歐洲難治性癲癇治療市場：分析與預測（2025-2035）

歐洲難治性癲癇治療市場規模預計將從2024年的13.432億美元增至2035年的28.228億美元，預測期內的年複合成長率為 6.98%。

歐洲治療難治性癲癇的模式轉向更加個人化，充分利用每位患者的臨床特徵、基因標記和生活方式選擇。歐洲醫療機構突破傳統的「one-size-fits-all」模式，結合基因組學、分子診斷和高階資料分析領域的發展，制定個人化治療方案。除了改善癲癇發作控制和減少副作用外，這項精準技術還能最大限度地減少昂貴的試驗藥物。

歐洲藥品管理局（EEA）的嚴格監管、跨境臨床註冊以及強大的歐洲生物樣本庫基礎設施，加速新型抗癲癇藥物的檢驗和生物標記的開發。預測演算法能夠及早發現抗藥性患者，能夠及時採用神經調節療法和標靶藥物進行干預。學術機構、癲癇專科診所以及生命科學產業創新者之間的合作，也推動著涵蓋西歐、中歐和東歐的精準神經病學網路（Precision Neurology Network）實現更精準的預後、更早期的診斷和更最佳化的治療途徑。這有望改善患者的治療效果，並實現更具成本效益的醫療服務。

歐洲難治性癲癇治療市場迅速變化，醫療保健專業人員和醫療體係正轉向更個人化、技術主導的治療方案，以應對那些無法透過第一線藥物控制癲癇發作的患者。該市場涵蓋先進藥物、神經調節設備和新興生物製藥，其特點是，在歐洲約600萬癲癇患者中，約30%的患者存在抗藥性。隨著人們日益意識到難治性癲癇帶來的重大臨床和經濟負擔，推動了對創新治療方法和診斷工具的投資，實現早期發現和介入。

下一代抗癲癇藥物（基於大麻二酚的輔助性治療和新型分子實體）和神經調節技術（例如深部腦部刺激（DBS）、迷走神經刺激（VNS）和反應性神經刺激（RNS））為癲癇發作控制提供了新的途徑，已成為重要的細分市場。歐盟醫療設備法規（MDR）和歐洲藥品管理局（EMA）的嚴格監督確保了這些藥物的高安全性和有效性，而西歐健全的償付制度以及中東歐國家不斷成長的醫療支出也推動了這些藥物的推廣應用。

此外，分子診斷、基於人工智慧的預測演算法和基因組分析等技術進步為精準醫療鋪路，減少試驗用藥，改善治療效果。然而，挑戰依然存在：缺乏專業的癲癇中心、高昂的治療費用以及醫療服務可近性的地區差異阻礙了市場擴張。儘管如此，臨床專家、生物製藥公司和學術研究網路之間的合作為更有針對性和更有效的干涉措施奠定基礎，難治性癲癇的治療正迅速成為歐洲神經系統疾病的重點領域之一。

市場區隔:

細分1：依地區

• 歐洲
  • 德國
  • 英國
  • 法國
  • 義大利
  • 西班牙
  • 其他

本報告調查了歐洲難治性癲癇治療市場，並總結了主要趨勢、市場影響因素分析、通路趨勢、市場規模趨勢和預測、各個細分市場、地區/主要國家的詳細分析、競爭格局以及主要企業的概況。

目錄

執行摘要

範圍和定義

第1章 市場：產業展望

• 主要趨勢
• 難治性癲癇治療市場趨勢
  • 治療難治性癲癇的新型標靶治療
  • 商務策略
  • 企業策略
  • 市場機會
• Start-Ups概況
  • 生態系中的關鍵Start-Ups
• 研發藥物：難治性癲癇的治療
• 趨勢
  • 治療難治性癲癇的新型標靶治療
• 市場動態
  • 趨勢、促進因素、挑戰和機會：評估當前和未來的影響
  • 市場促進因素
  • 市場限制
  • 市場機會
  • 市場挑戰

第2章 區域

• 區域摘要
• 歐洲
  • 區域概況
  • 市場成長動力
  • 市場問題
  • 德國
  • 法國
  • 義大利
  • 西班牙
  • 英國
  • 其他

