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2032 年 Dravet 症候群市場預測：按藥物類型、治療類型、癲癇發作類型、分銷管道和地區進行的全球分析

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個工作天內

價格

根據 Stratistics MRC 的數據，全球 Dravet 症候群市場預計在 2025 年達到 4.357 億美元，到 2032 年達到 7.615 億美元，預測期內的複合年成長率為 8.3%。

Dravet症候群是一種罕見且嚴重的癲癇疾病，起病於嬰兒期，以持續性癲癇發作、發育遲緩和認知障礙為特徵。市場透過藥物、基因檢測和支持性護理來應對該疾病的診斷、治療和管理。人們對罕見疾病的認知不斷提高，精準醫療的進步以及孤兒藥資格認定正在推動研究和治療領域的創新。新型治療方法，例如基於大麻二酚的藥物和基因靶向解決方案，正在創造新的機會。

提高對罕見疾病的認知

患者權益組織的努力和醫生教育宣傳活動的不斷改進正在提高早期和準確診斷的比率。這種認知的提高對於市場擴張至關重要，因為它直接增加了確診人數，從而推動了對核准治療和支持性護理產品的需求。此外，孤兒藥資格認定等監管獎勵刺激了製藥公司對此細分領域的投資，確保了更強大的產品線。這些共同努力將提高現有和新興療法的市場滲透率和收益。

患者數量有限

Dravet症候群的主要市場限制因素是其患者群體極為有限。此疾病較為罕見，每15,700名新生兒中就有1人患病。如此小且分散的患者群體本身就限制了任何已上市治療方案的潛在收益，阻礙了大型製藥公司的大規模投資。藥物開發的經濟效益（包括高昂的研發成本）如果不採取溢價策略，很難收回，而且會受到付款方的嚴格審查。與更常見的適應症相比，這一限制從根本上限制了整體市場規模和商業性吸引力。

大麻二酚療法的發展

大麻二酚 (CBD)治療方法的推廣擁有巨大的市場機遇，該療法已被證明在降低難治性 Dravet 症候群患者癲癇發作頻率方面具有顯著療效。 Epidiolex® 等核准藥物的成功檢驗了此類治療層級，並為下一代大麻素候選藥物和聯合治療療法鋪平了道路。這種日益成長的認可度為臨床創新和市場拓展創造了肥沃的土壤。此外，孤兒藥的良好法規環境為企業提供了一條可行的途徑，使其能夠加快開發進程，並在高未滿足需求領域中獲得價值。

治療副作用的風險

許多抗癲癇藥物和CBD為基礎的療法都帶有黑框警告其可能有嚴重副作用，包括肝毒性和自殺意念。這些安全隱患導致了嚴格的監管規定，包括嚴格的REMS（Remote Remediation Management，快速反應管理）計劃，這可能會阻礙患者獲得藥物並降低處方率。此外，關鍵上市後安全資料的出現可能引發附加檔限制和產品召回，從而削弱投資者信心，甚至危及關鍵上市產品的商業性可行性。

COVID-19的影響：

新冠疫情最初擾亂了Dravet症候群市場，導致臨床試驗延遲，並擾亂了藥物開發平臺。供應鏈中斷也對藥品供應構成了挑戰。然而，這場危機加速了遠端醫療的普及，並提高了那些可以避免面對面就診的弱勢患者的照護連續性。此外，監管靈活性使臨床項目能夠適應，從而減輕了長期的衝擊。市場表現出韌性，成熟的治療方法因其慢性特性而保持穩定的需求，使其相對較快地恢復到疫情前的成長軌跡。

預測期內，抗癲癇藥物（AED）市場預計將成為最大的市場

抗癲癇藥物 (AED) 預計將在預測期內佔據最大的市場佔有率，這得益於其作為 Dravet 症候群癲癇發作的一線治療藥物的既定地位。該領域包括多種藥物，例如丙戊酸、Clobazam和司替戊醇，這些藥物常用於多藥物治療聯合治療。這些藥物已深深植根於治療指南，為醫生所熟知，並被廣泛納入醫保，因此得到了一致且廣泛的使用。此外，安全性較高的新型 AED 的持續開發進一步鞏固了該領域的基礎地位和治療收益優勢。

