Bioidentical Hormones Market

Market Overview

The Total Addressable Market (TAM) for bioidentical hormones was valued at USD 3.3 billion in 2022. It is estimated to reach USD 5.4 billion by 2031, growing at a CAGR of 5.7% during the forecast period (2023–2031).

Bioidentical hormones are biochemically engineered hormones that are the same as those in the human body formed by natural biological processes. The use of bioidentical hormones differs from conventional hormone therapy as the latter uses animal-based or synthetic hormones. Currently, estrogen, progesterone, and testosterone are available in the market in various forms, including tablets, capsules, creams, and gels. Bioidentical hormones control important tasks in the body, such as growth, food breakdown, sex, and brain function.

The global bioidentical hormones market is driven by increasing screening for hormonal deficiency, the rising geriatric population, and awareness among people. It is extensively used for the treatment of menopause. In October 2018, USFDA approved the usage of bioidentical hormones for the treatment of menopausal hot flashes, which is further adding fuel to the market growth. In extreme cases, women are also prescribed to undergo hormone-replacement therapy. The bio-identical hormones are easily available. Other factors driving the market include lack of nutrition, growing prevalence of sedentary lifestyles, and increasing expenditure power. Additionally, the increasing demand for bioidentical hormones is grabbing the attention of umpteen manufacturers in the market. However, the US Food and Drug Administration (USFDA) is reluctant to approve bioidentical hormones as their safety and purity cannot be guaranteed, further hampering the market growth to some extent. Similarly, the presence of alternative treatments for Hormone Replacement Therapy (HRT), such as antidepressants, tibolone, clonidine, and herbal medications, is likely to impede the market growth to some extent.

Market Dynamics

What are the factors driving the market growth?

Rising Investment in Healthcare

The increase in government funding is anticipated to spur market expansion. Moreover, the growth and expansion of the healthcare industry driven by both public and private players, particularly in developing economies, will create lucrative growth opportunities for the personal health devices market. In addition, the increasing acceptance of bioidentical hormone replacement therapy by government healthcare facilities is fueling market expansion. In addition, a rise in disposable personal income, the introduction of technologically driven products in hospitals, and an increase in investment for the development of advanced products, as well as an increased emphasis on women's health care and the treatment of hormonal imbalances, all contribute positively to the market growth rate. Increasing expenditures on research and development for medical instruments and devices, particularly in developed and developing economies, will generate lucrative market growth opportunities.

The High Prevalence of Hormonal Deficiencies

The escalating prevalence of hormonal deficiency, particularly in women around the world, as a result of various internal and external factors, is one of the major factors driving market expansion. Some hormonal imbalances are temporary, while others are chronic. Hormone imbalances cause several diseases. Among women's most prevalent hormone-related disorders are Irregular menstruation, Infertility, Acne, Hormonal acne, Diabetes, Thyroid illness, and Obesity. Rising patient numbers, particularly in developing economies, are driving market expansion.

What are the factors restraining the market growth?

Side Effects

There are a few potential risks and side effects associated with bioidentical hormone therapy. These may include mood changes, headache, breast tenderness, abdominal bloating or GI disturbance, skin changes/blemishes, fatigue, blurred vision, sleep disturbance, and weight gain or weight loss.

Regional Analysis

The bioidentical hormones market is divided into four regions: North America, Europe, Asia Pacific, and LAMEA.

North America is dominating the global bioidentical hormones market. The prevalence of women suffering from menopause-related issues is increasing at a significant rate. As per the American Congress of Obstetricians and Gynecologists, in the US alone, around 6,000 women reach menopause every day, which is over 2 million per year. The extensive use of medications and increasing healthcare expenditure are some of the factors driving the market growth. Similarly, leading pharma companies developing and marketing novel bio-identical hormones are likely to boost market growth to some extent. In September 2018, TherapeuticsMD, Inc., an advanced women's healthcare firm, announced the commercial availability of Imvexxy (estradiol vaginal inserts) 4 mcg dose in the US. The product is FDA approved and is used in the treatment of moderate to severe dyspareunia. Additionally, the rising focus of the North American Menopause Society and the British Menopause Society on providing safe hormone replacement therapy is adding fuel to the market growth. 

