The market for testosterone replacement drugs is booming, with no signs of easing in the future, market analysts say. Abbott Laboratories, the maker of Androgel 1.62% and Androgel 1% and Auxilium Pharmaceuticals, which makes Testim 1%, are aggressively marketing their testosterone drugs to millions of men in the U.S. with low testosterone levels, and those efforts are paying off.
Sales of testosterone replacement drugs hit $1.6 billion in 2011, up 133 percent in just four years. According to data compiled by Bloomberg analysts, 5.6 million prescriptions were written for testosterone replacement therapies last year and sales are expected to triple to $5 billion in just the next five years.
Abbott recently announced that U.S. sales of Androgel shot up more than 23 percent in the first quarter of 2012 to $230 million. According to Larry Peepo, divisional vice president of investor relations at Abbott, “AndroGel holds the number-one market share position in the testosterone replacement market, where growth is being driven by increasing diagnosis and treatment.”
“AndroGel 1.62, our new low-volume formulation, has quickly become the second most-prescribed therapy in the market, second only to our older formulation AndroGel 1%,” he explained in a recent first-quarter earnings conference call with investors.
Pennsylvania-based Auxilium Pharmaceuticals credits its testosterone drug Testim for most of the company’s $73.6 million in net revenues reported for the first quarter of 2012. Total U.S. revenues of Testim were $58.7 million, up 27 percent from $46.1 million in the first three months of 2012.
In the U.S., nearly 14 million men age 45 years and older have low testosterone levels, according to a 2006 study published in the International Journal of Clinical Practice. For them, testosterone replacement drugs may help them regain strength and improve libido and sexual function. Others with normal testosterone levels covet the drugs for muscle-building and sexual-enhancement purposes.
Many doctors are alarmed over the soaring sales of testosterone drugs for recreational and other off-label uses. Men who use topical testosterone drugs to achieve excessive testosterone levels are at risk of developing prostate tumors and prostate cancer, low sperm count, inflammation and swelling, blood clots, liver damage, hypertension, and other risks ranging from mild to life-threatening. But they aren’t the only ones at risk.
Because Androgel and Testim are applied topically to the skin, women and children who come into contact with the user or his clothes, towels, and sheets may develop signs of secondary exposure. For women, those signs include changes in hair distribution, acne breakouts, and other adverse testosterone-related effects. Young children exposed to the drug may experience inappropriate sexual development including enlargement of the penis or clitoris, pubic hair, increased erections, aggressive behavior, and advanced bone age.
With sales of topical testosterone drugs expect to more than triple in the next five years, it stands to reason that the risk of secondary exposure for women and children and adverse reactions for men who use the drugs inappropriately will also soar.