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市场调查报告书
商品编码
1813395

2032 年 Dravet 症候群市场预测：按药物类型、治疗类型、癫痫发作类型、分销管道和地区进行的全球分析

Dravet Syndrome Market Forecasts to 2032 - Global Analysis By Drug Type, Treatment Type, Seizure Type, Distribution Channel and By Geography
出版日期: | 出版商: Stratistics Market Research Consulting | 英文 200+ Pages | 商品交期: 2-3个工作天内

价格

根据 Stratistics MRC 的数据，全球 Dravet 症候群市场预计在 2025 年达到 4.357 亿美元，到 2032 年达到 7.615 亿美元，预测期内的复合年增长率为 8.3%。

Dravet症候群是一种罕见且严重的癫痫疾病，起病于婴儿期，以持续性癫痫发作、发育迟缓和认知障碍为特征。市场透过药物、基因检测和支持性护理来应对该疾病的诊断、治疗和管理。人们对罕见疾病的认识不断提高，精准医疗的进步以及孤儿药资格认定正在推动研究和治疗领域的创新。新型治疗方法，例如基于大麻二酚的药物和基因靶向解决方案，正在创造新的机会。

提高对罕见疾病的认识

患者权益组织的努力和医生教育宣传活动的不断改进正在提高早期和准确诊断的比率。这种认识的提高对于市场扩张至关重要，因为它直接增加了确诊人数，从而推动了对核准治疗和支持性护理产品的需求。此外，孤儿药资格认定等监管奖励刺激了製药公司对此细分领域的投资，确保了更强大的产品线。这些共同努力将提高现有和新兴疗法的市场渗透率和收益。

患者数量有限

Dravet症候群的主要市场限制因素是其患者群体极为有限。此疾病较为罕见，每15,700名新生儿中就有1人患病。如此小且分散的患者群体本身就限制了任何已上市治疗方案的潜在收益，阻碍了大型製药公司的大规模投资。药物开发的经济效益（包括高昂的研发成本）如果不采取溢价策略，很难收回，而且会受到付款方的严格审查。与更常见的适应症相比，这一限制从根本上限制了整体市场规模和商业性吸引力。

大麻二酚疗法的发展

大麻二酚 (CBD)治疗方法的推广拥有巨大的市场机会，该疗法已被证明在降低难治性 Dravet 症候群患者癫痫发作频率方面具有显着疗效。 Epidiolex® 等核准药物的成功检验了此类治疗层级，并为下一代大麻素候选药物和联合治疗疗法铺平了道路。这种日益增长的认可度为临床创新和市场拓展创造了肥沃的土壤。此外，孤儿药的良好法规环境为企业提供了一条可行的途径，使其能够加快开发进程，并在高未满足需求领域中获得价值。

治疗副作用的风险

许多抗癫痫药物和CBD为基础的疗法都带有黑框警告其可能有严重副作用，包括肝毒性和自杀意念。这些安全隐患导致了严格的监管规定，包括严格的REMS（Remote Remediation Management，快速反应管理）计划，这可能会阻碍患者获得药物并降低处方率。此外，关键上市后安全资料的出现可能引发附加檔限制和产品召回，从而削弱投资者信心，甚至危及关键上市产品的商业性可行性。

COVID-19的影响：

新冠疫情最初扰乱了Dravet症候群市场，导致临床试验延迟，并扰乱了药物开发平臺。供应链中断也对药品供应构成了挑战。然而，这场危机加速了远端医疗的普及，并提高了那些可以避免面对面就诊的弱势患者的照护连续性。此外，监管灵活性使临床项目能够适应，从而减轻了长期的衝击。市场表现出韧性，成熟的治疗方法因其慢性特性而保持稳定的需求，使其相对较快地恢復到疫情前的成长轨迹。

