The amyotrophic lateral sclerosis market is expected to grow owing to the increasing prevalence of the disease, along with the promising emerging pipeline therapies, such as Masitinib (AB Sciences), PrimeC (Neurosense Therapeutics), RNS60 (Revalesio), IFB-088 (InFlectis BioScience), NP001 (Neuvivo), Ibudilast (MediciNova), NurOwn (Brainstorm-Cell Therapeutics' MSC-NTF cells), Pridopidine (Prilenia Therapeutics), CBT101 (CERES Brain Therapeutics), and others.
DelveInsight's Amyotrophic Lateral Sclerosis Market Insightsreport includes a comprehensive understanding of current treatment practices, amyotrophic lateral sclerosisemerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan).
https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg
Amyotrophic Lateral Sclerosis Market Summary
— The market size for amyotrophic lateral sclerosis in the US was USD 800 million in 2024.
— Following the setback with RELYVRIO, RADICAVA emerges as the leading contender in the current ALS market and is expected to generate the highest revenue.
— The total prevalent cases of ALS in the 7MM comprised nearly 60,000 in 2024, which are estimated to increase by 2034.
— Leading amyotrophic lateral sclerosis companies developing emerging therapies, such as AB SCIENCE, BRAINSTORM CELL THERAPEUTICS, IONIS, OTSUKA PHARMACEUTICALS, MEDICINOVA, ABBVIE, CALICO LIFE SCIENCES, CLENE NANOMEDICINE BIOSCIENCES, SEELOS THERAPEUTICS, PRILENIA THERAPEUTICS, RAPA THERAPEUTICS, Neurosense Therapeutics, HELIXMITH, TRANSPOSON THERAPEUTICS, REVALESIO CORPORATION, ANNEXON BIOSCIENCES, CORCEPT THERAPEUTICS, AL-S PHARMA, ORPHAI THERAPEUTICS, NEUVIVO, InFlectis BioScience, and others, are developing new therapy for ALS that can be available in the ALSmarket in the coming years.
— The promising amyotrophic lateral sclerosis therapies in clinical trials include MASITINIB, NUROWN (MSC-NTF CELLS), ULEFNERSEN (ION363), IBUDILAST, ABBV-CLS-7262, CNM-AU8, SLS-005 (TREHALOSE), PRIDOPIDINE, RAPA-501, PrimeC, ENGENSIS (VM202), TPN-101, RNS60, ANX005, DAZUCORILANT (CORT113176), AP-101, AIT-101 (LAM-002A), NP001, IFB-088, and others.
— Brainstorm-Cell Therapeutics's NurOwn and Rapa Therapeutics's RAPA 501are pioneering novel treatments for ALS through stem cell and T-cell therapy approaches.
— Transposon Therapeutics' TPN-101 and Ionis Pharmaceuticals' Ulefnersenare therapies specifically tailored for mutations such as C9ORF72 and FUS in ALS.
Discover the amyotrophic lateral sclerosis new treatment @ New Treatments for Amyotrophic Lateral Sclerosis
Key Factors Driving the Growth of the Amyotrophic Lateral Sclerosis Market
Rising ALS Prevalence
The global incidence of ALS is on the rise, with nearly 5,000 new cases diagnosed annually in the United States alone. The total prevalent cases of ALS in the 7MM comprised nearly 67K in 2023 which are estimated to reach 75K by 2034. This increase in prevalence is fueling demand for effective treatments and driving market growth.
Regulatory Approvals of RADICAVA
RADICAVA has proven to be a successful treatment for ALS. Approval of oral RADICAVA in the United States and its approval in Japan in December 2022 have enhanced patient compliance.
Technological Innovations in Diagnosis and Treatment
Advancements in diagnostic technologies and treatment methodologies are improving patient outcomes. The development of personalized medicine and targeted therapies is enhancing the efficacy of ALS treatments, contributing to market expansion.
Rising Amyotrophic Lateral Sclerosis Clinical Trial Activities
Some of the drugs in the pipeline include Masitinib (AB Sciences), Prime C (Neurosense Therapeutics), RNS60 (Revalesio), NP001 (Neuvivo), Ibudilast (MediciNova), NurOwn (Brainstorm-Cell Therapeutics' MSC-NTF cells), Pridopidine (Prilenia Therapeutics), and others.
Amyotrophic Lateral Sclerosis Market Analysis
Currently, available drugs for the treatment of ALS include RILUTEK, TIGLUTEK (oral suspension), RADICAVA (IV and oral suspension/ORS), and QALSODY. Approved symptomatic therapies comprise NEUDEXTA, TIGLUTEK, and RILUTEK, along with supportive medications such as anti-epileptic drugs, opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), diuretics, selective serotonin reuptake inhibitors (SSRIs), and various antidepressants.
Following the approval of RADICAVA ORS, sales of the RADICAVA franchise rebounded significantly, reversing the previous decline in IV RADICAVA usage. The oral formulation was rapidly adopted in both the United States and Japan.
RELYVRIOexperienced rapid market adoption in the U.S. between 2022 and 2023. However, after the PHOENIX trial failed to meet its primary endpoints, Amylyx Pharmaceuticals upheld its earlier commitment to withdraw the drug. Consequently, RELYVRIO was officially discontinued on April 4, 2024, following consultations with the U.S. FDA and Health Canada.
The anticipated launches of emerging therapies such as IFB-088 (InFlectis BioScience), Ulefnersen (Ionis/Otsuka Pharmaceuticals), Ibudilast (MediciNova), Masitinib (AB Science), NurOwn (BrainStorm Cell Therapeutics), CNM-Au8 (Clene Nanomedicine), NP001 (Neuvivo), and CBT101 (Ceres Brain Therapeutics, early-stage) are expected to expand the ALS market in the coming years, supported by a rising number of diagnosed cases.
Additionally, NDC-011, a novel drug combination developed through DR.NOAH's AI-based drug discovery platform, received Orphan Drug Designation (ODD) from the U.S. FDA in 2023 and IND approval for a Phase I clinical trial in 2024. The therapy aims to slow disease progression, alleviate ALS symptoms, and extend patient survival.
To know more about ALS treatment options, visit @ Approved Amyotrophic Lateral Sclerosis Drugs
Amyotrophic Lateral Sclerosis Competitive Landscape
Some of the ALS drugs in clinical trials include Masitinib (AB Sciences), PrimeC (Neurosense Therapeutics), RNS60 (Revalesio), IFB-088 (InFlectis BioScience), NP001 (Neuvivo), Ibudilast (MediciNova), NurOwn (Brainstorm-Cell Therapeutics' MSC-NTF cells), Pridopidine (Prilenia Therapeutics), CBT101 (CERES Brain Therapeutics), and others.
AB Science's Masitinib (AB1010)is an oral tyrosine kinase inhibitor that regulates the activity of mast cells and macrophages, key immune cells, by selectively targeting a small subset of kinases. Notably, at therapeutic doses, it avoids inhibiting kinases linked to toxicity. The drug is currently undergoing a Phase III confirmatory trial for the treatment of amyotrophic lateral sclerosis (ALS).
NeuroSense's PrimeCis a novel combination of two FDA-approved drugs, ciprofloxacin and celecoxib, formulated at unique doses to work synergistically in slowing the progression of ALS. The therapy has received Orphan Drug Designation (ODD) from both the US FDA and EMA, and NeuroSense is advancing it through regulatory pathways while preparing for a pivotal Phase III trial. Following favorable feedback from the FDA, the company plans to initiate a multinational Phase III study in the second half of 2025.
CERES Brain Therapeutics' CBT101is a creatine prodrug formulated within a patented composition of matter, representing an innovative drug design. It is currently in a Phase I clinical trial for the treatment of adult patients with ALS.
The anticipated launch of these emerging therapies are poised to transform the ALS market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the ALS market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about therapy for ALS @ Amyotrophic Lateral Sclerosis Clinical Trials
Recent Developments in the Amyotrophic Lateral Sclerosis Market
— In September 2025, AL-S Pharma announced positive topline results from the Phase II clinical study evaluating AP-101. AP-101, in addition to the standard of care, met its primary endpoint related to safety and tolerability. Clinically meaningful changes in exploratory clinical outcome measures related to survival and non-invasive ventilation, as well as stabilization of clinical disease-staging and neurofilament biomarkers, were observed following 12 months of treatment. Results will be shared with regulatory authorities, presented at upcoming ALS conferences, and submitted for publication in a peer-reviewed scientific journal.
— In July 2025, AB Science announced that its confirmatory Phase III study of masitinib in ALS, designated study AB23005, had received authorization from the first group of European countries (Spain, Greece, and Slovenia) under Step 2 of the Clinical Trials Information System (CTIS) procedure. This authorization follows the validation of the harmonized protocol by the European Medicines Agency (EMA), which was approved during Step 1 of the CTIS process, and is preceded by prior authorization from the US FDA. As a result, AB Science is now positioned to initiate this registration study in both Europe and the US.
— In July 2025, NeuroSense Therapeutics presented late-breaking data from its Phase IIb PARADIGM trial (NCT05357950) of PrimeC at the 2025 American Academy of Neurology (AAN) Annual Meeting, held from April 5 to 9 in San Diego, California. The results demonstrated a significant effect of PrimeC on miRNA expression and iron regulation in patients with ALS, providing a solid foundation for the company to progress the therapy to a Phase III trial.
— In January 2025, CERES Brain Therapeutics raised EUR 6 million in financing led by ANJAC, to support the clinical development neurological treatments. The proceeds supported the set-up of a Phase I first-in-man trial of CERES' lead candidate CBT101.
What is Amyotrophic Lateral Sclerosis?
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord, leading to the gradual loss of muscle control. In ALS, the motor neurons responsible for transmitting signals from the brain to the muscles degenerate and die, resulting in muscle weakness, atrophy, and eventual paralysis. Over time, individuals with ALS lose the ability to speak, swallow, and breathe independently, while cognitive function typically remains intact. Although the exact cause of ALS is not fully understood, a combination of genetic and environmental factors is believed to contribute to its development.
Amyotrophic Lateral Sclerosis Epidemiology Segmentation
The ALS epidemiology section provides insights into the historical and current amyotrophic lateral sclerosis patient pool and forecasted trends for the leading markets. In the US, among mutation-specific cases of ALS in 2024, including C9ORF72, SOD1, FUS, and others such as TARDBP, OPTN, and ANG, non-mutated or unidentified mutations accounted for the largest proportion, representing approximately 75% of cases.
The ALS market reportproffers epidemiological analysis for the study period 2020-2034 in the leading markets, segmented into:
— Total Prevalent Cases of ALS
— Total Diagnosed Prevalent Cases of ALS
— Gender-Specific Distribution of ALS
— Mutation-Specific Distribution of ALS
— Type-Specific Distribution of ALS
— Distribution Based on Site of Onset of ALS
— Age-Specific Distribution of ALS
Scope of the Amyotrophic Lateral SclerosisMarket Report
— Therapeutic Assessment: Amyotrophic Lateral Sclerosiscurrent marketed and emerging therapies
— Amyotrophic Lateral SclerosisMarket Dynamics:Key Market Forecast Assumptions of Emerging Amyotrophic Lateral SclerosisDrugs and Market Outlook
— Competitive Intelligence Analysis:SWOT analysis and Market entry strategies
— Unmet Needs, KOL's views, Analyst's views, Amyotrophic Lateral Sclerosis Market Access and Reimbursement
Download the report to understand which factors are driving amyotrophic lateral sclerosis therapeutics markettrends@Amyotrophic Lateral Sclerosis Market Trends
Table of Contents
Related Reports
Amyotrophic Lateral Sclerosis Clinical Trial Analysis
Amyotrophic Lateral Sclerosis Pipeline Insight -2025report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ALS companies, includingIonis Pharmaceuticals, 1ST Biotherapeutics, Scholar Rock, Revalesio, QurAlis Corporation, Sanofi, MediciNova, Helixmith, Verge Genomics, UCB, among others.
Alzheimer's Disease Market
Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast -2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alzheimer's disease companies, includingNovo Nordisk, Eli Lilly, Suven Life Sciences, Bristol Myers Squibb, IGC Pharma, T3D Therapeutics, Lexeo Therapeutics, Axsome Therapeutics, Araclon Biotech S.L., Eisai, TauRx Therapeutics, GemVax & KAEL, AC Immune SA, Johnson & Johnson, Longeveron, Vaccinex, Sinaptica Therapeutics, Alpha Cognition, Biogen, Otsuka Pharmaceutical, Lundbeck, among others.
Parkinson's Disease Market
Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, Inc., Britannia Pharmaceutical, Pharma Two B, Mitsubishi Tanabe Pharma (NeuroDerm), AbbVie, Cerevel Therapeutics, LLC, among others.
Agitation in Alzheimer's Disease Market
Agitation in Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key agitation in Alzheimer's disease companies, including Eli Lilly and Co, BioVie Inc., AB Science SA, Annovis Bio Inc., Cognition Therapeutics Inc., Coya Therapeutics Inc., Actinogen Medical Limited, AC Immune SA, Biogen Inc., Longeveron Inc., among others.
AboutDelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance.Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platformPharmDelve.
Contact Us
Shruti Thakur info@delveinsight.com +14699457679www.delveinsight.com
Logo: https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg
https://edge.prnewswire.com/c/img/favicon.png?sn=IO42301&sd=2025-12-09
View original content:https://www.prnewswire.com/news-releases/amyotrophic-lateral-sclerosis-market-outlook-expanding-therapeutic-pipeline-and-novel-drug-launches-propel-growth-throughout-forecast-period-20252034–delveinsight-302636137.html
SOURCE DelveInsight Business Research, LLP
https://rt.newswire.ca/rt.gif?NewsItemId=IO42301&Transmission_Id=202512091731PR_NEWS_USPR_____IO42301&DateId=20251209