No alpha-synuclein inhibitors are approved, underscoring a major need for therapies that slow or halt Parkinson's progression. Developing safe, brain-penetrant drugs that target toxic alpha-synuclein while preserving normal function is vital for early intervention and better outcomes. Late-stage candidates like Buntanetap (Annovis Biopharm), Prasinezumab (Roche/Prothena), and Amlenetug (Lundbeck) highlight growing innovation and competition in the alpha-synuclein inhibitors market.
LAS VEGAS, July 28, 2025 /PRNewswire/ -- DelveInsight's Alpha-synuclein Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Parkinson's disease, Alzheimer's disease, Lewy body dementia, Multiple system atrophy, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging alpha-synuclein inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM.
Key Takeaways from the Alpha-synuclein Inhibitors Market Report
- As per DelveInsight's analysis, the total market size of alpha-synuclein inhibitors in the 7MM is expected to surge significantly by 2034.
- The report provides the total potential number of patients in the indications, such as Parkinson's disease, Alzheimer's disease, Lewy body dementia, Multiple system atrophy, and others.
- Leading alpha-synuclein inhibitors companies, such as Annovis Biopharm, Lundbeck, Roche, Prothena, and others, are developing novel alpha-synuclein inhibitors that can be available in the alpha-synuclein inhibitors market in the coming years.
- Some of the key alpha-synuclein inhibitors in the pipeline include Buntanetap, Amlenetug, Prasinezumab, and others.
- 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 February 2025, the FDA granted Fast Track Designation (FTD) to amlenetug for the treatment of MSA.
- 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.
Discover which indication is expected to grab the major alpha-synuclein inhibitors market share @ Alpha-synuclein Inhibitors Market Report
Alpha-synuclein Inhibitors Market Dynamics
The alpha-synuclein inhibitors market is driven by the growing prevalence of neurodegenerative disorders such as Parkinson's disease, Lewy body dementia, and multiple system atrophy, where alpha-synuclein aggregation plays a critical pathogenic role. With the global burden of Parkinson's disease expected to double by 2040, there is a pressing demand for disease-modifying therapies that can go beyond symptomatic relief. Current treatment options, such as dopaminergic drugs, primarily address motor symptoms but fail to halt disease progression. This unmet medical need is pushing pharmaceutical and biotechnology companies to focus on alpha-synuclein inhibitors, which target the underlying pathology by preventing protein misfolding, aggregation, and the subsequent neurodegenerative cascade.
Significant research and development investments are shaping the competitive landscape of the alpha-synuclein inhibitors market. Several leading pharmaceutical players are actively pursuing monoclonal antibodies and small molecule inhibitors targeting alpha-synuclein. Clinical trials have advanced the understanding of the therapeutic potential of targeting alpha-synuclein, though some setbacks have been observed due to limited clinical efficacy in late-stage trials. Nonetheless, advancements in biomarker discovery and imaging technologies for early diagnosis and monitoring disease progression are expected to enhance the success rate of ongoing and future clinical programs.
Market dynamics are also influenced by regulatory and reimbursement factors. Given the high cost and complexity of neurodegenerative disease drug development, regulatory agencies like the FDA and EMA are encouraging accelerated pathways and breakthrough therapy designations for promising candidates. However, high development costs, combined with stringent clinical efficacy requirements, pose challenges for new entrants and smaller biotech firms. Moreover, reimbursement policies in major markets will play a critical role in determining the commercial success of these therapies once approved.
Collaborations and strategic partnerships are increasingly shaping the alpha-synuclein inhibitors landscape. Big pharmaceutical companies are entering licensing agreements, mergers, or co-development partnerships with biotech firms to expand their neurodegenerative pipelines. For instance, Roche and Prothena's collaborationon prasinezumab reflects the industry trend of leveraging external innovation to accelerate drug development. Furthermore, increasing venture capital funding and public-private initiatives are supporting the growth of innovative startups working on novel alpha-synuclein-targeting approaches, such as antisense oligonucleotides and gene therapy-based strategies.
Looking ahead, the alpha-synuclein inhibitors market is poised for steady growth. The next decade is expected to witness significant milestones in the approval and commercialization of disease-modifying therapies, which could revolutionize the treatment paradigm for Parkinson's and related disorders.
Alpha-synuclein Inhibitors Treatment Market
Alpha-synuclein inhibitors are therapeutic agents developed to prevent the aggregation of alpha-synuclein, a protein closely linked to neurodegenerative disorders such as Parkinson's disease, Lewy body dementia, and multiple system atrophy. These inhibitors function by blocking protein misfolding, reducing toxic buildup, and promoting clearance pathways. By targeting alpha-synuclein pathology, they aim to slow the progression of these diseases, offering promising advancements in neuroprotection and symptom relief.
Although no alpha-synuclein inhibitors have yet received regulatory approval, the FDA has issued a 'Letter of Support' encouraging the use of the synuclein-based biomarker, aSyn-SAA, in clinical trials for Parkinson's disease and related disorders. This recognition underscores the biomarker's potential to improve disease monitoring, streamline drug development, and refine treatment strategies.
