Epilepsy Drug Market

Market Overview

The global epilepsy drug market size was valued at USD 10.35 billion in 2023. It is estimated to reach USD 14.92 billion by 2032, growing at a CAGR of 4.15% during the forecast period (2024–2032). The global epilepsy drug market is driven by the surging disease burden of epilepsy worldwide, especially in developing countries. The growing geriatric population, which is more prone to this disease, further adds to the growing burden of this disease, thereby fostering market expansion. Moreover, the growing number of incidents of brain injury are driving the epilepsy drug market as it is a common risk factor for epilepsy.

Highlights

• Second-generation drugs dominate the drug type segment
• North America is the highest shareholder in the global market

Market Overview

Epilepsy is a chronic neurological condition marked by repetitive and spontaneous seizures that impact the brain's electrical functioning. Epilepsy can arise from a range of circumstances, including genetic predisposition, brain injury, infection, stroke, tumor, or metabolic abnormalities. Epilepsy can exhibit many classifications, including focal, generalized, or combined, dependent upon the specific brain regions implicated and the level of their involvement in the occurrence of seizures.

Epilepsy drugs, usually referred to as anti-epileptic medicines (AEDs), are the primary form of treatment for epilepsy. The primary objective of anti-epileptic drugs (AEDs) is to decrease the occurrence and intensity of seizures, enhance the well-being of patients, and mitigate potential effects such as status epilepticus, sudden unexpected death in epilepsy (SUDEP), or cognitive decline. According to their market introduction, AEDs can be categorized into three generations, i.e., first-generation AEDs, second-generation AEDs, and third-generation AEDs.

Market Dynamics

Global Epilepsy Drug Market Drivers

Rising Prevalence of Epilepsy

The prevalence of epilepsy is rising worldwide as a result of population growth and aging, the higher occurrence of epilepsy in developing nations, and the improved survival rates of individuals with diseases that make them more susceptible to epilepsy, such as stroke, trauma, or infection. Approximately 50 million individuals across the globe are affected by epilepsy, making it one of the most dominant neurological disorders on a global scale, as reported by the World Health Organization. Approximately 80% of individuals diagnosed with epilepsy reside in nations with low- and middle-income levels.

Furthermore, as per the United Nations, the number of individuals aged 65 years and beyond has increased from 6.0% in 1990 to 9.0% in 2019. By 2050, this demographic will be estimated to make up 16% of the total population. Moreover, the global population of adults aged 65 years or over was roughly 727 million in 2020, and it is expected to reach around 1.5 billion by 2050. Hence, the increasing incidence of epilepsy and the growing elderly population, who are more sensitive to epilepsy, result in a greater need for anti-epileptic drugs (AEDs), thereby fueling market expansion.

Rising Cases of Brain Injuries Due to Road Accidents

A head injury or brain damage is a common cause of the onset of epilepsy. Falls, car accidents, and accidents at construction sites are among the primary sources of head injuries. As per the Epilepsy Foundation of America, in July 2020, 10% of individuals who experienced a Traumatic Brain Injury (TBI) also experienced an early seizure. The majority of these seizures are often classified as tonic-clonic.

In 2019, the CDC reported over 61,000 deaths in the US that were connected to traumatic brain injuries (TBI). Moreover, according to a February 2021 report from the Brown Firm (US), automobile accidents accounted for approximately 35% of all cases of traumatic brain injury (TBI). They were the second most common cause of TBI following falls. Consequently, there will be a rise in the need for epilepsy drugs as a result of the elevated incidence of car accidents resulting in traumatic brain injuries.

Global Epilepsy Drug Market Restraint

High Cost of AEDs

The high cost of anti-epileptic drugs (AEDs) poses a significant obstacle to the accessibility and affordability of epilepsy treatment, particularly in poor and middle-income nations, which are home to the majority of individuals with epilepsy. For instance, according to a study by the Epilepsy Foundation of America, the average monthly cost of AEDs in the United States ranged from USD 8.70 for phenobarbital to USD 1,315.90 for perampanel in 2021. The excessive expense of AEDs can place a substantial financial strain on patients, families, and healthcare systems, constraining market expansion.

Global Epilepsy Drug Market Opportunities

Increasing Number of New Drug Approvals

In recent years, there has been a significant increase in the approval of novel drugs for epilepsy. This has resulted in a wider range of treatment options and enhanced effectiveness and safety of anti-epileptic drugs (AEDs). For instance, in 2023, SK Biopharmaceuticals, Co., Ltd., a global pharmaceutical company specializing in the development and commercialization of treatments for central nervous system disorders, along with its U.S. subsidiary SK Life Science, Inc., announced that the U.S. FDA had granted approval for AED XCOPRI® (cenobamate tablets) as a treatment for partial-onset seizures in adults.

Similarly, in March 2022, UCB, a multinational biopharmaceutical company, announced that FINTEPLA® (fenfluramine) oral solution CIV has received approval from the U.S. FDA for the treatment of seizures linked to Lennox-Gastaut syndrome in patients aged two and above. UCB's approval demonstrates its dedication to providing unique medications to targeted epilepsy patient populations with significant unmet needs. The approval of these new drugs enhances market competition and fosters innovation, creating market expansion opportunities.

Regional Analysis

Based on region, the global epilepsy drug market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global epilepsy drug market shareholder and is expected to expand substantially during the forecast period. The market was primarily driven by North America, primarily due to the significant prevalence of epilepsy, a well-developed healthcare infrastructure, the accessibility of advanced anti-epileptic drugs (AEDs), and the advantageous reimbursement policies in the region. In August 2020, the Centers for Disease Control and Prevention released a report indicating that there are 3 million individuals in the United States who are affected by epilepsy, with 1 million of them being 55 years of age or older. Thus, the market is growing because of the increasing prevalence of epilepsy among the older population.

