Amyotrophic Lateral Sclerosis Market Outlook: Expanding Therapeutic Pipeline and Novel Drug Launches Propel Growth Throughout Forecast Period (2025-2034) | DelveInsight
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.
LAS VEGAS, Dec. 9, 2025 /PRNewswire/ -- DelveInsight's Amyotrophic Lateral Sclerosis Market Insights report includes a comprehensive understanding of current treatment practices, amyotrophic lateral sclerosis emerging 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).
Amyotrophic Lateral Sclerosis Market Summary
- The market size for amyotrophic lateral sclerosis in the US wasUSD 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 ALS market 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 501 are pioneering novel treatments for ALS through stem cell and T-cell therapy approaches.
- Transposon Therapeutics' TPN-101 and Ionis Pharmaceuticals' Ulefnersen are 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.
RELYVRIO experienced 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 PrimeC is 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' CBT101 is 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.
- InJuly 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 report proffers 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
Amyotrophic Lateral Sclerosis Market Report Metrics | Details |
Study Period | 2020–2034 |
Amyotrophic Lateral Sclerosis Market Report Coverage | 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. |
Amyotrophic Lateral Sclerosis Epidemiology Segmentation | 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, and Age-Specific Distribution of ALS |
Amyotrophic Lateral Sclerosis Market Size (US) in 2024 | USD 800 Million |
Key Amyotrophic Lateral Sclerosis Companies | 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, Biogen, Avanir Pharmaceuticals, ITF Pharma, Mitsubishi Tanabe Pharma Corporation, and others |
Key Amyotrophic Lateral Sclerosis Therapies | 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, QALSODY, NUEDEXTA, TIGLUTIK/TEGLUTIK (RILUZOLE), RADICAVA/RADICUT (EDARAVONE INJECTION), and RADICAVA ORS (EDARAVONE ORAL), and others |
Scope of the Amyotrophic Lateral Sclerosis Market Report
- Therapeutic Assessment: Amyotrophic Lateral Sclerosis current marketed and emerging therapies
- Amyotrophic Lateral Sclerosis Market Dynamics: Key Market Forecast Assumptions of Emerging Amyotrophic Lateral Sclerosis Drugs 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 market trends @ Amyotrophic Lateral Sclerosis Market Trends
Table of Contents
1 | Amyotrophic Lateral Sclerosis Market Key Insights |
2 | Amyotrophic Lateral Sclerosis Market Report Introduction |
3 | Executive Summary |
4 | Key Events |
5 | ALS Market Overview At A Glance |
6 | Epidemiology And Market Forecast Methodology |
7 | Disease Background And Overview |
7.1 | Introduction |
7.2 | Types of ALS |
7.2.1 | Sporadic ALS |
7.2.2 | Genetic or Familial ALS |
7.3 | ALS Causes |
7.4 | ALS Risk Factors |
7.5 | ALS Symptoms |
7.6 | ALS Clinical Features |
7.7 | ALS Pathogenesis |
7.8 | Biomarker |
7.9 | Prediction of Prognosis |
7.10 | Differential Diagnosis |
7.11 | ALS Diagnosis |
8 | Treatment And Management Of ALS |
9 | Epidemiology And Patient Population Of The 7MM |
9.1 | Key Findings |
