Dengue endemic vaccines: awaiting Takeda's TAK-003

dengue endemic vaccines

This month VacZine Analytics®, a UK-based strategic research publisher exclusively focused on vaccines and infectious diseases, releases a brand new global commercial forecast for dengue-endemic vaccines.

Dengue Fever (DF) is a mosquito-borne disease (Aedes) caused by single strand RNA viruses of the family flaviviridae. DF has a wide spectrum of symptoms ranging from a mild febrile illness to severe outcomes such as hospitalization and death as observed in dengue haemorrhagic fever (DHF) and dengue shock syndrome (DSS). Latest estimate indicates that 390m dengue infections occur each year of which 20-30% are symptomatic (any severity) and 17-49K deaths occur. It is estimated that 3.9bn of the world's population are thought to be at risk from dengue infection, mainly urban dwellers in tropical and sub-tropical countries. Importantly, most of the estimated deaths per year are in children (<15yrs). No specific treatment is available. With the COVID-19 pandemic placing continual strain on healthcare infrastructure/public funding in dengue-endemic countries, the situation becomes more acute for all arboviral diseases.

A Sanofi Pasteur vaccine (CYD-TDV Dengvaxia®) has been licensed since 2015 for the prevention of disease caused by all four dengue virus serotypes [DENV1-4] in preadolescents, adolescents and adults, 9 to 45 years of age living in endemic areas. In 2016, two countries: Brazil (Parana state) and the Philippines (selected regions) started mass immunization programs, albeit with later controversies. Due to the publication of retrospective analysis (1) indicating Dengvaxia® could increase the risk of hospitalization in certain seronegative vaccinees, the WHO SAGE committee revised their earlier July 2016 position in September 2018 (2) to recommend countries consider the introduction of CYD-TDV only in those individuals with laboratory evidence of prior dengue infection. Dengvaxia® has not had widespread use since this time but is now FDA approved (9-16 yrs) (May 2019) and recently received a US ACIP recommendation (June 2021) for use in certain US overseas territories (mainly Puerto Rico). Other dengue vaccines notably, TAK-003 (Takeda Vaccines) and TV-003/005 (NIAID, Instituto Butantan, Merck & Co) are in late-stage development, the former of which recently met its Phase III endpoints. Takeda has already stated they are beginning the global registration for their vaccine which should gain wider adoption due to its efficacy irrespective of vaccinee serostatus, although differences are observed according to dengue serotype. The long-term success of Takeda’s TAK-003 is heavily dependent on the outcome of a large Phase III study ongoing in Brazil for TV-003/005 (NIAID, Instituto Butantan, Merck & Co) which potentially has a better vaccine profile.

This MarketVIEW is composed of a detailed Executive presentation (~270 slides) and a newly INTERACTIVE MS Excel Workbook(s) (~250 worksheets) which forecast the potential commercial value of dengue-endemic vaccine(s) by competitor across 55 endemic markets to 2036. The model(s) contain value ($ m) and volume (mio doses) predictions (public and private sector) with now adjustable age segments e.g., >4-9 yrs, >18 yrs. LO, BASE and HI forecast scenarios include potential demand from selected country catch-up campaigns and expected approvals from 2022 onwards. An intra-state or region roll-out analysis is also included for Brazil and The Philippines. Competitor vaccines are described in some detail with launch, market share and pricing predictions/CE analyses. A global review of latest disease dynamics and global epidemiology is also presented. This is analysis would suit any client wishing to access an advanced forecast analysis of this highly important global vaccine market.

  1. Sridhar S et al. Effect of Dengue Serostatus on Dengue Vaccine Safety and Efficacy. N Engl J Med 2018; 379:327 340

  2. World Health Organisation. Dengue Vaccines. WHO Position. September 2018. Available at: vaccines who position paper, September 2018 Accessed August 2021

VacZine Analytics®  is a strategic research agency based in the United Kingdom since 2007. We aim to provide disease and commercial analysis for the vaccine industry and help build the case for developing new vaccines and biologics.

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VacZine Analytics® ® is a trading division of Assay Advantage Ltd, UK Company No. 5807728

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VacZine Analytics is an established strategic research publisher based in the United Kingdom.

VacZine Analytics Ltd (Assay Advantage)