Amyotrophic Lateral Sclerosis (ALS) Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Drug Type (Rilutek (Riluzole), Edaravone (Radicava)), By Treatment Type (Physical Therapy, Speech Therapy, Medication, Respiratory Therapy, Others), By End-Users (Hospitals & Clinics, Research and Academic institutes, others), by region, and Competition

Market Overview

Global Amyotrophic Lateral Sclerosis (ALS) Market has valued at USD 663.15 million in 2022 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 5.79% through 2028. Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease, is a progressive and devastating neurodegenerative disorder that primarily affects the motor neurons, which are the nerve cells responsible for controlling voluntary muscle movements. ALS leads to the gradual deterioration and death of these motor neurons, resulting in a loss of muscle control and function.  ALS primarily affects the motor neurons, which are found in the brain and spinal cord. These neurons transmit signals from the brain to the muscles, allowing for voluntary muscle movements such as walking, speaking, and swallowing. In ALS, these motor neurons progressively degenerate and die. Diagnosing ALS can be challenging, as there is no single test for the disease. Diagnosis is typically based on clinical symptoms, physical examination, and the exclusion of other potential causes of motor neuron dysfunction. Electromyography (EMG) and nerve conduction studies are often used to confirm the presence of motor neuron abnormalities. 

Ongoing research into the pathophysiology and genetics of ALS has led to a better understanding of the disease. This knowledge has paved the way for the development of targeted therapies and potential breakthroughs. The ALS market benefits from a robust pipeline of potential therapies and drugs in various stages of clinical trials. The active participation of pharmaceutical companies and research institutions in ALS research and development drives innovation. ALS advocacy groups and organizations play a vital role in raising awareness about the disease, providing support to patients and their families, and advocating for research funding. Their efforts help drive public awareness and research initiatives. Advances in technology, including genetics, biomarker discovery, and AI-driven drug discovery, have the potential to accelerate the development of ALS therapies and diagnostic tools.

Key Market Drivers

Advancements in Research and Understanding of ALS

Researchers have identified several genetic mutations associated with ALS, including mutations in genes like C9orf72, SOD1, and FUS. Understanding these genetic factors has provided insights into the mechanisms of ALS and potential targets for therapy. Moreover, studies have shown that a combination of genetic and environmental factors likely contributes to ALS risk. Inflammation within the central nervous system (neuroinflammation) has been recognized as a significant contributor to ALS progression. Researchers are studying immune system responses and inflammation pathways in ALS, with the aim of developing therapies that can modulate these processes. Abnormal protein aggregation in motor neurons is a hallmark of ALS. Research has focused on understanding how these protein aggregates form and spread, potentially leading to the development of treatments that can disrupt or clear these toxic aggregates. The search for reliable biomarkers for ALS has intensified. Biomarkers could aid in early diagnosis, tracking disease progression, and assessing treatment efficacy. Neurofilament light chain (NfL) levels in cerebrospinal fluid and blood have shown promise as potential biomarkers. RNA-based therapies, including antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs), have emerged as promising approaches to target specific ALS-causing genetic mutations. These therapies aim to reduce the production of toxic proteins associated with ALS.

Advances in stem cell technology, including induced pluripotent stem cells (iPSCs), have allowed researchers to create disease models that mimic ALS in the lab. This enables the testing of potential drug candidates and the study of disease mechanisms. Technologies like CRISPR-Cas9 have provided tools to precisely edit genes, offering the potential for correcting genetic mutations associated with ALS. The design of clinical trials for ALS treatments has evolved, with more emphasis on biomarker-driven trials, adaptive trial designs, and improved outcome measures to assess disease progression and treatment effects more accurately. Research has highlighted the heterogeneity of ALS, leading to efforts to stratify patients based on genetic profiles, clinical characteristics, and disease progression rates. Personalized medicine approaches are being explored. Various potential therapeutic targets have emerged, including neuroprotective factors, growth factors, mitochondrial function, and pathways related to inflammation and oxidative stress. These targets are being explored in preclinical and clinical studies. The establishment of ALS patient registries has facilitated the collection of longitudinal data on a large scale. This data is valuable for understanding disease progression, identifying trends, and recruiting participants for clinical trials. Collaboration among researchers, institutions, pharmaceutical companies, and patient advocacy groups has accelerated ALS research by fostering the sharing of data, resources, and expertise. This factor will help in the development of the Global Amyotrophic Lateral Sclerosis (ALS) Market.

