Multiple System Atrophy Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Diagnosis (Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Tilt Table Test, Others), By Age (Pediatric, Adults, Geriatric), By End User (Hospitals, Ambulatory Surgical Centers, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 154.39 Million
CAGR (2026-2031)	3.11%
Fastest Growing Segment	Magnetic Resonance Imaging (MRI)
Largest Market	North America
Market Size (2031)	USD 185.53 Million

Market Overview

The Global Multiple System Atrophy Market will grow from USD 154.39 Million in 2025 to USD 185.53 Million by 2031 at a 3.11% CAGR. The Global Multiple System Atrophy (MSA) Market encompasses the development and commercialization of symptomatic therapeutics and emerging disease-modifying agents designed to treat this rare, progressive neurodegenerative disorder. A primary driver propelling market growth is the enhancement of diagnostic protocols and heightened clinical awareness, which are collectively reducing the latency between symptom onset and accurate identification. Validating this trajectory of improved detection, according to the Multiple System Atrophy Trust, in 2024, the organization reported a 38% increase in community registrations since 2020, reflecting a marked expansion in the recognized patient population that requires specialized care.

Despite these advancements, the market encounters a significant challenge regarding diagnostic ambiguity, as early-stage MSA symptoms frequently mimic those of Parkinson’s disease. This clinical overlap often leads to misdiagnosis, which severely complicates patient recruitment for clinical trials and increases the risk of failure for investigational drugs, thereby impeding the timely introduction of novel therapies to the market.

Key Market Drivers

The Robust Clinical Pipeline of Novel Disease-Modifying Therapies is acting as a primary catalyst for the Global Multiple System Atrophy Market, shifting the focus from symptomatic management to potential curative interventions. This driver is characterized by an increasing number of late-stage clinical trials targeting alpha-synuclein pathology, which is central to the disease's progression. For instance, according to Alterity Therapeutics, July 2025, topline data from a Phase 2 trial demonstrated that their lead candidate, ATH434, reduced disease progression by approximately 50% compared to historical controls. Such advancements underscore the industry's success in identifying viable therapeutic targets, thereby attracting further scientific interest and validation. Reflecting this expanding research scale, according to Practical Neurology, in February 2025, a new Phase 3 clinical trial was initiated to evaluate amlenetug, aiming to enroll over 300 participants across multiple international sites.

Favorable Regulatory Incentives and Orphan Drug Designations are simultaneously accelerating market growth by mitigating the financial risks associated with developing treatments for rare neurodegenerative disorders. Regulatory agencies are actively encouraging innovation through expedited review pathways, which are essential for rapidly bringing promising therapies to patients with high unmet needs. A notable example of this support occurred when, according to Lundbeck, February 2025, the U.S. FDA granted Fast Track Designation to amlenetug after Phase 2 data indicated a 37% slower rate of clinical progression in a specific patient subgroup. These regulatory milestones not only expedite the development timeline but also signal commercial viability to investors, ensuring sustained funding for complex drug development programs in this niche market.

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Key Market Challenges

The diagnostic ambiguity associated with Multiple System Atrophy (MSA) stands as a critical impediment to the growth of the global market. Because early-stage symptoms of MSA—such as motor rigidity and autonomic dysfunction—closely mimic those of Parkinson’s disease, patients are frequently misdiagnosed or endure long delays before receiving an accurate confirmation. This clinical uncertainty directly hampers the market by disrupting the drug development pipeline; precise patient identification is essential for the success of clinical trials. When potential candidates are misidentified or diagnosed too late to meet inclusion criteria, recruitment becomes inefficient, and the risk of trial failure increases, which in turn discourages investment in new therapeutic agents.

The magnitude of this obstacle is significant within the current clinical landscape. According to the International Parkinson and Movement Disorder Society, in 2024, clinical data indicated that misdiagnosis rates for early-stage Multiple System Atrophy ranged between 21% and 38%. This substantial margin of error complicates patient stratification for research, thereby slowing the validation of emerging drugs and delaying the commercial introduction of effective treatments to the patient population.

Key Market Trends

The Adoption of Novel Neuroimaging and Fluid Biomarker Technologies is fundamentally reshaping the market by transitioning diagnostic protocols from subjective clinical observation to precise biological validation. This trend addresses the sector's most persistent challenge—distinguishing Multiple System Atrophy from similar synucleinopathies—by deploying advanced tools such as seed amplification assays. These technologies are rapidly moving from research settings to commercial availability, enabling earlier patient stratification and reducing the costly failure rates associated with misdiagnosed trial participants. Validating this commercial integration, according to Mayo Clinic Laboratories, March 2025, in a press release announcing a partnership with Amprion, the organization launched the SAAmplify-ɑSYN test, a fluid biomarker assay capable of detecting misfolded alpha-synuclein pathology years before the onset of overt clinical symptoms.

