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The global amyotrophic lateral sclerosis market size is valued at USD 0.79 billion in 2024 and is estimated to reach USD 1.38 billion by 2035, representing a CAGR of 5.2% during the forecast period.
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The new research report features an extensive study on the marketed, clinical and preclinical molecules available / being developed for the treatment of amyotrophic lateral sclerosis.
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder that affects nerve cells of the central nervous system which are responsible for controlling voluntary muscle movement. It is a progressive disease that begins with relatively mild symptoms such as muscle weakness and stiffness, and gradually progresses to permanent paralysis. In recent years, the healthcare sector has experienced the burden of growing incidence of amyotrophic lateral sclerosis which necessitates the demand for advanced therapeutic solutions. It is important to highlight here that in May 2024, European Medicines Agency (EMA) approved Biogen’s antisense oligonucleotide therapy Qalsody for the treatment of patients with a rare genetic form of amyotrophic lateral sclerosis. The drug was first approved by the FDA in April 2023. Discovered by Ionis Pharmaceuticals, the drug was licensed by Biogen under a development and licensing agreement signed in 2018. Driven by the recent approval and unmet need for a therapy, several stakeholders are increasing research and development activities to provide target specific therapies that can aid in the treatment of this neurodegenerative disorder.
It is important to highlight here that several research organizations and regulatory agencies have taken strategic initiatives for accelerating research on the treatment of ALS. For instance, in May 2024. The National Institutes of Health announced the launch of public-private partnership (Accelerating Medicines Partnership®) for amyotrophic lateral sclerosis (AMP® ALS). This partnership has brought together expertise and resources National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), the Food and Drug Administration (FDA), Critical Path Institute (C-Path), and other stakeholders with a commitment of USD 60 million. However, the primary focus will be on unmet requirements such as early diagnosis methods and disease-modifying therapies that can slow down disease progression or completely reverse the disease. As more regulatory agencies continue to collaborate to explore new treatment options for ALS, we believe that the amyotrophic lateral sclerosis treatment market will grow at a higher rate during the forecast period, making this industry investible for long term.
The market report provides comprehensive details of the key drug and industry leaders who are currently active across various segments of the industry as mentioned in the table below.
| Key Report Attributes | Details | |
| Historical Trend | Since 2019 | |
| Base Year | 2025 | |
| Forecast Period | Till 2035 | |
| Market Size 2035 | USD 1.38 Billion | |
| Distribution by Type |
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| Types of Treatment |
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| Type of Distribution Channel |
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| Key Geographical Region |
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| Key Companies Profiled |
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| PowerPoint Presentation (Complimentary) |
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| Customization Scope | 15% Free Customization | |
| Excel Data Packs (Complimentary) |
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One of the key objectives of the report was to estimate the existing market size and the future opportunity for companies developing ALS treatment, over the next decade. Based on multiple parameters, such as disease prevalence, anticipated adoption of the therapies and the likely selling price of such therapeutic products, we have provided informed estimates on the evolution of the amyotrophic lateral sclerosis market for the forecast period till 2035. The market report provides sales forecasts for the overall market, wherein both the current and upcoming opportunity is segmented across Type of ALS (Sporadic ALS and Familial ALS), Treatment (Medication, Respiratory Therapy, Speech Therapy Physical Therapy, Chemotherapy, Stem Cell Therapy and Other Treatments), Distribution Channel (Hospital, Retail and Others) and Geographical Region (North America, Europe, Asia-Pacific, Middle East and North Africa, Latin America).
In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market research report are in USD, unless otherwise specified.
Based on the type of amyotrophic lateral sclerosis, the market is segmented into sporadic ALS and familial ALS. According to our analysis, currently sporadic ALS accounts for the highest share, capturing 86% of the overall revenue share. This can be attributed to the growing research on sporadic ALS and availability of therapeutic drugs. Of all the cases of ALS, 90-95% of the patients have sporadic ALS and only 10% show a family history. It is worth noting that companies such as Mitsubishi Tanabe Pharma and Amylyx Pharmaceuticals has developed therapeutic drugs such as edaravone (Radicava) and AMX0035 (Relyvrio) that has shown higher efficacy in the treatment of sporadic ALS. These drugs have already received approval from the FDA.
In the long run, familial ALS is expected to grow at a higher CAGR during the forecast period, driven by the increasing research on familial ALS for understanding disease progression and treatment. Further, the growing research on genetic factors to find targeted therapies has further contributed to the growth of this segment.
This segment highlights the distribution of amyotrophic lateral sclerosis market on the basis of treatment into medication, respiratory therapy, speech therapy, physical therapy, chemotherapy, stem cell therapy and other treatments. According to our projection, currently medication accounts for the highest share of the market, holding 22% of the overall revenue share. The dominance is likely to be the result of the fact that therapeutic drugs such as edaravone has shown significant potential to slow disease progression that has pulled attention of the companies to drive research on advanced medicines. Furthermore, the growing demand for effective disease modifying therapies will further drive the growth of this segment during the forecast period. Owing to the increasing demand for medication, this segment will continue to grow at a higher CAGR rate during the projected period.
While medication holds the highest share, stem cell therapy holds potential in the market, owing to growing usage of stem cell therapies for the treatment of neurological disorders. Within ALS, stem cell therapies have shown promising results; however, none is near approval at present. CL2020, is a stem cell therapy under development by Mitsubishi Chemical Group. Phase 2 results from a clinical trial running in Japan deemed the drug safe; however, the development of CL2020 is currently halted owing to change in company’s business focus.
