Hormone Replacement Therapy Market – Insights
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.
The global hormone replacement therapy market size was valued at US$ 10.58 billion in 2017 and is expected to witness a CAGR of 5.2% over the forecast period (2018 – 2026).
Global Hormone Replacement Therapy Market Share (%) Analysis, By Therapy Type 2017
Source: Coherent Market Insights Analysis (2018)
Increasing prevalence of various chronic conditions are expected to drive growth of the hormone replacement therapy market
Increasing prevalence of hypogonadism in adult men worldwide is expected to drive growth of the hormone replacement therapy market.
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.
Hormone Replacement Therapy Market Restraints
Stringent regulations proposed by the U.S. Food and Drug Administration (FDA) regarding the application of hormone replacement products, owing to increasing risk of adverse cardiovascular diseases is expected to hamper growth of the hormone replacement therapy market over the forecast period.
In February 2018, the U.S. FDA updated 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.
Furthermore, in January 2018 committee meeting, the FDA proposed the regulation demanding testosterone manufacturers to conduct a post-marketing randomized, double-blind, placebo-controlled trial, before marketing the product to determine whether this therapy increases major adverse cardiovascular diseases such as myocardial infarction and stroke or not.
Hormone Replacement Therapy Market - Regional Insights
On the basis of region, the global hormone replacement therapy market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to hold dominant position in the global hormone replacement therapy market, owing to continuous launch of various generic products for hormone replacement therapies by manufacturers.
Furthermore, Europe is expected to be the second largest contributor to the hormone replacement therapy market, in terms of revenue and is expected to gain significant traction in the near future. This is owing to launch of new drugs and therapies to combat secondary hyperparathyroidism and presence of significant population suffering from the disease in this region.
For instance, in December 2016, Amgen’s drug etecalcetide (Parsabiv) received marketing approval in Europe by the European Commission for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney diseases.
Asia Pacific is expected to witness fastest growth over the forecast period, owing to increasing healthcare associated issues with rising incidence of chronic diseases, high prevalence of hypogonadism in men with type II diabetes mellitus, and rising prevalence of diabetes population in this region.
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 region and Western Pacific region in 2017, was 82 million and 159 million, respectively.
Global Hormone Replacement Therapy Market Value (US$ Mn) & Y-o-Y Growth (%)
Source: Coherent Market Insights Analysis (2018)
Hormone Replacement Therapy Market - Competitive Landscape
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.
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.