Amyotrophic Lateral Sclerosis (ALS) Disease

Published Date : Oct 2023
Category : Neurodegenerative Disorders
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Service Architecture for Amyotrophic Lateral Sclerosis

“Fighting Against Amyotrophic Lateral Sclerosis: Making Healthy Choices and Establishing Stable Business”

Amyotrophic lateral sclerosis is one of the most severe diseases that impairs nerve and muscle function. Cases of ALS estimated that the global yearly incidence of ALS will rise by 69% during the following 25 years. According to target ALS current statistics, ALS is more frequent in white men aged 60 to 79. However, there is no cure for ALS, and there is no effective treatment to slow or stop its development. Innovations in the treatment field of ALS are very important for now.

Amyotrophic lateral sclerosis is a kind of motor neuron disease that is potentially fatal. It is characterized by gradual nerve cell degeneration in the spinal cord and brain. It's also known as Lou Gehrig's disease, after the great baseball star who died from it.

Since the ALS disease progresses, the symptoms get worse with time. The common symptoms of Amyotrophic lateral sclerosis are Muscle twitching and cramping, particularly in the hands and feet, motor control problems in the hands and arms, impaired ability to move the arms and legs, falling and stumbling, dropping items, persistent exhaustion, uncontrollable bursts of laughter or tears, slurred or thick speech, as well as difficulty projecting one's voice, having difficulty breathing and swallowing, paralysis and so on.

However, amyotrophic lateral sclerosis is caused by various factors like environmental factors and genetic factors. Depending upon the source of cause the ALS is divided into 2 types. Sporadic and Familial ALS are the main types of ALS. According to NIH, sporadic ALS appears to strike at random, with no known risk factors and no family history of the condition. Approximately 90 to 95% of cases are of sporadic ALS. Although family relatives of persons with sporadic ALS are more likely to get the disease, the vast majority will not develop ALS.

Moreover, familial ALS is caused by genetic mutations. NIH states that around 5% to 10% of total cases are of familial ALS which is caused by mutations in dozens of genes. A deficiency in the C9ORF72 gene, which produces a protein that is present in motor neurons and nerve cells, accounts for between 25 to 40% of all familial cases. Mutations in the SOD1 gene, which is involved in the creation of the enzyme copper-zinc superoxide dismutase 1, account for another 12 to 20 percent of total familial cases.

In addition to that, scientists from the NIH and the Uniformed Services University of the Health Sciences reported in 2021 that they had found a rare hereditary variant of ALS that occurs in young people as young as 4. The SPTLC1 gene, a component of the body's fat-manufacturing system, is associated with the infantile form of ALS and may result from changes to the body's lipid metabolism.

The prevalence and incidence of ALS vary from different region. In the case of America, According to estimates, 18,000 Americans are now living with ALS. The incidence is around 2 per 100,000 individuals annually and there are around 4 to 6 cases per 100,000 persons each year. However, ALS is more common in males by 20% than the females.

There are several risk factors associated with ALS. Age, sexuality, and ethnicity are some common risk factors for ALS. Several studies reported at the National Institute of Neurological Disorders and Stroke indicate that veterans are between 1.5 and 2 times more likely to get ALS. Veterans are potentially in danger from lead exposure, pesticides, and other environmental hazards.

Many researchers anticipate that by becoming aware of the ALS epidemiology and the possibility of a major rise in ALS incidence rates, healthcare professionals and legislators invest more time and money in learning about the ALS disease. Discovery in the preventive, diagnostic, and treatment fields has been identified as an important element of expanding the marketplace on a global scale for industry players.

DiseaseLandscape Insights assists the stakeholders by providing data related to the ALS disease marketplace, knowledgeable choices in healthcare equipment, therapies, and diagnostic techniques where various new technologies and innovations are impacting the market of disease and driving higher expansion.

