Market Challenges And Opportunities

Global Synthetic Hormones Market Restraints

According to National Center for Biotechnology Information (NCBI), 2017, some anti-depressants (non-hormonal) such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) (paroxetine (Paxil), citalopram (Celexa) and escitolapram (Lexapro)) were reported to show a decrease in severity of hot flashes in menopausal as well as post-menopausal women compared to synthetic hormones.

The cost effectiveness of the hormonal replacement therapy is one of the important restraining factor. According to NCBI, at least 18 tablets of Vagifem has to be used by the patient per month, therefore, the cost of the medicine per month comes down to $400 – 500 while Paroxetine is to be taken once daily per month, and hence the cost of 30 tablets comes down to $50 – 100. Moreover, Paroxetine is available as an oral dose while Vagifem is a vaginal insert. Hence, patients prefer the oral route of administration over the inserts.

Global Synthetic Hormones Market Drivers

Leading manufacturers are indulged in the development of new products in the global synthetic hormone market. For instance, Lyndra Therapeutics Inc. completed pre-clinical trials for an oral contraceptive pill in December 2019. The contraceptive pill is made of a gelatin capsule, which when ingested, produces a star-shaped polymer and releases the synthetic hormones for three weeks in order to prevent pregnancy.

In October 2019, Mayne Pharma signed a 20?year exclusive supply and license agreement with Mithra Pharmaceuticals, SA (Mithra) to commercialize a novel oral contraceptive comprising Estetrol (E4), and Drospirenone, (E4/DRSP) in the United States. The product is expected to be launched in 2021 post U.S. Food and Drug Administration’s (U.S. FDA) approval. Lupin Pharmaceuticals, Inc. received approval from the U.S. FDA in April 2019 for the Testosterone Gel (Strength 1.62%) which is a generic version of AbbVie, Inc.’s (AbbVie) AndroGel 1.62%. It is used for hormone replacement therapy in males who are incapable of producing endogenous testosterone.

According to the Global Reproductive Health, International Federation of Fertility Societies, 2018, prevalence of menopausal hot flashes have been increasing in the United States. Around 23 million women in the age group of 45 to 55 years are expected to experience menopausal symptoms like heavy or irregular bleeding, breast tenderness, and hot flashes, which will increase more physician visits. According to National Center for Biotechnology information (NCBI), 2018, increasing incidence of irregular menstrual cycles has led to an increase in use of oral contraceptives, birth control pills, birth control shots, vaginal rings, hormonal intrauterine devices (IUD) etc. According to American Thyroid Association, 2019, 12% of the U.S population will develop some kind of thyroid condition in their lifetime, and around 20 million Americans have been diagnosed with some kind of thyroid disorders. These factors are expected to boost the global synthetic hormone market growth over the forecast period.