US respiratory test market faces uncertainty as flu season approaches amid shift to complex assays, finds GlobalData

The US respiratory test market remains volatile post-COVID-19 pandemic, with fluctuating demand influenced by seasonal factors and evolving testing preferences. As flu season approaches, the market faces uncertainty, particularly due to the shift toward more complex and higher-priced testing assays. This transition could lead to significant variations in sales volumes and revenue, highlighting the market’s ongoing unpredictability, according to GlobalData.

In December 2021, GlobalData’s Respiratory Disease Tests Stock Keeping Unit (SKU) Tracker estimated revenue to be $1.77 billion. Compared to the peak in the 2023 flu season in January 2024 of $535 million. Since 2021, COVID-19 test and related product sales have decreased as the demand for testing has declined. GlobalData estimates that the peak monthly sales for respiratory tests in the US to be between 8.8 to 16.7 million tests depending on if there are outbreaks, lockdowns, or changes in testing protocols.

Selena Yu, Senior Medical Analyst, at GlobalData, states, “Based on sample data collected in May 2024, if trough-to-peak sale trends follow 2022, an estimated 8.8 to 10.5 million respiratory tests will be sold in the US at the peak of flu season (excluding over-the-counter tests). However, if sales trends follow 2023, it will be an estimated 14.1 to 16.7 million tests (excluding over-the-counter tests). This analysis is based on the growth between the lowest month of sales, typically spring and summer, and the highest month of sales, during flu season (November to February).”

There has been a shift from single plex (1 target) to mid plex (3-10 targets) in the past three years. Thus, the volume may be lower than anticipated if we see more of a shift toward mid and broad plex assays. However, the average selling price (ASP) of mid and broad plex tends to be higher than single and low plex assays. As of June 2024, the ASP of single plex and low plex tests are $17.31 and $22.07, respectively. On the other hand, mid and broad plex assays are $54.58 and $109.99, respectively.

“It is difficult to estimate peak monthly revenue for the 2024 flu season since there is a shift favouring mid and broad-plex testing compared to single plex tests. If we see a similar trough-to-peak trend 2022, the lowest revenue for the peak sales month will be $104.9 million and a maximum of $124.5 million. However, if the trend is like 2023, we can see a minimum of $618.0 million and a maximum of $733.8 million. This truly demonstrates the volatility of the respiratory tests market,” adds Yu.