Hormone Replacement Therapy Market Size, Share & COVID-19 Impact Analysis, By Therapy Type (Estrogen and Combinations Replacement Therapy, Growth Hormone Replacement Therapy, Thyroid Hormone Replacement Therapy, and Testosterone 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, Retails Pharmacies & Stores, and Online Pharmacies), and Regional Forecast, 2021-2028

The global hormone replacement therapy market size was USD 13.40 billion in 2020. The market is projected to grow from USD 14.17 billion in 2021 to USD 21.49 billion in 2028 at a CAGR of 6.1% in the 2021-2028 period. The global impact of COVID-19 has been unprecedented and staggering, with witnessing a decline across all regions amid the pandemic. Based on our analysis, the global market witnessed a decline of -2.6% in 2020 as compared to the average year-on-year growth during 2017-2019. The sudden rise in CAGR is attributable to this market’s demand and growth returning to pre-pandemic levels once the pandemic is over.

Over the years, hormone replacement therapy is widely used for the treatment of disorders associated with menopause in women, which has positively influenced the reduction of hot flashes, risks of osteoporosis, and other menopause symptoms. Additionally, these therapies are propelling the market growth, owing to its expansion in various other hormone-related disorders oriented to different age groups that are affecting women and men. Thus, disorders such as growth deficiency, thyroid disorders, and others are also projected to upscale the global market growth during the forecast period.

Moreover, due to rise in the prevalence of the menopausal disorders in developing countries, increased awareness toward the modern treatment of estrogen and combination therapy is potentially propagating the scope of these products. For instance, according to data published by the NCBI in July 2020 after a community based study, the prevalence of menopausal symptoms was found to be 87.7%. 80.0% of women suffered from anxiety, followed by 71.5% women suffering from mental exhaustion, 61.2% women had sleep problems, and 54.0% experienced heart problems. Furthermore, rise in incidences of male hypogonadism and growth hormone deficiency globally in adults led to the rise of adoption of these therapies.

Scarcity of Hormone Replacement Therapy due to COVID-19 Impacts the Global Market Negatively

The impact of COVID-19 on the hormone replacement market has been negative due to the widespread shortage of these therapies’ supplies across the globe. The shortage has further led to the distress of pre and post-menopausal women globally. Due to the COVID-19 pandemic, the difficulty of the manufacturers in procuring raw materials is one of the reasons leading to the scarcity of these products. For instance, Theramex, Novartis, Pfizer, Inc., and many more companies have released a notice regarding the non-availability of the products. For instance, to mitigate the ongoing issue of the shortage of the hormone replacement product in the U.K., the British Menopausal Society released updates in September 2021. The BMS produced a document with alternative HRT preparations for the general practitioners and healthcare providers facing problems in procuring the supplies.  

Furthermore, the pandemic has led to a negative impact on the sales of these products across the globe due to the closure of healthcare facilities, such as hospitals and clinics, in the initial days of the pandemic. These closures have led to a significant negative impact on the diagnosis of patients suffering from hormonal disorders. Prominent companies in the market reported strong sales declines in their annual revenues of FY 2020. For instance, Merck KGaA, a key company in the global market reported a decrease of 1.8% in revenue in FY 2020 compared to FY 2019 in the sales of their product of Saizen (somatropin [rDNA origin]). Other prominent players have also recorded slower growth in the sales performance of their hormone replacement therapies products. However, strong demand for these therapies coupled with the resumption of normal healthcare visits worldwide is expected to enable the market to return to its pre-pandemic growth levels.

