ハンチントン病治療薬の世界市場機会分析

◆英語タイトル:OpportunityAnalyzer: Huntington’s Disease - Opportunity Analysis and Forecast to 2024
◆商品コード:GDHC056POA
◆発行会社(調査会社):GlobalData
◆発行日:2016年5月3日
◆ページ数:250
◆レポート言語:英語
◆レポート形式:PDF
◆納品方法:Eメール
◆調査対象地域:グローバル
◆産業分野:製薬・医療
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当調査レポートでは、ハンチントン病治療薬の世界市場機会について調査・分析し、以下の構成でお届けいたします。
・イントロダクション
・ハンチントン病の概要:病因、病態生理、症状
・疫学:リスク要因、併存症、グローバル動向、予測方法、疫学的予測結果
・ハンチントン病治療薬市場の現状:診断、治療概要、臨床診療、主要な医薬品
・アンメット・ニーズ及び市場機会分析
・研究開発戦略
・パイプライン分析
・パイプラインの価値分析
【レポートの概要】

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

Summary

Huntington’s Disease (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.

Highlights

Key Questions Answered

- 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?

Key Findings

- The main driver of growth in the HD market will be the introduction of premium-priced disease-modifying drugs and improved symptomatic therapies over the forecast period. The launch of these treatments will act as a stimulant for growth in this chronically underserved market.
- Significant barriers to growth in the HD market will be the high cost of novel treatments and potential issues surrounding reimbursement, which will limit the use of more expensive drugs. Patients who have an acceptable level of symptomatic control with currently marketed drugs could result in limited treatment costs for HD.
- The arrival of new therapies across the 7MM will increase treatment rates and provide alternative options for many patients.
- The largest unmet needs in the HD market are the development of efficacious disease-modifying drugs and symptomatic treatments. In addition, the identification of a robust HD biomarker for monitoring disease progression, as well as determining the effects of therapeutic interventions, is a significant unmet need in this field.

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.

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. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global HD therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HD therapeutics market in 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.
- Track drug sales in the global HD therapeutics market from 2014-2024.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

