Alpha-synuclein Inhibitors - Target Population, Competitive Landscape, and Market Forecast - 2034

Key Highlights:

• Alpha-synuclein inhibitors are therapeutic agents designed to prevent the aggregation of alpha-synuclein, a protein implicated in neurodegenerative diseases like Parkinson's disease, Lewy body dementia and Multiple System Atrophy (MSA). These inhibitors work by blocking misfolding, reducing toxic accumulation, and enhancing clearance mechanisms. By targeting alpha-synuclein pathology, they aim to slow disease progression, offering potential breakthroughs in neuroprotection and symptom management.
• While no alpha-synuclein inhibitors have received regulatory approval yet, the FDA has issued a 'Letter of Support' advocating for the use of the synuclein-based biomarker, aSyn-SAA, in clinical trials targeting Parkinson's disease and related neurodegenerative disorders. This endorsement highlights the biomarker's potential role in improving disease tracking, enhancing drug development, and refining therapeutic strategies.
• Given the scarcity of approved alpha-synuclein inhibitors, multiple companies, including Annovis Bio, Roche/Prothena, Lundbeck, and among others, are actively working to advance their pipelines and develop new therapeutic candidates. These efforts aim to enhance treatment strategies, improve drug efficacy, and address the unmet medical need in neurodegenerative diseases like Parkinson's, Lewy body dementia, and MSA.
• Emerging alpha-synuclein inhibitors in the pipeline, including buntanetap, prasinezumab, amlenetug, and others, are showing promise for expanding treatment options.
• In January 2025, Annovis Bio secured a significant milestone with the issuance of a US patent protecting its novel methods for treating and preventing acute brain and nerve injuries through buntanetap. This intellectual property win reinforces the company's strategic positioning and expands the therapeutic potential of its lead candidate beyond neurodegenerative diseases.

DelveInsight's "Alpha-synuclein Inhibitors" - Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the alpha-synuclein inhibitors, historical and projected epidemiological data, competitive landscape as well as the alpha-synuclein inhibitors market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

The alpha-synuclein inhibitors market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM alpha-synuclein inhibitors market size from 2020 to 2034. The report also covers current alpha-synuclein inhibitors treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

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

Alpha-synuclein Inhibitors Understanding and Treatment Algorithm

Alpha-synuclein Inhibitors Overview

Alpha-synuclein (a-Syn) is a highly soluble, unstructured protein that accumulates in Lewy bodies and Lewy neurites, contributing to Parkinson's disease and other synucleinopathies. It is primarily found in the brain, with smaller amounts present in the heart, muscles, and other tissues. Within neurons, it is concentrated in presynaptic terminals, where it plays a role in synaptic vesicle regulation. Research suggests that alpha-synuclein may limit vesicle mobility, affecting synaptic recycling and neurotransmitter release. An alternative perspective posits that it binds to VAMP2 (a synaptobrevin) and stabilizes SNARE complexes, with recent findings linking alpha-synuclein-VAMP2 interactions to synaptic function. Additionally, alpha-synuclein may help modulate dopamine release, influencing voluntary and involuntary movement control.

Synucleinopathies are characterized by alpha-synuclein amyloid build-up in the brain, leading to neurodegeneration. Preventing its aggregation remains a challenge due to the disordered nature of the protein and the unpredictable process of fibrillogenesis. However, targeting alpha-synuclein offers a promising therapeutic approach, providing potential strategies for treating Parkinson's disease and related disorders.

Alpha-synuclein Inhibitors Clinical Relevance

a-Syn is a presynaptic protein, and its misfolding and aggregation are associated with several neurodegenerative disorders, including Parkinson's disease, dementia with Lewy bodies, and MSA. Despite its significance, no approved drugs currently target a-Syn-related pathology. However, multiple biopharmaceutical companies are actively working to expand the therapeutic pipeline. Given the growing need for effective disease-modifying treatments, the demand for alpha-synuclein inhibitors has surged, offering potential breakthroughs in neurodegenerative disease management.

Alpha-synuclein Inhibitors Epidemiology

The alpha-synuclein inhibitors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases in selected indications for alpha-synuclein inhibitors, total eligible patient pool in selected indications for alpha-synuclein inhibitors, and total treated cases in selected indications for alpha-synuclein inhibitors in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.

