Hormone Replacement Therapy Market Size, Share & Industry Analysis, By Therapy Type (Estrogen and Combinations Replacement Therapy, Growth Hormone Replacement Therapy, Thyroid Hormone Replacement Therapy), By Indication (Menopause, Hypothyroidism, Male Hypogonadism, and Growth Hormone Deficiency), By Route of Administration (Oral, Transdermal, and Parenteral), By Distribution Channel (Hospital Pharmacies), and Regional Forecast, 2019-2026

The global hormone replacement therapy market size stood at USD 13.00 billion in 2018 and is projected to reach USD 20.76 billion by 2026, exhibiting a CAGR of 6.0% during the forecast period.

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Hormone replacement therapy is widely used for the treatment of disorders associated with menopause in women which has positively influenced the reduction of the hot flashes, risks of osteoporosis, and other menopause symptoms. Additionally, hormone replacement therapy is also experiencing positive market growth owing to its expansion in various other hormone-related disorders occurring in different age groups that are affecting women and men. Thus, disorders such as growth deficiency, thyroid disorders, and others are also projected to augment the hormone replacement therapy market growth during the forecast period. Moreover, a rise in the prevalence of the menopausal disorders in the developing countries, increased awareness towards the modern treatment of estrogen and combination therapy is potentially propagating the scope of the hormone replacement therapy products. According to the Baystate Medical Center Women’s Health Department, some of the most occurring symptoms of menopause included hot flashes (which accounted for 40.0% of the cases), followed by night sweats (occurring in 17.0% of the cases), vaginal dryness (occurring in 13.0% of the cases), and weight gain (occurring in 12.0% of the cases). Therefore, an increase in the prevalence of menopause, growth deficiency, and others are expected to project the market growth during the course of the period.

MARKET TRENDS

The introduction of advanced hormonal replacement therapy products is prominently boosting the growth of the market.

Increase in unmet needs of hormone replacement in the developing countries, rise in awareness oriented to the treatment of hormone disorders, and others are constantly influencing pharmaceutical companies to launch new drugs for the advanced hormone replacement therapy. In addition to this, a rise in menopause, hormone deficiency disorders in key countries has triggered manufacturers to launch new products such as combination therapy products, leading to replacement of long-acting parenteral drugs with the parenteral drugs that can be taken on a short-term basis. For instance, the launch of transCon by Ascendis Pharma for the treatment of children suffering from growth hormone disorder, and other products such as estrogen and combination drugs for menopausal treatment is also contributing to market growth. Increasing hormone disorders has constantly triggered growth in research and development activities for providing improved hormone replacement therapies which are significantly boosting the market growth.

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MARKET DRIVERS

Introduction of advanced drug delivery systems with increased effectiveness likely to boost growth of the market

Hormone replacement therapy is mainly favorable for the patients with growth hormone deficiency, women suffering with menopausal disorders, and geriatric people having the hypogonadism, and other patients. The HRT treatment is available in various forms which include skin and buccal patches, injectable, tablets, and others. Owing to, rise in the adoption of the hormone replacement therapy across the globe, manufacturers are focusing on the development of the advanced drug delivery systems such as vaginal estrogen patches and transdermal estrogen patches, launch of low dose estrogen replacement therapy over the high dose estrogen replacement therapy oriented with the safety concern of the patients, introduction of gel-based formulation for estrogen patches, and others. The launch of estradiol gel formulation which is mainly prescribed for low doses and patients resisting to oral estrogen therapy. Furthermore, these estradiol gels have received the FDA approval for the percutaneous estradiol gel for the treatment of the menopausal symptoms which is easy to apply and hold least skin reactions. For instance, a drug named estrasorb holds liposomal formulation which is applied to the skin of the thigh. In addition to this, in the U.S., the gel named hydroalcoholic is packed in a pump which tends to deliver 1.25g doses containing 0.75mg of 17beta-estradiol. This gel gets absorbed into the skin and dries in 2 to 5 minutes without leaving the trace of the residue. Such introductions of advanced drug delivery systems with advanced hormone replacement therapy is significantly driving the growth of the hormone replacement therapy market during the forecast period.