Technological Advances

High-throughput DNA sequencing technologies, including whole-genome sequencing and whole-exome sequencing, have enabled researchers to identify genetic mutations associated with ALS. This has expanded our understanding of the genetic underpinnings of the disease and provided insights into potential targets for therapy. Technologies such as functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) have allowed researchers to visualize brain activity and track changes in neural networks in ALS patients. These tools provide insights into the functional consequences of disease. Electromyography (EMG) and nerve conduction studies, supported by technological improvements, help diagnose ALS by assessing the electrical activity of muscles and nerves. These tests aid in confirming the presence of motor neuron dysfunction. Advances in neuroimaging, including magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI), have enhanced our ability to visualize the structural changes in the brain and spinal cord of ALS patients. This technology aids in diagnosing ALS and tracking disease progression. Telemedicine and telehealth technologies have become increasingly important, especially in the context of the COVID-19 pandemic. These technologies enable remote consultations with healthcare providers, allowing ALS patients to receive care and support while minimizing in-person visits.

Technological innovations have led to the development of sophisticated assistive communication devices and eye-tracking systems that enable individuals with advanced ALS to communicate effectively. Motorized wheelchairs and mobility devices equipped with advanced navigation and control technologies enhance the mobility and independence of ALS patients. Non-invasive ventilation (NIV) and other respiratory support devices have become more advanced and accessible, helping ALS patients manage respiratory difficulties and maintain their quality of life. Digital patient registries and databases allow for the collection and analysis of clinical and genetic data from ALS patients on a larger scale. This supports research and facilitates patient recruitment for clinical trials. AI and machine learning are being used to analyze large datasets in ALS research. These technologies help identify potential drug candidates, predict disease progression, and personalize treatment approaches. Computational tools and high-throughput screening technologies are accelerating drug discovery and repurposing efforts to identify potential ALS therapies. Wearable devices and sensors are enabling remote monitoring of ALS patients' vital signs and symptoms, providing healthcare providers with real-time data for better disease management. This factor will pace up the demand of the Global Amyotrophic Lateral Sclerosis (ALS) Market.

Increasing Patient Advocacy and Awareness

Patient advocacy groups and awareness campaigns educate the public and healthcare professionals about the signs and symptoms of ALS. This leads to earlier diagnosis and intervention, as individuals and healthcare providers become more vigilant about recognizing the disease. Early diagnosis can result in a greater demand for ALS-related healthcare services and treatments. Patient advocacy organizations often collaborate with researchers and pharmaceutical companies to recruit participants for clinical trials. Their efforts to raise awareness about ongoing trials can increase patient enrollment and accelerate the development of potential ALS therapies. This, in turn, drives demand for clinical trial-related services and treatments. Patient advocacy groups actively engage in fundraising and advocacy efforts to secure funding for ALS research. The availability of research funding fuels scientific discoveries, leading to the development of new treatments and therapies. Increased research activity generates demand for research-related services and products in the ALS market. Patient advocacy efforts can influence policymakers, healthcare systems, and pharmaceutical companies to improve access to existing ALS treatments. This can include measures such as advocating for insurance coverage or reducing the cost burden on patients. Improved access to treatments can lead to increased demand for these therapies.

