Ultra Market Research | United States Amyotrophic Lateral Sclerosis Market
United States Amyotrophic Lateral Sclerosis Market
Report ID : 1182
Category : United-States(US)
No Of Pages : 146
Published on: July 2025
Status: Published
Format :
Key Question Answer
Global Market Outlook
In-depth analysis of global and regional trends
Analyze and identify the major players in the market, their market share, key developments, etc.
To understand the capability of the major players based on products offered, financials, and strategies.
Identify disrupting products, companies, and trends.
To identify opportunities in the market.
Analyze the regional penetration of players, products, and services in the market.
Comparison of major players financial performance.
Evaluate strategies adopted by major players.
Recommendations
Introduction
Lou Gehrig's disease, or amyotrophic lateral sclerosis (ALS), is a progressive neurodegenerative disease that damages motor neurones, resulting in muscle weakness, paralysis, and eventually respiratory failure. The market for ALS in the United States includes supportive therapies, diagnostic equipment, and pharmaceutical treatments (such as tofersen, edaravone, and riluzole). Stronger drug pipelines, increased approval of gene-targeted and combination therapies (such as Relyvrio and Qalsody/tofersen), and a rise in the use of diagnostics and personalised care are some of the recent trends. Depending on its size, the total U.S. ALS therapeutics market was projected to be worth between USD 345 and USD 920 million in 2023; according to IMARC, the U.S. is the largest of the seven markets. More than 70% of the value of therapies worldwide is found in North America, where early diagnosis, research funding,and high-priced therapies.
Market Segmentation
By Treatment Type
Medication
Riluzole
Edaravone
Other medications
Gene & Antisense Therapy
Tofersen (Qalsody) for SOD1‑ALS
Others in development
Stem‑Cell Therapy
Mesenchymal stem cells
Neural progenitor cells
Others
Supportive Care
Respiratory therapy
Physical therapy
Speech & nutritional therapy
Others
By Distribution Channel
Hospital pharmacies
Inpatient dispensaries
Specialty hospital outpatient centers
Retail pharmacies
Chain pharmacies
Independent pharmacies
Online/mail‑order pharmacies
Long‑term care facilities
Skilled nursing
Hospice
Home infusion services
Others
By End‑User Facility
Hospitals & medical centers
Neuromuscular clinics
Diagnostic centers
Home‑care providers
Others
Key Market Players
Mitsubishi Tanabe Pharma Corporation (Japan)
Biogen Inc. (USA)
Amylyx Pharmaceuticals, Inc. (USA)
Ionis Pharmaceuticals, Inc. (USA)
BrainStorm Cell Limited (Israel)
Cytokinetics Inc. (USA)
Eledon Pharmaceuticals, Inc. (USA)
Revalesio Corporation (USA)
Sanofi (France)
F. Hoffmann‑La Roche Ltd (Switzerland)
Otsuka Pharmaceutical Co., Ltd. (Japan)
Corestem, Inc. (USA)
Ascend Laboratories LLC (USA)
Sun Pharmaceutical Industries Ltd. (India)
Treeway B.V. (Netherlands)
Drivers The market for amyotrophic lateral sclerosis in the United States is driven by a number of important factors, including an ageing population's increasing incidence and prevalence, increased advocacy and awareness of the disease (such as through funding from ALS associations), robust reimbursement frameworks (such as Medicare coverage), and active research and development that results in the approval of new therapies. With an incidence of about 5 per 100,000 people in the US, ALS calls for early diagnosis and treatment initiation . Investments are further boosted by the FDA's orphan drug incentives, expedited approval processes, and expanding pipeline, which now includes more than 30 candidates. Innovation and market readiness have also increased as a result of partnerships between pharmaceutical companies and academic institutions.
Restraints However, there are obstacles to growth. Financing ALS is challenging due to the high costs of drug development and low success rates. Significant regulatory obstacles still exist; even treatments with accelerated approval, like Tofersen, need confirmatory testing. Due to the market's small patient base, commercial scope is limited, and ROI is marginal for smaller firms. Furthermore, payers oppose expensive treatments like Relyvrio; Cigna recently limited coverage because of its questionable effectiveness and high annual cost of almost USD 158,000. Accessibility problems still exist, particularly in underprivileged areas, and patient recruitment and long-term clinical trial design are made more difficult by the disease's quick progression.
