DelveInsight’s “Amyotrophic Lateral Sclerosis Market Insights, Epidemiology, and Market Forecast–2034” report delivers an in-depth understanding of ALS, historical and forecasted epidemiology as well as the ALS market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

 

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Key Takeaways from the Amyotrophic Lateral Sclerosis Market Report

• In November 2024:- Woolsey Pharmaceuticals- The study population will consist of subjects with a diagnosis of probable laboratory-supported, probable, or definite ALS, as defined by El Escorial Revised ALS diagnostic criteria; with ALS symptom onset within 48 months; and with percent predicted SVC ≥ 50% at Screening 1. Subjects must also have an average rate of decline in ALSFRS-R at Screening 1 of 0.5 to 3.0 points/month, with rate of decline calculated using historical data (either prior ALSFRS-R score or date of ALS symptom onset).
• In November 2024:- Argenx- This study aims to evaluate the safety of ARGX-119 in adults with ALS. The study will also assess the impact of ARGX-119 on ALS disease outcomes, including muscle function. The study consists of 2 periods: a treatment period when participants will receive one of three ARGX-119 doses or placebo and an extension period when all participants will receive the same dose of ARGX-119. Participation in the study will last up to approximately 100 weeks.
• In November 2024: Ionis Pharmaceuticals Inc.- A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis Patients With Fused in Sarcoma Mutations (FUS-ALS). Part 1 will consist of participants who will be randomized in a 2:1 ratio to receive a multi-dose regimen of ION363 or placebo for a period of 60 weeks, followed by Part 2, in which participants will receive open-label ION363 for a period of 84 weeks. Participants may continue to receive open-label ION363 in Part 3 for up to 3 additional years or until ION363 becomes commercially available in the patient’s country or until the Sponsor discontinues the ION363 development program, whichever occurs earlier.
• Among the 7MM, the US accounted for the highest Amyotrophic Lateral Sclerosis prevalent cases in 2023, with around 26,000 cases; these cases are expected to increase during the forecast period.
• Amongst EU4 and the UK, the Amyotrophic Lateral Sclerosis diagnosed prevalent cases were highest in Germany, while the lowest number of cases was in Spain in 2023.
• The major sites of onset of Amyotrophic Lateral Sclerosis are the bulbar, and spinal, along with other uncertain regions. In 2023, the patients with the spinal as a site of onset accounted highest cases, i.e., 15,000, followed by the bulbar site of onset.
• According to the estimates, in Japan, it is observed that Amyotrophic Lateral Sclerosis was most prevalent in the 70-79 years age group, followed by 60-69 years, and 50–59 years.
• The leading Amyotrophic Lateral Sclerosis Companies such as Helixmith, Sanofi, Denali Therapeutics, Alector, GSK, NeuroSense Therapeutics, Biogen, Ionis, Brainstorm Cell Therapeutics, Cytokinetics, Astellas Pharma, Apellis Pharmaceuticals, Clene Nanomedicine Biosciences, AL-S Pharma, MediciNova, Seelos Theraputics, Prilenia Therapeutics, AB Science, Eledon Pharmaceuticals, Revalesio Corporation, Biohaven Pharmaceuticals, UCB Pharma, Ra Pharmaceuticals, and others.
• Promising Amyotrophic Lateral Sclerosis Pipeline Therapies such as Reldesemtiv, Albutein 5%, Tofersen, FAB122, sNN0029, ABBV-CLS-7262, SPG302, Dazucorilant 300 mg, and others.

 

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Amyotrophic Lateral Sclerosis Epidemiology Segmentation in the 7MM

• Amyotrophic Lateral Sclerosis Prevalence

• Amyotrophic Lateral Sclerosis Diagnosed Prevalence

• Amyotrophic Lateral Sclerosis Gender-specific Distribution

• Amyotrophic Lateral Sclerosis Mutation-specific Distribution

• Amyotrophic Lateral Sclerosis Type-specific Distribution

• Amyotrophic Lateral Sclerosis Distribution based on Site of onset

• Amyotrophic Lateral Sclerosis Age-specific Distribution

 

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Amyotrophic Lateral Sclerosis Marketed Drugs

• RADICAVA/RADICUT (edaravone injection) and RADICAVA ORS: Mitsubishi Tanabe Pharma Corporation

RADICAVA is a product of Mitsubishi Tanabe Pharma that contains the active substance edaravone. It is a novel neuroprotective agent that slows down ALS progression. Notably, RADICAVA is the second drug to be approved for the treatment of ALS after more than two decades from the first US FDA approval of riluzole. Edaravone is available as a clear, colorless liquid provided as a sterile injection solution supplied for IV infusion; the substituted 2-pyrazolin-5-one class has the chemical name 3-methyl-1-phenyl-2-pyrazolin-5-one. The mechanism by which RADICAVA exerts its therapeutic effect in patients with ALS is unknown; however, it has anti-oxidant properties (Cruz, 2018b). Even after getting approval, the company is still conducting various clinical trial studies to better understand the drug’s effects on a larger scale.

 

• RELYVRIO: Amylyx Pharmaceuticals

RELYVRIO (AMX0035) is an investigational neuroprotective therapy being developed to minimize neuronal death and dysfunction. In ALS and other neurodegenerative disorders, the drug targets endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways and blocks stress to maintain a balance between them. AMX0035 is a fixed-dose co formulation of two active compounds, namely, sodium phenylbutyrate (PB) and taurursodiol (tauroursodeoxycholic acid [TUDCA].

