ANTI-EPILEPTIC DRUGS FOR PEDIATRICS MARKET ANALYSIS

The global anti-epileptic drugs for pediatrics market size is expected to reach US$ 2,034.7 Mn by 2030, from US$ 1,202.4 Mn in 2023, exhibiting a compound annual growth rate (CAGR) of 7.8% during the forecast period.

Global Anti-epileptic Drugs for Pediatrics Market Regional Insights

• North America is expected to account for the largest market share in the anti-epileptic drugs for pediatrics market during the forecast period, accounting for over 41.3% of the market share in 2023. The growth of the market in North America is due to the high prevalence of epilepsy, favorable reimbursements, and the presence of key players.
• Europe is expected to be the second-largest region for the anti-epileptic drugs for pediatrics market, accounting for over 23.1% of the market share in 2023. The growth of the market in Europe is due to rising healthcare expenditures and strategic developments by companies.
• Asia Pacific is expected to be the fastest-growing region for anti-epileptic drugs for pediatrics market, growing at a CAGR of 7.2% during the forecast period. The growth of the market in Asia Pacific is due to the improving healthcare infrastructure and expanding insurance coverage.

Figure 1. Global Anti-epileptic Drugs for Pediatrics Market Share (%), By Region, 2023

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Analyst’s Views on the Global Anti-epileptic Drugs for Pediatrics Market:

The global anti-epileptic drugs for pediatrics market is expected to witness steady growth over the forecast period driven by the rising incidence of epilepsy among children worldwide. Moreover, favorable government support through funding for research related to pediatric epilepsy treatment will also propel the market growth. However, strict regulatory guidelines for drug approval and high costs associated with drug development and clinical trials may hamper the market growth to some extent.

Global Anti-epileptic Drugs for Pediatrics Market Drivers

• Increasing incidence of neurological disorders: Rising incidences of pediatric epilepsy is a major public health issue globally and is driving the growth of the anti-epileptic drugs for pediatric market. As per the World Health Organization (WHO), the incidence of epilepsy in children is significantly high, especially in developing nations. Around four to 10 per 1,000 children are diagnosed with epilepsy each year. Developing nations account for over 80% of children with epilepsy, mainly due to preventable causes like infections, injuries, and malnutrition. If left untreated, epilepsy can impact a child's physical, cognitive, and social development.
• Increasing research and development activities: Increasing research and development activities by key market players are expected to drive the market growth over the forecast period. For instance, in April 2022, Marinus Pharmaceuticals, Inc., a pharmaceutical company, started a clinical trial of adjunctive Ganaxolone (GNX) treatment in children and adults with tuberous sclerosis complex (TSC)-related epilepsy (TrustTSC). The study is estimated to complete in February 2025.

Favorable reimbursement policies

Favorable reimbursement policies across various countries are positively impacting the growth of the global anti-epileptic drugs for pediatrics market for pediatric indications. Governments and healthcare systems worldwide recognize epilepsy as a chronic neurological condition requiring long term treatment. This clinical perspective is translating to supportive reimbursement guidelines that aim to enhance access to quality care and improved outcomes for young patients.

For instance, the Indian government in 2018 updated its National List of Essential Medicines to include newer anti-seizure medications specifically for use in children. This helped reduce financial barriers for families by making these vital drugs available at affordable costs through public health facilities. Similarly, many European countries like U.K., Germany, and France have reimbursement schemes either through national health insurers or social security systems to cover part or full expenses of anti-epileptic prescriptions for the pediatric population.

Global Anti-epileptic Drugs for Pediatrics Market Restraints

• Increasing product recalls by regulatory authorities: Increasing product recalls by regulatory authorities are expected to hinder the market growth over the forecast period. For instance, in November 2021, Sagent Pharmaceuticals, Inc., a pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) recalled Levetiracetam Injection, which is used for the treatment of certain types of seizures. It is packaged in a 5 mL single-does vial. The product was recalled due to intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life threatening. 
• Side effects of anti-epileptic drugs: Side effects of anti-epileptic drugs pose a significant restraint on the growth of the global anti-epileptic drugs for pediatrics market. A majority of pediatric patients experience unpleasant and sometimes serious side effects during their medication regime. Common side effects include drowsiness, lack of coordination, irritability, behavioral issues, and learning difficulties. Some of the noticeable side effects include skin rashes, nausea, vomiting, and weight gain or loss. In rare cases, serious side effects like liver damage, blood disorders, and hypersensitivity have also been reported.
• Stringent regulatory guidelines associated with drug development: Stringent regulatory guidelines associated with drug development is significantly restraining the growth of the global anti-epileptic drugs for pediatrics market. Developing new drugs and getting them approved for pediatric use is a lengthy process. Medical research involving children is considered much more complex and riskier compared to adults. Regulators rightly impose stringent safety and efficacy standards to protect child participants involved in clinical trials. However, this lengthy approval process acts as a deterrent for pharmaceutical companies from investing in developing new anti-epileptic drugs for pediatric indications.

