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.
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.
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.
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.
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.
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.
Due to rising incidence and product penetration, the thyroid hormone replacement market is anticipated to develop quickly throughout the forecast period. The National Organization for Rare Disease's 2021 database estimates that 70,000 Americans have hypoparathyroidism. One medicine, Natpara, has received approval in the parathyroid hormone market.
Due to the introduction of new medicine for treating male hypogonadism, the testosterone hormone replacement therapy market is anticipated to expand steadily throughout the forecast period. The recent FDA approval of a novel medicine also contributes to the expansion of this market. For instance, the U.S. Food and Drug Administration stated in March 2019 that Jatenzo, an oral testosterone pill, has been approved for the treatment of males with different types of hypogonadism.
Due to its widespread prescription and simplicity of use, the oral category dominated the market in 2022. Typically, tablets and pills are part of HRT medications.
During the anticipated term, the parenteral segment is anticipated to increase profitably. Improvements in parenteral medication delivery, such as pen-based drug delivery, are predicted to increase patient compliance and simplify administration, spurring the segment's expansion. Popular items offered in pen form include the Humatrope HumatroPen, Norditropin FlexPro Pen, and Genotropin Mixer Pen.
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.
Due to an increase in new treatments and product introductions, the hypoparathyroidism segment is anticipated to grow significantly throughout the projected period. For instance, at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting in September 2020, Ascendis Pharma A/S presented the TransCon technology. At the annual meeting, it also released the top-line findings of the TransCon PTH phase 2 clinical trial. Clinical trials for the medication are underway in phase 3. There will be additional possibilities for replacing parathyroid hormone once this medicine is approved and launched.
The global hormone replacement therapy market is primarily segmented into three regions, namely North America, Europe, and Asia-Pacific.
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.
North America is estimated to have a sizeable share in 2022 and expand significantly over the forecast period. The most significant market share in the area is a result of several reasons, including significant product launches, manufacturer collaboration agreements, and benevolent reimbursement policies. For instance, Novo Nordisk A/Sogroya S's (somapacitan-beco), a medication for HGH replacement therapy, received FDA approval in August 2020. This medication is given subcutaneously once a week when an adult is diagnosed with a growth hormone shortage.
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