Opportunity
United States Amyotrophic Lateral Sclerosis Market opportunities involve advances in personalized and genotype-directed treatments—particularly gene therapies and antisense products such as Tofersen. Stem-cell and regenerative medicine hold promise for neuroprotection and functional restoration effects . Ancillary services associated with diagnostics (early biomarker tests, genetic screening) should expand with more targeted disease management frameworks. In addition, expanding tele-medicine and tele-pharmacy devices can increase reach, especially in the rural regions, support medication compliance and ongoing care. Finally, secondary markets—long-term care, palliative, home-intervention devices—will develop together with prolonged survival through new therapy.
Trends
Current trends in the United States Amyotrophic Lateral Sclerosis Market indicate a transition from traditional medications to precision medicine: Tofersen received FDA approval in April 2023 as the first SOD1-targeted oligonucleotide (en.wikipedia.org). While Relyvrio approval (Sept 2022) was withdrawn in 2024 following Phase III failures. Accelerated pathways by FDA are becoming more frequent in ALS, an indicator of pressing treatment demands. Hospital-to-home transitions of care through telehealth are increasing, offering improved distant monitoring and decreased inpatient load. Vertical integration of pharma and clinics for recruitment into trials is enhancing trial efficiency. Furthermore, patient ventures like PatientsLikeMe bring real-world feedback, influencing regulatory and commercial strategies
Other antisense & gene therapies targeting C9orf72, FUS, etc.
Key Target Audience
Pharmaceutical & biotech companies
Investors & venture capitalists
Regulatory & health authorities
Neurology clinics & hospitals
ALS advocacy organizations
Contract research organizations & CROs
Market research firms
Insurance & payer entities
Diagnostic & genetic testing centers
Homecare and long-term care providers
The U.S. ALS therapeutics market was around USD 920 million in 2023, with projected multi‑billion‑dollar growth by 2030s.
Approved therapies include Riluzole, Edaravone (Radicava), and Tofersen (Qalsody).
Key hurdles include drug development costs, small patient population, regulatory delays, and payor pushback on pricey treatments
It’s an antisense oligonucleotide targeting mutant SOD1 mRNA, approved under FDA’s accelerated pathway in April 2023 for SOD1-ALS.
Upcoming treatments include AMX0035, combination therapies (e.g., masitinib + riluzole), stem-cell options, and gene-targeted antisense treatments.
1. Introduction
1.1 Report Description 1.2 Research Methodology
1.2.1 Data Mining
1.2.2 Market Modeling and Forecasting
1.2.3 Data Validation
1.2.4 Industry Analysis
2. Market Dashboard
3. Market Overview
3.1 Market Definition and Scope 3.2 Market Segmentation
3.2.1 By Treatment Types
3.2.2 By Patient Demographics
3.2.3 By Distribution Channels
3.2.4 By Therapeutic Applications 3.3 Market Dynamics
3.3.1 Drivers
3.3.2 Restraints
3.3.3 Opportunities
3.3.4 Challenges
4. United States Amyotrophic Lateral Sclerosis Market by Treatment Types
4.1 Introduction 4.2 Market Size and Growth Rate by Treatment Types (2024–2030)
4.2.1 Medications
4.2.1.1 Riluzole
4.2.1.2 Edaravone
4.2.1.3 Other Medications
4.2.2 Gene & Antisense Therapies
4.2.2.1 Tofersen
4.2.2.2 Other Genetic Therapies
4.2.3 Stem Cell Therapies
4.2.3.1 Mesenchymal Stem Cells
4.2.3.2 Neural Stem Cells
4.2.3.3 Others
4.2.4 Supportive and Palliative Care
4.2.4.1 Respiratory Therapy
4.2.4.2 Speech and Physical Therapy
4.2.4.3 Nutritional Support
5. United States Amyotrophic Lateral Sclerosis Market by Patient Demographics
5.1 Introduction 5.2 Market Size and Growth Rate by Patient Demographics (2024–2030)
5.2.1 Children
5.2.1.1 Infants
5.2.1.2 Toddlers and Young Children
5.2.2 Adults
5.2.2.1 Young Adults
5.2.2.2 Seniors
6. United States Amyotrophic Lateral Sclerosis Market by Distribution Channels
6.1 Introduction 6.2 Market Size and Growth Rate by Distribution Channels (2024–2030)
6.2.1 Hospital Pharmacies
6.2.1.1 ALS Specialty Clinics
6.2.1.2 Tertiary Medical Centers
6.2.2 Retail Pharmacies
6.2.2.1 Local Pharmacies
6.2.2.2 Chain Pharmacies
6.2.3 Online Pharmacies
6.2.3.1 eCommerce Platforms
6.2.3.2 Home Delivery Services
