Multiple System Atrophy Market Expect to see more than 50% CAGR as Novel Therapies, AI Diagnostics, and FDA Fast Tracks Drive Growth | DelveInsight

The Multiple System Atrophy (MSA) market in the 7MM is expected to surge from USD 44 million in 2025 to ~USD 1.8 billion by 2034, fueled by rapid clinical advancements, AI-powered diagnostics, and the launch of Phase II/III pipeline therapies from leading companies including Lundbeck, Genmab, Teva, MODAG, Alterity Therapeutics, Theravance Biopharma, AskBio, Ono Pharmaceuticals, and AstraZeneca, alongside impactful FDA Fast Track designations and key 2025 milestones.
Key Insights on Multiple System Atrophy Market

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Market Size Projection: As per DelveInsight's analysis, the total market size of Multiple System Atrophy in the 7MM is expected to grow from USD 44 million in 2025 to USD 1.8 billion by 2034, driven by a CAGR of more than 50% in major regions (US, EU4, UK, Japan).

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Market Drivers: Key market drivers of Multiple System Atrophy include the launch of innovative therapies targeting alpha-synuclein, increased clinical trial activities, AI diagnostic breakthroughs, and robust investment in biomarker research and partnership strategies.

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Multiple System Atrophy Epidemiology: The report provides the total Multiple System Atrophy potential pool of approximately 71000 prevalent cases in the 7MM, projected to rise with expanding awareness and improved detection protocols.

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Key Companies: Leading Multiple System Atrophy companies include H. Lundbeck/Genmab (Amlenetug), Teva/MODAG (Emrusolmin), Theravance Biopharma (Ampreloxetine), Alterity Therapeutics (ATH434), AskBio, Ono Pharmaceuticals, AstraZeneca/Takeda, and others.

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Pipeline Assets: Some of the key Multiple System Atrophy assets in the pipeline include Amlenetug (Lu AF82422), Emrusolmin (TEV-56286), ATH434, TAK-341/MEDI1341, and Ampreloxetine; most are in Phase II/III stages with breakthrough designations.

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Recent Developments:

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January 2025: Lantheus Holdings acquires Evergreen Theragnostics and plans acquisition of Life Molecular Imaging, advancing neurodegenerative diagnostics.

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February 2025: Alterity Therapeutics reports positive Phase II results for ATH434; FDA grants Fast Track designation to ATH434 for MSA.

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February 2025: The FDA Fast Track designation for Amlenetug; progress in alpha-synuclein inhibitor clinical trials.

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April 2025: Tiziana Life initiates dosing in Phase IIa study, securing FDA approval for clinical protocol.

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May 2025: FDA Fast Track designation for ATH434 (Alterity Therapeutics).

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September 2025: Teva's Emrusolmin receives FDA Fast Track designation for Multiple System Atrophy treatment; AskBio completes Phase I trial enrollment for AB-1005 gene therapy in MSA-P.

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August-September 2025: Major clinical trial updates: CYPRESS Phase III ampereplexotine trial (Theravance) fully enrolled; Amlenetug Phase III study ongoing.

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Ongoing: NKGen Biotech receives FDA expanded access for NK cell therapy in MSA and other neurodegenerative diseases.

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Multiple System Atrophy Market and Epidemiology Analysis

Multiple System Atrophy (MSA) is a complex, rapidly progressive neurodegenerative disorder with hallmark symptoms in movement and autonomic nervous system functioning. According to DelveInsight, the MSA market is poised for exponential growth, rising from USD 44 million in 2025 to USD 1.8 billion by 2034. North America (especially the US) dominates, hosting around ~60% of cases, followed by the EU4, the UK, and Japan.

According to DelveInsight's comprehensive Multiple System Atrophy Market Insight, Epidemiology and Market Forecast report [https://www.delveinsight.com/sample-request/multiple-system-atrophy-msa-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr], the market growth is driven by high unmet medical needs due to a lack of approved disease-modifying therapies, increased clinical research activities, advances in diagnostic imaging, biomarker identification, and the emergence of targeted therapies.

Furthermore, the epidemiological segmentation reveals two main subtypes: MSA-P (predominant Parkinsonism) and MSA-C (predominant cerebellar ataxia); notably, MSA-P is more prevalent except in Japan, where MSA-C dominates.