 

Amyotrophic Lateral Sclerosis Emerging Drugs

• Masitinib: AB Science

Masitinib (AB1010) is an orally administered tyrosine kinase inhibitor. It modulates mast cells and macrophages’ activity – important cells for immunity – by targeting a limited number of kinases without inhibiting, at therapeutic doses, kinases associated with known toxicities. Masitinib distinguishes itself from other ALS developmental drugs by exerting neuroprotection in both central and peripheral nervous systems. Based on its unique mechanism of action, masitinib can be developed in many conditions in oncology, inflammatory diseases, and certain diseases of the central nervous system. AB Science completed a Phase II/III trial and has attained positive results, followed by a green signal from the US FDA on the IND application. However, the drug is under investigation for a Phase III trial in patients with ALS.

 

• NurOwn (MSC-NTF cells): Brainstorm Cell Therapeutics

MSC-NTF cells (NurOwn) are autologous bone marrow-derived mesenchymal stem cells (MSC) induced in culture to secrete high levels of neurotrophic factors (NTFs) that support neuronal growth and survival. Thus, MSC-NTF cells combine MSC’s immunomodulatory therapeutic benefits with enhanced neurotrophic factor secretion.

 

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Amyotrophic Lateral Sclerosis Market Outlook

Scarcely any drugs have been approved by the FDA that can slow the course of the disease and improve the quality of life. Therefore, the management of ALS remains supportive and symptom-based. In recent years, research on new treatment strategies has increased, taking heed of gene therapy, cellular therapy, and neuroprotective agents. There are limited approved drugs that slow disease progression by prolonging autonomy and increasing survival rates (measured by the ALS functional rating scale (ALSFRS-R). Moreover, approved by the US FDA to treat ALS, including riluzole, NUEDEXTA, RADICAVA, TIGLUTIK, RELYVRIO, and QALSODY. Medications are also prescribed to help manage symptoms of ALS, including pain, muscle cramps, stiffness, excess saliva and phlegm, and the pseudobulbar effect (involuntary or uncontrollable episodes of crying and/or laughing, or other emotional displays). Drugs also are available to help individuals with pain, depression, sleep disturbances, and constipation.

 

Amyotrophic Lateral Sclerosis Drugs Market

The drug chapter segment of the ALS report encloses a detailed analysis of the marketed and late-stage (Phase III) pipeline drug. The marketed drugs segment encloses drugs such as RADICAVA (Mitsubishi Tanabe Pharma Corporation), RELYVRIO (Amylyx Pharmaceuticals), TIGLUTIK (ITF Pharma), and others. Furthermore, the current key players for emerging drugs and their respective drug candidates include AB Science (Masitinib), Brainstorm Cell Therapeutics (NurOwn), and others. The drug chapter also helps understand the ALS clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.

 

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Scope of the Amyotrophic Lateral Sclerosis Market Research Report

• Coverage- 7MM
• Study Period- 2020-2034
• Amyotrophic Lateral Sclerosis Companies- Helixmith, Sanofi, Denali Therapeutics, Alector, GSK, NeuroSense Therapeutics, Biogen, Ionis, Brainstorm Cell Therapeutics, Cytokinetics, Astellas Pharma, Apellis Pharmaceuticals, Clene Nanomedicine Biosciences, AL-S Pharma, MediciNova, Seelos Theraputics, Prilenia Therapeutics, AB Science, Eledon Pharmaceuticals, Revalesio Corporation, Biohaven Pharmaceuticals, UCB Pharma, Ra Pharmaceuticals, and others.
• Amyotrophic Lateral Sclerosis Pipeline Therapies- Reldesemtiv, Albutein 5%, Tofersen, FAB122, sNN0029, ABBV-CLS-7262, SPG302, Dazucorilant 300 mg, and others.Amyotrophic Lateral Sclerosis Market Dynamics: Amyotrophic Lateral Sclerosis Market Drivers and Barriers
• Amyotrophic Lateral Sclerosis Market Access and Reimbursement, Unmet Needs, and Future Perspectives

 

Table of Content

1. Key Insights

2. Report Introduction

3. Amyotrophic Lateral Sclerosis Market Overview At A Glance

4. Amyotrophic Lateral Sclerosis Epidemiology And Market Forecast Methodology

5. Executive Summary

6. Key Events

7. Disease Background And Overview

8. Amyotrophic Lateral Sclerosis Treatment And Management

9. Epidemiology And Patient Population Of The 7mm

10. Patient Journey

11. Amyotrophic Lateral Sclerosis Key Endpoints

12. Amyotrophic Lateral Sclerosis Marketed Drugs

13. Amyotrophic Lateral Sclerosis Emerging Drugs

14. Amyotrophic Lateral Sclerosis: 7mm Analysis

15. Unmet Needs

16. Amyotrophic Lateral Sclerosis SWOT Analysis

17. Amyotrophic Lateral Sclerosis KOL Views

18. Amyotrophic Lateral Sclerosis Market Access and Reimbursement

19. Appendix

20. DelveInsight Capabilities

21. Disclaimer

22. About DelveInsight

 

About DelveInsight

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