Bioidentical Hormones Market Analysis

Global Bioidentical Hormones Market Overview

Bioidentical Hormones Market Size was prized at USD 2.23 Billion in 2023. The bioidentical hormones market is projected to grow from USD 2.37 Billion in 2024 to USD 3.70 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 5.70% during the forecast period (2024 - 2032). The prevalence of menopausal disorders is on the rise, and women are becoming more aware of the problems associated with post-menopause are the key market drivers enhancing market growth. The market for bioidentical hormones is expected to grow significantly due to recent introductions of hormone replacement treatment.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

In February 2024, Knight Therapeutics Inc., a specialized pharmaceutical business operating in North and South America (except the United States), announced the introduction of BIJUVA® (estradiol and progesterone) capsules in Canada. BIJUVA® is prescribed to treat menopausal women with an intact uterus who are experiencing moderate to severe vasomotor symptoms (VMS). Vasomotor symptoms (VMS) occur in 60% to 80% of women experiencing menopause and are typically referred to as hot flashes or flushes and night sweats. BIJUVA® is a daily medication that combines bioidentical estradiol and progesterone in a single capsule that is taken orally. The two hormones present in BIJUVA® possess an identical structure to the hormones naturally produced and circulating throughout a woman's body. BIJUVA® provides women with a convenient solution to manage the difficult symptoms of hot flashes and night sweats that are commonly experienced during menopause. This is achieved through the use of a single oral capsule taken once daily. In July 2018, Knight and TherapeuticsMD entered into a license agreement. According to the agreement, TherapeuticsMD granted Knight the exclusive rights to commercialize BIJUVA® in Canada. According to the license agreement for BIJUVA® in Canada, Knight will compensate TherapeuticsMD with sales milestone fees and royalties. These payments will be determined by the total yearly sales of BIJUVA® in Canada.

In May 2024, My HealthMatrix Alachua, a branch of Wolf Health Group, commenced operations and is already welcoming new patients. The incorporation of these services is a component of a strategic plan to provide all-encompassing health and longevity services, consolidated in a single facility. The current services provided consist of a 4500 square foot strength training facility that is air-conditioned. This facility offers group classes and personal training, functional rehabilitation, sports performance training, metabolic health and dietary coaching, sports and deep tissue massage, spinal health, and mental health counseling. The expanded range of services now includes a clinical provider who has received specialized training in health optimization, which encompasses bioidentical hormone replacement therapy, testosterone therapy, pellets, peptides, weight management, thyroid health, thorough health exams, and advanced lab testing. Unlike a typical visit to a regular healthcare facility, your consultation with HealthMatrix Alachua is anticipated to have a duration of up to 2 hours. Our goal is to achieve the highest level of healthcare, rather than focusing solely on treating illness. By consolidating all the services in a single place, it allows each provider to work together and provide a higher standard of patient care.

Bioidentical Hormones Market Trends

• Growing prevalence of hormonal deficiencies is driving the market growth

Market CAGR for bioidentical hormones is driven by the rising number of people suffering from hormonal deficiencies. The commonality of growth hormone and metabolic hormone deficits influences the market. The need for hormone biosimilars is growing as the treatments for illnesses connected to hormones change over time, and hormonal shortages become more common. For example, in January 2022, the British Medical Journal, a peer-reviewed medical trade publication in the UK, reported that the prevalence of GH deficit (GHD) in children is estimated to range from 1 in 3500 to 1 in 10000 worldwide. Additionally, 6,000 persons in the USA are anticipated to receive a diagnosis of growth hormone (GH) deficiency in June 2022, according to Medscape research. The market for biosimilar hormones is driven by the expanding need to treat individuals with ongoing hormonal deficits.

