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Market development key for testosterone replacement therapy, set to be a $1.4 billion market in



Staff Member
Aug 11, 2010
Despite growing at a compound annual growth rate of more than 24% over the last five years, the testosterone replacement therapy market is severely underdeveloped. This suggests there are great opportunities for pharmaceutical companies in this field, claims independent market analyst Datamonitor.

The testosterone replacement therapy market, valued at $838 million across the seven major markets - the USA, Japan, France, Germany, Italy, Spain and the UK - is far from saturated, with only an estimated 5% of people affected by the disorder receiving treatment.

Over 57 million men across the seven major markets suffer from testosterone deficiency syndrome, also known as male hypogonadism. Studies suggest that up to 50% of men could have very low levels of testosterone leading to a variety of symptoms including decreased muscle mass, decreased libido and erectile dysfunction. Treatment consists in restoring the hormone levels in the body through testosterone replacement therapy.

Maya Marescotti, health care analyst at Datamonitor, comments: “Given the low diagnosis and treatment rates, there is an opportunity for companies to invest resources and develop the market. Common strategies to raise awareness include didactic symposia for physicians and educational campaigns in the media for the public.”

The USA is by far the largest market, accounting for over 95% of sales in 2009 and was also the fastest growing.

Generic erosions for existing products; Lilly’s Axiron expected in 2011
Going forward, Datamonitor expects the market, which is driven primarily by topical formulation, to display growth, reaching $1.4 billion in 2019. However, growth will be slower due to the generic incursion for key products such as Androgel (testosterone gel, from Abbott/Solvay) and Androderm (testosterone patch, from Watson) in the USA. While all drugs have similar efficacy and side-effect profile, drugs will have to mainly differentiate on price and formulations.

Assuming US Food and Drug Administration approval, Eli Lilly (NYSE: LLY) is expected to launch Axiron (testosterone) - the first underarm metered dose spray - in 2011. Lilly will be able to drive Axiron’s sales, which will reach over $370 million in 2019, by leveraging its sales and marketing resources, as well as its experience in the men’s health sector with erectile dysfunction drug Cialis (tadalafil),says Datamonitor.
Lilly acquired rights to the drug earlier this year in a deal worth a potential $335 million to Austrian firm Acrux, with an upfront $50 million (The Pharma Letter March 16).