Changing Market Landscape
Healthcare analytics firm Airfinity significantly revised its U.S. market forecast for respiratory syncytial virus (RSV) vaccines targeting older adults. The revision amounted to a massive 64% decline, triggered by a recent pivotal decision from a panel of CDC experts.
The CDC Influence
In a noteworthy development, a CDC advisory committee meeting in June recommended a single lifetime RSV vaccine for individuals aged 75 years and above. Concurrently, the CDC’s Advisory Committee on Immunization Practices (ACIP) opted against recommending RSV vaccines for adults in the 60–74 age bracket who are not at an elevated risk of the disease.
Market Adjustment
The altered guidelines prompted the London-based Airfinity to slash its projection for the U.S. RSV vaccine market by a substantial 64%, down to $1.7 billion from the earlier estimation of $4.7 billion. This adjustment reflects the reduced estimated eligible population by 44% to 46 million individuals.
Key Players
Currently, the U.S. market for RSV vaccines is predominantly comprised of three major players. The FDA recently greenlit a messenger RNA-based RSV vaccine under the brand mRESVIA from Moderna (NASDAQ: MRNA) to combat the risk of lower respiratory tract disease in individuals aged 60 and above.
Last year, GSK (NYSE: GSK) and Pfizer (NYSE: PFE) achieved significant milestones by becoming the first to garner FDA approvals for RSV shots. Their more conventionally developed vaccines, Arexvy and Abrysvo, were approved for the same indication.
Market Impact
The delayed decision on recommending RSV shots for high-risk 50- to 59-year-olds can potentially lead to a revenue setback of approximately $300 million for GSK. Notably, GSK utilized a priority review voucher worth $20 million to $100 million to hasten the label expansion.
Industry Insights
Isabella Huettner, Airfinity’s RSV Lead, highlighted the implications of the ACIP recommendations. Revenue growth in the U.S. market is expected to be hindered unless fresh data can substantiate the benefits of booster shots. However, there is a silver lining as the global rollout stands to benefit the three major market players.
The U.K., Canada, and key EU nations are poised to launch their RSV immunization programs this winter. Despite the evolving landscape, Huettner emphasized the likelihood of a single lifetime vaccine recommendation for individuals aged 75 and above, echoing recent trends acknowledged in the U.K.
