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.
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?
- 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.
- 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.
- 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.
1.1 List of Tables
1.2 List of Figures
2.2 Related Reports
2.3 Upcoming Related Reports
3 DISEASE OVERVIEW
3.1 Etiology and Pathophysiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global Trends
4.3.1 Incidence and Geographic Distribution
4.3.2 Dengue Periodic and Seasonal Patterns
4.3.3 Dengue Serotypes
4.4 Forecast Methodology
4.4.1 Sources Used
4.4.2 Sources Not Used
4.4.3 Forecast Assumptions and Methods
4.5 Epidemiological Forecast for Dengue (2013-2023)
4.5.1 Reported Laboratory-Confirmed Dengue Cases
4.5.2 Sex-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases
4.5.3 Age-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases
4.5.4 Age-Standardized Incidence of Reported Laboratory-Confirmed Dengue
4.6.1 Epidemiological Forecast Insight
4.6.2 Limitations of the Analysis
4.6.3 Strengths of the Analysis
5 CURRENT SURVEILLANCE, PREVENTION, AND CONTROL MEASURES
5.2.1 Surveillance and Diagnosis
5.2.2 Vector Control
5.2.3 Immunization Recommendations and Infrastructure
5.3.1 Surveillance and Diagnosis
5.3.2 Vector Control
5.3.3 Immunization Recommendations and Infrastructure
5.4.1 Surveillance and Diagnosis
5.4.2 Vector Control
5.4.3 Immunization Recommendations and Infrastructure
5.5.1 Surveillance and Diagnosis
5.5.2 Vector Control
5.5.3 Immunization Recommendations and Infrastructure
5.6.1 Surveillance and Diagnosis
5.6.2 Vector Control
5.6.3 Immunization Recommendations and Infrastructure
6 UNMET NEEDS ASSESSMENT AND OPPORTUNITY ANALYSIS
6.2 Unmet Needs Analysis
6.2.1 Unmet Need: Safe and Efficacious Vaccines
6.2.2 Unmet Need: An Improved Understanding of Dengue Immunity
6.2.3 Unmet Need: Reliable Immunological Correlates of Protection
6.2.4 Unmet Need: Country-Specific Immunization Program Preparedness
6.2.5 Unmet Need: Upgraded Vector Control and Surveillance Infrastructures
6.2.6 Unmet Need: Improved Diagnostic Tools
6.2.7 Unmet Need: High-Quality Animal Models
6.3 Opportunity Analysis
6.3.1 Opportunity: Develop a Single-Dose Dengue Vaccine
6.3.2 Opportunity: Further Elucidate the Role(s) of T Cells in Dengue Immunity
6.3.3 Opportunity: Streamline Vaccine Development with Innovative Clinical Trial Design
6.3.4 Opportunity: Partner with Public Health Stakeholders to Integrate Vaccines into Multifaceted Dengue Prevention Programs
6.3.5 Opportunity: Establish Country-Specific Vaccine Launch Strategies
6.3.6 Opportunity: Leverage Diagnostics to Demonstrate Vaccine Effectiveness Post-Licensure
7 RESEARCH AND DEVELOPMENT STRATEGIES
7.2 Technological Approaches to Vaccine Development
7.2.1 Vaccine Antigen Selection
7.2.2 Tetravalent Vaccine Construction
7.3 Partnerships, Acquisitions, and Licensing Agreements
7.4 Clinical Trial Design
7.4.1 Current Clinical Trial Design
7.4.2 Inclusion of Representative Patient Populations in Clinical Trials
7.4.3 Demonstration of Protective Efficacy
7.4.4 Dengue Human Infection Model
8 PIPELINE ASSESSMENT
8.2 Live-Attenuated Vaccines in Clinical Development
8.3 Other Vaccines in Clinical Development
8.4 Vaccines in Preclinical Development
9 PIPELINE VALUATION ANALYSIS
9.1 Clinical Benchmarking of Key Pipeline Vaccines
9.2 Commercial Benchmarking of Key Pipeline Vaccines
9.3 Competitive Assessment
9.4 Top-Line Five-Year Forecast
10.4 Forecasting Methodology
10.4.1 Vaccinated Patients
10.4.2 Vaccination Coverage Rates
10.4.3 Vaccines Included in Each Class
10.4.4 Vaccine Launch Dates
10.4.5 General Pricing Assumptions
10.4.6 Individual Vaccine Assumptions
10.4.7 Pricing of Pipeline Vaccines
10.5 Physicians and Specialists Included in this Study
10.6 About the Authors
10.6.3 Therapy Area Director
10.6.4 Global Head of Healthcare
10.7 About GlobalData
LIST OF FIGURES
Figure 1: DENV Structure and Genome
Figure 2: Laboratory Methods for Dengue Diagnosis
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
Figure 4: 5MM, Reported Laboratory-Confirmed Dengue Cases, Men and Women, All Ages, 2014-2023
Figure 5: 5MM, Sex-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases, All Ages, Annual Average, 2009-2013
Figure 6: 5MM, Age-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases, Men and Women, Annual Average, 2009-2013
Figure 7: 5MM, Age-Standardized Incidence of Reported Laboratory-Confirmed Dengue Cases, All Ages, Annual Average, 2009-2013
Figure 8: Competitive Assessment of Pipeline Dengue Vaccines, 2015-2020
Figure 9: Global Sales for Pipeline Dengue Vaccines by Country, 2015-2020
While the dengue vaccine pipeline possesses a high level of diversity in terms of vaccine class and technological approach, GlobalData expects the live-attenuated vaccines, which include Sanofi Pasteur's CYD-TDV, Takeda's DENVax, and the US National Institute of Health's (NIH's) TV-003 (licensed to the Butantan Institute in Brazil and Panacea Biotech/Biological E in India), to rule the marketplace for the duration of the forecast period. Despite lingering questions regarding their safety and ability to provide balanced short- and long-term protection against the four dengue virus (DENV) serotypes, key opinion leaders (KOLs) interviewed by GlobalData cited live-attenuation as the most promising technological approach to dengue vaccine research and development.
