Amyotrophic Lateral Sclerosis Market 2034 | Mitsubishi Tanabe Pharma Corporation, Sanofi, Covis, Aquestive Therapeutics, Avanir Pharmaceuticals, Biogen, Ionis Pharmaceuticals, MediciNova, AB Science, Brainstorm Cell Therapeutics, Amylyx Pharmaceuticals, D

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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Key highlights from the amyotrophic lateral sclerosis market report:
The market size for Amyotrophic Lateral Sclerosis (ALS) in the seven major markets (7MM) was approximately USD 1,000 million in 2023. The current standard of care includes the prescription of riluzole, which has proven effective in slowing disease progression and extending patient lifespan.

A recent development in the ALS landscape is the approval of RELYVRIO (sodium phenylbutyrate and taurursodiol) by the US FDA on September 29, 2022, for the treatment of adults with ALS. Following some challenges with RELYVRIO, RADICAVA has emerged as the leading contender in the current ALS market and is expected to generate the highest revenue. The approval of RADICAVA ORS led to a significant increase in sales, reversing a prior decline in IV RADICAVA usage, with strong uptake observed in both the US and Japan.

Innovative therapies like TPN-101 from Transposon Therapeutics and Ulefnersen (ION363) from Ionis Pharmaceuticals are being developed for specific mutations such as C9ORF72 and FUS in ALS. These advancements underscore the unmet needs among patients with mutation-specific ALS, with a current focus on key mutations like SOD1, C9ORF72, and FUS. However, there remains a notable gap in targeting mutations such as TARDBP, OPTN, and ANG, presenting significant opportunities for future research and therapeutic development. Many ALS patients still have undiscovered mutations.

Current ALS treatments include EXSERVAN (riluzole oral film), RELYVRIO, QALSODY, RADICAVA (edaravone injection), RADICAVA ORS (edaravone oral suspension), NEUDEXTA, TIGLUTEK, and RILUTEK, along with symptomatic treatments such as anti-epileptic drugs, opioids, NSAIDs, SSRIs, and antidepressants.

The anticipated launch of potential therapies, including Ulefnersen (Ionis Pharmaceuticals), Ibudilast (MediciNova), Masitinib (AB Science), NurOwn (Brainstorm-Cell Therapeutics), and CNM-Au8 (Clene Nanomedicine), is expected to further expand the ALS market size in the coming years, supported by an increase in the diagnosed prevalence of ALS. These therapies are projected to positively impact the ALS market post-launch during the forecast period (2024-2034).

Amyotrophic Lateral Sclerosis Overview
Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease, is a progressive neurodegenerative disorder that affects motor neurons in the brain and spinal cord. This leads to the gradual loss of muscle control, impacting voluntary movements such as speaking, walking, and swallowing. ALS ultimately results in respiratory failure and can significantly affect quality of life.

Causes
The exact cause of ALS remains unclear, but several factors are believed to contribute, including:

Genetic Factors: Approximately 5-10% of cases are familial, linked to inherited genetic mutations. Notable genes associated with ALS include SOD1, C9orf72, and TARDBP.
Environmental Factors: Exposure to certain toxins, heavy metals, and chemical agents may increase risk.
Age: ALS is more common in people aged 40 to 70.
Gender: Men are more frequently affected than women.
Other Medical Conditions: Some studies suggest a link between ALS and conditions such as traumatic brain injury or certain infections.
Signs and Symptoms
Symptoms of ALS vary but typically include:

Muscle Weakness: Initial weakness may occur in the hands, arms, or legs.
Muscle Cramps and Spasticity: Involuntary muscle contractions and stiffness.
Difficulty Speaking: Slurred speech or changes in vocal quality (dysarthria).
Difficulty Swallowing: Problems with chewing and swallowing (dysphagia).
Weight Loss: Due to muscle wasting and decreased mobility.
Fatigue: Increased tiredness and reduced endurance.
Respiratory Issues: Difficulty breathing as the disease progresses.
Diagnosis
Diagnosing ALS involves several steps:

Clinical Evaluation: A thorough medical history and physical examination to assess symptoms and neurological function.
Electromyography (EMG): This test measures electrical activity in muscles and can help identify motor neuron damage.
Nerve Conduction Studies: To evaluate the function of peripheral nerves.
Magnetic Resonance Imaging (MRI): Used to rule out other conditions that may mimic ALS symptoms.
Blood and Urine Tests: To exclude other diseases and conditions.
Lumbar Puncture (Spinal Tap): May be performed to analyze cerebrospinal fluid for abnormalities.
Treatment Options
Currently, there is no cure for ALS, but several treatment options can help manage symptoms and improve quality of life:

