Amyotrophic Lateral Sclerosis (ALS) Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Drug Type (Rilutek (Riluzole), Edaravone (Radicava)), By Treatment Type (Physical Therapy, Speech Therapy, Medication, Respiratory Therapy, Others), By End-Users (Hospitals & Clinics, Research and Academic institutes, others), by region, and Competition 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 787.81 Million
CAGR (2026-2031)	6.15%
Fastest Growing Segment	Hospitals & Clinics
Largest Market	North America
Market Size (2031)	USD 1127.05 Million

Market Overview

The Global Amyotrophic Lateral Sclerosis (ALS) Market will grow from USD 787.81 Million in 2025 to USD 1127.05 Million by 2031 at a 6.15% CAGR. The Global Amyotrophic Lateral Sclerosis Market comprises pharmaceutical therapeutics and assistive technologies aimed at managing the symptoms and progression of this neurodegenerative disorder. Market expansion is driven by the rising prevalence of the condition among the aging population and the emergence of precision medicine tailored to specific genetic mutations. This growth is further underpinned by substantial investment in scientific inquiry and a broadening pipeline of potential therapies. According to the ALS Association, in 2024, the organization supported 149 active research projects across 13 countries to accelerate drug development.

However, the industry encounters a substantial obstacle regarding the high attrition rate of candidates in advanced clinical trials. The complex biological mechanisms of the condition frequently result in efficacy shortfalls during pivotal testing phases which creates uncertainty for developers and investors. This persistent difficulty delays regulatory approvals and impedes the introduction of effective therapeutic options, thereby restricting the potential revenue streams within this sector.

Key Market Drivers

Increasing public and private investment in research and development acts as a primary engine for market growth, fueled by the urgent demand for effective disease-modifying treatments. This influx of capital is critical for sustaining the high costs of clinical trials and fostering the transition of therapeutic candidates from early-stage discovery to commercial viability. For instance, according to Trace Neuroscience, November 2024, in the 'Launch Announcement', the company secured a capital investment of $101 million to advance genomic therapies for neurodegenerative conditions into clinical settings. This financial momentum is mirrored in the non-profit sector, which plays a pivotal role in de-risking early scientific inquiries. According to FightMND, November 2024, in the '2024 Cure & Care Investment', the organization committed a further $18.89 million into research and care initiatives, underscoring the robust global funding environment dedicated to overcoming the efficacy barriers in current standards of care.

Advancements in genetic research and precision medicine serve as the second significant driver, fundamentally shifting the industry focus from symptom management to targeted biological intervention. The identification of specific mutations, such as those in the SOD1 gene, has enabled the development of antisense oligonucleotides designed to address the root causes of the disorder. This scientific progress allows for more stratified clinical trials, potentially reducing failure rates by ensuring therapies are tested on the most responsive patient populations. Illustrating this commitment to targeted validation, according to LifeArc, May 2024, in the 'MND Translational Challenge News', the organization pledged £1.5 million to a new partnership aimed specifically at validating human genetic therapeutic targets to bridge the translational gap in drug development. These precision approaches represent a transformative leap in clinical strategy, attracting continued interest from stakeholders aiming to deliver personalized solutions.

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Key Market Challenges

The high attrition rate of therapeutic candidates in advanced clinical phases constitutes a primary impediment to the growth of the Global ALS Market. This challenge stems largely from the complex and heterogeneous nature of the disease, which makes it difficult for researchers to identify robust biological markers for measuring drug efficacy. Consequently, pharmaceutical companies frequently encounter setbacks where promising early-stage compounds fail to demonstrate statistically significant clinical benefits during pivotal Phase III trials. These late-stage failures represent a substantial financial loss, as the cost of clinical development increases exponentially as candidates progress, thereby deterring risk-averse investors and reducing the necessary capital inflow for future scientific endeavors.

This persistent cycle of failure directly restricts market expansion by delaying the commercialization of viable treatments and creating a bottleneck in the product pipeline. The uncertainty surrounding regulatory approval forces developers to extend timelines and significantly increase research budgets, which erodes potential profit margins and limits the number of successful market entrants. According to the ALS Association, in 2025, there were more than 50 ALS drugs under development targeting various mechanisms of the disease. Despite this active pipeline, the industry’s historical inability to translate these candidates into approved therapies means that the actual introduction of revenue-generating options remains low, directly hampering the sector's financial growth.

Key Market Trends

The adoption of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing the identification of novel therapeutic targets, addressing the industry's struggle with complex disease biology. By analyzing vast genomic datasets, these platforms predict causal mechanisms with greater accuracy than traditional animal models, significantly streamlining the discovery phase. This shift relies on AI-driven validation to de-risk candidate selection before clinical entry, ensuring resources are focused on compounds with the highest probability of success. According to Verge Genomics, November 2024, in the 'Announces Milestones in Collaboration with Lilly', the company’s AI-enabled platform achieved an 83% validation rate for prioritized targets in disease-relevant models, significantly outperforming standard industry benchmarks.

