Emerging therapies for Amyotrophic Lateral Sclerosis (ALS), including Masitinib, NurOwn (MSC-NTF cells), and others, are expected to drive substantial growth in the ALS market in the coming years.
DelveInsight has released a new report, “Amyotrophic Lateral Sclerosis – Market Insights, Epidemiology, and Market Forecast 2034”, offering a comprehensive overview of ALS, including historical and projected epidemiology, as well as market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Discover about the Amyotrophic Lateral Sclerosis market report @ https://www.delveinsight.com/report-store/amyotrophic-lateral-sclerosis-als-market?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
During the ERS Congress 2025 in September 2025, several biotechnology and pharmaceutical companies shared notable advancements in pulmonary and cardiopulmonary research:
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In September 2025, Diagonal Therapeutics presented new preclinical data highlighting the potential of its lead clustering antibody, DIAG723, as a disease-modifying therapy for pulmonary arterial hypertension (PAH).
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In September 2025, a study revealed that babies raised with dogs may have a reduced risk of developing childhood asthma.
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In September 2025, Savara shared data from the Phase 3 IMPALA-2 trial of Molgramostim Inhalation Solution for patients with autoimmune pulmonary alveolar proteinosis (aPAP).
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In September 2025, AllRock Bio, Inc. reported encouraging Phase 1 results for ROC-101, a first-in-class oral pan-ROCK inhibitor for cardiopulmonary and fibrotic diseases.
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In September 2025, Gossamer Bio, Inc., in collaboration with Chiesi Group, announced five scientific presentations on seralutinib for PAH and PH-ILD.
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In September 2025, Boehringer Ingelheim presented pooled analyses from the Phase III FIBRONEER™ program on nerandomilast, an investigational oral PDE4B inhibitor, showing a nominally significant reduction in mortality risk across IPF and PPF.
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In September 2025, Kaia Health launched a pilot program of Kaia Breathe, a digital pulmonary rehabilitation solution for COPD patients, in partnership with MedImprove.
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In September 2025, aTyr Pharma, Inc. shared additional findings from the Phase 3 EFZO-FIT™ study of efzofitimod in 268 patients with pulmonary sarcoidosis, a key form of interstitial lung disease.
Some of the key facts of the Amyotrophic Lateral Sclerosis Market Report:
In 2023, the Amyotrophic Lateral Sclerosis (ALS) market across the seven major markets (7MM) was valued at approximately USD 1 billion. Current standard treatment, primarily riluzole, helps slow disease progression and modestly extends survival.
A major milestone was the FDA approval of RELYVRIO (sodium phenylbutyrate and taurursodiol) on September 29, 2022, for adults with ALS. Following some challenges with RELYVRIO, RADICAVA, particularly its oral formulation RADICAVA ORS, has become the leading therapy, gaining strong adoption in the U.S. and Japan and reversing prior declines in intravenous edaravone sales.
Next-generation therapies are being developed to target specific genetic forms of ALS. For instance, TPN-101 (Transposon Therapeutics) and Ulefnersen (ION363, Ionis Pharmaceuticals) focus on patients with C9ORF72 and FUS mutations. While attention is increasing on mutations like SOD1, C9ORF72, and FUS, other variants such as TARDBP, OPTN, and ANG remain largely unaddressed, highlighting opportunities for future development. Many ALS patients, however, still have unidentified underlying genetic mutations.
Current treatment options include disease-modifying and symptomatic therapies such as EXSERVAN (riluzole oral film), RELYVRIO, QALSODY, RADICAVA, RADICAVA ORS, NEUDEXTA, TIGLUTEK, and RILUTEK, alongside supportive treatments like anti-epileptics, NSAIDs, opioids, SSRIs, antidepressants, and diuretics.
The ALS market is expected to grow substantially between 2024 and 2034, driven by the anticipated launch of promising pipeline therapies including Ulefnersen, Ibudilast (MediciNova), Masitinib (AB Science), NurOwn (BrainStorm Cell Therapeutics), and CNM-Au8 (Clene Nanomedicine), as well as rising diagnosis rates and increasing prevalence.
Recent clinical developments include:
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May 2025: Neuralink received FDA breakthrough designation for its neural interface device to restore communication in patients with severe speech impairments, including ALS.
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April 2025: BrainStorm Cell Therapeutics submitted an IND amendment to the FDA for NurOwn®, an autologous stem cell therapy.
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March 2025: DiagnaMed Holdings received Orphan Drug Designation from the FDA for its molecular hydrogen therapy targeting ALS.
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January 2025: Zydus Lifesciences received FDA approval to start a randomized Phase IIb trial of Usnoflast, an oral NLRP3 inflammasome inhibitor, as a potential ALS therapy.
Key ALS companies developing novel therapies include Ab Science, Alector, GSK, BrainStorm Cell Therapeutics, Ionis Pharmaceuticals, MediciNova, Denali Therapeutics, AbbVie, Calico Life Sciences, Clene Nanomedicine Biosciences, Seelos Therapeutics, Prilenia Therapeutics, Rapa Therapeutics, Neurosense Therapeutics, Helixmith, Transposon Therapeutics, Revalesio Corporation, Annexon Biosciences, Corcept Therapeutics, and others.
Promising pipeline therapies include Masitinib, NurOwn (MSC-NTF cells), and additional candidates expected to enhance ALS treatment outcomes.
Amyotrophic Lateral Sclerosis Overview
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a progressive neurodegenerative disorder that affects nerve cells in the brain and spinal cord, leading to muscle weakness, reduced mobility, and ultimately respiratory failure. While the exact cause remains unclear, ALS is thought to result from a combination of genetic factors and environmental influences.
