DefinedHealth

To date, the “sexual dysfunction” market has been limited to (1) the big-pharma dominated and serendipitously developed $1.34 billion US PDE-V inhibitor market, and (2) a $500 million US testosterone drug delivery market. Otherwise, male and female sexual dysfunction categories remain dormant and ill-defined therapeutic categories. After a flurry of analyst and popular press coverage subsequent to the launch of Viagra, Levitra and Cialis, followed by interest in 2005 around the potential market for female sexual dysfunction (FSD), there has been a curious lull in the buzz around new products to treat both male and female sexual dysfunction.

Sexual dysfunction is complex on many levels. In addition to the fact that there are a myriad of etiologies — including concomitant drug therapies — pathways are complex, involving physical as well as psychological mechanisms, and neither the underlying causes, nor the pathways are well understood. The FDA, managed care and society play confounding roles, in that there is a perceived “lifestyle” aspect to sexual dysfunction, and a corresponding reticence to approve or pay for treatments, particularly given side effect and toxicity considerations.

Moreover, patients and physicians are reluctant to even discuss the condition. In this installment of our 6th annual Insight Series, Defined Health will attempt to characterize the market, elucidate the currently understood science behind male and female sexual dysfunction, and explore the pipeline with an eye toward biopharma’s ability to innovate in a meaningful way to tap into this market.