Peptides have quietly become a booming wellness market, promising everything from faster recovery to better metabolism and skin. Much of that demand currently sits outside the regulated drug market, but that could be starting to change.
Hims & Hers Health stock jumped as much as 12% in a recent session after an FDA advisory committee voted to recommend BPC-157, a popular injectable peptide, for use by compounding pharmacies.
The FDA committee voted 8-6-1 in favor of BPC-157, but the recommendation isn't binding. Six more peptides remain under review, with five more due by early 2027. FDA staff have already raised concerns about the evidence, and formal rulemaking would still be required before widespread compounding.
The committee's close vote on BPC-157 is the first domino, not the finish line. Leerink Partners analyst Michael Cherny estimates a roughly $2.2B annual telehealth market opportunity if all seven peptides are approved.
He also rates HIMS as market-perform with a $25 price target, calling it overvalued at current levels. He sees any meaningful earnings contribution as a 2027 story at the earliest.
The market opportunity
The reason investors are excited is that demand already exists, regardless of what regulators decide. The peptide black market is estimated at $1B to $3B annually, according to investors inside the industry. US Customs and Border Protection logged $328M in active pharmaceutical ingredient imports for peptides during just the first nine months of 2025.
Peptide quality-testing firm Janoshik Analytical saw its peptide test volume increase more than 1,200% from 2023 to 2025.
Peptides are short chains of amino acids that bond to receptors in the body to trigger various physiological effects. BPC-157 is marketed online for muscle and injury repair.
Other peptides in the review set claim metabolic benefits, improved focus, and skin quality improvements. Most lack large-scale clinical trials in humans. Known safety risks include severe allergic reactions, liver or kidney damage, and possible acceleration of tumor growth.
Companies are positioning ahead of the rules
Hims acquired a peptide manufacturing facility in Menlo Park, Calif. in early 2025. Digital health company Noom recently acquired Tailor Made Compounding, whose facility operates across 46 states.
Longevity telehealth platform Geviti Health says its pharmacy partners are already building supply pipelines in anticipation of expanded access.
Protocole raised a $6M seed round in April to offer physician-supervised peptide subscriptions priced at roughly $200 to $300 per compound.
The businesses racing in are taking real regulatory risk. Alabama's Board of Medical Examiners issued an official notice warning practitioners that prescribing research-grade medications is prohibited even with patient waivers.
The Alliance for Pharmacy Compounding warns that demand could outpace pharmacy capacity by months, with estimates of three to nine months needed to establish regulatorily sound ingredient sourcing.
Lilly is fighting the market it helped create
Eli Lilly filed lawsuits against US businesses selling illegal versions of retatrutide, its experimental weight-loss peptide that has shown up to 30% body weight reduction in clinical trials.
The company has warned consumers about black-market versions for two years, but enforcement has consisted mainly of FDA warning letters. Lilly also asked the FDA to do more to stop the proliferation.
The legal fight over retatrutide mirrors the earlier battle over GLP-1 compounding, but with a key difference: retatrutide is still experimental and not approved, meaning there is no shortage exception that previously allowed compounders to produce copycat GLP-1s legally.
Retatrutide is currently in Phase III clinical trials and would not be included in any near-term compounding authorization.
The peptide market is real, large, and moving fast. But the regulatory path is narrow, the science is thin, and the biggest publicly traded beneficiary is already trading above most analyst targets.
