Hormone Replacement Therapy - Market Insights, Competitive Landscape, and Market Forecast - 2030

Hormone Replacement Therapy - Market Insights, Competitive Landscape, and Market Forecast - 2030

Hormone Replacement Therapy Market By Therapy (Estrogen Hormone Replacement, Growth Hormone Replacement, Thyroid Hormone Replacement, Testosterone Hormone Replacement, And Others), By Indication (Menopause, Hypothyroidism, Male Hypogonadism, Growth Hormone Deficiency, And Others), By Route Of Administration (Oral, Parenteral, And Transdermal), and by geography is expected to advance at a substantial CAGR forecast till 2030 owing to the increasing burden of menopause, thyroid disorder, osteoporosis, male hypogonadism, and others and the increasing research & developmental activities regarding the hormone replacement therapy across the globe

The global hormone replacement therapy is estimated to grow at a CAGR of 6.48% during the forecast period from 2024 to 2030. The hormone replacement therapy market is observing substantial market growth due to the growing burden of hormonal and targeted diseases such as menopause and osteoporosis, among others. Further, the increasing geriatric population base prone to low hormonal-related diseases, the rising awareness about menopause issues management among women, and the increasing demand for regenerative medicines such as anti-aging and reproductive-cycle boosting therapy will aid in surging the demand for hormonal replacement therapy. Additionally, the increasing research & developmental activities on hormonal replacement therapy, for instance, research on transdermal patches to improve the efficacy and other such research will increase the demand for hormonal replacement therapy in the market. Likewise, the increasing research & developmental activities along with the surging drug approvals and launches, the presence of key players in the market, and other factors will create a requisite for hormone replacement therapy in the market. Therefore, the market for hormone replacement therapy is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.

Hormone Replacement Therapy Market Dynamics:

ONE OF THE KEY ASPECTS DRIVING THE HORMONE REPLACEMENT therapy market is the rising awareness among women about the management of menopausal issues, across the globe.

The global average age for menopause onset in women is around 50 years. Women's estrogen and progesterone production levels decrease significantly after the age of 50. The pituitary gland compensates for the decrease in estrogen and progesterone production by increasing the production of follicle-stimulating hormone (FSH). This manifests physically in women as post-menopausal symptoms such as flushing and others. Further, according to the data published in 2022 by the World Health Organization (WHO), it was stated that, in 2022, women aged 50 and over accounted for 26% of all women and girls globally. The increasing burden of women aged 50 across the globe will ultimately increase the overall menopausal load, thereby increasing the demand for hormonal replacement therapy used in the management of menopausal issues such as flushing of the skin, perspiration, and palpitations, among others.

Additionally, the growing R&D activities by the key players for the discovery of novel therapeutics to treat hormonal imbalances and rising product approvals are expected to aid in the growth of the studied market over the forecast period. Also, the increasing contribution of key players in the expansion of novel therapies is ultimately bringing about the introduction of new products in the market. For instance, in January 2022, Ascendis Pharma A/S received European Commission's market authorization for its drug SKYTROFA for the treatment of children and adolescents suffering from growth hormone disorders. This product is the first once-weekly treatment for growth hormone deficiency in the pediatric population.

Also, in June 2022, Halozyme Therapeutics, Inc. announced the commercial launch of TLANDO (testosterone undecanoate), an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Thus, the rising number of approvals and launches will in turn upsurge the market of hormone replacement therapy during the forecast period.

Therefore, the factors stated above collectively will drive the overall hormone replacement therapy market throughout the forecast period from 2024-2030.

However, the high cost of drug development and launches, side effects associated with hormone replacement therapy, and the stringent regulatory approval process may prove to be challenging factors for the hormone replacement therapy market growth.

The hormone replacement therapy market was moderately impacted during the period of COVID- 19 pandemic. During the initial stage of the pandemic, the sale of the HRT suffered a downfall owing to the imposition of strict lockdown rules, and disruption in manufacturing, and supply. However, the government classified medicines and drugs under emergency products during the pandemic, thereby leading to an increase in their demand or sales. Moreover, with the involvement of online pharmacies, the sale of many over-the-counter medicines increased, impacting the market of hormone replacement drugs. Additionally, with the ease of lockdown restrictions, the upturn of resources and supply chain, the administration of the vaccine to the public, and the rising diagnosis of hormonal imbalance-related diseases, the demand for hormone replacement therapy increases and is anticipated to do the same during the forecast period from 2022 – 2028.

Hormone Replacement Therapy Market Segment Analysis:

Hormone Replacement Therapy Market by Therapy (Estrogen Hormone Replacement, Growth Hormone Replacement, Thyroid Hormone Replacement, Testosterone Hormone Replacement, and Others), Indication (Menopause, Hypothyroidism, Male Hypogonadism, Growth Hormone Deficiency, and Others), Route of Administration (Oral, Parenteral, and Transdermal), , and Geography (North America, Europe, Asia-Pacific, and Rest of the World).

In the indication segment of the hormone replacement therapy market, the menopause segment is expected to have a significant revenue share in the year 2023. This was primarily owing to the increasing prevalence of menopause in women across the globe. Also, the intensifying launches and strategic investments, and other activities by the key players related to the segment will aid in driving its market during the forecast period.

As per the latest study conducted by the Meno Martha, International Menopause Directory, it was stated that worldwide, nearly 985 million women in 2020 were aged 50 and over, and this figure is expected to rise to 1.65 billion by 2050. The rising number of women aged 50 and above will increase the overall burden of menopausal-related issues thereby increasing the demand for various HRT. For instance, a combination therapy of levonorgestrel releasing-intrauterine system (LNG-IUS) with oral or percutaneous estrogen, low-dose combined oral contraceptives (COCs), and estrogen-progestogen therapy (EPT) is usually suggested for treating the symptoms of menopause during the menopausal transition. Thus, the increasing burden of women aged 50 and above will lead to an increase in the number of menopausal issues across the globe, ultimately leading to the increased demand for menopausal treating hormone replacement therapy.

Moreover, the presence of a robust number of menopausal issues treating hormonal replacement therapy in the pipeline will also drive market growth. For instance, nearly 20 drugs are currently under clinical trial, which may create a profitable opportunity for the key players in the upcoming years.

Further, various other strategic steps by the key players in the market will help in increasing the demand for hormone replacement therapy. For instance, in June 2022, Astellas Pharma Inc. announced that a New Drug Application (NDA) for fezolinetant has been submitted to the U.S. Food and Drug Administration (FDA). Fezolinetant is an investigational oral, non-hormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.

Also, in September 2022, Theramex announced the approval of Bijuva / Bijuve across Europe and the UK. Bijuva, body-identical hormone therapy treatment (HRT) for estrogen deficiency symptoms in postmenopausal women with an intact uterus and at least 12 months since last menses, which combines estradiol and progesterone in a single daily oral capsule.

Therefore, owing to the above-mentioned factors, the demand for menopausal treating hormone replacement drugs upsurges, thereby the category is expected to witness considerable growth eventually contributing to the overall growth of the global hormone replacement therapy market during the forecast period.

North America is expected to dominate the overall Hormone Replacement Therapy Market:

Among all the regions, North America is expected to dominate the global hormone replacement therapy market in the year 2023 and is expected to do the same during the forecast period from 2024-2030.

This can be ascribed to the increasing demand for hormone replacement drugs among women in the region owing to the increasing prevalence of menopausal-related issues. Further, the rising prevalence of growth deficiency disease, thyroid disorder, osteoporosis, hypogonadism, surging research and developmental activities in the region, presence of key domicile players in the region, and others are among the key factors that contribute to the growth of the hormone replacement therapy market in North America region during the forecast period from 2022 - 2028.

For instance, as per the latest study conducted by the American Thyroid Association, more than 12% of the United States population will develop a thyroid condition during their lifetime and around 20 million Americans have some form of thyroid disease. Also, as per the U.S. Department of Health and Human Services, it was estimated that in 2022 nearly 43,800 new cases of thyroid cancer will be diagnosed in the United States. During thyroid cancer, physicians may prescribe thyroid hormone therapy to prevent the cancer cells from growing. Thus, the increasing prevalence of thyroid-related issues in the United States will ultimately upsurge the demand for hormone replacement therapy in the region.

Further, major product launches, collaborative agreements between manufacturers, favorable reimbursement policies in the region, and others are among the factors responsible for the market growth in the region. For instance, in December 2020, the US FDA approved Thyquidity (levothyroxine) oral solution, of VistaPharm, for replacement therapy of primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism, along with an additional approval as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Also, in December 2020, the US FDA approved the Myovant Sciences' Orgovyx (relugolix), which is an orally administered treatment that works by blocking the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone, thus leading to the reduction in the amount of testosterone produced by the testicles. This aids in the treatment of adult patients with advanced prostate cancer.

Therefore, the interplay of the aforementioned factors above would provide a conducive growth environment for the North American region in the hormone replacement therapy market.

