Norovirus vaccines - time to rethink the market segments?

This month VacZine Analytics, a UK-based strategic research publisher exclusively focused on vaccines and infectious diseases, releases an updated global demand analysis for norovirus vaccines.

Noroviruses (NoVs) called "Norwalk-like viruses" are a group of single-stranded positive sense RNA viruses and members of the family Caliciviridae. Noroviruses are transmitted from human-to-human (fecal-oral) and via food sources. They are highly infectious viruses with a reproductive number Ro >2 (1). In the community, NVs most commonly cause a self-limiting mild disease of short duration with gastrointestinal symptoms, usually resolving after 1 to 3 days. However, in infants, elderly and immunocompromised persons severe dehydration can occur requiring medical attention and/or hospital admission for the administration of IV fluids. In some cases NoV infection can be fatal.

Globally, norovirus is associated with approximately one-fifth of all diarrhea cases, with similar prevalence in both children and adults. It is the 2nd most common cause of death in children <5 yrs and the most common cause of diarrheal death in children >5 yrs with similar patterns across WHO regions (WHO FERG) (2). In developing countries, norovirus is estimated in the range of 171-277,000 deaths annually and around 700 million illnesses (3). NoV outbreaks are also a well-known issue in confined environments such as long-term care facilities, hospitals, military installations and commercial cruise ship liners. In these cases, the virus can cause severe disruption and economic loss.

Because of the success of the rotavirus vaccine reducing disease burden, it is hoped a new norovirus vaccine can have a similar impact, now that the virus has taken a more prominent role. However, the SARS-CoV-2 pandemic (2020) will undoubtedly impact the norovirus vaccine development timeframe and market proposition. It already seems that social distancing and lockdown measures have dramatically impacted upon norovirus transmission in the US. The US NoroSTAT system, which reports suspected and confirmed norovirus outbreaks from 12 state departments, indicates the outbreak level from early March 2020 onwards is far below the range reported during the same period over the previous 6 years (4). It remains to be seen whether norovirus transmission and disease burden reach pre-pandemic levels in Western countries given the enhanced focus on infection control.

The two main norovirus programs operated by Takeda Pharmaceuticals (TAK-214) and Vaxart (oral platform) were in clinical stages of testing and we await further status updates. However, it has already been announced that Vaxart has deprioritized funding to their program (Financial Results, March 31st 2020). Despite some delays, Chinese developers such as the National Vaccine and Serum Institute are pressing ahead with a new Phase I study initiated in 2020.

This new MarketVIEW product is a comprehensive Executive presentation + MS Excel-based model(s), which forecasts the potential commercial value of Norovirus vaccines across 113 major Western and emerging markets and GAVI to 2035*. The model contains value ($ m) and volume (mio doses) predictions along with launch timeframe, TPP, pricing and penetration estimates for all major market segments. There is a thorough review of global epidemiology, economic burden, competitive vaccine landscape. Brand new model scenarios explore segment prioritization (post-COVID-19), vaccine duration of immunity and various new adjustments. This product is ideally suited to those organisations wanting an extended, up-to-date global forecast for this vaccine opportunity.

References:

  1. Gaythorpe KAM et al. Norovirus transmission dynamics: a modelling review. Epidemiol Infect. 2018 Jan; 146(2): 147–158
  2. Kirk MD et al. World Health Organization Estimates of the Global and Regional Disease Burden of 22 Foodborne Bacterial, Protozoal, and Viral Diseases, 2010: A Data Synthesis [published correction appears in PLoS Med. 2015 Dec;12(12):e1001940]. PLoS Med. 2015;12(12):e1001921. Published 2015 Dec 3. doi:10.1371/journal.pmed.1001921
  3. Bartsch SM et al. Global Economic Burden of Norovirus Gastroenteritis. PLoS ONE (2016) 11(4): e0151219
  4. US Centers For Disease Control (CDC). NoroSTAT Data. Available at: https://www.cdc.gov/norovirus/reporting/norostat/data.html. Accessed June 2020

Image Credit: Photo by Georg Arthur Pflueger on Unsplash

*A limited number of countries are rolled up into region blocks

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

For more information, please visit the website www.vacZine-analytics.com or contact info@vaczine-analytics.com

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

Copyright. All Rights Reserved, 2020

 



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