Multiple System Atrophy (MSA) - Market Insight, Epidemiology and Market Forecast - 2032

Key Highlights:

• MSA is a rapidly progressive synucleinopathies, group of disorders characterized by the abnormal deposition of the protein aS in the central and peripheral autonomic nervous system.
• In 2022, the market size of MSA was highest in the US among the 7MM accounting for approximately USD 131 million that is further expected to increase by 2032.
• The first line treatment include Levodopa, Adrenergic receptor agonists, and others (off label therapies like Clonazepam, gabapentin, etc.).
• While the larger market is covered by Adrenergic receptor agonists, making up the total market of around USD 75 million in 2022, in the 7MM.
• MSA approximately accounted 51 thousand cases in 2022 in the 7MM, the treatment market of MSA lacks approved therapy specific to MSA treatment
• Theravance Biopharma's Ampreloxetine (TD-9855) is being developed for treating patients with symptomatic neurogenic orthostatic hypotension (nOH) in MSA. It is estimated to launch by 2026 in the US.
• This emerging therapy have the potential to create a significant positive shift in the Multiple System Atrophy market size

This “Multiple System Atrophy- Market Insights, Epidemiology and Market Forecast- 2032” report delivers an in-depth understanding of the Multiple System Atrophy, historical and forecasted epidemiology as well as the Multiple System Atrophy market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Multiple System Atrophy market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM MSA market size from 2019 to 2032. The report also covers current MSA treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2019-2032

Multiple System Atrophy Disease Understanding and Treatment Algorithm

Multiple System Atrophy Overview

Multiple system atrophy is a rare, rapidly progressing, fatal neurodegenerative disorder of uncertain etiology that is clinically characterized by a variable combination of Parkinsonism, cerebellar impairment, and autonomic and motor dysfunctions. Depending on the predominant clinical phenotype, the disease is sub-classified into a parkinsonian variant (MSA-P) associated with SND, a cerebellar (MSA-C) variant with OPCA with predominant cerebellar features, and a combination of both forms, referred to as “mixed” MSA

Multiple System Atrophy Diagnosis

The accurate clinical diagnosis of MSA is based on a careful medical history and meticulous neurological examination. Ancillary investigations are helpful to support the diagnosis, rule out potential mimics, and define therapeutic strategies. This review summarizes diagnostic investigations useful in diagnosing MSA.

Current consensus guidelines include neuroimaging criteria for the diagnosis of possible MSA. These include the presence of atrophy of the putamen, middle cerebellar peduncle, pons or cerebellum on brain magnetic resonance imaging (MRI), and putamen, brainstem or cerebellum hypo metabolism on brain fluorodeoxyglucose (FDG) positron emission tomography (PET), as well as dopaminergic denervation on PET or single photon emission computed tomography (SPECT).

Brain MRI is the gold standard imaging technique for the evaluation of parkinsonian and cerebellar syndromes, including MSA. A brain MRI including standard sequences and diffusion weighted imaging (DWI) should be included in the initial evaluation of every patient with suspected MSA. Several brain MR modalities are available.

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

Multiple System Atrophy Treatment

Current therapeutic management is based on symptomatic treatment. To date, no curative treatment is available for MSA.

Tremor, rigidity, bradykinesia, and postural instability are core features of MSA-P and are observed irrespective of subtype in nearly 90% of cases. A poor or unstained response to levodopa is common and among the core diagnostic features of MSA, helping to differentiate MSA-P from PD. Nearly a third of MSA-P patients benefit from levodopa therapy, but temporarily with a mean duration of 3.5 years in one study. Levodopa remains the first-line therapy with trial up to 2 g total daily dose of levodopa (titrated from 100 mg to 300 mg 3-4 times daily) recommended for at least 3 months. Clinically significant improvement is a 30% decrease in the UMSARS. Levodopa may worsen OH or cause other more severe side effects less common among PD patients. Reports of deterioration with the medication withdrawal, even in the context of apparent nonresponse, are common and may justify the continuation of treatment.

Multiple System Atrophy Epidemiology

As the market is derived using the patient-based model, the Multiple System Atrophy epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, total diagnosed prevalent cases of Multiple System Atrophy, gender-specific diagnosed prevalent cases of Multiple System Atrophy, age-specific diagnosed prevalent cases of Multiple System Atrophy, type-specific diagnosed prevalent cases of Multiple System Atrophy, and nOH symptomatic cases of multiple system atroph in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032. The total diagnosed prevalent cases of Multiple System Atrophy in the 7MM comprised approximately 51 thousand cases in 2022 and are projected to increase during the forecasted period.

• The total diagnosed prevalent cases of Multiple System Atrophy in the United States were around 24 thousand cases in 2022.
• The United States contributed to the largest diagnosed prevalent population of Multiple System Atrophy, acquiring ~48% of the 7MM in 2022. Whereas, EU4 and the UK, and Japan accounted for around 28% and 24% of the total population share, respectively, in 2022.
• Among the EU4 countries, Germany accounted for the largest number of Multiple System Atrophy cases followed by France, whereas Spain accounted for the lowest number of cases in 2022.
• In 7MM, approximately 54% of the patient share is attributed to males whereas remaining 46% of females suffer from Multiple System Atrophy.
• A higher number of diagnosed cases were estimated in the 50-59 age group, suggesting that the prevalence of MSA increases with age.
• According to the publisher estimates, based on type there were around 31 thousand cases of MSA-P, while for MSA-C around 20 thousand cases were estimated, in the 7MM in 2022.

Multiple System Atrophy Drug Chapters

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

Emerging Drugs

Ampreloxetine (TD-9855): Theravance Biopharma

TD-9855 is an investigational, once-daily Norepinephrine Reuptake Inhibitor (NRI) in development for treating patients with symptomatic neurogenic orthostatic hypotension (nOH). It has a high affinity for binding to norepinephrine transporters. By blocking the action of these transporters, ampreloxetine causes an increase in extracellular concentrations of norepinephrine.

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

Drug Class Insights

The current therapeutic management of Multiple System Atrophy is based on symptomatic treatment and has witnessed little change since a decade. Considering the approved market segment, NORTHERA (droxidopa) is the world's first approved therapy for symptomatic nOH.

Moreover, the upcoming treatment landscape is poised to see further expansion after the emergence of new classes such as Ampreloxetine, is in Phase III for treating patients with symptomatic neurogenic orthostatic hypotension. Lu AF82422, a monoclonal antibody; AAV2-GDNF, a gene therapy is in early phase of clinical investigation for MSA. Such novel drugs are expected to change the dynamics of the current treatment regime.

Multiple System Atrophy Market Outlook

Currently, no disease-modifying agent is approved. The drug used to treat PD (parkinsonism), most notably levodopa (SINEMET), is also prescribed for MSA individuals. However, the efficacy of such medications varies greatly among affected individuals. Apart from levodopa, other drugs used to treat PD may be used to treat MSA individuals. These include dopamine agonists such as ropinirole (Requip) and pramipexole (Mirapexin), which increase the activity of dopamine receptors in the brain. This helps the brain receive dopamine signals. Midodrine hydrochloride (ProAmatine) has been used to treat low blood pressure, sometimes associated with MSA. Adrenergic drugs such as ephedrine may be used to treat low blood pressure. L-threo-dihydroxyphenylserine (L-DOPS or L-threo-DOPS) can also treat low blood pressure.

The major challenge and unmet need in MSA treatment are that no drug is approved for the direct treatment of MSA. The key competitive factors that may affect the success of these products, and any other product candidates that are yet to reach the market, if approved, are likely to be efficacy, safety, convenience, cost, the availability of generic competition, and the reimbursement from government and/or other third-party payers.

Few new agents are being developed and tested as potential treatments for MSA; the emerging drugs include Ampreloxetine, Lu AF82422, AAV2-GDNF, and others.

• The total market size of Multiple System Atrophy in the 7MM was approximately USD 182 million in 2022 and is projected to increase during the forecast period (2023-2032)
• The market size in the 7MM will increase at a constant CAGR due to increasing awareness of the disease, better diagnosis, and the launch of the emerging therapy.
• Among EU4 countries, Germany with about USD 7 million accounts for the maximum market size in 2022 while Spain occupies the bottom of the ladder with around USD 4 million in 2022.
• Japan's treatment market lacks approved targeted treatment for MSA, but with the expected approval of Ampreloxetine by 2028 the market is expected to experience positive growth.

Multiple System Atrophy Drugs Uptake

This section focuses on the rate of uptake of the potential drugs expected to get launched in the market during the study period 2019-2032. For example, for Ampreloxetine, we expect the drug uptake to be medium with a probability-adjusted peak share of around 27%, and years to the peak is expected to be 6 years from the year of launch.

Further detailed analysis of emerging therapies drug uptake in the report.

Multiple System Atrophy Pipeline Development Activities

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

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for Multiple System Atrophy emerging therapies.

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's therapy switching acceptability, and drug uptake along with challenges related to accessibility, include Medical/scientific writers, Medical Professors, Director of Henry Mayo Newhall Memorial Hospital, and Others.

This analysts connected with 50+ KOLs to gather insights, however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as Brain Research Institute, University of California, University of Utah, Johannes-Gutenberg-University etc. were contacted. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or Multiple System Atrophy market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

The publisher performs Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis, 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 is done to analyze multiple approved and 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.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and 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

Reimbursement is a crucial factor affecting the drug's market access. Often, the decision to reimburse comes down to the drug's price relative to the benefit it produces in treated patients. NORTHERA patient support provides support to the patients requiring NORTHERA prescription. According to this plan, the patient's health insurance plan will determine the financial coverage, the amount they will pay for prescriptions, and additional savings they may be eligible for.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, 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, descriptive overview of Multiple System Atrophy, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies

• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression along with treatment guidelines
• Additionally, an all-inclusive account of both the current and emerging therapies along with the elaborative profiles of late-stage and prominent therapies will have an impact on 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 preference that help in shaping and driving the 7MM Multiple System Atrophy market

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

• Ten Years Forecast
• 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 Conjoint Analysis)

Key Questions Answered

Market Insights:

• What was the Multiple System Atrophy total market size, the market size by therapies, and market share (%) distribution in 2019, and how it would all look in 2032? What are the contributing factors for this growth?
• What unmet needs are associated with the current treatment market of MSA?
• How is Ampreloxetine going to compete with other treatments?
• Which drug is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burden, and unmet needs of Multiple System Atrophy? What will be the growth opportunities across the 7MM concerning the patient population of 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?
• Which type is more prevalent and why?
• What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Multiple System Atrophy? What are the current treatment guidelines for the treatment of Multiple System Atrophy in the US and Europe?
• 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 the treatment of Multiple System Atrophy?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Multiple System Atrophy?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted market of Multiple System Atrophy?

Reasons to Buy

• The report will help in developing 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
• 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 approved products 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 Conjoint analysis section to provide visibility around leading classes
• Highlights of Market 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 future
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy