Synthetic hormones are foreign substances, synthesized in the laboratory and are used for the treatment of hormonal imbalance in the human body. Hormones such as progesterone, estrogen, thyroid hormone, testosterone, and insulin are some of the synthetic hormones used widely for different health conditions. Some examples of the synthetic hormones available in the market are Ferring B.V. product Zomacton injection (Somatropin) which is used to treat growth hormone deficiency in children. Moreover, IBSA Institute Biochimique SA’s product, Tirosint, is also available as a liquid levothyroxine formulation for the treatment of hypothyroidism in individuals suffering from deficiency of thyroid hormone. Some of the manufacturers operating in the global synthetic hormones market are Pfizer Inc., McGuff Pharmaceuticals, Inc. and others.
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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.
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.
North America is expected to witness significant growth in the global synthetic hormones market over the forecast period owing to widespread presence of several key manufacturers across North America and a large customer base. Moreover, key players are engaged in development and introduction of generic products in the region. For instance, Teva Pharmaceutical Industries Ltd., launched generic version of Vagifem (estradiol vaginal inserts) in the U.S. in July 2019 which is indicated for the treatment of atrophic vaginitis in menopausal women.
Moreover, Clarus Therapeutics, a manufacturer in the U.S., recently received an U.S. FDA approval in March 2019, for the production of a soft gel capsule containing prodrug for the hormone testosterone which will be useful for the hormone replacement therapy in hypogonadal males. Other manufacturers like Pfizer Inc., McGuff Pharmaceuticals, Inc., Lyndra Therapeutics, Inc., American Regent, Inc., Acerus Pharmaceuticals Corporation and Lupin Pharmaceuticals have presence in North America.The increasing incidence of hormonal imbalance in the population is expected to support growth of the North America synthetic hormones market. Highest incidence of hormonal imbalance have been recorded in the North America region. According to the Global Reproductive Health, International Federation of Fertility Societies, 2018, in the U.S., around 70 million women are over the age of 45 years, out of which, around 58.8% of women are expected to experience hot flashes during the menopausal and post-menopausal stage. Therefore, increasing incidences of hormonal imbalance across North America are expected to boost the global synthetic hormones market over the forecast period.
Some of the key players operating in the global synthetic hormones market are Pfizer Inc., McGuff Pharmaceuticals, Inc., Lyndra Therapeutics, Inc., Ferring B.V., Slayback Pharma LLC, American Regent, Inc., Endo Pharmaceuticals Inc., IBSA Institute Biochimique SA, Acerus Pharmaceuticals Corporation, and Lupin Pharmaceuticals, Inc.
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