Based on the distribution channel, the global market is segmented into hospital, retail and others. According to our projection, currently hospital accounts for the highest amyotrophic lateral sclerosis market share. The dominance is likely to be the result of the fact that this disease has a critical nature which requires healthcare experts for treatment and monitoring disease progression as well as treatment response. However, retail and other segments such as online pharmacy will grow at a higher CAGR during the forecast period. This highest growth rate is due to the rising adoption of telehealth services for monitoring diseases and enhancing medication accessibility.
Based on the geographical region, the global amyotrophic lateral sclerosis market is distributed into North America, Europe, Asia-Pacific, Middle East and North Africa, Latin America. According to our projection, currently North America occupies the highest share of the market, holding 31.0% of the overall revenue share. This dominance is likely to be the result of advanced healthcare infrastructure that aids the treatment of amyotrophic lateral sclerosis and increasing R&D activities by established players in this domain. Additionally, according to the National Amyotrophic Lateral Sclerosis (ALS) Registry maintained by Centers for Disease Control and Prevention (CDC), there are approximately 30,000 people living with ALS in the US. Additionally, the availability of drugs including Qalsody, Relyvrio, Radicava amongst others is responsible for this market share.
However, in Asia-Pacific the market will grow at a higher CAGR during the forecast period. This highest growth rate is primarily due to the increasing awareness about the amyotrophic lateral sclerosis and its associated complications. Moreover, the increasing investment by the industry leaders and government organizations to improve healthcare infrastructure for supporting the treatment of neurodegenerative disease such as Alzheimer’s disease is the key reason behind high growth rate.
The “Global Amyotrophic Lateral Sclerosis Market: Industry Trends and Global Forecasts, till 2035” market report features a comprehensive study of the current market landscape, market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunities in the ALS treatment market.
Currently, the market landscape witnesses the presence of well-established and new entrants who are currently engaged in the industry for driving innovation in therapeutic treatments for amyotrophic lateral sclerosis. Notably, the key industry leaders are adopting various strategic initiatives such as therapeutic drug development, production expansion, and partnerships to maintain a competitive edge. Overall, the market seems highly fragmented featuring the presence of several small, medium-sized and large players who are increasing their efforts for the development of novel therapeutic drugs. Furthermore, the supportive guidelines by the FDA have caught the attention of drug developers which signifies that the market will remain investible for long term.
One of the key drivers of amyotrophic lateral sclerosis market growth is growing incidence of this neurodegenerative disease across the globe. According to the recent published report of Centers for Disease Control and Prevention, nearly 5,000 cases of amyotrophic lateral sclerosis are diagnosed every year. Hence, the rising concern of patients with amyotrophic lateral sclerosis has underscored the requirement of advanced therapeutic treatment which is anticipated to be the key driver for the ALS market growth.
The pipeline for ALS holds some hope for the patients, as 2024 saw several companies present positive results from clinical trials. In August 2024, University of Birmingham and Sweden based TikoMed presented results from a phase II trial of an investigative drug ILB. Another company, NeuroSense Therapeutics presented 12-month data from a phase IIb clinical trial for PrimeC, showing slower disease progression and improved survival rates. India based Zydus Lifesciences is also developing an oral small molecule NLRP3 inhibitor Usnoflast, which has completed phase II clinical trials in September 2024. As per our market data analysis, as more molecules progress in clinical trials, the market will witness growth.
Some of the potential challenges that may impede the ALS market growth included limited availability of the FDA approved drugs. Not many treatment options are available for patients with ALS. More recently, Amylyx Pharmaceuticals announced its plans to discontinue Relyvrio from the US and Canada markets, after the drug failed in a phase III clinical trial. The drug had received conditional approval based on phase II clinical trials. Its removal from the market will mean even fewer options for the ALS patients.
Furthermore, high cost of amyotrophic lateral sclerosis treatment can restrain their adoption. It is worth noting here that Qalsody is the recently approved drug that is used for the treatment of ALS that costs over $14,230 per dose. Considering around 13-14 doses per year, the annual treatment cost is around $200,000. This is at par with the price points for other available drugs. Hence, high cost can create challenges in widespread usage of therapeutic drug.
Despite the challenges, the global amyotrophic lateral sclerosis market will continue to expand driven by the increasing investment in research of advanced therapies. For instance, in March 2023, QurAlis successfully raised USD 88 million in Series B Funding round for the development of precision medicine to treat amyotrophic lateral sclerosis and other degenerative diseases. The company also aims to utilize these funds for the clinical development of its leading ALS candidates QRL-201 and QRL-101. Furthermore, the growing innovation for the therapies advancements such as stem cell therapies and target specific therapeutic drugs are providing dynamic opportunities for drug developers to make significant contribution towards the growth of the industry.
The global ALS market is currently valued at USD 0.79 billion and is poised to reach USD 1.38 billion by 2035. The highest growth potential is likely to be the result of growing incidence of amyotrophic lateral sclerosis and expanding research by companies to develop innovative drugs for the treatment of this neurodegenerative disease, where there is lack of treatment options. Owing to the growing research, we believe that the market will grow at a CAGR of 5.2% during the forecast period, till 2035.
Examples of key companies engaged in the development of drugs for amyotrophic lateral sclerosis (which have also been profiled in this market report; the complete list of leading players is available in the full report) include Avanir Pharmaceuticals, Anavex Life Sciences, AB Science, BrainStorm Therapeutics, Biogen, Biohaven Pharmaceutical Holding Company, Bausch Health Companies, Biocytogen, Cytokinetics, Genentech, GW Pharmaceuticals, Ionis Pharmaceuticals, Mitsubishi Chemical Corporation, Novartis International, Neuraltus Pharmaceuticals, Ono Pharmaceutical, Pfizer, Regeneron Pharmaceuticals and Sanofi.
Several recent developments have taken place in amyotrophic lateral sclerosis treatment market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.