Amyotrophic Lateral Sclerosis Diagnostic Analysis

“Diagnosis of Amyotrophic Lateral Sclerosis To Unlocks The Health”

Diagnosis of ALS is initiated by physical examinations and the medical history of patients. Along with that clinicians performed neurological examinations to test the reflexes of patients and other symptoms associated with ALS. However, there is no single test available in the market which diagnoses the ALS accurately. According to the FDA, every year, around 5,000 people in the United States are diagnosed with ALS.

However, ALS patients eventually lose their capacity to function and take care of themselves, according to UCSF Health. About 20% of ALS patients live longer than five years following diagnosis, with survival rates ranging from two to ten years after the disease's beginning.

The following tests are performed to eliminate the chances of other diseases and detect ALS accurately.

  1. Blood and Urine Tests

Blood and urine tests are prescribed depending on symptoms, test results, and findings from a doctor's assessment. These tests are recommended by a doctor to rule out the potential for other disorders.

  1. Electromyography

Electromyography (EMG) is a method for monitoring electrical activity in muscle fibers that is useful in the diagnosis of ALS. Electromyography shows very less side effects which include bleeding, infection, and nerve injury at which the needle electrode is inserted.

  1. Nerve Conduction Study

A nerve conduction study (NCS) assesses the capacity of a nerve to deliver a signal down the nerve or to the muscle while tracking the electrical activity of nerves and muscles.

  1. Magnetic Resonance Imaging

Magnetic resonance imaging (MRI) is a noninvasive process that produces comprehensive pictures of the brain and spinal cord using a magnetic field and radio waves. Images of the brain and spinal cord assist the clinician in ruling out other neurological disorders.

  1. Muscle Biopsy

A muscle biopsy is performed if a physician suspects that the patient is suffering from a muscle disorder other than ALS. A small fragment of muscle is taken while under local anesthetic and delivered to the lab for testing. The muscle sample is analyzed for all possible diseases that show symptoms similar to ALS.

The market for diagnosis of amyotrophic lateral sclerosis is very crowded and competitive. Market participants should use new technology to produce a variety of diagnostic kits. The development of rapid, low-cost diagnostic tests is also crucial in the diagnosis of ALS. The development of single accurate diagnostic tests for ALS is essential now a day.

DiseaseLandscape Insights assists the industry leader in the use of new technologies for improving the existing diagnostic method and provides data on current market players and their products for more knowledge about market dynamics. By using the data from DLI, stakeholders choose the path of their business and implement strategies for the growth of the market.

The following table lists the names of the market leaders who are redefining healthcare with their forefront diagnostic innovations.

                                                                                  Diagnostic Market Players

Blood and Urine Tests


Magnetic Resonance Imaging

Cipla Limited

Human-Device Interaction Lab

Siemens Healthineers

Sun Pharmaceuticals Industries Ltd


Med Imaging Solutions

Apollo Diagnostics

Allengers Global Healthcare Private Limited

DiagnoTech Corporation

Dr. Reddy’s Laboratory

Nexus Health Care

UltraScan diagnostics

Fortis Healthcare

Electrotech Medi Systems

Radiance Imaging System

Metropolis Healthcare Ltd.

Cadwell Industries Inc.

FUJIFILM Holdings America Corporation


                                                                                  Diagnostic Products

Blood and Urine Test


Magnetic Resonance Imaging






PreXion 3D Excelsior CBCT Scanner




Isoton III®




Wave Plus



Electromyography (EMG) plus Inertial Measurement Unit (IMU) Sensor System



Amyotrophic Lateral Sclerosis Treatment Analysis

“Achieving Better Health with Advanced Treatments”

There are various options available for amyotrophic lateral sclerosis. Although treatments cannot cure the damage caused by ALS, they only decrease the progression of symptoms. They can also assist in avoiding complications and make patients feel more relaxed and independent. The following are some treatments available in the market for ALS.

  1. Medications

There are various medicines available to decrease the progression of ALS and reduce the symptoms and complications. The following are the FDA-approved Drugs used to manage amyotrophic lateral sclerosis.