Moreover, the increase in the number of epilepsy cases has led to the approval and introduction of new drugs for the treatment of epilepsy. For instance, in January 2023, Zydus Lifesciences, through its subsidiary Zydus Pharmaceuticals (USA) Inc., announced the introduction of Topiramate Extended-Release Capsules in the United States. The drug is intended for the treatment of epilepsy. The pharmaceutical company had obtained final permission from the United States Food and Drug Administration (USFDA) to market the mentioned capsules in USP 25 mg, 50 mg, and 100 mg.

Similarly, in June 2018, Dr Reddy's Laboratories Ltd announced the availability of Levetiracetram, an anti-epileptic medicine, in Sodium Chloride injection form, with various strengths, in the US market. The pharmaceutical company introduced Levetiracetram in Sodium Chloride Injection in three different concentrations: 500 mg/100 mL (5 mg/mL), 1,000 mg/100 mL (10 mg/mL), and 1,500 mg/100 mL (15 mg/mL). These single-dose infusion bags are a generic version of HQ Specialty Pharma Corporation's Levetiracetam in Sodium Chloride Injection and have the same therapeutic effects. All of these factors are expected to accelerate the regional market's growth.

Europe is anticipated to experience substantial growth over the forecast period, primarily attributable to the increasing prevalence of epilepsy in this region. For instance, in the United Kingdom, there are over 600,000 individuals afflicted with epilepsy, and Epilepsy Action reports that around 87 persons in the UK are diagnosed with epilepsy each day. According to the World Health Organization (WHO), the disease incurs an annual cost of around USD 22.3 billion to the European Union (EU). Moreover, effective administration and increasing drug approval for the treatment of epilepsy can significantly diminish the likelihood of fatality. According to a survey by the UK government, over 33,000 individuals succumb to epilepsy annually, with 40% of these deaths being avoidable. Thus, the regulatory agencies in the region have granted increased approval for new pharmaceuticals, resulting in potential growth opportunities for the European market.

In April 2021, SK Biopharmaceuticals, Co., Ltd., a global pharmaceutical company, announced that cenobamate was granted marketing authorization by the European Commission (EC) under the brand name ONTOZRY®. This authorization allows for the use of ONTOZRY® as an additional treatment for focal-onset seizures in adult patients who have not responded well to at least two other anti-epileptic drugs.

The Asia-Pacific market expansion may be ascribed to several factors, including the rising prevalence of epilepsy and the growing awareness about its treatment, the increasing disposable income, the improvement of healthcare facilities, and the expanding availability of cost-effective, innovative medications in the region. For instance, in February 2021, Sun Pharmaceutical Industries Limited declared its intention to launch a variety of Brivaracetam dosage forms at a reasonable cost to treat epilepsy in India. Sun Pharma has announced that Brivaracetam has received approval from India's Drugs Controller General of India (DCGI) as an additional medicine for the treatment of partial-onset seizures in patients aged 16 and above with epilepsy.

Moreover, in September 2022, China's drug regulatory authority approved a vital medication for treating epilepsy in children. The domestic maker of the drug formally introduced it to the market in October 2022, asserting that it is the most competitively priced worldwide. A generic form of Clobazam will be accessible at local pharmacies nationwide for a price of 84 yuan (USD 12) for each box containing 28 tablets. As a result, these variables contribute to the expansion of the regional market.

Segmental Analysis

The global epilepsy drug market is segmented by drug type.

Based on drug type, the global epilepsy drug market is bifurcated into first-generation drugs, second-generation drugs, and third-generation drugs. 

The second-generation drugs segment dominates the global market. The second-generation anti-epileptics dominated the market due to their superior effectiveness, reduced side effects, and wider range of therapeutic benefits compared to the first-generation anti-epileptics. The second-generation drugs used for the treatment of epilepsy include lamotrigine, levetiracetam, topiramate, and gabapentin. Moreover, more drugs are currently undergoing research as second-generation anti-epileptics, demonstrating favorable clinical outcomes. For instance, in November 2023, Marinus Pharmaceuticals released initial findings from a Phase 1 MAD study on a new version of ganaxolone.

The study showed that this second-generation formulation exhibited consistent and predictable behavior across various doses. This characteristic could potentially enable personalized treatment for patients with refractory epilepsy, which is a primary objective for the development of this new formulation. Marinus plans to use extended-release technology in the formulation to achieve constant exposure and enable once or twice a day administration. This will also allow physicians to adjust the dosage to attain higher serum concentrations of ganaxolone.

The third-generation drugs segment will exhibit the most rapid growth rate in the predicted timeframe. This can be attributed to their innovative modes of action, enhanced safety and tolerability profiles, and the rising number of newly approved drugs in this segment. The third-generation drugs used for treating epilepsy encompass medications such as lacosamide, perampanel, brivaracetam, and cannabidiol.

Recent Developments

• June 2023- Akums received approval from the Drug Controller General of India (DCGI) for the use of perampanel oral suspension as an additional medication for the treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy who are 12 years of age or older in India.
• January 2024- Akumentis Healthcare announced the launch of a drug specifically designed for the management of epilepsy. The business based in Mumbai has introduced Clasepi, a prescription cannabidiol (CBD) that has been approved by the Drug Controller General of India (DCGI).