Clomiphene citrate is an oral medication that is often used to treat certain types of female infertility. Infertility is a global health issue, as its affects both men and women. Infertility in females could be due to increasing age, polycystic ovarian syndrome (PCOS), obesity, and multiple miscarriages.
Clomiphene citrate works by stimulating an increase in the amount of hormones that support the growth and release of a mature egg (ovulation). This medication is not recommended for women whose ovaries no longer make eggs properly (primary pituitary or ovarian failure). Other names of clomiphene citrate are Clomid, Clomifene, Chloramifene, and Chloramiphene. It is also used for the treatment of polycystic ovary syndrome (PCOS), secondary amenorrhea, psychogenic amenorrhea, amenorrhea galactorrhea syndrome, and others. It is taken as a 50 mg pill that is usually taken for five days in a row in the beginning of a woman’s menstrual cycle.
Clomiphene Citrate Market - Impact of Coronavirus (Covid-19) Pandemic
The COVID-19 pandemic has significantly hampered demand for clomiphene citrate because the women who are under treatment of clomiphene citrate for infertility or PCOS, tests positive for COVID-19 infection, they must suspend the clomiphene citrate treatment and other fertility treatment alongside, as per the American Society for Reproductive Medicine (ASRM). However, according to the American Society for Reproductive Medicine data of March 2020, there are reports of women who have tested positive for COVID-19 delivering babies free of the COVID-19 infection. The coronavirus is not a fatal infection for a pregnant women.
The clomiphene citrate market is estimated to be valued at US$ 10.02 million in 2020 and is expected to exhibit a CAGR of 5.4% during the forecast period (2020-2027).
Figure 1: Clomiphene Citrate Market Share (%) Analysis, By Indication, 2020
The increasing rate of infertility is expected to drive growth of the clomiphene citrate market
Infertility is a health issue that affects both men and women, worldwide. Increasing infertility rates is expected to propel global demand for clomiphene citrate over the forecast period. For instance, according to the Centers for Disease Control and Prevention (CDC) report of 2018, around 6% of women aged 15 to 44 years in the U.S. were unable to conceive after one year of continuous intercourse. Furthermore, around 12% of women aged 15 to 44 years in the U.S. had difficulty in conceiving or carrying a pregnancy till child birth in 2017. Infertility also affects men. According to the same source, around 9% of men aged 25 to 44 years in the U.S. reported that they required medical help for reproduction in 2017. Clomiphene is used to treat infertility in both men and women. The U.S. FDA approved clomiphene citrate for women infertility in 1960s whereas, its often prescribed off-label for treatment of male infertility.
Clomiphene Citrate Market – Restraints
The clomiphene citrate market is expected to be negatively affected, owing to clomiphene citrate’s inefficiency in terms of being a less effective treatment to achieve pregnancy and live child births when compared to other medicines such as Letrozole. For instance, in 2014, a team of researchers at National Institutes of Health’s (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) found that women treated with Letrozole showed high rate of ovulation and live births than women treated with the standard drug, clomiphene citrate. Furthermore, as per the same source, among women who received Letrozole, 27.5% of them eventually had a live birth and among women who received clomiphene, only 19.1% of them experienced a live child birth. The cumulative ovulation rate was higher for Letrozole group, with ovulation occurring 61.7% of the time and the women in the clomiphene group ovulated 48.3% of the time.
|Base Year:||2019||Market Size in 2019:||US$ 10.02 Mn|
|Historical Data for:||2017 to 2019||Forecast Period:||2020 to 2027|
|Forecast Period 2020 to 2027 CAGR:||5.4%||2027 Value Projection:||US$ 14.51 Mn|
Sanofi S.A., Par Pharmaceutical, Merck & Co. Inc., Teva Pharmaceutical Industries Ltd., Cipla Inc., Unichem Laboratories Ltd., Emcure Pharmaceuticals Ltd., Serum Institute of India Pvt. Ltd., Incepta Pharmaceuticals Ltd., and Shanghai Trifecta Pharma Co. Ltd.