Parkinson's Disease

• In 2024, the total diagnosed prevalent cases of Parkinson's disease in the 7MM were approximately 2.7 million.
• Analysis reveals that in the US, 57% of those diagnosed with Parkinson's disease were male, while females accounted for the remaining 43% of cases.
• In 2024, in the US, reported cases were distributed by age group as follows: individuals aged 49 and younger accounted for around 20 thousand cases; those between 50 and 64 saw approximately 220 thousand cases; people aged 65 to 74 contributed roughly 462 thousand cases; and those aged 75 and older experienced about 543 thousand cases.

Multiple System Atrophy (MSA)

• DelveInsight's analysis indicates that in 2024, the total diagnosed prevalence of MSA across the 7MM was estimated to be around 71 thousand cases.
• In Germany, data suggests a slight female predominance in diagnosed cases of MSA, with women comprising 55% of those affected, compared to 45% in men. This gender imbalance may hint at potential biological or diagnostic factors influencing disease prevalence-an aspect worth exploring further in epidemiological studies.
• In France during 2024, reported cases were grouped by age brackets. There were approximately 450 cases among individuals aged 50 to 59, 640 cases in the 60 to 69 age group, and 1,120 cases among those aged 70 and above.
• In 2024, clinical data from the UK indicates that the majority of patients diagnosed with MSA present with the parkinsonian subtype (MSA-P), accounting for approximately two-thirds of all cases. In contrast, the cerebellar variant (MSA-C) comprises only about one-third, highlighting a notable predominance of MSA-P in the country's diagnostic landscape.
• In 2024, Japan reported a higher concentration of MSA cases in Stage 3, with approximately 6 thousand individuals affected-making it the most common disease stage nationwide. Stage 4 followed in prevalence, while Stage 1 had the fewest documented cases. This trend suggests that diagnosis or healthcare engagement often occurs at more advanced stages, possibly pointing to delays in early detection or limited symptom recognition in initial phases.

Alpha-synuclein Inhibitors Drug Chapters

The drug chapter segment of the alpha-synuclein inhibitors reports includes a detailed analysis of alpha-synuclein inhibitors early-, mid-, and late-stage (Phase I, Phase II and Phase III) pipeline drugs. It also helps understand the alpha-synuclein inhibitors' 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.

Alpha-Synuclein Inhibitors Emerging Drugs

Buntanetap: Annovis Biopharm

Buntanetap, previously known as Posiphen or ANVS401, combats neurodegeneration by blocking the accumulation of several toxic proteins, including amyloid beta, tau, alpha-synuclein, and TDP43. This inhibition helps enhance synaptic activity, improve axonal transport, and reduce neuroinflammation, all of which are critical for maintaining healthy nerve cell function. The disruption of these pathways contributes to neuronal deterioration and cell death, leading to diseases like Alzheimer's and Parkinson's. By addressing these key mechanisms, buntanetap holds promise in reversing neurodegeneration, aiming to restore brain function and significantly improve patients' quality of life

In March 2025, Annovis Bio participated in AD/PD 2025, scheduled from April 1-5 in Vienna. During the conference, the company Annovis gave two presentations, showcasing findings from its Phase III Parkinson's disease trial and data on buntanetap in ApoE4 carriers from its Phase II/III Alzheimer's disease study.

In July 2024, the company announced results from the Phase III study (NCT05357989) of patients with Parkinson's disease. In patients diagnosed with Parkinson's disease for longer than 3 years, use of buntanetap resulted in measurable declines in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II, III, and II+III, as well as Total scores compared with placebo and baseline.

Prasinezumab: Roche/Prothena

Prasinezumab is an investigational monoclonal antibody designed to selectively bind aggregated a-syn and reduce neuronal toxicity. By targeting the build-up of a-syn protein in the brain, prasinezumab can potentially prevent further accumulation and spreading between cells, thereby slowing down the progression of the disease. The evidence supporting targeting a-syn aggregates as a mechanism of action in Parkinson's disease is based on a wide range of scientific evidence in the field.

At the AD/PD 2025 International Conference, the company shared findings from the Phase IIb PADOVA study, the drug showed potential benefits in slowing the progression of motor symptoms, but it did not reach statistical significance in the main analysis. Although the company is evaluating further for better results.

Amlenetug (Lu AF82422): Lundbeck

Amlenetug is a human monoclonal antibody (mAb) designed to target and bind to all major extracellular forms of a-syn, aiming to prevent its uptake and block aggregation seeding. Equipped with an active Fc region, it may enhance immune-mediated clearance of a-syn/mAb complexes via microglia-driven uptake, potentially reducing pathological accumulation. The therapy is being developed by Lundbeck under a joint research and licensing agreement with Genmab A/S, reinforcing efforts to advance disease-modifying treatments for neurodegenerative disorders.