【レポートの目次】

1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 14
1.2 List of Figures 17
2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 18
3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 22
3.2 Quality of Life 29
3.3 Symptoms 29
3.4 Diagnosis and Disease Monitoring 30
4 Epidemiology 35
4.1 Disease Background 35
4.2 Risk Factors and Complications 36
4.3 Global Trends 36
4.3.1 Diagnosed Prevalence of HD-7MM 36
4.4 Forecast Methodology 39
4.4.1 Sources Used 42
4.4.2 Sources Not Used 44
4.4.3 Forecast Assumptions and Methods 45
4.5 Epidemiological Forecast of HD (2014-2024) 47
4.5.1 Diagnosed Prevalent Cases 47
4.5.2 Diagnosed Prevalent Cases of HD by Age at Onset 59
4.5.3 Diagnosed Prevalent Cases of Adults with Juvenile-Onset HD that Progressed to Adulthood, Ages ≥20 Years 60
4.6 Discussion 62
4.6.1 Epidemiological Forecast Insight 62
4.6.2 Limitations of the Analysis 63
4.6.3 Strengths of the Analysis 64
5 Current Treatment Options 65
5.1 Overview 65
5.1.1 Antipsychotic Drugs 67
5.1.2 Antidepressant Drugs 73
5.1.3 Benzodiazepines 77
5.1.4 Anticonvulsant Drugs 81
5.1.5 Antiparkinson Drugs 85
5.1.6 Botulinum Toxin Type A 87
5.2 Product Profiles-Major Brands 89
5.2.1 Xenazine (Tetrabenazine) 89
5.2.2 Tiapride 97
6 Unmet Needs Assessment and Opportunity Analysis 102
6.1 Overview 102
6.2 Disease-Modifying Drugs 103
6.2.1 Unmet Need 103
6.2.2 Gap Analysis 104
6.2.3 Opportunity 107
6.3 Efficacious Cognitive Enhancers 108
6.3.1 Unmet Need 108
6.3.2 Gap Analysis 109
6.3.3 Opportunity 110
6.4 Improved Symptomatic Treatments 111
6.4.1 Unmet Need 111
6.4.2 Gap Analysis 112
6.4.3 Opportunity 114
6.5 Identification of Disease Biomarker 115
6.5.1 Unmet Need 115
6.5.2 Gap Analysis 116
6.5.3 Opportunity 117
6.6 Increased Knowledge of HD Pathogenesis 118
6.6.1 Unmet Need 118
6.6.2 Gap Analysis 119
6.6.3 Opportunity 119
6.7 More Comprehensive Treatment Guidelines 119
6.7.1 Unmet Need 119
6.7.2 Gap Analysis 121
6.7.3 Opportunity 122
6.8 Novel Formulations 122
6.8.1 Unmet Need 122
6.8.2 Gap Analysis 123
6.8.3 Opportunity 124
7 R&D Strategies 125
7.1 Overview 125
7.1.1 Disease-Modifying Drugs 125
7.1.2 Clinical Measures and Biomarker Identification 127
7.2 Clinical Trial Design 129
7.2.1 Efficacy Endpoints 130
7.2.2 Patient Inclusion 131
7.2.3 Trial Locations 133
7.2.4 Type of Clinical Trial 135
8 Pipeline Assessment 136
8.1 Overview 136
8.1.1 SD-809 (Deutetrabenazine) 137
8.1.2 Pridopidine Hydrochloride 144
8.1.3 RP103 (Cysteamine Bitartrate) 154
8.1.4 PF-02545920 162
8.1.5 Laquinimod 166
8.1.6 PBT2 170
8.2 Innovative Early-Stage Approaches 176
8.2.1 VX-15 178
8.2.2 IONIS-HTTRx 179
9 Pipeline Valuation Analysis 182
9.1 Clinical Benchmark of Key Pipeline Drugs 183
9.2 Commercial Benchmark of Key Pipeline Drugs 185
9.3 Competitive Assessment 186
9.4 Top-Line 10-Year Forecast 187
9.4.1 US 191
9.4.2 5EU 192
9.4.3 Japan 193
10 Appendix 195
10.1 Bibliography 195
10.2 Abbreviations 223
10.3 Methodology 227
10.4 Forecasting Methodology 227
10.4.1 Diagnosed HD Patients 227
10.4.2 Percent Drug-Treated Patients 227
10.4.3 Drugs Included in Each Therapeutic Class 228
10.4.4 Launch and Patent Expiry Dates 232
10.4.5 General Pricing Assumptions 232
10.4.6 Individual Drug Assumptions 233
10.4.7 Generic Erosion 242
10.4.8 Pricing of Pipeline Agents 242
10.5 Primary Research 244
10.5.1 Physicians and Specialists Included in this Study 244
10.5.2 Online Survey of High-Prescribing Physicians 245
10.6 About the Authors 246
10.6.1 Author 246
10.6.2 Reviewer 246
10.6.3 Therapy Area Director 246
10.6.4 Epidemiologist 247
10.6.5 Global Director of Therapy Analysis and Epidemiology 247
10.6.6 Global Head of Healthcare 248
10.7 About GlobalData 249
10.8 Disclaimer 249