With no approved therapies in this category, several companies, including Annovis Bio, Roche/Prothena, and Lundbeck, are actively progressing their pipelines to develop innovative candidates. These initiatives aim to enhance therapeutic approaches, improve drug effectiveness, and address the significant unmet needs in neurodegenerative conditions such as Parkinson's, Lewy body dementia, and MSA.
Learn more about the alpha-synuclein inhibitors @ Alpha-synuclein Inhibitors Analysis
Key Emerging Alpha-synuclein Inhibitors and Companies
Emerging alpha-synuclein inhibitors in the pipeline, including buntanetap (Annovis Biopharm), prasinezumab (Roche/Prothena), amlenetug (Lundbeck), and others, are showing promise for expanding treatment options.
Buntanetap, formerly known as Posiphen or ANVS401, works against neurodegeneration by preventing the build-up of toxic proteins such as amyloid beta, tau, alpha-synuclein, and TDP43. This action helps boost synaptic function, improve axonal transport, and reduce neuroinflammation-key processes required to maintain healthy neurons. The accumulation of these proteins disrupts neural pathways, leading to neuronal damage and cell death, which underlie diseases like Alzheimer's and Parkinson's. By targeting these mechanisms, buntanetap aims to reverse neurodegeneration, restore brain function, and significantly enhance patients' quality of life.
In March 2025, Annovis Bio participated in the AD/PD 2025 conference (April 1-5, Vienna), where it delivered two presentations highlighting data from its Phase III Parkinson's disease trial and findings on buntanetap in ApoE4 carriers from its Phase II/III Alzheimer's disease study. Earlier, in July 2024, Annovis announced results from its Phase III Parkinson's disease trial (NCT05357989). Among patients diagnosed with Parkinson's for over three years, buntanetap demonstrated significant improvements in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores, Parts II, III, II+III, and Total, compared with placebo and baseline.
Prasinezumab, an experimental monoclonal antibody, is designed to selectively bind aggregated alpha-synuclein (a-syn) and reduce its neurotoxic effects. By targeting a-syn accumulation and its cell-to-cell spread, prasinezumab has the potential to slow disease progression. Targeting a-syn aggregates is supported by extensive research as a viable therapeutic strategy for Parkinson's disease. At the AD/PD 2025 conference, the company presented results from the Phase IIb PADOVA study. While the drug showed potential in slowing motor symptom progression, it did not achieve statistical significance in the primary analysis, and further evaluations are ongoing.
Amlenetug, a human monoclonal antibody, is designed to bind all major extracellular forms of a-syn, preventing their uptake and halting aggregation seeding. Its active Fc region may promote immune-mediated clearance of a-syn/antibody complexes through microglial uptake, thereby reducing pathological deposits.
Developed by Lundbeck in collaboration with Genmab A/S, amlenetug is part of ongoing efforts to develop disease-modifying therapies for neurodegenerative conditions. In February 2025, the FDA granted Fast Track Designation (FTD) for amlenetug in treating multiple system atrophy (MSA). It previously received Orphan Drug Designation (ODD) from the FDA in April 2024, SAKIGAKE designation from Japan's Ministry of Health, Labour and Welfare in March 2023, and ODD from the European Medicines Agency (EMA) in May 2021.
The anticipated launch of these emerging therapies are poised to transform the alpha-synuclein inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the alpha-synuclein inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about alpha-synuclein inhibitors clinical trials, visit @ Alpha-synuclein Inhibitors Treatment
Alpha-synuclein Inhibitors Overview
Alpha-synuclein is a highly soluble and intrinsically disordered protein that accumulates in Lewy bodies and Lewy neurites, playing a key role in the development of Parkinson's disease and other synucleinopathies. While predominantly located in the brain, smaller amounts are also present in the heart, muscles, and various tissues. Within neurons, a-Syn is concentrated in presynaptic terminals, where it regulates synaptic vesicle dynamics. Studies indicate that it may restrict vesicle mobility, thereby influencing synaptic recycling and neurotransmitter release. Another view suggests that a-Syn interacts with VAMP2 (synaptobrevin) to stabilize SNARE complexes, with recent research linking these interactions to synaptic function. Moreover, a-Syn may modulate dopamine release, affecting both voluntary and involuntary motor control.
Synucleinopathies are marked by the accumulation of a-Syn amyloid deposits in the brain, driving neurodegeneration. Preventing a-Syn aggregation remains challenging due to its inherently disordered structure and the complex, unpredictable nature of fibrillogenesis. Nevertheless, targeting a-Syn is considered a promising therapeutic strategy, offering potential avenues for the treatment of Parkinson's disease and related conditions.
