Multiple System Atrophy (MSA) - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• According to DelveInsight's estimates, in 2023, there were approximately 70,800 prevalent cases of MSA in the 7MM. Of these, the US accounted for 60% of the cases, while EU4 and the UK accounted for nearly 16% and Japan represented 24% of the cases, respectively.
• The MSA market is poised for steady growth, with a strong compound annual growth rate (CAGR) projected from 2024 to 2034. This expansion across the 7MM will be driven by the launch of innovative therapies, including, Amlenetug (Lu AF82422), Ampreloxetine ATH434, TAK-341/MEDI1341, and Emrusolmin.
• According to DelveInsight's analysis, the MSA in the 7MM was valued at approximately USD 43 million in 2023. Over the forecast period from 2024 to 2034, this market is projected to grow at a CAGR of 44.7%.
• There are no approved therapies to slow MSA's neurodegeneration, but symptom management options include levodopa, amantadine, droxidopa, adrenergic receptors agonists, and various off-label therapies that provide relief and help patients cope with the disease's effects.
• Challenges in accurately diagnosing and defining the condition hinder the advancement of clinical trials for potential disease-modifying therapies.
• The rapid progression, severe morbidity, and shortened life expectancy of the disease lead to poor patient outcomes, profoundly affecting the quality of life for individuals and their caregivers, creating significant emotional, physical, and social challenges for both parties.

DelveInsight's "Multiple System Atrophy (MSA) - Market Insights, Epidemiology, and Market Forecast - 2034" 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 provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM MSA market size from 2020 to 2034. The report also covers MSA treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Multiple System Atrophy (MSA) Understanding and Treatment Algorithm

Multiple System Atrophy overview

MSA is a progressive neurodegenerative disease marked by symptoms affecting movement and the autonomic nervous system. Its cause remains unknown, and most cases are sporadic. A hallmark of MSA is the accumulation of alpha-synuclein in oligodendroglial cells, which produce myelin, essential for efficient nerve signal transmission.

In 1969, the term MSA was introduced to combine three previously recognized neurological conditions: Shy-Drager syndrome (focused on autonomic dysfunction), Striatonigral Degeneration (emphasizing Parkinsonian symptoms), and sporadic Olivopontocerebellar Atrophy (highlighting cerebellar symptoms). This unification helped categorize overlapping clinical features under a single diagnosis.

Early symptoms of MSA include bradykinesia, tremors, stiffness, and lack of coordination. Diagnostic subtypes are MSA-P, resembling Parkinson's disease with Parkinsonian features, and MSA-C, distinguished by cerebellar dysfunction, primarily presenting as ataxia and impaired balance, reflecting the diverse neurological impacts of this progressive disorder.

MSA is divided into two main subtypes: MSA with predominant Parkinsonism (MSA-P) and MSA with predominant cerebellar ataxia (MSA-C). However, these classifications are flexible, as a patient's symptoms can shift between the two over time.

Multiple System Atrophy diagnosis

Diagnosing of MSA is challenging, especially in its early stages, as it shares symptoms with Parkinson's disease. Diagnostic methods may include autonomic testing (e.g., blood pressure and heart rate monitoring), bladder function assessment, and neuroimaging techniques like MRI or PET scans.

Multiple System Atrophy treatment

Pharmacological treatments for MSA target Parkinsonism, autonomic dysfunction, cerebellar ataxia, and sleep issues. Levodopa is the first-line treatment for Parkinsonism, with temporary benefits, while dopamine agonists and amantadine offer alternative options but may cause more side effects.

Multiple System Atrophy Epidemiology

As the market is derived using a patient-based model, the MSA epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Diagnosed Prevalence Cases of MSA, Gender-specific Diagnosed Prevalent Cases of MSA, Age-specific Diagnosed Prevalent Cases of MSA, Type-specific Diagnosed Prevalent Cases of MSA in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.

• In 2023, the US accounted for the highest prevalent cases of MSA with approximately 42,500 cases, which are expected to increase by 2034 at a CAGR of 1.0%.
• In 2023, the Germany reported the highest number of prevalent cases of MSA among the EU4 and the UK, with approximately 2,700 cases. UK followed with around 2,400 cases, while Spain recorded the lowest prevalent cases, with nearly 1,500 cases.
• In 2023, Japan reported approximately 5,100 prevalent cases of MSA in males and 12,000 cases in females, with numbers projected to rise by 2034.
• In the US, the number of cases in 2023 were as follows: around 400 cases in stage 0, around 800 in stage 1, ~2,100 in stage 2, ~15,000 in stage 3, ~13,000 in stage 4, and ~10,000 in stage 5 and these numbers projected to rise by 2034.
• In Japan, around 30% of MSA cases reported in 2023 were associated with MSA-P, while 70% were linked to MSA-C, indicating that MSA-C is the dominant type than MSA-P.
• In 2023, Germany recorded the highest number of MSA around 1,400 cases in the 70 years and above age group. Among the age groups 50-59 years and 60-79 years, the 70 years and above group is expected to see an increase to 1,500 cases by 2034.
• In 2023, Japan recorded around 13,700 cases of symptomatic nOH in MSA patients, with the number projected to reach around 14,100 cases by 2034.

