TESTOSTERONE REPLACEMENT THERAPY MARKET ANALYSIS

Market Challenges And Opportunities

Testosterone Replacement Therapy Market – Restraints

Stringent regulations proposed by the U.S. Food and Drug Administration (FDA), regarding the application of testosterone products, owing to increased risk of adverse cardiovascular events is expected to hamper the growth of the testosterone replacement therapy market, in near future. The U.S. FDA in February 2018 updated policies, stated that testosterone replacement product manufactures requires to change the labelling to inform the patients about possible increased risk of heart attack and stroke.

...Furthermore, in January 2018 committee meeting, FDA proposed the regulation, demanding testosterone manufactures to conduct a post-marketing randomized, double-blind, placebo-controlled trial to definitively determine whether these therapies increase major adverse cardiovascular events, such as myocardial infarction and stroke or not before marketing the product.