Amyotrophic Lateral Sclerosis Market to Witness Growth by 2032 | Major Player: Mitsubishi Tanabe Pharma Corporation, Sanofi, Covis, Aquestive Therapeutics, Avanir Pharmaceuticals, Biogen, Ionis Pharmaceuticals, MediciNova, AB Science, Brainstorm Cell Ther

DelveInsight's "Amyotrophic Lateral Sclerosis Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of 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.

The Amyotrophic Lateral Sclerosis market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Amyotrophic Lateral Sclerosis market size from 2019 to 2032, segmented by seven major markets. The Report also covers current Amyotrophic Lateral Sclerosis treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Amyotrophic Lateral Sclerosis market.

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Amyotrophic Lateral Sclerosis: An Overview
Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease, is a progressive neurodegenerative disorder that affects nerve cells in the brain and spinal cord. ALS belongs to a group of motor neuron diseases that lead to the gradual deterioration and death of motor neurons, the nerve cells responsible for controlling voluntary muscle movements.
Symptoms: ALS initially presents with muscle weakness, twitching (fasciculations), and cramping. As the disease progresses, individuals may experience difficulty walking, speaking, swallowing, and breathing. ALS does not affect sensation, cognition, or intellect in most cases.
Progression: ALS is progressive, meaning symptoms worsen over time. The rate of progression can vary widely among individuals. In some cases, the disease progresses rapidly, while in others, it progresses more slowly. Eventually, ALS leads to paralysis and respiratory failure, typically within a few years of symptom onset.
Causes: The exact cause of ALS is not completely understood, but it is believed to involve a combination of genetic and environmental factors. In some cases, there may be a genetic predisposition, while in others, environmental factors may play a role. Most cases of ALS are sporadic (occurring randomly) with no clear family history, while about 5-10% of cases are inherited (familial ALS).
Diagnosis: Diagnosis of ALS is based on a thorough medical history, neurological examination, electromyography (EMG), nerve conduction studies, and ruling out other conditions that mimic ALS. There is no single definitive test for ALS, so diagnosis can sometimes be challenging.
Treatment: Currently, there is no cure for ALS. Treatment focuses on managing symptoms, improving quality of life, and providing supportive care. Medications such as riluzole and edaravone are approved to help slow disease progression. Other interventions include physical therapy, occupational therapy, speech therapy, assistive devices, and respiratory support as the disease advances.
Research and Awareness: Ongoing research seeks to better understand the underlying mechanisms of ALS and develop more effective treatments. Awareness campaigns and fundraising efforts aim to support research, provide resources for individuals with ALS, and raise public awareness about the disease.
ALS poses significant challenges for those affected and their families due to its progressive nature and impact on motor function. Multidisciplinary care involving neurologists, physical therapists, speech therapists, respiratory therapists, nutritionists, and palliative care specialists is crucial in managing the complex needs of individuals with ALS. Support from ALS associations and organizations also plays a vital role in providing assistance and resources to affected individuals and their caregivers.

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Amyotrophic Lateral Sclerosis Market

Amyotrophic Lateral Sclerosis (ALS) comprises a group of rare neurological disorders primarily impacting the nerve cells governing voluntary muscle control, crucial for actions like chewing, walking, and speaking. The condition progresses over time, exacerbating its symptoms.

As of now, there exists no cure or definitive treatment to halt or reverse ALS progression. Management involves a multidisciplinary approach encompassing physical therapy, speech therapy, dietary guidance, heat or whirlpool therapy, and other supportive measures. Medications aim to alleviate symptoms such as pain, muscle cramps, stiffness, excessive saliva and phlegm, and the pseudobulbar affect (uncontrollable crying, laughing, or emotional outbursts). Additionally, drugs may address pain, depression, sleep disturbances, and constipation in ALS patients.

There isn't a globally approved drug specifically designed to slow down ALS progression. Rilutek, Tiglutik, and Exservan are different forms of riluzole used in ALS treatment. While Neudexta is approved for treating pseudobulbar affect, Radicut (edaravone or MCI-186) is strictly limited to Japan, and Radicava was the first new ALS treatment in the US in over two decades, approved in May 2017.

Recent efforts focus on developing ALS treatments, with major pharmaceutical companies actively involved. Some are in late or mid-stage clinical development, indicating potential launches within projected timelines.

The ALS pipeline features drugs in advanced development stages, promising potential launches within the estimated timeframe. Key players include AMX0035 (Amylyx Pharmaceuticals), Tofersen/BIIB067 (Biogen/Ionis Pharmaceuticals), ION363 (Ionis Pharmaceuticals), Ibudilast (MediciNova), Masitinib (AB Science), Pegcetacoplan (Apellis Pharmaceuticals), NurOwn (Brainstorm-Cell Therapeutics), Reldesemtiv (Cytokinetics), Gold Nanocrystals/CNM-Au8 (Clene Nanomedicine), Verdiperstat (Biohaven Pharmaceuticals), Zilucoplan (UCB Pharma), and others exploring ALS treatment across major markets.

