Despite the innovative trends observed across many therapy areas, including oncology, immunology and metabolic disorders, innovation within women’s health has generally lagged behind. Notable drug classes within the women’s health market include anti-microbials for gynecological infections; painkillers and non-steroidal anti-inflammatory drugs (NSAID) for the relief of menstrual pain; hormone replacement therapy (HRT) for the relief of menopausal symptoms; and contraceptives for the regulation of menstruation, as well as the prevention of pregnancy. These therapies have been in use for many years and are highly genericized.
Prevalence rates are high across many indications within women’s health. Approximately 20–30% of reproductive age women are thought to suffer from menstrual disorders while infertility/subfertility affects approximately 13%. In addition, 25% of menopausal women suffer severe symptoms. Sexual dysfunction disorders are also highly prevalent, affecting approximately 40% of women.
Further, barriers to innovative drug development include the
low political priority historically given to women’s health disorders and
underinvestment in R&D. Consequently, the pathophysiology of many women’s
health conditions remains poorly understood, endometriosis and polycystic
ovarian syndrome (PCOS) being notable examples of this. Despite these
developments unmet needs remain high across many women’s health disorders.
Subsequently, there is strong rationale for continued R&D investment in
this therapy area.