💪 The rise of testosterone replacement therapy
Are D2C treatments for 'low-t' helping men navigate the ageing process?
Testosterone replacement is on the rise. Between 2003 and 2013, there was a four-fold increase in the rate of testosterone use among 18 to 45-year-old men in the United States. The market for testosterone replacement therapy (TRT) is expected to hit $2.2B by 2027.
But what has driven the growth? A study published in JAMA investigated the impact of direct to consumer (D2C) advertising and found exposure to televised D2C advertising was associated with greater testosterone testing, new initiation, and initiation without recent testing.
Interesting…
So why are men drawn to the testosterone replacement?
🤷♂️ Problem
Low sex drive? Struggling to maintain erections? Feeling depressed? Experiencing brain fog? All of these could be a sign of a low testosterone.
Testosterone levels decline about 1.6 percent per year from your mid-30s. About 20 percent of men age 60 and older have low testosterone, and that figure rises to 30 percent for men in their 70s.
💡 Solution
Replenish those levels using formulations that can be prescribed online and delivered discreetly to your door. Testosterone can be administered in a load of different ways: injections, skin creams, patches, gels, or subcutaneous pellets. Whatever you prefer.
n.b. This author is sceptical about the value of online TRT providers and the over-medicalisation of normal ageing.
📖 Terms
Lets clarify a few things about testosterone…
Endocrinology 101. Testosterone is a hormone produced in the testes of men. Production is regulated by a feedback loop between the hypothalamus and pituitary gland (both located in the brain). The biological effects of the hormone can be split into two categories:
Anabolic stuff like increasing muscle growth and bone density
Androgenic stuff like beard growth and maturation of sexual organs during puberty.
Hypogonadism. In men, this is the reduced production of sex hormones by the testes. It can have multiple causes, including genetic conditions, diabetes, obesity, traumatic head injuries or infections like mumps.
Late-onset hypogonadism (LOH). A clinical and biochemical syndrome associated with advancing age and characterised by typical symptoms (see above) and a deficiency in serum testosterone levels. It may significantly reduce quality of life and adversely affect the function of multiple organ systems.
Male menopause. An unhelpful term alongside ‘andropause’ popularised by the media. Draws misleading parallels to the female menopause. Refers to the decline in testosterone levels seen in men after age 30.
Low-T. Another term for LOH. Before 2009, it was not commonly used, but direct-to-consumer advertising by the makers of testosterone medications helped turn it into a household condition, despite there being little evidence of an actual problem.
📚 History
2000s. Prescriptions for testosterone for men over 40 are fairly rare. But over the course of the next decade, the number of prescriptions will rise sharply (thanks to direct-to-consumer advertising).
2010s. Enthusiasm for testosterone therapy cools somewhat when two studies linking testosterone therapy with cardiovascular disease are published.
2014. FDA cautions about using testosterone products for low testosterone due to ageing, requires labelling change to inform of possible increased risk of heart attack and stroke with use
2015. Results from the TEAAM study suggest testosterone use does not affect the progression of atherosclerosis in older males. Confusing…
2018. The blinded and placebo-controlled TRAVERSE study of topical testosterone TRT in symptomatic hypogonadal men with increased risk for cardiovascular disease is launched. Results are currently awaited and will hopefully provide a definitive answer to the cardiovascular disease question.
👥 Players
Annual prescription testosterone sales in the United States (U.S.) have increased from $18 million in 1988 to $70 million in 2000 to more than $2 billion in 2013. D2C players can be separated into those who actually provide different versions of the hormone for replacement purposes, and those which provide a mix of minerals and vitamins to ‘support’ its production.
Testosterone replacement
Optimale. UK-based testosterone replacement therapy (TRT) provider. Treatments prescribed by UK GMC registered doctors.
TrumanRx. Denver-based TRT provider. They combine at home blood testing with telehealth consultations. Partnered with telehealth provider HealthPoint Plus to increase reach across the US.
Opt Health. San Francisco-based provider. Aims to track impact of testosterone replacement with wearables and analytics dashboard.
