New Studies Reestablishing Safety of HRT & Launch of Safer Drugs to Drive Growth of the Global HRT Market Amidst Challenges Posed by Widespread Off-Label Prescriptions

Revised studies re-establishing the health benefits and safety of hormone therapy, launch of new and safer drugs, and increasing demand for bioequivalent drugs are poised to drive the global market for Hormone Replacement Therapy (HRT) to reach US$10.7 billion by 2024.

Hormone Replacement Therapy (HRT), also known as Menopausal Hormone Therapy (MHT), refers to administration of [estrogen] hormones to female patients for replenishing declining natural hormone levels due to menopause.  Menopause happens during the age of 45 to 55 years on average in women, when ovaries stop producing estrogens and menstruation stops. Major menopausal symptoms include hot flashes and night sweating, heart palpitations/anxiety, and genital dryness, all caused due to drop in the estrogen hormonal levels. About 75% of menopausal women experience these symptoms. Hormonal Replacement Therapy (HRT) refers to administration of natural or synthetic estrogens, either alone or in combination with progesterone, to alleviate menopausal symtoms. In the 1980s and 90s, HRT was widely popular among the physician community and patients alike. Doctors prescribed the therapy not just for symptomal relief, but also age-related diseases including bone fractures, colorectal cancer, heart disease and overall mortality as well.

But the 2002 Women’s Health Initiative (WHI) study had shaken up the market with its findings that HRT drugs resulted in increased risk of breast cancer and heart disease. While the therapy was used by 22% of women over 40 during 1999-2000, usage had fallen down to a mere 12% by 2003-2004 and less than 5% by 2010. However, newer research undertaken in 2013 settles the WHI study concerns. A long-term follow-up trial was conducted on the women in the WHI study, which evaluated risks and advantages of HRT, and the ideal age for menopausal hormone therapy. The new studies established that HRT offers more benefits than risks for relief of menopausal symptoms in healthy women in the specific age group of 50-60 years or within 10 years of their last period, in the absence of risk factors, such as breast cancer and heart disease.

Accordingly, the North American Menopause Society and the Endocrine Society updated their guidelines for HRT, favoring the therapy for ideal candidates. The updated research findings and the large target group of menopausal women worldwide, bode well for the HRT market. This, coupled with the launch of two new drugs by TherapeuticsMD, TX-001HR (Bijuva) and TX-004HR (Imvexxy) for the treatment of VMS and VVA respectively, may boost the market significantly. Cost of the therapy may be a market restraint, with high costs of hormone products rendering them unaffordable for a large patient population. Compounding pharmacy products that are unapproved by the FDA, and growing penetration of generics are other major market restraints.

As stated by the new market research report on Hormone Replacement Therapy (HRT), the United States represents the largest and the fastest growing market worldwide, supported by high target population, revised guidelines by North American Menopause Society and The Endocrine Society supporting HRT, and new FDA approvals.

Major players in the market include Abbott Laboratories, Allergan Plc, Bayer AG, Noven Pharmaceuticals Inc., Novartis AG, Novo Nordisk A/S, Orion Pharma AB, Pfizer Inc., and TherapeuticsMD Inc.

The research report titled “Hormone Replacement Therapy (HRT) – Market Analysis, Trends, and Forecasts” announced by Global Industry Analysts Inc., provides a comprehensive review of market trends, issues, drivers, mergers, acquisitions and other strategic industry activities of global companies. The report provides market estimates and projections for Hormone Replacement Therapy (HRT) in terms of US$ for all major geographic markets such as the US, Canada, Europe (France, Germany, Italy, UK, Spain and Rest of Europe) Asia-Pacific, Latin America and Rest of World.

For enquiries e-mail us at rsd@strategyr.com or info411@strategyr.com.

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