预测期内，抗癫痫药物（AED）市场预计将成为最大的市场

抗癫痫药物 (AED) 预计将在预测期内占据最大的市场份额，这得益于其作为 Dravet 综合征癫痫发作的一线治疗药物的既定地位。该领域包括多种药物，例如丙戊酸、Clobazam和司替戊醇，这些药物常用于多药物治疗联合治疗。这些药物已深深植根于治疗指南，为医生所熟知，并被广泛纳入医保，因此得到了一致且广泛的使用。此外，安全性较高的新型 AED 的持续开发进一步巩固了该领域的基础地位和治疗收益优势。

预计生酮饮食部分在预测期内将实现最高的复合年增长率。

预计生酮饮食领域将在预测期内实现最高成长率，这得益于越来越多的临床证据支持其作为难治性癫痫辅助性治疗的有效性。这种高脂肪、低碳水化合物的饮食能够诱导一种称为酮症的代谢状态，并已被证明能够显着降低癫痫发作频率。医师的推荐增加以及改良、更偏好的饮食计画的出现，提高了病患的依从性和接受度。此外，这种干预措施的非药物性质吸引了那些寻求副作用不同的替代疗法的看护者，从而推动了其在管理模式中的快速增长。

占比最大的地区：

预计北美将在预测期内占据最大的市场份额，这得益于其先进的医疗基础设施、强大的诊断能力以及昂贵孤儿药的优惠报销政策。主要市场参与者的存在，以及强大的倡导团体（致力于提高公众意识和早期疗育）为这一领先地位做出了重要贡献。此外，该地区的监管框架，例如FDA的孤儿药资格认定和简审类，积极鼓励新型疗法的开发和快速商业化，确保患者能够快速获得药物，并保持其作为该地区最大收益市场的地位。

复合年增长率最高的地区：

预计亚太地区将在预测期内实现最高的复合年增长率，这得益于医疗保健可及性的改善、对罕见神经系统疾病的医疗意识的提升以及新兴经济体医疗支出的增加。各国政府正逐步实施支持罕见疾病患者的政策，预计将提高诊断和治疗的普及率。此外，越来越多的全球製药公司在这个欠发达地区进行临床试验并寻求市场批准，也带来了巨大的成长潜力。

提供免费客製化：

此报告的订阅者将获得以下免费自订选项之一：

  • 公司简介
    • 对最多三家其他市场公司进行全面分析
    • 主要企业的SWOT分析（最多3家公司）
  • 区域细分
    • 根据客户兴趣对主要国家进行的市场估计、预测和复合年增长率（註：基于可行性检查）
  • 竞争基准化分析
    • 根据产品系列、地理分布和策略联盟对主要企业基准化分析

目录

第一章执行摘要

第二章 前言

  • 概述
  • 相关利益者
  • 调查范围
  • 调查方法
    • 资料探勘
    • 数据分析
    • 数据检验
    • 研究途径
  • 研究材料
    • 主要研究资料
    • 次级研究资讯来源
    • 先决条件

第三章市场走势分析

  • 驱动程式
  • 抑制因素
  • 机会
  • 威胁
  • 新兴市场
  • COVID-19的影响

第四章 波特五力分析

  • 供应商的议价能力
  • 买方的议价能力
  • 替代品的威胁
  • 新进入者的威胁
  • 竞争对手之间的竞争

5. 全球 Dravet 症候群市场（依药物类型）

  • 抗癫痫药物（AED）
  • 大麻二酚类药物
  • 血清素调节剂
  • 基因治疗和新治疗方法

6. 全球 Dravet 症候群市场（依治疗类型）

  • 症状治疗
  • 生酮饮食
  • 迷走神经刺激（VNS）

7. 全球 Dravet 症候群市场（依癫痫发作类型）

  • 肌阵挛性癫痫
  • 猝倒症
  • 局部性癫痫发作
  • 强直阵挛性发作
  • 其他癫痫类型

8. 全球 Dravet 症候群市场（依分销管道）

  • 医院药房
  • 零售药局
  • 网路药局

9. 全球 Dravet 症候群市场（按地区）

  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 义大利
    • 法国
    • 西班牙
    • 其他欧洲国家
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 澳洲
    • 纽西兰
    • 韩国
    • 其他亚太地区
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 其他南美
  • 中东和非洲
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 卡达
    • 南非
    • 其他中东和非洲地区

