OpportunityAnalyzer: Huntington’s Disease – Opportunity Analysis and Forecast to 2024

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Published: May 01, 2016 Report Code: GDHC056POA-ST

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HD is a rare, autosomal-dominant, neurodegenerative disorder, characterized by impaired motor control, cognitive dysfunction, behavioral changes, and mood disorders. Approved treatments for HD across the 7MM are extremely limited, consisting of only two symptomatic treatments, tetrabenazine and tiapride, which are both approved for the treatment of HD-associated chorea. Other treatment options contributing to the HD market are off-label symptomatic drugs, many of which are widely genericized throughout the 7MM. Four late-stage pipeline drugs, two symptomatic treatments (SD-809 and pridopidine) and two potential DMDs (RP103 and PBT2) are expected to launch in the US and 5EU markets during the forecast period, and will be a source of significant growth in the HD market. It is anticipated that SD-809 and pridopidine will also launch in Japan within the forecast period.

Scope

Overview of HD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized HD market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.

Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the HD therapeutics market.

Pipeline analysis: focus on the six late-stage pipeline HD drugs discussing emerging trends as well as overview of earlier phase drugs.

Analysis of the current and future market competition in the global HD 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 Highlights

The HD market has been dominated by tetrabenazine and tiapride (approved in Germany, Italy, and Spain; off-label in France and Japan) for many years, with little approved therapeutic options available in the 7MM. New classes of drugs are anticipated to reach the market within the forecast period. How will these change the market overall during the forecast period? Will tetrabenazine maintain market dominance in 2024?

The current late stage HD pipeline is varied, with first-in-class drugs in development with innovative modes of action. Which of these will have the biggest impact on the market? What strategies are developers undertaking to penetrate this chronically underserved market? Will these fulfil any unmet needs?

Alfresa
Alliance Pharma
Astellas
Chiesi Group
EUSA Pharma
Lundbeck
Pfizer
Prana Biotechnology
Raptor Pharmaceutical
Sanofi
Temmler
Teva
UCB
Valeant

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Quality of Life

3.3Symptoms

3.4Diagnosis and Disease Monitoring

4Epidemiology

4.1Disease Background

4.2Risk Factors and Complications

4.3Global Trends

4.3.1Diagnosed Prevalence of HD—7MM

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Sources Not Used

4.4.3Forecast Assumptions and Methods

4.5Epidemiological Forecast of HD (2014–2024)

4.5.1Diagnosed Prevalent Cases

4.5.2Diagnosed Prevalent Cases of HD by Age at Onset

4.5.3Diagnosed Prevalent Cases of Adults with Juvenile-Onset HD that Progressed to Adulthood, Ages =20 Years

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Current Treatment Options

5.1Overview

5.1.1Antipsychotic Drugs

5.1.2Antidepressant Drugs

5.1.3Benzodiazepines

5.1.4Anticonvulsant Drugs

5.1.5Antiparkinson Drugs

5.1.6Botulinum Toxin Type A

5.2Product Profiles—Major Brands

5.2.1Xenazine (Tetrabenazine)

5.2.2Tiapride

6Unmet Needs Assessment and Opportunity Analysis

6.1Overview

6.2Disease-Modifying Drugs

6.2.1Unmet Need

6.2.2Gap Analysis

6.2.3Opportunity

6.3Efficacious Cognitive Enhancers

6.3.1Unmet Need

6.3.2Gap Analysis

6.3.3Opportunity

6.4Improved Symptomatic Treatments

6.4.1Unmet Need

6.4.2Gap Analysis

6.4.3Opportunity

6.5Identification of Disease Biomarker

6.5.1Unmet Need

6.5.2Gap Analysis

6.5.3Opportunity

6.6Increased Knowledge of HD Pathogenesis

6.6.1Unmet Need

6.6.2Gap Analysis

6.6.3Opportunity

6.7More Comprehensive Treatment Guidelines

6.7.1Unmet Need

6.7.2Gap Analysis

6.7.3Opportunity

6.8Novel Formulations

6.8.1Unmet Need

6.8.2Gap Analysis

6.8.3Opportunity

7R&D Strategies

7.1Overview

7.1.1Disease-Modifying Drugs

7.1.2Clinical Measures and Biomarker Identification

7.2Clinical Trial Design

7.2.1Efficacy Endpoints

7.2.2Patient Inclusion

7.2.3Trial Locations

7.2.4Type of Clinical Trial

8Pipeline Assessment

8.1Overview

8.1.1SD-809 (Deutetrabenazine)

8.1.2Pridopidine Hydrochloride

8.1.3RP103 (Cysteamine Bitartrate)

8.1.4PF-02545920

8.1.5Laquinimod

8.1.6PBT2

8.2Innovative Early-Stage Approaches

8.2.1VX-15

8.2.2IONIS-HTTRx

9Pipeline Valuation Analysis

9.1Clinical Benchmark of Key Pipeline Drugs

9.2Commercial Benchmark of Key Pipeline Drugs

9.3Competitive Assessment

9.4Top-Line 10-Year Forecast

9.4.1US

9.4.25EU

9.4.3Japan

10Appendix

10.1Bibliography

10.2Abbreviations

10.3Methodology

10.4Forecasting Methodology

10.4.1Diagnosed HD Patients

10.4.2Percent Drug-Treated Patients

10.4.3Drugs Included in Each Therapeutic Class

10.4.4Launch and Patent Expiry Dates

10.4.5General Pricing Assumptions

10.4.6Individual Drug Assumptions

10.4.7Generic Erosion

10.4.8Pricing of Pipeline Agents

10.5Primary Research

10.5.1Physicians and Specialists Included in this Study

10.5.2Online Survey of High-Prescribing Physicians

10.6About the Authors

10.6.1Author

10.6.2Reviewer

10.6.3Therapy Area Director

10.6.4Epidemiologist

10.6.5Global Director of Therapy Analysis and Epidemiology

10.6.6Global Head of Healthcare

10.7About GlobalData

10.8Contact Us

10.9Disclaimer

Table

Table 1: Common Symptoms of HD

Table 2: The UHDRS Total Functional Capacity Scale

Table 3: The Shoulson-Fahn Huntington’s Disease Severity Scale

Table 4: Risk Factors and Complications for HD

Table 5: 7MM Estimates for the Diagnosed Prevalence of HD

Table 6: 7MM, Sources of Epidemiological Data Used for the Forecast of HD Diagnosed Prevalent Cases

