Amyotrophic Lateral Sclerosis (ALS) Market to Witness Growth by 2032, Estimates DelveInsight | Companies- Mitsubishi Tanabe Pharma Corporation, Sanofi, Covis, Aquestive Therapeutics, Avanir Pharmaceuticals, Biogen, Ionis Pharmaceuticals, MediciNova, AB Sc

DelveInsight's "Amyotrophic Lateral Sclerosis (ALS) Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of Amyotrophic Lateral Sclerosis (ALS), historical and forecasted epidemiology as well as the Amyotrophic Lateral Sclerosis (ALS) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Amyotrophic Lateral Sclerosis (ALS) market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Amyotrophic Lateral Sclerosis (ALS) market size from 2019 to 2032, segmented by seven major markets. The Report also covers current Amyotrophic Lateral Sclerosis (ALS) 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 (ALS) market.

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Amyotrophic Lateral Sclerosis (ALS): An Overview

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a group of rare neurological diseases that mainly involve the nerve cells (neurons) responsible for controlling voluntary muscle movement. The disease is progressive, meaning the symptoms get worse over time. ALS belongs to a wider group of disorders known as motor neuron diseases caused by gradual deterioration (degeneration) and death of motor neurons. Motor neurons are nerve cells that extend from the brain to the spinal cord and muscles throughout the body. Messages from motor neurons in the brain (called upper motor neurons; UMN) are transmitted to motor neurons in the spinal cord and to motor nuclei of the brain (called lower motor neurons; LMN) and from the spinal cord and motor nuclei of the brain to a particular muscle or muscles. ALS can be either sporadic or genetic. The sporadic type is the most common and can affect anyone. The genetic or familial type is rarer. Common symptoms include painless, progressive muscle weakness. The first thing a person might notice is tripping more often, or dropping things because of the weakness. Slurred speech, difficulty swallowing, and trouble breathing can occur.
Amyotrophic Lateral Sclerosis Diagnosis

ALS is a difficult disease to diagnose. There is no one test or procedure to establish the diagnosis of ALS ultimately. It is through a clinical examination and a series of diagnostic tests, often ruling out other diseases that mimic ALS. The diagnosis of ALS relies on medical history, physical examination, electrodiagnostic testing (with needle EMG), and neuroimaging. Biomarkers can play a crucial role in diagnostic, prognostic, or predictive research studies. They could potentially become important for the stratification of patients and monitoring treatment effects in clinical trials. Genetic testing of the five most prevalent genes found to be mutated in ALS is routinely offered to patients with a positive family history (C9orf72, SOD1, TDP‐43, FUS, and TBK‐1).

Amyotrophic Lateral Sclerosis Treatment

There is no cure for ALS, so treatment aims to alleviate symptoms, prevent unnecessary complications, and slow the rate of disease progression. Medical interventions and technology have vastly improved the quality of life for people with ALS by assisting with breathing, nutrition, mobility, and communication. Modern therapeutic strategies comprise of neuroprotective treatment focused on antiglutamatergic, antioxidant, antiapoptotic, and anti-inflammatory molecules. Drugs approved for the treatment of ALS are IV Radicava (Mitsubishi Tanabe Pharma), Rilutek/Riluzole) (Sanofi/Covis), Exservan (Aquestive Therapeutics), and Tiglutik/ Teglutik (ITF Pharma). In ALS, opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used to relieve discomfort. A combination of quinidine and dextromethorphan called Nuedexta (Avanir Pharmaceuticals) has been approved by the US Food and Drug Administration to treat pseudobulbar effect, however it can lengthen the QT interval, raising the risk of cardiac arrhythmia.

Learn more about Amyotrophic Lateral Sclerosis (ALS), treatment algorithms in different geographies, and patient journeys. Contact to receive a sample @ https://www.delveinsight.com/report-store/amyotrophic-lateral-sclerosis-als-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr


Amyotrophic Lateral Sclerosis (ALS) Market

Amyotrophic lateral sclerosis (ALS) is a collection of rare neurological disorders primarily affecting the nerve cells responsible for voluntary muscle control. These muscles enable actions such as chewing, walking, and talking. The condition is progressive, meaning that symptoms worsen over time.

Currently, there is no cure for ALS, and no effective treatment exists to stop or reverse its progression. The management of ALS typically involves a multidisciplinary approach, including physical therapy, speech therapy, dietary counseling, heat or whirlpool therapy, and other supportive measures. Medications are prescribed to help alleviate symptoms such as pain, muscle cramps, stiffness, excessive saliva and phlegm, and the pseudobulbar affect (uncontrollable episodes of crying, laughing, or emotional outbursts). Drugs are also available to address pain, depression, sleep disturbances, and constipation in individuals with ALS.

There is no globally approved drug specifically designed to slow down ALS progression. Rilutek, Tiglutik, and Exservan are brand names for different forms of riluzole, a medication used in ALS treatment. Rilutek is taken orally as a tablet, Tiglutik is an oral suspension, and Exservan is an oral film. Neudexta is approved for treating pseudobulbar affect in conditions like multiple sclerosis and ALS. Mitsubishi Tanabe Pharma has received approval to market Radicut (edaravone or MCI-186) for ALS treatment, but it is strictly limited to Japan. Radicava was approved in the US in May 2017 as the first new ALS treatment in the country in 22 years.

However, there have been recent efforts in the development of treatments for ALS. Several major pharmaceutical companies are actively working to address the unmet needs of the ALS market. Some of these companies have drug candidates in the late-stage or mid-stage clinical development.

The ALS pipeline includes drugs in advanced stages of development, and many of them have the potential to be launched within the projected timeframe. Key players in this field 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 who are investigating their candidates for ALS treatment across the seven major markets (7MM).

According to DelveInsight, the ALS market in the seven major markets (7MM) is anticipated to undergo significant changes during the study period from 2019 to 2032.

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Amyotrophic Lateral Sclerosis (ALS) 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 (ALS) 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 (ALS) Pipeline Development Activities

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

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Amyotrophic Lateral Sclerosis (ALS) 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 (ALS) Therapeutics market to develop novel therapies which will drive the Amyotrophic Lateral Sclerosis (ALS) treatment markets in the upcoming years.

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Amyotrophic Lateral Sclerosis (ALS) Report Key Insights

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

Table of Contents

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

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