- An FDA panel is expected to recommend legal production of as many as seven peptides, and compounding pharmacies and telehealth companies are preparing for the coming bonanza.
- The potential market could be worth multi-billion dollars, putting companies like Empower Pharmacy and Hims & Hers within reach.
- Compounding pharmacies are actively preparing: Strive Pharmacy says it is “waiting for the green light from the FDA” and wants to make peptides.
- No pharma companies own patents on the peptides under review, so compounders face no traditional pharma competition. Shaun Noorian of Empower notes: “No one can say these medications should be made by traditional pharma companies.”
- Empower Pharmacy has been “prepping for months” with R&D for stable formulations in injections, pills, and nasal sprays, and expects peptide revenue to reach “several hundred million dollars.”
- Hims & Hers is building infrastructure and clinical protocols to produce and sell peptides if approved, and recently hired a Harvard-trained longevity expert as chief medical officer to focus on peptide therapy.
- Private-equity and VC firms are already positioning: “The compounders and the telehealth companies are in talks right now with private-equity groups and with VC firms.”
- Even if the panel recommends approval, the timing and supply chain remain uncertain. Setting up pharmaceutical-grade ingredient supply chains could take months, but the market potential may dwarf the GLP-1 boom.
An FDA panel is reviewing seven peptides, with a recommendation for legal production expected soon. Compounding pharmacies and telehealth companies are gearing up for a potential multi-billion-dollar market, as no pharmaceutical companies hold patents on these peptides.12
Mike Walker, cofounder of Strive Pharmacy, stated, “We’d love to make them, and we’re getting ready to do it.”4
Companies like Empower have been preparing for months, with expectations of revenue reaching “several hundred million dollars.”691011
Jesse Dresser from Frier Levitt noted that clients are already positioning themselves for the anticipated approval, with discussions ongoing between compounders and private-equity groups.
However, even if the FDA committee recommends approval, the timeline for final approval remains uncertain.
The supply chain for these peptides poses challenges, as current ingredients are research-grade and not permitted for human use.
Brunner from the compounding industry trade group explained that establishing compliant supply chains could take months, especially if sourcing requirements change.
“Given the number of peptides we are talking about, this has the potential to make the experience we have just gone through with GLP-1s look little by comparison,” he added.
“Compounding pharmacies like Empower have spent months on R&D for stable injections, pills, and nasal sprays, expecting peptide revenue to reach several hundred million dollars. Private-equity and VC firms are already in talks with compounders and telehealth companies, eyeing a market that some predict could dwarf the GLP-1 boom.”
Forbes
