Testosterone replacement therapies enjoyed a boom in sales in recent years thanks to heavy advertising by drug companies like AbbVie Inc., which peddled its testosterone treatment AndroGel through television ads and websites aimed directly at male consumers. But the expansion of the testosterone market is slowing down thanks to stiffer prescribing requirements by the Food and Drug Administration (FDA).
Sales may also be affected by high risk cardiovascular diseases, legal regulations and the risk of prostate cancer, according to WiseGuyReports’ latest analysis titled “The U.S. Testosterone Market Report: 2016 Edition.”
Testosterone therapy has emerged as a prominent segment of the pharmaceutical industry. Testosterone is the male hormone that is responsible for maintaining muscle mass, bone growth, sexual function and an overall sense of well-being. Some men suffer from hypogonadism, a condition in which the body does not produce enough testosterone. This is generally caused by injury or loss of testicles, chemotherapy, genetic abnormalities, chronic diseases and alcoholism. Testosterone treatments are indicated for men with hypogonadism.
However, as men age, their testosterone levels tend to drop. This is not an approved indication for testosterone treatment, and the FDA has taken measures to ensure the medication is not used for unapproved uses.
Key factors driving the growth of the testosterone industry include an aging population, decrease in fertility rate, and increase in obesity, according to the report. More testosterone products are also vying for FDA approval. But the growth of the market is likely to be affected by health risks and legal regulations.
Testosterone manufacturers currently face about 7,000 lawsuits alleging the hormones put men at risk of serious cardiovascular events including heart attacks, strokes and blood clots, some of which can be fatal. The lawsuits also accuse drug companies of aggressively marketing their products for unapproved uses, such as so-called Low T.
In the first testosterone side effects trial to reach verdict, the jury slapped testosterone maker AbbVie with a $150 million verdict for deceptive marketing of its testosterone treatment AndroGel.