7. United States Amyotrophic Lateral Sclerosis Market by Therapeutic Applications
7.1 Introduction 7.2 Market Size and Growth Rate by Therapeutic Applications (2024–2030)
7.2.1 First-Line Treatment
7.2.1.1 Medication-Based Regimens
7.2.1.2 Targeted Genetic Therapies
7.2.2 Relapse or Refractory ALS
7.2.2.1 Experimental Drug Therapies
7.2.2.2 Cell-Based Interventions
7.2.2.3 Assistive Technology & Palliative Tools
8. Competitive Landscape
8.1 Company Profiles
8.1.1 Amgen Inc. (United States)
8.1.2 Novartis AG (Switzerland)
8.1.3 Pfizer Inc. (United States)
8.1.4 Gilead Sciences (United States)
8.1.5 Kite Pharma (United States)
8.1.6 Takeda Pharmaceutical Company (Japan)
8.1.7 Bristol-Myers Squibb (United States)
8.1.8 Jazz Pharmaceuticals (Ireland)
8.1.9 AbbVie Inc. (United States)
8.1.10 Sanofi (France)
8.1.11 Autolus Therapeutics (United Kingdom)
8.1.12 Cellectis (France)
8.1.13 Allogene Therapeutics (United States)
8.1.14 Celgene Corporation (United States)
8.1.15 Eli Lilly and Company (United States) Each Profile Includes: • Business Overview • Product Portfolio • Strategic Developments • Financial Overview
9. Conclusion and Recommendations
10. Appendix
10.1 List of Tables
Table United States Amyotrophic Lateral Sclerosis Market Size by Treatment Types (2024–2030)
Table Medications Market Size by Sub-Type (2024–2030)
Table Gene & Antisense Therapies Market Size by Sub-Type (2024–2030)
Table Stem Cell Therapies Market Size by Sub-Type (2024–2030)
Table Supportive and Palliative Care Market Size by Sub-Type (2024–2030)
Table United States Amyotrophic Lateral Sclerosis Market Size by Patient Demographics (2024–2030)
Table Children Market Size by Sub-Type (2024–2030)
Table Adults Market Size by Sub-Type (2024–2030)
Table United States Amyotrophic Lateral Sclerosis Market Size by Distribution Channels (2024–2030)
Table Hospital Pharmacies Market Size by Sub-Type (2024–2030)
Table Retail Pharmacies Market Size by Sub-Type (2024–2030)
Table Online Pharmacies Market Size by Sub-Type (2024–2030)
Table United States Amyotrophic Lateral Sclerosis Market Size by Therapeutic Applications (2024–2030)
Table First-Line Treatment Market Size by Sub-Type (2024–2030)
Table Relapse or Refractory ALS Market Size by Sub-Type (2024–2030)
Table Financial Overview of Key Companies
10.2 List of Figures
Figure United States ALS Market Size and Growth Rate by Treatment Types (2024–2030)
Figure Medications Market Growth Rate by Sub-Type (2024–2030)
Figure Gene & Antisense Therapies Growth Rate by Sub-Type (2024–2030)
Figure Stem Cell Therapy Market Growth by Sub-Type (2024–2030)
Figure Supportive Care Market Growth Rate by Sub-Type (2024–2030)
Figure Market Size and Growth Rate by Patient Demographics (2024–2030)
Figure Children Segment Growth Rate by Sub-Type (2024–2030)
Figure Adults Segment Growth Rate by Sub-Type (2024–2030)
Figure ALS Market Size by Distribution Channels (2024–2030)
Figure Hospital Pharmacies Growth Rate by Sub-Type (2024–2030)
Figure Retail Pharmacies Growth Rate by Sub-Type (2024–2030)
Figure Online Pharmacies Growth Rate by Sub-Type (2024–2030)
Figure ALS Market Size by Therapeutic Applications (2024–2030)
Figure First-Line vs Refractory ALS Therapy Growth Rate Comparison
Research Methodology
The process of market research at Ultra Market Research is an iterative in application and usually follows following path. Information from secondary used to build data models, then results from data models are validated from primary participants. Then cycle repeats where, according to inputs from primary participants, additional secondary research is done, and new Information is again incorporated into data model. The process continues till desired level of Information is not generated
To calculate the market size, the report considers the revenue generated from the sales of Ultra Market Research providers. The revenue generated from the sales of Ultra Market Research has been calculated through primary and secondary research. The report also presents the key players operating in the Ultra Market Research market across the globe identified through secondary research and a corresponding detailed analysis of the top vendors in the market. The market size calculation also includes distribution channel segmentation determined using secondary sources and verified through primary sources.
