After the COVID-19 pandemic, the importance of preventing infectious diseases has been re-emphasized. A new anti-RSV (Respiratory Syncytial Virus) antibody injection for infants, Beyfortus, is gaining attention as a potential turning point in the vaccine market Korea.

Attention has been focused on whether a presidential pledge to support this antibody injection, which marks a global shift in RSV prevention strategy away from only high-risk groups, will lead to its inclusion in the National Immunization Program (NIP).

According to the '2024 Vaccine Industry Trend Report' published by the Ministry of Food and Drug Safety (MFDS), the global vaccine market size in 2023 was approximately $34 billion, showing a steep growth from 2022 and marking the most significant increase in the last five years.

Analysis suggests that the primary reason for this is attributed to the increased focus on the entire vaccine industry, as infectious disease response capabilities emerge as a national competitive asset following the COVID-19 pandemic.

The RSV prevention options market, in particular, is experiencing significant growth. The two RSV prevention options recently launched in Korea are Sanofi's 'Beyfortus' and GSK's 'Arexvy.'

Arexvy can be administered to adults aged 60 and over, while Beyfortus is for all newborns and infants entering their first RSV season.

Children up to 24 months of age who are at high risk for severe RSV disease during their second RSV season can also receive it.

The MFDS report projects that the RSV market, which began with approvals in 2023, will grow rapidly to $4.5 billion to $ 7.5 billion by 2027.

However, the growth trajectory is expected to vary slightly depending on the indication, for instance, pediatric vs. adult. Due to factors such as adjusted recommended ages in the U.S., Arexvy's cumulative global sales decreased by 37% year-over-year by Q3 2024.

In contrast, Beyfortus recorded cumulative sales of approximately KRW 1.2609 trillion during the same period, representing a 516% year-over-year increase.


This growth is interpreted as a significant expansion in demand for infant and newborn RSV prevention options, as their immature bronchi and lungs can worsen to bronchiolitis or pneumonia, leading to hospitalization.

RSV is a common respiratory virus that infects 90% of infants and young children under the age of two.

It's a leading cause of hospitalization for respiratory infections in this age group during late autumn and winter, requiring special attention from families with young children.

The issue is the lack of a clear prevention option for RSV infection until recently. Before Beyfortus was launched, an antibody injection called Synagis was only used for high-risk infants and young children, such as those who were premature or had underlying conditions like heart or lung disease.

However, persistent criticism has been raised about the existence of a preventive blind spot, as approximately 80% of infants who visited hospitals for RSV were healthy full-term babies with no underlying conditions.

Consequently, there has been a high unmet need for a preventive option for all newborns and infants.

The introduction of the RSV preventive antibody injection, Beyfortus, has started to address these unmet needs.

Launched in Korea in February of this year, Beyfortus is an RSV preventive antibody injection that can be administered to all newborns and infants entering their first RSV season, as well as high-risk children under 24 months.

Since it provides continuous protection for at least five months with a single injection, either before or during the season, garnering significant interest from parents of infants and young children since its launch.

Dr. Ki Wook Yun, a professor in the infectious diseases division of the Department of Pediatrics at Seoul National University College of Medicine, explained, "RSV is a virus that infects 90% of infants and young children under the age of two, and in some infants, symptoms can worsen to bronchiolitis or pneumonia, leading to hospitalization."


This response is also confirmed in the global market. In places like Galicia, Spain, and Queensland, Australia, Beyfortus has been included in their National Immunization Programs (NIPs) and regional immunization programs, leading to a reduction in RSV-related hospitalizations.

Notably, in Queensland, Australia, the importance of vaccination is being re-emphasized, as evidenced by the fact that there were no RSV hospitalizations in infants who received Beyfortus over a four-week period.

In Korea, however, the Beyfortus vaccination is paid for entirely out of pocket. Although it's a preventive option for RSV, which is known to infect two out of three infants under one year old, its cost burden means only a few families can afford it. This raises concerns about health equity.

However, the current administration's presidential pledge included support for an anti-RSV antibody injection for infants and young children, which has led to growing expectations for future policy changes.

If this policy is implemented through measures such as including Beyfortus in the NIP, all newborns and infants in Korea will be able to receive Beyfortus without incurring the cost burden.

In this regard, Yun commented, "Although only out of pocket vaccination is currently possible in Korea, I hope that support for the anti-RSV antibody injection will be expanded as part of the government's low birth rate and infant health policies."