatric patients when oral administration is temporarily not possible, and it is the only IV formulation U.S. FDA approved to treat partial-onset seizures in children one month and older or  nearly 7 years.

Global Antiepileptic Drugs Market - Impact of Coronavirus (COVID-19) Pandemic

• Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe, and the World Health Organization (WHO) declared it a public health emergency on January 30, 2020.
• COVID-19 affected the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, the U.A.E., Egypt, and others, facedproblems regarding transportation of things from one place to another.
• In April 2020, according to a report published by National Center for Biotechnology Information (NCBI), many clinical trials suspended their trial enrollment, in order to minimize the risk of contracting COVID-19, and this led to the delay in the activation of new clinical trials. Moreover, many companies missed the follow-up for the patients already in trials. Product development had experienced disruption to adjust to remote-work environments and the capacity of the lab capacity was also  reduced. Clinical trials were severely affected with disruptions in both new enrollment and in keeping existing patients on therapies. To conclude, the COVID-19 pandemic had a negative impact on the market owing to disocontinuation of clinical trials amid the fear of transmitting virus.

Global Antiepileptic Drugs Market- Segmentation

Global Antiepileptic Drugs Market is segmented based ongeneration, route of administration, distribution channel, and region.

• By generation, the market is segmented into first generation, second generation, and third generation. Out of which, the second generation segment is expected to hold a dominant position in the global Antiepileptic Drugs Market during the forecast period, owing to ongoing clinical and research studies being conducted by key market players.  
• By route of administration, the market is segmented into oral, intravenous, and others (nasal,etc.). Out of which, the intravenous segment is anticipated to register the highest CAGR over the projected period as novel drugs are being approved for treatment of epilepsy in older and infant patients.  
• By distribution channel, the market is segmented into hospital pharmacies, retail pharmacies, and e-commerce. Out of which, hospital pharmacies segment  is expected to dominate the market over the forecast period, owing to increase in number of hospital pharmacies across the globe.  
• By region, the market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Out of which, the North America region is anticipated to lead the market over the forecast period, owing to organic growth strategies such as facility expansion, new product launch, and others adopted by key market players.
• Among all the segments, the second generation segment is expected to dominate the market over the forecast period, owing to the large number of ongoing clinical studies to study the efficacy of novel second generation drugs to treat seizures.

Global Antiepileptic Drugs Market - Cross Sectional Analysis

New product approvals by the U.S. FDA is anticipated to drive the other (nasal) segment growth over the forecasted period in the North America regiob. For instance, in January 2020, Neurelis, Inc., a neuroscience-based company, announced that the U.S. FDA had approved VALTOCO (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in people with epilepsy 6 years of age and older. VALTOCO's proprietary formulation includes Intravail for consistent and reliable absorption.  

Global Antiepileptic Drugs Market- Key Developments

• On January 12, 2023, IAMA Therapeutics, a pre-clinical stage pharmaceutical company, and PsychoGenics Inc., a leader in AI-enabled phenotypic drug discovery, announced that both companies had signed an agreement to identify the efficacy of novel drug candidates in pre-clinical animal models of Dravet syndrome. Dravet syndrome is a rare type of intractable epilepsy that develops in childhood and progresses with increasing morbidity that has a substantial impact on individuals throughout their lives.
• In July 2022, Marinus Pharmaceuticals, Inc., a pharmaceutical company that is dedicated to the development of novel therapeutics for seizure disorders, announced the commercial launch of ZTALMY (ganaxolone) oral suspension, CV, in the U.S. for the treatment of seizures associated with CDKL5 deficiency disorder (CDD) in patients of two years of age and older. The U.S. Food and Drug Administration authorized ZTALMY in March 2022, based on findings from the Phase 3 Marigold double-blind placebo-controlled trial of 101 patients with CDD.
• In June 2022, Lipocine Inc., a biopharmaceutical company that focuses on developing novel products for neuroendocrine and metabolic disorders, presented "LPCN 2101: An Endogenous Neuroactive Steroid for Epilepsy" at the Epilepsy Foundation Pipeline Conference in 2022 at California, U.S  Every two years, the conference brings together decision-makers in the fields of epilepsy treatment, therapeutic innovation, and development, displaying the most recent breakthroughs in the epileptic pipeline.
• In March 2021, Angelini Pharma, an international pharmaceutical company, announced that the European Commission (EC) had approved ONTOZRY for the adjunctive treatment of focal-onset seizures with or without secondary generalization in adults who have not been adequately controlled, despite a history of treatment, with at least two anti-epileptic medicinal products. The EC marketing authorization is valid in all European Union member countries, as well as Iceland, Norway, and Liechtenstein.

 Global Antiepileptic Drugs Market: Key Trends

• Commencement of new clinical trials: Growing demand for novel epilepsy treatment options leads to development of innovative drug candidates by key market players. In order to check its efficacy, clinical trails are being conducted, thus supporting the market growth over the forecastperiod. For instance, in May 2022, Shanghai Zhimeng Biopharma, Inc., a startup biotechnology company, announced the dosing of the first healthy subject in the U.S. Phase I study of its revolutionary small-molecule KCNQ2/3, a selective opener (CB03), that is developed for the treatment of refractory epilepsy. CB03 is a potential medication for the treatment of refractory epilepsy, developed independently by Shanghai Zhimeng Biopharma, Inc. The purpose of the phase 1 study is to evaluate CB03's safety, tolerability, and pharmacokinetics in healthy individuals.

Global Antiepileptic Drugs Market: Restraint

• Product recall: The key factor hindering the market growth is product recall. Product recall hampers the companies image in the market as well affect sales of other products in the same segment. According to the Government of U.K., on July 13, 2023, Sanofi, a  U.K.based  pharmaceutical company, recalled  the listed batches of Sabril tablets and Sabril granules as a precautionary measure, due to the discovery of residues of tiapride in batches of the manufacturer's source material for vigabatrin. Sabril (vigabatrin) is approved as an additional treatment for focal seizures with or without subsequent generalization that have not been adequately managed with other anti-epileptics (under professional supervision) and as monotherapy for infantile spasms (West's syndrome).
• Counterbalance: Key players operating in this market should adhere to good manufacturing practices (GMO), thus, decreasing the chances ofunwanted residues in the final product.

Global Antiepileptic Drugs Market - Key Players

The major players operating in the global Antiepileptic Drugs Market include Novartis AG, GlaxoSmithKline Plc, Johnson & Johnson Service, Inc., Teva Pharmaceutical Industries Ltd., Pfizer, Inc., Zogenix, Dr. Reddy's Laboratories Ltd., Shanghai Zhimeng Biopharma, Inc., Alkem Labs, SK Biopharmaceuticals, Eisai Co., Ltd., IAMA Therapeutics, Angelini S.p.a, Sun Pharmaceutical Industries Ltd., UCB S.A, Marinus Pharmaceuticals, Inc., Sanofi S.A., Sumitomo Dainippon Pharma Co., Ltd., and Bausch Health Companies Inc.

Definition: Anti-epileptic drugs are prescription medications that aid in the treatment and prevention of seizures. These drugs may also be prescribed by healthcare providers to treat epilepsy, symptomatic seizures, and other ailments . These drugs are also prescribed to prevent and/or treat seizures that occur during or after brain surgery.