Multiple System Atrophy Competitive Landscape

Key companies and their Assets:

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H. Lundbeck/Genmab: Amlenetug (Lu AF82422), monoclonal antibody targeting alpha-synuclein, Phase III; largest forecast revenue among emerging therapies, estimated at USD 795 million by 2034 in the 7MM.

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Teva/MODAG: Emrusolmin (TEV-56286, Anle-138b), oral small molecule, Phase II, targeting toxic alpha-synuclein; Fast Track and Orphan Drug Designations.

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Alterity Therapeutics: ATH434, targets iron dysregulation in alpha-synuclein aggregation, Phase II; Fast Track and Orphan Drug Designations.

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Theravance Biopharma: Ampreloxetine, norepinephrine reuptake inhibitor for symptomatic nOH, enrolled in CYPRESS Phase III trial with ODD.

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AskBio, Ono Pharmaceuticals, AstraZeneca/Takeda: advancing gene therapies and alpha-synuclein inhibitors.

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Multiple System Atrophy Market Drivers and Barriers

Some of Multiple System Atrophy Market Drivers include:

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Unmet medical need: No approved disease-modifying therapies, high demand for novel interventions.

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AI/Imaging breakthroughs: MSA-Atrophy Index and radiomics-based MRI models allow earlier and more accurate diagnosis, facilitating timely therapeutic intervention.

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Emerging pipeline therapies: Robust clinical trial activity and regulatory support (ODD, Fast Track, SAKIGAKE) accelerating time to market and investment.

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Patient advocacy and awareness: Earlier detection is increasing as advocacy and education efforts expand.

Some of Multiple System Atrophy Market Barriers include:

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Diagnostic challenges: Overlap with Parkinsonian syndromes causes misdiagnosis and treatment delays.

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Limited access: Geographic variability and high costs impede equitable therapy access, especially outside North America and Europe.

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Latest Key Opinion Leader Perspective on Multiple System Atrophy

KOLs across the US, Germany, and Japan highlight diagnosis complexity, limited symptom management options for autonomic and cerebellar dysfunction, and the critical role of emerging imaging (MIBG myocardial scintigraphy, MRI radiomics) in improving diagnostic accuracy. Physicians also emphasize the urgent need for novel, targeted, and accessible therapies to address high disease burden and unmet patient needs.

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DelveInsight Analysis on Multiple System Atrophy Market and Patient Pool

DelveInsight analysts anticipate exponential market growth in MSA thanks to transformative clinical and regulatory milestones, ongoing pharma-academic collaborations, AI-powered diagnostic tools, and rising investment in pipeline therapies. Advancing precision diagnostics and the first disease-modifying treatments are expected to redefine the market landscape, benefiting patients and innovators alike.

Scope of the Report

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Executive summary and descriptive overview of MSA: causes, symptoms, pathogenesis, and emerging therapies.

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Comprehensive epidemiology segmentation and market forecasting for 7MM countries.

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Future growth potential: diagnosis rate, disease progression, treatment guidelines.

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Profiles of late-stage and pipeline therapies, including clinical trial details and strategic collaborations.

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Country-wise accessibility, reimbursement, and cost-effectiveness assessment.

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SWOT analysis, KOL perspectives, and market attractiveness evaluation.

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Key questions addressed: historical/current/future market size, major contributors, disease risks, growth drivers, pipeline status, and patient acceptability of therapies.

Table of Contents

1. Key Insights

2. Executive Summary of Multiple System Atrophy

3. Competitive Intelligence Analysis for Multiple System Atrophy

4. Multiple System Atrophy Market Overview at a Glance

5. Multiple System Atrophy: Disease Background and Overview

6. Multiple System Atrophy Patient Journey

7. Multiple System Atrophy Epidemiology and Patient Population

8. Treatment Algorithm, Current Treatment, and Medical Practices

9. Multiple System Atrophy Unmet Needs

10. Key Endpoints of Multiple System Atrophy Treatment

11. Multiple System Atrophy Marketed Products

12. Multiple System Atrophy Emerging Therapies

13. Multiple System Atrophy: Seven Major Market Analysis

14. Attribute analysis

15. 7MM: Market Outlook

16. Access and Reimbursement Overview of Multiple System Atrophy

17. KOL Views

18. Multiple System Atrophy Market Drivers

19. Multiple System Atrophy Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

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