Peptide API (SPPS) Capacity by Provider
Cumulative solid-phase peptide synthesis (SPPS) reactor capacity in liters by provider, 2022 through 2028E. The 2023 to 2024 peptide-API bottleneck (when both tirzepatide and semaglutide were on FDA shortage) eases through 2026 to 2028 as CordenPharma's EUR 1B+ expansion, Bachem's CHF 400M capex, and the in-house Lilly and Novo build-outs come online. CDMO-only capacity (CordenPharma + Bachem + PolyPeptide + Lonza) more than doubles 2022 to 2028; in-house Lilly and Novo grow even faster on absolute basis.
Sterile Fill-Finish Capacity by Site
Major sterile fill-finish sites contributing to GLP-1 pen and cartridge production, ranked by approximate annualized pen-equivalent capacity. Lilly Concord NC leads at 240M pens/yr as the network ramps through 2025 to 2026. Novo Holdings' three Catalent sites (Bloomington IN, Anagni IT, Brussels BE) add ~460M pens/yr collectively. Samsung Biologics and Lonza are the largest non-traditional contributors. Pen-equivalent definitions vary by site and dose; figures are directional from management commentary and consultant estimates.
Cumulative CDMO + In-House Capex 2023 to 2027
Cumulative announced peptide-platform capex 2023 to 2027E, stacked by participant. Lilly's in-house spend dwarfs every other line item, reflecting the multi-site North Carolina, Wisconsin, and Indiana buildout. Novo Holdings' $16.5B Catalent acquisition (Feb 2024) is included at announcement value. CordenPharma's EUR ~1B platform expansion lands in 2024 to 2026 announcements. Bachem and PolyPeptide are smaller absolute spenders but disproportionately important to the pure-play peptide CDMO public-equity case.
FDA Shortage and Compounding Rulemaking Timeline
Tirzepatide added to FDA shortage list (Mounjaro launch ramp)
Tirzepatide shortage resolved by FDA
Semaglutide shortage resolved by FDA
FDA proposes removing semaglutide, tirzepatide, liraglutide from 503A bulk substances list
Public comment period closes June 29, 2026
FDA Drug Shortage database tracking for the four GLP-1 molecules subject to compounding activity. Tirzepatide came off the FDA shortage list December 2024; semaglutide followed February 2025. The April 2026 FDA proposal to remove semaglutide, tirzepatide, and liraglutide from the 503A bulk substances list (with public comment closing June 29, 2026) is the structural end-state for large-scale compounding. Compounding pharmacies and telehealth operators retain various civil-suit and litigation exposures from Novo Nordisk and Eli Lilly enforcement.
Compounded GLP-1 Shadow Market (Modeled Monthly Volume)
Modeled monthly compounded GLP-1 fills in non-traditional channels (503A pharmacies, telehealth-affiliated 503Bs, cash-pay clinics). Volume ramped through 2023 to 2024 during the FDA tirzepatide and semaglutide shortages, peaked around late 2024 (~1.24M fills/month at best estimate), then declined as the FDA resolved shortages (Dec 2024, Feb 2025) and Novo + Lilly intensified civil suits against compounding pharmacies and telehealth operators. The April 2026 FDA bulk substances proposal accelerates the decline. Figures are directional; precise compounder volumes are not publicly disclosed.