Amyotrophic Lateral Sclerosis Market: Epidemiology, Therapies, Companies, DelveInsight | AB SCIENCE, ALECTOR, GSK, BRAINSTORM CELL THERAPEUTICS, IONIS PHARMACEUTICALS, MEDICINOVA, DENALI THERAPEUTICS, ABBVIE, CALICO LIFE SCIENCES, CLENE NANOMEDICINE BIOSC

Amyotrophic Lateral Sclerosis therapies, such as Masitinib, NurOwn (MSC-NTF cells), and others, are expected to boost the Amyotrophic Lateral Sclerosis Market in the upcoming years.

DelveInsight has launched a new report on "Amyotrophic Lateral Sclerosis - Market Insights, Epidemiology, and Market Forecast-2034" that delivers an in-depth understanding of the Amyotrophic Lateral Sclerosis, historical and forecasted epidemiology as well as the Amyotrophic Lateral Sclerosis market trends in the United States, EU5 (Germany, Spain, Italy, France, and 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=openpr&utm_medium=pressrelease&utm_campaign=kpr

Some of the key facts of the Amyotrophic Lateral Sclerosis Market Report:

In 2023, the Amyotrophic Lateral Sclerosis (ALS) market across the 7MM was valued at approximately USD 1 billion. The standard treatment, primarily involving the use of riluzole, has shown effectiveness in slowing disease progression and modestly extending patient survival.
A significant milestone in ALS treatment was the FDA's approval of RELYVRIO (sodium phenylbutyrate and taurursodiol) on September 29, 2022, for adult patients with ALS. However, following some setbacks with RELYVRIO, RADICAVA has emerged as the leading therapy in the current ALS landscape, particularly after the launch of RADICAVA ORS, the oral formulation of edaravone. This newer version saw strong adoption in the U.S. and Japan, reversing the previous decline in sales of its IV counterpart.
Innovative therapies are also being developed to target specific genetic forms of ALS. Notably, TPN-101 from Transposon Therapeutics and Ulefnersen (ION363) from Ionis Pharmaceuticals focus on patients with C9ORF72 and FUS mutations. While there is increasing attention on mutations like SOD1, C9ORF72, and FUS, other genetic variants such as TARDBP, OPTN, and ANG remain largely unaddressed, presenting valuable opportunities for future therapeutic development. Additionally, for most ALS patients, the underlying genetic mutations remain unidentified.
Currently, treatment options include a range of disease-modifying and symptomatic drugs such as EXSERVAN (riluzole oral film), RELYVRIO, QALSODY, RADICAVA, RADICAVA ORS, NEUDEXTA, TIGLUTEK, and RILUTEK, along with supportive treatments like anti-epileptics, NSAIDs, opioids, SSRIs, antidepressants, and diuretics.
Looking ahead, the anticipated launch of promising pipeline therapies, including Ulefnersen, Ibudilast (MediciNova), Masitinib (AB Science), NurOwn (Brainstorm Cell Therapeutics), and CNM-Au8 (Clene Nanomedicine), is expected to significantly expand the ALS market in the 7MM over the 2024-2034 forecast period. This growth will likely be supported by rising diagnosis rates and the increasing prevalence of ALS.
In May 2025, Neuralink announced via X that it had received the FDA's "breakthrough" designation for its neural interface device aimed at restoring communication in individuals with severe speech impairments. The technology is intended to support patients with conditions such as ALS, stroke, spinal cord injuries, cerebral palsy, and multiple sclerosis.
In April 2025, BrainStorm Cell Therapeutics (NASDAQ: BCLI) reported submitting an Investigational New Drug (IND) amendment to the FDA for its ALS treatment candidate, NurOwn®, an autologous stem cell therapy.
In March 2025, DiagnaMed Holdings Corp. achieved a key milestone in rare disease research when the U.S. FDA granted Orphan Drug Designation (ODD) for its molecular hydrogen therapy targeting amyotrophic lateral sclerosis.
Earlier, in January 2025, the FDA gave Zydus Lifesciences approval to initiate a randomized Phase IIb clinical trial of Usnoflast, its oral NLRP3 inflammasome inhibitor, as a potential treatment for ALS.
Key Amyotrophic Lateral Sclerosis companies such as 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 are evaluating new drugs for Amyotrophic Lateral Sclerosis to improve the treatment landscape.
Promising Amyotrophic Lateral Sclerosis therapies include Masitinib, NurOwn (MSC-NTF cells), and others.