9.2 | Assumptions and Rationale |
9.3 | Total Prevalent Population of ALS in the 7MM |
9.4 | Total Diagnosed Prevalent Population of ALS in the 7MM |
9.5 | The United States |
9.5.1 | Diagnosed Prevalence of ALS in the United States |
9.5.2 | Type-specific Distribution of ALS in the United States |
9.5.3 | Gender-specific Distribution of ALS in the United States |
9.5.4 | Mutation-specific Distribution of ALS in the United States |
9.5.5 | Distribution Based on Site of Onset of ALS in the United States |
9.5.6 | Age-specific Distribution of ALS in the United States |
9.6 | EU4 and UK |
9.7 | Japan |
10 | ALS Patient Journey |
11 | Key Endpoints In ALS |
12 | Marketed ALS Drugs |
12.1 | Key Cross |
12.2 | QALSODY (TOFERSEN): BIOGEN/IONIS |
12.2.1 | Product Description |
12.2.2 | Regulatory Milestones |
12.2.3 | Other Developmental Activities |
12.2.4 | Summary of Pivotal Trials |
12.2.5 | Clinical Development |
12.3.5.1 | Clinical Trial Information |
12.2.6 | Safety and Efficacy |
12.2.7 | Analyst Views |
12.3 | NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE/QUINIDINE SULFATE): AVANIR PHARMACEUTICALS (A SUBSIDIARY OF OTSUKA AMERICA) |
12.4 | TIGLUTIK/TEGLUTIK (RILUZOLE): ITF PHARMA (A US SUBSIDIARY OF ITALFARMACO) |
12.5 | RADICAVA/RADICUT (EDARAVONE INJECTION) AND RADICAVA ORS (EDARAVONE ORAL): MITSUBISHI TANABE PHARMA CORPORATION |
13 | Emerging ALS Drugs |
13.1 | Key Competitors |
13.2 | MASITINIB: AB SCIENCE |
13.2.1 | Product Description |
13.2.2 | Other Developmental Activities |
13.2.3 | Clinical Development |
13.2.3.1 | Clinical Trial Information |
13.2.4 | Safety and Efficacy |
13.2.5 | Analyst Views |
13.4 | NUROWN (MSC-NTF CELLS): BRAINSTORM CELL THERAPEUTICS |
13.5 | ULEFNERSEN (ION363): IONIS/ OTSUKA PHARMACEUTICALS |
13.6 | IBUDILAST: MEDICINOVA |
13.7 | ABBV-CLS-7262: ABBVIE/CALICO LIFE SCIENCES |
13.8 | CNM-AU8: CLENE NANOMEDICINE BIOSCIENCES |
13.9 | SLS-005 (TREHALOSE): SEELOS THERAPEUTICS |
13.10 | PRIDOPIDINE: PRILENIA THERAPEUTICS |
13.11 | RAPA-501: RAPA THERAPEUTICS |
13.12 | PrimeC: Neurosense Therapeutics |
13.13 | ENGENSIS (VM202): HELIXMITH |
13.14 | TPN-101: TRANSPOSON THERAPEUTICS |
13.15 | RNS60: REVALESIO CORPORATION |
13.16 | ANX005: ANNEXON BIOSCIENCES |
13.17 | DAZUCORILANT (CORT113176): CORCEPT THERAPEUTICS |
13.18 | AP-101: AL-S PHARMA |
13.19 | AIT-101 (LAM-002A): ORPHAI THERAPEUTICS |
13.20 | NP001: NEUVIVO |
13.21 | IFB-088: InFlectis BioScience |
14 | ALS Market: 7MM Analysis |
14.1 | Key Findings |
14.2 | ALS Market Outlook |
14.3 | Conjoint Analysis |
14.4 | Key ALS Market Forecast Assumptions |
14.5 | Total Market Size of ALS in the 7MM |
14.6 | The United States ALS Market Size |
14.6.1 | Total Market Size of ALS in the United States |
14.6.2 | Market Size of ALS by Therapies in the United States |
14.7 | EU4 and the UK ALS Market Size |
14.8 | Japan ALS Market Size |
15 | ALS Market Unmet Needs |
16 | ALS Market SWOT Analysis |
17 | KOL Views on ALS |
18 | ALS Market Access And Reimbursement |
18.1 | The United States |
18.2 | EU4 and the UK |
18.3 | Japan |
18.4 | Summary and Comparison of Market Access and Pricing Policy Developments in 2025 |
18.5 | Market Access and Reimbursement of ALS |
19 | Bibliography |
20 | ALS Market Report Methodology |
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