For a very long time, Botox was synonymous with the facial injections industry — the drug made by pharma company Allergan (ABBV) was approved for cosmetic use in 2002 and has since become widely used as an anti-wrinkle cosmetics treatment.
In 2020, it was even approved for medical use for certain limb conditions in children.
Botox's dominance of the anti-wrinkle market slowly started to shift with the emergence of new products on the scene. In 2019, the Federal Drug Administration (FDA) approved the Jeuveau injectable serum made by beauty company Evolus (EOLS).
Despite a legal dispute with Allergan that caused Evolus to temporarily halt production, the anti-wrinkle product is now being made and growing in popularity following a settlement.
Sales of Juveau brought in $34.7 million in the fourth quarter of 2021 and 76% more in 2022 than in 2021. Evolus shares are also up nearly 50% year-over-year.
To date, Botox makes up approximately 70% of the facial injections market and brought in $862 million for the first half of 2022.
FDA Approves an Alternative Product
On Thursday, the FDA approved yet another anti-wrinkle product called Daxxify. Made by the larger Revance Therapeutics (RVNC), the injectable serum received approval as a treatment for moderate to severe frown lines and wrinkles.
Studies and tests referred to by the FDA found, despite some mild symptoms such as headaches, the overall efficiency of neuromodulator.
Treatment providers reported seeing no or mild facial lines four months after use on 2,700 patients and 4,200 treatments. The single injection of daxibotulinumtoxin works by blocking the signals that cause muscles to contract and cause wrinkles.
Daxxify's biggest edge over Botox is the length of time the effect will last — while Botox lasts an average of three to four months, Daxxify's creators claim that it remains effective for up to six.
"The most unmet need with toxins is duration," Revance CEO Mark Foley told Fierce Pharma in an interview. "[...] We worked very closely with the agency to get the full 36 weeks of data into our label, which will allow us to support these marketing claims."
Worth approximately $4.6 billion in 2020, the facial injections market is expected to grow at a 9.6% CAGR rate to $9.07 billion in 2028.
Shares of Revance rose sharply after the FDA approval. When approval was still up in the air, shares were down to a low of $11.52 in June.
'Disrupting' The Botox Industry
While Revance did not reveal how much the treatment would cost or whether it will keep the name Daxxify or go for something even snappier, it released all kinds of excited statements about how it plans to take on the facial injections market.
"The FDA approval of Daxxify is a foundational achievement for the company as it marks the culmination of years of pioneering research and development [...]," Foley said in a press release. "It has been an incredible and rewarding journey to realize our vision and bring this disruptive innovation to an industry that has remained largely unchanged for over 30 years."
But given Botox's popularity, Daxxify is unlikely to "overtake" or "push out" Botox as much as become a strong competitor and gradually squeeze out some market share over time.
