Amyotrophic Lateral Sclerosis Market Set for Groundbreaking Advancements by 2034, with Neuralink's Speech Restoration Device Receiving FDA Breakthrough Designation | DelveInsight

The Amyotrophic Lateral Sclerosis (ALS) market is progressing with innovative treatments and active research. DelveInsight's report offers in-depth insights into ALS epidemiology and market dynamics. A major development is Neuralink's speech restoration device, recently granted FDA's 'Breakthrough' designation, which could significantly improve life for ALS patients with severe motor impairments.
DelveInsight's "Amyotrophic Lateral Sclerosis Market Report [https://www.delveinsight.com/report-store/amyotrophic-lateral-sclerosis-als-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr]" provides a thorough analysis of ALS, including historical and forecasted epidemiological data, along with trends in the treatment landscape across key regions such as the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. The report also highlights emerging therapies, market growth drivers, and the leading companies shaping the ALS market, offering valuable insights for stakeholders in the healthcare sector.

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

- The Amyotrophic Lateral Sclerosis market size across the 7MM is estimated to be approximately USD 1 billion in 2023.

- In 2023, the US had the highest number of ALS cases among the 7MM, with around 26K cases, expected to rise.

- In Japan, ALS prevalence was highest in the 70-79 age group, followed by 60-69 and 50-59 years.

- RADICAVA emerges as the leading ALS treatment after the setback with RELYVRIO and is projected to achieve the highest revenue.

- Current ALS treatments include EXSERVAN (Riluzole oral film), RELYVRIO, QALSODY, RADICAVA (edaravone injection), RADICAVA ORS (edaravone oral suspension), NEUDEXTA, TIGLUTEK, and RILUTEK.

- Symptomatic treatments used alongside include anti-epileptics, opioids, NSAIDs, SSRIs, and antidepressants.

- In May 2025, Neuralink received the FDA's "breakthrough" designation for its device designed to restore communication in individuals with severe speech impairments. The device aims to assist those with conditions such as ALS, stroke, spinal cord injury, cerebral palsy, and multiple sclerosis, as announced by the company on X.

- In March 2025, DiagnaMed Holdings Corp. announced a significant milestone in rare disease research, receiving Orphan Drug Designation (ODD) from the U.S. FDA for molecular hydrogen in the treatment of amyotrophic lateral sclerosis.

- In January 2025, the FDA granted approval for Zydus Lifesciences to proceed with a randomized Phase IIb trial of its oral NLRP3 inflammasome inhibitor, Usnoflast, for the treatment of amyotrophic lateral sclerosis.

- In December 2024, NeuroSense Therapeutics Ltd. announced the conclusion of a Type C meeting with the FDA regarding PrimeC for the treatment of amyotrophic lateral sclerosis (ALS). The meeting focused on the design of a proposed Phase 3 clinical study and the plan for a future 505(b)(2) marketing application submission.

- In November 2024, Ractigen Therapeutics announced that the FDA granted Orphan Drug Designation (ODD) to its novel siRNA therapy, RAG-21, targeting the FUS gene for amyotrophic lateral sclerosis (ALS).

- Emerging amyotrophic lateral sclerosis drugs include Masitinib, Latozinemab (AL001/GSK4527223), NurOwn (MSC-NTF Cells), Ulefnersen (ION363), Ibudilast, DNL343, ABBV-CLS-7262, CNM-AU8, SLS-005 (Trehalose), Pridopidine, RAPA-501, PRIMEC, Engensis (VM202), TPN-101, RNS60, ANX005, Dazucorilant (CORT113176), AP-101, SAR443820/DNL788, AIT-101 (LAM-002A), and others.

- Leading companies in the amyotrophic lateral sclerosis market 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, AL-S Pharma, Sanofi, Orphai Therapeutics, and others.

- The increasing prevalence of amyotrophic lateral sclerosis (ALS) and advancements in therapeutic options are driving the demand for effective treatments for the condition.

