Hormone Replacement Therapy Market

The global hormone replacement therapy market size was valued at USD 31,060.5 million in 2021. It is expected to reach USD 55,973.9 million by 2030, growing at a CAGR of 5.5% during the forecast period (2022–2030). Hormone replacement therapy involves administering synthetic estrogen, human growth hormone, thyroid hormone, testosterone hormone, and progestogen hormone to replenish male and female hormone levels and alleviate the symptoms of menopause, hypothyroidism, hypogonadism, and growth hormone deficiency.

Factors such as an increase in the prevalence of menopausal disorders, women's awareness of postmenopausal symptoms and treatment options, and the introduction of new hormone replacement therapy products are expected to drive this growth. Nonetheless, adverse effects of hormone replacement therapy, such as bloating, breast swelling or tenderness, headache, mood change, nausea, vaginal bleeding, acne, depression, and leg cramps, are anticipated to limit market growth during the forecast period. It is expected that these effects will be the primary factor. In addition, the high cost of hormone replacement therapy (HRT) products limits their use, which impedes the global market expansion.

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Market Dynamics

Market Driving Factors

Increase in Menopause Symptoms Globally

Hormone replacement therapy is the type of treatment that is most commonly used to alleviate common menopausal symptoms. Because a woman's hormone levels constantly shift as she transitions to menopause, she is more likely to experience several symptoms and conditions. In addition, a clinical trial that BMC Women's Health carried out reveals that the most common menopausal symptoms are hot flushes (experienced by 40 percent of women), night sweats (experienced by 17 percent), insomnia (experienced by 16 percent), vaginal dryness (experienced by 13 percent), mood disorders (experienced by 12 percent), and weight gain (experienced by 12 percent). Therefore, an increase in the population of females between the ages of 45 and 59, which expands the range of the menopausal window, is contributing to the rise in the demand for hormone replacement products. In the United States, the National Menopause Foundation estimates that between the ages of 51 and 52, menopause affects approximately 1.3 million women each year. These women are in the middle of their reproductive years.

On the other hand, between 40 and 45, early menopause affects approximately 5% of all females. In addition, one percent of women go through menopause before age 40 due to permanent ovarian failure. This condition, linked to sex chromosome abnormalities, causes premature menopause in these women. In addition, the National Menopause Foundation reports that during menopause, approximately 65 percent of women experience symptoms of menopause that interfere with their quality of life and that during menopause, roughly 75 percent of women experience hot flashes.

Increase in Women's Awareness Regarding the Issues after Menopause

As a direct result of increased health education efforts on a global scale, between 88 and 98 percent of women are now aware of the various health concerns associated with menopause. It is estimated in a study of clinical trials carried out by the Journal of Education and Health Promotion that structured educational and knowledge training can help women develop a positive outlook on issues related to post-menopause. It is highly recommended that menopause-oriented health education programs be put into place. Additionally, female patients visiting primary healthcare centers in western Saudi Arabia and several other countries have raised awareness of hormone replacement therapy. These patients come from a variety of different countries. Because of the reasons above, the market will grow in the not-too-distant future.

Market Restraining Factors

Rising Adverse Side Effects

During menopause, the decline of a woman's natural hormones is associated with various symptoms, including hot flashes, night sweats, mood swings, and difficulty concentrating. Long-term effects can include bone loss, fracture risk, and heart disease. For 15 years, these studies have uncovered scant or no evidence that HRT reduces the risk of cardiovascular disease. In contrast, there is evidence of increased blood clots and stroke risk. In addition, current or former users of hormonal replacement therapy have an increased risk of developing breast cancer. During the forecast period, approximately 645 million premenopausal and a quarter million postmenopausal breast cancer cases were diagnosed worldwide, resulting in over 130,000 and 490,000 deaths due to menopausal disorder. In addition, the FDA has identified certain estrogen therapy drugs that can cause adverse reactions and increase women's cancer risk.

Moreover, the U.S. Food and Drug Administration (FDA) revised its policies. It stated that manufacturers of testosterone replacement products must alter their labels to inform patients of a possible risk of heart attack and stroke.

