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市場調査レポート
商品コード
1634147
てんかん治療薬の世界市場 - 2025年~2032年Global Epilepsy Drugs Market - 2025 - 2032 |
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カスタマイズ可能
適宜更新あり
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てんかん治療薬の世界市場 - 2025年~2032年 |
出版日: 2025年01月13日
発行: DataM Intelligence
ページ情報: 英文 176 Pages
納期: 即日から翌営業日
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世界のてんかん治療薬市場は、2024年に110億9,000万米ドルに達し、2032年には163億8,000万米ドルに達し、予測期間2025年~2032年のCAGRは5.4%で成長すると予測されています。
てんかんは、世界中で約5,000万人が罹患する慢性神経疾患です。てんかんは、重症度や頻度にばらつきのある予測不能な発作を特徴とします。この疾患は、遺伝的素因、脳損傷、感染症、発達障害など様々な要因によって発症します。てんかんは罹患者だけでなく、その家族や介護者にも大きな課題をもたらし、生活の質に影響を与え、継続的な管理と治療を必要とします。
てんかん治療薬は、抗てんかん薬(AED)または抗発作薬とも呼ばれ、てんかんと診断された患者の発作を予防したり、発作の頻度を減らしたりするために使用される薬理学的薬剤です。特定の薬剤の選択は、経験した発作の種類、患者の年齢、全身状態、その他の個々の考慮事項など、いくつかの要因に影響されます。
これらの薬剤は発作を効果的にコントロールすることを目的としていますが、てんかんを治癒させるものではありません。その代わり、脳内の神経伝達物質のレベルを調節して電気的活動を安定させ、発作エピソードを予防することで効果を発揮します。AEDの選択は患者のてんかんの特性によって異なり、ヘルスケアプロバイダーは通常、潜在的な副作用を最小限に抑えながら最適な発作制御を達成するために治療計画を調整します。このような要因が、世界のてんかん治療薬市場拡大の原動力となっています。
促進要因と抑制要因
てんかん有病率の上昇
てんかんの有病率の上昇は、世界のてんかん治療薬市場の成長を大きく牽引しており、市場予測期間中も牽引していくと予測されています。この増加は、人口動態の変化、診断能力の向上、ヘルスケアアクセスの格差など、さまざまな要因の影響を受けています。
世界のてんかん疫学
2024年のSingleCare Epilepsy Statisticsデータによると、世界で約5,000万人がてんかんに罹患しており、最も一般的な神経疾患の1つとなっています。てんかんの生涯有病率は1,000人あたり7.60人、活動有病率は1,000人あたり約6.38人と推定されています。毎年、世界で約500万人が新たに診断されています。高所得国(HICs)と中低所得国(LMICs)では、診断率に顕著な格差があります。HICでは、人口10万人あたり年間約49人がてんかんと診断されるのに対し、LMICでは10万人あたり139人がてんかんと診断されます。
LMICでは、中枢神経系(CNS)感染症の有病率が高いこと、外傷性脳損傷(TBI)の発生率が高いこと、ヘルスケア資源へのアクセスが限られていることなどの要因により、てんかんの発生率は有意に高いです。てんかん患者の約80%がこれらの地域に居住しており、ヘルスケアシステムが治療需要に対応するのに苦労している可能性があります。世界では毎年460万人が新たにてんかんを発症していると推定されており、効果的な治療オプションが急務となっています。このような需要は、医療従事者が発作を効果的に管理するためにAEDの処方を検討していることから、市場成長の原動力となっています。このように、これらすべての要因が世界のてんかん治療薬市場の拡大を促しています。
さらに、業界の主要企業は、この世界のてんかん治療薬市場の成長を促進するような製品の発売や重要なイニシアチブをとっています。例えば、2023年1月、Zydus Lifesciences社は米国市場で抗てんかん薬のジェネリック医薬品、特にTopiramate徐放カプセルの発売を発表しました。同社は米国食品医薬品局(USFDA)より、トピラマート徐放性カプセルの最終承認を取得しました。承認された強度は25mg、50mg、100mgです。ザイダス社は、これらの特定の強度でこの承認を受けた最初の会社です。
また、2024年7月、Invitae社は特に小児てんかん患者を対象とした「Unlock Behind the Seizure Program」を開始しました。このイニシアチブは、てんかんを患う小児の診断プロセスを強化することを目的としたもので、特に、てんかんの病態に関与している可能性のある根本的な遺伝的原因を特定することに重点を置いています。これらすべての要因が、世界のてんかん治療薬市場に需要をもたらしています。
さらに、診断技術の進歩に対する需要の高まりも、世界のてんかん治療薬市場の拡大に寄与しています。
薬剤に関連する副作用
抗てんかん薬(AED)に伴う副作用は、患者の治療アドヒアランスに大きな影響を与え、ひいてはてんかん管理全体の効果に影響を与え、てんかん治療薬市場の成長を妨げます。
AEDは、眠気、疲労、胃腸障害(吐き気や嘔吐など)、認知障害(集中力や記憶力の低下など)など、さまざまな副作用を引き起こすことが知られています。これらの副作用は患者にとって特に苦痛であり、服薬を中止せざるを得なくなることもあります。
JMC2021の神経内科クリニックにおけるてんかん患者の副作用プロファイル。
研究によると、AEDによる副作用は最大40%の患者の治療失敗の原因となっています。患者が耐え難い症状を経験した場合、医療従事者に相談することなく服薬を中止することがあり、発作が制御できなくなり、健康に潜在的な合併症が生じる可能性があります。国民保健サービス(NIH)のデータによると、抗てんかん薬(AED)の治療を開始すると、しばしば一般的な副作用が現れることがあります。これらの副作用は投薬開始後すぐに現れ、通常数日から数週間で消失することもあれば、現れるまでに時間がかかるものもあります。そのため、上記のような要因が世界のてんかん治療薬市場の潜在的な成長を制限している可能性があります。
