Amyotrophic Lateral Sclerosis Market Summary
The total Amyotrophic Lateral Sclerosis Market Size in the US was estimated to be ~USD 920 million in 2023, which is expected to grow during the forecast period (2024–2034). The current standard treatment primarily involves riluzole, which helps slow disease progression and extend patient survival. A notable recent advancement was the FDA approval of RELYVRIO (sodium phenylbutyrate and taurursodiol) in September 2022 for adult ALS patients. Despite some setbacks with RELYVRIO, RADICAVA remains a leading therapy, especially after the launch of RADICAVA ORS (oral suspension), which boosted sales in the US and Japan, reversing previous declines seen with the intravenous form.
Emerging Amyotrophic Lateral Sclerosis therapies are increasingly targeting specific genetic mutations linked to ALS. Transposon Therapeutics’ TPN-101 and Ionis Pharmaceuticals’ Ulefnersen focus on mutations like C9ORF72 and FUS, addressing unmet needs in mutation-specific Amyotrophic Lateral Sclerosis. However, many mutations remain unaddressed, presenting opportunities for future research. Current ALS treatments include EXSERVAN (riluzole oral film), RELYVRIO, QALSODY, RADICAVA (injection and oral), NEUDEXTA, TIGLUTEK, and symptomatic drugs like anti-epileptics, opioids, and antidepressants. Several promising Amyotrophic Lateral Sclerosis therapies, such as Ulefnersen, Ibudilast, Masitinib, NurOwn, and CNM-Au8, are expected to enter the market during 2024-2034, likely expanding the ALS treatment landscape alongside a growing diagnosed patient population.
DelveInsight’s report, “Amyotrophic Lateral Sclerosis Market Insights, Epidemiology, and Market Forecast-2034,” offers a comprehensive analysis of ALS, including its historical and projected epidemiology across major regions—the United States, EU5 (Germany, Spain, Italy, France, and the UK), and Japan. The report details current treatment approaches, emerging therapies, and the market share of individual treatments. It provides market size estimates and forecasts from 2020 to 2034 for seven key markets. Additionally, the report examines treatment algorithms, identifies market drivers and barriers, and highlights unmet medical needs, aiming to identify key opportunities and evaluate the overall potential of the ALS market.
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Some facts of the Amyotrophic Lateral Sclerosis Market Report are:
- DelveInsight projects that the Amyotrophic Lateral Sclerosis market will experience steady growth with a respectable CAGR through 2034.
- The Amyotrophic Lateral Sclerosis market size in the seven major markets (7MM) was approximately USD 1,000 million in 2023.
- Prominent companies actively involved in the Amyotrophic Lateral Sclerosis market include Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, AL-S Pharma, Rapa Therapeutics LLC, Cytokinetics, MediciNova, Retrotope, Inc., Woolsey Pharmaceuticals, Sanofi, PTC Therapeutics, Helixmith Co., Ltd., Annexon, Inc., Denali Therapeutics Inc., Revalesio Corporation, Clene Nanomedicine, Ashvattha Therapeutics, Inc., Apellis Pharmaceuticals, Inc., Procypra Therapeutics, Knopp Biosciences, InFlectis BioScience, AI Therapeutics, Inc., Cellenkos, ZZ Biotech, LLC, QurAlis Corporation, Alector Inc., NeuroSense Therapeutics Ltd., Novartis Pharmaceuticals, Eledon Pharmaceuticals, among others.
- Key therapies expected to enter the Amyotrophic Lateral Sclerosis market include BIIB067, FAB122, ABBV-CLS-7262, Trametinib, BIIB105, AstroRx, Dazucorilant, AP-101, RAPA-501, ION-363, Reldesemtiv, MN-166, RT001, Fasudil, SAR443820, PTC857, ANX005, DNL343, RNS60, BIIB100, CNMAu8, 18F-OP-801, Pegcetacoplan (APL-2), Cu(II)ATSM, KNS-760704, IFB-088, LAM-002A, CK 0803, 3K3A-APC, QRL-201, Dexpramipexole, AL001, PrimeC, BLZ945, AT-1501, and others.
- In May 2025, BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced that the FDA has granted approval to initiate its Phase 3b clinical trial of NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS).
- In May 2025, Athira Pharma (NASDAQ: ATHA) reported its Q1 2025 results and provided updates on its pipeline, including the successful completion of a Phase 1 trial of ATH-1105 in healthy volunteers as a potential therapy for ALS. Complete trial data is anticipated in the latter half of 2025.