Table 7: 7MM, Sources of Epidemiological Data Used for the Forecast of JHD Diagnosed Prevalent Cases

Table 8: 7MM, Sources of Epidemiological Data Used for the Forecast of HD Diagnosed Prevalent Cases by Age at Onset

Table 9: 7MM, Diagnosed Prevalent Cases of HD, All Ages, Both Sexes, N, 2014–2024

Table 10: 7MM, Diagnosed Prevalent Cases of HD by Age Group, Both Sexes, N (%), 2014

Table 11: 7MM, Sex-Specific Diagnosed Prevalent Cases of HD, All Ages, N (%), 2014

Table 12: 7MM, Diagnosed Prevalent Cases of JHD, Age <20 Years, Both Sexes, N, 2014–2024

Table 13: 7MM, Age-Specific Diagnosed Prevalent Cases of JHD, Both Sexes, N (%), 2014

Table 14: 7MM, Sex-Specific Diagnosed Prevalent Cases of JHD, Age <20 Years, N (%), 2014

Table 15: 7MM, Diagnosed Prevalent Cases of Adults with Juvenile-Onset HD that Progressed to Adulthood, Age =20 Years, Both Sexes, N, 2014–2024

Table 16: Leading Treatments for HD, 2016

Table 17: Antipsychotics SWOT Analysis, 2016

Table 18: Antidepressants SWOT Analysis, 2016

Table 19: Benzodiazepines SWOT Analysis, 2016

Table 20: Anticonvulsants SWOT Analysis, 2016

Table 21: Antiparkinson Drugs SWOT Analysis, 2016

Table 22: Botulinum Toxin Type A SWOT Analysis, 2016

Table 23: Product Profile—Xenazine

Table 24: Xenazine SWOT Analysis, 2016

Table 25: Product Profile—Tiapride

Table 26: Tiapride SWOT Analysis, 2016

Table 27: Overall Unmet Needs—Current Level of Attainment

Table 28: HD—Late-Stage Pipeline, 2016

Table 29: Product Profile—SD-809

Table 30: Summary of Treatment Effects of SD-809 on the Motor Endpoints in the FIRST-HD Clinical Trial

Table 31: Summary of Treatment Effects of SD-809 on the Secondary Endpoints in the FIRST-HD Clinical Trial

Table 32: SD-809 SWOT Analysis, 2016

Table 33: Product Profile—Pridopidine

Table 34: Summary of Adverse Events in the MermaiHD Clinical Trial of Pridopidine

Table 35: Summary of the Most Common Adverse Events in the HART Clinical Trial of Pridopidine

Table 36: Pridopidine SWOT Analysis, 2016

Table 37: Product Profile—RP103

Table 38: RP103 SWOT Analysis, 2016

Table 39: Product Profile—PF-02545920

Table 40: PF-02545920 SWOT Analysis, 2016

Table 41: Product Profile—Laquinimod

Table 42: Laquinimod SWOT Analysis, 2016

Table 43: Product Profile—PBT2

Table 44: Summary of the Adverse Events in the REACH2HD Clinical Trial of PBT2

Table 45: PBT2 SWOT Analysis, 2016

Table 46: Early-Stage Pipeline Products in HD

Table 47: Clinical Benchmark of Key Pipeline Drugs—HD

Table 48: Commercial Benchmark of Key Pipeline Drugs—HD

Table 49: Top-Line Sales Forecast ($m) for HD, 2014–2024

Table 50: Key Events Impacting Sales for HD, 2014–2024

Table 51: HD Market—Drivers and Barriers, 2014–2024

Table 52: Key Launch Dates

Table 53: Key Patent Expiries

Table 54: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

Figures

Figure 1: Cortico-basal Ganglia Network Indicating the Direct and Indirect Pathways

Figure 2: 7MM, Diagnosed Prevalent Cases of HD, All Ages, Both Sexes, N, 2014–2024

Figure 3: 7MM, Diagnosed Prevalent Cases of HD by Age Group, Both Sexes, N, 2014

Figure 4: 7MM, Diagnosed Prevalent Cases of HD by Sex, All Ages, N, 2014

Figure 5: 7MM, Age-Standardized Diagnosed Prevalence of HD (%) by Sex, All Ages, 2014

Figure 6: 7MM, Diagnosed Prevalent Cases of JHD, Age <20 Years, Both Sexes, N, 2014–2024

Figure 7: 7MM, Diagnosed Prevalent Cases of JHD by Age Group, Both Sexes, N

Figure 8: 7MM, Diagnosed Prevalent Cases of JHD by Sex, Age <20 Years, N, 2014

Figure 9: 7MM, Diagnosed Prevalent Cases of HD by Age at Onset, Both Sexes, N, 2014

Figure 10: 7MM, Diagnosed Prevalent Cases of Adults with Juvenile-Onset HD that Progressed to Adulthood, Age =20 Years, Both Sexes, N, 2014

Figure 11: Competitive Assessment of Marketed and Late-Stage Pipeline HD Drugs, 2014–2024

Figure 12: Sales for HD by Region, 2014–2024

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