The global epilepsy drugs market reached US$ 11.09 billion in 2024 and is expected to reach US$ 16.38 billion by 2032, growing at a CAGR of 5.4% during the forecast period 2025-2032.
Epilepsy is a chronic neurological disorder that affects approximately 50 million people worldwide. It is characterized by unpredictable seizures that can vary in severity and frequency. The condition can arise from various factors, including genetic predispositions, brain injuries, infections, and developmental disorders. Epilepsy poses significant challenges not only to those affected but also to their families and caregivers, impacting their quality of life and requiring ongoing management and treatment.
Epilepsy drugs, also referred to as antiepileptic drugs (AEDs) or antiseizure medications, are pharmacological agents used to prevent or reduce the frequency of seizures in individuals diagnosed with epilepsy. The selection of a specific medication is influenced by several factors, including the type of seizures experienced, the patient's age, overall health condition, and other individual considerations.
These medications aim to control seizures effectively; however, they do not cure epilepsy. Instead, they work by modifying the levels of neurotransmitters in the brain to stabilize electrical activity and prevent seizure episodes. The choice of AED may vary based on the specific characteristics of the patient's epilepsy, and healthcare providers typically tailor treatment plans to achieve optimal seizure control while minimizing potential side effects. These factors have driven the global epilepsy drugs market expansion.
Market Dynamics: Drivers & Restraints
Rising Prevalence of Epilepsy
The rising prevalence of epilepsy is significantly driving the growth of the global epilepsy drugs market and is expected to drive throughout the market forecast period. This increase is influenced by various factors, including demographic changes, improved diagnostic capabilities, and disparities in healthcare access.
Global Epilepsy Epidemiology
According to the SingleCare Epilepsy Statistics data in 2024, approximately 50 million people worldwide are affected by epilepsy, making it one of the most common neurological disorders. The lifetime prevalence of epilepsy is estimated at 7.60 per 1,000 persons, while the active prevalence is around 6.38 per 1,000 persons. Each year, about 5 million new cases are diagnosed globally. There are notable disparities in diagnosis rates between high-income countries (HICs) and low- and middle-income countries (LMICs). In HICs, approximately 49 out of every 100,000 people are diagnosed annually with epilepsy, compared to 139 per 100,000 in LMICs.
