Amyotrophic Lateral Sclerosis Market: Expanding Revenue Landscape to 2034 - DelveInsight

DelveInsight launched a report titled as "Amyotrophic Lateral Sclerosis Market Insight, Epidemiology And Market Forecast - 2034". This comprehensive report delves into epidemiology based market analysis, providing a roadmap for success in the dynamic landscape of Amyotrophic Lateral Sclerosis market.

To Know in detail about the Amyotrophic Lateral Sclerosis market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Amyotrophic Lateral Sclerosis Market Forecast
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Key Highlights from Amyotrophic Lateral Sclerosis market Report:
• The Amyotrophic Lateral Sclerosis market size in the 7mm was valued ~1 billion in 2023 and is expected to grow with a significant CAGR during the forecast period (2020-2034).
• In August 2025, Coya Therapeutics announced that the FDA has accepted its Investigational New Drug (IND) application for COYA 302, an immunomodulatory biologic being developed for the treatment of amyotrophic lateral sclerosis (ALS).
• In August 2025, Neurizon Therapeutics announced that manufacturing has commenced for the first registration batch of NUZ-001 tablets, its lead therapeutic candidate for amyotrophic lateral sclerosis (ALS). This milestone underpins upcoming pivotal studies, regulatory filings, and potential commercial production, representing a key step toward global market access.
• In August 2025, Neurizon Therapeutics reported that the U.S. FDA is expected to issue a decision by October 3, 2025, regarding its Clinical Hold Complete Response (CHCR) submission for NUZ-001, the company's lead investigational treatment for amyotrophic lateral sclerosis (ALS).
• In July 2025, AB Science announced that its confirmatory Phase 3 trial of masitinib in amyotrophic lateral sclerosis (ALS), known as study AB23005, has been authorized by the initial group of European countries Spain, Greece, and Slovenia through the CTIS procedure, following EMA validation and earlier FDA clearance. This approval enables the company to initiate the registration study in both Europe and the United States.
• In July 2025, Neurizon Therapeutics has submitted a formal response to the FDA to address the clinical hold placed on its Investigational New Drug (IND) application for NUZ-001, its lead therapeutic candidate for amyotrophic lateral sclerosis (ALS).
• In July 2025, NKGen Biotech has received FDA authorization to implement an Expanded Access Program (EAP) allowing the use of its NK cell therapy, troculeucel, across multiple neurodegenerative disorders including Alzheimer's, Parkinson's, ALS, MSA, PSP, FTD, MS, and Lewy body dementia beyond its ongoing Phase 2a study in patients with moderate-stage Alzheimer's disease.
• In July 2025, Klotho Neurosciences announced that the FDA has granted Orphan Drug Designation to KLTO-202 (s-KL-AAV.myo), its secreted-Klotho gene therapy candidate, for the treatment of amyotrophic lateral sclerosis (ALS).
• In June 2025, Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) announced that the FDA has awarded Fast Track designation to AMX0114, an investigational antisense oligonucleotide designed to target calpain-2 for the treatment of amyotrophic lateral sclerosis (ALS).
• In May 2025, BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) has announced that it has received FDA approval to initiate its Phase 3b clinical trial evaluating NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS).
• In January 2025, The US Food and Drug Administration (FDA) has authorized Zydus Lifesciences to initiate a randomized Phase IIb clinical trial of Usnoflast, its oral NLRP3 inflammasome inhibitor, for the treatment of amyotrophic lateral sclerosis (ALS). This multi-center, double-blind, placebo-controlled study will evaluate the drug's safety, pharmacodynamics, efficacy, and pharmacokinetics in adult ALS patients.
• In January 2025, The US Food and Drug Administration (FDA) has removed the clinical hold on Amylyx Pharmaceuticals' Phase I trial of AMX0114 for amyotrophic lateral sclerosis (ALS). With the hold lifted, Amylyx can now initiate screening, enrollment, and dosing at US sites for the Phase I LUMINA study (NCT06665165). This multi-center, multiple ascending dose trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AMX0114 in 48 ALS patients. Participants will be randomized in a 3:1 ratio to receive either AMX0114 or a placebo via intrathecal injection every four weeks, for up to four doses.
• The market size for ALS in the US was estimated at approximately USD 920 million in 2023, with expectations for growth throughout the forecast period (2024-2034).
• RADICAVA is expected to be the top performer in the current ALS market, with projected revenue reaching USD 923 million in the US by 2034.
• By 2034, Masitinib in combination with riluzole is projected to generate the highest revenue among emerging therapies, reaching USD 37 million in Japan.
• Currently, ALS treatments include EXSERVAN (Riluzole oral film), RELYVRIO, QALSODY, RADICAVA (edaravone injection), RADICAVA ORS (edaravone oral suspension), NEUDEXTA, TIGLUTEK, and RILUTEK, along with other symptomatic therapies such as anti-epileptic drugs, opioids, NSAIDs, diuretics, SSRIs, and antidepressants.
• In 2023, the US reported the highest number of ALS cases among the 7MM, with approximately 26,000 cases, and this number is expected to rise throughout the forecast period.
• In 2023, Germany had the highest number of diagnosed prevalent ALS cases among the EU4 and the UK, whereas Spain had the fewest cases.
• In 2023, the majority of ALS cases originated from the spinal site, with approximately 15,000 cases, followed by the bulbar site of onset. Other uncertain regions also contributed to the onset of ALS cases.
• Estimates indicate that in Japan, ALS was most common in the 70-79 age group, followed by the 60-69 and 50-59 age groups.
• Key Amyotrophic Lateral Sclerosis Companies: Helixmith, Sanofi, Denali Therapeutics, Transposon Therapeutics, Alector, GSK, NeuroSense Therapeutics, Biogen, Ionis Pharmaceuticals, Brainstorm Cell Therapeutics, Cytokinetics, Astellas Pharma, Apellis Pharmaceuticals, Clene Nanomedicine Biosciences, AL-S Pharma, MediciNova, and others
• Key Amyotrophic Lateral Sclerosis Therapies: Engensis (VM202), SAR443820/DNL788, TPN-101, Latozinemab (AL001/GSK4527223), PrimeC, Tofersen (BIIB067), ION363, NurOwn (MSC-NTF cells), Reldesemtiv, Pegcetacoplan (APL-2), Gold Nanocrystals/CNM-Au8, AP-101, MN-166 (ibudilast), and others

Amyotrophic Lateral Sclerosis Country based Treatment Overview:
The Amyotrophic Lateral Sclerosis market research report provides current treatment practices, emerging drugs, Amyotrophic Lateral Sclerosis market share of the individual therapies, current and forecasted Amyotrophic Lateral Sclerosis market Size from 2020 to 2034 segmented by seven major markets.
Lou Gehrig's disease, often known as amyotrophic lateral sclerosis (ALS), is a collection of uncommon neurological disorders primarily affecting the nerve cells (neurons) in charge of voluntary muscular movement. Movements like chewing, walking, and talking are produced by voluntary muscles. Since the illness is progressive, the symptoms worsen with time.

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Amyotrophic Lateral Sclerosis Epidemiology Insights:
The Amyotrophic Lateral Sclerosis epidemiology section offers insights into the past and present patient population affected by the disease, along with predicted trends across seven major countries. It assists in understanding the reasons behind current and anticipated trends by analyzing multiple studies and opinions from key experts.
• In 2023, the US had the highest prevalence of ALS among the 7MM, with approximately 26,000 cases. This number is anticipated to rise throughout the forecast period.
• In 2023, Germany had the highest number of diagnosed ALS cases among the EU4 and the UK, whereas Spain had the fewest cases.
• The primary onset sites for ALS include the bulbar and spinal regions, along with other indeterminate areas. In 2023, spinal onset ALS had the highest number of cases, totaling 15,000, followed by bulbar onset.
• The Amyotrophic Lateral Sclerosis epidemiology based on gender analyzed that males are more affected than females in case of Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Epidemiology Segmentation:
• Total Prevalence of Amyotrophic Lateral Sclerosis
• Prevalent Cases of Amyotrophic Lateral Sclerosis by severity
• Gender-specific Prevalence of Amyotrophic Lateral Sclerosis
• Diagnosed Cases of Episodic and Chronic Amyotrophic Lateral Sclerosis

Download the report to understand which factors are driving Amyotrophic Lateral Sclerosis epidemiology trends @ Amyotrophic Lateral Sclerosis Epidemiology Forecast
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Amyotrophic Lateral Sclerosis Drugs and Key Companies
• Engensis (VM202): Helixmith
• SAR443820/DNL788: Sanofi/Denali Therapeutics
• TPN-101: Transposon Therapeutics
• Latozinemab (AL001/GSK4527223): Alector/GSK
• PrimeC: NeuroSense Therapeutics
• Tofersen (BIIB067): Biogen/Ionis
• ION363: Ionis Pharmaceuticals
• NurOwn (MSC-NTF cells): Brainstorm Cell Therapeutics
• Reldesemtiv: Cytokinetics/Astellas Pharma
• Pegcetacoplan (APL-2): Apellis Pharmaceuticals
• Gold Nanocrystals/CNM-Au8: Clene Nanomedicine Biosciences
• AP-101: AL-S Pharma
• MN-166 (ibudilast): MediciNova

Emerging Amyotrophic Lateral Sclerosis drugs Uptake:
• The Drug Uptake section of the Amyotrophic Lateral Sclerosis report provides an in-depth analysis of both the available Amyotrophic Lateral Sclerosis drugs in the market and those in the late stages of development (Phase-III, Phase-II, and Phase I/II).
• In September 2022, The FDA in the United States granted approval for RELYVRIO to treat ALS. RELYVRIO, a combination of sodium phenylbutyrate and taurursodiol, demonstrated a reduced rate of decline in daily functioning assessment and showed an association with extended overall survival.
• In May 2022, The US FDA authorized the use of RADICAVA ORS (edaravone) in an oral formulation for the treatment of ALS.
• Amyotrophic Lateral Sclerosis treatments anticipated for potential launch within the projected period encompass Tofersen, ION363, NurOwn, Masitinib, among other potential therapies.

