難治性てんかん治療の世界市場：2024年～2031年

概要

世界の難治性てんかん治療市場は、2023年に39億7,000万米ドルに達し、2031年には57億8,000万米ドルに達すると予測され、予測期間2024-2031年のCAGRは4.8%です。

難治性てんかんは（薬剤耐性または治療困難性てんかんとも呼ばれる）、少なくとも2種類の抗てんかん薬（AED）を適切に選択し忍容化した治療にも反応しない発作の持続を特徴とするてんかんの一種です。この疾患は、てんかん患者の約30～40％に影響を及ぼし、その結果、治療がかなり困難になり、生活の質が低下します。

てんかん患者は、脳内の神経細胞間の異常な情報伝達により電気的活動が変化し、発作を起こします。発作の持続時間は様々で、ほんの数秒から数分間続きます。てんかん患者の約3分の1は、標準的な薬物療法では発作を効果的に抑えることができない難治性てんかんを発症します。少なくとも2種類の抗てんかん薬（AED）が適切に選択され、忍容性も確認されているにもかかわらず、発作が持続します。

市場力学：

促進要因

てんかん罹患率の増加、事故や脳損傷の増加

世界の難治性てんかん治療市場の需要は、複数の要因によって牽引されています。主な要因の1つは、てんかん罹患率の上昇と事故・脳損傷の増加です。てんかんの世界の有病率は上昇傾向にあり、高齢化、診断技術の向上、脳損傷の増加といった要因が複合的に絡み合っています。てんかんと診断される患者数の増加、特に難治性てんかん患者数の増加は、難治性てんかん治療に対するより効果的な治療ソリューションに対する重大な需要を浮き彫りにしています。

事故や脳損傷の増加により、外傷後てんかん（PTE）や外傷後発作（PTS）の有病率が高くなっています。これらの疾患はしばしば難治性てんかんを引き起こし、標準的な抗てんかん薬（AED）に反応しない発作を特徴とします。2022年12月の Chicago Medical Centerのデータによると、てんかん患者数は全世界で推定6,500万人であり、そのうち30％から40％が薬剤抵抗性または医療抵抗性、つまり標準的な抗てんかん薬に反応しないてんかんでした。

低侵襲の手術手技と先進的な神経調節療法の登場は、薬剤耐性てんかんの治療に大きな変革をもたらすものです。これらの革新的なアプローチは、これまで有効な選択肢がほとんどなかった多くの患者にとって、生活の質を高め、発作管理を改善する新たな希望となります。

制約

抗てんかん薬に伴う副作用、限られた治療選択肢、薬剤耐性てんかんの複雑性などの要因が、難治性てんかん治療市場の阻害要因になると予測されます。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • てんかん罹患率の増加、事故と脳損傷の増加
  • 抑制要因
    • 抗てんかん薬に伴う副作用
  • 事業機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析

第6章 発作タイプ別

• 一次/全般発作
• 部分発作/局所発作

第7章 治療タイプ別

• 薬剤タイプ
  • ビガバトリン
  • フェンフルラミン
  • ルフィナミド
  • ガナキソロン
  • スティリペントール
  • エベロリムス
  • その他
• 電気刺激/神経調節療法
  • 脳深部刺激療法（DBS）
  • 迷走神経刺激（VNS）
  • その他
• その他

第8章 エンドユーザー別

• 病院および専門クリニック
• 外来手術センター
• その他

第9章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • スペイン
  • イタリア
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• 中東・アフリカ

第10章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第11章 企業プロファイル

• Sanofi
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• UCB S.A.
• GLENMARK PHARMACEUTICALS LTD.
• Marinus Pharmaceuticals, Inc.
• Biocodex, Inc.
• Teva Pharmaceuticals USA, Inc.
• Novartis AG
• Hikma Pharmaceuticals PLC
• Lupin
• Amneal Pharmaceuticals

第12章 付録

Overview

The global refractory epilepsy treatment market reached US$ 3.97 billion in 2023 and is expected to reach US$ 5.78 billion by 2031 growing with a CAGR of 4.8% during the forecast period 2024-2031.

Refractory epilepsy, often referred to as drug-resistant or intractable epilepsy, is a type of epilepsy characterized by the persistence of seizures that do not respond to treatment with at least two appropriately selected and tolerated antiepileptic drugs (AEDs). This condition impacts around 30-40% of people with epilepsy, resulting in considerable difficulties in treatment and a diminished quality of life.

People with epilepsy experience seizures due to abnormal communication between nerve cells in the brain, which leads to altered electrical activity. These seizures can vary in duration, lasting from just a few seconds to several minutes. Approximately one-third of individuals with epilepsy will eventually develop refractory epilepsy, a condition where standard medications fail to control their seizures effectively. Despite trying at least two different antiepileptic drugs (AEDs) that have been appropriately chosen and tolerated, the seizures persist.

