多發性硬化症：新型療法、未滿足的需求和TPP洞察報告，2026年

市場概覽

• 美國多發性硬化症（MS）市場預計將從 86億美元成長到 185億美元，反映出強勁且持續的成長。
• 以下因素推動市場成長：
• 昂貴的生物製藥和標靶治療（例如抗CD20藥物）的使用日益增多
• 擴大符合治療條件的患者人數，並推廣早期療育策略。
• 市場規模得益於慢性病和終身治療以及疾病修正治療（DMT）的高昂價格。
• 針對髓鞘再生和神經保護的新一代療法擁有強大的研發管線。
• 未來的成長取決於能夠解決進行性多發性硬化症（MS）並預防長期殘疾的創新。

多發性硬化症（MS）的新治療方法及對 TPP 的深入研究

Thelansis 發布的《多發性硬化症（MS）新型治療方法、未滿足的需求和目標產品概況（TPP）洞察報告 -2026》全面分析了該適應症的關鍵新型治療方法和主要藥物發現機會，包括新興的競爭格局、未滿足的需求、目標產品概況（TPP）、試驗設計和關鍵意見領袖（KOL）的見解。

多發性硬化症（MS）概述

多發性硬化症（MS）是一種慢性、免疫介導的去髓鞘化神經退化性疾病，主要影響中樞神經系統（CNS），其病因是自體反應性T細胞和B細胞穿過功能異常的血腦障壁。這種免疫介導的攻擊會導致局部發炎、髓鞘破壞、軸突損傷和進行性神經退化，最終在大腦和脊髓中形成特徵性的硬化斑塊。

這種疾病主要發生於青年人，臨床表現以反覆出現的神經功能缺損為特徵，例如視神經炎、運動和感覺障礙、協調障礙以及嚴重疲勞。疾病進展可呈現復發緩解型或進行型，其特徵是空間和時間上的擴散。

診斷依據麥克唐納標準，該標準整合了 MRI 檢查觀察（例如，腦室周圍病變如道森指）和腦脊髓液（CSF）分析結果，顯示寡克隆區帶。

治療方法正朝著積極且有效率的治療方向發展，強調早期啟動疾病修正治療（DMT）以防止不可逆損傷。目前的標準治療方案優先採用標靶治療，例如抗CD20單株抗體（如Ocrelizumab）、S1P受體調變器和整合素抑制劑，這些藥物能有效抑制神經發炎並降低復發率。

儘管治療方法取得了進展，但在解決疾病進行性、治療抗藥性、長期安全性和與發炎無關的神經退化方面仍然存在挑戰，這凸顯了多發性硬化症治療方面仍然存在未滿足的需求。

主要亮點

• 在美國，確診的多發性硬化症病例數預計將從 717,716 例增加到 737,991 例，這表明該疾病的負擔穩步上升。
• 多發性硬化症主要影響年輕人，並可能導致長期殘疾和嚴重的社會經濟後果。
• 治療模式向早期使用高效的疾病修飾療法（DMT）以減緩疾病進展的方向轉變。
• 除了控制發炎之外，在進行進行性多發性硬化症和神經退化方面仍然存在未滿足的需求。
• 人們對標靶 B 細胞的治療方法和先進的免疫調節策略越來越感興趣。

基於對醫生和關鍵意見領袖（KOL）的調查得出的結論：

• 透過對關鍵意見領袖（KOL）的訪談，獲得了更多見解，進一步完善了調查結果。
• 調查問卷將根據客戶的要求進行客製化。

交付成果格式：

• PowerPoint簡報
• MS Excel

主要問題

• 詳細的競爭格局趨勢
• 管道分析
• 符合新興治療方法的患者
• 主要企業
• 主要作用機制
• 發布日期等的預測
• 臨床試驗趨勢分析
• 目標患者群
• 試驗終點
• 測試設計
• 受試者招募標準等
• 未滿足的需求和機會
• 目前主要治療方法的有效性
• 未滿足需求的關鍵領域
• 主要未滿足需求的市場規模估算
• 目標產品概況
• 屬性和級別
• 醫生開立的處方
• 預期患者佔有率
• 關鍵KOL洞察對領先新興治療方法的見解
• 意識
• 預期用途/治療線
• 對主要未滿足需求的滿意度
• KOL評論