第十章：重大进展

  • 协议、伙伴关係、合作和合资企业
  • 收购与合併
  • 新产品发布
  • 业务扩展
  • 其他关键策略

第十一章 公司概况

  • Biocodex
  • Biogen
  • Bright Minds Bio
  • Encoded Therapeutics
  • Epygenix Therapeutics
  • Harmony Biosciences
  • Jazz Pharmaceuticals
  • Lundbeck
  • Marinus Pharmaceuticals
  • Meiji Seika Pharma
  • Novartis
  • Ovid Therapeutics
  • Pfizer
  • Praxis Precision Medicines
  • Stoke Therapeutics
  • Supernus Pharmaceuticals
  • Takeda Pharmaceutical Company
  • UCB
  • Xenon Pharmaceuticals
Product Code: SMRC30844

According to Stratistics MRC, the Global Dravet Syndrome Market is accounted for $435.7 million in 2025 and is expected to reach $761.5 million by 2032 growing at a CAGR of 8.3% during the forecast period. Dravet Syndrome is a rare, severe form of epilepsy that begins in infancy, characterized by prolonged seizures, developmental delays, and cognitive impairment. The market addresses diagnosis, treatment, and management of this condition through pharmaceuticals, genetic testing, and supportive therapies. Rising awareness of rare diseases, advancements in precision medicine, and orphan drug designations are fueling research and treatment innovation. Emerging therapies, including cannabidiol-based drugs and gene-targeted solutions, are creating new opportunities.

Market Dynamics:

Driver:

Increasing awareness of rare diseases

Initiatives from patient advocacy groups and improved physician education campaigns are enhancing early and accurate diagnosis rates. This heightened recognition is crucial for market expansion, as it directly increases the diagnosed prevalent pool, thereby driving demand for approved therapeutics and supportive care products. Furthermore, regulatory incentives like orphan drug designation stimulate pharmaceutical investment in this niche, ensuring a more robust pipeline. This collective effort translates into greater market penetration and revenue generation for existing and forthcoming treatments.

Restraint:

Limited patient population

The primary market restraint for dravet syndrome is its exceedingly limited patient population, as it is a rare disease with an incidence of approximately 1 in 15,700 live births. This small and fragmented addressable patient pool inherently caps the potential revenue ceiling for any launched therapy, discouraging broad investment from large pharmaceutical entities. The economics of drug development, including high R&D costs, are challenging to recoup without premium pricing strategies, which in turn face intense scrutiny from payers. This limitation fundamentally restricts the overall market size and commercial attractiveness compared to more prevalent indications.

Opportunity:

Growth in cannabidiol-based therapies

Significant market opportunity lies in the expansion of cannabidiol (CBD)-based therapies, which have demonstrated substantial efficacy in reducing seizure frequency in treatment-resistant Dravet syndrome patients. The success of approved drugs like Epidiolex(R) has validated this therapeutic class, paving the way for next-generation cannabinoid candidates and combination therapies. This growing acceptance creates fertile ground for clinical innovation and market expansion. Additionally, the favorable regulatory environment for orphan drugs accelerates the development pathway, offering companies a viable route to capture value in a space with high unmet need.

Threat:

Risk of therapy side effects

Many antiepileptic drugs and CBD-based treatments carry black box warnings for severe side effects, such as hepatotoxicity or suicidal ideation. These safety concerns can lead to stringent regulatory mandates, including rigorous REMS programs, which can impede patient access and dampen prescribing rates. Moreover, the emergence of significant safety data post-marketing can trigger label restrictions or even product withdrawals, eroding investor confidence and destabilizing the commercial viability of key market products.