LATEST TRENDS

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Development of Technologically Advanced Therapies by Key Players to Boost Market Growth

Increase in unmet needs of hormone replacement in developing countries and rise in awareness regarding the treatment of hormone disorders are constantly motivating the pharmaceutical companies to launch new advanced drugs in the global market. In addition to this, rise in menopause and hormone deficiency disorders in key countries has triggered manufacturers to launch new products, such as combination therapy products, replacing the long acting parenteral drugs, which were consumed on daily basis. For instance, in August 2021, Ascendis Pharma A/S announced that it received approval from the U.S. FDA for its product SKYTROFA for the treatment of pediatric patients of age one year and older suffering from growth hormone deficiency. The company utilized the TransCon technology to develop this treatment

Furthermore, the rise in preference for transdermal route of administration over oral administration of estrogen leads to the reduction in risks associated with venous thromboembolism, thereby leading to a symptom free menopause for women.

DRIVING FACTORS

Introduction of Advanced Drug Delivery Systems with Greater Efficacy to Fuel Market Growth

These therapies are critical for patients with growth hormone deficiencies, women suffering from menopausal disorders, and geriatric people having hypogonadism, amongst other patients. The treatment is available in various forms which include skin and buccal patches, injectable, tablets, and others. Owing to the rise in adoption of these products across the globe, various manufacturers are focusing on the development of the advanced drug delivery systems such as vaginal estrogen drugs and transdermal estrogen patches. They are also focusing on the launch of low dose estrogen therapy over high dose estrogen therapy, keeping in line with the safety concerns. Furthermore, introduction of gel-based formulation for estrogen patches and others is one of the advancements in the global market adopted by the key market players.

The launch of estradiol gel formulation, which is mainly prescribed for low doses and patients resisting oral estrogen therapy also helps in driving the growth of the market. Estradiol gels have received the FDA approval for the percutaneous estradiol gel for the treatment of menopausal symptom, which is easy to apply and has least skin reactions. For instance, a drug named Estrasorb holds liposomal formulation, which is applied to the skin of the thigh. In addition, 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 a trace of the residue. Such introductions of advanced drug delivery systems with advanced hormone therapies are significantly driving the growth of the market during the forecast period.

Rise in Prevalence of Various Hormonal Disorders 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 a rare endocrine disorder which consists of various symptoms such as reduced energy levels, insulin resistance, lipid abnormalities, and low physical activities in adults. Hence, the prevalence of the growth hormone disorder is noted to be high in patients suffering with Langerhans cell histiocytosis which further triggers the diabetic insipidus leading to growth hormone deficiency amongst patients with diabetes insipidus, according to The Journal of Clinical Endocrinology & Metabolism. The rise in growth of hormone deficiency incidence in adults led to the increase in adoption of these therapies globally. The GHRT observes low incidence of side effects and improves most of the alterations in GH deficiency with the appropriate amount of dosage.

Furthermore, rise in menopausal conditions and growth deficiency from diabetes insipidus globally is triggering the increase in the development of new products by shifting the focus of the manufacturers towards more research and development initiatives. Thus, strong prevalence is leading to the adoption of novel products and successful launch strategies for the expansion of product portfolio, boosting the market growth in the forecast period.

RESTRAINING FACTORS

Adverse Effects of These Therapies to Restrict Market Growth

Although the growth of the market is observed to be growing over the years due to increase in awareness of the treatment options, rise in prevalence of menopause across the globe, and new product launches, there are some factors that are negatively impacting the market growth. These therapies are available in various formulations such as patches, gel, capsules, and injections. However, these products may also have side effects, such as increase in cholesterol levels, blood clots, bloating, swelling, and others, that might hinder the market growth.

Also, adverse impacts of testosterone replacement therapy, which includes benign prostatic hyperplasia, obstructive sleep apnea, and prostate cancer are expected to hinder the market growth in future. Furthermore, the rise in cardiovascular disorders in patients going through testosterone replacement therapy have alarmed the U.S. FDA to communicate regarding the approved indication and the rising incidences of cardiovascular risks associated with the testosterone replacement therapy products.

Moreover, stringent regulations, delay in FDA approvals, product recalls, and other such factors might also impede the growth of the hormone replacement market. For instance, in March 2021, Dr. Reddy’s Laboratories Ltd. announced a product recall of its progesterone capsules. The U.S. FDA report suggests that the drug could lead to temporary or reversible health problems. Similarly, in March 2018, Perrigo Pharma International D.A.C. released a notice regarding the voluntary recall of their product Evamist transdermal spray from the marketplace. This was due to product damage which would make it difficult for patients to dispense the dose.

