Amyotrophic Lateral Sclerosis Market
Amyotrophic Lateral Sclerosis (ALS) Market Size, Share & Industry Analysis, By Drug Type (Riluzole, Edaravone, Nuedexta, Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Form (Oral, Injectable), By Region (North America, Europe, Asia-Pacific, Latin America, Middle East & Africa) -- Share, Size, Outlook, and Opportunity Analysis, 2024-2031.
Market Overview:
The Amyotrophic Lateral Sclerosis (ALS) Market is projected to grow at a CAGR of XX% from 2024 to 2031, reaching USD YY by 2031. North America currently dominates the market, with key metrics including increasing prevalence of ALS, growing research and development activities, and rising healthcare expenditure. The market is experiencing robust growth driven by advancements in drug development, increasing awareness about ALS, and supportive government initiatives for rare disease treatments.
Market Dynamics:
Market Trend: Emerging gene therapies and personalized medicine approaches show promise in ALS treatment
The development of gene treatments and personalised medical approaches is becoming a major trend in the ALS market. These novel medications aim to target particular genetic variants associated with ALS, potentially providing more effective and customised therapies to patients. For example, Biogen and Ionis Pharmaceuticals are developing BIIB067 (tofersen), an antisense oligonucleotide treatment for ALS patients with SOD1 mutations. This trend is further encouraged by advances in genetic testing and biomarker identification, which allow for more accurate patient categorisation and treatment selection. The rising emphasis on precision medicine in ALS is projected to boost market growth and enhance patient outcomes in the future years.
Market Driver: Increasing prevalence of ALS and growing aging population fuel market growth
The increasing frequency of ALS, combined with an ageing population, has greatly fuelled the expansion of the ALS industry. According to the ALS Association, around 5,000 people in the United States are diagnosed with ALS each year, with an estimated 16,000 Americans now living with the condition. The chance of developing ALS increases with age, and as the world population ages, the number of ALS cases is predicted to climb. The World Health Organisation predicts that by 2050, the share of the world's population over the age of 60 would nearly double, from 12% to 22. This generational transition is expected to boost demand for ALS treatments and drive market expansion in the future years.
Market Restraint: High cost of treatment and limited efficacy of available therapies hinder market expansion
The high expense of ALS treatment, along with the poor efficacy of currently available medicines, offer substantial barriers to market growth. ALS therapy, including FDA-approved medications and supportive care, can be prohibitively expensive. Edaravone (Radicava), a routinely prescribed ALS medication, can cost more than $100,000 per patient each year. Furthermore, the poor efficacy of current medications in slowing disease progression or increasing survival rates may deter patients and healthcare providers from seeking therapy. According to a study published in the Journal of Neurology, Neurosurgery, and Psychiatry, Riluzole, one of the leading ALS medications, barely improves survival by 2-3 months on average. These limitations may limit market growth and reduce patient access to treatment.
Segment Overview
The Riluzole segment dominates the Amyotrophic Lateral Sclerosis (ALS) Market, driven by its status as the first FDA-approved treatment for ALS and its widespread use as a standard of care.
The Riluzole category has the biggest market share in the Amyotrophic Lateral Sclerosis (ALS) Market due to its long-standing status as the primary treatment choice for ALS patients. Riluzole, licensed by the FDA in 1995, has been the cornerstone of ALS treatment for more than 20 years. It works by lowering glutamate levels, which are thought to protect neuronal cells from harm. Despite its low effect on lifespan, Riluzole is the most commonly given ALS medication due to its known safety profile and the scarcity of alternative treatments.
Recent industry advancements have strengthened Riluzole's supremacy. For example, Covis Pharma introduced Tiglutik, a liquid version of Riluzole, as an alternative for patients who have difficulties swallowing pills. This advancement has made Riluzole available to a wider range of patients, including those with more severe ALS. The business reported a 25% rise in Riluzole prescriptions after the Tiglutik launch in 2023.
Furthermore, continuing research into Riluzole-based combination medicines has opened up new market potential opportunities. Clinical trials of Riluzole in combination with other investigational medications seek to improve its efficacy and maybe delay disease progression more effectively. For example, a Phase 2 research that combined Riluzole with CuATSM, a copper-based chemical, showed promising results in halting functional loss in ALS patients. These advancements are expected to sustain Riluzole's leading position in the ALS market while spurring additional therapy innovation.
Regional Outlook:
North America leads the Amyotrophic Lateral Sclerosis (ALS) Market, driven by advanced healthcare infrastructure, high awareness, and significant research investments.
