Multiple System Atrophy Market Summary

• The MSA market is anticipated to witness steady growth during the 2026–2036 forecast period, driven by increasing disease recognition, improvements in diagnostic capabilities, growing disease awareness, and the anticipated emergence of disease-modifying therapies addressing the significant unmet need across the 7MM.
• In 2025, the US accounted for the largest share, approximately 60%, of diagnosed prevalent MSA cases across the 7MM, highlighting the substantial addressable patient population in the US market.
• MSA remains challenging to diagnose, particularly in the early stages, because several clinical features overlap with Parkinson’s disease and other atypical parkinsonian disorders. Diagnosis relies primarily on clinical assessment, supported by autonomic testing, bladder-function assessment, and neuroimaging such as MRI; PET may be used in selected research or differential-diagnostic settings.
• Approximately 20% of MSA cases may initially present with cerebellar features, including cerebellar ataxia, disequilibrium, dysarthria, and nystagmus, reflecting the heterogeneous clinical presentation of the disease.
• Currently, no disease-modifying therapies (DMTs) are approved for MSA, and treatment remains primarily symptomatic. Levodopa may be used for parkinsonian symptoms, although its efficacy is often limited and tends to be less sustained as the disease progresses.
• The MSA market could gradually shift toward disease modification as investigational therapies advance, with emrusolmin (TEV-56286) potentially launching in 2028 based on forecast assumptions and amlenetug (Lu AF82422) projected for around Q1 2029. Their distinct approaches to α-synuclein pathology could contribute to a more differentiated and competitive treatment landscape.
• Looking ahead, the MSA pipeline is expected to become increasingly competitive, with novel therapies investigating mechanisms including α-synuclein pathology, neuroinflammation, oxidative stress, and neuroprotection. The successful introduction of effective disease-modifying therapies could substantially reshape treatment patterns, address key unmet needs, and support continued expansion of the MSA market through 2036.

DelveInsight’s “Multiple System Atrophy – Market Insights, Epidemiology, and Market Forecast – 2036” report delivers an in-depth understanding of MSA, historical and forecasted epidemiology, as well as the MSA market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

The MSA market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, MSA patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment and growth rate projections (Historical & Forecast 2022–2036) across the 7MM regions. The report highlights key unmet medical needs in MSA and maps the competitive and clinical landscape to uncover high‑value opportunities, providing a clear outlook on future market growth potential.

Geography Covered 

North America: The United States 

Europe: Germany, France, Italy, Spain and the United Kingdom

Asia-Pacific: Japan

Multiple System Atrophy Understanding and Treatment Algorithm

Multiple System Atrophy Overview and Diagnosis

MSA is a rare, progressive neurodegenerative disorder characterized by the combination of autonomic dysfunction, Parkinsonism, cerebellar impairment, and varying degrees of pyramidal involvement. The disease is associated with abnormal accumulation of α-synuclein in oligodendroglia cells and is broadly classified into MSA-P, where parkinsonian features predominate, and MSA-C, where cerebellar symptoms are more prominent. 

Diagnosis of MSA remains challenging because its early clinical presentation can overlap with other neurodegenerative disorders, particularly Parkinson’s disease, progressive supranuclear palsy, and other atypical parkinsonian syndromes. Clinical assessment remains central to diagnosis, with particular emphasis on the presence and progression of autonomic dysfunction alongside parkinsonian or cerebellar features. The 2022 Movement Disorder Society (MDS) diagnostic criteria introduced standardized categories, including clinically established MSA, clinically probable MSA, and possible prodromal MSA, to improve diagnostic consistency.

Further details related to country-based variations are provided in the report…

Current MSA Treatment Landscape

MSA management remains symptomatic because no curative treatment exists, so care aims to relieve symptoms, improve quality of life, and slow progression. Pharmacological treatment targets Parkinsonism, autonomic dysfunction, cerebellar ataxia, and sleep disturbances. Levodopa is first-line for MSA-P but gives limited, temporary benefit and needs monitoring for side effects such as orthostatic hypotension, with dopamine agonists and amantadine as secondary options. Non-pharmacological care, including physical, occupational, and speech therapy and nutritional support, is essential for symptoms that respond poorly to medication. Against this limited toolkit, regulatory support is building for the first disease-modifying candidates. Emrusolmin (TEV-56286) received US FDA Fast Track Designation (FTD) for MSA after its EU Orphan Drug Designation (ODD), while amlenetug holds ODD from the EMA and US FDA, Japan's SAKIGAKE and ODD, and US FDA FTD, supporting their development as potential first-in-class therapies for MSA.

Further details related to country-based variations are provided in the report…

Multiple System Atrophy Epidemiology

The epidemiology section of the MSA market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of MSA. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings from MSA Epidemiological Analysis and Forecast

• The US represented the largest MSA patient pool in the 7MM, accounting for nearly 60% of diagnosed prevalent cases in 2025, while Japan contributed approximately 20%, highlighting the concentration of the addressable MSA population in these two markets.
• As per DelveInsight, MSA-P predominates in North American and European populations, whereas MSA-C is more prevalent among Japanese patients. MSA-C affects 60%-80% of individuals with MSA.
• In 2025, Japan reported nearly 12,000 cases of MSA-C and nearly 5,000 cases of MSA-P.

Multiple System Atrophy Drug Analysis & Competitive Landscape

The MSA drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase II-III clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships upcoming key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the MSA treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the MSA therapeutics market.