Patient advocacy organizations often focus on enhancing the quality of life and care for ALS patients. This may involve the development of supportive care programs, the provision of assistive devices, and the establishment of ALS care centers. These services contribute to the overall demand for ALS-related healthcare services. Patient advocacy groups advocate for increased research into ALS and the development of innovative treatments. Their efforts can stimulate pharmaceutical companies and researchers to invest in ALS drug development and related technologies, driving the demand for research and development services. Many patient advocacy organizations collaborate on a global scale, sharing knowledge, resources, and best practices. This collaboration can amplify their impact and lead to more coordinated efforts to address ALS, ultimately driving the demand for ALS-related products and services on a larger scale. Patient advocacy groups often establish partnerships with both public and private sectors, including government agencies, research institutions, and pharmaceutical companies. These partnerships can lead to increased funding, research collaboration, and the development of new therapies, all of which contribute to market demand. This factor will accelerate the demand of the Global Amyotrophic Lateral Sclerosis (ALS) Market.

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Key Market Challenges

Complexity of Disease Mechanisms

ALS is a multifactorial and complex neurodegenerative disease with diverse underlying mechanisms. Despite decades of research, there is still limited understanding of the precise causes and drivers of the disease. This complexity hinders the development of targeted therapies. ALS is not a uniform disease; it is characterized by significant heterogeneity in terms of clinical presentation, progression rate, and genetic factors. Some cases are sporadic, while others have a familial component. This heterogeneity complicates clinical trial design and the identification of suitable patient populations for specific therapies.

Researchers have identified several potential pathogenic pathways in ALS, including excitotoxicity, protein misfolding and aggregation, mitochondrial dysfunction, neuroinflammation, and more. These pathways often interact and overlap, making it challenging to pinpoint the primary drivers of the disease. ALS has a strong genetic component, with various genetic mutations associated with the disease. Different genetic mutations can lead to distinct pathological mechanisms, further complicating therapeutic development. The absence of reliable biomarkers for ALS diagnosis, prognosis, and disease monitoring is a major challenge. Biomarkers would be invaluable for assessing treatment efficacy and stratifying patients for clinical trials. ALS progresses at varying rates in different individuals. Understanding the factors that contribute to this variability and tailoring treatments accordingly is challenging. ALS involves a cascade of neurodegenerative events, including the degeneration of motor neurons, glial cell dysfunction, and synaptic loss. Targeting these processes effectively requires a deep understanding of the intricate interplay between them.

High Development Cost

ALS is a rare disease, with a relatively small patient population compared to more common conditions. Developing treatments for rare diseases can be economically challenging due to the limited market size and potential return on investment. Understanding the complex mechanisms of ALS and developing effective therapies requires extensive research and development efforts. This involves conducting preclinical studies, clinical trials, and long-term follow-up, all of which are resource intensive. Clinical trials for ALS therapies are costly endeavors. These trials often require large sample sizes and extended periods to observe meaningful outcomes, contributing to high research and development expenses. Developing ALS treatments must adhere to rigorous regulatory requirements, particularly from agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Complying with these regulations adds both time and cost to the drug development process. ALS research often involves innovative approaches, such as gene therapy, stem cell therapy, and RNA-based therapies. Developing and testing these innovative technologies can be expensive, requiring specialized expertise and resources. Identifying potential drug candidates and validating their safety and efficacy in preclinical studies is a resource-intensive process. Many potential drug candidates fail to progress beyond this stage, incurring significant costs.

Key Market Trends

Biomarker Discovery

Biomarkers can facilitate earlier and more accurate diagnosis of ALS. This is particularly important as early intervention may have a more significant impact on disease progression and treatment outcomes. Biomarkers can help predict the likely course of ALS in individual patients. They can identify those at higher risk of rapid progression or those who may benefit from specific treatment approaches. Biomarkers allow for the continuous monitoring of disease progression in ALS patients. This helps clinicians adjust treatment plans as needed and provides valuable data for clinical trials. Biomarkers can serve as objective measures of treatment efficacy. They allow researchers and clinicians to assess whether a therapy is having the desired effect on the underlying disease processes. Biomarkers can be used to stratify ALS patients into more homogeneous groups for clinical trials. This can enhance trial design and increase the likelihood of detecting treatment effects. Biomarker research can uncover novel biological pathways and targets involved in ALS, potentially leading to the development of innovative therapies.