Riluzole (Rilutek, Exservan, Tiglutik) - Riluzole (Rilutek, Exservan, Tiglutik) is approved by the FDA for the treatment of ALS. It is an oral drug. This drug increases the life expectancy of patients by 25% as stated by myoclinic. It causes dizziness, stomach issues, and liver problems as adverse effects.

Edaravone (Radicava) - Edaravone (Radicava) medication can slow the rate of decrease in everyday functioning. It is administered as a liquid through a vein in the arm or by mouth.  Bruising, headaches, and difficulty walking are some of the side effects of this drug. This medication is used twice a month for two weeks.

Sodium Phenylbutyrate-Taurursodiol (Relyvrio) - Sodium Phenylbutyrate-Taurursodiol (Relyvrio) reduces the rate of functional deterioration in persons with ALS by approximately 25%. It also helps those with ALS survive an extra six months. This medication is a powder that is combined with water at room temperature. Diarrhea, stomach discomfort, nausea, and upper respiratory infection are all possible adverse effects.

  1. Therapies

ALS also affects the ability of a patient to breathe, speak, and move. Different therapies are given to patients depending on which part they have been affected.

  1. Breathing Care

ALS causes the muscles that control breathing to weaken, resulting in shortness of breath during physical activity and difficulty breathing at night or when lying down. Noninvasive ventilation (NIV) is breathing assistance provided through a mask placed over the nose and/or mouth. NIV is required only at night at first, but later on, it is needed full-time.

  1. Physical Therapy

A physical therapist addresses pain, walking, mobility, bracing, and equipment requirements to assist the patient in being independent. Low-impact workouts help to keep cardiovascular fitness, muscle strength, and range of motion as long as feasible.

A physical therapist also assists a patient in overcoming weakness by utilizing a brace, walker, or wheelchair. The therapist suggests items such as ramps to help with mobility.

  • Speech therapy

Eye-tracking technology is used by devices like computer-based speech synthesizers, which are used to create nonverbal responses to yes-or-no inquiries.

However, a brain-computer interface (BCI) is a device that enables people with ALS to communicate or operate devices like wheelchairs only with their brain activity. For those with severe ALS and/or visual impairments, researchers are creating BCIs that are more effective, portable, and even auditory-based in some cases.

There are multiple opportunities for business firms in the realm of the amyotrophic lateral sclerosis treatment market. The market players focus on the production of diverse cost-effective therapy products, as well as the redevelopment of current medicines via the use of new technologies to enhance patient health while increasing the profit of the company.

Market participants tap into DiseaseLandscape Insights' market research and consulting services to explore and flourish in the ALS treatment industry. We help clients stay stronger and ahead of the competition by doing in-depth analyses of treatment alternatives, new goods, and technology. DLI provides substantial assistance in the planning, execution, and evaluation of clinical studies for novel medication development.

The below table shows the name of the treatment market player and their product name used to manage amyotrophic lateral sclerosis.

Treatment Market Player


Sun Pharmaceutical Industries Ltd.

Riluzole (Rilutek, Exservan, Tiglutik)

Mitsubishi Tanabe Pharma America, Inc.

Edaravone (Radicava)

Amylyx Pharmaceuticals

Sodium phenylbutyrate-taurursodiol (Relyvrio)

Amneal Pharmaceuticals

Baclofen (Lioresal, Gablofen )

Hoffmann-La Roche



Gabapentin (Neurontin)

Manus Aktteva Biopharma LLP.

Trihexyphenidyl (Benzhexol)


Recent Development

The American Food and Drug Administration (FDA) granted approval for Relyvrio to treat ALS on September 29, 2022. Relyvrio, a combination of Taurursodiol and Sodium Phenylbutyrate, has been linked to prolonged overall survival and has been demonstrated to slow the rate of decline on a clinical evaluation of daily functioning. Advancement and evolution in the treatment field have increased the life expectancy of the patient.

