Demand Grows for Alternative to Hormone Therapy in Menopausal Women

Tuesday 27 November 2012, Amsterdam

There is room for improvement in the female health disorders market, and this is fuelling pharmaceutical companies to invest in R&D programs, stated a new report by healthcare experts.

The new report states that increased focus is being shown in therapy areas such as menopause, female sexual dysfunction and infertility, as large target markets and unsatisfactory existing treatments make patients a willing target for new treatments.

The ageing population is driving the menopause therapeutics market, as menopausal symptoms often emerge after the age of 50, with indications such as hot flashes affecting up to 85% of menopausal women. As the population grows older, the number of postmenopausal women will increase.

The menopause therapeutics market is currently dominated by hormone therapies with highly questionable safety profiles. Patients as well as physicians are often reluctant to try hormone therapy as the first line treatment for menopausal symptoms and osteoporosis, as a result of studies such as the WHI Memory Study (WHIMS), the Estrogen Replacement and Atherosclerosis (ERA) study, and the Million Women Study, which have all raised concerns over the safety profile of hormone treatment (HT). Results suggested that hormone treatment (HT) was associated with an increased risk of breast cancer, venous thromboembolism and stroke. The availability of alternative options such as lifestyle and diet changes, exercise and home remedies has also damaged the hormone therapy market, as despite the severity of postmenopausal symptoms, a majority of postmenopausal women tend to opt for home remedies and lifestyle changes rather than using hormone therapy.

Aprela is a progesterone-free treatment for menopausal symptoms which combines conjugated estrogens and bazedoxifene. The drug is currently under review by the US FDA for approval, and is predicted to restore the HT market with peak sales of approximately $1 bn after its expected approval next year. Aprela has shown favorable results in initial studies in comparison to other HT therapeutics, with studies suggesting that Aprela may pose fewer risks and milder side effects than Prempro and Premarin, and no evidence of breast tenderness and pain or increased breast cancer rates as compared to Evista. Other studies revealed that Aprela recipients experienced better sleep and diminished hot flashes compared to women who were treated with a placebo. The drug may therefore provide a better line of treatment for postmenopausal women. Once approved, the treatment is expected to compete strongly with medication currently on offer, significantly altering the menopause market dynamics.

Progression is also being made in the treatment of related menopausal conditions. The female sexual dysfunction therapeutics market currently does not have any FDA approved drugs that are comparable to Viagra for males, but there are many promising molecules in the late stage development phase, most of which have demonstrated high safety and efficacy profiles in clinical trials. If these new therapies can cater to the significant unmet need associated with current treatment options for female sexual dysfunction, they can command a price premium and drive the women’s therapy market. 

Steps are also being made in the postmenopausal osteoporosis market, with Amgen Inc recently launching first-in-class drug Prolia, and Merck’s cathepsin K inhibitor Odanacatib (MK-0822) also showing promising results.

The women’s health therapeutics market, including treatments for postmenopausal osteoporosis, hormone replacement therapy, infertility, contraceptives and endometriosis, was valued at $18.8 bn in 2011.

This report provides insights into the women’s health therapeutics market until 2018.

The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by a team of industry experts.