Agile Therapeutics’ Twirla (ethinyl estradiol + levonorgestrel) could have an edge over competitors based on milder side-effects and a potentially safer profile, says GlobalData, a leading data and analytics company.

As the largest contraceptives market, the US will experience moderate growth at a compound annual growth rate (CAGR) of 4.8%, reaching $5.2bn total sales by 2027. This market offers several options, including both on-demand and longer-acting approaches, and has been dominated by intrauterine devices and oral contraceptives during the past decade.

Despite Twirla’s rocky regulatory history, it will become the only low-dose combination hormonal contraceptive patch, once it hits the market. Moreover, as Twirla delivers a much lower dose of ethinyl estradiol per day compared to the only similar approved option, namely the high-dose Xulane patch, it could have an edge over Xulane.

Kelly Lambrinos, Senior Pharma Analyst at GlobalData, comments: “Compliance difficulties are more common among oral contraceptive users, while other long-lasting forms, such as hormonal intrauterine devices, tend to cause various unwanted side effects. As there is a need in the female contraception space for a method that is not an inserted device or an ingested pill, the demand for a novel weekly transdermal option will be evident and there is space for Twirla’s addition to the current US market.

“However, there still remains a need for more alternatives, and particularly, non-hormonal options. Key opinion leaders (KOLs) interviewed by GlobalData have expressed that there are some women who remain hesitant in taking hormonal contraceptives because of the associated side effects.”