Amyotrophic Lateral Sclerosis (ALS) Market Set for Significant Growth by 2036, Driven by Emerging Gene Therapies and Rising Disease Burden | DelveInsight

The Amyotrophic Lateral Sclerosis (ALS) market is expected to grow steadily across the 7MM during the forecast period (2026-2036), driven by increasing disease prevalence, advancements in genetic and neuroprotective therapies, and the anticipated launch of emerging therapies such as Ulefnersen (Ionis/Otsuka Pharmaceuticals), Masitinib (AB Science), PrimeC (NeuroSense Therapeutics), NurOwn (BrainStorm Cell Therapeutics), CNM-Au8 (Clene Nanomedicine), and others. These innovative therapies are expected to reshape the treatment landscape for this devastating neurodegenerative disorder.

DelveInsight's report, "Amyotrophic Lateral Sclerosis (ALS) Market Insight, Epidemiology, and Market Forecast-2036," provides a comprehensive analysis of the ALS landscape. The report delivers detailed insights into the disease, including historical and forecasted epidemiology, helping stakeholders understand diagnosed prevalence, patient burden, and market opportunities across key regions.

Additionally, it examines ALS market dynamics, offering a thorough assessment of current treatment practices, unmet needs, and emerging therapeutic developments. The analysis spans major markets, including the United States, EU4 (Germany, Spain, Italy, France, and the United Kingdom), and Japan, equipping decision-makers with actionable intelligence for strategic planning, investment, and commercialization initiatives.

To know in detail about the Amyotrophic Lateral Sclerosis (ALS) market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-market?utmsource=openpr&utm_medium=pressrelease&utm_campaign=kspr

Key Takeaways from the Amyotrophic Lateral Sclerosis (ALS) Market Report
• The ALS market size in the 7MM is projected to increase significantly by 2036, mainly due to the launch of upcoming therapies and the increasing diagnosed prevalent population of ALS.
• The United States accounted for the highest market size among the 7MM in 2025.
• In 2025, the total prevalent cases of ALS in the 7MM comprised nearly 68,000 cases, which are expected to increase by 2036.
• In the US, the total diagnosed prevalent cases of ALS were approximately 24,794 in 2025.
• Among mutation-specific cases of ALS in the US in 2025, non-mutated or unidentified mutations accounted for approximately 71% of cases.
• Among the EU4 and the UK, nearly 90% of cases comprised sporadic ALS, while around 10% comprised familial ALS in 2025.
• Among the gender-specific cases in Japan, nearly 55% comprised males, while nearly 45% comprised females in 2025.
• Leading companies advancing the pipeline include AB Science, NeuroSense Therapeutics, BrainStorm Cell Therapeutics, Ionis Pharmaceuticals/Otsuka Pharmaceuticals, Clene Nanomedicine, MediciNova, and others.
• Masitinib is currently in a Phase III confirmatory trial for ALS, with AB Science receiving authorization to initiate registration studies in Europe and the US.
• PrimeC received Orphan Drug Designation (ODD) from both the US FDA and EMA and is preparing for a pivotal Phase III trial following positive regulatory feedback.
• QALSODY became the first approved therapy targeting a genetic cause of ALS linked to SOD1 mutations.

Key Factors Driving the Amyotrophic Lateral Sclerosis (ALS) Market
• Increasing Disease Burden and Diagnosis Rates: Growing awareness of neurodegenerative disorders and advances in genetic testing and biomarkers are supporting earlier diagnosis and improved patient identification across the 7MM.
• Advancements in Gene and Neuroprotective Therapies: Ongoing R&D advancements are driving the ALS market by improving understanding of disease mechanisms and enabling novel therapies, including gene-targeted and neuroprotective approaches.
• High Unmet Need Driving Innovation: Current therapies mainly slow disease progression or manage symptoms without curing the disease, creating strong demand for more effective disease-modifying therapies.
• Supportive Regulatory Environment: Regulatory incentives such as Orphan Drug Designation and accelerated pathways are encouraging investment and clinical development activities in ALS.