Diagnosis involves a thorough neurological evaluation, detailed medical history, and multiple tests to rule out other conditions. Electromyography (EMG) and nerve conduction studies assess nerve and muscle health, while imaging methods such as MRI help exclude alternative causes of symptoms. Despite these tools, ALS is challenging to diagnose due to the absence of a single definitive test.
Early and accurate diagnosis is critical for initiating symptom management and connecting patients with necessary care and support. Although there is currently no cure, treatments focus on improving quality of life and alleviating symptoms. Research is ongoing to develop new therapies and deepen understanding of the disease. Emerging biomarkers, such as elevated neurofilament levels in cerebrospinal fluid, show promise for assisting diagnosis, monitoring disease progression, and evaluating treatment response. While not yet common in clinical practice, these biomarkers could play an important role in patient stratification and clinical trials, especially when symptoms overlap with other neurological disorders.
Amyotrophic Lateral Sclerosis Market Outlook
Currently, there is no cure for Amyotrophic Lateral Sclerosis (ALS), and existing treatments have limited ability to halt or reverse disease progression. Only a few FDA-approved therapies modestly slow the disease and help enhance patients’ quality of life. Consequently, ALS management remains largely supportive, focusing on symptom relief. Approved treatments—including riluzole, RADICAVA, TIGLUTIK, RELYVRIO, QALSODY, and NEUDEXTA—aim to slow progression or alleviate specific symptoms such as muscle cramps, stiffness, excessive saliva, emotional disturbances, pain, depression, and sleep problems.
Riluzole is considered the first-line therapy for ALS in the U.S., Europe, and Japan. Approved by the FDA in 1995, it may extend survival by a few months by blocking sodium and calcium channels and enhancing glutamate clearance. Riluzole is available in several formulations, including RILUTEK (oral tablet), TIGLUTIK (oral suspension), and EXSERVAN (oral film). NEUDEXTA, used to manage pseudobulbar affect, provides symptomatic relief but does not alter disease progression.
Despite increasing interest in gene therapies, neuroprotective agents, and cell-based treatments, the success rate of ALS drug development remains low. Several recent candidates, such as arimoclomol, levosimendan, ravulizumab, and zilucoplan, have failed in clinical trials. Nonetheless, ongoing research into disease-modifying therapies and agents targeting specific genetic mutations offers promise for addressing unmet needs and improving long-term outcomes in ALS.
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Amyotrophic Lateral Sclerosis Marketed Drugs
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RADICAVA/RADICUT (edaravone injection) and RADICAVA ORS: Mitsubishi Tanabe Pharma Corporation
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RELYVRIO: Amylyx Pharmaceuticals
Amyotrophic Lateral Sclerosis Emerging Drugs
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Masitinib: AB Science
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NurOwn (MSC-NTF cells): Brainstorm Cell Therapeutics
Scope of the Amyotrophic Lateral Sclerosis Market Report
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Study Period: 2020-2034
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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
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Key Amyotrophic Lateral Sclerosis Companies: AB SCIENCE, ALECTOR, GSK, BRAINSTORM CELL THERAPEUTICS, IONIS PHARMACEUTICALS, MEDICINOVA, DENALI THERAPEUTICS, 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, SANOFI, DENALI THERAPEUTICS, ORPHAI THERAPEUTICS, and others
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Amyotrophic Lateral Sclerosis Therapies: Masitinib, NurOwn (MSC-NTF cells), and others.
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Amyotrophic Lateral Sclerosis Therapeutic Assessment: Amyotrophic Lateral Sclerosis current marketed and Amyotrophic Lateral Sclerosis emerging therapies
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Amyotrophic Lateral Sclerosis Market Dynamics: Amyotrophic Lateral Sclerosis market drivers and Amyotrophic Lateral Sclerosis market barriers
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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
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Amyotrophic Lateral Sclerosis Unmet Needs, KOL's views, Analyst's views, Amyotrophic Lateral Sclerosis Market Access and Reimbursement
To know what’s more in our Amyotrophic Lateral Sclerosis report, visit https://www.delveinsight.com/report-store/amyotrophic-lateral-sclerosis-als-market?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Key benefits of the Amyotrophic Lateral Sclerosis Market Report:
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Amyotrophic Lateral Sclerosis market report covers a descriptive overview and comprehensive insight of the Amyotrophic Lateral Sclerosis Epidemiology and Amyotrophic Lateral Sclerosis market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).
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The Amyotrophic Lateral Sclerosis market report provides insights into the current and emerging therapies.
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The Amyotrophic Lateral Sclerosis market report provides a global historical and forecasted market covering drug outreach in 7MM.
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The Amyotrophic Lateral Sclerosis market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Amyotrophic Lateral Sclerosis market.
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Table of Contents
1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Amyotrophic Lateral Sclerosis Patient Share (%) Overview at a Glance
5. Amyotrophic Lateral Sclerosis Market Overview at a Glance
6. Amyotrophic Lateral Sclerosis Disease Background and Overview
7. Amyotrophic Lateral Sclerosis Epidemiology and Patient Population
8. Country-Specific Patient Population of Amyotrophic Lateral Sclerosis
9. Amyotrophic Lateral Sclerosis Current Treatment and Medical Practices
10. Unmet Needs
11. Amyotrophic Lateral Sclerosis Emerging Therapies
12. Amyotrophic Lateral Sclerosis Market Outlook
13. Country-Wise Amyotrophic Lateral Sclerosis Market Analysis (2020–2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Amyotrophic Lateral Sclerosis Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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Amyotrophic Lateral Sclerosis Pipeline Insights, DelveInsight
"Amyotrophic Lateral Sclerosis Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Amyotrophic Lateral Sclerosis market. A detailed picture of the Amyotrophic Lateral Sclerosis pipeline landscape is provided, which includes the disease overview and Amyotrophic Lateral Sclerosis treatment guidelines.
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