The incidence of epilepsy is significantly higher in LMICs due to factors such as a greater prevalence of central nervous system (CNS) infections, higher rates of traumatic brain injuries (TBI), and limited access to healthcare resources. Approximately 80% of individuals with epilepsy reside in these regions, where healthcare systems may struggle to meet treatment demands. With an estimated 4.6 million new cases of epilepsy each year globally, there is a pressing need for effective treatment options. This demand drives market growth as healthcare providers look to prescribe AEDs to manage seizures effectively. Thus, all these factors demand the global epilepsy drugs market expansion.
Furthermore, key players in the industry product launches and key initiatives that would drive this global epilepsy drugs market growth. For instance, in January 2023, Zydus Lifesciences announced the launch of a generic anti-epilepsy medication in the U.S. market, specifically Topiramate extended-release capsules. The company received final approval from the U.S. Food and Drug Administration (USFDA) to market Topiramate in extended-release capsule form. The approved strengths include 25 mg, 50 mg, and 100 mg. Zydus is noted as the first company to receive this approval for these specific strengths.
Also, in July 2024, Invitae launched the Unlock Behind the Seizure Program, aimed specifically at pediatric epilepsy patients. This initiative is designed to enhance the diagnostic process for children suffering from epilepsy, particularly focusing on identifying underlying genetic causes that may contribute to their condition. All these factors demand the global epilepsy drugs market.
Moreover, the rising demand for advancements in diagnostic techniques contributes to the global epilepsy drugs market expansion.
Adverse Effects Associated with the Drugs
The adverse effects associated with antiepileptic drugs (AEDs) significantly impact patient adherence to treatment, which in turn affects the overall effectiveness of epilepsy management and hinders epilepsy drugs market growth.
AEDs are known to cause a range of side effects, including drowsiness, fatigue, gastrointestinal issues (such as nausea and vomiting), and cognitive impairment (including difficulties with concentration and memory). These side effects can be particularly distressing for patients, leading them to discontinue their medication.
Adverse Drug Reactions Profile Among Epileptic Patients At The Neurology Clinic Of JMC 2021.
Studies indicate that adverse effects from AEDs contribute to treatment failure in up to 40% of patients. When patients experience intolerable symptoms, they may choose to stop taking their medication without consulting their healthcare provider, leading to uncontrolled seizures and potential health complications. According to the National Health Service (NIH) data starting treatment with antiepileptic drugs (AEDs) can often lead to common side effects. These side effects may manifest shortly after beginning the medication and typically resolve within a few days or weeks, while others might take longer to appear. Thus, the above factors could be limiting the global epilepsy drugs market's potential growth.
The global epilepsy drugs market is segmented based on disease type, drug type, route of administration, distribution channel, and region.
The second-generation anti-epileptics segment is expected to dominate the global epilepsy drugs market share
The second-generation anti-epileptics segment holds a major portion of the global epilepsy drugs market share and is expected to continue to hold a significant portion of the global epilepsy drugs market share during the forecast period.
Second-generation antiepileptic drugs (AEDs) are designed to provide enhanced efficacy with fewer side effects, making them suitable for a broader range of patients, including those with multiple comorbidities. Their innovative mechanisms of action contribute to their effectiveness in controlling seizures while minimizing adverse reactions. Second-generation AEDs are favored for their ability to manage seizures effectively while being better tolerated than first-generation drugs. This improved tolerability leads to higher prescription rates among neurologists, as these medications are less likely to cause severe side effects that can affect patient compliance.
Notable examples of second-generation AEDs include Lamotrigine, Levetiracetam, Brivaracetam, and Perampanel. These medications are effective in treating various types of seizures and are often preferred in clinical practice due to their favorable safety profiles. The mechanisms by which second-generation AEDs operate often involve modulation of neurotransmitter release or stabilization of neuronal membranes, which helps reduce seizure activity. For instance, levetiracetam binds to synaptic vesicle protein 2A (SV2A), influencing neurotransmitter release and stabilizing neuronal excitability.
Furthermore, key players in the industry product launches that would drive this segment growth in the global epilepsy drugs market growth. For instance, in April 2024, Eisai Co., Ltd. announced the launch of an intravenous (IV) formulation of its antiepileptic drug (AED), Fycompa (perampanel hydrate), in Japan. This new injection formulation received manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare, and has now been included in Japan's National Health Insurance (NHI) Drug Price List. These factors have solidified the segment's position in the global epilepsy drugs market.