DelveInsight forecasts significant shifts in the ALS market across the seven major markets (7MM) from 2019 to 2032.

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Amyotrophic Lateral Sclerosis Epidemiology

The ALS epidemiology division provides insights about historical and current ALS patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Amyotrophic Lateral Sclerosis Epidemiology Insights
DelveInsight's estimates shows that the highest cases of ALS in the 7MM were in the United States, followed by Japan, Germany, the United Kingdom, Italy, France, and Spain in the year 2021.
The total diagnosed prevalent cases of ALS in the 7MM range from 52,099 in 2021 growing at a CAGR of 1.04% during the study period (2019-2032).


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Amyotrophic Lateral Sclerosis Emerging Therapies
Marketed Drugs
Radicava (Mitsubishi Tanabe Pharma Corporation)
Radicava (edaravone) is a free radical scavengers and administered as intravenous infusion of 60 mg over 60 minutes. Radicava received fast track and orphan drug designation by FDA and Orphan drug designation by EMA. It is approved in the USA and Japan for the treatment of ALS. In May 2019, Radicava, Mitsubishi Tanabe Pharma notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Radicava intended for the treatment of ALS. The company is currently conducting a Phase III trial for long-term safety and tolerability of oral edaravone for the treatment of ALS.
Exservan (Aquestive Therapeutics)
Exservan (Riluzole oral film) consists of a thin film that is placed on the tongue, utilizes the company's "PharmFilm" technology. The dissolving oral film can be taken twice daily without water, making it easier for patients who have difficulty swallowing pills or liquids. Riluzole oral film received the US FDA Orphan Drug designation which is used as adjunctive therapy in the treatment of ALS. Aquestive Therapeutics announced the exclusive license to Mitsubishi Tanabe Pharma Holdings America (MTHA) for the commercialization Exservan in the United States and Zambon for the development and commercialization of Exservan in the European Union for the treatment of ALS.
Tiglutik/ Teglutik (ITF Pharma)
Tiglutik (riluzole) oral suspension is indicated for the treatment of ALS. Tiglutik is the first and only easy-to-swallow thickened riluzole liquid for ALS and is administered twice daily via an oral syringe. Teglutik was first launched in the European markets after it was approved by US FDA as Tiglutik for the treatment of ALS.
Nuedexta (Avanir Pharmaceuticals)
Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) is the only approved medication that has proven to be effective in lowering down the Pseudobulbar Affect (PBA). Nuedexta acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which Nuedexta exerts therapeutic effects in patients with PBA is unknown. It is approved in the USA and Europe for the treatment of PBA associated with certain neurological conditions such as ALS.
ALS Emerging Drugs
AMX0035 (Amylyx Pharmaceuticals)
Amylyx Pharmaceuticals is developing AMX0035, an investigational neuroprotective therapy, which is a fixed-dose co-formulation of two active compounds, namely, sodium phenylbutyrate (PB) and Taurursodiol (tauroursodeoxycholic acid [TUDCA]). Based on data from the Phase II CENTAUR trial, the FDA has accepted Amylyx's NDA for AMX0035 for the treatment of ALS. The FDA also granted Priority Review and assigned a prescription drug user fee act date for AMX0035 of June 29, 2022. A phase III (Phoenix) trial of the drugs is currently ongoing. AMX0035 has the potential to become the newest approval for the treatment of ALS. We expect this drug to compete with Oral Radicava, and other drugs from the HEALEY ALS platform trial. Although Amylyx is expected to enter the US and EU5 market first when compared to Oral Radicava, which is expected to follow the footsteps of IV Radicava in terms of first market entry in Japan.
Tofersen (Biogen/Ionis Pharmaceuticals)
Tofersen (Biogen/Ionis Pharmaceuticals), also known as BIIB067, is an antisense drug designed to reduce the production of superoxide dismutase 1 (SOD1), which is the best understood genetic cause of familial ALS. The drug is being currently investigated in two Phase III trials for the treatment of ALS caused by SOD1 mutation. In October 2021, the company presented the Phase III results from VALOR (Part C), which showed that the trial did not meet the primary endpoint. This failure could likely hinder Biogen's planned filing for FDA approval in the ALS market.
ION363 (Ionis Pharmaceuticals)
Ionis Pharmaceuticals' portfolio for ALS also includes ION363, another investigational antisense medicine for ALS, designed to reduce the Fused in Sarcoma (FUS) protein production. The drug is owned by Ionis and is in development for patients with a rare genetic form of ALS caused by mutations in the FUS gene, which causes motor neuron degeneration through a toxic gain of function mechanism. ION363 can potentially reduce or prevent disease progression in FUS-ALS patients, and the data from the ongoing Phase III trial is expected in 2024.
Masitinib (AB Sciences)
AB Sciences' Masitinib is an orally administered tyrosine kinase inhibitor, which has already completed a Phase II/III trial and has attained positive results, followed by a green signal from the US FDA on the IND application. The drug is under investigation for a Phase III trial in patients with ALS but was previously put on hold due to a potential risk of ischemic heart disease with masitinib, voluntary by the company - the trial was resumed after the FDA authorization.
Verdiperstat (Biohaven)
Biohaven's Verdiperstat is a first-in-class, potent, selective, brain-permeable, irreversible myeloperoxidase (MPO) enzyme inhibitor. The drug was licensed from AstraZeneca in 2018. It was selected as an investigational therapy for inclusion in the first HEALEY ALS platform trial by an independent scientific advisory committee in September 2019 and is currently in Phase II/III clinical trial for the treatment of ALS, for which top-line results are anticipated in mid-2022. The drug has recently failed in a Phase III trial of Multiple System Atrophy, thereby disappointing our hopes for ALS till the time any convincing results are out for ALS specifically.




