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MarketVIEW: Respiratory Syncytial Virus (RSV) vaccines & monoclonals

Published: April 2022
Elderly vaccine forecast (now updated to order in 2023)

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 and 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 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. ModernaTX's recent announcement for a pan-respiratory vaccines concept (mRNA-1230) which includes RSV could be a game-changer but recently GSK has been the first to report that it's elderly vaccine met pre-specified endpoints in the AReSVi 006 Phase III study. Newer long-acting monoclonal antibodies such as nirsevimab, BEYFORTUS, MEDI8897 (Sanofi/AstraZeneca) have recently met Phase III trial endpoints (MELODY/MEDLEY) and are currently undergoing global regulatory submissions. The EU has recently recommended approval (September 2022). Merck & Co's clesrovimab (MK-1654) has also recently entered Phase II/III clinical studies.

This MarketVIEW product is a comprehensive Executive Presentation (~385 slides, .pdf) and interactive MS-Excel forecast model 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.

THIS PRODUCT IS A SUMMARY PRESENTATION (~400 slides, .pdf) + 1 scenario-based interactive MS Excel Workbook(s)
Photo credit: Picsea@picsea

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