Alpha-synuclein Inhibitors Epidemiology Segmentation
The alpha-synuclein inhibitors market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM, segmented into:
- Total Cases in Selected Indications for Alpha-synuclein Inhibitors
- Total Eligible Patient Pool in Selected Indications for Alpha-synuclein Inhibitors
- Total Treated Cases in Selected Indications for Alpha-synuclein Inhibitors
Alpha-synuclein Inhibitors Report Metrics | Details |
Study Period | 2020-2034 |
Alpha-synuclein Inhibitors Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
Key Indications Covered in the Report | Parkinson's disease, Alzheimer's disease, Lewy body dementia, Multiple system atrophy, and others |
Key Alpha-synuclein Inhibitors Companies | Annovis Biopharm, Lundbeck, Roche, Prothena, and others |
Key Alpha-synuclein Inhibitors | Buntanetap, Amlenetug, Prasinezumab, and others |
Scope of the Alpha-synuclein Inhibitors Market Report
- Alpha-synuclein Inhibitors Therapeutic Assessment: Alpha-synuclein Inhibitors current marketed and emerging therapies
- Alpha-synuclein Inhibitors Market Dynamics: Conjoint Analysis of Emerging Alpha-synuclein Inhibitors Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Alpha-synuclein Inhibitors Market Access and Reimbursement
Discover more about alpha-synuclein inhibitors in development @ Alpha-synuclein Inhibitors Clinical Trials
Table of Contents
1 | Key Insights |
2 | Report Introduction |
3 | Executive Summary |
4 | Key Events |
5 | Market Forecast Methodology |
6 | Alpha-synuclein Inhibitors Market Overview at a Glance in the 7MM |
6.1 | Market Share (%) Distribution by Indication in 2024 |
6.2 | Market Share (%) Distribution by Indication in 2034 |
7 | Alpha-synuclein Inhibitors: Background and Overview |
7.1 | Introduction |
7.2 | Evolution of Alpha-synuclein Inhibitors |
7.3 | Treatment |
8 | Target Patient Pool |
8.1 | Key Findings |
8.2 | Assumptions and Rationale: 7MM |
8.3 | Epidemiology Scenario in the 7MM |
8.3.1 | Total Cases in Selected Indications for Alpha-synuclein Inhibitors in the 7MM |
8.3.2 | Total Eligible Patient Pool in Selected Indications for Alpha-synuclein Inhibitors in the 7MM |
8.3.3 | Total Treated Cases in Selected Indications for Alpha-synuclein Inhibitors in the 7MM |
8.4 | The US |
8.4.1 | Total Cases in Selected Indications for Alpha-synuclein Inhibitors in the US |
8.4.2 | Total Eligible Patient Pool in Selected Indications for Alpha-synuclein Inhibitors in the US |
8.4.3 | Total Treated Cases in Selected Indications for Alpha-synuclein Inhibitors in the US |
8.5 | EU4 and the UK |
8.5.1 | Total Cases in Selected Indications for Alpha-synuclein Inhibitors in EU4 and the UK |
8.5.2 | Total Eligible Patient Pool in Selected Indications for Alpha-synuclein Inhibitors in EU4 and the UK |
8.5.3 | Total Treated Cases in Selected Indications for Alpha-synuclein Inhibitors in EU4 and the UK |
8.6 | Japan |
8.6.1 | Total Cases in Selected Indications for Alpha-synuclein Inhibitors in Japan |
8.6.2 | Total Eligible Patient Pool in Selected Indications for Alpha-synuclein Inhibitors in Japan |
8.6.3 | Total Treated Cases in Selected Indications for Alpha-synuclein Inhibitors in Japan |
9 | Emerging Therapies |
9.1 | Key Cross Competition |
9.2 | Buntanetap: Annovis Biopharma |
9.2.1 | Drug Description |
9.2.2 | Others Developmental Activities |
9.2.3 | Clinical Trials Information |
9.2.4 | Safety and Efficacy |
9.2.5 | Analyst's View |
9.3 | Prasinezuma: Roche/Prothena |
9.4 | Amlenetug: Lundbeck |
List of drugs to be continued in the final report... | |
10 | Alpha-synuclein Inhibitors: the 7MM Analysis |
10.1 | Key Findings |
10.2 | Key Market Forecast Assumptions |
10.2.1 | Cost Assumptions and Rebates |
10.2.2 | Pricing Trends |
10.2.3 | Analogue Assessment |
10.2.4 | Launch Year and Therapy Uptakes |
10.3 | Market Outlook |
10.4 | Attribute Analysis |
10.5 | Total Market Size of Alpha-synuclein Inhibitors in the 7MM |
10.6 | The US Market Size |
10.6.1 | Total Market Size of Alpha-synuclein Inhibitors in the US |
10.6.2 | Market Size of Alpha-synuclein Inhibitors by Therapies in the US |
10.7 | EU4 and the UK Market Size |
10.7.1 | Total Market Size of Alpha-synuclein Inhibitors in EU4 and the UK |
10.7.2 | Market Size of Alpha-synuclein Inhibitors by Therapies in EU4 and the UK |
10.8 | Japan Market Size |
10.8.1 | Total Market Size of Alpha-synuclein Inhibitors in Japan |
10.8.2 | Market Size of Alpha-synuclein Inhibitors by Therapies in Japan |
11 | Unmet Needs |
12 | SWOT Analysis |
13 | KOL Views |
14 | Market Access and Reimbursement |
14.1 | The US |
14.2 | EU4 and the UK |
14.3 | Japan |
15 | Bibliography |
16 | Report Methodology |
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