Multiple System Atrophy Drug Chapters

The drug chapter segment of the MSA report encloses a detailed analysis of MSA early and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the MSA clinical trial details, expressive pharmacological action, agreements and collaborations, advantages and disadvantages of each included drug, and the latest news and press releases.

Emerging Drugs

Emrusolmin (TEV-56286, Anle-138b): Teva Pharmaceutical/MODAG GmBH

Anle138b is a small molecule designed to target toxic alpha-synuclein oligomers, dissolving them and preventing new formations, thus addressing neurodegenerative disorders. Preclinical studies show it halts disease progression. Unlike antibody treatments, it is orally administered and crosses the blood-brain barrier. In July 2022, it received orphan drug designation for MSA and is currently in Phase II clinical studies.

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

Lu AF82422 is a human monoclonal antibody designed to target toxic alpha-synuclein proteins involved in MSA pathology. It seeks to slow or stop disease progression by clearing these harmful proteins. The compound has demonstrated effectiveness in Phase II and has received orphan drug and SAKIGAKE designations. It is now in Phase III trials.

Ampreloxetine (TD-9855): Theravance Biopharma

Ampreloxetine is an investigational norepinephrine reuptake inhibitor being developed for symptomatic neurogenic orthostatic hypotension (nOH) in MSA patients. It increases norepinephrine levels by blocking its transporters. Currently in Phase III trials, it has received ODD status from the US FDA and patent protection until 2037.

Drug Class Insights

MSA treatment primarily focuses on symptom management, as there is no cure. Pharmacological therapies, such as levodopa for Parkinsonism and other medications for autonomic dysfunction, cerebellar ataxia, and sleep disturbances, are commonly used. Immunotherapy is not typically part of MSA treatment, as it targets underlying protein aggregation rather than immune response.

Emerging therapies include Amlenetug, Ampreloxetine, ATH434, TAK-341/MEDI1341 and Emrusolmin (Anle138b).

Amlenetug, developed by H. Lundbeck A/S and Genmab, is a monoclonal antibody targeting toxic alpha-synuclein in MSA, aiming to slow progression, now in Phase III.

Ampreloxetine, a norepinephrine reuptake inhibitor for symptomatic neurogenic orthostatic hypotension in MSA, is in Phase III trials with ODD status.

Emrusolmin (Anle138b), is a small molecule targeting toxic alpha-synuclein oligomers to halt disease progression. It is orally administered, crosses the blood-brain barrier, and received orphan drug designation for MSA, currently in Phase II trials.

Market Outlook

MSA is a rare neurodegenerative disorder that typically begins in adulthood, usually after age 30. It shares symptoms with Parkinson's disease, such as Parkinsonism, but also includes additional features like cerebellar ataxia and autonomic dysfunction, affecting involuntary processes such as heart rate and blood pressure. MSA is classified as MSA-P when Parkinsonism predominates, and MSA-C when cerebellar symptoms are more prominent. Currently, no disease-modifying treatments are approved for MSA, offering a significant opportunity for pharmaceutical companies to develop the first effective therapies. Existing Parkinson's treatments like levodopa have limited effectiveness, underscoring the need for targeted treatments for MSA.

Currently, no disease-modifying treatments are approved for MSA in the 7MM, creating a significant opportunity for pharmaceutical companies to develop the first approved therapy. While Parkinson's drugs like levodopa are used, their effectiveness varies. northera (droxidopa) is commonly prescribed for neurogenic orthostatic hypotension (nOH), a common MSA symptom. Approved in 2014, northera addresses nOH but lost market exclusivity in 2021, despite its impact on MSA-related disability and injury risk.

Pharmacological treatments for MSA focus on Parkinsonism, autonomic dysfunction, cerebellar ataxia, and sleep issues. Levodopa is the first-line treatment for Parkinsonism, providing temporary relief, especially in MSA-P patients. While effective, its benefits are limited, and side effects like orthostatic hypotension require management. Dopamine agonists and amantadine may offer alternatives, though they are less preferred due to side effects.

Currently, there are no approved therapies to slow neurodegeneration in MSA. However, symptom management includes options like Levodopa, Amantadine, Droxidopa, Anticholinergic agents, and off-label treatments to help patients cope. Potential future therapies for MSA include Lu AF82422 (H. Lundbeck A/S/Genmab), Ampreloxetine (Theravance Biopharma), Emrusolmin (Teva Pharmaceutical/MODAG GmbH), and others.

