Male hypogonadism is defined as a reduction or absence of testosterone secretion or other physiological activity of the testes. Testosterone is the hormone that is responsible for inducing and maintaining male secondary sex characteristics. Male hypogonadism can result from dysfunction of the testicles (referred to as primary hypogonadism), or from disease of the pituitary gland or hypothalamus (referred to as secondary hypogonadism) which then affects the testicular production of testosterone. Hypogonadism can be congenital (present from birth) or acquired.
Hypogonadism can cause complications during fetal development, during puberty and throughout adulthood. Pubertal development can be delayed or rendered incomplete as a result of hypogonadism, resulting in diminished or lack of beard and body hair, impaired penis and testicle growth, disproportional body growth, with unusually increased length of arms and legs compared with the trunk, and enlarged male breasts, referred to as gynecomastia. Hypogonadism in adult males can result in infertility, erectile dysfunction, decreased sex drive, fatigue, muscle loss or weakness, gynecomastia, decreased beard and body hair growth, and osteoporosis (a progressive bone disease that is characterized by a decrease in bone mass and density).
Male Hypogonadism Market
It is estimated that up to 24% of men greater than 30 years old have primary or secondary hypogonadism, translating to approximately 22 million men in the United States1,2. Up to 8 million of these men are symptomatic1,2. Although hypogonadism may occur in men at any age, low testosterone levels are especially common in older males, affecting 20%, 30%, and 50% of men greater than 60, 70, and 80 years, respectively3. The median age of symptom development and diagnosis is 50 years. With the growth rates of the aging U.S population rising, it is expected that the prevalence of hypogonadism will increase substantially.
Testosterone replacement therapy (TRT) rates are low. It is, estimated that approximately 12 to 18% of symptomatic men receive treatment4. It is believed that this low treatment rate is a result of the non-specific symptoms, which are dominated by erectile dysfunction, fatigue, and low sex drive. Another contributing factor to low treatment rates may be a lack of familiarity with the medical literature regarding hypogonadism and the benefits of testosterone replacement among primary care physicians, or PCPs. Testosterone treatment discontinuation rates are high, irrespective of age, diagnosis, or dose. According to one authority, 75% of men discontinue therapy after six months, and 85% discontinue therapy after one year of treatment5. The average duration of therapy is only about three to four months. Discontinuation rates for injectable testosterone are even higher, with only 31% remaining on therapy after three months. We believe that the high discontinuation rates are primarily the result of the challenges and inconvenience of topical and injectable formulations described below.
According to IMS Health, which maintains a large data base of prescription drug information, sales of testosterone products in 2014 (not including office-based injectable products) were $2.7 billion6, representing an 18% compounded annual growth rate over the prior five years. Industry analysts expect sales of testosterone products, including off-label use, to increase to around $5 billion by 2017.
Current Hypogonadism Treatments and Limitations
Current TRT products consist of topical and injectable formulations, which are approved for the indications of primary and secondary hypogonadism (congenital or acquired). Based on volume, the testosterone replacement market is about 70% topical formulations and about 30% injectable formulations7.
Topical and injectable testosterone formulations have significant shortcomings. Topical products create the risk of drug transference to others, can irritate the patient’s skin, are inconvenient, and can be messy. With topical products, patients need to apply the product to clean, dry skin, thoroughly wash their hands following administration, and wait for the product to dry before they can dress. A waiting period of up to several hours may also be required before swimming or bathing. Injectable products can result in wide-ranging blood testosterone levels and associated mood swings, can be painful, and require more frequent physician office visits.
We believe that a market opportunity exists for an oral testosterone product that overcomes the shortcomings of existing products for the treatment of male hypogonadism. An oral product would eliminate the potential for drug transference to others and the skin irritation associated with topical products. And, an oral product would be taken directly by the patient, unlike many injectable products that are administered by a doctor. An oral product would therefore provide a more convenient route of administration than topical or injectable products – patients would simply swallow it and continue with their daily activities. This convenience offered by an oral product will most likely improve drug persistency and adherence and keep patients on therapy longer.
- Araujo AB, Esche GR, Kupelian V, et al. Prevalence of symptomatic androgen deficiency in men. J Clin Endocrinol Metab. 2007;92(11):4241-4247.
- US Census Bureau, Annual Estimates of the Resident Population by Single Year of Age and Sex for the United States: April 1, 2010 to July 1, 2013 Population Estimates.
- Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006;60;762-769.
- Hall SA, Araujo AB, Esche GR, et al. Treatment of symptomatic androgen deficiency: results from the Boston Area Community Health Survey. Arch Intern Med.2008;168:1070-1076.
- Schoenfeld MJ1, Shortridge E, Cui Z, Muram D. Medication adherence and treatment patterns for hypogonadal patients treated with topical testosterone therapy: a retrospective medical claims analysis. J Sex Med. 2013;10(5):1401-9.
- IMS Health National Prescription Audit & National Sales Perspective 2014
- IMS Health National Sales Perspectives January 2009-December 2013.