Segmental Insights

Drug Type Insights

In 2022, the Global Amyotrophic Lateral Sclerosis (ALS) Market largest share was held by Rilutek (Riluzole) segment and is predicted to continue expanding over the coming years. ilutek was one of the first drugs to receive approval from the U.S. Food and Drug Administration (FDA) for the treatment of ALS. Its approval provided a sense of validation for its use in ALS therapy, and it became an established standard of care. Clinical trials and studies had shown that Rilutek could modestly extend the survival of ALS patients. While it did not provide a cure, it was one of the few drugs available at the time that had demonstrated some efficacy in slowing down the progression of the disease. Rilutek had been used for ALS treatment for many years prior to 2021. Its long history of use and familiarity among healthcare providers made it a trusted option for ALS management. Until that time, there were limited alternatives for ALS treatment. Rilutek was often prescribed as a standard of care for ALS patients because there were few other FDA-approved medications specifically indicated for the disease. Rilutek works by inhibiting the release of glutamate, which is believed to play a role in the death of motor neurons in ALS. Its mechanism of action made it a rational choice for treatment.

Treatment Type Insights

In 2022, the Global Amyotrophic Lateral Sclerosis (ALS) Market largest share was held by Physical Therapy segment and is predicted to continue expanding over the coming years. ALS is a progressive neurodegenerative disease that leads to muscle weakness and atrophy. Physical therapy is instrumental in helping patients maintain their mobility for as long as possible. Therapists can provide exercises and techniques to strengthen muscles, improve range of motion, and preserve functional abilities. ALS can lead to muscle contractures and joint stiffness. Physical therapists collaborate with patients to prevent these complications by providing stretching exercises and mobility techniques. As ALS progresses, respiratory muscles weaken, and breathing difficulties may arise. Physical therapists can teach breathing exercises and techniques to help patients maintain optimal respiratory function and potentially delay the need for respiratory support. ALS can affect balance and coordination. Physical therapy exercises and balance training can help patients reduce the risk of falls and maintain better control over their movements. Physical therapists can evaluate the need for assistive devices such as wheelchairs, mobility aids, and orthotics. They can also provide training on how to use these devices safely and effectively.

End-User Insights

In 2022, the Global Amyotrophic Lateral Sclerosis (ALS) Market largest share was held by Hospitals & Clinics segment in the forecast period and is predicted to continue expanding over the coming years.  Hospitals and clinics are typically the first point of contact for individuals experiencing symptoms of ALS. Patients often seek medical attention when they notice muscle weakness, twitching, or other neurological symptoms. Neurologists, who work in hospitals and clinics, are the healthcare professionals most likely to diagnose ALS based on clinical evaluation, medical history, and various diagnostic tests. ALS is a complex disease that affects multiple aspects of a patient's life, including motor function, respiratory function, and quality of life. Hospitals and clinics often house multidisciplinary care teams that include neurologists, physical therapists, occupational therapists, speech therapists, respiratory therapists, and social workers. These teams collaborate to provide comprehensive care and support to ALS patients. Hospitals and academic medical centres are hubs for ALS research and clinical trials. Many clinical trials for potential ALS treatments and therapies are conducted in hospital settings. Patients often enrol in these trials through their healthcare providers in hospitals and clinics. Hospitals and clinics are responsible for prescribing and managing medications for ALS patients. This includes prescribing drugs like Riluzole and Edaravone, which are commonly used in the treatment of ALS. Patients often receive these medications through hospitals and clinics.