目標國家

• G8
  • 美國
  • EU5
    • 法國
    • 德國
    • 義大利
    • 西班牙
    • 英國
  • 日本
  • 中國

大公司

• Hoffmann-La Roche
• TG Therapeutics, Inc.
• Biogen
• Tr1X, Inc.
• Sanofi
• Biocad
• Kite, A Gilead Company
• Zenas BioPharma（USA）, LLC
• Novartis Pharmaceuticals
• AstraZeneca
• Truway Health, Inc.
• Miltenyi Biomedicine GmbH
• Autolus Limited
• Qilu Pharmaceutical（Hainan）Co., Ltd.
• Vidya Therapeutics Inc
• Genentech, Inc.
• Cabaletta Bio
• NeuroGenesis Ltd.
• Tiziana Life Sciences LTD
• Sandoz
• Celgene
• ModernaTX, Inc.
• Amgen
• Contineum Therapeutics
• Abata Therapeutics
• Cellerys AG
• Bristol-Myers Squibb
• Kyverna Therapeutics
• Reveal Pharmaceuticals Inc.
• Eli Lilly and Company
• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
• Motric Bio
• LAPIX Therapeutics Inc.
• Inventage Lab., Inc.
• Ever Supreme Bio Technology Co., Ltd.
• AB Science
• Ashvattha Therapeutics, Inc.
• Immunic AG
• GlaxoSmithKline
• ImStem Biotechnology
• Anokion SA
• Clene Nanomedicine
• Actelion
• Genzyme, a Sanofi Company

目錄

第1章 主要調查結果及分析師說明

• 主要趨勢：市場概況、SWOT分析、商業性利益與風險等。

第2章 競爭情勢

• 目前的治療方法
• 重點
• 診斷和治療過程/演算法
• 主要治療方法概述及KOL洞察
• 新興治療方法
• 重點
• 診斷和治療過程/演算法
• 領先的新興治療方法 - 概述和KOL洞察

第3章 產品屬性分析

• 重點
• 科學屬性
• 商業屬性
• 產品定位

第4章 初步調查

• 目前治療狀態
• 主要治療方法與目標患者族群的比較
• 主要特點和優勢
• 未來治療環境
• 當前挑戰
• 未滿足的需求
• 新興治療方法
• 主要治療方法與目標患者族群的比較
• 主要特點和優勢
• 未來治療前景
• 未滿足的需求和關鍵意見領袖的期望

第5章 未滿足的需求和TPP分析

• 主要未滿足需求和新興治療方法的未來成就
• TPP分析與KOL預期

第6章 法規與償付環境

第7章 附錄

Multiple Sclerosis (MS) Emerging Therapy and TPP Insights

Thelansis's "Multiple Sclerosis (MS) Emerging Therapy, with Unmet Needs and TPP Insights Report - 2026" provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

Multiple Sclerosis (MS) Overview

Multiple sclerosis (MS) is a chronic, immune-mediated, demyelinating, and neurodegenerative disorder of the central nervous system (CNS), driven by autoreactive T- and B-cell infiltration across a compromised blood-brain barrier. This immune-mediated attack leads to focal inflammation, myelin destruction, axonal injury, and progressive neurodegeneration, resulting in the formation of characteristic sclerotic plaques across the brain and spinal cord.

The disease predominantly affects young adults, with clinical presentation marked by episodic neurological deficits such as optic neuritis, motor and sensory impairment, coordination dysfunction, and severe fatigue. Disease progression follows patterns including relapsing-remitting and progressive forms, characterized by dissemination in space and time.

Diagnosis is based on the McDonald criteria, integrating MRI findings (e.g., periventricular lesions such as Dawson's fingers) and cerebrospinal fluid analysis showing oligoclonal bands.

