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OpportunityAnalyzer: Dengue Vaccines - Opportunity Analysis and Forecasts to 2020

Summary

Dengue is a febrile illness caused by the dengue virus (DENV), a single-stranded flavivirus most commonly transmitted by the Aedes aegypti (A. aegypti) mosquito. Thought to be responsible for upwards of 100 million infections each year, DENV is the most prevalent arthropod-borne virus in the world. Individuals infected with DENV can present with a wide spectrum of symptoms, including fevers, retro-orbital pain, severe headache, muscle and joint pain, and rash. The severity of dengue fever ranges from asymptomatic cases, to classic dengue fever, and to dengue hemorrhagic fever (DHF) or dengue shock syndrome (DSS) that have a mortality rate of 5%-15%. Because there are no marketed dengue-specific vaccines or therapeutics, current treatment strategies are limited to supportive care for those already infected with the virus, and vector control to reduce DENV transmission. The near-universal failure of these measures to curtain transmission and reduce disease burden across the global marketplace - which for the purposes of this report is comprised of Brazil, India, Mexico, Singapore, and Thailand - has further enhanced the need for safe and effective vaccines. GlobalData expects the launch of the first dengue vaccines, led by Sanofi Pasteur’s CYD-TDV and Takeda’s DENVax, to revolutionize the treatment and prevention paradigm.

Highlights

Key Questions Answered

- Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the dengue vaccine marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2015-2020)?
- What research and development (R&D) strategies will companies leverage to compete in the future dengue vaccine marketplace?
- Which patient population(s) are most likely to be targeted for routine immunization?
- What clinical and environmental factors are likely to influence dengue vaccine uptake in Brazil, India, Mexico, Singapore, and Thailand? Which of these markets will experience the strongest growth from 2015-2020?

Key Findings

- GlobalData projects the dengue vaccine market in Brazil, India, Mexico, Singapore, and Thailand to grow from $69.6m in 2015 to $398.6m in 2020, at a compound annual growth rate (CAGR) of 41.8%. This rapid growth will be due to the expected incorporation of newly-launched dengue vaccines into routine immunization programs.
- KOLs interviewed by GlobalData expect the live-attenuated dengue vaccines - led by Sanofi Pasteur’s CTD-TDV and Takeda’s DENVax - to dominate the marketplace for the duration of the forecast period.
- GlobalData anticipates that firms will increasingly turn to innovative R&D strategies, in particular the exploration of alternative approaches to early-stage clinical trial design - such as the dengue human infection model (DHIM) - in order to increase developmental efficiency, minimize upfront risk, and gain a competitive advantage over rivals.
- Domestically-supplied vaccines, most notably Butantan Institute’s TV-003 in Brazil and Panacea Biotech’s/Biological E’s TV-003 in India, are projected to limit market growth due to their low price relative to vaccines produced by privately-held foreign companies.

Scope

- Overview of dengue virus (DENV), including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current disease surveillance and prevention measures.
- Topline dengue vaccine market revenue from 2015-2020. Annual cost of therapy (ACOT) and major pipeline vaccine sales in this forecast period are included.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the dengue vaccine market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline vaccines. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the global dengue vaccine 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

- 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 dengue vaccine market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the dengue vaccine 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

OpportunityAnalyzer: Dengue Vaccines - Opportunity Analysis and Forecasts to 2020
1 Table of Contents

