Last week Pfizer (NYSE:PFE) took significant steps that would allow it to capitalize on a market opportunity worth over $10 billion for respiratory syncytial virus (RSV) vaccines. This move comes at a time when the pharmaceutical giant seeks to duplicate a business model that worked effectively during the pandemic era for other infectious diseases with significant unmet medical needs.
During the company’s announcement of its global Phase 3 trial data on Thursday for its bivalent vaccine candidate intended to treat RSV, Pfizer showed that RSVpreF had an 86% efficacy rate against the condition for patients aged 60 years and over.
Unmet Medical Needs
RSV infections are responsible for roughly 177,000 hospitalization cases among older adults in the U.S every year, with 14,000 of these ending up as fatalities, according to data from the Centers for Disease Control and Prevention (CDC). While it is a common childhood infection that causes only mild illness, RSV can lead to death in older adults or infants.
Currently, there isn’t any vaccine available to prevent RSV infection, and the only means of prevention that can reduce the risk of severe disease in high-risk infants is a monoclonal antibody called Synagis.
The market for RSV treatments is expected to be worth at least $10.5 billion by 2030, according to projections by SVB Leerink and Pfizer seems to be the front runner in the race to get a piece of this market as it begins to pursue regulatory approval for RSVpreF early this fall. Competition from rivals is, however, slowly heating up, with the likes of GlaxoSmithKline (NYSE:GSK) and Johnson &Johnson (NYSE:JNJ) also joining the race.
Two-Pronged Strategy
Pfizer sets itself apart from the competition as its strategy involves addressing both the preventative and curative aspects of RSV. According to projections, a similar model used during the pandemic for its COVID-19 vaccine and tablet Paxlovid will net over $50 billion in revenue for the company in 2022.
In April, Pfizer bought ReViral for about $252 million, with projections indicating that revenue from the former’s RSV programs, including an oral antiviral, could bring in more than $1.5 billion in revenue. During this time, the RSV compound called sisunativor was in Phase 2 human studies in healthy adults and infants.
Race for RSV Vaccines
There have been clear signs that more and more drug makers are angling for a piece of this multi-billion market.
According to GSK’s Phase 3 clinical data reported in June for its RSV vaccine candidate RSVPreF3 OA was the first to show statistically significant and clinically meaningful efficacy in patients aged 60 years and above. But since the drug maker didn’t give more detailed results, it remains difficult to compare with Pfizer.
JNJ’s Janssen unit also expects to post data from a global Phase 3 study designed to evaluate the efficacy of its RSV vaccine candidate in approximately 23,000 adults aged 60 years and above.
Moderna (MRNA) is currently conducting a Phase 3 trial for adults and Phase 1 trial for children evaluating the efficacy of its messenger-RNA-based RSV vaccine called mRNA-1345 developed using technology for its blockbuster COVID-19 vaccine.
Pfizer Market Estimates
After Pfizer’s Phase 3 trial results for RSVpreF, SVB’s Geoffrey Porges forecasted that the company was poised to capture $2.1 billion of the RSV vaccine market compared to GSK’s $2.9 billion and JNJ’s $1.7 billion. He also expects other drug and vaccine developers like Bavarian Nordic (OTCPK:BVNKF) (OTCPK:BVNRY) to capture roughly $2.6 billion worth of a market share.
But the analyst’s predictions indicate that the opportunity for infants could only account for about 18% of the RSV market compared to 72% for adults. This hasn’t deterred vaccine developers, as Sanofi recently announced it would begin enrolling patients in Phase 3 open-label study that would evaluate the efficacy of nirsevimab in preventing RSV hospitalization in infants under one year.
Featured Image: Megapixl @Brasilnut