SEGMENTATION

By Therapy Type Analysis

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Presence of Strong Estrogen and Combination Therapy Products to Elevate Segment to Market Dominance

Based on therapy type, the hormone replacement market is segmented into estrogen and combinations replacement therapy, growth, thyroid, and testosterone hormone 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 adoption of these improved therapies, and the availability of these drugs in various formulations. For instance, in September 2021, Theramex announced the launch of Bijuva/Bijuve, the first body identical combined hormone therapy treatment for post-menopausal women in the European regions and U.K. Such launches are expected to drive the segment’s growth.

Growth hormone replacement therapy is expected to contribute to a strong CAGR during the forecast period. Owing to rise in the prevalence of the growth hormone deficiencies in key countries, there is increase in demand for growth hormone therapies, which is safe and effective comparatively with minimum risks such as fluid retention, peripheral edema, carpal tunnel syndrome, glucose intolerance, and others. Additionally, the drugs of this therapy segment hold larger revenue in the market. For instance, Norditropin, a GHRT by Novo Nordisk 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 has witnessed growth in revenue during FY 2020 due to its high demand. Furthermore, approvals from various government regulatory bodies for therapies associated with growth hormone deficiency disorders also fuel the market growth. For instance, in February 2021, Pfizer, Inc. and OPKO Health Inc. announced that the European Medicines Agency has validated the Market Authorization Application for somatrogon for the treatment of pediatric patients suffering from growth hormone deficiency (GHD).

The testosterone hormone replacement therapy segment is expected to witness steady growth in the forecast period, as a result of the launch of new drugs for the treatment of hypogonadism in men. The recent approval from the U.S. FDA for new treatment also fuels the growth of this segment. For instance, in March 2019, the U.S. Food and Drug Administration announced the approval of Jatenzo, an oral testosterone capsule, for the treatment of men with various forms of hypogonadism.

The thyroid hormone replacement therapy segment has also witnessed development in the past few years and is expected to demonstrate a positive growth during the forecast period owing to increased prevalence of thyroid disorders, which led to R&D advancements made by manufacturing companies in thyroid hormones products and increased approvals from key regulatory bodies. For instance, in December 2020, VistaPharm, Inc. announced that it received approval from the U.S. FDA for Thyquidity as a thyroid hormone therapy for patients suffering from primary, secondary, and tertiary congenital or acquired hypothyroidism.

By Indication Analysis

Menopause to Emerge as the Largest Segment over the Forecast Period

In terms of indication, the market is segmented into menopause, hypothyroidism, male hypogonadism, and growth hormone deficiency.

Amongst these, the menopause segment holds the largest hormone replacement therapy 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 replenish 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. For instance, according to an article published in BioMed Central, 1.2 billion women would be menopausal or post-menopausal by the year 2030. Furthermore, it is also estimated that approximately 40-50 million women have suffered from the vasomotor symptom in the U.S.

Hypothyroidism is anticipated to hold the second-largest market share, owing to the rise in prevalence of thyroid disease. For instance, according to an article in BioMed Central journal published in September 2020, the prevalence of overt hypothyroidism in Europe is between 0.2%-5.3% and 0.3%-3.7% in the U.S.

Growth hormone deficiency also is one of the major concerns globally due to the subsequent rise in cases over the years. According to insights published in the Novo Nordisk’s website, every year, 6,000 new cases of adult-onset growth hormone deficiency are witnessed in the U.S. Furthermore, in the U.K., the prevalence of adult-onset GHD is approximately 3 per 10,000 adults, which equates to 15,000 adults annually.