North America is expected to hold a significant position in the global epilepsy drugs market share
North America holds a substantial position in the global epilepsy drugs market and is expected to hold most of the market share.
The rising number of individuals diagnosed with epilepsy is a major factor propelling epilepsy drugs market growth. The aging population in North America significantly contributes to market expansion. As individuals age, the incidence of epilepsy tends to rise due to age-related neurological conditions and higher rates of brain injuries. This demographic shift is expected to drive greater demand for antiepileptic drugs (AEDs) specifically designed for older adults.
According to the Centers for Disease Control and Prevention (CDC), in May 2024, almost 3 million U.S. adults have epilepsy, representing about 1% of the adult population. Additionally, approximately 456,000 children aged 17 and younger are affected by active epilepsy. This neurological condition is more prevalent in certain populations and presents significant challenges in accessing necessary medical care. During the period from 2021 to 2022, around 2.9 million U.S. adults aged 18 and older reported having active epilepsy, illustrating the ongoing impact of this condition on a significant portion of the population.
Moreover, in this region, a major number of key players' presence, well-advanced healthcare infrastructure, government initiatives & regulatory support, and awareness programs, research activities, and product launches & approvals would propel this epilepsy drugs market growth. For instance, in March 2022, the U.S. Food and Drug Administration (FDA) approved FINTEPLA (fenfluramine) oral solution for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS). This approval expands the indications for FINTEPLA, which was previously approved for Dravet Syndrome, another severe form of epilepsy.
Also, in January 2023, Sun Pharmaceutical Industries Ltd. launched SEZABY, an advanced injectable formulation for the treatment of seizures in term and preterm infants in the United States. This product is particularly significant as it is the first and only medication approved by the U.S. Food and Drug Administration (USFDA) specifically for neonatal seizures. Thus, the above factors are consolidating the region's position as a dominant force in the global epilepsy drugs market.
Asia Pacific is growing at the fastest pace in the global epilepsy drugs market share
Asia Pacific holds the fastest pace in the global epilepsy drugs market and is expected to hold most of the market share.
The prevalence of epilepsy is notably higher in developing countries within the Asia-Pacific region. For instance, it is estimated that approximately 9 million people in China have epilepsy, with a significant proportion being children. This rising incidence creates a growing demand for effective antiepileptic medications.
According to the BioMed Central Ltd (BMC) research article in October 2023, epilepsy affects approximately 50 million people worldwide, with nearly 80% of those living with the condition residing in resource-constrained low-income and middle-income countries. In Asia, which is home to over 4 billion people about 50% of the world's population around 23 million individuals are affected by epilepsy. This highlights the significant burden of the disorder, particularly in regions with limited healthcare resources.
Similarly, according to the World Health Organization (WHO), epilepsy represents a significant global health challenge, impacting approximately 50 million individuals worldwide, with about 20% of these patients residing in India.
Favorable government initiatives, such as the Intersectoral Global Action Plan on Epilepsy and the Global Campaign Against Epilepsy, are promoting awareness and improving access to treatment. These initiatives are crucial in addressing the healthcare needs of individuals with epilepsy.
Furthermore, key players in the industry product launches that would drive this epilepsy drugs market growth. For instance, in January 2024, Akumentis Healthcare announced the launch of Clasepi, a new prescription drug aimed at treating epilepsy in India. This product is a DCGI-approved cannabidiol (CBD) specifically designed to address seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome, and Tuberous Sclerosis Complex (TSC) in patients aged 1 year and older. Thus, the above factors are consolidating the region's position as the fastest-growing force in the global epilepsy drugs market.
The major global players in the epilepsy drugs market include Novartis AG, F Hoffmann-La Roche Limited, Pfizer Inc., Teva Pharmaceutical Industries Ltd., UCB S.A., Glenmark Pharmaceuticals Inc., AdvaCare Pharma, GSK plc, Sunovion Pharmaceuticals (Aptiom), and Camber Pharmaceuticals, Inc. among others.
The global epilepsy drugs market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.
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