Covid-19 Impact:

The COVID-19 pandemic initially disrupted the Dravet syndrome market through delayed clinical trials, hindering drug development pipelines. Supply chain interruptions also posed challenges for drug availability. Conversely, the crisis accelerated the adoption of telehealth, improving continuity of care for vulnerable patients avoiding in-person visits. Furthermore, regulatory flexibility ensured that clinical programs could adapt, mitigating long-term setbacks. The market demonstrated resilience, with established therapies maintaining stable demand due to the chronic nature of the condition, leading to a relatively swift recovery to pre-pandemic growth trajectories.

The antiepileptic drugs (AEDs) segment is expected to be the largest during the forecast period

The antiepileptic drugs (AEDs) segment is expected to account for the largest market share during the forecast period due to its established role as the first-line standard of care for managing Dravet syndrome seizures. This segment encompasses a broad range of medications, including valproate, clobazam, and stiripentol, which are routinely used in polytherapy regimens. Their deep-rooted presence in treatment guidelines, widespread physician familiarity, and extensive insurance formularies ensure consistent and dominant usage. Moreover, the continued development of novel AEDs with improved safety profiles further solidifies this segment's foundational position and revenue dominance within the treatment landscape.

The ketogenic diet segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the ketogenic diet segment is predicted to witness the highest growth rate, driven by growing clinical evidence supporting its efficacy as an adjunctive therapy for drug-resistant seizures. This high-fat, low-carbohydrate diet induces a metabolic state of ketosis, which is proven to significantly reduce seizure frequency. Increasing physician recommendations and the emergence of modified, more palatable diet versions are improving patient adherence and adoption rates. Additionally, the non-pharmacological nature of this intervention appeals to caregivers seeking alternatives with different side effect profiles, fueling its rapid growth within the management paradigm.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share, attributable to its advanced healthcare infrastructure, high diagnostic capabilities, and favorable reimbursement policies for expensive orphan drugs. The presence of key market players, coupled with strong advocacy groups that drive awareness and early intervention, significantly contributes to this leadership. Moreover, the region's regulatory framework, through the FDA's orphan drug and fast-track designations, actively encourages the development and rapid commercialization of novel therapies, ensuring prompt patient access and sustaining the region's position as the largest revenue-generating market.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR, fueled by improving healthcare access, rising medical awareness about rare neurological disorders, and increasing healthcare expenditure in emerging economies. Governments are gradually implementing policies to support rare disease patients, which are expected to improve diagnosis rates and treatment adoption. Furthermore, the expanding presence of global pharmaceutical companies conducting clinical trials and seeking market authorization in this underserved region presents significant growth potential.

Key players in the market

Some of the key players in Dravet Syndrome Market include Biocodex, Biogen, Bright Minds Bio, Encoded Therapeutics, Epygenix Therapeutics, Harmony Biosciences, Jazz Pharmaceuticals, Lundbeck, Marinus Pharmaceuticals, Meiji Seika Pharma, Novartis, Ovid Therapeutics, Pfizer, Praxis Precision Medicines, Stoke Therapeutics, Supernus Pharmaceuticals, Takeda Pharmaceutical Company, UCB, and Xenon Pharmaceuticals.

Key Developments:

In June 2025, UCB, a global biopharmaceutical company, today announced that the phase 3 study investigating the safety and efficacy of adjunctive fenfluramine in CDKL5 Deficiency Disorder (CDD) met its primary and key secondary endpoints.1 The study is a randomized, double-blind, placebo-controlled, fixed-dose, multi-center study examining the efficacy, safety, and pharmacokinetics of adjunctive fenfluramine treatment in 87 children and adults aged 1 - 35, with a CDD diagnosis and uncontrolled seizures.2.

In February 2025, Stoke Therapeutics Inc. and Biogen Inc. said Tuesday they are entering a collaboration to develop and commercialize a treatment for Dravet syndrome, a severe form of epilepsy that starts in childhood.

