Amyotrophic Lateral Sclerosis Market Report and Forecast 2025-2034

The National Institute of Health study conducted in 2023 revealed that the global incidence of ALS lies between 4-6 cases per 100,000 individuals. According to the Centers for Disease Control and Prevention (CDC), the number of ALS patients in the U.S. is projected to rise by over 10%, increasing from approximately 32,800 cases in 2022 to 36,300 cases by 2030, reflecting the growing burden of the disease and the need for advanced treatment options. ALS treatment is advancing through the development of new drugs and innovative therapies. Approved medications like Riluzole, Edaravone, and Nuedexta improve symptom management and patient outcomes. Continuous innovation and advancements in treatment options support market growth by offering improved therapeutic solutions. 

Growing awareness about ALS among patients and healthcare professionals is improving diagnosis rates and facilitating early intervention. Increased education and better treatment options enhance patient outcomes and support market growth. The availability of advanced ALS drugs enables more effective management of the disease, improving quality of life. Additionally, public health initiatives and patient advocacy efforts play a crucial role in encouraging access to appropriate care, leading to better disease management and improved patient outcomes.

Reimbursement policies and evolving distribution channels are vital to ensuring broader access to ALS treatments. Patients can obtain ALS drugs through hospital pharmacies, retail pharmacies, and online channels, improving patient access to essential therapies. Favorable reimbursement frameworks reduce financial barriers, supporting growth and expansion in the market. Increased availability through diverse distribution networks ensures timely access to advanced therapies, fostering better treatment outcomes and improving the quality of care for ALS patients.

Amyotrophic Lateral Sclerosis Treatment Market Treatment Insights

The medication segment holds a significant market share in the amyotrophic lateral sclerosis (ALS) treatment market due to the availability of approved medications targeting the disease’s underlying mechanisms. Key drugs such as Riluzole and Edaravone play a crucial role in prolonging survival and improving quality of life for ALS patients. In 2023, the approval of new therapies, including Tofersen (QALSODY) for SOD1-ALS, further strengthened this segment. Continuous drug development is expanding pharmacological options, focusing on slowing disease progression and managing symptoms, thereby enhancing patient care and contributing to the segment's dominance within the ALS treatment landscape.

Stem cell therapy is expected to exhibit the fastest CAGR during the forecast period, driven by growing interest in its potential to treat ALS. This innovative approach offers promising outcomes through cell replacement, neuroprotection, and inflammation modulation. Advances in preclinical trials and ongoing clinical trials highlight its ability to slow disease progression and improve patient outcomes. Increased research efforts continue to refine stem cell applications, making this segment a key focus for future ALS treatment strategies.

Amyotrophic Lateral Sclerosis Treatment Market Type Insights

Sporadic ALS holds a significant market revenue share, driven by its increasing incidence and the growing aging population. This form of ALS accounts for approximately 90-95% of all cases, with no clear familial link. Factors such as rising awareness, a potential genetic link, and ongoing research continue to drive drug development efforts. The availability of FDA-approved medications, including Riluzole and Edaravone, has improved disease management and extended patient survival. With continuous innovation in treatment approaches and increased public and medical understanding, the segment is expected to maintain its dominant position and contribute significantly to market growth.

Familial ALS (FALS) is projected to experience the fastest CAGR during the forecast period due to its hereditary nature and the 50% transmission risk to offspring. Advances in genetic testing allow for earlier diagnosis and better identification of familial cases, increasing the number of instances. Growing knowledge of genetic factors is accelerating the development of targeted therapies tailored to the FALS profile, reshaping the treatment landscape and improving patient care.

Amyotrophic Lateral Sclerosis Treatment Market Distribution Channel Insights

Hospital pharmacies held a significant revenue share in the amyotrophic lateral sclerosis (ALS) treatment market in 2023, driven by the large number of ALS patients requiring frequent hospital stays and regular treatment visits. The need for specialized care and continuous administration of ALS drugs has led to increased demand for hospital-based dispensing. This demand is expected to drive segment growth, as hospital pharmacies play a crucial role in providing advanced treatments and ensuring accurate drug administration for patients with complex medical needs.