Market Dynamics: Drivers

Rising incidence of epilepsy and increase in accidents and brain injuries

The demand for the global refractory epilepsy treatment market is driven by multiple factors. One of the key factors is the rising incidence of epilepsy and the increase in accidents and brain injuries. The global prevalence of epilepsy is on the rise, driven by a combination of factors such as an aging population, enhanced diagnostic technologies, and a greater occurrence of brain injuries. This increase in the number of people diagnosed with epilepsy, especially those with refractory epilepsy, highlights the critical demand for more effective treatment solutions for refractory epilepsy treatment.

The increase in accidents and brain injuries has led to a higher prevalence of post-traumatic epilepsy (PTE) and post-traumatic seizures (PTS). These conditions often result in refractory epilepsy, which is characterized by seizures that do not respond to standard anti-epileptic drugs (AEDs). As per The University of Chicago Medical Center data in December 2022, an estimated 65 million people globally have epilepsy, with 30% to 40% experiencing drug-resistant or medically refractory epilepsy, meaning they do not respond to standard anti-seizure medications.

The emergence of minimally invasive surgical techniques and advanced neuromodulation therapies marks a significant transformation in the treatment of drug-resistant epilepsy. These innovative approaches offer renewed hope for enhancing the quality of life and improving seizure management for many patients who previously had few effective options.

Restraints

Factors such as adverse effects associated with antiepileptic drugs, limited availability of treatment options, and complexity of drug-resistant epilepsy are expected to hamper the refractory epilepsy treatment market.

Segment Analysis

The global refractory epilepsy treatment market is segmented based on seizure type, treatment type, end-user, and region.

The drug type segment accounted for approximately 74.3% of the global refractory epilepsy treatment market share

The drug type segment is expected to hold the largest market share over the forecast period. The drug type segment in the global refractory epilepsy treatment market includes various medications specifically designed to manage drug-resistant epilepsy. Each of these drugs has unique mechanisms of action and indications, making them suitable for different patient needs.

As per NCBI research publication in January 2023, Vigabatrin is a medication utilized in the treatment and management of infantile spasms and refractory complex partial seizures. Classified as an anti-epileptic drug, it works by irreversibly inhibiting the enzyme responsible for breaking down gamma-aminobutyric acid (GABA), thereby increasing GABA levels in the brain.

According to the Neurological Research and Practice in February 2024, a research study stated that Four cases of refractory status epilepticus (SE) were successfully treated with fenfluramine. The refractory SE resolved within 4 to 7 days after initiating treatment with fenfluramine. The rapid up-titration of fenfluramine during the treatment was well tolerated by the patients.

Moreover, key player's product launches and approvals would drive this refractory epilepsy treatment market growth. For instance, in March 2022, UCB, a global biopharmaceutical company, announced that the FDA has approved FINTEPLA (fenfluramine) oral solution for treating seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged two years and older. Lennox-Gastaut syndrome is a severe form of childhood-onset epilepsy characterized by multiple types of seizures, often resistant to treatment. Patients typically experience drug-refractory seizures, leading to significant morbidity and serious impairments in neurodevelopment, cognitive abilities, and motor functions.

Geographical Analysis

North America accounted for approximately 44.3% of the global refractory epilepsy treatment market share

North America region is expected to hold the largest market share over the forecast period owing to the prevalence of epilepsy rising in North America, with around 3.4 million individuals affected in the U.S. This increase can be attributed to several factors, including an aging population, enhanced diagnostic capabilities, and a greater incidence of brain injuries. As more people are diagnosed with epilepsy, particularly those with drug-resistant forms, there is an escalating demand for effective treatment options.

Recent advancements in treatment approaches, including minimally invasive surgeries and neuromodulation therapies such as Vagus Nerve Stimulation (VNS) and Responsive Neurostimulation (RNS), are improving the management of refractory epilepsy. These innovative methods offer alternatives for patients who do not respond to conventional anti-epileptic drugs (AEDs).

Moreover, in this region, a major number of key players' presence, well-advanced healthcare infrastructure, government initiatives & regulatory support, and awareness programs, & funding and product approvals would propel this refractory epilepsy treatment market growth. For instance, in June 2024, in San Francisco, Neurona Therapeutics has recently announced that the FDA has granted its lead product candidate, NRTX-1001, the Regenerative Medicine Advanced Therapy (RMAT) designation for treating drug-resistant mesial temporal lobe epilepsy (MTLE).

NRTX-1001 signifies a potential transformative advancement in the treatment of drug-resistant epilepsy, particularly in cases where the conventional approach involves the surgical removal or ablation of the affected brain area.