第3章 市場：競爭基準化分析與公司概況

• Biocodex-SP
• GSK plc.
• LivaNova PLC
• Novartis AG
• UCB SA

第4章 調查方法

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Introduction to Europe Refractory Epilepsy Treatment Market

The Europe refractory epilepsy treatment market is projected to reach $2,822.8 million by 2035 from $1,343.2 million in 2024, growing at a CAGR of 6.98% during the forecast period 2025-2035. The paradigm for treating refractory epilepsy in Europe is changing to one that is more individualised and makes use of each patient's clinical profile, genetic markers, and lifestyle choices. Beyond the conventional ""one-size-fits-all"" approach, European healthcare providers can create customised treatment plans by combining developments in genomics, molecular diagnostics, and advanced data analytics. In addition to improving seizure control and lowering side effects, this precise technique also minimises expensive trial-and-error dosing.

The European Medicines Agency's strict regulations, cross-border clinical registries, and Europe's strong biobanking infrastructure are helping to validate new antiseizure drugs and speed up the development of biomarkers. Timely intervention with neuromodulation or targeted pharmaceuticals is made possible by the early detection of drug-resistant patients using prediction algorithms. Collaboration between academic institutions, speciality epilepsy clinics, and life-science innovators promises more precise prognoses, earlier diagnoses, and optimised treatment pathways as precision neurology networks spread throughout Western, Central, and Eastern Europe. This will ultimately improve patient outcomes and drive cost-effective care.

Market Introduction

The market for refractory epilepsy treatments in Europe is rapidly changing as medical professionals and healthcare systems shift towards more individualised, technologically driven care for individuals whose seizures are still uncontrollable with first-line treatments. The market, which includes advanced pharmaceuticals, neuromodulation devices, and emerging biologics, is characterised by drug-resistant cases, which affect approximately 30% of the estimated 6 million individuals with epilepsy on the continent. Investment in innovative treatments and diagnostic tools that facilitate earlier detection and intervention is being driven by growing awareness of the significant clinical and financial burden of refractory epilepsy.

Next-generation antiseizure drugs (like cannabidiol-based adjuncts and novel molecular entities) and neuromodulation technologies (like deep brain stimulation (DBS), vagus nerve stimulation (VNS), and responsive neurostimulation (RNS)) that provide alternate methods of controlling seizures are important market segments. While strict EU Medical Device Regulation (MDR) and EMA oversight guarantee high levels of safety and efficacy, adoption is being aided by Western Europe's favourable reimbursement environment and Central and Eastern Europe's growing healthcare spending.

Molecular diagnostics, AI-powered predictive algorithms, and genomic profiling are some of the technological advancements that are enabling precision treatment paths, decreasing trial-and-error prescribing, and increasing patient outcomes. However, obstacles still exist: a lack of specialised epilepsy centres, high therapeutic costs, and unequal access across regions impede expansion. However, cooperation between clinical experts, biopharma firms, and academic research networks is creating the foundation for more focused, successful interventions and making the treatment of refractory epilepsy a crucial area of attention within the larger neurology industry in Europe.

Market Segmentation:

Segmentation 1: By Region

• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Rest-of-Europe

Europe Refractory Epilepsy Treatment Market Trends, Drivers and Challenges

Trends

• Rising uptake of neuromodulation therapies (Vagus Nerve Stimulation, Responsive Neurostimulation, Deep Brain Stimulation) alongside pharmacologic options
• Growth in cannabidiol (CBD)-based and other novel adjunctive medications following EU approvals
• Expansion of precision medicine approaches, including genetic profiling to tailor treatment regimens
• Increased use of tele-health and remote monitoring platforms for treatment adherence and seizure tracking

Drivers

• Persistent unmet need: ~30% of epilepsy patients remain drug-resistant despite multiple AED trials
• Strong R&D pipeline and strategic partnerships between pharma and device manufacturers
• Supportive reimbursement frameworks and increasing healthcare budgets in many European countries
• Patient advocacy and greater disease awareness driving early specialist referrals

Challenges

• High cost of advanced therapies and unequal access across Western versus Eastern Europe
• Complex regulatory environment for novel biologics and devices under EU MDR
• Limited number of specialized epilepsy centers and trained multidisciplinary teams
• Variability in national treatment guidelines and slow adoption of cutting-edge options in some markets

How can this report add value to an organization?

