Human respiratory syncytial virus (RSV) is one of the most common viruses to infect children worldwide and now is recognized as an important pathogen in adults, especially the elderly. Globally, each year, there are over 33m episodes of RSV-associated acute lower respiratory infection (RSV-ARI) in children <5 yrs resulting in at least 3.2m hospital admissions and 59,600 in-hospital deaths (Shi T et al., 2017). In children, <5 yrs, the burden of RSV exceeds that of influenza and other respiratory viral pathogens. In adults, about 1.5m episodes of RSV-ARI occur in industrialized countries. Globally, 336,000 hospital admissions and 14,000 in-hospital deaths have been estimated although the true burden is believed to be higher (Shi T et al., 2020).
There is no specific treatment for RSV infection or licensed prophylatic vaccine. For those children who require hospitalization (~1-2% of healthy), supportive therapy is still the mainstay of care. Palivizumab (anti-RSV monoclonal, Synagis®) has been FDA-approved since 1998 for the prophylaxis of specific subsets of premature infants with chronic lung disease (CLD) or congenital heart disease (CHD). The product, however, has drawbacks in that it requires multiple doses and is considered expensive so making its use very restricted.
The RSV vaccine development field is one of the most active in the industry with several pivotal Phase III studies now ongoing with readouts expected in 2022. Major companies such as Pfizer, GSK Biologicals, Janssen NV, ModernaTX, Sanofi Pasteur and Bavarian Nordic have a range of vaccine approaches targeting the maternal, infant/toddler and older adult/elderly segments. Newer long-acting monoclonal antibodies such as nirsevimab, MEDI8897 (Sanofi/AstraZeneca) have recently met Phase III trial endpoints (MELODY/MEDLEY) and are undergoing global regulatory submissions with an EMA accelerated process approved 18th February 2022. Merck & Co's clesrovimab (MK-1654) has also recently entered Phase II/III clinical studies. GSK recently paused their Phase III maternal RSV vaccine GRACE trial (18th February 2022) stimulating new debate around which approach will eventually become the mainstay of at-birth infant protection against RSV.
This MarketVIEW product is a comprehensive Executive Presentation (~385 slides, .pdf) and interactive MS-Excel forecast model (~190 worksheets) which investigate the scenario-based interplay and commercial potential of 4 RSV vaccine profiles along with monoclonal antibodies in all relevant target groups (e.g. maternal, infant/toddler, at-risk, older adult and elderly) to 2037. 52 countries and sub-regions are included (public/private sector) where the impact of different country-specific pricing analogues and cohort target ranges can be explored. Country specific roll-out is forecasted according to specific local factors and RSV transmission patterns. Issues regarding the positioning of monoclonals in the at-birth segment versus maternal vaccination are explored with an innovative uptake case study analysis. The report contains a thorough review of disease background/epidemiology/cost-effectiveness along with vaccinology/R&D competitive landscape with an emphasis on future product differentiators, product longevity & company specific revenues/share. This product is ideally suited to organisations wishing to access an up-to-date advanced global quantification of the RSV vaccine/monoclonal opportunity.
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.
For more information, please visit the website www.vaczine-analytics.com or contact info@vaczine-analytics.com
VacZine Analytics® is a trading division of Assay Advantage Ltd, UK Company No. 5807728
Image credit: @kellysikima (unsplash)