Male hypogonadism is also a rising concern globally. According to an article in Boston University School of Medicine, 4-5 million men in the U.S. are affected by hypogonadism. However, it was earlier witnessed that only 5.0% of them received treatment. Recent developments in the testosterone replacement therapy and the guidelines from the U.S. FDA provided various options for the patients suffering from hypogonadism. For example, in December 2020, the U.S. FDA granted tentative approval for the oral testosterone, Tlando by Lipocine to be used as a hormone therapy. The drugs can be used to treat patients with hypogonadism.

By Route of Administration Analysis

Oral Route of Administration Dominated Global Market

In terms of route of administration, the hormone replacement 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 significant CAGR during the forecast period, owing to the introduction of new gel formation therapies that hold more effectively without any risk in the treatment. For instance, in April 2020, Gedeon Richter announced that it launched a transdermal spray, Lenzetto (estradiol spray) in the U.K. The spray is used for the treatment and management of post-menopausal women having symptoms of oestrogen deficiency. The parenteral segment is anticipated to register the lowest CAGR during the forecast period.

By Distribution Channel Analysis

Higher Adoption of These Products in Hospital Pharmacies to Propagate Market Growth

Based on distribution channel, the market is classified into hospital pharmacies, retail pharmacies & stores, and online pharmacies.

Increase in the number of multispecialty hospitals around the globe has led to the rise in number of pharmacies inside hospitals. Major healthcare providers focus on providing advanced healthcare facilities to their patients hence, for the convenience of their customers most of the multispecialty hospitals have their own pharmacies. Thus, due to the increase in adoption of hormone replacement therapies in the hospitals, the hospital pharmacies keep stock of these drugs which eventually contributes to the growth of the segment in the forecast period.

Additionally, the retail pharmacies & stores segment is expected to emerge as the second-largest market contributor, owing to the rise in adoption of hormone replacement therapies and availability of over the counter HRT products. For instance, according to STATISTA, in 2020, there were an estimated 315,000 pharmacies and drug store businesses in the U.S. Thus, this is leading to the rapid supply of drugs, which further contributes to the growth of the segment during the forecast period.

Due to the ongoing COVID-19 pandemic, the rise in demand for the online pharmacies was witnessed as it ensured more safety to the people, which subsequently fueled the growth of the segment. For instance, according to an article published by Invest India in June 2021, there are approximately 50 online pharmacies in India. Furthermore, the market is estimated to be at USD 500.0 million in 2019 and is expected to reach USD 4,500.0 million by 2025, owing to the growth rate of 44.0%.

REGIONAL INSIGHTS

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On the basis of region, the global market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

The market size in North America stood at USD 7.07 billion in 2020. The market in North America is expected to dominate the global market, owing to rise in prevalence of menopause and growth hormone deficiency disorders, and high awareness of the therapy amongst the patients of the age group of 35 years and above. For instance, according to an article published in January 2019 in Medscape, every year approximately 6,000 adults are diagnosed with hyposomatotropism (growth hormone deficiency) in the U.S. Along with this, launches of various therapies, availability of advanced products in the region, and robust healthcare expenditure are also adding to the increased adoption of these therapies in North America, boosting the region’s growth.

Europe is the second dominant region, owing to a surge in the hormonal disorders in women suffering from menopausal symptoms, geriatric population suffering from hypothyroidism, and rise in growth hormone disorders. Furthermore, rise in development of new drugs by manufacturers to expand the market across the globe has spurred the demand for drugs in the specific region influencing the market growth. For instance, according to statistics published in the Frontier in June 2021, the prevalence of thyroid disorders ranges from 0.2-5.3% in Europe. Thus, this is leading to the increase in demand for thyroid replacement therapies in Europe, further boosting the growth of the market in the region.

Asia Pacific is expected to emerge as one of the largest contributors of the market along with the highest CAGR in the near future. Increasing awareness among people about the post-menopausal hazards, rise in unmet medical needs, changes in reimbursement policies, development of novel formulations by the regional players and ongoing R&D programs will boost the growth of the market during the forecast period. For instance, in October 2019, VISEN Pharmaceuticals announced that it received approval for a new drug (IND) application from the China National Drug Administration for the initiation of the phase 3 clinical trial for TransCon human growth hormone therapy for the treatment of childhood growth hormone deficiency. TransCon is the first long acting growth hormone therapy in China. 

