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Amyotrophic Lateral Sclerosis Market

The Amyotrophic Lateral Sclerosis market growth is driven by factors like increase in the prevalence of Amyotrophic Lateral Sclerosis, investments in research and development, entry of emerging therapies during the study period 2019-2032.

The Amyotrophic Lateral Sclerosis market report also offers comprehensive insights into the Amyotrophic Lateral Sclerosis market size, share, Amyotrophic Lateral Sclerosis epidemiology, emerging therapies, market drivers and barriers, ongoing clinical trials, key collaboration in the space, market uptake by key therapies and companies actively pushing Amyotrophic Lateral Sclerosis market size growth forward. 

Some of the key highlights from the Amyotrophic Lateral Sclerosis Market Insights Report:

• Several key pharmaceutical companies, including 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 developing novel products to improve the Amyotrophic Lateral Sclerosis treatment outlook. 
• The total Amyotrophic Lateral Sclerosis market size will include the market size of the potential upcoming therapies and current treatment regimens in the seven major markets.
• As per DelveInsight analysis, the Amyotrophic Lateral Sclerosis market is anticipated to witness growth at a considerable CAGR
• Estimates show 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).
• Epidemiology assessed for the condition showed that the US, in 2021, accounted for approximately 20,556 diagnosed prevalent cases of ALS.
• Among the EU-5 countries in 2021, Germany had the highest diagnosed prevalent cases of ALS with 5,061 cases, followed by UK (4,276) and Italy (4,226). In contrast, Spain had the lowest cases (3,065) in 2021.
• Japan accounted for 10,742 diagnosed prevalent ALS cases in 2021.
• The market size of ALS in the seven major markets is expected to rise from USD 460.4 million in 2021 during the study period (2019–2032).
• Current market dynamics are dominated by the use of Rilutek, Tiglutik, Exservan, Neudexta, Radicava and others (Anti-epileptic drugs, Opioids, NSAIDs, Diuretics, SSRIs, Antidepressants, etc.)

Strategise your business goals by understanding market dynamics @ Amyotrophic Lateral Sclerosis Market Landscape

Amyotrophic Lateral Sclerosis 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.

Do you know the treatment paradigms for different countries? Download our Amyotrophic Lateral Sclerosis Market Sample Report

Amyotrophic Lateral Sclerosis Epidemiology Segmentation 

DelveInsight’s Amyotrophic Lateral Sclerosis market report is prepared on the basis of epidemiology model. It offers comprehensive insights to the Amyotrophic Lateral Sclerosis historical patient pools and forecasted Amyotrophic Lateral Sclerosis patients. The report provides in-depth data of various subtypes and for the same epidemiology is segmented further. The Amyotrophic Lateral Sclerosis Market report proffers epidemiological analysis for the study period 2019-32 in the 7MM segmented into:

• Amyotrophic Lateral Sclerosis Prevalence 
• Age-Specific Amyotrophic Lateral Sclerosis Prevalence 
• Gender-Specific Amyotrophic Lateral Sclerosis Prevalence 
• Diagnosed and Treatable Cases of Amyotrophic Lateral Sclerosis

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Amyotrophic Lateral Sclerosis Treatment Market 

Amyotrophic lateral sclerosis (ALS) is a group of rare neurological diseases mainly involving the nerve cells (neurons) responsible for controlling voluntary muscle movement. Voluntary muscles produce movements like chewing, walking, and talking. The disease is progressive, meaning the symptoms get worse over time.

Currently, there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease. The treatment landscape of ALS includes multidisciplinary care, such as physical therapy, speech therapy, dietary counselling, heat or whirlpool therapy and others. Medications are also prescribed to help manage symptoms of ALS, including pain, muscle cramps, stiffness, excess saliva and phlegm, and the pseudobulbar affect (involuntary or uncontrollable episodes of crying and/or laughing, or other emotional displays). Drugs also are available to help individuals with pain, depression, sleep disturbances, and constipation.

There is no other drug which is globally approved for slowing the progression of ALS. Rilutek, Tiglutik, and Exservan are brand names for different formulations of riluzole, a medicine used in the treatment of ALS. Rilutek is an oral tablet, Tiglutik is an oral suspension, and Exservan is an oral film. Neudexta is approved for the treatment of pseudobulbar effects in conditions such as multiple sclerosis and ALS. Mitsubishi Tanabe Pharma received approval to market Radicut (edaravone or MCI-186) for ALS treatment, strictly limited to Japan. Radicava was approved to treat ALS in the US in May 2017, the first new ALS treatment agent in the US in 22 years.