Amyotrophic Lateral Sclerosis (ALS) Market Analysis
• ALS is a progressive neurodegenerative disease characterized by degeneration of motor neurons, leading to muscle weakness, paralysis, respiratory failure, and eventual death. Currently, there is no cure for ALS, and treatment primarily focuses on slowing disease progression, symptom management, and multidisciplinary supportive care.
• Approved therapies for ALS include RILUTEK, TIGLUTIK/TEGLUTIK (riluzole oral suspension), RADICAVA (IV and oral), and QALSODY. Supportive therapies include physical therapy, speech therapy, respiratory therapy, nutritional support, and symptomatic management with agents such as antiepileptic drugs, opioids, NSAIDs, SSRIs, and antidepressants.
• After the approval of RADICAVA ORS, there was a notable increase in RADICAVA uptake in both the US and Japan. However, RELYVRIO was withdrawn from the market following disappointing PHOENIX trial results.
• Despite recent therapeutic advances, ALS remains an area of substantial unmet need due to high disease heterogeneity, genetic variability, limited long-term efficacy of available therapies, and the lack of curative treatment options.

Get a Free sample for the Amyotrophic Lateral Sclerosis (ALS) Market Forecast, Size & Share Analysis Report: https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-market?utmsource=openpr&utm_medium=pressrelease&utm_campaign=kspr

Amyotrophic Lateral Sclerosis (ALS) Competitive Landscape
Key companies such as AB Science, NeuroSense Therapeutics, BrainStorm Cell Therapeutics, Ionis Pharmaceuticals/Otsuka Pharmaceuticals, and Clene Nanomedicine are leading the pipeline with differentiated approaches that could transform future treatment options and create meaningful commercial opportunities.

Masitinib: AB Science
Masitinib is an orally administered tyrosine kinase inhibitor that modulates mast cells and macrophage activity involved in immune responses. The therapy is currently in a Phase III confirmatory trial for ALS. In July 2025, AB Science received authorization to initiate registration studies in Europe and the US.

PrimeC: NeuroSense Therapeutics
PrimeC is a novel combination therapy composed of ciprofloxacin and celecoxib designed to synergistically inhibit ALS progression. The therapy has received Orphan Drug Designation from both the US FDA and EMA. NeuroSense plans to initiate a multinational Phase III study following encouraging Phase IIb PARADIGM trial results.

NurOwn: BrainStorm Cell Therapeutics
NurOwn is a stem cell-based therapy designed to deliver neurotrophic factors that support neuron survival and modulate neuroinflammation. In July 2025, BrainStorm Cell Therapeutics highlighted the FDA's consideration of a Citizen Petition requesting a new review of the therapy's clinical data.

Ulefnersen (ION363): Ionis Pharmaceuticals/Otsuka Pharmaceuticals
Ulefnersen is an antisense oligonucleotide therapy targeting FUS-associated ALS. The therapy represents a precision medicine approach aimed at genetically defined patient populations.

Discover more about therapies set to grab major Amyotrophic Lateral Sclerosis (ALS) market share @ https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-market?utmsource=openpr&utm_medium=pressrelease&utm_campaign=kspr

Recent Development in the Amyotrophic Lateral Sclerosis (ALS) Treatment Landscape:
• In March 2026, NeuroSense Therapeutics announced that the Phase III PARAGON trial for PrimeC is expected to launch in mid-2026 with an adaptive design intended to accelerate regulatory approval timelines.
• In February 2026, AB Science identified a plasma biomarker indicating the activity of masitinib in ALS, which will be incorporated into its ongoing Phase III development program.
• In July 2025, AB Science announced authorization from European countries under the CTIS procedure for its confirmatory Phase III study of masitinib in ALS.
• In July 2025, NeuroSense Therapeutics presented late-breaking data from the Phase IIb PARADIGM trial of PrimeC at the 2025 American Academy of Neurology (AAN) Annual Meeting.
• In July 2025, BrainStorm Cell Therapeutics acknowledged FDA consideration of a Citizen Petition requesting a new review of NurOwn clinical data.