One of the most prevalent gynecological problems in women is menopause. Contrarily, growth hormone is also thought to be a rare endocrine condition that manifests in adults as a lack of energy, insulin resistance, abnormal lipid levels, and a low level of physical activity. According to Journal of Clinical Endocrinology & Metabolism, Langerhans cell histiocytosis patients have a high prevalence of the growth hormone disorder, which further causes diabetic insipidus and results in growth hormone deficiency in patients with diabetes insipidus. Global acceptance of these medicines has increased due to the rise in adult incidence of hormone insufficiency. With the right dosage, GHRT shows a low frequency of side effects and improves most GH-deficient changes.  Strong adoption of new goods and successful launch strategies for developing the product line drive market growth during the projection period. With the right dosage, GHRT shows a low frequency of side effects and improves most GH-deficient changes.  Strong adoption of new goods and successful launch strategies for developing the product line drive market growth during the projection period. Thus, driving the bioidentical hormones market revenue.

Bioidentical Hormones Market Segment Insights

Bioidentical Hormones Type Insights

The Bioidentical Hormones Market segmentation, based on type, includes estrogens, progesterone, and testosterone. In 2022, the estrogens segment dominated the market. The dominance was attributed to an increase in the proportion of women going through menopause. As a result, estrogens and their combination aid in treating menopausal symptoms in women by restoring their estrogen levels by introducing external estrogen hormones. Additionally, in 2022, the testosterone segment witnessed the fastest growth rate. Testosterone insufficiency is a prevalent health issue among males between the ages of 40 and 79. Men over 60 and 70 years old with low testosterone levels make up about 20% and 30% of the male population, respectively. Between 10% and 40% of people worldwide suffer from a testosterone shortage.

August 2022: Marius Pharmaceuticals was permitted to market KYZATREX (testosterone undecanoate) by the US Food and Drug Administration. KYZATREX is an oral testosterone replacement treatment ("TRT") approved in adult males for disorders associated with a deficiency or absence of endogenous testosterone, generally known as hypogonadism.

Bioidentical Hormones Product Type Insights

The Bioidentical Hormones Market segmentation, based on product type, include tablets and capsules, creams and gels, injectables, and patches and implants. The tablets and capsules segment dominated the market, accounting for 46.5% of market revenue (1.0 Billion). Due to patients' shifting preferences towards convenient dose forms and convenience of administration, the tablet and capsule sector is anticipated to dominate the market. One of the most popular estrogen replacement treatment (ERT) types is an oral medication, which is driving up demand for estradiol and additional lab tablets. Several major producers are producing estrogens, progestins, and mixed hormones in the form of capsules and tablets to meet the rising demand. The creams and gels market is projected to expand at a major growth rate throughout the projected period due to the launch of novel gel formation therapies that perform more efficiently with no risk in the treatment.

Figure 1: Bioidentical Hormones Market by Product Type, 2022 & 2032 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Bioidentical Hormones End-User Insights

The Bioidentical Hormones Market segmentation, based on end-user, includes clinics and hospitals. The hospital segment controls the bioidentical hormones market. This is due to the fast-evolving healthcare system and abundant facilities offering worldwide bioidentical hormone therapy. Several pharmaceutical companies are also making significant investments in the area and promoting their bioidentical hormone products among hospitals by employing various marketing techniques. The clinic's segment's expansion can be due to these facilities' lower costs than other healthcare facilities, like hospitals.

Bioidentical Hormones Regional Insights

By region, the study provides market insights into North America, Europe, Asia-Pacific and Rest of the World. The North American bioidentical hormones market area will dominate this market. Due to the rising frequency of illnesses related to menopause and growth hormone deficiency and the high knowledge of the therapy among patients aged 35 and older, North America is predicted to dominate the global market. Nearly half of all post-menopausal women in the United States reported using bioidentical hormone therapy at least once throughout their lives, according to the National Institutes of Health (NIH).

Further, the major countries studied in the market report are US, Canada, France, German, Italy, UK, Spain, Japan, China, Australia, India, South Korea, and Brazil.

Figure 2: BIOIDENTICAL HORMONES MARKET SHARE BY REGION 2022 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe’s bioidentical hormones market accounts for the second-largest market share due to increased growth hormone abnormalities, hypothyroidism in the elderly population, and hormonal disorders in women experiencing menopausal symptoms. Additionally, the increased development of new pharmaceuticals by manufacturers to extend the market globally has stoked the need for drugs in a particular region driving the industry's expansion. Further, the German bioidentical hormones market held the largest market share, and the UK bioidentical hormones market was the rapidly growing market in the European region.