2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 19
2.3 Upcoming Related Reports 20
3 Disease Overview 21
3.1 Etiology and Pathophysiology 21
3.1.1 Etiology 21
3.1.2 Pathophysiology 24
3.2 Symptoms 27
3.3 Prognosis 30
4 Epidemiology 31
4.1 Disease Background 31
4.2 Risk Factors and Comorbidities 31
4.3 Global Trends 34
4.3.1 Incidence and Geographic Distribution 34
4.3.2 Dengue Periodic and Seasonal Patterns 36
4.3.3 Dengue Serotypes 37
4.4 Forecast Methodology 38
4.4.1 Sources Used 40
4.4.2 Sources Not Used 43
4.4.3 Forecast Assumptions and Methods 43
4.5 Epidemiological Forecast for Dengue (2013-2023) 46
4.5.1 Reported Laboratory-Confirmed Dengue Cases 46
4.5.2 Sex-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases 48
4.5.3 Age-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases 50
4.5.4 Age-Standardized Incidence of Reported Laboratory-Confirmed Dengue 51
4.6 Discussion 52
4.6.1 Epidemiological Forecast Insight 52
4.6.2 Limitations of the Analysis 53
4.6.3 Strengths of the Analysis 54
5 Current Surveillance, Prevention, and Control Measures 55
5.1 Overview 55
5.2 Brazil 61
5.2.1 Surveillance and Diagnosis 61
5.2.2 Vector Control 61
5.2.3 Immunization Recommendations and Infrastructure 62
5.3 India 64
5.3.1 Surveillance and Diagnosis 65
5.3.2 Vector Control 65
5.3.3 Immunization Recommendations and Infrastructure 66
5.4 Mexico 68
5.4.1 Surveillance and Diagnosis 68
5.4.2 Vector Control 69
5.4.3 Immunization Recommendations and Infrastructure 70
5.5 Singapore 72
5.5.1 Surveillance and Diagnosis 72
5.5.2 Vector Control 73
5.5.3 Immunization Recommendations and Infrastructure 73
5.6 Thailand 75
5.6.1 Surveillance and Diagnosis 75
5.6.2 Vector Control 76
5.6.3 Immunization Recommendations and Infrastructure 76
6 Unmet Needs Assessment and Opportunity Analysis 79
6.1 Overview 79
6.2 Unmet Needs Analysis 81
6.2.1 Unmet Need: Safe and Efficacious Vaccines 81
6.2.2 Unmet Need: An Improved Understanding of Dengue Immunity 83
6.2.3 Unmet Need: Reliable Immunological Correlates of Protection 83
6.2.4 Unmet Need: Country-Specific Immunization Program Preparedness 84
6.2.5 Unmet Need: Upgraded Vector Control and Surveillance Infrastructures 85
6.2.6 Unmet Need: Improved Diagnostic Tools 86
6.2.7 Unmet Need: High-Quality Animal Models 87
6.3 Opportunity Analysis 88
6.3.1 Opportunity: Develop a Single-Dose Dengue Vaccine 88
6.3.2 Opportunity: Further Elucidate the Role(s) of T Cells in Dengue Immunity 88
6.3.3 Opportunity: Streamline Vaccine Development with Innovative Clinical Trial Design 89
6.3.4 Opportunity: Partner with Public Health Stakeholders to Integrate Vaccines into Multifaceted Dengue Prevention Programs 90
6.3.5 Opportunity: Establish Country-Specific Vaccine Launch Strategies 91
6.3.6 Opportunity: Leverage Diagnostics to Demonstrate Vaccine Effectiveness Post-Licensure 92
7 Research and Development Strategies 93
7.1 Overview 93
7.2 Technological Approaches to Vaccine Development 93
7.2.1 Vaccine Antigen Selection 93
7.2.2 Tetravalent Vaccine Construction 95
7.3 Partnerships, Acquisitions, and Licensing Agreements 97
7.4 Clinical Trial Design 99
7.4.1 Current Clinical Trial Design 99
7.4.2 Inclusion of Representative Patient Populations in Clinical Trials 102
7.4.3 Demonstration of Protective Efficacy 102
7.4.4 Dengue Human Infection Model 103
8 Pipeline Assessment 105
8.1 Overview 105
8.2 Live-Attenuated Vaccines in Clinical Development 110
8.2.1 CYD-TDV 110
8.2.2 DENVax 118
8.2.3 TV-003 123
8.3 Other Vaccines in Clinical Development 129
8.3.1 TDENV-PIV 129
8.3.2 DEN-80E 131
8.4 Vaccines in Preclinical Development 135
9 Pipeline Valuation Analysis 137
9.1 Clinical Benchmarking of Key Pipeline Vaccines 137
9.2 Commercial Benchmarking of Key Pipeline Vaccines 139
9.3 Competitive Assessment 141
9.4 Top-Line Five-Year Forecast 143
9.4.1 Brazil 146
9.4.2 India 147
9.4.3 Mexico 148
9.4.4 Singapore 148
9.4.5 Thailand 149
10 Appendix 150
10.1 Bibliography 150
10.2 Abbreviations 170
10.3 Methodology 174
10.4 Forecasting Methodology 174
10.4.1 Vaccinated Patients 174
10.4.2 Vaccination Coverage Rates 175
10.4.3 Vaccines Included in Each Class 175
10.4.4 Vaccine Launch Dates 175
10.4.5 General Pricing Assumptions 176
10.4.6 Individual Vaccine Assumptions 177
10.4.7 Pricing of Pipeline Vaccines 180
10.5 Physicians and Specialists Included in this Study 183
10.6 About the Authors 185
10.6.1 Analyst 185
10.6.2 Epidemiologist 185
10.6.3 Therapy Area Director 186
10.6.4 Global Head of Healthcare 186
10.7 About GlobalData 187
10.8 Disclaimer 187