Vault Health. Membership-based consumer health platform for men, with at-home practitioner appointments, 24/7 telemedicine and ePrescribing.
Testosterone support
Numan. D2C digital healthcare brand for men. Provide treatments and supplements for hair loss, erectile dysfunction as well as a selection of minerals and vitamins to support testosterone levels.
Roman. Digital health clinic for men. Also ship a ‘testosterone support’ supplement with a variety of different vitamins and minerals. Different ingredients to the the Numan product interestingly.
Kane. Provide a natural testosterone support product. Website is chock full of buff dudes working out and driving sports cars next to attractive women…
Manual. Online pharmacy for a range of male focussed conditions like erectile dysfunction and hair loss. Provide at home testosterone blood test and a testosterone support supplement.
🤔 Considerations
Cardiovascular disease. The evidence from both trials and observational studies is conflicting and inconclusive as to whether testosterone replacement increases the risk of heart attacks and strokes. For those with pathological hypogonadism, the benefits of treatment probably outweigh the risks. But can the same be sad for otherwise healthy men? One provider of testosterone therapy recently settled a class-action lawsuit brought by men who claimed the treatment causes blood clots, strokes and heart attacks…
Prostate issues. The relationship between testosterone and prostate cancer remains complex. While most studies suggest no relationship between testosterone supplementation and prostate cancer incidence and progression, findings in the literature are mixed. Large, randomized placebo-controlled trials are lacking.
Fertility. Use of TRT can impact the feedback loop between the brain and the testes (see above). For men of reproductive age, this could impact on sperm production and therefore fertility. Stopping TRT should help sperm production to normal, but some providers recommend using a second hormone (hCG) to help maintain fertility whilst on TRT.
Guidelines. The American College of Physicians (ACP) has advised physicians should prescribe testosterone for men with age-related low testosterone only to treat sexual dysfunction. Their advice is based on this systematic review of the available evidence. The Endocrine Society’s latest guidelines states that testosterone therapy should only be given for men who have proven low levels of testosterone and avoided in men who have had a stroke or heart attack within the last six months or who are at high risk for prostate cancer.
Timing. Testosterone levels in the blood vary throughout the day. They are at their highest in the morning (around 8am) and decline throughout the day before rising again overnight. Blood tests need to be repeated at the same time (normally in the morning) to establish if someone has truly low levels. At home testing might not be carried out to these exacting standards.
Avoiding the issue. Obesity and diabetes are on the up. Both of these can suppress testosterone levels in men. Rather than replacing testosterone and potentially suffering side-effects, more focus should be put on dealing with the underlying cause. Weight loss, regular exercise, and a balanced diet should be explored before replacement therapies are prescribed.
Monitoring. Some studies estimate that up to 25% of men who receive testosterone therapy do not have their testosterone tested prior to initiation of treatment. Of the men who are treated with testosterone, nearly half do not have their testosterone levels checked after therapy commences. Ideally, patients should be evaluated at 3 to 6 months after treatment initiation and then annually to assess whether symptoms have abated.
🔮 Predictions
Brand appeal. The growth of online brands offering easy access to TRT will encourage a growth in prescriptions amongst a younger cohort of men.
Onboarding. Combining online assessments with telehealth consultations and home delivery of medicines will reduce the friction in acquiring TRT. The same model will probably be applied to other conditions and prescriptions.
Access to healthcare. Difficulties accessing their usual primary care doctors will push people to seek online solutions for their problems or symptoms.
Market size. The D2C prescription market is increasing and will encourage new entrants. Motivations are likely to be predicated on profit rather than providing holistic healthcare.
🌅 Opportunities
Education. Improving understanding around testosterone levels, such as how they can change throughout life, and what underlying conditions can influence them, is key.
Regulation. Increased scrutiny should be applied to online D2C brands providing TRT, particularly around appropriateness of prescribing, suitable monitoring and patient follow-up to assess for side-effects and unintended outcomes.
That’s it for this week - catch ya next time 👋