What is Amyotrophic Lateral Sclerosis (ALS)?
Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease, is a progressive neurodegenerative disorder affecting upper and lower motor neurons in the brain and spinal cord. The disease causes gradual muscle weakness, paralysis, difficulty speaking and swallowing, respiratory failure, and ultimately death. ALS may occur sporadically or as a familial inherited condition linked to genetic mutations such as C9ORF72, SOD1, FUS, TARDBP, OPTN, and ANG. The disease has significant clinical heterogeneity, making treatment development challenging. Current treatment strategies include riluzole formulations, edaravone therapies, antisense oligonucleotides, supportive multidisciplinary care, respiratory support, nutritional management, and symptomatic therapies.

Amyotrophic Lateral Sclerosis (ALS) Epidemiology Segmentation:
The ALS market report proffers epidemiological analysis for the study period 2022-2036 in the 7MM segmented into:
• Total Prevalent Cases of ALS in the 7MM
• Total Diagnosed Prevalent Cases of ALS in the 7MM
• Gender-Specific Diagnosed Prevalent Cases of ALS
• Mutation-Specific Diagnosed Prevalent Cases of ALS
• Type-Specific Diagnosed Prevalent Cases of ALS
• Diagnosed Prevalent Cases Based on Site of Onset
• Age-Specific Diagnosed Prevalent Cases of ALS

Download the report to understand which factors are driving Amyotrophic Lateral Sclerosis (ALS) epidemiology trends @ https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-market?utmsource=openpr&utm_medium=pressrelease&utm_campaign=kspr

Scope of the Amyotrophic Lateral Sclerosis (ALS) Market Report
• Study Period: 2022-2036
• Coverage: 7MM [The United States, EU4 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Companies: AB Science, NeuroSense Therapeutics, BrainStorm Cell Therapeutics, Ionis Pharmaceuticals/Otsuka Pharmaceuticals, Clene Nanomedicine, MediciNova, and others
• Key Therapies: Masitinib, PrimeC, NurOwn, Ulefnersen, CNM-Au8, Ibudilast, and others
• Market Dynamics: Drivers and Barriers
• Competitive Intelligence Analysis: SWOT, market entry strategies, reimbursement scenario
• Unmet Needs, KOL Views, Analyst Views, Market Access and Reimbursement

To know more about Amyotrophic Lateral Sclerosis (ALS) companies working in the treatment market, visit @ https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-market?utmsource=openpr&utm_medium=pressrelease&utm_campaign=kspr

Table of Contents
• Amyotrophic Lateral Sclerosis (ALS) Market Report Introduction
• Executive Summary for Amyotrophic Lateral Sclerosis (ALS)
• SWOT Analysis of Amyotrophic Lateral Sclerosis (ALS)
• Amyotrophic Lateral Sclerosis (ALS) Patient Share (%) Overview at a Glance
• Amyotrophic Lateral Sclerosis (ALS) Market Overview at a Glance
• Amyotrophic Lateral Sclerosis (ALS) Background and Overview
• Amyotrophic Lateral Sclerosis (ALS) Epidemiology and Patient Population
• Country-Specific Patient Population of Amyotrophic Lateral Sclerosis (ALS)
• Amyotrophic Lateral Sclerosis (ALS) Current Treatment and Medical Practices
• Amyotrophic Lateral Sclerosis (ALS) Unmet Needs
• Amyotrophic Lateral Sclerosis (ALS) Emerging Therapies
• Amyotrophic Lateral Sclerosis (ALS) Market Outlook
• Country-Wise Amyotrophic Lateral Sclerosis (ALS) Market Analysis (2022-2036)
• Amyotrophic Lateral Sclerosis (ALS) Market Access and Reimbursement of Therapies
• Amyotrophic Lateral Sclerosis (ALS) Market Drivers
• Amyotrophic Lateral Sclerosis (ALS) Market Barriers
• Amyotrophic Lateral Sclerosis (ALS) Appendix
• Amyotrophic Lateral Sclerosis (ALS) Report Methodology
• DelveInsight Capabilities
• Disclaimer
• About DelveInsight

Company Name: DelveInsight Business Research LLP
Contact Person: Kirti Sharma
Email: info@delveinsight.com
Phone: +14699457679
Address: 304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/

About DelveInsight
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 platform PharmDelve.

This release was published on openPR.