1.1 List of Tables
Table 1: Common Symptoms of HD 30
Table 2: The UHDRS Total Functional Capacity Scale 32
Table 3: The Shoulson-Fahn Huntington’s Disease Severity Scale 32
Table 4: Risk Factors and Complications for HD 36
Table 5: 7MM Estimates for the Diagnosed Prevalence of HD 39
Table 6: 7MM, Sources of Epidemiological Data Used for the Forecast of HD Diagnosed Prevalent Cases 40
Table 7: 7MM, Sources of Epidemiological Data Used for the Forecast of JHD Diagnosed Prevalent Cases 41
Table 8: 7MM, Sources of Epidemiological Data Used for the Forecast of HD Diagnosed Prevalent Cases by Age at Onset 42
Table 9: 7MM, Diagnosed Prevalent Cases of HD, All Ages, Both Sexes, N, 2014-2024 48
Table 10: 7MM, Diagnosed Prevalent Cases of HD by Age Group, Both Sexes, N (%), 2014 50
Table 11: 7MM, Sex-Specific Diagnosed Prevalent Cases of HD, All Ages, N (%), 2014 52
Table 12: 7MM, Diagnosed Prevalent Cases of JHD, Age <20 Years, Both Sexes, N, 2014-2024 55
Table 13: 7MM, Age-Specific Diagnosed Prevalent Cases of JHD, Both Sexes, N (%), 2014 56
Table 14: 7MM, Sex-Specific Diagnosed Prevalent Cases of JHD, Age <20 Years, N (%), 2014 58
Table 15: 7MM, Diagnosed Prevalent Cases of Adults with Juvenile-Onset HD that Progressed to Adulthood, Age ≥20 Years, Both Sexes, N, 2014-2024 61
Table 16: Leading Treatments for HD, 2016 66
Table 17: Antipsychotics SWOT Analysis, 2016 73
Table 18: Antidepressants SWOT Analysis, 2016 77
Table 19: Benzodiazepines SWOT Analysis, 2016 81
Table 20: Anticonvulsants SWOT Analysis, 2016 85
Table 21: Antiparkinson Drugs SWOT Analysis, 2016 87
Table 22: Botulinum Toxin Type A SWOT Analysis, 2016 89
Table 23: Product Profile-Xenazine 95
Table 24: Xenazine SWOT Analysis, 2016 97
Table 25: Product Profile-Tiapride 100
Table 26: Tiapride SWOT Analysis, 2016 101
Table 27: Overall Unmet Needs-Current Level of Attainment 103
Table 28: HD-Late-Stage Pipeline, 2016 137
Table 29: Product Profile-SD-809 141
Table 30: Summary of Treatment Effects of SD-809 on the Motor Endpoints in the FIRST-HD Clinical Trial 142
Table 31: Summary of Treatment Effects of SD-809 on the Secondary Endpoints in the FIRST-HD Clinical Trial 142
Table 32: SD-809 SWOT Analysis, 2016 144
Table 33: Product Profile-Pridopidine 149
Table 34: Summary of Adverse Events in the MermaiHD Clinical Trial of Pridopidine 152
Table 35: Summary of the Most Common Adverse Events in the HART Clinical Trial of Pridopidine 153
Table 36: Pridopidine SWOT Analysis, 2016 154
Table 37: Product Profile-RP103 159
Table 38: RP103 SWOT Analysis, 2016 162
Table 39: Product Profile-PF-02545920 164
Table 40: PF-02545920 SWOT Analysis, 2016 166
Table 41: Product Profile-Laquinimod 168
Table 42: Laquinimod SWOT Analysis, 2016 170
Table 43: Product Profile-PBT2 173
Table 44: Summary of the Adverse Events in the REACH2HD Clinical Trial of PBT2 175
Table 45: PBT2 SWOT Analysis, 2016 176
Table 46: Early-Stage Pipeline Products in HD 177
Table 47: Clinical Benchmark of Key Pipeline Drugs-HD 183
Table 48: Commercial Benchmark of Key Pipeline Drugs-HD 185
Table 49: Top-Line Sales Forecast ($m) for HD, 2014-2024 188
Table 50: Key Events Impacting Sales for HD, 2014-2024 190
Table 51: HD Market-Drivers and Barriers, 2014-2024 191
Table 52: Key Launch Dates 232
Table 53: Key Patent Expiries 232
Table 54: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 245

1.2 List of Figures
Figure 1: Cortico-basal Ganglia Network Indicating the Direct and Indirect Pathways 24
Figure 2: 7MM, Diagnosed Prevalent Cases of HD, All Ages, Both Sexes, N, 2014-2024 49
Figure 3: 7MM, Diagnosed Prevalent Cases of HD by Age Group, Both Sexes, N, 2014 51
Figure 4: 7MM, Diagnosed Prevalent Cases of HD by Sex, All Ages, N, 2014 53
Figure 5: 7MM, Age-Standardized Diagnosed Prevalence of HD (%) by Sex, All Ages, 2014 54
Figure 6: 7MM, Diagnosed Prevalent Cases of JHD, Age <20 Years, Both Sexes, N, 2014-2024 55
Figure 7: 7MM, Diagnosed Prevalent Cases of JHD by Age Group, Both Sexes, N 57
Figure 8: 7MM, Diagnosed Prevalent Cases of JHD by Sex, Age <20 Years, N, 2014 59
Figure 9: 7MM, Diagnosed Prevalent Cases of HD by Age at Onset, Both Sexes, N, 2014 60
Figure 10: 7MM, Diagnosed Prevalent Cases of Adults with Juvenile-Onset HD that Progressed to Adulthood, Age ≥20 Years, Both Sexes, N, 2014 62
Figure 11: Competitive Assessment of Marketed and Late-Stage Pipeline HD Drugs, 2014-2024 186
Figure 12: Sales for HD by Region, 2014-2024 189

【掲載企業】

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

【レポートのキーワード】

ハンチントン病

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