In February 2025, the FDA granted Fast Track Designation (FTD) to amlenetug, for the treatment for MSA. Additionally, in April 2024, amlenetug received Orphan Drug Designation (ODD) from the FDA, highlighting its importance in addressing this rare and debilitating neurodegenerative disease.

The treatment also received SAKIGAKE designation from Japan's Ministry of Health, Labour and Welfare (MHLW) in March 2023 and The European Medicines Agency (EMA) granted ODD in May 2021.

Alpha-synuclein Inhibitors Market Outlook

With no approved alpha-synuclein inhibitors on the market, there's a critical unmet need for therapies that can slow or prevent Parkinson's disease progression. Developing safe, brain-penetrant agents that selectively target toxic alpha-synuclein aggregates-while sparing normal function-and demonstrate clinical efficacy is essential to transform early intervention and improve long-term patient outcomes.

The advancing late-stage pipeline-led by candidates such as Buntanetap (Annovis Biopharm), Prasinezumab (Roche/Prothena), and Amlenetug (Lundbeck)-reflects a dynamic wave of innovation and rising competitive momentum. These developments signal a robust trajectory for market expansion across multiple therapeutic fronts, underscoring the growing strategic value of alpha-synuclein targeting in neurodegenerative disease treatment.

Alpha-synuclein Inhibitors Uptake

This section focuses on the uptake rate of potential approved and emerging alpha-synuclein inhibitors expected to be launched in the market during 2020-2034.

Alpha-synuclein Inhibitors Pipeline Development Activities

The Alpha-synuclein Inhibitors pipeline report provides insights into different Alpha-synuclein Inhibitors clinical trials within Phase III, Phase II and Phase I. It also analyzes key players involved in developing targeted therapeutics.

The presence of numerous drugs under different stages is expected to generate immense opportunity for alpha-synuclein inhibitors market growth over the forecasted period.

Alpha-synuclein Inhibitors Pipeline Development Activities

The Alpha-synuclein Inhibitors clinical trials analysis report covers information on collaborations, acquisitions and mergers, licensing, and patent details for alpha-synuclein inhibitors emerging therapies.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on alpha-synuclein inhibitors evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 25+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM.

Their opinion helps understand and validate current and emerging therapy treatment patterns or alpha-synuclein inhibitors 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

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT 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.

Market Access and Reimbursement

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 Alpha-synuclein Inhibitors Market Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of alpha-synuclein inhibitors, explaining its mechanism, and therapies (current and emerging).
• Comprehensive insight into the Competitive Landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the alpha-synuclein inhibitors 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 expert insights/KOL views, and treatment preferences that help shape and drive the 7MM Alpha-synuclein Inhibitors market.

Alpha-synuclein Inhibitors Market Report Insights

• Alpha-synuclein Inhibitors Targeted Patient Pool
• Alpha-synuclein Inhibitors Therapeutic Approaches
• Alpha-synuclein Inhibitors Pipeline Analysis
• Alpha-synuclein Inhibitors Market Size and Trends
• Existing and Future Market Opportunity

Alpha-synuclein Inhibitors Market Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Alpha-synuclein Inhibitors Report Assessment

• Current Alpha-synuclein Inhibitors Treatment Practices
• Alpha-synuclein Inhibitors Unmet Needs
• Alpha-synuclein Inhibitors Pipeline Product Profiles
• Alpha-synuclein Inhibitors Market Attractiveness
• Qualitative Analysis (SWOT)

Key Questions:

• What was the alpha-synuclein inhibitors total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for alpha-synuclein inhibitors?
• Which drug accounts for maximum sales among alpha-synuclein inhibitors?
• What are the pricing variations among different geographies for approved therapies?
• How has the reimbursement landscape for alpha-synuclein inhibitors evolved since the first one was approved? Do patients face any access issues driven by reimbursement decisions?
• What are the risks, burdens, and unmet needs of treatment with alpha-synuclein inhibitors? What will be the growth opportunities across the 7MM for the patient population on alpha-synuclein inhibitors?
• What are the key factors hampering the growth of the alpha-synuclein inhibitors market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for alpha-synuclein inhibitors?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the alpha-synuclein inhibitors market.
• Understand the existing market opportunities 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 UK, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the attribute analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, 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.