The market in Latin America and the Middle East & Africa is currently expected to have slower growth, owing to the unmet needs of these therapies, low awareness among the population, reduced healthcare expenditure, and others. For instance, according to an article published in the National Library of Medicine in December 2021, the prevalence of menopausal hormone therapy is 12.5% in these regions, which is still lower compared to other regions globally. Furthermore, launch of new products in this region by various key players may fuel the subsequent growth of the market.

KEY INDUSTRY PLAYERS

Diverse Product Portfolio of Novo Nordisk A/S and Pfizer Inc. to Gain a Dominant Position

In terms of competitive landscape, the key players dominating this market are Novo Nordisk A/S and Pfizer Inc., owing to their diverse product portfolio across the globe. In terms of revenue, Novo Nordisk holds the dominance, owing to its popular product, Norditropin. The significant upscale of the product across the globe is anticipated to propel the growth of the market during the forecast period. Apart from Norditropin, the recent approval from the U.S. FDA for sogroya for the treatment of adult growth hormone deficiency also aids the company’s growth prospects in the global market. Pfizer Inc. is considered as a prominent market player, owing to its focus on the development of these therapies along with its product, such as Genotropin, supporting the company through strong sales. Furthermore, continuous R&D initiatives of the company to expand its product portfolio also fuel the growth of the company in this market. For instance, in October 2020, the company announced positive top line results from their phase 3 trial for somatrogon as a treatment for children between the ages of 3 to <18 years with growth hormone deficiency. 

However, some of the regional and domestic key players, such as Mithra Pharmaceuticals, and others have entered this market through prominent product launches. For example, in December 2020, Mithra Pharmaceuticals announced positive results from its independent ‘Data and Safety Monitoring Board’ during the end of the year safety assessment for its phase 3 clinical trials for the drug Donesta. The drug can be used by women suffering from menopausal vasomotor symptoms (MVS). Hence, the market is expected to witness subsequent growth due to the launch of new products by various global and regional players.

LIST OF KEY COMPANIES PROFILED:

• Novo Nordisk A/S (Bagsværd, Denmark)


• Pfizer Inc. (New York, U.S.)


• AbbVie’s (Lake Bluff, U.S.)


• Merck KGaA (Dermstadt, Germany)


• Endo International plc (Dublin, Ireland)


• Allergan plc (Irvine, U.S.)


• Eli Lilly and Company (Indianapolis, U.S.)


• Mithra Pharmaceuticals (Liege, Belgium)


• Amgen (Thousand Oaks, U.S.)

KEY INDUSTRY DEVELOPMENTS:

• May 2021 – Myovant Sciences GmbH announced that it received approval from the U.S. FDA for its hormone therapy Myfembree as a treatment for uterine fibroid bleeding. The drug launched by Myovant will give direct competition to AbbVie with an added dosing advantage.


• April 2021 – TherapeuticsMD, Inc. and Theramex announced that they received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) and Federal Agency of Medicines and Health Products (FAMHP) for the use of BIJUVE in U.K and under BIJUVA trade name in Belgium. The capsule will be used as a hormone replacement therapy.


• October 2020 – Pfizer Inc. and OPKO Health Inc. announced positive top line results from their Phase 3 trial for their investigational long acting hormone, which is used as a treatment for children with growth hormone deficiency.

REPORT COVERAGE

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The global market research report provides a detailed market analysis and focuses on key aspects such as pipeline analysis, prevalence of hormonal disorders – by key country/region and key mergers, acquisitions, and partnerships. Additionally, considers the impact of COVID-19 on the global market. Beside these, the report offers insights into the hormone replacement therapy market trends and highlights key strategies by market players. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market over recent years.

Report Scope & Segmentation