Hormone Replacement Market In-depth Analysis by Key players Novartis AG, Abbott Laboratories, Mylan N.V., Merck KgaA, Bayer AG, Pfizer Inc., Novo Nordisk A/S

New mergers and acquisitions is one of the major factor driving the growth of the hormone replacement therapy market. For instance, in 2014, Pfizer Inc., a U.S.-based pharmaceutical company, merged with OPKO Health Inc., a U.S.-based company, to develop a long acting growth hormone (hGH-CTP) and innovative treatments for growth hormone deficient patients. hGH-CTP is more convenient, as the patients need to take just one injection in a week rather than daily doses. hGH-CTP has an orphan drug designation in the U.S. and Europe for adults and children with growth hormone deficiency.

Robust pipeline is also expected to support growth of the hormone replacement therapy market size. For instance, Somapacitan sponsored by Novo Nordisk A/S, a Denmark-based company, completed phase 3 clinical trials in 2017. This drug is used for the treatment of growth hormone deficiency in adults.

Increasing prevalence of hypogonadism in adult men worldwide is expected to drive growth of the hormone replacement therapy market.

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According to the European Association of Urology: 2016 report, in middle-aged men, the incidence of hypogonadism varies from 2.1% to 12.8%. The incidence of low testosterone and symptoms of hypogonadism in men aged 40-79 varies form 2.1% to 5.7%, in Europe.

Ease in access and government support for research and development activities is expected to aid in growth of the hormone replacement therapy market. Financial help by NGOs such as the National Gaucher Society help patients receive enzyme replacement therapy that are costly.

Manufacturers are focusing on developing generic versions of various drugs for the treatment of certain disorders that are highly prevalent in women such as hypothyroidism. For instance, Teva Pharmaceutical Industries Ltd. launched generic version of Vagifem (estradiol vaginal inserts), 10 mcg in the U.S. on 24, July 2017. Estradiol vaginal inserts are an estrogen indicated for the treatment of atrophic vaginitis due to menopause.

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Moreover, on December 29, 2017, Mylan N.V. got the U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Estradiol Vaginal Cream USP, 0.01% and thus, the company launched this drug in the U.S. This cream is the first generic version of Allergan's Estrace Cream, indicated for the treatment of vulvar and vaginal atrophy.

Mylan is one of the few companies that offers Estradiol in four delivery systems – cream, gel, transdermal patch, and tablet. This provides greater benefit to healthcare professionals and patients, and brings long-term sustainability to their business.

Key players operating in the global hormone replacement therapy market include Novartis AG, Abbott Laboratories, Mylan N.V., Merck KgaA, Bayer AG, Pfizer Inc., Novo Nordisk A/S, QuatRx Pharmaceuticals, Teva Pharmaceutical Industries Ltd., Amgen, Inc., and Eli Lilly and Company.

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