Relyvrio originates in single-dose packets containing 3 g Sodium Phenylbutyrate and 1 g Taurursodiol, which is given orally or through a feeding tube. These two chemicals function together to prevent nerve cell death by inhibiting stress signals in two cellular compartments mitochondria and the endoplasmic reticulum.

Regulatory Framework

“Navigating the Regulatory Framework for Better Business Decision”

The Disease Landscape Insights considers the regulatory ecosystem of different countries for ALS. DLI supplies data on risk assessment regulations, import/export legislation, and monitoring to industry players. DLI offers data related to global organizations, their schemes, and rules for a better understanding of the ALS domain.

However, to promote patients' health and manage the ALS symptoms the United States Food and Drug Administration approved RADICAVA ORS (Edaravone) for the treatment of amyotrophic lateral sclerosis in May 2022.            

Moreover, Edavarone is administered intravenously once a day at a dose of 60 mg. The subsequent monthly cycles all last for 10 days, as opposed to the initial administration, which lasts for 14 days. However, compared to taking a drug orally, this therapeutic procedure is less convenient. The FDA authorized an oral solution of 105 mg per day in 2022.

Furthermore, Relyvrio medicine had acquired conditional authorization to treat ALS in Canada, in June 2022, where it is marketed under the trade name Albrioza. This was the first time the therapy had been approved by a regulatory authority in any country.

Competitive Analysis

“Empowering the Business by Analysing the Strategies of Competitors”

Several worldwide industries are concentrating on developing new products and enhancing the use of technology for the improvement of existing techniques to boost their competitive position. To broaden their selection of products, industries are also working on growth initiatives, which principally involve regulatory approval for medication research, acquisition partnerships, and a focus on cooperation.

However, companies like Mitsubishi Tanabe Pharma, America have developed a drug called RADICAVA ORS (Edaravone). Launching of such products in the market has increased the awareness of diseases and products. Manufacturing and selling of this drug has increased the overall revenue of Mitsubishi Tanabe Pharma, America Company.

Moreover, NeuroSense Therapeutics company is researching on novel therapy for ALS using a combination of drugs. PrimeC is a novel fixed-dose combination medication that combines Ciprofloxacin and Celecoxib to address numerous disease pathways such as microRNA dysregulation, iron accumulation, and neuroinflammation. PrimeC has been studied in ALS patients in a phase 2a clinical trial, and NeuroSense is now planning a major phase 2b/3 research utilizing PrimeC.

Innovations in the treatment field have increased the collaboration of NeuroSense Therapeutics with other research agencies. Research and development of novel drugs and therapies encourage the other competitors to do concentrated research and set a standard for key players.

DiseaseLandscape Insights assists industry companies by giving extensive knowledge about all current market players, their inventions, tactics, and partnerships, as well as assisting in the selection of the appropriate marketplace to grow exponentially.

Market Trends

“Chasing the Wave of Market Trends: Making Informed Decision”

The market is rising and growing continuously due to developments and innovations in the treatment field of ALS. The launching of new medications and the discovery of various drugs from many sources are now trending in the market. The development of a single accurate diagnostic test is essential. New market players and existing market players are working on various new technologies to evolve the diagnostic and treatment domain of ALS disease.

However, researchers are researching to better understand the genes that cause this disease, the mechanisms that cause motor neurons to degenerate in ALS, and techniques to halt the progression that leads to cell death. Revolutions and discovery in such domain raises the chances of the development of goods and also helps to develop more effective therapies and diagnostic techniques.

Currently, research on gene-specific therapies is booming in the market. The use of antisense oligonucleotides (ASOs) and CRISPR Cas technologies in the treatment of ALS is another field where many key players are working and developing new genetic therapies specific to diseases such as ALS. Key players should enter this domain with innovative approaches and comprehensive strategies that help to expand the business and ultimately the revenue of the company.