While the other vaccine classes in clinical development - inactivated virus, subunit, and deoxyribonucleic acid (DNA) vaccines - may theoretically minimize the chance of viral interference and could be perceived as safer by patients, KOLs overwhelmingly viewed them as inferior to live-attenuated vaccines and cited their need for adjuvants and late arrival to the marketplace as key weaknesses. GlobalData projects live-attenuated dengue vaccines to account for over $395m in sales by 2020, with a CAGR of 41.5% from 2015–2020.
The figure below summarizes GlobalData's competitive assessment of the most promising dengue vaccine candidates in clinical development from 2015–2020. GlobalData based the ratings for each pipeline agent's clinical and commercial attributes on discussions with KOLs from across the markets covered in this report, analysis of clinical trial data, and a thorough review of the literature.
The material was prepared in July, 2014.
Table 1: Symptoms and WHO Case Definitions of Dengue
Table 2: Risk Factors for DENV Transmission and Severe Dengue (DHF and DSS)
Table 3: Periodicity and Seasonality of Dengue Fever in the 5MM, 2003-2013
Table 4: 5MM, Circulating DENV Serotypes and Predominant Serotype, 2003-2013
Table 5: 5MM, Sources of Reported Laboratory-Confirmed Dengue Fever Data
Table 6: 5MM, Reported Laboratory-Confirmed Dengue Cases, N (Col %), Men and Women, All Ages, Selected Years, 2009-2023
Table 7: 5MM, Sex-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases, All Ages, Annual Average, 2009-2013
Table 8: 5MM, Age-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases, All Ages, Annual Average, 2009-2013
Table 9: Routine Immunization Recommendations in Brazil, 2014
Table 10: Routine Immunization Recommendations in India, 2014
Table 11: Routine Immunization Recommendations in Mexico, 2014
Table 12: Routine Immunization Recommendations in Singapore, 2014
Table 13: Routine Immunization Recommendations in Thailand, 2014
Table 14: Unmet Need and Opportunity in Dengue Vaccines
Table 15: Acquisitions and Licensing Agreements in the Dengue Vaccine Market, 2014
Table 16: Design of Selected Dengue Vaccine Clinical Trials
Table 17: Dengue Vaccines - Clinical Development Pipeline, 2014
Table 18: Comparison of Dengue Vaccine Classes in Clinical Development, 2014
Table 19: Product Profile - CYD-TDV
Table 20: Efficacy Profile - CYD-TDV
Table 21: Safety Profile - CTD-TDV
Table 22: CYD-TDV SWOT Analysis, 2014
Table 23: Product Profile - DENVax
Table 24: Efficacy Profile - DENVax
Table 25: DENVax SWOT Analysis, 2014
Table 26: Product Profile - TV-003
Table 27: Efficacy Profile - TV-003
Table 28: Safety Profile - TV-003
Table 29: TV-003 SWOT Analysis, 2014
Table 30: Product Profile - TDENV-PIV
Table 31: TDENV-PIV SWOT Analysis, 2014
Table 32: Product Profile - DEN-80E
Table 33: Efficacy Profile - DEN-80E
Table 34: DEN-80E SWOT Analysis, 2014
Table 35: Dengue Vaccines - Innovative Vaccines in Preclinical Development, 2014
Table 36: Clinical Benchmarking of Key Pipeline Vaccines
Table 37: Commercial Benchmarking of Key Pipeline Vaccines
Table 38: Top-Line Sales Forecast ($m) for Dengue Vaccines, 2015-2020
Table 39: Key Events Impacting Sales for Dengue Vaccines, 2015-2020
Table 40: Dengue Vaccines Market - Drivers and Barriers, 2015-2020
Table 41: Key Launch Dates