The Expansion of Clinical Trials for Neurogenic Orthostatic Hypotension represents a parallel trend focused on addressing the severe autonomic dysfunction that characterizes the disease, distinct from curative efforts. While disease-modifying agents target underlying neurodegeneration, this trend prioritizes immediate quality-of-life improvements for patients suffering from debilitating blood pressure volatility. Pharmaceutical developers are aggressively advancing late-stage studies for this indication, recognizing the urgent need for durable symptomatic relief alongside potential cures. For instance, according to Theravance Biopharma, August 2025, in a corporate update regarding the Phase 3 CYPRESS trial, the company announced the completion of patient enrollment for ampreloxetine, a therapy designed to treat symptomatic neurogenic orthostatic hypotension in a targeted population of approximately 40,000 U.S. patients.

Segmental Insights

The Magnetic Resonance Imaging segment constitutes the fastest-growing area in the Global Multiple System Atrophy Market due to its essential role in resolving diagnostic uncertainty. Clinicians rely on this modality to differentiate the condition from Parkinson’s disease by identifying specific neurological biomarkers. This demand is amplified by the lack of specific laboratory tests, making imaging central to clinical assessment. Additionally, evolving consensus criteria from groups like the International Parkinson and Movement Disorder Society increasingly emphasize neuroimaging features to support accurate diagnosis, directly encouraging the broader adoption of this technology across healthcare facilities.

Regional Insights

North America leads the Global Multiple System Atrophy market, driven by a well-established healthcare infrastructure and high rates of clinical diagnosis. The region benefits from substantial investment in research and development by major pharmaceutical companies targeting rare neurodegenerative conditions. Additionally, supportive initiatives from regulatory bodies like the U.S. Food and Drug Administration, including orphan drug designations, actively encourage the creation of new therapeutics. These factors, combined with favorable healthcare reimbursement policies that improve patient access to treatment, firmly establish North America as the primary market for these medical interventions.

Recent Developments

• In August 2025, Theravance Biopharma announced the successful completion of patient enrollment in its pivotal Phase 3 CYPRESS clinical trial. This study was designed to evaluate the safety and efficacy of ampreloxetine, an investigational norepinephrine reuptake inhibitor, for the treatment of symptomatic neurogenic orthostatic hypotension in individuals with multiple system atrophy. The company highlighted that the trial utilized a randomized withdrawal design based on insights from earlier studies to robustly assess the drug's durability and clinical benefit. This operational milestone positioned the organization to proceed toward potential regulatory filings for this rare and debilitating neurodegenerative condition.
• In February 2025, the U.S. Food and Drug Administration granted Fast Track designation to Lundbeck’s investigational antibody, amlenetug, for the treatment of multiple system atrophy. This regulatory decision was supported by promising data from a completed Phase 2 clinical trial, which suggested that the therapy could potentially slow disease progression relative to placebo. The designation was intended to facilitate the development and expedite the review of the drug, which functions by targeting extracellular alpha-synuclein to prevent its uptake and aggregation. The company emphasized that this milestone underscored the urgent need for disease-modifying treatments for patients suffering from this rapidly progressive neurological condition.
• In January 2025, Alterity Therapeutics announced positive topline results from its randomized, double-blind Phase 2 clinical trial evaluating the lead asset ATH434 in patients with early-stage multiple system atrophy. The study met its primary objectives, confirming that the oral agent was well-tolerated and maintained a favorable safety profile comparable to placebo. Furthermore, the company reported that the treatment demonstrated potential clinical benefits as measured by standard neurological rating scales and biomarker assessments. These encouraging findings provided the necessary evidence to support the continued clinical development of the drug candidate, which is designed to reduce pathological protein aggregation in the brain.
• In October 2024, Ionis Pharmaceuticals presented interim data from its Phase 1/2 HORIZON clinical trial evaluating ION464 at a major international medical congress. The investigational antisense oligonucleotide, which is designed to inhibit the production of alpha-synuclein, was reported to be safe and well-tolerated in participants with multiple system atrophy. The presented data indicated that the treatment achieved successful target engagement, evidenced by reductions in specific protein levels within the cerebrospinal fluid. These findings supported the company's strategy to continue the development of the therapy, aiming to potentially slow the progression of this fatal neurodegenerative disorder by addressing its underlying genetic driver.

Key Market Players

• Biohaven Ltd.
• Theravance Biopharma
• Sumitomo Dainippon Pharma Co., Ltd.
• Alterity Therapeutics
• AstraZeneca plc.
• Biogen
• Merck & Co., Inc.
• Neuropore Therapies, Inc.
• WaveBreak Therapeutics
• Newron Pharmaceuticals SPA

By Diagnosis	By Age	By End User	By Region
Magnetic Resonance Imaging (MRI) Positron Emission Tomography (PET) Single Photon Emission Computed Tomography (SPECT) Tilt Table Test Others	Pediatric Adults Geriatric	Hospitals Ambulatory Surgical Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Multiple System Atrophy Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Multiple System Atrophy Market, By Diagnosis:

• Magnetic Resonance Imaging (MRI)
• Positron Emission Tomography (PET)
• Single Photon Emission Computed Tomography (SPECT)
• Tilt Table Test
• Others

• Multiple System Atrophy Market, By Age:

• Pediatric
• Adults
• Geriatric

• Multiple System Atrophy Market, By End User:

• Hospitals
• Ambulatory Surgical Centers
• Others

• Multiple System Atrophy Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE