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RSV Treatment Development: Prophylactic Antibodies, Vaccines & Antivirals

Insight by , and


Respiratory Syncytial Virus (RSV) can be a serious medical condition in the very young and old, leading to morbidity and sometimes mortality globally. Existing treatment options are limited. Prophylactic antibodies, vaccines and antivirals are in development to treat it. We size the market at $9.7B+ in 2028, with a single pharmaceutical company capturing nearly half. However, many companies seek to participate.

Large Market With Great Unmet Need Has Attracted Much Development Activity

Annually in the U.S., RSV causes over 50,000 hospitalizations in children under 5 and over 150,000 in adults over 65. There are over 150,000 deaths globally each year. At least 25 programs are in development from 15+ companies to prevent or treat these infections. The programs target children, pregnant women and/or older adults and most will read out at least some data this year or next.

Children: Target Of Most Development Activity

About half of all agents in development spanning all modalities (vaccines, antibodies, antivirals) seek indications in children. Readouts on many of these agents are anticipated this year, including three programs that are in phase III. Two of the phase III readouts are of antibodies, and the third is of an antiviral.

Our KOLs believe that reduction in hospitalization is the most important endpoint to watch in these readouts. In premature infants, our KOLs would prefer a single dose, prophylactic antibody over a vaccine. Infant immune systems are immature and may not generate a protective response. In addition, infant respiratory tracts are susceptible to inflammation/mucous that might occur post vaccination. However, unlike antibodies and vaccines, antivirals can be used after infection, and might be more cost effective than either antibodies and vaccines. We estimate worldwide pediatric antibodies at $1.2B in 2025 and $2B in 2028, pediatric vaccines at $220MM in 2028, and pediatric antivirals at $105MM in 2028.

Pregnant Women: Only Three Programs, But All Are In Phase III

Vaccinating pregnant women is another way to protect the child, at least for the duration of the antibodies, which is around 6 months. However, this population is witnessing the least development activity. Only three programs are underway although all three are in Phase III, and all are vaccines. They are poised to generate data in 2023. We estimate worldwide maternal vaccines at$430MM in 2025 and $850MM in 2028.

Older Adults: Potentially The Largest Market Opportunity

Nine programs target older adults, including five vaccine and four antiviral programs. All but one will read out some data this year or next. One vaccine, poised to read out phase III data in 2022, is unique in that it utilizes an adjuvant. We estimate worldwide adult vaccines at $2.5B in 2025 and $6.2B in 2028.

RSV Market Opportunity Sized At $4.3B In 2025 And $9.7B+ In 2028

When considering all three modalities targeting all three relevant age groups, pricing is on par with existing agents treating other infectious diseases. There is moderate penetration in the U.S. and EU. We size the RSV market opportunity at $4.3B in 2025, rising to $9.7B+ in 2028. One pharmaceutical company appears positioned to capture around half of this market in 2028, but more than a dozen other companies are seeking to capture share.

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