Amyotrophic Lateral Sclerosis (ALS) – Opportunity Analysis and Forecasts to 2029

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

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Generic Erosion

11.3.9 Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.4.1 KOLs

11.4.2 Payers

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Managing Analyst

11.6.3 Therapy Area Director

11.6.4 Epidemiologist

11.6.5 Managing Epidemiologists

11.6.6 Global Director of Therapy Analysis and Epidemiology

11.6.7 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

Table 1: ALS: Key Metrics in the 8MM

Table 2: Genes Involved in the Familial Forms of ALS

Table 3: Symptoms of ALS

Table 4: Risk Factors and Comorbidities for ALS

Table 5: Leading Treatments for ALS, 2020

Table 6: Treatment Guidelines for ALS

Table 7: Comparison of Therapeutic Classes in Development for ALS, 2019-2029

Table 8: Innovative Early-Stage Approaches for ALS, 2020

Table 9: Clinical Benchmark of Key Pipeline Drugs – ALS

Table 10: Commercial Benchmark of Key Pipeline Drugs – ALS

Table 11: Commercial Benchmark of Key Pipeline Drugs – ALS

Table 12: Key Events Impacting Sales for ALS, 2019-2029

Table 13: ALS Market – Global Drivers and Barriers, 2019-2029

Table 14: Key Historical and Projected Launch Dates for ALS

Table 15: Key Historical and Projected Patent Expiry Dates for ALS

Table 16: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figure 1: Global Sales Forecast by Country for ALS in 2019 and 2029

Figure 2: Competitive Assessment of Marketed and Pipeline Drugs, Benchmarked Against the SOC, Rilutek

Figure 3: Pathophysiology of ALS

Figure 4: Staging Systems for ALS

Figure 5: 8MM, Total Prevalence of ALS (%), Both Sexes, Ages ≥40 Years, 2019

Figure 6: 8MM, Diagnosed Prevalence of ALS, Both Sexes, Ages ≥40 Years, 2019

Figure 7: 8MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of ALS

Figure 8: 8MM, Sources Used to Forecast the Total and Diagnosed Prevalent Cases of ALS by Type

Figure 9: 8MM, Total Prevalent Cases of ALS, N, Both Sexes, Ages ≥40 Years, 2019

Figure 10: 8MM, Total Prevalent Cases of ALS, N, by Sex, Ages ≥40 Years, 2019

Figure 11: 8MM, Total Prevalent Cases of ALS by Age, N, Both Sexes, 2019

Figure 12: 8MM, Total Prevalent Cases of ALS by Type, N, Both Sexes, Ages ≥40 Years, 2019

Figure 13: 8MM, Diagnosed Prevalent Cases of ALS, N, Both Sexes, Ages ≥40 Years, 2019

Figure 14: 8MM, Diagnosed Prevalent Cases of ALS, N, by Sex, Ages ≥40 Years, 2019

Figure 15: 8MM, Diagnosed Prevalent Cases of ALS by Age, N, Both Sexes, 2019

Figure 16: 8MM, Diagnosed Prevalent Cases of ALS by Type, N, Both Sexes, Ages ≥40 Years, 2019

Figure 17: Unmet Needs and Opportunities in ALS

Figure 18: Overview of the Development Pipeline in ALS

Figure 19: Key Phase IIb and III Trials for Promising Pipeline Agents in ALS

Figure 20: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Rilutek

Figure 21: Global (8MM) Sales Forecast by Country for ALS in 2019 and 2029

Figure 22: Sales Forecast by Class for ALS in the US in 2019 and 2029

Figure 23: Sales Forecast by Class for ALS in the 5EU in 2019 and 2029

Figure 24: Sales Forecast by Class for ALS in Japan in 2019 and 2029

Figure 25: Sales Forecast by Class for ALS in Canada in 2019 and 2029