Hormone Replacement Therapy Market Key Players:

Some of the key market players operating in the hormone replacement therapy market include Abbott., Novartis AG, Pfizer Inc., Merck KGaA, Bayer AG, Halozyme Therapeutics, Inc., Eli Lilly and Company, Viatris Inc., F.Hoffman-La Roche, Novo Nordisk A/S, Amgen Inc., Genentech, Inc., AbbVie Inc., Teva Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories Ltd., Ascendis Pharma Endocrinology, Inc., Vista Pharma, Inc., Clarus Therapeutics, Inc., Gedeon Richter Plc, Endo International plc, and others.

Recent Developmental Activities in the Hormone Replacement Therapy Market:

In January 2022, Pfizer, Inc. and OPKO Health, Inc. received approval from the Ministry of Health, Labor and Welfare, Japan, for the commercialization of NGENLA to treat growth hormone disorders. This product is the next-generation long-acting growth hormone injection, with a treatment frequency of a once-a-week dosage.

In November 2022, I-MAB Biopharma Co., Ltd. entered into a collaboration with Jumpcan Pharmaceutical Group for the development & commercialization of eftansomatropin alfa (TJ101) in China. TJ101 is a long-acting recombinant human growth hormone, which is currently under phase 3 clinical trial for the treatment of pediatric growth hormone deficiency.

In August 2020, the U.S. FDA approved Sogroya (somapacitan-beco), an HGH replacement therapy product developed by Novo Nordisk A/S. This product is administered once a week through a subcutaneous route in adults diagnosed with growth hormone deficiency.

Key Takeaways from the Hormone Replacement Therapy Market Report Study

Market size analysis for current hormone replacement therapy market size (2023), and market forecast for 6 years (2024-2030)

The effect of the COVID-19 pandemic on this market is significant. To capture and analyze suitable indicators, our experts are closely watching the hormone replacement therapy market.

Top key product/services/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years

Key companies dominating the global hormone replacement therapy market.

Various opportunities available for the other competitor in the hormone replacement therapy market space.

What are the top-performing segments in 2023? How these segments will perform in 2030.

Which are the top-performing regions and countries in the current hormone replacement therapy market scenario?

Which are the regions and countries where companies should have concentrated on opportunities for hormone replacement therapy market growth in the coming future?

Target Audience who can be benefited from this Hormone Replacement Therapy Market Report Study

Hormone replacement therapy providers

Research organizations and consulting companies

Hormone replacement therapy-related organizations, associations, forums, and other alliances

Government and corporate offices

Start-up companies, venture capitalists, and private equity firms

Distributors and Traders dealing in hormone replacement therapy

Various end users who want to know more about the hormone replacement therapy market and the latest developments in the hormone replacement therapy market.

Frequently Asked Questions for the Hormone Replacement Therapy Market:

1. What is hormone replacement therapy?

Hormone replacement therapy (HRT) is a treatment technique for replacing and/or replenishing hormones in the human body, which are at inadequate levels than those required for the normal physiology of the human body.

2. What is the global market for hormone replacement therapy market?

The global hormone replacement therapy is estimated to grow at a CAGR of 6.48% during the forecast period from 2024 to 2030.

3. What are the drivers for the global hormone replacement therapy market?

The hormone replacement therapy market is witnessing positive market growth owing to the factors such as the growing burden of targeted and hormonal disorders, increasing awareness about post-menopausal issues among women and other hormone deficiency diseases, surging demand for advanced drug delivery systems such as transdermal drugs or gels with greater efficacy, increased demand of regenerative medicines such as anti-aging and reproductive-cycle boosting therapy, increasing new drug launches and approvals, presence of key players in the market, and others will create an exigency for the hormone replacement therapy market.

4. Who are the key players operating in the global hormone replacement therapy market?

Some of the key market players operating in the hormone replacement therapy market include Abbott., Novartis AG, Pfizer Inc., Merck KGaA, Bayer AG, Halozyme Therapeutics, Inc., Eli Lilly and Company, Viatris Inc., F.Hoffman-La Roche, Novo Nordisk A/S, Amgen Inc., Genentech, Inc., AbbVie Inc., Teva Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories Ltd., Ascendis Pharma Endocrinology, Inc., Vista Pharma, Inc., Clarus Therapeutics, Inc., Gedeon Richter Plc, Endo International plc, and others.

5. Which region has the highest share of the hormone replacement therapy market?

Among all the regions, North America is estimated to hold a significant revenue share in the global hormone replacement therapy market. This can be ascribed to the increasing demand for hormone replacement drugs among women in the region owing to the increasing prevalence of menopausal-related issues. Further, the rising prevalence of growth deficiency disease, thyroid disorder, osteoporosis, hypogonadism, surging research and developmental activities in the region, and the presence of key domicile players in the region are the reasons which act as a supportive factor for the North America hormone replacement therapy market growth.