- In May 2025, Neuralink announced it received the FDA’s Breakthrough Device designation for its innovative device designed to restore communication abilities in patients with severe speech impairments, targeting conditions such as ALS, stroke, spinal cord injury, cerebral palsy, and multiple sclerosis, as shared by the company on X.
- In April 2025, BrainStorm Cell Therapeutics (NASDAQ: BCLI) disclosed that it has submitted an Investigational New Drug (IND) amendment to the FDA for NurOwn®, its personalized stem cell therapy aimed at treating ALS.
- In March 2025, SineuGene Therapeutics announced that the FDA approved its Investigational New Drug application for SNUG01, a novel TRIM72-targeted gene therapy candidate for ALS, enabling a global Phase I/IIa clinical trial to assess safety, tolerability, and early efficacy in adults with ALS through dose escalation and expansion studies.
- In January 2025, Zydus revealed that the US FDA granted Orphan Drug Designation to Usnoflast, an innovative oral NLRP3 inhibitor developed for treating ALS.
- In April 2024, Corcept Therapeutics shared results from a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of CORT113176 (Dazucorilant) in ALS patients (DAZALS study).
- In March 2024, Verge Genomics announced outcomes from a Phase 1b, open-label, multiple ascending dose, multicenter trial of VRG50635 involving both sporadic and familial ALS patients, including long-term treatment follow-up.
- In August 2023, AL-S Pharma presented data from a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study assessing safety, tolerability, pharmacodynamic markers, and pharmacokinetics of AP-101 in patients with familial and sporadic ALS.
Amyotrophic Lateral Sclerosis Overview
Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disorder characterized by the selective degeneration of motor neurons in the brain and spinal cord. This degeneration leads to muscle weakness, atrophy, and eventual paralysis, affecting voluntary muscle control, including those responsible for movement, speech, swallowing, and breathing. ALS is typically fatal within two to five years following diagnosis due to respiratory failure. The exact cause of ALS remains unclear, though it is believed to involve a combination of genetic and environmental factors. Approximately 10% of cases are familial, linked to specific genetic mutations such as SOD1, C9ORF72, and FUS, while the majority are sporadic with unknown etiology.
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Amyotrophic Lateral Sclerosis Market Outlook
Amyotrophic lateral sclerosis (ALS) currently has no cure or treatment that can halt or reverse disease progression. Only a few FDA-approved drugs exist that modestly slow the disease and improve quality of life, making management primarily supportive and symptom-focused. Recently, research has intensified on gene therapies, cellular therapies, and neuroprotective agents. Approved treatments include riluzole, NUEDEXTA, RADICAVA, TIGLUTIK, RELYVRIO, and QALSODY, which help slow progression or manage symptoms such as muscle cramps, stiffness, excess saliva, and emotional episodes. Riluzole is the first-line therapy in the US, Japan, and Europe and is known to extend survival by a few months through blocking sodium and calcium channels and enhancing glutamate clearance.
Despite a promising pipeline of disease-modifying agents and mutation-specific therapies, clinical trial failure rates remain high, with recent setbacks including drugs like arimoclomol and levosimendan. The total ALS market size in the US was approximately USD 920 million in 2023 and is expected to grow through 2034. RADICAVA is projected to be the top-selling drug, with revenues reaching about USD 923 million in the US by 2034. Additionally, emerging therapies such as Masitinib combined with riluzole are anticipated to generate significant revenue, especially in markets like Japan.
Amyotrophic Lateral Sclerosis Epidemiology
The Amyotrophic Lateral Sclerosis epidemiology section provides insights into the historical and current Amyotrophic Lateral Sclerosis patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Amyotrophic Lateral Sclerosis market report also provides the diagnosed patient pool, trends, and assumptions.
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Amyotrophic Lateral Sclerosis Market Drivers and Barriers
The Amyotrophic Lateral Sclerosis (ALS) market is propelled by several key factors. Increasing awareness about ALS and improvements in diagnostic capabilities have led to earlier and more accurate detection, expanding the diagnosed patient population. The approval and adoption of new therapies such as RELYVRIO and RADICAVA have enhanced treatment options, driving market growth by improving patient outcomes and extending survival. Moreover, advances in genetic research and precision medicine are fostering the development of mutation-specific therapies, addressing unmet needs among distinct patient subgroups. The growing investment from biopharmaceutical companies and ongoing clinical trials for innovative drugs further stimulate market expansion.