• In 2023, the MSA market size in the US was around USD 38 million, accounting for 88% of the total market. This figure is expected to grow significantly with the introduction of emerging therapies.
• The total market size of EU4 and the UK was estimated to be approximately USD 2.3 million in 2023, which was nearly 5% of the total market revenue for the 7MM.
• Among EU4 and the UK, Germany accounted for the highest market share with approximately USD 0.57 million in 2023, followed by UK with approximately USD 0.50 million in the respective year, and Spain, capturing the least market with nearly USD 0.32 million in 2023.
• In 2023, the total market size of MSA was approximately USD 2.98 million in Japan which is anticipated to increase during the forecast period (2024-2034).
• According to estimates, among the emerging therapies, Amlenetug (Lu AF82422) is expected to capture the largest market share, generating around USD 795 million in revenue by 2034 across the 7MM.

Multiple System Atrophy Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034.

Multiple System Atrophy Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for MSA.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on MSA evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of California, the US, University of Maryland School of Medicine, the US, University of Texas Southwestern, the US, University Medical Center, Johannes-Gutenberg-University, Germany, Department of Neurology Center Hospitalier de la Cote Basque Bayonne, France, University of Pisa, Italy, Barcelona Clinical Hospital, Spain, University of Aberdeen, the UK, Hyogo College of Medicine, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy 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 unmet needs.

Physician's View

As per the KOLs from the US, The diagnosis of MSA is complicated, and this is mostly due to the overlap with other similar Parkinsonian syndromes. It was found that some cases are misdiagnosed as other clinical syndromes when there is no severe dysautonomia or cerebellar dysfunction (like cerebellar ataxia or dysarthria). Importantly, there are not great treatment options for the autonomic and cerebellar symptoms in patients with MSA clinical phenotype, but there are many clinical trials still in progress to find treatments for these aspects.

As per the KOLs from Germany, The MSA distinction into MSA-P and MSA-C is based on the predominant clinical features. MSA-P is more common in most of the countries, with the exception of Japan, where MSA-C is the predominant phenotype. Patients with MSA have an early, usually transient, and in general poorer, response to L-Dopa compared to patients with Parkinson's disease.

As per the KOLs from Japan, Distinguishing MSA from other neurodegenerative parkinsonisms, such as Parkinson's disease, dementia with Lewy bodies, and progressive supranuclear palsy, can be challenging. However, advancements in imaging techniques, like [123I]-Meta-iodo Benzyl Guanidine (MIBG) myocardial scintigraphy, have shown promise in helping differentiate PD from other Parkinsonian syndromes, improving diagnosis and treatment strategies for MSA.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The National Institute of Neurological Disorders and Stroke (NINDS).

The National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH, is crucial in advancing MSA research. By funding top medical institutions, NINDS supports studies to better understand and treat MSA. In 2007, NINDS held a global consensus conference to improve diagnostic criteria, aiding quicker and more accurate diagnoses. Ongoing research aims to uncover the mechanisms behind synuclein buildup in MSA and Parkinson's disease, with the goal of developing preventative and therapeutic approaches for these neurodegenerative conditions. Further details will be provided in the report.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of multiple system atrophy, explaining its causes, signs and symptoms, pathogenesis, and emerging therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the multiple system atrophy market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM multiple system atrophy.

Multiple System Atrophy report insights

• Patient Population
• Therapeutic Approaches
• Multiple System Atrophy Pipeline Analysis
• Multiple System Atrophy Market Size and Trends
• Existing and Future Market Opportunity

Multiple System Atrophy report key strengths

• 11 years Forecast
• The 7MM Coverage
• Multiple System Atrophy Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Multiple System Atrophy report assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Attribute Analysis)

Key Questions:

Market Insights

• What was the total market size of multiple system atrophy, the market size of multiple system atrophy by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will amlenetug (Lu AF82422) affect the treatment paradigm of multiple system atrophy?
• What would be the multiple system atrophy market growth till 2034 and what will be the resultant market size in the year 2034?
• Which drug is going to be the largest contributor by 2034?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest multiple system atrophy market size during the forecast period (2024-2034)?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of multiple system atrophy? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to multiple system atrophy?
• What is the historical and forecasted multiple system atrophy patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent cases of multiple system atrophy population during the forecast period (2024-2034)?
• What factors are contributing to the growth of multiple system atrophy cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of multiple system atrophy? What are the current clinical and treatment guidelines for treating multiple system atrophy?
• How many companies are developing therapies for the treatment of multiple system atrophy?
• How many emerging therapies are in the mid-stage and late stage of development for treating multiple system atrophy?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the challenges of multiple system atrophy?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted market of multiple system atrophy?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the multiple system atrophy 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.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of market access and reimbursement policies for multiple system atrophy, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand key opinion leaders' perspectives 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.