1.1 List of Tables

Table 1: Symptoms and WHO Case Definitions of Dengue 28
Table 2: Risk Factors for DENV Transmission and Severe Dengue (DHF and DSS) 33
Table 3: Periodicity and Seasonality of Dengue Fever in the 5MM, 2003-2013 37
Table 4: 5MM, Circulating DENV Serotypes and Predominant Serotype, 2003-2013 38
Table 5: 5MM, Sources of Reported Laboratory-Confirmed Dengue Fever Data 39
Table 6: 5MM, Reported Laboratory-Confirmed Dengue Cases, N (Col %), Men and Women, All Ages, Selected Years, 2009-2023 47
Table 7: 5MM, Sex-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases, All Ages, Annual Average, 2009-2013 49
Table 8: 5MM, Age-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases, All Ages, Annual Average, 2009-2013 50
Table 9: Routine Immunization Recommendations in Brazil, 2014 63
Table 10: Routine Immunization Recommendations in India, 2014 67
Table 11: Routine Immunization Recommendations in Mexico, 2014 71
Table 12: Routine Immunization Recommendations in Singapore, 2014 74
Table 13: Routine Immunization Recommendations in Thailand, 2014 77
Table 14: Unmet Need and Opportunity in Dengue Vaccines 81
Table 15: Acquisitions and Licensing Agreements in the Dengue Vaccine Market, 2014 98
Table 16: Design of Selected Dengue Vaccine Clinical Trials 100
Table 17: Dengue Vaccines - Clinical Development Pipeline, 2014 106
Table 18: Comparison of Dengue Vaccine Classes in Clinical Development, 2014 109
Table 19: Product Profile - CYD-TDV 113
Table 20: Efficacy Profile - CYD-TDV 115
Table 21: Safety Profile - CTD-TDV 116
Table 22: CYD-TDV SWOT Analysis, 2014 117
Table 23: Product Profile - DENVax 120
Table 24: Efficacy Profile - DENVax 121
Table 25: DENVax SWOT Analysis, 2014 122
Table 26: Product Profile - TV-003 125
Table 27: Efficacy Profile - TV-003 126
Table 28: Safety Profile - TV-003 127
Table 29: TV-003 SWOT Analysis, 2014 128
Table 30: Product Profile - TDENV-PIV 130
Table 31: TDENV-PIV SWOT Analysis, 2014 131
Table 32: Product Profile - DEN-80E 133
Table 33: Efficacy Profile - DEN-80E 134
Table 34: DEN-80E SWOT Analysis, 2014 135
Table 35: Dengue Vaccines - Innovative Vaccines in Preclinical Development, 2014 136
Table 36: Clinical Benchmarking of Key Pipeline Vaccines 138
Table 37: Commercial Benchmarking of Key Pipeline Vaccines 140
Table 38: Top-Line Sales Forecast ($m) for Dengue Vaccines, 2015-2020 143
Table 39: Key Events Impacting Sales for Dengue Vaccines, 2015-2020 145
Table 40: Dengue Vaccines Market - Drivers and Barriers, 2015-2020 146
Table 41: Key Launch Dates 176

1.2 List of Figures

Figure 1: DENV Structure and Genome 23
Figure 2: Laboratory Methods for Dengue Diagnosis 26
Figure 3: 5MM, Incidence Rate (Cases per 100,000 Population) of Reported Laboratory-Confirmed Dengue Cases (Including Classic Dengue Fever and DHF), Men and Women, All Ages, 2003-2013 35
Figure 4: 5MM, Reported Laboratory-Confirmed Dengue Cases, Men and Women, All Ages, 2014-2023 48
Figure 5: 5MM, Sex-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases, All Ages, Annual Average, 2009-2013 49
Figure 6: 5MM, Age-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases, Men and Women, Annual Average, 2009-2013 51
Figure 7: 5MM, Age-Standardized Incidence of Reported Laboratory-Confirmed Dengue Cases, All Ages, Annual Average, 2009-2013 52
Figure 8: Competitive Assessment of Pipeline Dengue Vaccines, 2015-2020 142
Figure 9: Global Sales for Pipeline Dengue Vaccines by Country, 2015-2020 144

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