Retail pharmacies are anticipated to achieve the fastest CAGR during the forecast period, owing to their accessibility and convenience in providing essential medications. These pharmacies offer personalized services such as medication counseling and management support, which enhance patient adherence and treatment outcomes. The expanding role of retail pharmacies within the ALS treatment landscape increases patient reach and boosts patient satisfaction by offering timely access to medications. This growth reflects the rising preference for community-based care and the need for comprehensive patient support systems.

Amyotrophic Lateral Sclerosis Treatment Market Regional Insights

The amyotrophic lateral sclerosis treatment market exhibits significant regional variation, with the United States leading the global market domination due to its high disease prevalence, substantial healthcare expenditure, and advanced healthcare infrastructure. In 2023, EU-4 and the United Kingdom also held a considerable revenue share, supported by the presence of several pharmaceutical companies, favourable reimbursement policies, and ongoing research initiatives. Japan and India are experiencing growth due to rising awareness, improved patient access, and increasing ALS treatment advancements. Across all regions, continuous innovation and collaborative research efforts are enhancing patient outcomes and expanding the availability of effective ALS therapies.

U.S. Amyotrophic Lateral Sclerosis Treatment Market Trends

The U.S. ALS treatment market remains a leader due to high disease prevalence, significant healthcare expenditure, and advanced infrastructure supporting medical innovation. Collaborative efforts between pharmaceutical companies and research institutions are accelerating therapeutic advancements, improving patient care and expanding treatment options. In January 2025, Amylyx Pharmaceuticals announced that the FDA lifted the clinical hold on the AMX0114 Phase 1 trial for ALS treatment, allowing U.S. sites to begin patient enrollment. This development reflects the nation’s commitment to advancing ALS research and highlights the ongoing efforts to deliver innovative therapies, reinforcing the U.S.'s prominent role in shaping the future of ALS treatment.

EU-4 and the United Kingdom Amyotrophic Lateral Sclerosis Treatment Market Trends

The United Kingdom holds a substantial market share in the ALS treatment market, driven by robust research initiatives, advanced healthcare infrastructure, and strong collaborative efforts with academic institutions. Supportive regulatory frameworks foster the development of new treatments, contributing to market growth. According to a 2023 study, in the United Kingdom it affects around 1 in 300 individuals. United Kingdom is a hub for ALS research, exemplified by the EXPERTS-ALS trial, which screens potential drugs for efficacy in reducing neurofilament light chain (NFL) levels. This ongoing adaptive trial, aims to test 9-12 drugs over five years, enhancing therapeutic discovery and market growth.

ALS treatment market in EU-4 (Germany, France, Italy, and Spain) will also experience significant growth during the forecast period, fueled by increasing research initiatives, advanced healthcare infrastructure, and enhanced collaborative efforts. Supportive regulatory frameworks are accelerating the approval of new treatments, including personalized medicine and targeted interventions, driving market expansion. ALS is the most common motor neuron disease, with an incidence of 2.58 per 100,000 people and approximately 8,000 patients living with ALS in France. These developments are fostering innovation and improving access to advanced therapies across the EU-4 region.

Japan and India Amyotrophic Lateral Sclerosis Treatment Market Trends

In Japan, the ALS treatment market is expected to record the fastest CAGR during the forecast period, driven by rising healthcare investments, increasing awareness, and improved healthcare infrastructure. With the prevalence of neurodegenerative diseases increasing, innovative therapies are accelerating market growth. The prevalence of ALS in Japan is reported to be 9.9 per 100,000, with familial ALS accounting for 5.1% of cases. In October 2024, Japan approved Rozebalamin, an ultra-high dose of Vitamin B12, to slow functional decline in ALS patients, manufactured by Eisai.