Amyotrophic Lateral Sclerosis Pipeline Development Activities

The Amyotrophic Lateral Sclerosis report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Amyotrophic Lateral Sclerosis key players involved in developing targeted therapeutics.

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Amyotrophic Lateral Sclerosis Therapeutics Assessment

Major key companies such as Mitsubishi Tanabe Pharma Corporation, Sanofi, Covis, Aquestive Therapeutics, Avanir Pharmaceuticals, Biogen, Ionis Pharmaceuticals, MediciNova, AB Science, Brainstorm Cell Therapeutics, Amylyx Pharmaceuticals, DS Pharma, PTC Therapeutics, Seelos Therapeutics, Prilenia Therapeutics, Biohaven Pharmaceuticals, UCB Pharma, Ra Pharmaceuticals, Clene Nanomedicine Biosciences, Annexon, Eledon Pharmaceuticals, AL-S Pharma, Apellis Pharmaceuticals, Cytokinetics, Astellas Pharma, Revalesio Corporation, NeuroSense Therapeutics, and others are working proactively in the Amyotrophic Lateral Sclerosis Therapeutics market to develop novel therapies which will drive the Amyotrophic Lateral Sclerosis treatment markets in the upcoming years.

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Amyotrophic Lateral Sclerosis Report Key Insights

1. Amyotrophic Lateral Sclerosis Patient Population
2. Amyotrophic Lateral Sclerosis Market Size and Trends
3. Key Cross Competition in the Amyotrophic Lateral Sclerosis Market
4. Amyotrophic Lateral Sclerosis Market Dynamics (Key Drivers and Barriers)
5. Amyotrophic Lateral Sclerosis Market Opportunities
6. Amyotrophic Lateral Sclerosis Therapeutic Approaches
7. Amyotrophic Lateral Sclerosis Pipeline Analysis
8. Amyotrophic Lateral Sclerosis Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Amyotrophic Lateral Sclerosis Market

Table of Contents

1. Key Insights
2. Executive Summary
3. Amyotrophic Lateral Sclerosis Competitive Intelligence Analysis
4. Amyotrophic Lateral Sclerosis Market Overview at a Glance
5. Amyotrophic Lateral Sclerosis Disease Background and Overview
6. Amyotrophic Lateral Sclerosis Patient Journey
7. Amyotrophic Lateral Sclerosis Epidemiology and Patient Population
8. Amyotrophic Lateral Sclerosis Treatment Algorithm, Current Treatment, and Medical Practices
9. Amyotrophic Lateral Sclerosis Unmet Needs
10. Key Endpoints of Amyotrophic Lateral Sclerosis Treatment
11. Amyotrophic Lateral Sclerosis Marketed Products
12. Amyotrophic Lateral Sclerosis Emerging Therapies
13. Amyotrophic Lateral Sclerosis Seven Major Market Analysis
14. Attribute Analysis
15. Amyotrophic Lateral Sclerosis Market Outlook (7 major markets)
16. Amyotrophic Lateral Sclerosis Access and Reimbursement Overview
17. KOL Views on the Amyotrophic Lateral Sclerosis Market
18. Amyotrophic Lateral Sclerosis Market Drivers
19. Amyotrophic Lateral Sclerosis Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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