After a year of regulatory warnings and safety debates over "Low T" drugs, it's no surprise that drugmakers like Eli Lilly ($LLY) and AbbVie ($ABBV) expect their testosterone sales to suffer in 2015. But as the mainstream medical community apparently moves away from testosterone-replacement meds, specialized clinics are taking up the charge.
The rise of testosterone use has opened new doors for entrepreneurial doctors, Fusion reports. All over the U.S., clinics that distribute the meds are popping up--across the South in particular. The FDA and EMA may discourage use of the drugs for "lifestyle purposes," but these centers encourage men to do just that. Testosterone can boost energy, muscle mass and sex drive, so why not take advantage, they say.
As one doctor told Fusion, his testosterone clinic is meant to promote wellbeing rather than treat hypogonadism, a medical condition characterized by low testosterone levels. "Our philosophy is to stay out of medical buildings, even though we are medical doctors, because we don't want to be sick-oriented," he said. "I don't prescribe any 'sick' medicines. I prescribe hormones and supplements."
The market shift could keep testosterone meds chugging along--and judging by recent sales figures and forecasts, they could use the help. Androgel maker AbbVie saw Q4 sales plunge 20% in the fourth quarter, reaching just $230 million. And that's not to mention the generic competition headed its way for the 1% Androgel formulation, which it expects to hit early this year.
Fellow testosterone marketer Eli Lilly also expects a decline for its Axiron drug, which didn't help the Indianapolis drugmaker's already-bleak revenue forecasts. Earlier this month, the company said its 2015 sales would range from $20.3 billion to $20.8 billion, only to later bring the prediction down a peg to $19.5 billion to $20.0 billion.
"The U.S. testosterone market has declined significantly and may be headed lower, affecting our U.S. Axiron sales," CFO Derica Rice said on a guidance call in early January.
And Low-T critics would like to keep it that way, after a testosterone surge--prompted in part by Big Pharma DTC advertising--took the market to all-time highs in recent years. As many experts argue, the therapies come along with cardio risks--safety concerns that regulators are looking into. In the meantime, in September an FDA committee of experts voted 14-1 to recommend that the agency restrict testosterone-replacement therapies to men with a related medical condition, such as a tumor or genetic disorder.
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