Multiple System Atrophy Market Summary
In 2025, the Multiple System Atrophy market size across the 7 Major Markets (7MM) was approximately USD 45 million and is projected to grow significantly by 2036, driven by pipeline advancements and rising diagnosed prevalence.
- The US accounted for the largest share, valued at approximately USD 40 million in 2024
- Germany led within EU4 and the UK, with a market size of approximately USD 1 million in 2024
- Japan’s Multiple System Atrophy market stood at approximately USD 3 million in 2025, with substantial growth expected through 2036
Explore the Full Multiple System Atrophy Market Report to Unlock Detailed Epidemiology, Pipeline, and Commercial Forecasts Through 2036
Multiple System Atrophy Overview
Multiple System Atrophy (Multiple System Atrophy) is a rare, progressive neurodegenerative disease affecting movement and the autonomic nervous system. Its cause remains unknown, and most cases are sporadic. A defining pathological hallmark is the accumulation of alpha-synuclein in oligodendroglial cells – the myelin-producing cells essential for efficient nerve signal transmission.
The term Multiple System Atrophy was introduced in 1969 to unify three previously distinct neurological conditions:
- Shy–Drager syndrome (autonomic dysfunction)
- Striatonigral Degeneration (Parkinsonian symptoms)
- Sporadic Olivopontocerebellar Atrophy (cerebellar symptoms)
Early symptoms include bradykinesia, tremors, stiffness, and poor coordination. Multiple System Atrophy is classified into two primary subtypes:
- Multiple System Atrophy-P – predominant Parkinsonism features
- Multiple System Atrophy-C – predominant cerebellar ataxia and impaired balance
These classifications remain flexible, as symptoms can shift between subtypes over time.
Multiple System Atrophy Diagnosis
Diagnosing Multiple System Atrophy remains challenging, particularly in early stages due to overlap with Parkinson’s disease. Key diagnostic approaches include:
- Autonomic testing (blood pressure and heart rate monitoring)
- Bladder function assessment
- Neuroimaging via MRI or PET scans
Multiple System Atrophy Treatment
Pharmacological treatments target Parkinsonism, autonomic dysfunction, cerebellar ataxia, and sleep disturbances:
- Levodopa – first-line for Parkinsonism, offering temporary benefits
- Dopamine agonists and amantadine – alternative options, though associated with more side effects
- Northera (droxidopa) – approved in 2014 for neurogenic orthostatic hypotension (nOH); lost market exclusivity in 2021
Currently, no disease-modifying therapy is approved for Multiple System Atrophy in any of the 7MM, creating a substantial unmet need.
Multiple System Atrophy Epidemiology
The Multiple System Atrophy epidemiology analysis covers historical and forecasted data (2022–2036) across the 7MM – United States, EU4 (Germany, France, Italy, Spain), United Kingdom, and Japan – segmented by:
- Diagnosed prevalence cases
- Gender-specific diagnosed prevalent cases
- Age-specific diagnosed prevalent cases
- Type-specific diagnosed prevalent cases
Key Epidemiology Findings:
- In 2025, the US had the highest number of diagnosed prevalent Multiple System Atrophy cases among 7MM – more than 43,000 cases – followed by Japan with nearly 17,000 cases
- Stage 3 of Multiple System Atrophy (out of six stages: Stage 0–5) carried the highest diagnosed prevalence in EU4 and the UK, with approximately 4,000 cases in 2025
- In the UK, patients aged 70 years and above had the highest case count at approximately 1,200 cases in 2025, with projections indicating further increases through 2036
Multiple System Atrophy Recent Developments and Breakthroughs
The Multiple System Atrophy pipeline has seen considerable momentum, with multiple clinical milestones recorded in 2025–2026:
- March 2026 – Lundbeck announced ahead-of-schedule completion of patient randomization in the Phase III MASCOT trial of amlenetug for Multiple System Atrophy; results expected Q3 2027, potential launch Q1 2029
- December 2025 – Lundbeck presented the design of the MASCOT trial at the 2025 International Congress of Parkinson’s Disease and Movement Disorders, evaluating amlenetug, a monoclonal antibody targeting alpha-synuclein
- December 2025 – Asklepios BioPharmaceutical (AskBio), a Bayer subsidiary, completed enrollment for its Phase 1 trial of AB-1005, an AAV2 gene therapy delivering the GDNF gene directly to the brain in Multiple System Atrophy-P patients
