HORMONE REPLACEMENT THERAPY MARKET ANALYSIS

Market Size and Trends

The global hormone replacement therapy market is estimated to be valued at USD 14.89 Bn in 2024 and is expected to reach USD 22.04 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 5.8% from 2024 to 2031.

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The global hormone replacement therapy is expected to witness significant growth over the forecast period. Rising prevalence of hormonal deficiencies due to the increasing geriatric population is expected to drive the demand for hormone replacement therapy. Additionally, increasing consumer awareness about benefits of the treatment in managing menopausal symptoms is further expected to propel the market growth. However, risks and side effects associated with long-term use of hormone replacement therapy such as blood clots, heart attacks, and breast cancer could hamper the market growth.

Market Driver – Increasing Product Launches by Key Market Players

Market players are involved in launching new drugs and this is expected to drive growth of the global hormone replacement therapy market over the forecast period. For instance, in October 2021, Theramex, a pharmaceutical company, announced that it had launched Bijuva/Bijuve (estradiol and progesterone) across Europe and the U.K. Bijuva/Bijuve (estradiol and progesterone) is the first and only body-identical combined hormone therapy treatment for post-menopausal women.

Market Concentration and Competitive Landscape

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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 the 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 1,000 people per year in the U.S. Testosterone production declines as a function of age, and the prevalence of hypogonadism increases with aging.

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One of the major factors hindering the growth of the global hormone replacement therapy market is various side effects associated with these therapies. Hormone replacement therapies aim to alleviate symptoms of menopause by compensating for the loss of estrogen and progesterone, however, in doing so they can also cause undesirable side effects in many patients. Common side effects include breast tenderness, headaches, nausea, mood changes, and weight gain. More serious potential side effects include increased risks of blood clots, stroke, and certain types of cancers like breast and endometrial cancer. The risk of side effects has led many patients to avoid hormone replacement therapies or stop treatment prematurely. For example, data from the National Health and Nutrition Examination Survey conducted between 2015 and 2018 showed over 25% of U.S. women who started hormone replacement therapy discontinued use within the first year, often citing side effects and safety concerns. This skepticism around long-term use means the market relies heavily on new patients needing short-term symptom relief, rather than retention of patients on ongoing treatment regimens. Manufacturers have struggled to convince those who experienced side effects to continue usage or to attract those wary of potential issues.

Market Opportunities – Government Support for Research and Development Activities

Increasing government support for research and development activities is expected to offer lucrative growth opportunities over the forecast period. For instance, 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.

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The therapy type segment includes estrogen replacement therapy, human growth hormone (HGH) replacement therapy, thyroid replacement therapy, testosterone replacement therapy, and others. The human growth hormone (HGH) replacement therapy sub-segment is estimated to hold 35.6% of the market share in 2024 owing to increasing product launch. For instance, in May 2022, Lindora Wellness, Inc., a medically supervised health and fitness organization, launched Hormone Replacement Therapy (HRT). Lindora, which 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 growth.

Insights, By Route of Administration: Oral Administration Steals Limelight Driven by Convenience

The route of administration segment includes oral, parenteral, and others. The oral sub-segment is estimated to hold 32.4% of the market share in 2024 owing to convenience advantages. The hormone replacement therapy landscape has seen a persistent shift away from parenteral routes towards oral medications. Various formulations in development focus on oral drug delivery to tap into these perceived benefits driving its popularity. The dominance of the oral administration segment therefore stems primarily from heightened convenience and discretion it provides patients.

Insights, By End User: Specialized Hospitals Lead Uptake Concentrated Services

The end user segment includes hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies sub-segment is estimated to hold 43.1% of the market share in 2024 owing to their specialized expertise. Hormone replacement usually demands oversight from experienced endocrinologists involved in complex diagnoses and treatment planning. Hospitals are better equipped than other channels to handle the multifaceted requirements of HRT. They employ trained staff across departments to efficiently manage the entire treatment cycle from consultation and testing to dispensing therapies and monitoring patient response. This level of integrated care helps address issues often underlying hormonal imbalance. Their consultative role additionally creates greater confidence and adherence to long-term HRT management. Hence, their concentrated clinical services remain irreplaceable for streamlining specialized HRT services.