Discover more about therapies set to grab major Amyotrophic Lateral Sclerosis market share @ Amyotrophic Lateral Sclerosis Treatment Market
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Amyotrophic Lateral Sclerosis Market Forecast:
• Potential Amyotrophic Lateral Sclerosis treatments are being developed in the mid- and late stages and could soon be released. The main participants in the market are Verdiperstat (Biohaven Pharmaceuticals), Masitinib (AB Science), Gold Nanocrystals/CNM-Au8 (Brainstorm-Cell Therapeutics), Tofersen/BIIB067 (Biogen/Ionis Pharmaceuticals), and others. This could lead to a rise in the market size in the upcoming years, helped along by a rise in the number of people with Amyotrophic Lateral Sclerosis diagnosis.
• RADICAVA (edaravone) has been an effective therapy for ALS. Recently, oral RADICAVA got approved in the US for the treatment of patients with ALS to increase the patient compliance.
• Most of the 7MM possess their own ALS registries, thereby providing a near precise country-wise number for diagnosed prevalent cases of the disease

Scope of the Amyotrophic Lateral Sclerosis Market Report:
• Study Period: 2020-2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Amyotrophic Lateral Sclerosis Companies: Helixmith, Sanofi, Denali Therapeutics, Transposon Therapeutics, Alector, GSK, NeuroSense Therapeutics, Biogen, Ionis Pharmaceuticals, Brainstorm Cell Therapeutics, Cytokinetics, Astellas Pharma, Apellis Pharmaceuticals, Clene Nanomedicine Biosciences, AL-S Pharma, MediciNova, Seelos Theraputics, Prilenia Therapeutics, AB Science, Eledon Pharmaceuticals, Revalesio Corporation, Biohaven Pharmaceuticals, UCB Pharma, Ra Pharmaceuticals, AI Therapeutics, and others, and others
• Key Amyotrophic Lateral Sclerosis Therapies: Engensis (VM202), SAR443820/DNL788, TPN-101, Latozinemab (AL001/GSK4527223), PrimeC, Tofersen (BIIB067), ION363, NurOwn (MSC-NTF cells), Reldesemtiv, Pegcetacoplan (APL-2), Gold Nanocrystals/CNM-Au8, AP-101, MN-166 (ibudilast), and others
• Amyotrophic Lateral Sclerosis Therapeutic Assessment: Amyotrophic Lateral Sclerosis current marketed and Amyotrophic Lateral Sclerosis emerging therapies
• Amyotrophic Lateral Sclerosis Market Dynamics: Amyotrophic Lateral Sclerosis market drivers and Amyotrophic Lateral Sclerosis market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Amyotrophic Lateral Sclerosis Unmet Needs, KOL's views, Analyst's views, Amyotrophic Lateral Sclerosis Market Access and Reimbursement

To know more about Amyotrophic Lateral Sclerosis companies working in the treatment market, visit @ Amyotrophic Lateral Sclerosis Clinical Trials and Therapeutic Assessment
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DelveInsight's report offers comprehensive insights, market analysis, and forecasts aiding leading companies in strategic decision-making for the Amyotrophic Lateral Sclerosis market landscape.
• Gain Competitive Edge in Indication Market : Understand the current landscape of the Amyotrophic Lateral Sclerosis market, including the competitive environment, key companies developing drugs for Amyotrophic Lateral Sclerosis, and their strategies. By analyzing market dynamics, treatment approaches, and emerging Amyotrophic Lateral Sclerosis therapies, stakeholders can identify opportunities to position themselves effectively, gaining a competitive edge over others.
• Identify Market Gaps and indication market opportunities : Analyzing epidemiological trends, country wise patient journeys and existing treatment practices can help in identifying gaps and opportunities within the Amyotrophic Lateral Sclerosis market. This involves recognizing areas where current Amyotrophic Lateral Sclerosis treatments may be insufficient or where there is an unmet need. The report is curated by taking account of various KOLs dealing with Amyotrophic Lateral Sclerosis. Identifying these gaps allows stakeholders to explore new therapeutic avenues, potentially leading to the development of novel treatments that address specific market needs and price their emerging products strategically to gain a competitive edge.
• Strategic decision making : Armed with insights from epidemiological and market forecasts, stakeholders can make informed and strategic decisions. This may involve deciding on research and development investments, portfolio expansion, pricing - reimbursement strategies, partnerships, or other strategic moves. Understanding the market dynamics enables stakeholders to align their goals with the prevailing trends and future projections.
• Plan RoadMap to Success : Through this report the leading companies can set short-term and long-term goals, define strategies for market penetration, and outline steps for product development or market expansion. A well-informed roadmap ensures that stakeholders navigate the complexities of the Amyotrophic Lateral Sclerosis market with clarity and purpose.

Related Reports:

Amyotrophic Lateral Sclerosis Epidemiology
DelveInsight's 'Amyotrophic Lateral Sclerosis Epidemiology Forecast to 2034' report delivers an in-depth understanding of the disease, historical and forecasted Amyotrophic Lateral Sclerosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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