Drug Types Covered:

  • Antiepileptic Drugs (AEDs)
  • Cannabidiol-Based Drugs
  • Serotonin Modulators
  • Gene Therapy & Emerging Treatments

Treatment Types:

  • Symptomatic Treatment
  • Ketogenic Diet
  • Vagus Nerve Stimulation (VNS)

Seizure Types Covered:

  • Myoclonic Seizures
  • Atonic Seizures
  • Partial Seizures
  • Tonic-Clonic Seizures
  • Other Seizure Types

End Users Covered:

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

Regions Covered:

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • Italy
    • France
    • Spain
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • New Zealand
    • South Korea
    • Rest of Asia Pacific
  • South America
    • Argentina
    • Brazil
    • Chile
    • Rest of South America
  • Middle East & Africa
    • Saudi Arabia
    • UAE
    • Qatar
    • South Africa
    • Rest of Middle East & Africa

What our report offers:

  • Market share assessments for the regional and country-level segments
  • Strategic recommendations for the new entrants
  • Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
  • Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
  • Strategic recommendations in key business segments based on the market estimations
  • Competitive landscaping mapping the key common trends
  • Company profiling with detailed strategies, financials, and recent developments
  • Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

  • Company Profiling
    • Comprehensive profiling of additional market players (up to 3)
    • SWOT Analysis of key players (up to 3)
  • Regional Segmentation
    • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
  • Competitive Benchmarking
    • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

  • 2.1 Abstract
  • 2.2 Stake Holders
  • 2.3 Research Scope
  • 2.4 Research Methodology
    • 2.4.1 Data Mining
    • 2.4.2 Data Analysis
    • 2.4.3 Data Validation
    • 2.4.4 Research Approach
  • 2.5 Research Sources
    • 2.5.1 Primary Research Sources
    • 2.5.2 Secondary Research Sources
    • 2.5.3 Assumptions

3 Market Trend Analysis

  • 3.1 Introduction
  • 3.2 Drivers
  • 3.3 Restraints
  • 3.4 Opportunities
  • 3.5 Threats
  • 3.6 Emerging Markets
  • 3.7 Impact of Covid-19

4 Porters Five Force Analysis

  • 4.1 Bargaining power of suppliers
  • 4.2 Bargaining power of buyers
  • 4.3 Threat of substitutes
  • 4.4 Threat of new entrants
  • 4.5 Competitive rivalry

5 Global Dravet Syndrome Market, By Drug Type

  • 5.1 Introduction
  • 5.2 Antiepileptic Drugs (AEDs)
  • 5.3 Cannabidiol-Based Drugs
  • 5.4 Serotonin Modulators
  • 5.5 Gene Therapy & Emerging Treatments

6 Global Dravet Syndrome Market, By Treatment Type

  • 6.1 Introduction
  • 6.2 Symptomatic Treatment
  • 6.3 Ketogenic Diet
  • 6.4 Vagus Nerve Stimulation (VNS)

7 Global Dravet Syndrome Market, By Seizure Type

  • 7.1 Introduction
  • 7.2 Myoclonic Seizures
  • 7.3 Atonic Seizures
  • 7.4 Partial Seizures
  • 7.5 Tonic-Clonic Seizures
  • 7.6 Other Seizure Types

8 Global Dravet Syndrome Market, By Distribution Channel

  • 8.1 Introduction
  • 8.2 Hospital Pharmacies
  • 8.3 Retail Pharmacies
  • 8.4 Online Pharmacies

9 Global Dravet Syndrome Market, By Geography

  • 9.1 Introduction
  • 9.2 North America
    • 9.2.1 US
    • 9.2.2 Canada
    • 9.2.3 Mexico
  • 9.3 Europe
    • 9.3.1 Germany
    • 9.3.2 UK
    • 9.3.3 Italy
    • 9.3.4 France
    • 9.3.5 Spain
    • 9.3.6 Rest of Europe
  • 9.4 Asia Pacific
    • 9.4.1 Japan
    • 9.4.2 China
    • 9.4.3 India
    • 9.4.4 Australia
    • 9.4.5 New Zealand
    • 9.4.6 South Korea
    • 9.4.7 Rest of Asia Pacific
  • 9.5 South America
    • 9.5.1 Argentina
    • 9.5.2 Brazil
    • 9.5.3 Chile
    • 9.5.4 Rest of South America
  • 9.6 Middle East & Africa
    • 9.6.1 Saudi Arabia
    • 9.6.2 UAE
    • 9.6.3 Qatar
    • 9.6.4 South Africa
    • 9.6.5 Rest of Middle East & Africa

