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Amyotrophic Lateral Sclerosis: Opportunity Analysis and Forecast to 2027

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  • 95 Pages
  • July 2018
  • Region: Global
  • GlobalData
  • ID: 4661774
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Amyotrophic Lateral Sclerosis: Opportunity Analysis and Forecast to 2027


Amyotrophic Lateral Sclerosis (ALS) drug sales in 2017 were approximately $187M across the seven major markets - the US, 5EU (France, Germany, Italy, Spain and the UK), and Japan. 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. Currently, the highest-selling drug in the market is Mitsubishi’s Radicava (edaravone).

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).

The major drivers of growth in the Amyotrophic Lateral Sclerosis (ALS) market during the forecast period include:
  • The launch of five pipeline agents that aim to extend patient survival. These drugs will be used as adjunctive therapies to Rilutek and Radicava.

  • The launch of BrainStorm Therapeutics’ NurOwn stem cell therapy, which has the potential to significantly slow the progression of the disease and is, expected to expand the market in the future. Biologic products have a high cost of therapy and as such are expected to generate high sales.

The major barriers to growth in the Amyotrophic Lateral Sclerosis (ALS) market during the forecast period will be:
  • Major brands are expected to see their patents expire throughout the forecast period, which will act as a barrier as cheap generic versions of the drug will enter the market.

  • Due to the rarity of the disease, recruiting a representative patient sample for clinical trials can be difficult and may slow the clinical trial development process.

The report "Amyotrophic Lateral Sclerosis: Opportunity Analysis and Forecast to 2027", is aimed to:
  • Assess the current competitive landscape and its evolution over the forecast period (2017-2027)

  • Evaluate the significance of late-stage pipeline products entering the ALS market and determine how these products will impact the future treatment landscape

  • Highlight the significant unmet needs in the ALS market

  • Identify any opportunities in the ALS market

Companies Mentioned: Sanofi, Mitsubishi Tanabe, Brainstorm Therapeutics, ViroMed, Ionis Pharmaceuticals, Genevrone Biopharmaceuticals, Biogen, Orphazyme, Orion Pharmaceuticals, KringlePharma, Aquestive Therapeutics, Apotex, Valeant Pharmaceuticals, Neuralstem, Impicit Bioscience, Roche, Treeway BV, Cytokientics, AB Science, Concordia Healthcare Corp

  • 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.

Table of Contents

1 Table of Contents
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
11.8 Contact
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: 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 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

Companies Mentioned

A selection of companies mentioned in this report includes:

  • 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