Bioidentical hormones are defined as biochemically engineered hormones that are the same as those in the human body formed by natural biological processes. The use of bioidentical hormones is different from conventional hormone therapy as the latter uses animal-based hormones or synthetic hormones. Currently, estrogen, progesterone, and testosterone are available in the market in various forms, including tablets, capsules, creams, and gels. For the record, bioidentical hormones control important tasks in the body, such as growth, food breakdown, sex, and brain function, among others.
The global bioidentical hormones market is majorly driven by increasing screening for hormonal deficiency, rising geriatric population, and rising awareness among people. It is extensively used for the treatment of menopause. In October 2018, USFDA approved the usage of bioidentical hormones for the treatment of menopausal hot flashes, which is further adding fuel to the market growth. In extreme cases, women are also prescribed to undergo hormone-replacement therapy. The bio-identical hormones possess no side-effects and are easily available. Other factors driving the market include lack of nutrition, growing prevalence of sedentary lifestyle, increasing expenditure power, and rising geriatric population. Additionally, the increasing demand for bioidentical hormones is grabbing the attention of umpteen manufacturers in the market. However, the US Food and Drug Administration (USFDA) is reluctant to approve bioidentical hormones as its safety and purity cannot be guaranteed, which is further hampering the market growth to some extent. Similarly, the presence of alternative treatments for Hormone Replacement Therapy (HRT), such as antidepressants, tibolone, clonidine, and herbal medications, is likely to impede the market growth to some extent.
The estrogen segment is expected to hold a major market share in the bioidentical hormones market as it is extensively used for the treatment of menopause. Some of the symptoms of menopause include a reduction in estrogen, vaginal dryness, night sweats, and hot flashes, which can lead to a much severe disease, named osteoporosis. As per the American College of Obstetricians and Gynecologists (ACOG), in the U.S. alone, nearly 80% of the women are suffering from osteoporosis. Thereby, the rising prevalence of menopause and hormonal imbalance is subsequently increasing the demand for FDA approved estrogen. Other factors driving the market include the abundance of plant estrogens and rising demand for estrogen hormones such as estrone, estradiol, and estriol. Currently, a number of estrogens, including Estrace, Innofem, FemPatch, Evamist, and Esclim, are under the process of getting approval from the FDA. Moreover, Premarin, Menest, and Combipatch are the chief contributors to the market revenue. As per the study published by Pfizer, Premarin autonomously recorded a sale of 1,076 million in 2014. Apart from this, the development of drugs with improved safety profiles and novel delivery systems such as vaginal estrogen and transdermal estrogen is likely to boost the market growth to some extent.
The tablet and capsule segment is expected to lead the market on account of shifting preference of patients towards ease of administration and convenient dosage form. Oral medication is one of the most preferred forms of estrogen replacement therapy (ERT), which is further increasing the demand for estradiol and extra lab pills. In line with the growing demand, a number of leading players are manufacturing estrogens, progestins, and combined hormones in the form of capsules and tablets.
The oral administration route is one of the most popular modes of drug delivery. It is safe, easy to digest, inexpensive, convenient, and versatile, which is why it is prescribed by several healthcare professionals for the treatment of hormonal imbalance.
The hospital segment is dominating the bioidentical hormones market and will continue the same during the forecast period. This can be attributed to the rapidly developing healthcare infrastructure and the presence of bioidentical hormone replacement therapy centers across the globe. Additionally, a number of drug companies are investing heavily in the field and are using several marketing strategies to promote their bioidentical hormone products among the hospitals.
North America is dominating the global bioidentical hormones market. The prevalence of women suffering from menopause-related issues is increasing at a significant rate. As per the American Congress of Obstetricians and Gynecologists, in the U.S alone, around 6,000 women reach menopause every day, which is over 2 million per year. The extensive use of medications and increasing healthcare expenditure are some of the factors driving the market growth. Similarly, leading pharma companies developing and marketing novel bio-identical hormones is likely to boost the market growth to some extent. In September 2018, TherapeuticsMD, Inc., an advanced women’s healthcare firm, announced the commercial availability of Imvexxy (estradiol vaginal inserts) 4 mcg dose in the U.S. The product is FDA approved and is used in the treatment of moderate to severe dyspareunia. Additionally, the rising focus of the North American Menopause Society and the British Menopause Society on providing safe hormone replacement therapy is adding fuel to the market growth.
Europe is second in the bio-identical hormones market. This can be attributed to the increasing expenditure power, well-developed healthcare sector, rising geriatric population, and increasing screening for hormonal deficiency.
Asia Pacific is accounting for a promising growth in the bioidentical hormones market on account of rapidly rising population and expanding the healthcare sector. In China and India, the bioidentical hormones market is projected to witness significant growth in the years to come. This can be accredited to the increasing prevalence of menopause and rising expenditure power.
In the Middle East, the UAE and Saudi Arabia are projected to witness positive growth in the bioidentical hormones market. Whereas, Africa is emerging in the bioidentical hormones market on account of poor healthcare and economic development, lack of awareness among women regarding pre and post-menopausal symptoms, political instability, and lack of technological advancements. However, the region is likely to offer umpteen opportunities to the leading pharma players in the years to come.
Global bioidentical hormones market is fragmented in nature. The presence of several large and small-scale players are focusing on price, brand, and new product development to expand their consumer base. Some of the key players are engaging in acquisitions, collaborations, and partnerships to gain a competitive edge.
Some of the leading market players include Advantage Pharmaceuticals Inc., TherapeuticsMD Inc., Biostation, BioTE Medical, Defy Medical, Full Life Wellness Center, Neuva Aesthetics, and SottoPelle.
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