The Asia-Pacific Bioidentical Hormones Market is expected to grow at the fastest CAGR from 2023 to 2032. The prevalence of vasomotor symptoms linked with menopause has been observed to range from 43% to 83% among women in East Asian countries, according to Journal of the North American Menopause Society (May 2022). The region's demand for bioidentical hormone therapy is thus anticipated to increase as more women enter menopause. Moreover, China’s bioidentical hormones market held the largest market share, and the Indian bioidentical hormones market was the rapidly growing market in the Asia-Pacific region.

Bioidentical Hormones Key Market Players & Competitive Insights

Leading market players are largely investing in research and development to expand their product lines, which will help the bioidentical hormones market, grow even more. The launch of new products, larger-scale mergers and acquisitions, contractual agreements, and collaboration with other organizations are significant market developments in which market participants engage to increase their global presence. The bioidentical hormones industry must provide affordable products to expand and thrive in a more competitive and challenging market environment.

One of the major business strategies manufacturers use in the global bioidentical hormones industry to increase the market sector and benefit customers is local manufacturing to lower operational costs. In recent years, the bioidentical hormones industry has stipulated some of the most important medicinal benefits.  Major players in the bioidentical hormones industry, including BioTE Medical, Bio station, Neuva Aesthetics, Advantage Pharmaceuticals Inc., SottoPelle, and others, are funding operations for research and development to boost market demand.

Theramex is a London-based pharmaceutical firm specializing in women's health goods such as contraception, fertility, menopause, and osteoporosis. It was founded in 2018 to acquire certain Teva Active Pharmaceutical Ingredients' assets belonging to Theramex Laboratories, a pharmaceutical firm in Monaco. In September 2021, Theramex announced the approval of Bijuva / Bijuve (1mg estradiol / 100mg progesterone) in Europe and the United Kingdom. The first and only body-identical hormone therapy (HRT) medication, known as Bijuva (Bijuve in the UK), combines progesterone and estradiol in a single daily oral capsule to treat the symptoms of estrogen insufficiency in postmenopausal women with a functioning uterus and a minimum of 12 months since their last menstrual period.

I-MAB Biopharma Co., Ltd. is a pharmaceutical product development and manufacturing company. I-Mab Biopharma is a Chinese clinical-stage biotech startup that plans to IPO on the Nasdaq in January 2020. Its first commercial medicine will likely be eftansomatropin, a long-acting growth hormone with a huge market in China among pediatric patients with low height, and will be available in 2024 or 2025. In November 2021, I-MAB Biopharma Co., Ltd. collaborated with Jumpcan Pharmaceutical Group to develop and market eftansomatropin alfa (TJ101) in China. TJ101 is a long-lasting recombinant form of human growth hormone that is now being investigated in a phase 3 clinical trial for treating pediatric growth hormone deficiency.  This agreement is intended to help it strengthen its position in the market for bioidentical hormone therapy.

Key Companies in the bioidentical hormones market include

• SottoPelle


• BioTE Medical


• Advantage Pharmaceuticals Inc.


• Full Life Wellness Center


• Neuva Aesthetics


• Defy Medical


• Bio station

Bioidentical Hormones Industry Developments

April 2023 Novo Nordisk announced that the FDA had approved a new indication for Sogroya (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg for the treatment of children aged 2.5 years and older who have growth failure because of insufficient endogenous growth hormone secretion. Thanks to this new indication, Sogroya is now the first and only once-weekly growth hormone (GH) treatment for children and adults.

June 2022 Astellas Pharma Inc. announced the submission of a New Drug Application (NDA) for fezolinetant to US Food and Drug Administration. Fezolinetant is a nonhormonal oral chemical under research for treating moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes or night sweats, is a frequent menopausal symptom.

Bioidentical Hormones Market Segmentation

Bioidentical Hormones Type Outlook

• Estrogens


• Progesterone


• Testosterone

Bioidentical Hormones Product Type Outlook

• Tablets and Capsules


• Creams and Gels


• Injectable


• Patches and Implants

Bioidentical Hormones End-User Outlook

• Clinics


• Hospitals

Bioidentical Hormones Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World




• Middle East


• Africa


• Latin America