Europe is the second-most dominant in the bio-identical hormones market. This can be attributed to the increasing expenditure power, well-developed healthcare sector, rising geriatric population, and increasing screening for hormonal deficiency. However, using alternatives like tibolone is expected to impede growth. Tibolone is a synthetic steroid whose metabolites possess estrogenic, androgenic, and progestogenic qualities. It has been widely used in Europe and other countries for many years to treat hot flashes. Compared to placebo, tibolone decreases vasomotor symptoms. However, it is less effective than estrogen therapy. Additionally, it has a positive impact on bone mineral density (BMD). However, tibolone raises the chance of recurrence in women with a history of breast cancer, and it may also increase the risk of stroke in women over the age of 60.

Asia Pacific is accounting for promising growth in the market on account of the rapidly rising population and expanding the healthcare sector. In China and India, the bioidentical hormones market is projected to witness significant growth in the years to come. This can be accredited to the increasing prevalence of menopause-related issues and rising expenditure power.

In the Middle East, the UAE and Saudi Arabia are projected to witness positive growth in the market. Whereas Africa is emerging at a slower pace in the market on account of poor healthcare and economic development, lack of awareness among women regarding pre and post-menopausal symptoms, political instability, and lack of technological advancements. However, the region is likely to offer umpteen opportunities to the leading pharma players in the years to come.

Segmental Analysis

The bioidentical hormones market is segmented based on type, form, route of administration, and end-use.

Based on type, the market is segmented into estrogens, progesterone, testosterone, and others.

The estrogen segment is expected to hold a major market share in the market as it is extensively used to treat menopause. Some of the symptoms of menopause include a reduction in estrogen, vaginal dryness, night sweats, and hot flashes, which can lead to a much more severe disease named osteoporosis. The rising prevalence of menopause and hormonal imbalance is subsequently increasing the demand for FDA-approved estrogen. Other factors driving the market include the abundance of plant estrogens and the rising demand for estrogen hormones such as estrone, estradiol, and estriol. Currently, a number of estrogens, including Estrace, Innofem, FemPatch, Evamist, and Esclim, are in the process of getting approval from the FDA. Moreover,  Premarin, Menest, and Combipatch are the chief contributors to the market revenue. As per the study published by Pfizer, Premarin autonomously recorded a sale of 1,076 million in 2014. Apart from this, developing drugs with improved safety profiles and novel delivery systems, such as vaginal and transdermal estrogen, is likely to boost market growth to some extent.

Based on form, the market is segmented into tablets and capsules, creams and gels, injectables, patches and implants, and others.

The tablet and capsule segment is expected to lead the market on account of the shifting preference of patients towards ease of administration and convenient dosage form. Oral medication is one of the most preferred forms of estrogen replacement therapy (ERT), which is further increasing the demand for estradiol and extra lab pills. In line with the growing demand,  a number of leading players are manufacturing estrogens, progestins, and combined hormones in the form of capsules and tablets.

Based on the route of administration, the market is segmented into oral, parenteral, and topical.

The oral administration route is one of the most popular modes of drug delivery. It is safe, easy to digest, inexpensive, convenient, and versatile, which is why several healthcare professionals prescribe it to treat hormonal imbalances. 

Based on end-use, the market is segmented into hospitals, gynecology clinics, research laboratories, and others.

The hospital segment is dominating the market and will continue to do the same during the forecast period. This can be attributed to the rapidly developing healthcare infrastructure and the presence of bioidentical hormone replacement therapy centers across the globe. Additionally, several drug companies are investing heavily in the field and are using several marketing strategies to promote their bioidentical hormone products among hospitals.

Recent Developments

• September 2021- Theramex announced that Bijuva (1mg estradiol / 100mg progesterone) had been approved in Europe and the United Kingdom. Combining estradiol and progesterone in a daily oral capsule, Bijuva is the first and only body-identical hormone replacement therapy (HRT) for the treatment of estrogen deficiency symptoms in post-menopausal women.
• September 2020- Sogroya has been approved by the US Food and Drug Administration for adults with growth hormone deficiency. Sogroya is the first human growth hormone (hGH) therapy administered subcutaneously once weekly; other FDA-approved hGH formulations for adults with growth hormone deficiency require daily administration.