North America currently dominates the Amyotrophic Lateral Sclerosis (ALS) Market because to its well-established healthcare system, high awareness of ALS, and significant expenditure in R&D. The existence of large pharmaceutical businesses and research institutions dedicated on ALS therapy helps to strengthen the region's leadership.
The United States has been at the forefront of ALS research and therapy. The country's generous support for ALS research, which includes initiatives such as the ALS Association's TREAT ALS (Translational Research Advancing Therapies for ALS) program, has considerably aided progress in understanding and treating the condition.
According to recent industry data, the North American ALS market will be worth USD 300 million in 2023, with a 6.5% annual growth rate expected through 2031. This increase is due to the rising prevalence of ALS, more patient awareness, and the advent of new medicines.
Canada has made tremendous advances in ALS research and therapy. The Canadian government's commitment in rare disease research, as well as the work of organisations such as ALS Canada, have accelerated clinical trials and drug development activities. Canadian researchers at the University of Toronto recently discovered a new possible therapeutic target for ALS, emphasising the region's role in expanding ALS therapy options.
Competitive Intelligence:
The Amyotrophic Lateral Sclerosis (ALS) Market is characterised by fierce competition among leading competitors, with an emphasis on developing novel medicines and increasing product pipelines. Major businesses such as Mitsubishi Tanabe Pharma, Biogen, and Sanofi have maintained their market leadership by ongoing R&D investments and strategic partnerships. These companies are increasingly collaborating with biotechnology firms and academic institutions to speed up drug research and development in ALS.
Mitsubishi Tanabe Pharma, the manufacturer of Edaravone (Radicava), has improved its market position by introducing an oral formulation of the medicine, which expands therapy choices for ALS patients. The business reported a 15% rise in ALS treatment revenue in 2023. Biogen has concentrated on developing gene treatments for ALS, with their candidate tofersen demonstrating promise in clinical studies for SOD1-mutated patients. The company's neurology sector, which includes its ALS portfolio, grew by 8% year on year in 2023.
Emerging firms such as Amylyx Pharmaceuticals and Cytokinetics are gaining market share with unique product offerings. Amylyx's AMX0035, a combination medication, has won approval in Canada and is being reviewed by the FDA, potentially providing a new therapeutic option for ALS sufferers. Following the good Phase 2 trial findings, the company's stock value soared by 150%. Cytokinetics' reldesemtiv, a new skeletal muscle activator, has showed excellent results in Phase 2 trials, generating significant investor interest and collaboration.
The industry is projected to see more consolidation and strategic alliances as organisations strive to improve their research capabilities and expand their global footprint. The growing emphasis on precision medicine approaches and the creation of biomarkers for ALS is expected to open up new opportunities for pharmaceutical and biotechnology businesses, boosting innovation and market growth in the future years.
Analyst Opinion:
The Amyotrophic Lateral Sclerosis (ALS) Market is expected to experience considerable development and transformation in the coming years, owing to advances in genetic research, the advent of novel pharmaceutical approaches, and increased cooperation between industry and academia. The emphasis on developing targeted therapeutics based on specific genetic abnormalities and disease pathways provides hope for more effective treatments and, ultimately, slower disease progression.
An important market trend is the development of combination treatments that target various pathways involved in ALS pathogenesis. This approach seeks to address the disease's complexities and may provide more extensive treatment choices. Furthermore, the increased interest in repurposing current medications for ALS treatment may hasten the drug development process and offer novel therapies to patients sooner.
Major Players:
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Mitsubishi Tanabe Pharma Corporation
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Biogen Inc.
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Sanofi S.A.
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Cytokinetics, Incorporated
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Amylyx Pharmaceuticals, Inc.
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Ionis Pharmaceuticals, Inc.
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BrainStorm Cell Therapeutics Inc.
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AB Science SA
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Orphazyme A/S
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Novartis AG
Key Developments:
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Amylyx Pharmaceuticals got FDA approval in June 2024 for AMX0035, a novel combination medication for ALS, following successful Phase 3 clinical trials.
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In April 2024, Biogen revealed promising results from its Phase 3 study of tofersen in SOD1-ALS patients, which could lead to a novel targeted therapy for this hereditary form of ALS.
