Pfizer/BioNTech’s Comirnaty (tozinameran) is forecast to have peak sales of $24.8bn by 2021, which is only its second year on the market. This is a 20 per cent increase over Humira’s peak sales of $20.5 billion, suggesting that Comirnaty could be the next top drug by peak sales within only two years of its launch, says GlobalData.

Quentin Horgan MSc, Analyst for Drugs Database at GlobalData, comments, “Humira has been the top drug by sales for nearly a decade, despite having been on the market for nearly 20 years and having lost its market exclusivity within the EU in 2018 and Japan in 2017. The fact that Pfizer/BioNTech is estimated to end this reign after only two years is unprecedented and shows the power of this drug’s high efficacy, its first-to-market status, the demand presented by ongoing vaccination programs and that Comirnaty is considered the gold standard for COVID-19 vaccines.”

Since its UK EMA approval as a COVID-19 vaccine in December 2020, Comirnaty has received regulatory approval in multiple geographies, including the EU and Japan. It has also gained EUAs in other geographies such as the US, Canada, Australia and Switzerland.

Horgan continues, “Comirnaty is currently the leading vaccine by 2020 sales with Pfizer and BioNTech Se recording combined sales of $456 million over double what Moderna and over 100 times more than Astrazeneca has reported for 2020.

In February 2021, the FDA approved Comirnaty to be stored at temperatures ranging from -25°C to -15°C (-13°F to 5°F) for a total of two weeks, which is much higher than its previous storage requirement of -80°C (-112°F).

Horgan adds, “This new temperature range places it on par with its rival, Moderna’s mRNA-1273.The temperature range also allows for greater flexibility in managing and maintaining Comirnaty’s distribution and supply, and makes it more appealing to emerging markets, which do not have sufficient supercooling capacity.

“It remains to be seen if Comirnaty’s actual sales in 2021 will meet these forecast predictions. Several vaccines have received EUAs and approvals, including Moderna’s mRNA-1273, AstraZeneca’s AZD-1222, and Johnson & Johnson’s JNJ-7843673; these may take market share away from Comirnaty.”