 Rise in prevalence of the menopausal disorders across the globe likely to drive market growth

Menopause is considered to be one of the most common gynecological disorders in women. Whereas, growth hormone is also considered as the rare endocrine disorder which consists of various symptoms such as reduced energy levels, insulin resistance, lipid abnormalities, and low physical activities in adults. Therefore, the prevalence of the growth hormone disorder is noted to be high in patients suffering with langerhans cell histiocytosis which further trigger the diabetic insipidus. This is leading to growth hormone deficiency among patients with diabetes insipidus and the 5 year and 10-year risks of growth hormone deficiency among patients with diabetes insipidus were 34.7 and 53.7% according to The Journal of Clinical Endocrinology & Metabolism. The increase in global prevalence of diabetes insipidus is resulting in a rise of incidences of menopausal conditions and growth deficiency disorders. This is triggering an increase in the development of new hormone replacement therapies by shifting the focus of the manufacturers towards more research and development. Thus, the adoption of product approval and launch strategies to expand product portfolio is also boosting the market growth in the near future.

MARKET RESTRAINT

High adverse effects of hormone replacement therapy to impede market growth

Although the growth of the market is observed to be projecting over the years due to increase in awareness of the treatment options, rise in prevalence of menopause across the globe, increase in the launch of new drugs, and other developments, there are some of the factors that are negatively influencing the market growth. As hormone replacement therapy is available in various formulations such as patches, gel, capsules, injections, etc. These products also have side effects such as increase in cholesterol levels, blood clots, bloating, swelling, etc. that might hinder the market growth. Along with this, negatively affecting testosterone replacement therapy which includes benign prostatic hyperplasia, obstructive sleep apnea, prostate cancer, etc. are also expected to hinder the market growth in the near future. Moreover, the stringent regulations, delay in FDA approvals, product recalls, and other such factors might also impede the growth of the hormone replacement market. For instance, FDA issued warning orders on prempro hormone replacement therapy owing to its linkages to the occurrence of breast cancer and severe health disorders.

SEGMENTATION

By Therapy Type Analysis

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Estrogen and combination therapy dominated the global hormone replacement therapy market

Based on the therapy type, the hormone replacement therapy market is segmented into estrogen and combination, growth hormone replacement therapy, thyroid HRT, and testosterone replacement therapy. Estrogen and combination hormone replacement therapy dominated the market growth owing to rise in the awareness related to menopause symptoms across the globe, increase in the alternatives of the treatments such as estrogen and combination drugs for the improved therapies, availability of the HRT drugs in various forms that makes the patient adopt the replacement therapies.

Growth hormone replacement therapy is expected to contribute to the highest CAGR during the forecast period owing to a rise in the prevalence of the growth hormone deficiencies in the key countries, increase in demand for therapeutic areas which is safe and effective comparatively with minimum risks of incidence oriented with vasomotor symptoms, osteoporosis, cardiovascular diseases, and others. Additionally, the drugs of this therapy segment hold larger revenue in the market. For instance, Norditropin by Novo Nordisk which is used for the treatment of the pediatric suffering with short stature associated with Noonan syndrome, short stature associated with Turner syndrome and short stature, born with no catch-up growth by age 2 to 4 years.

By Indication Analysis

The menopausal indication is expected to lead the market growth

In terms of indication, the market is segmented into menopause, hypothyroidism, male hypogonadism, and growth hormone deficiency. Amongst these, menopause holds the largest market share owing to the rise in women suffering from various debilitating symptoms that often change the hormone levels in the body. Thus, estrogen and combination help in treating the women suffering from menopausal symptoms that replenishment of estrogen hormone levels in women through the administration of external estrogen and progesterone hormones. Therefore, a rise in menopausal symptoms is expected to lead the market growth during the forecast period.

Hypothyroidism is anticipated to hold the second-largest market share owing to the rise in the prevalence of thyroid disease is orders and others. For instance, according to the Cleveland Clinic, in 2016, it is noted that almost more than 20 million Americans have some form of thyroid disease.

By Route of Administration Analysis

Oral route of administration dominated the global market

In terms of route of administration, the hormone replacement therapy market is segmented into oral, transdermal and parenteral. Among these, the oral route of administration holds the largest market share owing to an increase in adoption of the oral drugs globally, and large production of the oral consumption drugs by the key players of the market. Transdermal segment is anticipated to register a relatively higher CAGR during the forecast period owing to the introduction of new gel formation therapies that hold more effectively without any risk in the treatment.

