Progesterone Receptor Agonists Market: Competitive Landscape, Pipeline, and Market Analysis 2023

Progestins are the substances that convert the estrogen-primed proliferative endometrium to secretory and maintain pregnancy in animals spayed after conception. Progesterone is a 21-carbon steroid derived from cholesterol that is secreted by the corpus luteum in the later half of the menstrual cycle under the influence of luteinizing Hormone (LH). Progesterone Receptor Agonists are the Progesterone derivatives that act as substitutes for Progesterone and function to prepare the uterus for nidation and maintenance of pregnancy. It does this by preventing endometrial shedding, decreasing uterine motility, and inhibiting immunological rejection of the fetus. These agonists are used in Hormone Replacement Therapy (HRT), Threatened Abortion, Endometriosis, Dysfunctional Uterine Bleeding, and others. The development of new and novel molecules by the market players is imminent.  Extensive research is being conducted globally to discover new and novel molecules to be used as Progesterone Receptor Agonists like etonogestrel are used to prevent pregnancy. The development and launch of new products will thus increase the market’s revenue in the forecasted years. According to the NHSBSA statistics of England, in 2021/2022, an estimated 1.93 million identified patients were prescribed HRT, which was an increase of 30.5% than the last year. Also, according to the U.S. Department of Health and Human Services report in 2021, 11% - 13% of women of reproductive age at any given time experience abnormal uterine bleeding. This increases with age, with prevalence increasing to nearly 24% in women in the age range of 36 to 40 years. There is a great demand for medical  intended to provide relief from these disorders and drive the growth of the market.

A number of these inhibitors are in the market, while many are in ongoing clinical trials. Many companies have various products in their pipelines, with 48 products in different stages of clinical trials. 9 products in Phase 4, 14 in Phase 3, 5 in Phase 2, and 2 in Phase 1 of the clinical trials.

Key Developments of Progesterone Receptor Agonists

• In August 2022, FDA approved Myfembree (relugolix/estradiol/norethindrone acetate)

 for management of moderate to severe pain associated with endometriosis.

• In July 2021, FDA approved Myfembree (relugolix/estradiol/norethindrone acetate)

was approved in Europe by the EU as Ryeqo for the treatment of moderate to severe symptoms of Uterine Fibroids in women of reproductive age.

• In May 2021, FDA approved Myfembree (relugolix/estradiol/norethindrone acetate)

for heavy menstrual bleeding associated with Uterine Fibroids.

• In July 2018, FDA approved Orilisa (elagolix) for the management of pain associated with endometriosis.

Approved molecules of Progesterone Receptor Agonists

• Nexplanon (Etonogestrel Implant)
• Utrogestan (Progesterone)
• Visanne (Dienogest)
• Climara (Estradiol)
• Zoely (Nomegestrol/Estradiol)
• Combipatch (Estradiol/Norethindrone Acetate)
• Depo-Subq Provera (Medroxyprogesterone Acetate)
• Slinda (Drospirenone)
• Progendo (Micronized Natural Progesterone)
• Myfembree (Relugolix/Estradiol/Norethindrone Acetate)

Drugs In The Pipeline Of Progesterone Receptor Agonists

• Nestorone MDTS (Elcometrine Transdermal Spray)            
• Premphase (Conjugated Estrogens/Medroxyprogesterone Acetate)
• Progesterone
• Estradiol/Etonogestrel Intravaginal Ring (MK-8342B)
• Twirla (Ethinyl Estradiol/Levonorgestrel)
• Oriahnn (Elagolix/Estradiol/Norethindrone Acetate)
• Milprosa (Progesterone Vaginal Ring)
• Dienogest/Ethinylestradiol (LPRI-424)
• Anastrozole/Levonorgestrel (BAY 98-7196)
• Virexxa (Sodium Cridanimod)
• Estrogen/Progesterone Intravaginal Ring (DARE-HRT1)
• Levonorgestrel Butanoate (HRP002)
• Bijuva (Estradiol/Progesterone)
• MK-8342
• NTS-104
• Indomethacin/Levonorgestrel (BAY98-7443)
• Levonorgestrel (AG890)
• Progesterone (TX 12-002HR)
• Progesterone Intravenous (BHR 100)

Clinical Activity and Developments of Progesterone Receptor Agonists

As of July 2023, 31 companies have approximately 46 products for 270 diseases. For these diseases, 293 trials are being conducted by players globally. For instance,

• Eastern Virginia Medical School is conducting a Phase 4 clinical trial to study the impact of contraceptives on Cervico-Vaginal mucosa that is expected to complete by November 2022.
• Mansoura University is conducting a Phase 4 clinical trial to evaluate the efficacy of dienogest (DNG) in comparison to goserline acetate in a complete 12-week treatment of pain in women suffering from chronic pelvic pain diagnosed as endometriosis by laparoscopy and histopathology which was expected to complete by December 2021.
• Johns Hopkins University is conducting a Phase 4 clinical trial to explore the role of estrogen in bone development in adolescent and young adult women with cystic fibrosis (CF) and low estrogen levels that is expected to complete by December 2024.