Product/Innovation Strategy: The report offers in-depth insights into the latest technological advancements in refractory epilepsy treatment, enabling organizations to drive innovation and develop cutting-edge products tailored to market needs.

Growth/Marketing Strategy: By providing comprehensive market analysis and identifying key growth opportunities, the report equips organizations with the knowledge to craft targeted marketing strategies and expand their market presence effectively.

Competitive Strategy: The report includes a thorough competitive landscape analysis, helping organizations understand their competitors' strengths and weaknesses and allowing them to strategize effectively to gain a competitive edge in the market.

Regulatory and Compliance Strategy: It provides updates on evolving regulatory frameworks, approvals, and industry guidelines, ensuring organizations stay compliant and accelerate market entry for new Refractory Epilepsy Treatment solutions.

Investment and Business Expansion Strategy: By analyzing market trends, funding patterns, and partnership opportunities, the report assists organizations in making informed investment decisions and identifying potential M&A opportunities for business growth.

Key Market Players and Competition Synopsis

Profiled companies have been selected based on inputs gathered from primary experts, as well as analyzing company coverage, product portfolio, and market penetration.

Some prominent names established in this market are:

• UCB S.A.
• Novartis AG
• LivaNova PLC
• GSK plc.
• Biocodex-SP

Table of Contents

Executive Summary

Scope and Definition

1 Market: Industry Outlook

• 1.1 Major Trend
• 1.2 Trend in Refractory Epilepsy Treatment Market
  • 1.2.1 Emerging Targeted Therapy for Refractory Epilepsy Treatment
  • 1.2.2 Business Strategies
    • 1.2.2.1 Product Developments
    • 1.2.2.2 Market Developments
  • 1.2.3 Corporate Strategies
    • 1.2.3.1 Partnerships and Joint Ventures
  • 1.2.4 Market Opportunities
    • 1.2.4.1 Advances in Neuromodulation Devices in the Refractory Epilepsy Treatment Market
    • 1.2.4.2 Shift from Neo-Adjuvant Approaches Driven by Diagnostic Advancements
• 1.3 Start-Ups Landscape
  • 1.3.1 Key Start-Ups in the Ecosystem
• 1.4 Pipeline Drugs, Refractory Epilepsy Treatment
• 1.5 Trends
  • 1.5.1 Emerging Targeted Therapy for Refractory Epilepsy Treatment
• 1.6 Market Dynamics
  • 1.6.1 Trends, Drivers, Challenges, and Opportunities: Current and Future Impact Assessment
  • 1.6.2 Market Drivers
    • 1.6.2.1 Increasing Prevalence of Drug-resistant Epilepsy and Ever-expanding Pipeline of Novel Therapeutics
    • 1.6.2.2 Growing Impact of Orphan Drug Development and Role of Advocacy Groups and Awareness Programs
    • 1.6.2.3 Emerging Treatment Modalities in Refractory Epilepsy
  • 1.6.3 Market Restraints
    • 1.6.3.1 Off-Label Medication Practices Hindering the Refractory Epilepsy Treatment Market
    • 1.6.3.2 High R&D Cost as a Barrier to New Entry for New and Small-Scale Companies
  • 1.6.4 Market Opportunities
    • 1.6.4.1 Advances in Neuromodulation Devices in the Refractory Epilepsy Treatment Market
    • 1.6.4.2 Shift from Neo-Adjuvant Approaches Driven by Diagnostic Advancements
  • 1.6.5 Market Challenges
    • 1.6.5.1 Financial Constraints on Patient Access
    • 1.6.5.2 Underdiagnosis of Patients who Meet the Criteria for Drug-Resistant Epilepsy (DRE)

2 Region

• 2.1 Regional Summary
• 2.2 Europe
  • 2.2.1 Regional Overview
  • 2.2.2 Driving Factors for Market Growth
  • 2.2.3 Factors Challenging the Market
  • 2.2.4 Germany
  • 2.2.5 France
  • 2.2.6 Italy
  • 2.2.7 Spain
  • 2.2.8 U.K.
  • 2.2.9 Rest-of-Europe