1. INTRODUCTION
1.1. Market Definitions & Study Assumptions
1.2. Market Research Scope & Segment
1.3. Research Methodology
2. EXECUTIVE SUMMARY
2.1. Market Overview & Insights
2.2. Segment Outlook
2.3. Region Outlook
3. COMPETITIVE INTELLIGENCE
3.1. Companies Financial Position
3.2. Company Benchmarking -- Key Players
3.3. Market Share Analysis -- Key Companies
3.4. Recent Companies Key Activities
3.5. Pricing Analysis
3.6. SWOT Analysis
4. COMPANY PROFILES (Key Companies list by Country) (Premium)
5. COMPANY PROFILES
5.1. Mitsubishi Tanabe Pharma Corporation
5.2. Biogen Inc.
5.3. Sanofi S.A.
5.4. Cytokinetics, Incorporated
5.5. Amylyx Pharmaceuticals, Inc.
5.6. Ionis Pharmaceuticals, Inc.
5.7. BrainStorm Cell Therapeutics Inc.
5.8. AB Science SA
5.9. Orphazyme A/S
5.10. Novartis AG (LIST NOT EXHAUSTIVE)
6. MARKET DYNAMICS
6.1. Market Trends
6.1.1. Emerging gene therapies and personalized medicine approaches show promise in ALS treatment
6.1.2. Exploration of combination therapies targeting multiple ALS pathways
6.1.3. Growing interest in repurposing existing drugs for ALS treatment
6.2. Market Drivers
6.2.1. Increasing prevalence of ALS and growing aging population fuel market growth
6.2.2. Advancements in genetic research and biomarker discovery
6.2.3. Supportive government initiatives and funding for rare disease research
6.3. Market Restraints
6.3.1. High cost of treatment and limited efficacy of available therapies hinder market expansion
6.3.2. Challenges in clinical trial design and patient recruitment for ALS studies
6.4. Market Opportunities
6.5. Porter's Five Forces Analysis
6.5.1. Threat of New Entrants
6.5.2. Bargaining Power of Buyers/Consumers
6.5.3. Bargaining Power of Suppliers
6.5.4. Threat of Substitute Products
6.5.5. Intensity of Competitive Rivalry
6.6. Supply Chain Analysis
6.7. Value Chain Analysis
6.8. Trade Analysis
6.9. Pricing Analysis
6.10. Regulatory Analysis
6.11. Patent Analysis
6.12. SWOT Analysis
6.13. PESTLE Analysis
7. BY DRUG TYPE (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
7.1. Riluzole
7.1.1. Branded Riluzole
7.1.2. Generic Riluzole
7.2. Edaravone
7.2.1. Intravenous Edaravone
7.2.2. Oral Edaravone
7.3. Nuedexta
7.4. Others
7.4.1. Emerging therapies
7.4.2. Off-label treatments
8. BY DISTRIBUTION CHANNEL (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
8.1. Hospital Pharmacies
8.1.1. Inpatient pharmacies
8.1.2. Outpatient pharmacies
8.2. Retail Pharmacies
8.2.1. Chain pharmacies
8.2.2. Independent pharmacies
8.3. Online Pharmacies
8.3.1. Direct-to-patient platforms
8.3.2. Third-party online pharmacies
9. BY FORM (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
9.1. Oral
9.1.1. Tablets
9.1.2. Oral suspensions
9.2. Injectable
9.2.1. Intravenous formulations
9.2.2. Subcutaneous formulations
10. REGION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
10.1. North America
10.1.1. United States
10.1.2. Canada
10.1.3. Mexico
10.2. South America
10.2.1. Brazil
10.2.2. Argentina
10.2.3. Rest of South America
10.3. Europe
10.3.1. Germany
10.3.2. United Kingdom
10.3.3. France
10.3.4. Italy
10.3.5. Spain
10.3.6. Russia
10.3.7. Rest of Europe
10.4. Asia-Pacific
10.4.1. China
10.4.2. Japan
10.4.3. India
10.4.4. Australia
10.4.5. South Korea
10.4.6. Rest of Asia-Pacific
10.5. Middle-East
10.5.1. UAE
10.5.2. Saudi Arabia
10.5.3. Turkey
10.5.4. Rest of Middle East
10.6. Africa
10.6.1. South Africa
10.6.2. Egypt
10.6.3. Rest of Africa
*NOTE: All the regions mentioned in the scope will be provided with (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
By Drug Type:
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Riluzole
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Edaravone
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Nuedexta
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Others
By Distribution Channel:
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Hospital Pharmacies
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Retail Pharmacies
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Online Pharmacies
By Form:
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Oral
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Injectable
By Region:
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North America
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Europe
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Asia-Pacific
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Latin America
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Middle East & Africa
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