Hormone Replacement Therapy Market Analysis

Hormone replacement therapy is used when human body is not able to produce enough hormones. It is used for the treatment for menopause, hypothyroidism, male hypogonadism, and growth hormone deficiency conditions. The signs that the individual requires hormone replacement therapy are hot flashes, night sweats, vaginal dryness, pain, itching, or burning during intercourse, bone loss, low sex-drive, mood changes, and irritability.

Global hormone replacement therapy market is estimated to be valued at US$ 13,556.7 million in 2022 and is expected to exhibit a CAGR of 5.4% during the forecast period (2022-2030).

Figure 1. Global Hormone Replacement Therapy Market Share (%), by Distribution Channel, 2022

Increasing prevalence of various chronic conditions are expected to drive growth of the hormone replacement therapy market.

Increasing prevalence of chronic conditions such as hypogonadism in adult men worldwide is expected to drive growth of the hormone replacement therapy market. For instance, in June 2021, according to European Association of Urology, male hypogonadism is a disorder associated with decreased functional activity of the testes, with decreased production and/or action of androgens and/or impaired sperm production. This is caused by poor testicular function or as a result of inadequate stimulation of the testes by the hypothalamic-pituitary-gonadal (HPG) axis. Likewise, several congenital or acquired disorders causing impaired action of androgens have also been described. In men aged between 40 and 79 years old, the incidence of symptomatic hypogonadism varies between 2.1% and 5.7%. The incidence of hypogonadism has been reported to be 12.3 and 11.7 cases per 1000 people per year in the U.S. Testosterone production declines as a function of age, and the prevalence of hypogonadism increases with ageing. Moreover, there is a higher prevalence of hypogonadism within specific populations, including men with type 2 diabetes (T2DM), metabolic syndrome (MetS), obesity, cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), renal disease, and cancer. According to the Lancet healthy longevity, testosterone sales increased 12-fold globally from US$150 million in 2000 to US$1·8 billion. During this period, testosterone had been used increasingly in men aged 40–65 years, and has been over-prescribed by some clinicians.

Hormone Replacement Therapy Market Report Coverage

Report Coverage	Details
Base Year:	2021	Market Size in 2022:	US$ 13,556.7 Mn
Historical Data for:	2017 to 2020	Forecast Period:	2022 to 2030
Forecast Period 2022 to 2030 CAGR:	5.4%	2030 Value Projection:	US$ 20,576.3 Mn
Geographies covered:	North America: U.S. and Canada Latin America: Brazil, Argentina, Mexico, and Rest of Latin America Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific Middle East: GCC Countries, Israel, and Rest of Middle East Africa: South Africa, North Africa, and Central Africa
Segments covered:	By Therapy Type: Estrogen Replacement Therapy, Human Growth Hormone (HGH) Replacement Therapy, Thyroid Replacement Therapy, Testosterone Replacement Therapy By Route of Administration: Oral, Parenteral, Others By Application: Hypothyroidism, Male Hypogonadism, Growth Hormone Deficiency, Menopause, Others By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies
Companies covered:	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.
Growth Drivers:	Increasing prevalence of various chronic conditions Ease in access  hormonal replacement therapy and government support for research and development activities for hormonal replacement therapy drugs
Restraints & Challenges:	Stringent regulations proposed by the regulatory authorities regarding the application of hormone replacement products, owing to increasing risk of adverse cardiovascular diseases High cost associated with the replacement therapy

Figure 2.Global Hormone Replacement Therapy Market Share (%), by Region, 2022

Ease in access of the hormonal replacement therapy and government support for research and development activities is expected to aid in growth of the hormone replacement therapy market.  

Increasing research and development activities by key players in market for the development of hormonal replacement drugs is expected to drive the growth of the global hormone replacement therapy market. For instance, in Juanuary 2022, AbbVie Biopharmaceutical Company, had cleared phase two trial for the Armour Thyroid being investigated for treatment of hypothyroidism.

Moreover, in July 2021, Clinical Gerontology Branch, NIA Division of Geriatrics and Clinical Gerontology funded scientists were working to answer the several questions about the health impacts of menopause. Researchers continued to gather evidence on hormone therapy. Both the American College of Obstetricians and Gynecologists and the North American Menopause Society provide guidance to clinicians on the use of hormone therapy to treat vasomotor symptoms related to menopause, including identifying the most appropriate dose and formulation that would involve the least risk. Financial help by Non-governmental organizations such as the National Gaucher Society help patients receive enzyme replacement therapy that is costly.

Global Hormone Replacement Therapy Market– Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization had declared it a public health emergency on January 30, 2020.

COVID-19 can affect the economy in three main ways: by directly affecting production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, U.A.E., Egypt, and others, are facing problems with regards to the transportation of drugs from one place to another.

However, the COVID-19 pandemic had a negative impact on the global hormone replacement therapy market, owing to decrease in production of hormone replacement drugs due to ongoing COVID-19 pandemic. For instance, in June 2022, according to National Center for Biotechnology Information, the COVID-19 pandemic had adverse effect across the globe causing enormous strain on societies and healthcare systems. The impact of the measures implemented to address the COVID-19 pandemic appears had most homogenous to date at the very end of the drug supply chain, in the destination markets. Hormone replacement therapy was associated with a 22% reduction in all-cause mortality in COVID-19.

Global Hormone Replacement Therapy Market: Key Developments

In May 2022, Lindora Wellness, Inc., a medically supervised health and fitness organization, launched Hormone Replacement Therapy (HRT). Lindora, operates 33 medically based weight loss and wellness clinics in Southern California in the U.S., had been a leader in weight loss and wellness for more than five decades. Over the last five years, the company has introduced a number of new, innovative wellness services including body composition analyses, body contouring and cryotherapy. This new program of hormonal replacement therapy launched by the Lindora Wellness, Inc., is anticipated to drive the global hormone replacement therapy market.

In June 2022, Myovant Sciences, a biotech company and Pfizer Inc., a pharmaceutical and biotechnology company announced the U.S. Food and Drug Administration (FDA) accepted for reviewing a supplemental New Drug Application (sNDA) for MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg). The sNDA proposes updates to MYFEMBREE’s United States Prescribing Information (USPI) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years. The U.S. Food and Drug Administration set a target action date of January 29, 2023 for this sNDA under the Prescription Drug User Fee Act (PDUFA). MYFEMBREE was approved in the U.S. in 2021 for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women with a treatment duration of up to 24 months.

Global Hormone Replacement Therapy Market: Restraint

The major factors that hinder growth of the global hormone replacement therapy market include high cost associated with the replacement therapy and stringent regulations proposed by the regulatory authorities regarding the application of hormone replacement products, owing to increasing risk of adverse cardiovascular diseases. In February January 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.

Key Players                                           

Major 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.