Amyotrophic Lateral Sclerosis: Opportunity Analysis and Forecast to 2027

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).

Currently there are only two drugs on the market that are approved for the treatment of ALS; Sanofi’s Rilutek (riluzole) and Mitsubishi Tanabe Pharma’s Radicava (edaravone). The drugs were special cases in terms of FDA approval, they did not meet the normal regulatory requirements for approval but due to the increase in survival of patients they were granted approval.

GlobalData estimates that drug sales for ALS in 2017 were approximately $203M across the seven major markets covered in this report. Over the 10-year forecast period, the market is expected to grow to $1.2B at a CAGR of 19.4%. This growth will be driven by the launch of six late-stage pipeline products. The two highest selling drugs are expected to be Brainstorm Therapeutics’ NurOwn and Aquestive Therapeutics’ Riluzole OSF, which both address some of the unmet needs in the market.

Key Questions Answered

What are the key ALS treatments in 2017?

When will the late stage pipeline products launch, and how will it affect drug sales and the overall ALS market in the 7MM?

Which unmet needs will remain unaddressed in the forecast period and what opportunities remain for pharmaceutical companies?

Scope

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 2017 to 2027.

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 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.

Reasons to buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Develop business strategies by understanding the trends shaping and driving the global ALS therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global ALS therapeutics market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Companies mentioned

Sanofi

Mitsubishi Tanabe

Brainstorm Therapeutics

ViroMed

Ionis Pharmaceuticals

Genevrone Biopharmaceuticals

Biogen

Orphazyme

Orion Pharmaceuticals

Kringle Pharma

Aquestive Therapeutics

Apotex

Valeant Pharmaceuticals

Neuralstem

Impicit Bioscience

Roche ...

Sanofi

Mitsubishi Tanabe

Brainstorm Therapeutics

ViroMed

Ionis Pharmaceuticals

Genevrone Biopharmaceuticals

Biogen

Orphazyme

Orion Pharmaceuticals

Kringle Pharma

Aquestive Therapeutics

Apotex

Valeant Pharmaceuticals

Neuralstem

Impicit Bioscience

Roche

Treeway BV

Cytokientics

AB Science

Concordia Healthcare Corp

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Amyotrophic Lateral Sclerosis: Executive Summary

2.1 ...

Table of Contents

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 Experience Explosive Growth by 2027

2.2 Pharmaceutical Companies Target Novel MOAs in a Market with Few Approved Therapies

2.3 Several Key Unmet Needs Identified in the ALS Market, Providing Opportunity for New Players

2.4 Several Different Classes in the ALS Pipeline Look to Fill the Gaps in the Market

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

5.3.1 US

5.3.2 5EU

5.3.3 Japan

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for ALS (2017–2027)

5.5.1 Diagnosed Prevalent Cases of ALS

5.5.2 Age-Specific Diagnosed Prevalent Cases of ALS

5.5.3 Sex-Specific Diagnosed Prevalent Cases of ALS

5.5.4 Diagnosed Prevalent Cases of ALS by Type

5.5.5 Total Prevalent Cases of ALS

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Current Treatment Options

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Faster Diagnosis

7.3 Curative Agent

7.4 Extended Patient Survival

7.5 Identification of Biomarkers Associated with ALS

8 R&D Strategies

8.1 Overview

8.1.1 Novel Targets

8.1.2 Disease-Modifying Therapies

8.1.3 Reformulations

8.2 Clinical Trials Design

8.2.1 Endpoints

8.2.2 Length of Clinical Trials

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

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 Therapy Area Director

11.6.3 Epidemiologist

11.6.4 Managing Epidemiologist

11.6.5 Global Director of Therapy Analysis and Epidemiology

11.6.6 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

List of Tables

Table 1: ALS: Key Metrics in the 7MM

Table 2: Gene Involved in the Familial Forms of ALS

Table 3: Symptoms of ALS

Table 4 ...

Table 1: ALS: Key Metrics in the 7MM

Table 2: Gene 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, 2018

Table 6: Treatment Guidelines for ALS

Table 7: Comparison of Therapeutic Classes in Development for ALS, 2017–2027

Table 8: Innovative Early-Stage Approaches for ALS, 2018

Table 9: Clinical Benchmark of Key Pipeline Drugs – ALS

Table 10: Commercial Benchmark of Key Pipeline Drugs – ALS

Table 11: Key Events Impacting Sales for ALS, 2017–2027

Table 12: ALS Market – Global Drivers and Barriers, 2017–2027

Table 13: Key Historical and Projected Launch Dates for ALS

Table 14: Key Historical and Projected Patent Expiry Dates for ALS

Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for ALS in 2017 and 2027

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

Figure 1: Global Sales Forecast by Country for ALS in 2017 and 2027

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

Figure 3: Overview of the human body and muscles involved in ALS

Figure 4: Pathophysiology of ALS

Figure 5: Staging Systems for ALS

Figure 6: 7MM, Age-Standardized Diagnosed Prevalence of ALS, Ages ≥40 Years, 2017

Figure 7: Sources Used for Diagnosed Prevalent Cases of ALS

Figure 8: Sources Used for Diagnosed Prevalent Cases of ALS Type

Figure 9: 7MM, Diagnosed Prevalent Cases of ALS, Men and Women, Ages ≥40 Years, 2017

Figure 10: 7MM, Age-Specific Diagnosed Prevalent Cases of ALS, Men and Women, 2017

Figure 11: 7MM, Sex-Specific Diagnosed Prevalent Cases of ALS, Men and Women, Ages ≥40 Years, 2017

Figure 12: 7MM, Diagnosed Prevalent Cases of ALS by Type, Men and Women, Ages ≥40 Years, 2017

Figure 13: 7MM, Total Prevalent Cases of ALS, Men and Women, Ages ≥40 Years, 2017

Figure 14: Unmet Needs and Opportunities in ALS

Figure 15: Overview of the Development Pipeline in ALS

Figure 16: Key Phase II and III Trials for Promising Pipeline Agents

Figure 17: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care (SOC), Rilutek

Figure 18: Global (7MM) Sales Forecast by Country for ALS in 2017 and 2027

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