U.S. Hormone Replacement Therapy Market Growth & Trends

The U.S. hormone replacement therapy market size is expected to reach USD 16.39 billion by 2027, according to a new study by Grand View Research Inc. The market is expected to expand at a CAGR of 6.1% from 2020 to 2027. The growth in the market is largely attributable to the technological advancements in the drug delivery systems coupled with the rising prevalence of hormonal disorders.

In February 2020, Clarus Therapeutics, Inc. announced the FDA approval of Jatenzo (testosterone undecanoate) capsules for the treatment of testosterone deficiency (hypogonadism). Jatenzo is the first and only oral soft gel of testosterone approved by the U.S. FDA. The product however has not yet been commercialized. Innovation and introduction of novel products may fuel market growth.

In addition, injectable testosterone and transdermal products have been the preferred treatment for male hypogonadism. In April 2016, Aytu BioScience, Inc. entered into the market with a long-term, exclusive license agreement for Natesto with Acerus Pharmaceuticals Corporation. Natesto is the first nasal formulation of testosterone approved by the U.S. FDA for the indication of hypogonadism.

Companies are taking the initiative to raise awareness regarding the diseases and thereby increase the adoption of their products. For instance, in September 2020, AbbVie introduced a direct-to-patient pharmacy program that offers Synthroid to be delivered at a patient’s doorstep. Synthroid Delivers Program initiative may help the company increase revenue during the pandemic while supporting people in following home quarantine. However, the duration of hormone replacement therapies differs from patient to patient. This treatment is generally expensive, which is a key parameter for limiting the market growth.

U.S. Hormone Replacement Therapy Market Report Highlights

  • By product, the estrogen and progesterone replacement therapy segment held the largest share in 2019 followed by the thyroid replacement therapy segment
  • In August 2020, Novo Nordisk A/S received the U.S. FDA approval for its HGH replacement therapy product Sogroya (somapacitan-beco). This product is administered once a week through a subcutaneous route in adults diagnosed with growth hormone deficiency
  • The parathyroid hormone segment is anticipated to witness the fastest growth over the forecast period due to the rising adoption of the product for the treatment of hypoparathyroidism. According to the National Organization for Rare Disease, around 70,000 people in the U.S. have hypoparathyroidism
  • The oral segment is anticipated to dominate the market on the basis of route of administration. However, certain notable adverse effects of estrogen-based drugs are expected to reduce the consumption rate, which may impede segment growth
  • The parenteral segment is expected to witness the fastest growth over the forecast period. Rapid technological advancements in the parenteral mode of administration, such as pen-based drug delivery and longer-acting human growth hormone products are anticipated to improve patient compliance and facilitate ease of administration, thereby propelling segment growth over the forecast period
  • The menopause segment may dominate the market over the forecast period due to the rising incidence, and treatment rates for vasomotor symptoms and vaginal atrophy in the post-menopausal women