Hormone Replacement Therapy Market Latest Innovations by Top Players Novartis AG, Abbott Laboratories, Mylan N.V., Merck KgaA, Bayer AG, Pfizer Inc

Key players in the market are focused on adopting M&A strategies in order to enhance their market share, which is expected to boost growth of the market. For inatance, 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 new therapies for growth hormone deficient patients. The hGH-CTP is easy to use and one injection can be administered in a week rather than daily doses. The U.S. Food and Drug Administration has designated hGH-CTP with orphan drug designation in the U.S. The growth hormone also received orphan drug designation in Europe for adults and children with growth hormone deficiency.

Increasing number of products in development phase is expected to boost growth of the hormone replacement therapy market. 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.

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Increasing number of adult men suffering from hypogonadism is contributing to high demand for hormone replacement therapy. For instance, 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.

Moreover, major governments worldwide are focused on supporting R&D in hormone replacement therapy, which is also expected to boost growth of the hormone replacement therapy market. For instance, NGOs such as the National Gaucher Society offer financial aid to patients requiring enzyme replacement therapy.

Major regulatory bodies worldwide have imposed stringent regulations for use of hormone replacement therapy and related products as these may make patient vulnerable to cardiovascular conditions. This scenario is expected to limit adoption of hormone replacement therapy, thereby hindering the market growth over the forecast period. For instance, in February 2018, the U.S. Food and Drug Administration updated its policies and stated that testosterone replacement product manufacturers need to change the labelling to inform the patients about possible increased risk of heart attack and stroke. Moreover, in January 2018, the agency proposed the regulation that required testosterone manufacturers to conduct a post-marketing randomized, double-blind, placebo-controlled trial, before marketing the product. Though this, manufacturers are required to assess if a particular treatment has adverse effects and if that may lead to cardiovascular diseases such as myocardial infarction and stroke.

The global hormone replacement therapy market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. The market in North America is expected to account for the largest market share over the forecast period. Key players in the market are focused on approval and launch of new products and therapies in order to enhance their market share, which is expected to drive growth of the market over the forecast period.

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The market is Europe is expected to follow North America in terms of market share. Key players in this market are focused on approval and launch of new therapies for the treatment of secondary hyperparathyroidism. Moreover, high prevalence of secondary hyperparathyroidism is also expected to contribute to growth of the market. For instance, in December 2016, Amgen received marketing approval from the European Commission for its drug etecalcetide (Parsabiv) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney diseases.

High prevalence of chronic disorders, hypogonadism in men with type II diabetes mellitus, and diabetes is expected to increase demand for hormone replacement therapy in Asia Pacific. For instance, according to the International Diabetes Federation (IDF) Diabetes Atlas: 2017, number of people suffering from diabetes aged between 20 to 79 years in South East Asia and Western Pacific in 2017 was 82 million and 159 million, respectively.

Key players in the market are focused on developing biologics of various drugs that can be used in management and treatment of hypothyroidism. For instance, in July 2017, Teva Pharmaceutical Industries Ltd. launched generic version of Vagifem (estradiol vaginal inserts), 10 mcg in the U.S. Estradiol vaginal inserts are estrogens indicated for the treatment of atrophic vaginitis due to menopause. Similarly, in December 2017, the U.S. FDA approved Abbreviated New Drug Application (ANDA) for Mylan N.V.’s Estradiol Vaginal Cream USP, 0.01%, following which the company launched this drug in the U.S. The product is the first generic version of Allergan’s Estrace Cream, indicated for the treatment of vulvar and vaginal atrophy. Mylan provides Estradiol in four delivery systems – cream, gel, transdermal patch, and tablet.

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

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