3 Markets - Competitive Benchmarking & Company Profiles

• 3.1 Biocodex-SP
  • 3.1.1 Overview
  • 3.1.2 Top Products/Product Portfolio
  • 3.1.3 Top Competitors
  • 3.1.4 Target Customers
  • 3.1.5 Strategic Positioning and Market Impact
  • 3.1.6 Analyst View
  • 3.1.7 Pipeline and Research Initiatives
• 3.2 GSK plc.
  • 3.2.1 Overview
  • 3.2.2 Top Products/Product Portfolio
  • 3.2.3 Top Competitors
  • 3.2.4 Target Customers
  • 3.2.5 Strategic Positioning and Market Impact
  • 3.2.6 Analyst View
  • 3.2.7 Research Initiatives
• 3.3 LivaNova PLC
  • 3.3.1 Overview
  • 3.3.2 Top Products/Product Portfolio
  • 3.3.3 Top Competitors
  • 3.3.4 Target Customers
  • 3.3.5 Strategic Positioning and Market Impact
  • 3.3.6 Analyst View
  • 3.3.7 Research Initiatives
• 3.4 Novartis AG
  • 3.4.1 Overview
  • 3.4.2 Top Products/Product Portfolio
  • 3.4.3 Top Competitors
  • 3.4.4 Target Customers
  • 3.4.5 Strategic Positioning and Market Impact
  • 3.4.6 Analyst View
  • 3.4.7 Pipeline and Research Initiatives
• 3.5 UCB S.A.
  • 3.5.1 Overview
  • 3.5.2 Top Products/Product Portfolio
  • 3.5.3 Top Competitors
  • 3.5.4 Target Customers
  • 3.5.5 Strategic Positioning and Market Impact
  • 3.5.6 Analyst View
  • 3.5.7 Pipeline and Research Initiative

4 Research Methodology

• 4.1 Data Sources
  • 4.1.1 Primary Data Sources
  • 4.1.2 Secondary Data Sources
  • 4.1.3 Inclusion and Exclusion
  • 4.1.4 Data Triangulation
• 4.2 Market Estimation and Forecast

List of Figures

• Figure 1: Europe Refractory Epilepsy Treatment Market (by Scenario), $Million, 2024, 2028, and 2035
• Figure 2: Europe Refractory Epilepsy Treatment Market, 2024-2035
• Figure 3: Timeline of Drugs Launched for Refractory Epilepsy Treatment
• Figure 4: Europe Refractory Epilepsy Treatment Market Snapshot
• Figure 5: Refractory Epilepsy Treatment Market, $Million, 2024 and 2035
• Figure 6: Europe Refractory Epilepsy Treatment Market, $Million, 2023-2035
• Figure 7: Germany Refractory Epilepsy Treatment Market, $Million, 2023-2035
• Figure 8: France Refractory Epilepsy Treatment Market, $Million, 2023-2035
• Figure 9: Italy Refractory Epilepsy Treatment Market, $Million, 2023-2035
• Figure 10: Spain Refractory Epilepsy Treatment Market, $Million, 2023-2035
• Figure 11: U.K. Refractory Epilepsy Treatment Market, $Million, 2023-2035
• Figure 12: Rest-of-Europe Refractory Epilepsy Treatment Market, $Million, 2023-2035
• Figure 13: Inclusion and Exclusion
• Figure 14: Data Triangulation
• Figure 15: Top-Down and Bottom-Up Approach
• Figure 16: Assumptions and Limitations

List of Tables

• Table 1: Market Snapshot
• Table 2: Recent Investments in Refractory Epilepsy Treatment
• Table 3: Key Development in Seizure Management by Key Companies
• Table 4: Start-ups and Investment Landscape
• Table 5: Pipeline Drugs and its Clinical Trial Phase
• Table 6: Recent Investments in Refractory Epilepsy Treatment
• Table 7: Major Development in the Refractory Epilepsy Treatment Market
• Table 8: Major Development in Refractory Epilepsy Treatment Market
• Table 9: Major Drugs and Their Indication
• Table 10: Major Devices Used in the Refractory Epilepsy Treatment Market
• Table 11: Refractory Epilepsy Treatment Market (by Regio), $Million, 2023-2035
• Table 12: Europe Refractory Epilepsy Treatment Market (By Country), $Million, 2023-2035