Key Market Opportunities

Growing Treatment Options besides Hormone Replacement Therapy

Bioidentical hormones differ from conventional hormone replacement therapy hormones. Plant estrogen generates bioidentical hormones. They are chemically identical to the hormones that the human body produces. In addition, traditional hormone replacement therapy uses hormones derived from pregnant horse urine and synthetic hormones. "Bioidentical Hormone Therapy" originated as a marketing term for custom-made hormones. Typically, the term now refers to compounds with the same chemical and molecular structure as naturally occurring hormones. Bioidentical hormones do not have to be custom-compounded (meaning custom mixed). Numerous well-tested, FDA-approved hormone therapy products are available from retail pharmacies. In addition, the FDA approved the first bioidentical hormone therapy combination of estradiol and progesterone for moderate to severe vasomotor symptoms related to menopause. However, the FDA has not approved any bioidentical hormones that are custom-made. Therefore, the availability of these alternative therapies is anticipated to present opportunities for expanding the hormone replacement therapy market.

Segmental Analysis of the Hormone Replacement Therapy Market

On the Basis of Type

Based on type, the global hormone replacement therapy market is segmented by Type and Route of Administration

The estrogen hormone dominates the market, growing with a CAGR of 4.4% during the forecast period. The global hormone replacement therapy market is segmented by therapy type, administration route, and indication. The global market for hormone replacement therapy is segmented by therapy type into estrogen hormone replacement therapy, human growth hormone replacement therapy, thyroid hormone replacement therapy, testosterone hormone replacement therapy, and progestogen hormone replacement therapy. The estrogen hormone replacement therapy segment dominated the market due to increased estradiol products in women who have undergone menopause or a hysterectomy to maintain hormonal balance. In contrast, human growth hormone replacement therapy is anticipated to proliferate due to increased growth hormone deficiency (GHD), dwarfism, and pituitary dwarfism, especially among infants. 

On the Basis of Concerning Induction

When segmented concerning induction, the menopause segment has the most dominant revenue generation growing with a CAGR of 4.4% during the forecast period. Based on the administration route, the market is divided into oral, parenteral, and other segments. In 2021, the oral segment dominated the market and was expected to grow faster during the forecast period. This is attributable to an increase in oral HRT product preference and consumption. Additionally, it enables fewer patients to reduce their clinic visits, thereby reducing healthcare costs. The market is segmented into menopause, hypothyroidism, male hypogonadism, and growth hormone deficiency due to the increasing population of postmenopausal women and the expansion of the menopause window from 40 to 55 years. According to the National Menopause Foundation, approximately 1.3 million American women enter menopause annually between 51 and 52.

Regional Analysis Of The Hormone Replacement Therapy Market

The global hormone replacement therapy market is primarily segmented into three regions, namely North America, Europe, and Asia-Pacific.

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The Asia-Pacific region is the most dominant and is expected to grow a CAGR of 6.8% during the forecast period. This region boasts the market share of cryogenic pumps because of the growing industries catering to the enormous market demands. The next region after Asia-Pacific to have a significant market share in Europe, which is expected to grow to USD 751.06 million in 2030, growing at a CAGR of 6.9% during the forecast period.

Competitive Analysis

• Abbott Laboratories
• Bayer AG
• Eli Lilly and Company
• Hoffmann-La Roche Ltd. (Genentech Inc.)
• Hisamitsu Pharmaceutical Co. Inc. (Noven Pharmaceuticals Inc.)
• Merck KGaA
• Mylan N.V. (Viatris Inc.)
• Novartis International AG
• Novo Nordisk A/S
• Pfizer Inc

Recent Developments

• May 2022- Pfizer Presents Positive Real-World Evidence for IBRANCE® (palbociclib) Combination Therapy in First-Line Treatment of HR+, HER2- Metastatic Breast Cancer at ESMO Breast Cancer 2022
• April 2022- In a Phase III study, the combination of tislelizumab and chemotherapy from Novartis significantly improved overall survival as the first-line treatment for advanced esophageal cancer.
• May 2022- Pfizer had severe shortages of several hormone replacement therapy products.

Global Hormone Replacement Therapy Market: Segmentation

By Therapy Type

• Estrogen Hormone Replacement Therapy
• Human Growth Hormone Replacement Therapy
• Thyroid Hormone Replacement Therapy
• Testosterone Hormone Replacement Therapy
• Progestogen Hormone Replacement Therapy

By Route of Administration

• Oral
• Parenteral

By Indication

• Menopause
• Hyperthyroidism
• Male Hypogonadism
• Growth Hormone Deficiency

By Regions

• North America
• Europe 
• Asia-Pacific