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Regional Insights

The North America region dominates the Global Amyotrophic Lateral Sclerosis (ALS) Market in 2022. North America, particularly the United States, has a relatively higher prevalence of ALS compared to other regions. The reasons for this higher prevalence are not fully understood, but genetic and environmental factors may play a role. The greater number of ALS cases in the region means a larger patient population potentially seeking treatment and participating in clinical trials. Region’s boasts advanced healthcare infrastructure, including well-established medical institutions, research centers, and pharmaceutical companies. This infrastructure supports ALS research, clinical trials, and the development of new treatments. North American governments, private foundations, and pharmaceutical companies have historically invested significantly in ALS research and drug development. This has led to a robust pipeline of potential therapies and clinical trials in the region. Many clinical trials for ALS treatments, including experimental drugs and therapies, take place in North America. The region's strong research ecosystem, along with the willingness of ALS patients to participate in trials, contributes to the prominence of North America in clinical research.

Recent Developments

• In April 2023, Biogen Inc. has received approval from the U.S. Food and Drug Administration (FDA) for QALSODY, a 100 mg/15mL injection, as a treatment for amyotrophic lateral sclerosis (ALS) in adults with a mutation in the superoxide dismutase 1 (SOD1) gene. This approval is granted under accelerated approval, based on the observed reduction in plasma neurofilament light chain (NfL) levels in patients treated with QALSODY. The continued approval for this indication will depend on the confirmation of clinical benefits in subsequent trial(s). The ongoing Phase 3 ATLAS study for tofersen in individuals with presymptomatic SOD1-ALS will serve as the confirmatory trial. Neurofilament proteins, released from damaged neurons, serve as a marker for neurodegeneration.
• In May 2022, Mitsubishi Tanabe Pharma America, Inc. (MTPA) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for RADICAVA ORS (edaravone), an oral form of edaravone, as a treatment for amyotrophic lateral sclerosis (ALS). ALS is a neurodegenerative disease without a cure, and it can progress rapidly. RADICAVA ORS is designed to offer the same effectiveness as RADICAVA (edaravone), which is an FDA-approved intravenous (IV) treatment. In pivotal trials, RADICAVA has been shown to help slow the decline in physical function in ALS patients. RADICAVA ORS is specifically formulated for ALS patients, offering a flexible administration option - it can be taken orally or through a feeding tube. It comes in a small 5 mL dose, a portable bottle, an oral dosing syringe, and does not require refrigeration or reconstitution before use. With appropriate guidance from a healthcare provider (HCP), administering RADICAVA ORS may take only a few minutes on treatment days. It is recommended to take RADICAVA ORS in the morning after fasting overnight.

Key Market Players

• Sanofi S.A.
• Brainstorm Cell Therapeutics Inc.
• Biogen Inc.
• Bausch Health Cos Inc.
• F Hoffmann-la Roche Ltd
• Ionis Pharmaceuticals
• Mylan Pharma Inc.
• Sun Pharmaceutical Industries Inc
• Orion Pharma A/S
• AB Science SA
  
  

Report Scope:

In this report, the Global Amyotrophic Lateral Sclerosis (ALS) Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Amyotrophic Lateral Sclerosis (ALS) Market, By Drug Type:

o   Rilutek (Riluzole)

o   Edaravone (Radicava)

• Amyotrophic Lateral Sclerosis (ALS) Market, By Treatment Type:

o   Physical Therapy

o   Speech Therapy

o   Medication

o   Respiratory Therapy

o   Others

• Amyotrophic Lateral Sclerosis (ALS) Market, By End-User:

o   Hospitals & Clinics

o   Research and Academic institutes

o   Others

• Amyotrophic Lateral Sclerosis (ALS) Market, By region:

o   North America

§  United States

§  Canada

§  Mexico

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Australia

§  Japan

o   Europe

§  Germany

§  France

§  United Kingdom

§  Spain

§  Italy

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Amyotrophic Lateral Sclerosis (ALS) Market.

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Global Amyotrophic Lateral Sclerosis (ALS) Market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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