Multiple System Atrophy Pipeline Analysis

Amlenetug (Lu AF82422): H. Lundbeck A/S 

Lu AF82422 is a human monoclonal antibody (mAb) designed to target toxic alpha-synuclein proteins, which are a key pathological feature of MSA. By mimicking the body’s immune response, it helps clear these harmful proteins. As it focuses on the underlying biology of MSA, Lu AF82422 has the potential to slow or halt disease progression, according to Lundbeck. In both in vitro and in vivo models, the compound has shown effectiveness in inhibiting the seeding of pathological forms of alpha-synuclein, offering promising therapeutic possibilities for treating MSA. Amlenetug has secured multiple regulatory designations across key markets, including EMA and US FDA ODD, Japan’s SAKIGAKE and ODD, and US FDA FTD, providing regulatory support for its development as a potential disease-modifying therapy for MSA.

• In March 2026, Lundbeck reported that patient randomization in the Phase III MASCOT trial of amlenetug for MSA was completed ahead of schedule, with topline results expected in Q3 2027 and a potential launch targeted for Q1 2029.

Note: Detailed emerging therapies assessment will be provided in the final report…

Multiple System Atrophy Key Players, Market Leaders and Emerging Companies

• H. Lundbeck A/S 
• Alterity Therapeutics
• Teva Pharmaceutical and more 

Multiple System Atrophy Drug Updates

• In May 2026, Ono Pharma announces poster presentation of new clinical data from Phase II study of ONO-2808 in MSA at the 7th World Parkinson Congress (WPC).
• In March 2026, Lundbeck reported that patient randomization in the Phase III MASCOT trial of amlenetug for MSA was completed ahead of schedule, with topline results expected in Q3 2027 and a potential launch targeted for Q1 2029.
• As reported in Teva’s Q1 2026 results, the Phase II TOPAS-MSA trial achieved faster-than-anticipated enrollment of more than 200 patients, enabling a larger sample size, with the futility analysis on track for Q4 2026 and the potential to support an accelerated approval pathway.

Multiple System Atrophy Market Outlook

DelveInsight’s ‘MSA – Market Insights, Epidemiology, and Market Forecast – 2036’ report provides a detailed outlook of the current and future MSA market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies. 

The MSA pipeline includes disease-modifying and symptomatic approaches, with key emerging therapies such as amlenetug, emrusolmin, ATH434, ONO-2808, and AAV2-GDNF. MSA management remains predominantly symptomatic, with no approved disease-modifying therapy currently available. The emergence of these investigational therapies could reshape the treatment landscape, with amlenetug and emrusolmin representing key potential future market entrants.

MSA Market Size by Countries

The MSA market size is assessed separately for various countries, including the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2025, the US held a significant share of the overall 7MM (Seven Major Markets) MSA market, primarily attributed to the country’s higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products. 

Country-wise Market Size Distribution of MSA

MSA Market Size by Therapies

MSA market size by therapies is categorized into current and emerging markets for the study period 2022–2036. 

Market Share Distribution of MSA by Therapies in 2036

Note: Detailed market segment assessment will be provided in the final report.

Multiple System Atrophy Drug Uptake

This section focuses on the sales uptake of potential of MSA drugs that have recently been launched or are anticipated to be launched in the MSA market between 2022 and 2036. It estimates the market penetration of MSA drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the MSA market.

The emerging MSA therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfil in the MSA market.

Note: Detailed assessment of drug uptake and attribute analysis will be provided in the full report on MSA

Multiple System Atrophy Market Access and Reimbursement

DelveInsight’s ‘MSA – Market Insights, Epidemiology, and Market Forecast – 2036’ report provides a descriptive overview of the market access and reimbursement scenario of MSA.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments. 

Key Opinion Leaders (KOLs) Views

To keep up with current MSA market trends and fill gaps in secondary findings, we interview KOLs and SMEs’ working in the MSA domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or MSA market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the MSA unmet needs.

MSA: KOL Insights

DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Duke University School of Medicine, University of Florida Gainesville, Stanford University, Hospital Clinic of Barcelona, Iwate Medical University, Leipzig University Hospital, University of Florida Gainesville, Florida, Service des Maladies de l'Appareil digestif, Hôpital Huriez, CHU, Lille, France, Hospital Clinic of Barcelona, Barcelona, Spain, Department of Internal Medicine, Iwate Medical University, Morioka, among others.

Note: Detailed assessment of KOL Views will be provided in the full report on MSA.

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the MSA Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

MSA Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for MSA. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging MSA therapies.

Multiple System Atrophy Report Insights

• MSA Patient Population
• Therapeutic Approaches
• MSA Pipeline Analysis
• MSA Market Size and Trends
• MSA Market Opportunities
• Impact of Upcoming Therapies

Multiple System Atrophy Report Key Strengths

• 11 Years Forecast
• The 7MM Coverage
• MSA Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed MSA Market
• MSA Drugs Uptake

Multiple System Atrophy Report Assessment

• MSA Current Treatment Practices
• Unmet Needs
• MSA Pipeline Product Profiles
• MSA Market Attractiveness

Key Questions

• How common is MSA?
• What are the key findings of MSA epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2022–2036)?
• What are the currently available treatments for MSA?
• What are the disease risk, burden, and unmet needs of MSA?
• At what CAGR is the MSA market and its epidemiology is expected to grow in the 7MM during the forecast period (2026–2036)?
• How would the unmet needs impact the MSA market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of MSA in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2026–2036)?
• How many companies are currently developing therapies for the treatment of MSA?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the MSA market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the attribute analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of key opinion leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future. 
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.