10 Key Developments

  • 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
  • 10.2 Acquisitions & Mergers
  • 10.3 New Product Launch
  • 10.4 Expansions
  • 10.5 Other Key Strategies

11 Company Profiling

  • 11.1 Biocodex
  • 11.2 Biogen
  • 11.3 Bright Minds Bio
  • 11.4 Encoded Therapeutics
  • 11.5 Epygenix Therapeutics
  • 11.6 Harmony Biosciences
  • 11.7 Jazz Pharmaceuticals
  • 11.8 Lundbeck
  • 11.9 Marinus Pharmaceuticals
  • 11.10 Meiji Seika Pharma
  • 11.11 Novartis
  • 11.12 Ovid Therapeutics
  • 11.13 Pfizer
  • 11.14 Praxis Precision Medicines
  • 11.15 Stoke Therapeutics
  • 11.16 Supernus Pharmaceuticals
  • 11.17 Takeda Pharmaceutical Company
  • 11.18 UCB
  • 11.19 Xenon Pharmaceuticals

List of Tables

  • Table 1 Global Dravet Syndrome Market Outlook, By Region (2024-2032) ($MN)
  • Table 2 Global Dravet Syndrome Market Outlook, By Drug Type (2024-2032) ($MN)
  • Table 3 Global Dravet Syndrome Market Outlook, By Antiepileptic Drugs (AEDs) (2024-2032) ($MN)
  • Table 4 Global Dravet Syndrome Market Outlook, By Cannabidiol-Based Drugs (2024-2032) ($MN)
  • Table 5 Global Dravet Syndrome Market Outlook, By Serotonin Modulators (2024-2032) ($MN)
  • Table 6 Global Dravet Syndrome Market Outlook, By Gene Therapy & Emerging Treatments (2024-2032) ($MN)
  • Table 7 Global Dravet Syndrome Market Outlook, By Treatment Type (2024-2032) ($MN)
  • Table 8 Global Dravet Syndrome Market Outlook, By Symptomatic Treatment (2024-2032) ($MN)
  • Table 9 Global Dravet Syndrome Market Outlook, By Ketogenic Diet (2024-2032) ($MN)
  • Table 10 Global Dravet Syndrome Market Outlook, By Vagus Nerve Stimulation (VNS) (2024-2032) ($MN)
  • Table 11 Global Dravet Syndrome Market Outlook, By Seizure Type (2024-2032) ($MN)
  • Table 12 Global Dravet Syndrome Market Outlook, By Myoclonic Seizures (2024-2032) ($MN)
  • Table 13 Global Dravet Syndrome Market Outlook, By Atonic Seizures (2024-2032) ($MN)
  • Table 14 Global Dravet Syndrome Market Outlook, By Partial Seizures (2024-2032) ($MN)
  • Table 15 Global Dravet Syndrome Market Outlook, By Tonic-Clonic Seizures (2024-2032) ($MN)
  • Table 16 Global Dravet Syndrome Market Outlook, By Other Seizure Types (2024-2032) ($MN)
  • Table 17 Global Dravet Syndrome Market Outlook, By Distribution Channel (2024-2032) ($MN)
  • Table 18 Global Dravet Syndrome Market Outlook, By Hospital Pharmacies (2024-2032) ($MN)
  • Table 19 Global Dravet Syndrome Market Outlook, By Retail Pharmacies (2024-2032) ($MN)
  • Table 20 Global Dravet Syndrome Market Outlook, By Online Pharmacies (2024-2032) ($MN)

Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.