Also, monoclonal antibodies for ALS are the category in which strong and stable businesses can be established. Human monoclonal antibody AL001 is in the clinical trial for the treatment of ALS. Market competitors have numerous opportunities in the development of products of monoclonal antibodies.

Furthermore, introducing long-term effects drugs with lesser side effects is trending in the market. Research and developments in drugs with long-term effects will improve the patient's health. An invention in this market has created an opportunity for industry players to grow continuously.

All in all, the key players have numerous opportunities in the treatment and diagnosis field. The existing players have generated tremendous income from the ALS disease business. Such developments have increased the scope and economy of the ALS treatment and diagnostic market globally.

Clinical Trial Assessment

The increasing emphasis on comparative effectiveness research by the government emphasizes the importance of clinical trials in the practice of evidence-based medicine and health care reform. Clinical data helps the market players to accurately compare medical therapy and achieve one of the primary goals of health care reform.

The study titles of the currently active clinical trials, as well as the phases in which they are being conducted, are included in the table below.


Phase I

Phase II

Phase III

Phase IV

Phase 1 Safety Run-in Study and Phase 1b Randomized, Double-Blinded, Placebo-Controlled Trial

Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis

Randomized Double-Blind Placebo-Controlled Phase 3 Trial of Triumeq in Amyotrophic Lateral Sclerosis

Randomized Double-blind Controlled Exploratory Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients

Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis

A Phase 2a Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) Study of Intravenous ANX005 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis


A Multi-Center, Randomized, Double-Blind Placebo-Controlled Multiple-Ascending Dose Study to Evaluate the Safety and Tolerability of QRL-201 in Amyotrophic Lateral Sclerosis


A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)

Phase 2/3 Trial of Autologous Hybrid TREG/Th2 Cell (RAPA-501) Therapy for Amyotrophic Lateral Sclerosis


Phase 1/2 Study of Bosutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)

Phase 2/3 Trial of Autologous Hybrid TREG/Th2 Cell (RAPA-501) Therapy for Amyotrophic Lateral Sclerosis

A Multi-arm, Adaptive, Group-sequential Trial NETwork to Evaluate Drug Efficacy in Patients With Amyotrophic Lateral Sclerosis (ALS)


A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the Ataxin-2 Gene

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacodynamic Markers, and Pharmacokinetics of AP-101 in Patients With Familial Amyotrophic Lateral Sclerosis (fALS) and Sporadic Amyotrophic Lateral Sclerosis (sALS)

A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 12 Month Clinical Trial to Evaluate the Efficacy and Safety of MN-166 (Ibudilast) Followed by Open-Label Extension Phase in Subjects With Amyotrophic Lateral Sclerosis


A Phase 1, Randomized, Double Blind, Placebo Controlled, Single and Multiple Dose Escalation Study in Healthy Volunteers and an Expansion Cohort in Adult Participants With Amyotrophic Lateral Sclerosis (ALS) to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPG302

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Efficacy, Safety, Tolerability, PK, and Biomarker Effects of PTC857 in Adult Subjects With Amyotrophic Lateral Sclerosis (CARDINALS)

A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis Patients With Fused in Sarcoma Mutations (FUS-ALS)




DiseaseLandscape Insights (DLI) assists manufacturers in developing and implementing viable remedies to interrupt and manage amyotrophic lateral sclerosis outbreaks. Furthermore, there is an increasing need for diagnostic tools, clinical evaluations, and ALS gene therapy as a result of greater awareness and estimated epidemics.

Disease Landscape Insights offers essential knowledge and expertise to major stakeholders involved in the manufacture of therapeutic goods. DiseaseLandscape Insights' support makes it easier for market participants to organize and carry out clinical trials for innovative medicines and pharmaceuticals, patient recruiting tactics, and regulatory compliance.

DLI also provides detailed information about market competitors, growth of the market, and new regulations and rules across the globe to industry players. DLI assists all market participants in gaining a stronger foothold in the ALS sector.

Vishal SawantBusiness Development

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