Secondary Research
The secondary research source that are typically referred to include, but are not limited to:
Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings
Internal and external proprietary databases, relevant patent and regulatory databases
National government documents, statistical databases and market reports
News articles, press releases and web-casts specific to the companies operating in the market
The source for secondary research includes but is not limited to: Factiva, Hoovers and Statista
Inner Circle Represents – Stage of Research Process
Middle Circle Represents – Source of Information
Outer Circle Represents – Information Derived from that source
Primary Research We conduct primary interviews on an ongoing basis with industry participants and commentators in order to validate data and analysis. A typical research interview fulfills the following functions:
It provides first-hand Information on the market size, market trends, growth trends, competitive landscape, future outlook etc.
Helps in validating and strengthening the secondary research findings
Further develops the analysis team’s expertise and market understanding
Primary research involves E-mail interactions, telephonic interviews as well as face-to-face interviews for each market, category, segment and sub-segment across geographies
The participants who typically take part in such a process include, but are not limited to:
Industry participants: CEOs, VPs, marketing/ distribution channel managers, market intelligence managers and national sales managers
Purchasing managers, technical personnel, distributors and resellers
Outside experts: Investment bankers, valuation experts, research analysts specializing in specific markets
Key opinion leaders specializing in different areas corresponding to different industry distribution channels
Models Where no hard data is available, we use modeling and estimates in order to produce comprehensive data sets. A rigorous methodology is adopted in which the available hard data is cross referenced with the following data distribution channels to produce estimates:
Demographic data: Population split by segment
Macro-economic indicators: GDP, etc.
Industry indicators: Expenditure, distribution channel stage & infrastructure, sector growth and facilities.
Data is then cross checked by the expert panel.
2..1 Company Share Analysis Model
Company share analysis is used to derive the size of Global market. As well as study of revenues of companies for last three to five years also provide the base for forecasting the market size and its growth rate. This model is built in following steps: 2..2 Revenue Based Modeling
Revenue based models can be built in two ways – Top-Down or Bottom-Up irrespective of industry. Market size estimated from company share analysis acts as a validation point for bottom-up approach where as it acts as starting point for top-down approach.
2.1 Research Limitations Inflation is not a part of pricing in this report. Prices ofUnited States Amyotrophic Lateral Sclerosis Market and its derivatives vary in each region and hence similar revenue ratio does not follow for each individual region. The same price for each distribution channel has been taken into account while estimating and forecasting market revenue Globally. Regional average price has been considered while breaking down this market by application in each region. This report provides market size of CANOMAD syndrome Market for the past year and forecasts for the next six years.United States Amyotrophic Lateral Sclerosis Marketsize is given in terms of revenue. Market revenue is defined in USD Million. Market numbers are given on the basis of differentUnited States Amyotrophic Lateral Sclerosis Marketcategories. Market size and forecasts for each major application is provided in the context of Global market. The numbers provided in this report are derived on the basis of demand forUnited States Amyotrophic Lateral Sclerosis Marketfrom different application industries in different regions.