Global Anti-epileptic Drugs For Pediatrics Market Opportunities

Untapped emerging markets: Untapped emerging markets could indeed present a major opportunity for growth in the global anti-epileptic drugs for pediatrics market. Many developing nations still have limited access to effective treatments for pediatric epilepsy due to various economic and infrastructure challenges. However, these nations are experiencing rapid development and expansion of their healthcare systems.

Investing in customized distribution and affordability programs for emerging markets could be key to capitalizing on this opportunity. Some adaptations may be required to package and deliver anti-epileptic drugs in ways that make them accessible even in remote communities with underdeveloped medical infrastructure and purchasing power limitations. Partnerships with local health authorities and not-for-profit organization (NGOs) working in these nations can help gain important insights into the socio-economic landscape as well as distribution challenges. This collaborative approach will be vital to ensure steady supply of effective anti-epileptic treatment options reach every child in need, thereby unlocking the growth prospects in these dynamic but underserved markets.

Rising demand for targeted therapy: The increasing demand for personalized treatment options is having a significant impact on the global anti-epileptic drugs market for pediatric market. With advancements in genetic research and molecular diagnostics targeted therapies that are designed for certain genetic subtypes or biomarkers of epilepsy are becoming increasingly prevalent. For example, some of the newer anti-epileptic drugs in the market, such as Fintepla, have been formulated for the treatment of seizures associated with specific genetic mutations related to Dravet syndrome and Lennox-Gastaut syndrome. These targeted medications promise higher efficacy for children with treatment-resistant forms of epilepsy caused by these underlying genetic traits. The success of such precision treatments has driven both patients and doctors to demand more customized therapeutic alternatives.

Global Anti-epileptic Drugs For Pediatrics Market Trends

Increasing investments by key market players

Increasing adoption of inorganic growth strategies, such as investments, is expected to drive the global anti-epileptic drugs for pediatrics market over the forecast period.

For instance, in March 2022, Aculys Pharma, Inc., a pharmaceutical company, announced that it has raised a total of US$ 24 million in Series B Round with the participation by JIC Venture Growth Investments, Mitsubishi UFJ Capital, and Spiral Capital as new investors. The funding helps for clinical development and commercial activities for launching research and development activities of epileptic seizure emergencies

Figure 2. Global Anti-epileptic Drugs for Pediatrics Market Share (%), by Drug Type, 2023

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Recent Developments

Product Approvals

• In March 2022, UCB S.A., a pharmaceutical company, announced the U.S. Food and Drug Administration (FDA) approval for FINTEPLA (fenfluramine) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. LGS is a severe childhood-onset developmental and epileptic encephalopathy (DEE) characterized by drug-refractory seizures with high morbidity as well as serious impairment of neurodevelopmental, cognitive, and motor functions.
• In January, 2020, Eisai Co., Ltd., a pharmaceutical company, announced the approval of supplementary new drug applications in Japan for its in-house developed antiepileptic drug (AED), Fycompa (perampanel) for an additional indication for monotherapy of partial-onset seizures and an additional indication for partial-onset seizures in pediatric patients aged 4 years and older, as well as a new fine granule formulation.

Acquisitions and agreements

• On January 25, 2023, Catalyst Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company, announced that it has completed the acquisition of the U.S. rights for FYCOMPA (perampanel) CIII, from Eisai Co., Ltd, a pharmaceutical company. The acquisition provides Catalyst Pharmaceuticals, Inc. with an increased U.S. commercial presence in neurology and an expanded product portfolio with an established, first-in-class, commercial stage epilepsy asset.
• In March 2021, Eisai Co., Ltd., a pharmaceutical company, announced that it had entered into an agreement with Catalyst Pharmaceuticals, Inc., a biopharmaceutical company, to transfer the U.S. commercial rights for the anti-epileptic drug (AED) Fycompa (generic name: perampanel). The agreement will provide the opportunity for Eisai’s neuroscience team to focus on its long-term strategic priorities on the research, development, and commercialization of its Alzheimer’s disease portfolio.

Top Companies in the Global Anti-epileptic Drugs For Pediatrics Market

• Sanofi
• Eisai Co., Ltd.
• Pfizer Inc.
• UCB S.A.
• Sunovion Pharmaceuticals Inc.
• Abbott
• Jazz Pharmaceuticals plc
• Ovid Therapeutics Inc.
• SK BIOPHARMACEUTICALS
• Alexza Pharmaceuticals, Inc.
• Taisho Pharmaceutical Holdings Co., Ltd.
• Xenon Pharmaceuticals Inc.
• Lundbeck A/S
• Teva Pharmaceutical Industries Ltd.

Definition: Epilepsy is associated with disrupted activities in the brain called seizures, which affects the central nervous system. Depending on the area of the brain obstructed by seizures, these are categorized into generalized seizures and partial seizures. Generalized seizures affect the whole brain, while partial seizures affect just one part of the brain. Depending on their severity, seizures are termed as mild seizures and stronger seizures. Mild seizures are difficult to diagnose, as these last for only a few seconds. Stronger seizures may last for a few seconds to several minutes, resulting in spasms and uncontrollable muscle twitches. This may cause the patient to lose consciousness, and experience temporary loss of cognition, or memory loss.