To know in detail about the amyotrophic lateral sclerosis market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: Amyotrophic Lateral Sclerosis Market Forecast [https://www.delveinsight.com/report-store/amyotrophic-lateral-sclerosis-als-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr]

Amyotrophic Lateral Sclerosis Overview

Amyotrophic Lateral Sclerosis (ALS), commonly known as Lou Gehrig's disease, is a progressive neurodegenerative disorder that impacts the nerve cells in the brain and spinal cord, resulting in muscle weakness, paralysis, and eventually respiratory failure. The precise cause of ALS is not fully understood, though it is believed to be influenced by a mix of genetic and environmental factors. Diagnosis is based on a neurological evaluation and a series of tests to exclude other possible conditions. While there is no cure for ALS at present, treatment aims to alleviate symptoms and enhance the patient's quality of life. Ongoing research efforts are focused on developing potential therapies and gaining a deeper understanding of the disease.

Get a free sample of the amyotrophic lateral sclerosis market report with key insights and emerging therapies here: https://www.delveinsight.com/report-store/amyotrophic-lateral-sclerosis-als-market [https://www.delveinsight.com/report-store/amyotrophic-lateral-sclerosis-als-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr]

Amyotrophic Lateral Sclerosis Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Amyotrophic Lateral Sclerosis Epidemiology Segmentation:

The amyotrophic lateral sclerosis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by:

- Total Prevalent Population of ALS

- Diagnosed ALS Prevalence of ALS

- Type-specific Distribution of ALS

- Gender-Specific Distribution of ALS

- Mutation-specific Distribution of ALS

- Distribution Based on Site of Onset of ALS

- Age-Specific Distribution of ALS

Download the report to understand which factors are driving amyotrophic lateral sclerosis epidemiology trends @ Amyotrophic Lateral Sclerosis Epidemiology Forecast [https://www.delveinsight.com/report-store/amyotrophic-lateral-sclerosis-als-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr]

Amyotrophic Lateral Sclerosis Drugs Uptake and Pipeline Development Activities

The amyotrophic lateral sclerosis drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the amyotrophic lateral sclerosis market or expected to be launched during the study period. The analysis covers the amyotrophic lateral sclerosis market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the amyotrophic lateral sclerosis pipeline development activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent collaborations, acquisitions, mergers, licensing, patent details, and other information for emerging therapies.

Amyotrophic Lateral Sclerosis Market Strengths

- A growing number of clinical trials and investigational therapies targeting diverse ALS pathways indicate strong R&D momentum and industry commitment.

- Expedited designations like Orphan Drug, Fast Track, and Breakthrough Therapy from agencies such as the FDA and EMA are accelerating drug development and approvals.

Amyotrophic Lateral Sclerosis Market Weaknesses

- Despite an active pipeline, many ALS drugs fail in late-stage trials due to the complexity of the disease and lack of validated biomarkers.

- Current therapies offer only modest benefits in slowing disease progression, with no available cure, leading to high unmet needs.

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 Therapies: Latozinemab (AL001/GSK4527223), NurOwn (MSC-NTF Cells), Ulefnersen (ION363), Ibudilast, DNL343, ABBV-CLS-7262, CNM-AU8, SLS-005 (Trehalose), Pridopidine, RAPA-501, PRIMEC, Engensis (VM202), TPN-101, RNS60, ANX005, Dazucorilant (CORT113176), AP-101, SAR443820/DNL788, AIT-101 (LAM-002A), and others.

- 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, Orphai Therapeutics, and others.

- Amyotrophic Lateral Sclerosis Therapeutic Assessment: Amyotrophic Lateral Sclerosis currently 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

To learn more about the key players and advancements in the amyotrophic lateral sclerosis treatment landscape, visit the Amyotrophic Lateral Sclerosis Market Analysis Report [https://www.delveinsight.com/report-store/amyotrophic-lateral-sclerosis-als-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr]

Table of Contents

1. Amyotrophic Lateral Sclerosis Market Report Introduction

2. Executive Summary for Amyotrophic Lateral Sclerosis

3. SWOT analysis of Amyotrophic Lateral Sclerosis

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. Amyotrophic Lateral Sclerosis 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. Amyotrophic Lateral Sclerosis Market Access and Reimbursement of Therapies

15. Amyotrophic Lateral Sclerosis Market Drivers

16. Amyotrophic Lateral Sclerosis Market Barriers

17. Amyotrophic Lateral Sclerosis Appendix

18. Amyotrophic Lateral Sclerosis Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare 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.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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