|Restraints & Challenges:||
Clomiphene Citrate Market – Regional Analysis
The North America clomiphene citrate market is expected to hold a dominant position in the global clomiphene citrate market, owing to the high prevalence of polycystic ovary syndrome (PCOS) in the U.S. For instance, according to the Centers for Disease and Disease Control Prevention 2019, PCOS is one of the most common causes of female infertility, affecting 6 to 12% (as many as 5 million) women of reproductive age in the U.S. Moreover, more than half of the women with PCOS develop type 2 diabetes by age 40.
Furthermore, Europe clomiphene citrate market is expected to gain traction in the near future, owing to various strategies implemented by the key players in the region. Key players are focused on providing reimbursements to patients to make the medicines available at affordable prices. For instance, Sanofi S.A. provides reimbursement for CLOMID under the Pharmaceutical Benefits Scheme (PBS) in Europe and Australia, in order to make the medicines available at affordable prices for patients. PBS provides timely, reliable, and affordable access to fertility medications to the people in Europe and Australia. The medicine is prescribed for the treatment of ovulatory failure in selected infertile women who wish to become pregnant.
Figure 2: Clomiphene Citrate Market Value (US$ Mn) & Y-o-Y Growth (%), 2017-2027
Clomiphene Citrate Market - Competitive Landscape
Key players operating in the clomiphene citrate market include Sanofi S.A., Par Pharmaceutical, Merck & Co. Inc., Teva Pharmaceutical Industries Ltd., Cipla Inc., Unichem Laboratories Ltd., Emcure Pharmaceuticals Ltd., Serum Institute of India Pvt. Ltd., Incepta Pharmaceuticals Ltd., and Shanghai Trifecta Pharma Co. Ltd.
According to the data published in the National Institutes of Health (NIH) in January 2017, the most common overall cause of female infertility is the failure to ovulate, which occurs in 40% of women with infertility issues, globally. To treat such infertility problems in females, clomiphene citrate is the first choice of medicine for the past 40 years, according to the Global Library of Women’s Medicine. Gynecologists prescribe clomiphene for 1 to 6 months or more with a low dose of 50 mg daily (1 tablet) for 5 days. If ovulation does not occur after the first course of therapy, a second course of 100 mg daily (two 50 mg tablets given as a single daily dose) for 5 days is prescribed.
According to a study called ‘Clomiphene citrate usage pattern in India' conducted by Fertility Science and Research in 2014, ovulation rate was reported to increase from 21% to 60% and the pregnancy rate was noticed to be increased by 11% to 30% by majority of participants. The ovulation rate and pregnancy rate was increased using clomiphene citrate because of increased secretion of hypothalamic gonadotropin-releasing hormone (GnRH) to increase the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which will, in turn, stimulate ovarian follicular activity.
High incidence of polycystic ovarian syndrome is expected to be a key driver for the clomiphene citrate market growth. For instance, according to an article published in 2014 in Clinical Epidemiology, polycystic ovarian syndrome affects 8% to 20% of the reproductive-age women, globally. According to the World Health Organization, in 2012, polycystic ovarian syndrome affected 116 million women, worldwide.
The clomiphene citrate market growth is hindered by side effects shown by this drug, which includes headache, nausea, upper respiratory tract infection, abdominal tenderness, sinus congestion, mood swings, acne, breast tenderness, weight gain, pelvic discomfort, abnormal bleeding or spotting, vomiting, injection site pain, redness, dizziness, and ovarian hyper-stimulation syndrome (OHSS). For instance, according to a study published in NCBI, in 2016, 10% to 20% of women who consumed clomiphene citrate developed a mild form of OHSS, which will usually resolve on its own. Severe cases of OHSS occurred in less than one percent of patients in the U.S.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.
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