The untapped business case for male contraception

For more than 60 years, contraception has been almost exclusively a women’s responsibility. Today, women have more than 14 modern contraceptive options, while men have just two: condoms and vasectomies. That imbalance has pushed women to shoulder physical side effects, financial burden, medical risks, and the career impact of family planning—costs that have been accepted as the “status quo” for far too long.

But the tide is shifting. Men are increasingly vocal about wanting to participate in family planning, and new science is finally catching up. For the first time in history, there are multiple male contraceptives in clinical trials, some only a few years away from approval. For companies and investors, this isn’t just a public health opportunity, it’s a multibillion-dollar business opportunity in modern healthcare.

A $25 Billion Opportunity

The numbers are staggering. In the U.S. alone, there are approximately 70 million sexually active men ages 19 to 60. A landmark survey of 6,313 men in the U.S. found that 82% would try a new male contraceptive at some point in their lives. The same survey found that 49% of men would try a new male contraceptive within 12 months of it being on the market. A “downside” case looks like 34.3 million potential male contraceptive users. Some estimate that there are 17 million early adopters.

Reaching just a fraction of the men interested in male contraception would result in a blockbuster product: For example, 5 million prescriptions for male contraception in the U.S. annually (half of the number of women who are on the Pill) would result in $10 billion-plus of annual recurring revenue.

Globally, the opportunity is even larger. There are roughly 2.5 billion sexually active men in the world, and surveys indicate that interest in male contraceptives is even higher in countries like the U.K., Europe, Canada, and Australia. This market potential is why Amboy St. Ventures highlighted male contraception as one of the largest ghost markets in women’s health.

Sexual health is routinely underestimated by investors, yet the category routinely proves its commercial strength time and time again. Viagra and Cialis each scaled to blockbuster status with annual revenues of $1.8 billion and $2.5 billion for Pfizer and Eli Lilly, respectively. Truvada for HIV preexposure prophylaxis generated approximately $3 billion for Gilead in 2018 by enabling safer sexual activity. Meanwhile, testosterone and hormone-replacement therapies represent another multibillion-dollar sector, driven largely in part by the desire to preserve libido and sexual well-being.

There’s no reason male contraception can’t become the next big sexual health blockbuster.

A Digital-First Model

We are in the age of telemedicine. Hims & Hers (valued at $8.7 billion today) launched by targeting men’s health needs, such as erectile dysfunction, premature ejaculation, and hair loss. It proved what many underestimated: Men will seek out healthcare when it is accessible, discreet, and convenient. The early adopters who want male contraceptives are similarly digitally native. They won’t need their doctor to recommend a new contraceptive; they’ll be actively searching for it on their phones.

On a recent episode of the podcast Cheeky Pint, Dave Ricks, the CEO of Eli Lilly, said that the reason why LillyDirect works so well for GLP-1s is because “The diagnosis step [is] dead easy. Everybody knows the biomarker tool in their bathroom. It’s called the scale. They can know if the drug’s working, and we can offer telehealth post-pandemic at scale.” ​​In other words, a straightforward condition and clear feedback loop make remote care feasible. Male contraception fits that mold perfectly: No complex diagnosis or workup is needed—a simple at-home sperm check can provide confidence that the method is working.

Furthermore, the need for contraception is even more universal than reducing obesity and presents a massive opportunity for a first mover to capture the male birth control market via a direct-to-consumer, digital-first approach.

What’s in Development

After decades of little progress, several novel male contraceptives are now in clinical trials, addressing a range of preferences:

1. NES/T (Nesterone-Testosterone gel): The most clinically advanced product, NES/T is a topical gel applied to the shoulders daily. Inspired by products in the TRT and HRT space, NES/T delivers a combination of hormones to suppress sperm production while maintaining normal hormone levels and minimizing side effects. A Phase II b trial including 462 couples was recently completed to evaluate its safety, efficacy, and reversibility. Contraline, which secured the development rights from the Population Council, is now preparing for a Phase III trial—the first Phase III male contraceptive trial in history.
   
2. YCT-529: The nonhormonal daily pill temporarily halts sperm production by blocking a vitamin A pathway in the testes. The first human safety study showed promising tolerability, and now YourChoice Therapeutics is testing whether it reliably suppresses sperm in a Phase I b/II a trial. This compound could become a convenient oral contraceptive for men if it proves safe, effective, and reversible.
   
3. ADAM: This is a long-acting, reversible contraceptive implant (essentially an “IUD for men”). ADAM is a nonhormonal hydrogel implanted into the vas deferens, blocking sperm passage until the gel dissolves or is removed. A first-in-human trial showed ADAM is safe and effective for two years. Contraline, the company behind ADAM, is advancing the device toward a larger trial.

Given the potential $25 billion-plus market size and men’s desire for having multiple options to choose from (just like women do), it is unlikely that male contraception will be a “winner-takes-all” market. Each of these products may be a blockbuster in its own right.

In 1960, the launch of the female Pill sparked a social revolution and created one of the most profitable drug categories in history. Sixty-plus years later, the next sexual health revolution is overdue. This time, it may be led by men.

(Disclosure: Foreground Capital is an investor in Contraline and YourChoice Therapeutics, and Amboy St. Ventures is an investor in Contraline.)

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