The ALS treatment market in India is projected to experience significant growth during the forecast period, supported by increased healthcare investments, government initiatives, and advancements in innovative therapies. The growing incidence of ALS, neurodegenerative diseases, and increasing clinical trials are expanding diagnosis and treatment options, enhancing market growth potential. ALS affects approximately 5 in every 100,000 people in India, causing an estimated 50,000 deaths annually. In September 2024, Zydus Lifesciences completed a Phase II(a) trial of Usnoflast, a novel NLRP3 inhibitor, showing promise in slowing ALS progression and improving patient outcomes.

Key Amyotrophic Lateral Sclerosis Treatment Market Company Insights

Key companies driving innovation in the amyotrophic lateral sclerosis (ALS) treatment market include Mitsubishi Tanabe Pharma Corporation, Biogen, BrainStorm Cell Limited, Amylyx Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc.. These companies focus on strategic partnerships, drug development, and clinical trials to deliver effective treatments. Emerging players continue to shape the market landscape, accelerating the search for novel therapies to address the growing patient needs and advance the 

Biogen Inc. remains a leader in innovative therapies for neurological diseases, particularly ALS. In February 2024, Biogen’s QALSODY® (tofersen), the first therapy targeting the genetic cause of SOD1-ALS, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). If approved by the European Commission (EC), QALSODY will be the first treatment in the EU to address this ultra-rare genetic form of ALS. Such positive EMA marketing authorizations, coupled with FDA approvals reflect the active involvement of leading companies for the treatment of the condition. 

Sanofi is a significant player in the ALS treatment market, emphasizing innovation and collaboration to address unmet medical needs. Through continuous research, advancements, and partnerships, Sanofi is expanding ALS treatment options and driving the development of novel therapies. The company’s commitment to improving patient care positions it as a significant player in ALS market.

Key Amyotrophic Lateral Sclerosis Treatment Market Companies

The ALS treatment market is highly competitive, with leading companies holding the largest market share. They focus on leveraging industry trends such as product innovations, strategic partnerships, acquisitions, mergers, and geographic expansions. These efforts aim to meet the evolving needs of patients and healthcare providers. The major companies in the market are as follows:

• Mitsubishi Tanabe Pharma Corporation (Mitsubishi Chemical Group Corporation)
• Biogen
• BrainStorm Cell Limited
• Amylyx Pharmaceuticals, Inc.
• Ionis Pharmaceuticals, Inc.
• Sanofi
• Otsuka Pharmaceutical Co., Ltd.
• F. Hoffmann-La Roche Ltd
• AB Science
• Sun Pharmaceutical Industries Ltd.
• Orion Corporation
• CORESTEMCHEMON Inc.
• Bausch Health Companies Inc.
• CYTOKINETICS, INC.
• Aquestive Therapeutics, Inc.
• Covis Pharma
• ViroMed Co., Ltd.
• Genervon Biopharmaceuticals, LLC
• Orphazyme A/S

Recent Developments

In May 2024, the NIH and Foundation for NIH (FNIH) launched Accelerating Medicines Partnership® in Amyotrophic Lateral Sclerosis AMP® ALS, a public-private partnership aimed at accelerating ALS treatment development. This initiative focuses on identifying new therapeutic targets, improving biomarkers, and enhancing clinical outcome assessments to advance ALS research and patient care.

In May 2024, Biogen received European Commission approval for QALSODY® (tofersen), the first therapy targeting SOD1-ALS, a rare genetic form of amyotrophic lateral sclerosis (ALS). This approval marks a significant advancement in ALS treatment, offering new hope for patients with limited therapeutic options.

In November 2024, Eisai Co., Ltd. launched Rozebalamin® (mecobalamin) 25 mg Injection in Japan for amyotrophic lateral sclerosis (ALS). Approved in September 2024, it aimed to slow functional impairment. This approval was based on positive Phase III JETALS trial results in 130 ALS patients.

In January 2025, LifeArc partnered with Neuropeutics Inc. to advance a new small molecule, JRMS-22, targeting TDP-43 pathology for motor neuron disease (MND)/amyotrophic lateral sclerosis (ALS) treatment. This collaboration aims to address the urgent need for effective therapies to combat ALS’s devastating neurodegenerative effects.

Amyotrophic Lateral Sclerosis Treatment Market Report Segmentation