Amyotrophic Lateral Sclerosis (ALS) Markets - $1.04 Billion Opportunity Analysis and Forecasts to 2029: Biogen, Mitsubishi, and BrainStorm are Forecast to Lead the ALS Market -

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Global sales in the ALS market are expected to grow to $1.04B by 2029, at a Compound Annual Growth Rate (CAGR) of 13.9%.

Amyotrophic Lateral Sclerosis (ALS) is a motor neuron degenerative disease which affects both upper motor neurons (UMN) and lower motor neurons (LMN). It is a progressive disease, with patients becoming increasingly dependent on carers and physicians as time from onset increases, and ultimately, it is fatal. ALS can be split into two origins, hereditary - which is known as FALS (Familial ALS) or idiopathic - known as SALS (sporadic ALS).

ALS current treatment includes only two disease-modifying drugs: Sanofi's Rilutek (riluzole) and Mitsubishi Tanabe's Radicava/Radicut (edaravone). Two reformulations of riluzole were approved recently: ITF Pharma's Tiglutik (riluzole oral suspension) in 2018 and Aquestive Therapeutics' Exservan (riluzole oral film) in 2019.

Both reformulations address problems of advanced-stage ALS patients who have difficulty in swallowing (dysphagia). Tiglutik is the first liquid formulation of riluzole to launch in the market; it can also be administrated via percutaneous endoscopic gastrostomy tubes (PEG-tubes), while Exservan is a thin oral film that dissolves on the tongue without the need of any muscle action.

Estimates forecast that sales of drugs in the ALS market were approximately $282M in 2019 in the 8MM. The US was the largest market, with sales of $197M, representing 70% of all sales from the 8MM. The highest-selling drug in the market was Mitsubishi's Radicava (edaravone), a free radical scavenger, which generated sales of $162M in the 8MM in 2019.

Key Highlights

  • Currently, the only treatment options for ALS are Rilutek (8MM) and Radicava/Radicut (US, Japan, and Canada), neither of which can stop nor significantly slow the progression of the disease. At best, these drugs may increase a patient's life span by up to six months.
  • Nine late stage pipeline drugs will launch over the forecast period. These drugs will be used as adjunctive therapies to Rilutek, Tiglutik, Exservan, and Radicava. They aim to address some of the longstanding clinical unmet needs and are expected to be the main driver of growth in the ALS market across the 8MM.
  • Biogen's BIIB067 (tofersen) antisense therapy is forecast to be a major player in the ALS market; due to its high ACOT despite its limited patient pool.
  • There are few therapies in the pipeline that aim at addressing major unmet needs, they will all have to translate promising Phase II results into Phase III successes, which KOLs have stated has been a stumbling block for previous therapies.
  • Opportunities are expected for pharmaceutical companies to develop drugs which have novel MOAs; which are potential curative agents, or extend patient survival more than the current SOC.


  • Overview of ALS, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized ALS therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in two patient segments (familial and sporadic) forecast from 2019 to 2029.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the ALS therapeutics market
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for ALS therapy. The most promising candidates in Phase IIb and Phase III development are profiled.
  • Analysis of the current and future market competition in the global ALS therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Topics Covered:

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Amyotrophic Lateral Sclerosis: Executive Summary

2.1 Global ALS Market Expected to Grow to $1.04B in 2029

2.2 Biogen, Mitsubishi, and BrainStorm Are Forecast to Lead the ALS Market By 2029

2.3 Unmet Need Will Remain for the Identification of Curative Drugs and Biomarkers

2.4 ALS Pipeline Moving Toward Disease-Modifying Drugs That Will Likely Transform Treatment Algorithm Especially for FALS Type

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification or Staging Systems

4.3 Symptoms

4.3.1 Complications

4.4 Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources Used

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for ALS (2019-2029)

5.5.1 Total Prevalent Cases of ALS

5.5.2 Sex-Specific Total Prevalent Cases of ALS

5.5.3 Age-Specific Total Prevalent Cases of ALS

5.5.4 Total Prevalent Cases of ALS by Type

5.5.5 Diagnosed Prevalent Cases of ALS

5.5.6 Sex-Specific Diagnosed Prevalent Cases of ALS

5.5.7 Age-Specific Diagnosed Prevalent Cases of ALS

5.5.8 Diagnosed Prevalent Cases of ALS by Type

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of the Analysis

5.6.3 Strengths of the Analysis

6 Current Treatment Options

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Curative Drugs

7.3 Earlier Diagnosis

7.4 Identification of Biomarkers Associated with ALS

7.5 Extended Patient Survival and Improved Control of Symptoms

8 R&D Strategies

8.1 Overview

8.1.1 Novel Targets

8.1.2 Disease-Modifying Biologic Therapies

8.1.3 Reformulations

8.2 Clinical Trials Design

8.2.1 Clinically Meaningful Endpoints

8.2.2 Clinical Trial Duration

8.2.3 Patient Recruitment

9 Pipeline Assessment

9.1 Overview

9.2 Innovative Early-Stage Approaches

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.2 Commercial Benchmark of Key Pipeline Drugs

10.3 Competitive Assessment

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

10.4.4 Canada

Companies Mentioned

  • Sanofi
  • Mitsubishi Tanabe
  • Brainstorm Therapeutics
  • Avanir
  • ViroMed
  • Ionis Pharmaceuticals
  • ViiV
  • GlaxoSmithKline
  • Biogen
  • Orphazyme
  • Orion Pharmaceuticals
  • Pfizer
  • Aquestive Therapeutics
  • Alexion
  • Amylyx
  • Neuralstem

For more information about this report visit

Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900