Regional Insights

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North America remains the dominant region in the global hormone replacement therapy market and is estimated to hold 39.2% of the market share in 2024. With the U.S. being home to some of the leading pharmaceutical companies, the regional market has robust infrastructure and supply chain for consistent production and distribution. Countries like the U.S. and Canada have solid healthcare systems and favorable reimbursement schemes driving the widespread adoption of hormone replacement therapy drugs. Moreover, North America is at the forefront of clinical research and drug innovation in this field. Regional players invest heavily in R&D to develop more effective and advanced formulations. This has enabled them to regularly roll out new products catering to unmet needs. The early approval and availability of such innovative drugs consolidate North America's market supremacy. It also helps companies protect their intellectual property and maintain higher pricing and market shares compared to other regions.

While North America reigns supreme currently, Asia Pacific is emerging as the fastest growing regional market for hormone replacement therapy. Countries like China, India, Japan and South Korea have large geriatric populations prone to hormonal decline. With improving access and affordability of healthcare in Asia Pacific, more women are opting for hormone therapy to alleviate menopausal symptoms. Rising medical tourism is also a significant growth driver as international patients travel to the region for low-cost treatment. Additionally, various Asia Pacific countries are actively working to strengthen their pharmaceutical manufacturing sectors. Regional players are enhancing their production capabilities and seeking technology transfer opportunities. Multinational corporations are also extending their reach through collaborations or by setting up local manufacturing plants. All these factors are contributing to Asia Pacific's rapid market expansion in the hormone replacement therapy domain.

Market Report Scope

Key Developments

• In June 2023, Pfizer Inc., a pharmaceutical company, announced that the DUAVEE (conjugated estrogens/bazedoxifene), an estrogen-based menopause hormone therapy, is back in stock in the U.S., with improved packaging, following a voluntary recall. The recall was due to an issue with the packaging and was not based on any efficacy or safety concerns with the product itself
• In June 2023, Pfizer Inc., a pharmaceutical company, and OPKO Health Inc., a pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) had approved NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone
• In May 2023, Astellas Pharma Inc., a pharmaceutical company, announced that the U.S. Food and drug Administration had approved VEOZAH (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause
• In June 2022, Myovant Sciences, a biotech company, and Pfizer Inc., a pharmaceutical and biotechnology company,y announced the U.S. Food and Drug Administration (FDA) had 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.

*Definition: 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.

Market Segmentation

• Therapy Type Insights (Revenue, USD Bn, 2019 - 2031)
  • Estrogen Replacement Therapy
  • Human Growth Hormone (HGH) Replacement Therapy
  • Thyroid Replacement Therapy
  • Testosterone Replacement Therapy
  • Others
•  Route of Administration Insights (Revenue, USD Bn, 2019 - 2031)
  • Oral
  • Parenteral
  • Others
•  Application Insights (Revenue, USD Bn, 2019 - 2031)
  • Hypothyroidism
  • Male Hypogonadism
  • Growth Hormone Deficiency
  • Others
•  Distribution Channel Insights (Revenue, USD Bn, 2019 - 2031)
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Novartis AG
  • Abbott 
  • Mylan NV
  • Merck KgaA
  • Bayer AG
  • Pfizer Inc.
  • Novo Nordisk A/S
  • QuatRx Pharmaceuticals
  • Teva Pharmaceutical Industries Ltd.
  • Amgen, Inc.
  • Eli Lilly and Company
  • Halozyme Therapeutics, Inc.
  • AbbVie, Inc.
  • Noven Pharmaceuticals, Inc.
  • I-MAB Biopharma Co., Ltd.
  • Myovant Sciences