Market Segmentation

By Seizure Type

• Primary/Generalized Seizures
• Partial/Focal Seizures

By Treatment Type

• Drug Type
  • Vigabatrin
  • Fenfluramine
  • Rufinamide
  • Ganaxolone
  • Stiripentol
  • Everolimus
  • Others
• Electrical Stimulation/Neuromodulation Therapies)
  • Deep Brain Stimulation (DBS)
  • Vagus Nerve Stimulation (VNS)
  • Others
• Others

By End-User

• Hospitals & Specialty Clinics
• Ambulatory Surgical Centers
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • The rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

The major global players in the refractory epilepsy treatment market include Sanofi, UCB S.A., GLENMARK PHARMACEUTICALS LTD., Marinus Pharmaceuticals, Inc., Biocodex, Inc., Teva Pharmaceuticals USA, Inc., Novartis AG, Hikma Pharmaceuticals PLC, Lupin, and Amneal Pharmaceuticals among others.

Key Developments

• In June 2024, EpilepsyGTx, a biotechnology firm dedicated to developing innovative gene therapies for focal refractory epilepsy, announced that it secured $10 million in seed funding. This financing round was led by the UCL Technology Fund, with additional participation from Health Technology Holding.

Why Purchase the Report?

• To visualize the global refractory epilepsy treatment market segmentation based on seizure type, treatment type, end-user, and region and understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of the refractory epilepsy treatment market with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in excel consisting of key products of all the major players.

The global refractory epilepsy treatment market report would provide approximately 62 tables, 51 figures, and 183 pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Seizure Type
• 3.2. Snippet by Treatment Type
• 3.3. Snippet by End-User
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Rising Incidence of Epilepsy and Increase in Accidents and Brain Injuries
  • 4.1.2. Restraints
    • 4.1.2.1. Adverse Effects Associated with the Antiepileptic Drugs
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis

6. By Seizure Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Seizure Type
  • 6.1.2. Market Attractiveness Index, By Seizure Type
• 6.2. Primary/Generalized Seizures*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Partial/Focal Seizures

7. By Treatment Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 7.1.2. Market Attractiveness Index, By Treatment Type
• 7.2. Drug Type*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.2.3. Vigabatrin
  • 7.2.4. Fenfluramine
  • 7.2.5. Rufinamide
  • 7.2.6. Ganaxolone
  • 7.2.7. Stiripentol
  • 7.2.8. Everolimus
  • 7.2.9. Others
• 7.3. Electrical Stimulation/Neuromodulation Therapies)
  • 7.3.1. Deep Brain Stimulation (DBS)
  • 7.3.2. Vagus Nerve Stimulation (VNS)
  • 7.3.3. Others
• 7.4. Others

8. By End-User

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 8.1.2. Market Attractiveness Index, By End-User
• 8.2. Hospitals & Specialty Clinics*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Ambulatory Surgical Centers
• 8.4. Others

9. By Region

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 9.1.2. Market Attractiveness Index, By Region
• 9.2. North America
  • 9.2.1. Introduction
  • 9.2.2. Key Region-Specific Dynamics
  • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Seizure Type
  • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.2.6.1. U.S.
    • 9.2.6.2. Canada
    • 9.2.6.3. Mexico
• 9.3. Europe
  • 9.3.1. Introduction
  • 9.3.2. Key Region-Specific Dynamics
  • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Seizure Type
  • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.3.6.1. Germany
    • 9.3.6.2. U.K.
    • 9.3.6.3. France
    • 9.3.6.4. Spain
    • 9.3.6.5. Italy
    • 9.3.6.6. Rest of Europe
• 9.4. South America
  • 9.4.1. Introduction
  • 9.4.2. Key Region-Specific Dynamics
  • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Seizure Type
  • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.4.6.1. Brazil
    • 9.4.6.2. Argentina
    • 9.4.6.3. Rest of South America
• 9.5. Asia-Pacific
  • 9.5.1. Introduction
  • 9.5.2. Key Region-Specific Dynamics
  • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Seizure Type
  • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.5.6.1. China
    • 9.5.6.2. India
    • 9.5.6.3. Japan
    • 9.5.6.4. South Korea
    • 9.5.6.5. Rest of Asia-Pacific
• 9.6. Middle East and Africa
  • 9.6.1. Introduction
  • 9.6.2. Key Region-Specific Dynamics
  • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Seizure Type
  • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

10. Competitive Landscape

• 10.1. Competitive Scenario
• 10.2. Market Positioning/Share Analysis
• 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

• 11.1. Sanofi *
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. UCB S.A.
• 11.3. GLENMARK PHARMACEUTICALS LTD.
• 11.4. Marinus Pharmaceuticals, Inc.
• 11.5. Biocodex, Inc.
• 11.6. Teva Pharmaceuticals USA, Inc.
• 11.7. Novartis AG
• 11.8. Hikma Pharmaceuticals PLC
• 11.9. Lupin
• 11.10. Amneal Pharmaceuticals

LIST NOT EXHAUSTIVE

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us