- December 2025 – Teva Pharmaceutical received FDA Fast Track Designation for emrusolmin, an oral small molecule inhibiting alpha-synuclein aggregation in Multiple System Atrophy
- September 2025 – Teva confirmed emrusolmin is currently in Phase 2 development for Multiple System Atrophy
- August 2025 – Tiziana Life Sciences received FDA IND clearance for a Phase 2a trial of intranasal foralumab (anti-CD3 monoclonal antibody) in Multiple System Atrophy patients
- July 2025 – NKGen Biotech received FDA authorization for an Expanded Access Program for its NK cell therapy, troculeucel, across multiple neurodegenerative diseases including Multiple System Atrophy
- May 2025 – Alterity Therapeutics received FDA Fast Track designation for ATH434 in Multiple System Atrophy, targeting an unmet treatment gap
- February 2025 – Alterity’s ATH434 demonstrated promising Phase 2 results in a randomized double-blind trial for early-stage Multiple System Atrophy, showing clinical and biomarker benefits, particularly at the 50 mg dose
Multiple System Atrophy Drug Analysis
The Multiple System Atrophy drug pipeline encompasses early-stage and mid-to-late stage (Phase II and Phase III) candidates, with detailed analyses covering clinical trial design, pharmacological mechanisms, collaborations, and the latest regulatory developments.
Multiple System Atrophy Emerging Drugs
Emrusolmin (TEV-56286 / Anle-138b) – Teva Pharmaceutical / MODAG GmbH A small molecule specifically targeting toxic oligomeric alpha-synuclein structures. By binding and dissolving these oligomers while preventing new formation, it addresses the underlying pathology of Multiple System Atrophy.
Amlenetug (Lu AF82422) – H. Lundbeck A/S / Genmab A human IgG1 monoclonal antibody targeting extracellular alpha-synuclein to block aggregation and enhance microglial clearance, developed through the Lundbeck–Genmab collaboration.
ONO-2808 – Deciphera Pharmaceuticals / ONO Pharma An orally available, selective sphingosine-1-phosphate receptor-5 (S1P5) agonist currently in Phase II evaluation for early-stage Multiple System Atrophy patients (within five years of symptom onset) across Japan and the US.
Multiple System Atrophy Market Outlook
The Multiple System Atrophy market outlook remains one of significant opportunity:
- No disease-modifying treatments are currently approved across the 7MM
- Existing Parkinson’s therapies like levodopa provide limited and inconsistent benefit in Multiple System Atrophy patients
- The first company to achieve approval of a disease-modifying therapy for Multiple System Atrophy will enter an essentially uncontested therapeutic category
- Northera (droxidopa), approved for nOH management in 2014, lost exclusivity in 2021 but continues to represent a meaningful symptomatic standard of care
- Symptomatic options currently in use include Levodopa, Amantadine, Droxidopa, and Anticholinergic agents, alongside various off-label treatments
Potential future disease-modifying therapies include Lu AF82422 (H. Lundbeck A/S/Genmab), Ampreloxetine (Theravance Biopharma), Emrusolmin (Teva Pharmaceutical/MODAG GmbH), and others advancing through clinical development.
- In 2025, the 7MM Multiple System Atrophy market was valued at approximately USD 45 million, projected for significant growth by 2036
- The US led with approximately USD 40 million in 2024
- Germany led EU4/UK with approximately USD 1 million in 2024
- Japan stood at approximately USD 3 million in 2025, with strong growth forecasted
Leading Multiple System Atrophy Companies
Key Multiple System Atrophy companies developing therapies include:
H. Lundbeck A/S · Brain Neurotherapy Bio, Inc. · Asklepios BioPharmaceutical, Inc. · Theravance Biopharma · Ono Pharmaceutical Co. Ltd · Ionis Pharmaceuticals, Inc. · Biogen · Alterity Therapeutics · Teva Pharmaceutical · MODAG GmbH · and others
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Conclusion
The Multiple System Atrophy market is at a pivotal inflection point. With the global 7MM market valued at approximately USD 45 million in 2025 and no approved disease-modifying therapy, the commercial and clinical opportunity is substantial. Robust late-stage pipeline activity – led by amlenetug, emrusolmin, and ATH434 – combined with multiple FDA Fast Track designations signals a transforming landscape. Rising diagnosed prevalence, particularly in the US and Japan, further supports strong market growth through 2036.
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