Supply and manufacturing
GLP-1 supply and manufacturing capacity
US shortages of semaglutide and tirzepatide were resolved in 2024 and 2025. The binding constraint has since shifted to sterile fill-finish capacity, autoinjectors and glass cartridges, which limit the growth of injectable therapies and underpin the investment both leading manufacturers are making in oral formulations.
The supply chain
Supply chain constraints by stage
Injectable peptides require five specialised manufacturing steps; oral small molecules require four standard ones.
Injectable peptide semaglutide, tirzepatide, retatrutide
Oral small molecule orforglipron (Foundayo)
Constraint ratings reflect our assessment of company and industry disclosures, not measured utilisation. The Wegovy pill is a peptide tablet and therefore remains dependent on large volumes of peptide API.
Capacity tracker
Announced capacity investments
Announced investment by project, in US$ billions. Hover for site scope.
Not shown: Eli Lilly parenteral and device sites in Concord and Research Triangle Park, North Carolina, and a $5B antibody facility in Virginia. Eli Lilly describes its overall programme as a $50B US manufacturing commitment.
Shortage status
FDA shortage status
Duration on the FDA drug shortage list, followed by the compounding transition period (hatched).
During a listed shortage, US pharmacies may compound copies. Tirzepatide was listed on December 15, 2022 and declared resolved on December 19, 2024; semaglutide was declared resolved on February 21, 2025. Compounding transition periods ended in 2025, and an April 2026 FDA update listed neither product in shortage.
Challengers
Viking Therapeutics: supply secured ahead of Phase 3
Viking Therapeutics has no in-house manufacturing. In March 2025, following its Phase 2 readout, it signed a multi-year agreement with CordenPharma covering injectable and oral VK2735.
At one pen per weekly dose, 100 million autoinjectors would support approximately 1.9 million patient-years of treatment (Peptide Analysis estimate, not a company figure). The Phase 3 VANQUISH programme is expected to complete in 2027.
Late-stage challengers: manufacturing strategy
| Company | Drug | Stage | Supply route | Disclosed scale | Source |
|---|---|---|---|---|---|
| Amgen | MariTide | Monthly injection; first Phase 3 readouts expected 2027 | In-house: more than $1.5B in a North Carolina drug-substance plant, announced days after MariTide's Phase 2 data; Amgen has not tied it to MariTide directly | No dose or volume figures disclosed | Amgen |
| Pfizer (Metsera) | Berobenatide | Monthly injection; in Phase 3 | Partner: Amneal, building peptide synthesis and sterile fill-finish plants in India | About $150M to $200M over four to five years (Amneal) | BioSpace |
| Roche | Enicepatide (CT-388), petrelintide | In Phase 3 | In-house: high-volume metabolic medicines plant in North Carolina | More than $700M, committed before Phase 2 data | BioSpace |
| Boehringer Ingelheim | Survodutide | Phase 3 complete | Combination of internal capacity and external partners | No specific plans disclosed | BioSpace |
Challengers are committing to manufacturing capacity before approval, in several cases before Phase 3 results, to avoid the supply constraints Novo Nordisk and Eli Lilly faced in 2022 to 2024. Viking is the only one to have disclosed volume commitments.
Generic supply
Generic manufacturers face capacity constraints
- Supply is the binding constraint. Following semaglutide patent expiries in 2026, Indian contract manufacturers report order books extending 12 to 24 months.
- Key constraints: peptide API, sterile fill-finish, injector devices and specialised glass cartridges.
- Long lead times: a new peptide or sterile line takes 18 to 24 months to commission, and regulatory filings for the US and Europe a further 18 to 24 months.
- Outlook: industry executives expect constrained supply in regulated markets for two to three years.
Oral formulations
Oral formulations bypass sterile capacity
- No sterile filling required. Small-molecule tablets are produced on standard oral solid-dose lines, which are more widely available and faster to scale than sterile fill-finish.
- Eli Lilly: three orforglipron plants (Texas, Alabama, Puerto Rico), representing approximately $13.7B of investment.
- Global launch: Foundayo is under regulatory review in more than 40 countries, with full rollout targeted for 2027.
- Novo Nordisk: the Wegovy pill is a peptide tablet and requires substantially more peptide API per patient than the weekly injection.
Sources
- Eli Lilly: Houston groundbreaking, ten US sites since 2020 (Sept 21, 2026)
- Fierce Pharma: Lilly's $3.5B Pennsylvania injectables and device plant
- Pharmaceutical Technology: Lilly's $6B Alabama orforglipron site
- Fierce Pharma: Novo's $4.1B second fill-finish plant in North Carolina
- Contract Pharma: Novo buys three Catalent fill-finish sites
- IntuitionLabs: GLP-1 drug manufacturing, expansion and tech transfer
- Foley: FDA removes semaglutide from the shortage list
- Pharmacy Times: FDA affirms tirzepatide shortage resolved
- Business Standard: GLP-1 boom exposes capacity crunch at India's CDMOs (June 28, 2026)
- Viking Therapeutics: manufacturing agreement with CordenPharma (Mar 11, 2025)
- BioSpace: to compete in obesity, late entrants invest early in manufacturing (Sept 23, 2025)
- Amgen: nearly $2 billion of US manufacturing investment (May 4, 2026)