However, the market also faces significant challenges. ALS remains a complex, progressive neurodegenerative disorder with no definitive cure, limiting therapeutic options primarily to symptomatic relief. The high cost of novel therapies and limited reimbursement in some regions can restrict patient access and adoption rates. Additionally, the rarity of the disease and heterogeneity in patient presentations complicate clinical trial recruitment and drug development. The incomplete understanding of ALS pathophysiology poses scientific hurdles in identifying effective treatments. Lastly, stringent regulatory requirements and lengthy approval processes can delay market entry for emerging therapies, slowing overall market growth. Addressing these barriers is critical to advancing ALS treatment and expanding market potential.
Amyotrophic Lateral Sclerosis Pipeline Development Activities
Masitinib (AB Science)
Masitinib is an oral tyrosine kinase inhibitor that targets immune cells, offering neuroprotection in both central and peripheral nervous systems. AB Science completed a Phase II/III trial with positive results and received FDA approval to proceed with a Phase III ALS trial. In early 2024, the CHMP requested a written response on outstanding issues, with an opinion expected by mid-2024.
NurOwn (MSC-NTF cells) – BrainStorm Cell Therapeutics
NurOwn is an autologous therapy using mesenchymal stem cells derived from bone marrow, cultured to release high levels of neurotrophic factors that aid neuron growth and survival. This approach combines immune-modulating effects with neuroprotection. In late 2023, BrainStorm Cell Therapeutics realigned its strategy to fast-track NurOwn’s development by initiating a double-blind, placebo-controlled Phase IIIb trial in ALS patients, including an open-label extension. The company also committed to ongoing data releases from Phase III trials focusing on biomarkers, long-term safety, survival, and expanded patient access to enhance transparency and support ALS drug progress.
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Amyotrophic Lateral Sclerosis Therapeutics Assessment
Major key companies are working proactively in the Amyotrophic Lateral Sclerosis Therapeutics market to develop novel therapies which will drive the Amyotrophic Lateral Sclerosis treatment markets in the upcoming years are Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, AL-S Pharma, Rapa Therapeutics LLC, Cytokinetics, MediciNova, Retrotope, Inc. Woolsey Pharmaceuticals, Sanofi, PTC Therapeutics, Helixmith Co., Ltd., Annexon, Inc., Denali Therapeutics Inc., Revalesio Corporation, Clene Nanomedicine, Ashvattha Therapeutics, Inc., Apellis Pharmaceuticals, Inc., Procypra Therapeutics, Knopp Biosciences, InFlectis BioScience, AI Therapeutics, Inc., Cellenkos, ZZ Biotech, LLC, QurAlis Corporation, Alector Inc., NeuroSense Therapeutics Ltd., Novartis Pharmaceuticals, Eledon Pharmaceuticals, and others.
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Amyotrophic Lateral Sclerosis Report Key Insights
1. Amyotrophic Lateral Sclerosis Patient Population
2. Amyotrophic Lateral Sclerosis Market Size and Trends
3. Key Cross Competition in the Amyotrophic Lateral Sclerosis Market
4. Amyotrophic Lateral Sclerosis Market Dynamics (Key Drivers and Barriers)
5. Amyotrophic Lateral Sclerosis Market Opportunities
6. Amyotrophic Lateral Sclerosis Therapeutic Approaches
7. Amyotrophic Lateral Sclerosis Pipeline Analysis
8. Amyotrophic Lateral Sclerosis Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Amyotrophic Lateral Sclerosis Market
Table of Contents
1. Key Insights
2. Executive Summary
3. Amyotrophic Lateral Sclerosis Competitive Intelligence Analysis
4. Amyotrophic Lateral Sclerosis Market Overview at a Glance
5. Amyotrophic Lateral Sclerosis Disease Background and Overview
6. Amyotrophic Lateral Sclerosis Patient Journey
7. Amyotrophic Lateral Sclerosis Epidemiology and Patient Population
8. Amyotrophic Lateral Sclerosis Treatment Algorithm, Current Treatment, and Medical Practices
9. Amyotrophic Lateral Sclerosis Unmet Needs
10. Key Endpoints of Amyotrophic Lateral Sclerosis Treatment
11. Amyotrophic Lateral Sclerosis Marketed Products
12. Amyotrophic Lateral Sclerosis Emerging Therapies
13. Amyotrophic Lateral Sclerosis Seven Major Market Analysis
14. Attribute Analysis
15. Amyotrophic Lateral Sclerosis Market Outlook (7 major markets)
16. Amyotrophic Lateral Sclerosis Access and Reimbursement Overview
17. KOL Views on the Amyotrophic Lateral Sclerosis Market
18. Amyotrophic Lateral Sclerosis Market Drivers
19. Amyotrophic Lateral Sclerosis Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
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