Although female infertility is a prevalent condition, it remains a niche indication on the industry level.
As such, only a limited number of companies have chosen to invest in this segment to date. EMD Serono and Merck & Co. have historically been the leading companies in the space since the development of the first recombinant follicle-stimulating hormone (FSH) products.
Today, Ferring Pharmaceuticals is also a strong player in the space with several drugs developed for the indication. Also, ObsEva and Myovant Sciences are making headway in the women’s health space and pursuing novel pipeline drugs for use in assisted reproductive technology (ART).
While GlobalData projects the female infertility drugs market to grow through 2028 across 7MM (the US, France, Germany, Italy, Spain, the UK and Japan), this growth will be restricted by the sparse pipeline and the limited number of innovative drugs under development.
For the few established companies competing in this space, the strategy has largely been to create improved versions of existing drugs. As such, the drugs involved in treating patients have remained largely unchanged in the past decade. The figure below summarises clinical trials for these five late-stage agents.
Figure: Key Phase II/III trials for notable female infertility pipeline agents
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At present only three drugs are in Phase III trials. Among these, Ferring Pharmaceuticals’ Rekovelle (follitropin delta) is already approved in the EU and is in Phase III studies in the US and Japan. A new drug application (NDA) was filed with the FDA in 2010 (by Teva Pharmaceutical Industries) for Milprosa (progesterone vaginal ring), followed by a complete response letter (CRL) in 2013.
In 2015, Ferring announced that it had acquired the global rights to the drug. No development update had been made until July 2018, when Ferring initiated the Phase III SARA trial for female infertility in the US (NCT03565211). Ferring has not stated any plans or specific timelines for potential filings for these two drugs.
ObsEva’s Phase III candidate, nolasiban, is a first-in-class, oral, oxytocin receptor antagonist. Its development aims to improve clinical pregnancy and live birth rates in women undergoing in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) by inhibiting uterine contractions during embryo transfers and subsequently improving embryo implantation rates.
Myovant Sciences recently completed a Phase IIa for MVT-602 as an alternative ovarian trigger shot, while ASKA Pharmaceuticals’ gonadotropin AKP-501 is also under Phase II development in Japan.