RSV Vaccines Surge: Pfizer's ABRYSVO Hits $10.8B in Sales Within 7 Months Post-Launch, Outpacing GLP-1 Blockbusters

Apr 10, 2024 20:19 CST Updated 20:19

GSK

Pharmaceutical R&D Manufacturer

Writing | Erin

Editor | Runyu

On April 9, Pfizer's official website disclosed that its respiratory syncytial virus (RSV) vaccine ABRYSVO achieved positive topline results in a Phase III clinical study among the 18 to 59 age group. Additionally, Pfizer plans to submit these data to regulatory authorities with the intention of expanding the age range from the current indication to include individuals aged 18 and above.

According to the press release, in individuals aged 18 to 59, RSV-A and RSV-B serum neutralizing titers increased at least fourfold one month after vaccination with ABRYSVO compared to before vaccination. During the trial period, ABRYSVO was well-tolerated, and the safety outcomes were consistent with previous clinical results of ABRYSVO conducted in other populations.

In fact, Pfizer's RSV vaccine ABRYSVO achieved sales of $890 million in 2023, becoming Pfizer's sixth largest product. Notably, ABRYSVO was only approved by the FDA in May 2023, meaning it generated nearly $1 billion in sales within just seven months of approval. It is foreseeable that as the indications for ABRYSVO continue to expand, its future sales prospects will be incredibly vast.

However, ABRYSVO is not the only RSV vaccine on the market. GSK's bivalent RSV recombinant protein vaccine, Arexvy, was approved in the same month of May last year as ABRYSVO, and its sales performance has been even more impressive, with revenue reaching £1.238 billion (approximately $1.5 billion) in 2023, propelling it to become one of GSK’s top-selling products.

In January this year, GSK submitted a marketing application to the European Medicines Agency (EMA) for the expansion of Arexvy's scope of use to include high-risk populations aged 50-59 for RSV, which was successfully accepted. The EMA is expected to make a decision in the second half of this year.

In addition to Pfizer and GSK, Sanofi and AZ's monoclonal antibody nirsevimab, used for the prevention of respiratory syncytial virus-associated lower respiratory tract disease in all infant populations, was approved by the FDA for marketing in July 2023. It has also received breakthrough therapy designation and priority review status in China. Financial report data shows that in 2023, the sales of nirsevimab were approximately US$600 million.

Overall, the RSV vaccines approved in the same year have achieved surprisingly strong sales performance.

Of course, the impressive sales performance of the three products is also closely related to the vast market potential of RSV vaccines. According to CIC Consulting, the global market size for RSV drugs (including both therapeutic and preventive drugs) is projected to grow from $18 billion in 2020 to $128 billion by 2030, with a compound annual growth rate (CAGR) of 21.4%.

In addition to GSK and Pfizer's recombinant protein vaccines, Sanofi/AZ's monoclonal antibodies, Pfizer/BioNTech and Moderna are also developing mRNA vaccines for RSV. Among them, Moderna's mRNA-1345, indicated for people aged 60 and above, has already initiated a rolling submission of its application for market approval to the FDA.

In China, Zhifei Biological became the exclusive partner for the co-development and commercialization of GSK's RSV vaccine for the elderly and has initiated clinical trials domestically. In addition, domestic companies such as Advaccine, Clover Biopharmaceuticals, and others are also developing RSV vaccines. Junshi Biosciences' oral COVID-19 drug VV116 has been approved for clinical trials intended to treat RSV infection, while Ark Biosciences' antiviral drug AK0529 has completed Phase III clinical trials in China and an NDA application has been submitted.

However, the RSV vaccine produced in China may still need to wait for a period of time before it hits the market. The fastest-progressing ADV110 by Aidersixin (Aidewei Xin) just announced positive Phase II clinical results in November last year. Another company, Clover Biopharmaceuticals, stated on April 8 that the Phase I clinical trial of its RSV vaccine SCB-1019 is currently underway, with the first batch of young adult participants showing positive preliminary immunogenicity and safety data. Other companies are still in Phase I clinical trials or in preclinical stages.

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