Medications:

Riluzole: The first drug approved for ALS, which may slow disease progression.
Edaravone: Another medication that may help slow functional decline in some patients.
Symptom Management:

Physical Therapy: To maintain mobility and manage muscle weakness.
Occupational Therapy: To assist with daily activities and use adaptive equipment.
Speech Therapy: To address communication difficulties and swallowing issues.
Nutritional Support: Diet modifications and, in some cases, feeding tubes to ensure adequate nutrition.

Respiratory Care: Use of non-invasive ventilation support as respiratory function declines.

Palliative Care: Focused on improving quality of life and providing support for patients and their families throughout the disease progression.

Amyotrophic Lateral Sclerosis is a complex and challenging disease that requires a multidisciplinary approach for management. Early diagnosis and comprehensive care can help improve quality of life for patients and support their families. Ongoing research is critical to better understand ALS and develop new therapeutic options. If you or someone you know is experiencing symptoms of ALS, seeking medical advice is essential.

Learn more about Amyotrophic Lateral Sclerosis, 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 Market

Currently, there is no cure for ALS, nor are there effective treatments to halt or reverse its progression. Few drugs approved by the FDA can slow the disease's course or enhance quality of life, making management largely supportive and symptom-focused. In recent years, research into new treatment strategies has increased, exploring options such as gene therapy, cellular therapy, and neuroprotective agents.

Only a limited number of approved drugs can slow disease progression by prolonging patient autonomy and improving survival rates, as measured by the ALS Functional Rating Scale (ALSFRS-R). The FDA has approved several medications for ALS treatment, including riluzole, NUEDEXTA, RADICAVA, TIGLUTIK, RELYVRIO, and QALSODY. Additionally, medications are prescribed to help manage symptoms such as pain, muscle cramps, stiffness, excess saliva, phlegm, and the pseudobulbar effect (involuntary episodes of crying or laughing). Other drugs are available to address issues like pain, depression, sleep disturbances, and constipation.

Riluzole is recommended as the first-line therapy in Japan, the US, and Europe. It was first approved by the FDA in 1995 and has since been approved in various other countries. Riluzole may extend the lives of some individuals with ALS by a few months and appears to work by blocking sodium and calcium channels while enhancing glutamate clearance. Other formulations of riluzole include RILUTEK (oral tablet), TIGLUTIK (oral suspension), and EXSERVAN (oral film). NEUDEXTA is approved for managing pseudobulbar effects in conditions like multiple sclerosis and ALS.

Although the pipeline includes several promising therapies in various development stages, clinical trials for ALS often have high failure rates. Recent examples of unsuccessful therapies include arimoclomol (Orphazyme), levosimendan (Orion Pharmaceuticals), ravulizumab (Ultomiris), and Zilucoplan (UCB Pharma). Nevertheless, the current pipeline holds significant potential, featuring disease-modifying agents, symptomatic treatments, and therapies targeting specific mutations, all of which could help meet the unmet needs of ALS patients.
The total market size in the US for ALS was estimated to be ~USD 920 million in 2023, which is expected to grow during the forecast period (2024-2034).
RADICAVA emerges as the leading contender in the current ALS market and is anticipated to achieve the highest revenue, i.e., USD 923 million in the US by 2034.
In 2034, among the emerging therapies, the highest revenue was generated by Masitinib in combination with riluzole, i.e., USD 37 million in Japan.

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Amyotrophic Lateral Sclerosis Epidemiology Insights
Among the seven major markets (7MM), the US reported the highest number of prevalent ALS cases in 2023, with approximately 26,000 cases expected to rise during the forecast period.
In the EU4 and the UK, Germany had the highest diagnosed prevalent cases of ALS, while Spain recorded the lowest in 2023.
The primary sites of ALS onset include the bulbar and spinal regions, along with other less defined areas. In 2023, spinal onset cases accounted for the largest share, with around 15,000 cases, followed by bulbar onset cases.
In Japan, ALS prevalence was highest in the 70-79 age group, followed by the 60-69 and 50-59 age groups.
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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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