預計生酮飲食部分在預測期內將實現最高的複合年成長率。

預計生酮飲食領域將在預測期內實現最高成長率，這得益於越來越多的臨床證據支持其作為難治性癲癇輔助性治療的有效性。這種高脂肪、低碳水化合物的飲食能夠誘導一種稱為酮症的代謝狀態，並已被證明能夠顯著降低癲癇發作頻率。醫師的推薦增加以及改良、更偏好的飲食計畫的出現，提高了病患的依從性和接受度。此外，這種干預措施的非藥物性質吸引了那些尋求副作用不同的替代療法的看護者，從而推動了其在管理模式中的快速成長。

佔比最大的地區：

預計北美將在預測期內佔據最大的市場佔有率，這得益於其先進的醫療基礎設施、強大的診斷能力以及昂貴孤兒藥的優惠報銷政策。主要市場參與者的存在，以及強大的倡導團體（致力於提高公眾意識和早期療育）為這一領先地位做出了重要貢獻。此外，該地區的監管框架，例如FDA的孤兒藥資格認定和簡審類，積極鼓勵新型療法的開發和快速商業化，確保患者能夠快速獲得藥物，並保持其作為該地區最大收益市場的地位。

複合年成長率最高的地區：

預計亞太地區將在預測期內實現最高的複合年成長率，這得益於醫療保健可及性的改善、對罕見神經系統疾病的醫療意識的提升以及新興經濟體醫療支出的增加。各國政府正逐步實施支持罕見疾病患者的政策，預計將提高診斷和治療的普及率。此外，越來越多的全球製藥公司在這個低度開發地區進行臨床試驗並尋求市場批准，也帶來了巨大的成長潛力。

提供免費客製化：

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  • 公司簡介
    • 對最多三家其他市場公司進行全面分析
    • 主要企業的SWOT分析（最多3家公司）
  • 區域細分
    • 根據客戶興趣對主要國家進行的市場估計、預測和複合年成長率（註：基於可行性檢查）
  • 競爭基準化分析
    • 根據產品系列、地理分佈和策略聯盟對主要企業基準化分析

目錄

第1章執行摘要

第2章 前言

  • 概述
  • 相關利益者
  • 調查範圍
  • 調查方法
    • 資料探勘
    • 數據分析
    • 數據檢驗
    • 研究途徑
  • 研究材料
    • 主要研究資料
    • 次級研究資訊來源
    • 先決條件

第3章市場走勢分析

  • 驅動程式
  • 抑制因素
  • 機會
  • 威脅
  • 新興市場
  • COVID-19的影響

第4章 波特五力分析

  • 供應商的議價能力
  • 買方的議價能力
  • 替代品的威脅
  • 新進入者的威脅
  • 競爭對手之間的競爭

5.全球Dravet 症候群市場（依藥物類型）

  • 抗癲癇藥物（AED）
  • 大麻二酚類藥物
  • 血清素調節劑
  • 基因治療和新治療方法

6.全球Dravet 症候群市場（依治療類型）

  • 症狀治療
  • 生酮飲食
  • 迷走神經刺激（VNS）

7.全球Dravet 症候群市場（依癲癇發作類型）

  • 肌陣攣性癲癇
  • 猝倒症
  • 局部性癲癇發作
  • 強直陣攣性發作
  • 其他癲癇類型

8.全球Dravet 症候群市場（依分銷管道）

  • 醫院藥房
  • 零售藥局
  • 網路藥局

9.全球Dravet 症候群市場（按地區）

  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 義大利
    • 法國
    • 西班牙
    • 其他歐洲國家
  • 亞太地區
    • 日本
    • 中國
    • 印度
    • 澳洲
    • 紐西蘭
    • 韓國
    • 其他亞太地區
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 其他南美
  • 中東和非洲
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 卡達
    • 南非
    • 其他中東和非洲地區

第10章：重大進展

  • 協議、夥伴關係、合作和合資企業
  • 收購與合併
  • 新產品發布
  • 業務擴展
  • 其他關鍵策略

第11章 公司概況

  • 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.