Amyotrophic Lateral Sclerosis Overview

Amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease, is a progressive neurodegenerative condition that targets nerve cells in the brain and spinal cord, resulting in muscle weakness, loss of mobility, and eventually respiratory failure. Although the precise cause of ALS is still unknown, it is believed to arise from a combination of genetic predispositions and environmental triggers. Diagnosing ALS involves a comprehensive neurological assessment, a detailed medical history, and various diagnostic tests aimed at ruling out other potential disorders. Electromyography (EMG) and nerve conduction studies help evaluate the health of nerves and muscles, while imaging techniques such as MRI are used to exclude other explanations for a patient's symptoms.

Despite these tools, diagnosing ALS remains difficult due to the lack of a single definitive test. Early and accurate diagnosis is essential to begin symptom management and provide patients access to necessary care and support services. Currently, there is no cure for ALS, and treatments are primarily focused on alleviating symptoms and enhancing the quality of life. However, ongoing research continues to investigate potential therapies and improve understanding of the disease. Emerging biomarkers, such as elevated levels of neurofilament in cerebrospinal fluid, hold promise for aiding in diagnosis, monitoring disease progression, and assessing treatment response. While not yet widely used in clinical settings, these biomarkers could play a vital role in future patient stratification and clinical trials, particularly in cases where symptoms overlap with other neurological disorders.

Amyotrophic Lateral Sclerosis Market Outlook

Currently, there is no cure for Amyotrophic Lateral Sclerosis (ALS), and available treatments have limited effectiveness in halting or reversing disease progression. Only a few FDA-approved drugs are available that modestly slow the course of the disease and help improve patients' quality of life. As a result, ALS management primarily remains supportive and symptom-focused. Approved treatments such as riluzole, RADICAVA, TIGLUTIK, RELYVRIO, QALSODY, and NEUDEXTA aim to either delay progression or alleviate specific symptoms like muscle cramps, stiffness, excess saliva, emotional disturbances, pain, depression, and sleep issues.

Riluzole is considered the first-line therapy for ALS in the U.S., Europe, and Japan. First 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 marketed under various formulations: RILUTEK (oral tablet), TIGLUTIK (oral suspension), and EXSERVAN (oral film). While NEUDEXTA is used to manage pseudobulbar affect, it does not alter disease progression.

Despite a growing interest in gene therapies, neuroprotective agents, and cellular 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. However, the current pipeline still holds promise, with ongoing research into disease-modifying agents and therapies targeting specific genetic mutations. These advancements could potentially address unmet needs in ALS treatment and improve long-term outcomes.

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Amyotrophic Lateral Sclerosis Marketed Drugs
RADICAVA/RADICUT (edaravone injection) and RADICAVA ORS: Mitsubishi Tanabe Pharma Corporation
RELYVRIO: Amylyx Pharmaceuticals

Amyotrophic Lateral Sclerosis Emerging Drugs

Masitinib: AB Science
NurOwn (MSC-NTF cells): Brainstorm Cell Therapeutics

Scope of the Amyotrophic Lateral Sclerosis Market Report
Study Period: 2020-2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
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
Amyotrophic Lateral Sclerosis Therapies: Masitinib, NurOwn (MSC-NTF cells), and others.
Amyotrophic Lateral Sclerosis Therapeutic Assessment: Amyotrophic Lateral Sclerosis current marketed and Amyotrophic Lateral Sclerosis emerging therapies
Amyotrophic Lateral Sclerosis Market Dynamics: Amyotrophic Lateral Sclerosis market drivers and Amyotrophic Lateral Sclerosis market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
Amyotrophic Lateral Sclerosis Unmet Needs, KOL's views, Analyst's views, Amyotrophic Lateral Sclerosis Market Access and Reimbursement

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Key benefits of the Amyotrophic Lateral Sclerosis Market Report:
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).
The Amyotrophic Lateral Sclerosis market report provides insights into the current and emerging therapies.
The Amyotrophic Lateral Sclerosis market report provides a global historical and forecasted market covering drug outreach in 7MM.
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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Related Reports:

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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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.

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