By Distribution Channel Analysis

Increasing number of patients in hospitals to drive the hospital pharmacies segment

Based on the distribution channel, the market is classified into hospital pharmacies, retail pharmacies & stores, and online pharmacies. Increase in number of patients in hospitals would lead to more demand from hospital pharmacies. Rise in government support towards awareness of the hormone replacement therapies by providing the effective drugs at the hospitals by boosting the strong pharmacy development in the hospitals is triggering the market growth. Additionally, retail pharmacies & stores segment is expected to emerge as the second-largest market contributor owing to the rise in the drug supply to the hospitals, and others.

REGIONAL ANALYSIS

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The hormone replacement therapy market in North America accounted for USD 6.89 billion in 2018. The North America market is expected to dominate owing to a rise in the prevalence of the menopause, increased incidence of the growth hormone deficiency disorders, and high awareness of the therapy among patients aging 35 years and above. Along with this, early adoption of the drug, and availability of the advanced therapy treatments in the region, increasing disposable income, availability of compounded drugs. The market in Europe is expected to emerge as the second-largest contributor of the market in the near future owing to a surge in the hormonal disorders in women suffering from the menopausal symptoms, geriatric population suffering from the hypothyroidism and rise in growth hormone disorders. In addition to this, the rise in the development of the new drugs by manufacturers to expand the market across the globe has spurred the demand for the drugs in the specific region influencing the growth of the market. The market in Asia Pacific is anticipated to grow at the highest CAGR owing to the due to the high prevalence of menopause and increase in adoption of the estrogen and combination replacement therapy. The market in Latin America and the Middle East & Africa region is currently expected to have steady growth owing to the unmet needs of the patient population, increase in awareness among the population, increased healthcare expenditure, and others. 

KEY INDUSTRY PLAYERS

Diverse product portfolio of Novo Nordisk A/S and Pfizer Inc. to propel the company share

The key players dominating the hormone replacement therapy (HRT) market are Novo Nordisk A/S and Pfizer Inc. due to its diverse product portfolio across the globe. In terms of revenue, Novo Nordisk holds the dominance owing to its blockbuster product norditropin. The significant upscale of the product across the globe is anticipated to propel the growth of the market during the forecast period. Pfizer Inc. is considered as the prominent market player owing to its focus on the development of the hormone replacement therapy along with its blockbuster product like genotropin supporting in terms of revenue.

However, some of the regional and domestic key players such as Mithra Pharmaceuticals, and others have entered the women's health market supporting hormone replacement therapy. Therefore, the market is expected to experience tough competition during the forecast period.

LIST OF KEY PLAYERS PROFILED:

• Novo Nordisk A/S


• Pfizer Inc.


• AbbVie Inc.


• Merck KGaA


• Endo Pharmaceuticals Solutions Inc.


• Allergan


• Eli Lilly and Company


• Mithra Pharmaceuticals


• Amgen


• Others

KEY INDUSTRY DEVELOPMENTS:

• January 2021 – Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency gave a positive opinion for their product Sogroya, for the treatment of adults with growth hormone deficiency and recommends the product for market authorization.


• December 2020 – Mithra Pharmaceuticals announced positive results from their independent DSMB safety review for their product Donesta, an orally administered E-4 based hormone therapy product. Donesta is currently in Phase 3 clinical trial and the company announced the continuation of this trial without any modification.


• December 2020- Myovant Sciences and Pfizer announced a collaboration to develop and commercialize relugolix, an oral gonadotropin releasing hormone. The drug will be developed to treat women health disorders as well as an oncology treatment in the U.S. and Canada region.

REPORT COVERAGE

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The hormone replacement therapy market report provides a detailed analysis of the market and focuses on key aspects such as leading companies, therapy types, and leading indications of the therapy. Besides this, the report provides key insights into the market trends and highlights major industry developments such as pipeline analysis, mergers, acquisitions, and collaborations.  In addition to this, the report also focuses on the major driving factors and restraints that are influencing the market growth over the course of the period.

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