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Amid the ongoing multidistrict litigation in Illinois federal court (In re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545), latest reports show that global testosterone replacement therapy revenues will fall to $1.3 Billion dollars by 2024, down from $2 Billion in 2015, with a prospective negative compound annual growth rate of 4.2%.
Men experience low testosterone levels from either a disease known as hypogonadism, in which the body is unable to produce normal amounts of testosterone, or merely be due to normal aging, where testosterone levels start gradually declining after men reach the age of 30. Around 30% of men worldwide suffer from hypogonadism or testosterone deficiency as shown by different studies. Common symptoms of low testosterone levels include muscle loss, lower strength, fatigue, depression, low libido, erectile dysfunction, infertility, osteoporosis or hair loss. Although the U.S. Food and Drug Administration (FDA) approved testosterone replacement therapy products only to treat hypogonadism, men seek to use these products for non-medical reasons including increasing physical development and performance or counteracting the natural aging process.
Testosterone Replacement Therapy Products
Doctors prescribe testosterone replacement therapy drugs, medications and treatments to treat low testosterone in millions of men in the U.S. each year. Testosterone products may be in the form of injection, cream/gel, implant, gum/buccal adhesives, patch or pill. Some of the more common treatments for low testosterone are or have been Androderm, AndroGel, Android, Androxy, Axiron, Bio-T Gel, Delatestryl, Depo-Testosterone, Fortesta, Methitest, Striant, Testim and Testopel.
After several studies linking testosterone replacement therapy products to increased risks of stroke, heart attack or death, the FDA issued several drug safety communications warning of the dangers of testosterone replacement therapy products, particularly for uses other than hypogonadism. Further, the FDA required manufacturers of all approved prescription testosterone products to (i) change their labeling to clarify the approved uses of testosterone therapy products and add information about a possible increased risk of heart attacks and strokes associated with testosterone use, and (ii) conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of testosterone products.
Many users of testosterone replacement therapy products have filed federal lawsuits across the United States against pharmaceutical manufacturers seeking damages for serious injuries, alleging that the manufacturers (i) recklessly marketed testosterone products in misleading advertisements which created a “disease” (“Low T”) based upon general symptoms and natural issues, causing otherwise healthy men to seek dangerous prescription medications, and (ii) failed to adequately research and warn the public of the risks of testosterone therapy products.
In June 2014, many of the lawsuits were consolidated into a multidistrict litigation (MDL) in Illinois federal court to resolve common issues among the cases (In re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545). Preliminary bellwether trials to test jury reaction to lawsuits representative of the MDL plaintiff pool are scheduled to continue through 2017.
Current Market Conditions
The global market for testosterone replacement therapy is highly consolidated, with the top five manufacturers comprising 80% of the market. Major manufacturers in the global testosterone replacement therapy market are Allergan plc, Novartis AG, AbbVie, Inc., Endo Pharmaceuticals, Inc., Bayer AG, Eli Lilly and Company, Mylan N.V., and Pfizer, Inc. North America dominates the global testosterone replacement market by accounting for approximately 85%, primarily from the high demand for advanced testosterone replacement therapy products in the United States, which made up 95% of the North America market in 2015. Europe, Asia Pacific, the Middle East and Africa, and Latin America follow.
The cream/gel segment of products presently accounts for a dominant share of the market due to sales of branded formulations. However, the injections product segment growth rate will outpace the others as more consumers purchase injections as they are relatively inexpensive and can be self-administered.
A major concern in the global testosterone replacement therapy market is the impending patent expiration of some of the top-selling products, which will flood the market with lower-priced generics and decrease revenues of the dominant manufacturers. The product segment predicted to be affected most is gels/cream, which maintains a high market share given its ease of use and reduced side effects. Another potential market hindrance is the possible risk of cardiovascular or metabolic disease resulting from the treatment of testosterone deficiency.
The foregoing adverse testosterone replacement therapy market effects may be countered by growing instances of testosterone deficiency and an increasing geriatric population. Also expected to help sales is increasing awareness of testosterone replacement therapy and the release of innovative testosterone replacement therapy technology including spray-on and unmodified testosterone. Asia Pacific is expected to demonstrate fast growth given significantly higher investment in healthcare, with South Korea and Japan having a growing elderly population.