Nevertheless, recently some developmental initiatives have been taken towards the treatment of ALS. Several pharmaceutical key players have taken to the initiative to meet the unmet needs of the present situation of the ALS market. Some of the key players are in the late and mid clinical development stages with their leading drug candidates.

The ALS pipeline possesses drugs in the late-stage development, many of which hold the potential to get launched in the forecast period. The 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 investigating their candidates for the treatment of ALS in the 7MM.

Amyotrophic Lateral Sclerosis Emerging Therapy Assessment

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 Key Companies

• Mitsubishi Tanabe Pharma Corporation
• Sanofi/Covis
• Aquestive Therapeutics
• Avanir Pharmaceuticals (a subsidiary of Otsuka America)
• 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

For more information, visit Amyotrophic Lateral Sclerosis Market Analysis, Patient Pool, and Emerging Therapies

Scope of the Amyotrophic Lateral Sclerosis Market Report:

• 10 Years Forecast
• 7MM Coverage 
• Descriptive overview of Amyotrophic Lateral Sclerosis, causes, signs and symptoms, diagnosis, treatment
• Comprehensive insight into Amyotrophic Lateral Sclerosis epidemiology in the 7MM
• Amyotrophic Lateral Sclerosis marketed and emerging therapies 
• Amyotrophic Lateral Sclerosis companies
• Amyotrophic Lateral Sclerosis market drivers and barriers 

Key Questions Answered in the Amyotrophic Lateral Sclerosis Market Report 2032:

• What was the Amyotrophic Lateral Sclerosis market share distribution in 2019, and how would it appear in 2032?
• What is the total Amyotrophic Lateral Sclerosis market size and the market size by therapy across the 7MM for the study period (2019-32)?
• What are the important findings from 7MM, and which country will have the greatest Amyotrophic Lateral Sclerosis market size from 2019-32?
• During the study period (2019-2032), at what CAGR is the Amyotrophic Lateral Sclerosis market projected to expand at 7MM?

Table of Contents:

1 Amyotrophic Lateral Sclerosis Market Key Comprehensive Insights 

2 Amyotrophic Lateral Sclerosis Market Report Introduction

3 Competitive Intelligence Analysis for Amyotrophic Lateral Sclerosis

4 Amyotrophic Lateral Sclerosis Market Analysis Overview at a Glance

5 Executive Summary of Amyotrophic Lateral Sclerosis

6 Amyotrophic Lateral Sclerosis Epidemiology and Market Methodology

7 Amyotrophic Lateral Sclerosis Epidemiology and Patient Population

8 Amyotrophic Lateral Sclerosis Patient Journey

9 Amyotrophic Lateral Sclerosis Treatment Algorithm, Amyotrophic Lateral Sclerosis Current Treatment, and Medical Practices

10 Key Endpoints in Amyotrophic Lateral Sclerosis Clinical Trials

11 Amyotrophic Lateral Sclerosis Marketed Therapies 

12 Amyotrophic Lateral Sclerosis Emerging Therapies

13 Amyotrophic Lateral Sclerosis: 7 Major Market Analysis

14 Attribute analysis

15 Access and Reimbursement Overview of Amyotrophic Lateral Sclerosis

16 Amyotrophic Lateral Sclerosis Market Key Opinion Leaders Reviews

18 Amyotrophic Lateral Sclerosis Market Drivers

19 Amyotrophic Lateral Sclerosis Market Barriers

20 SWOT Analysis

21 Disclaimer

22 DelveInsight Capabilities

23 About DelveInsight

Related Reports:

Amyotrophic Lateral Sclerosis Epidemiology 2032

DelveInsight’s “Amyotrophic Lateral Sclerosis – Epidemiology Forecast to 2032” report delivers an in-depth understanding of the disease, historical and forecasted Amyotrophic Lateral Sclerosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

Amyotrophic Lateral Sclerosis Pipeline 2023

“Amyotrophic Lateral Sclerosis Pipeline Insights, 2023” report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Amyotrophic Lateral Sclerosis market. A detailed picture of the Amyotrophic Lateral Sclerosis pipeline landscape is provided, which includes the disease overview and Amyotrophic Lateral Sclerosis treatment guidelines. 

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