Management has evolved toward a proactive, high-efficacy treatment approach, emphasizing early initiation of disease-modifying therapies (DMTs) to prevent irreversible disability. Current standards prioritize targeted therapies, including anti-CD20 monoclonal antibodies (e.g., ocrelizumab), S1P receptor modulators, and integrin inhibitors, which effectively suppress neuroinflammation and reduce relapse rates.

Despite therapeutic advances, challenges remain in addressing progressive disease, treatment resistance, long-term safety, and neurodegeneration independent of inflammation, highlighting ongoing unmet need in MS management.

Key Highlights

• In the United States, diagnosed MS cases are projected to increase from 717,716 to 737,991, indicating steady growth in disease burden.
• MS predominantly affects young adults, leading to long-term disability and significant socioeconomic impact.
• Treatment paradigm has shifted toward early use of high-efficacy DMTs to delay disease progression.
• Persistent unmet need exists in progressive MS and neurodegeneration beyond inflammation control.
• Increasing focus on B-cell targeted therapies and advanced immunomodulation strategies.

Market Overview

• The United States MS market is projected to grow from $8.6B to $18.5B, reflecting strong and sustained expansion.
• Market growth is driven by:
• Increased adoption of high-cost biologics and targeted therapies (e.g., anti-CD20 agents)
• Expansion of treated patient population and early intervention strategies
• Market value is supported by chronic, lifelong treatment and premium pricing of DMTs.
• Strong pipeline of next-generation therapies targeting remyelination and neuroprotection.
• Future growth will depend on innovations addressing progressive MS and long-term disability prevention.

Insights driven by surveys* with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs
• Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
• Pipeline analysis
• Target patients for emerging therapies
• Key companies
• Key mechanism of actions
• Launch date estimates, etc.
• Clinical trial landscape analysis
• Target patient segments
• Trial endpoints
• Trial design
• Recruitment criteria, etc.
• Unmet Needs and Opportunities
• Performance of key current therapies
• Top areas of unmet needs
• Opportunity sizing for key unmet needs
• Target Product Profiles
• Attributes and levels
• Physician likelihood of prescribing
• Expected patient shares
• KOL insights on key emerging therapies
• Level of awareness
• Expected use / line of therapy
• Extent to fulfil key unmet needs
• KOL quotes

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard will cost USD 1,750 per country

Companies Mentioned

• Hoffmann-La Roche
• TG Therapeutics, Inc.
• Biogen
• Tr1X, Inc.
• Sanofi
• Biocad
• Kite, A Gilead Company
• Zenas BioPharma (USA), LLC
• Novartis Pharmaceuticals
• AstraZeneca
• Truway Health, Inc.
• Miltenyi Biomedicine GmbH
• Autolus Limited
• Qilu Pharmaceutical (Hainan) Co., Ltd.
• Vidya Therapeutics Inc
• Genentech, Inc.
• Cabaletta Bio
• NeuroGenesis Ltd.
• Tiziana Life Sciences LTD
• Sandoz
• Celgene
• ModernaTX, Inc.
• Amgen
• Contineum Therapeutics
• Abata Therapeutics
• Cellerys AG
• Bristol-Myers Squibb
• Kyverna Therapeutics
• Reveal Pharmaceuticals Inc.
• Eli Lilly and Company
• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
• Motric Bio
• LAPIX Therapeutics Inc.
• Inventage Lab., Inc.
• Ever Supreme Bio Technology Co., Ltd.
• AB Science
• Ashvattha Therapeutics, Inc.
• Immunic AG
• GlaxoSmithKline
• ImStem Biotechnology
• Anokion SA
• Clene Nanomedicine
• Actelion
• Genzyme, a Sanofi Company

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risk, etc.

2. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key emerging therapies - profiles and KOL insights

3. Product Attribute Analysis

• Key takeaways
• Scientific attributes
• Commercial attributes
• Product positioning

4. Primary Market Research

• Current treatment landscape
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Current challenges
• Unmet needs
• Emerging therapies
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Unmet needs and KOL expectations

5. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

6. Regulatory and Reimbursement Environments (by country and payer insights)

7. Appendix (e.g., bibliography, methodology)