New Anti-RSV monoclonal antibodies - for the many? or still for the few?


This month VacZine Analytics, a UK-based strategic research publisher exclusively focused on vaccines and infectious diseases, releases a brand new commercial assessment of anti-Respiratory Syncytial Virus (RSV) monoclonal antibodies. If used in all, rather than selected infants, this product concept promises a new alternative to vaccines for tackling this dangerous pathogen. But does more choice bring more questions for policymakers?

Human respiratory syncytial virus (RSV) is one of the most common viruses to infect children worldwide and now increasingly is recognised as an important pathogen in adults, especially the elderly. Globally each year, there are over 33m episodes of RSV-associated acute lower respiratory infection in children younger than 5 yrs of age resulting at least 3.2m hospital admissions and 59,600 in-hospital deaths (2015 estimation, Shi T et al., 2017). In children below 5 yrs, the burden of RSV exceeds that of influenza and other respiratory viral pathogens. There is no specific treatment for RSV infection and for those children who require hospitalisation (~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 although in recent years recommendations, especially in the United States, have become more restrictive.

Newer long-acting monoclonal antibodies such as MEDI8897 (AZ/MedImmune/Sanofi) and MK-1654 (Merck & Co) are currently in development with promising data with the former due to enter Phase III. A key question is whether these type of interventions can obviate the need for prophylatic active vaccines and be used on a mass population basis.

This MarketVIEW is an Executive Presentation and MS-Excel forecast model which investigate two defined deployment scenarios and the commercial potential of newer long-acting anti-RSV monoclonal antibodies in all relevant birth types (healthy and risk early preterm, late preterm, full term) to 2035. Fifty-two countries and sub-regions are included in the model with expected public and private sector use being indicated. A methodology has been created whereby country-specific roll-out is forecasted according to specific local factors, RSV transmission patterns and vaccine considerations which may influence RSV mAb adoption timing. The report contains a review and analysis of the R&D competitive environment and expected pricing strategies of the new monoclonals according to their deployment regime. This product is ideally suited to organisations wishing to access an up-to-date global quantification of the monoclonal opportunity. It can be complementary to the VacZine Analytics sister product focused on RSV vaccines (CAT no: VAMV023, published March 2019). 

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Image Credit: Hush Naidoo @hush52 

VacZine Analytics, a world-leading supplier of vaccine-related commercial analyses, is a trading division of Assay Advantage Ltd (UK Company No: 5807728, UK VAT: 883584084)


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

VacZine Analytics Ltd (Assay Advantage)