Concurrently, the integration of Neurofilament Light Chain (NfL) biomarkers is transforming clinical trial design by providing an objective metric for disease monitoring. Unlike subjective functional rating scales, NfL levels offer a quantifiable readout of neuroaxonal damage, enabling researchers to detect patient responses to treatment more rapidly and accurately. This approach facilitates earlier decision-making in drug development and supports the stratification of patient populations to enhance trial efficacy. Highlighting this utility, according to ALS News Today, July 2024, in the article 'Blood NfL levels are impacted by ALS clinical subtype', blood-based NfL levels could accurately identify approximately 80% of ALS patients, significantly outperforming other potential protein markers in distinguishing the condition.

Segmental Insights

The Hospitals and Clinics segment is recognized as the fastest-growing area in the Global Amyotrophic Lateral Sclerosis Market, driven by the critical need for specialized, multidisciplinary care. Patients with ALS require frequent monitoring and complex interventions, such as respiratory assistance, which are best managed within these structured facilities. Additionally, the administration of specific FDA-approved treatments often involves intravenous infusion or intrathecal injection, requiring professional medical oversight available in clinical environments. This reliance on institutional infrastructure for both long-term disease management and the delivery of therapeutics supports the segment's rapid expansion.

Regional Insights

North America dominates the global Amyotrophic Lateral Sclerosis market due to widespread disease awareness and a strong research ecosystem. The region benefits from substantial investments in drug development and structured reimbursement frameworks that improve patient access to therapies. This leadership is strengthened by supportive regulatory initiatives from the US Food and Drug Administration which accelerate the approval of new treatments. Additionally, the Centers for Disease Control and Prevention plays a critical role in monitoring disease patterns through the National ALS Registry, providing essential data that drives clinical advancements and sustains regional market growth.

Recent Developments

• In December 2024, NeuroSense Therapeutics announced positive results from the 18-month analysis of its Phase 2b clinical trial evaluating a leading drug candidate for amyotrophic lateral sclerosis (ALS). The data indicated that the combination therapy achieved a statistically significant slowing of disease progression and improved survival rates in treated patients compared to the control group. The study highlighted a meaningful reduction in functional decline and suggested the potential for disease modification. Following these outcomes, the company initiated regulatory processes to seek early commercialization approval, aiming to address the urgent unmet needs of the ALS patient population.
• In June 2024, QurAlis Corporation signed an exclusive global license agreement with Eli Lilly and Company for a preclinical splice-switching antisense oligonucleotide therapy targeting amyotrophic lateral sclerosis (ALS). The collaboration focused on a candidate designed to restore UNC13A function, a key factor in disease pathology. Under the financial terms, QurAlis received an upfront payment of $45 million and remained eligible for up to $577 million in potential milestone payments, along with tiered royalties on net sales. This alliance intended to utilize Eli Lilly's development resources to advance the promising precision medicine program for patients suffering from neurodegenerative conditions.
• In May 2024, Biogen Inc. announced that the European Commission granted marketing authorization for its therapy designed to treat adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene. This approval established the drug as the first treatment in the European Union to target a specific genetic cause of the disease. The authorization was based on a comprehensive assessment of clinical and biomarker data, maintaining the therapy's orphan designation. The company emphasized that this regulatory milestone represented a significant step forward in providing targeted options for the ALS community across the region.
• In March 2024, Verge Genomics and Ferrer entered into a strategic collaboration to co-develop a clinical-stage therapy for sporadic and familial amyotrophic lateral sclerosis (ALS). Under the terms of the agreement, Ferrer acquired exclusive rights to develop and commercialize the lead drug candidate in Europe, Central and South America, Southeast Asia, and Japan. The partnership leveraged Verge Genomics' artificial intelligence-powered platform for target discovery and Ferrer's extensive capabilities in clinical development and market access. The companies aimed to accelerate the availability of this potential treatment to patients in these specific global territories.

Key Market Players

• Sanofi S.A.
• Brainstorm Cell Therapeutics Inc.
• Biogen Inc.
• Bausch Health Cos Inc.
• F Hoffmann-la Roche Ltd
• Ionis Pharmaceuticals
• Mylan Pharma Inc.
• Sun Pharmaceutical Industries Inc
• Orion Pharma A/S
• AB Science SA

By Drug Type	By Treatment Type	By End-Users	By Region
Rilutek (Riluzole) Edaravone (Radicava)	Physical Therapy Speech Therapy Medication Respiratory Therapy Others	Hospitals & Clinics Research and Academic institutes others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Amyotrophic Lateral Sclerosis (ALS) Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Amyotrophic Lateral Sclerosis (ALS) Market, By Drug Type:

• Rilutek (Riluzole)
• Edaravone (Radicava)

• Amyotrophic Lateral Sclerosis (ALS) Market, By Treatment Type:

• Physical Therapy
• Speech Therapy
• Medication
• Respiratory Therapy
• Others

• Amyotrophic Lateral Sclerosis (ALS) Market, By End-Users:

• Hospitals & Clinics
• Research and Academic institutes
• others

• Amyotrophic Lateral Sclerosis (ALS) Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE