Peptide use in oncology appears to be extending beyond established hormone analogs toward targeted medicines, in which the peptide carries a radioactive isotope or a drug to the tumor. Based on published product information, a full four-dose course of Lutathera, a peptide-based radioligand therapy, contains roughly 1 mg of peptide. One year of weekly semaglutide 2.4 mg contains about 125 mg. In CDMO Hub's assessment, this difference suggests that capacity planning for peptide-based oncology programs may depend less on reactor volume and more on specification control, small-scale GMP availability, timing, analytical capability and inspection readiness.
Issues #2 and #3 looked at peptide capacity mainly through the GLP-1 lens: who is building large solid-phase peptide synthesis (SPPS) trains, and what may limit how much those plants can run. Oncology programs appear to work differently. Volumes are generally smaller, molecules can be more complex, and for radioligand therapies the supply chain typically ends at a hospital on a scheduled treatment date.
Oncology is not new territory for peptides. Somatostatin and GnRH analogs have been used in neuroendocrine and hormone-driven cancers for decades. A more recent development is the use of peptides as targeting components that carry radioactive or cytotoxic payloads. This is where outsourcing requirements appear to be becoming more specialized.
Across this briefing, “peptides in oncology” refers to three distinct classes: hormone analogs such as somatostatin and GnRH analogs; targeting peptides for radioligand therapy, including peptide receptor radionuclide therapy (PRRT); and peptide-drug conjugates and macrocycles. The industry does not treat these as one category, and neither should a capacity plan.
What the Data Shows
Company disclosures, FDA and EMA product information, and CDMO Hub analysis. Figures current as of September 2026.
- Radioligand therapy has become a commercial category. Novartis reported 2025 net sales of US$816 million for Lutathera, which is peptide-based, and US$1,994 million for Pluvicto, which uses a small-molecule targeting ligand. Novartis reported Pluvicto sales of US$651 million in Q2 2026 (+43% at constant currency), and the FDA approved an expanded Pluvicto indication on 31 July 2026.
- Peptide quantity per patient appears to be very small. Lutathera product information indicates about 10 µg/mL of peptide in a 20.5–25 mL vial. On CDMO Hub's calculation, that is roughly 0.20–0.25 mg per dose and about 0.8–1.0 mg across four doses, compared with about 125 mg for one year of weekly semaglutide 2.4 mg.
- Large pharma has invested in the field. Lilly completed its acquisition of POINT Biopharma (US$1.4 billion) in December 2023. BMS acquired RayzeBio (US$4.1 billion) and AstraZeneca acquired Fusion Pharmaceuticals (up to US$2.4 billion) in 2024. In August 2026, Curium agreed to merge with Lantheus in a transaction valued at up to US$8.0 billion, subject to approvals.
- Manufacturing and supply issues have affected some clinical and regulatory timelines. RayzeBio paused new enrollment in a Phase III trial in 2024 amid an actinium-225 shortage. In August 2026, ITM announced that it had received an FDA complete response letter citing CMC and third-party commercial facility-related items; according to the company, the FDA did not identify concerns with the clinical or nonclinical data package or the safety profile.
- Peptide-drug conjugates have had a mixed record. Melflufen remains approved in the EU, while its US approval was withdrawn in 2024. Bicycle Therapeutics has reported deprioritizing its lead conjugate program in 2026 while continuing work on next-generation programs, including radioconjugates.
Three Different Businesses Under One Label
In CDMO Hub's view, “peptides in oncology” spans at least three distinct manufacturing profiles. They share synthesis chemistry, but they tend to be bought, specified and scheduled in different ways. Strength in one profile may not indicate qualification for the others.
| Category | Examples | What the CDMO supplies | What drives capacity |
|---|---|---|---|
| Established hormone analogs | Octreotide, lanreotide, leuprolide, goserelin, degarelix | Multi-kilogram API, much of it off-patent; long-acting injectable formulations | Cost per kilogram, raw material and building-block supply, depot formulation capacity |
| Targeting peptides for radioligand therapy | Lutathera (177Lu-dotatate); 177Lu-edotreotide (ITM); actinium-225 peptide candidates | GMP “cold” (non-radioactive) precursor: the peptide joined to a chelator, the chemical structure that later holds the isotope | Specification control, stability, release timing, alignment with isotope and labeling schedules |
| Peptide conjugates and macrocycles | Melflufen (EU); Bicycle conjugates; macrocyclic programs such as PeptiDream collaborations | Peptide plus linker and payload; non-natural amino acids and ring-closing steps | Containment, conjugation suites, analytical methods and control of the combined molecule |
Not every radioligand uses a peptide. Pluvicto, for example, uses a small-molecule targeting ligand, and antibodies are also used in radiopharmaceutical development. Peptides are one of several carrier options, so sponsor route choices at the discovery stage may shape which CDMO capabilities become relevant later.
The Kilogram Arithmetic
Published product labels help illustrate the difference in scale. On CDMO Hub's calculation, a full Lutathera course contains roughly 1 mg of peptide, while one year of weekly semaglutide at the 2.4 mg maintenance dose contains about 125 mg. That is a difference of more than a hundredfold per patient, and the number of patients on metabolic treatments is also considerably larger.
GLP-1: ≈125 mg peptide / patient / year | Lutathera: ≈1 mg peptide / full course
On this arithmetic, 10,000 Lutathera treatment courses would contain about 10 grams of peptide in final doses. Actual manufacturing requirements would be higher once process losses, quality-control samples and stability studies are included. Even so, annual demand for a single radioligand precursor appears likely to be measured in grams rather than in reactor-sized batches. Manufacturers do not generally publish precursor volumes, so this figure should be read as an order-of-magnitude estimate.
The commercial significance may therefore not be proportional to API mass. Where treatment slots, isotope availability and patient scheduling are linked, the value per gram and the cost of a failed or delayed batch could be high.
Where the Constraints May Sit
For a GLP-1 program, a major constraint is often how much a plant can run. For a radioligand program, an important constraint appears to be whether the time-sensitive links in the supply chain are aligned with the treatment schedule.
Four Links That Have to Align on One Treatment Day
| Link | Role |
|---|---|
| 1 · Peptide precursor | Peptide plus chelator. Can be manufactured ahead of use and stocked. |
| 2 · Isotope | Isotope availability is time-sensitive; Lu-177 has a half-life of 6.647 days. |
| 3 · Labeling + release | Dose preparation, labeling and release typically take place close to treatment. |
| 4 · Patient | Treatment dates are scheduled; Novartis has reported that more than 99% of doses are administered on the planned day. |
Because the peptide precursor can be manufactured and stocked ahead of treatment, CDMO Hub's view is that sponsors may benefit from treating precursor reliability as one of the more controllable elements in a time-critical supply chain. Safety stock, stability data and a second qualified source could therefore become commercial considerations in supply agreements.
Specification control may carry more weight than for a standard peptide API. In addition to purity and impurities, a radioligand precursor specification generally needs to address trace metals, which can compete with the intended isotope for the chelator and reduce labeling yield. Metal limits, chelator content and performance under labeling conditions may therefore become central elements of the specification.
Isotope supply has been a visible constraint. RayzeBio's 2024 enrollment pause suggested that clinical timelines in alpha-emitter programs may depend on an isotope supply chain that peptide sourcing teams have not traditionally needed to manage.
Generic entry could increase the number of sponsors sourcing the same or closely related precursors. In March 2026, Lantheus announced tentative FDA approval for a generic version of lutetium Lu 177 dotatate. In June 2026, a US district court ruled against the validity of key Lutathera patents, and Novartis has appealed the decision. The outcome of the appeal and the timing of any generic launch remain uncertain.
Inspection readiness appears to form part of the approval path. ITM's August 2026 complete response letter, as disclosed by the company, cited CMC and third-party commercial facility-related items. For sponsors, this example suggests that the regulatory status of an outsourced manufacturing site may be part of the filing risk rather than a separate procurement matter.
Recent Investment Activity
Recent transactions appear to reflect investment not only in molecules, but also in manufacturing sites, isotope access and specialist know-how. The implications below are CDMO Hub interpretations of disclosed transactions, not company-stated strategies.
| Company | What they have done | What it suggests for outsourcing |
|---|---|---|
| Novartis | Company disclosures describe an expanding US radioligand manufacturing network and investment in isotope production; Novartis also expanded its macrocyclic peptide collaboration with PeptiDream in 2024. | May indicate an integrated supply model. In-house final-dose and isotope capacity could reduce some dependencies, while some specialized inputs may still be sourced externally. |
| BMS, AstraZeneca, Lilly | The RayzeBio, Fusion and POINT transactions included pipeline assets alongside radiopharmaceutical manufacturing or isotope-related capabilities. | May indicate that manufacturing capability is being treated as part of asset value rather than only as a service purchased later. |
| Curium and Lantheus | Curium agreed in August 2026 to merge with Lantheus, subject to approvals; Lantheus had previously acquired Evergreen Theragnostics, a radiopharmaceutical CDMO. | May indicate that specialist radiopharmaceutical capacity is consolidating within companies that also own product portfolios. Ownership and customer-priority questions could become more relevant in diligence. |
| ITM | Announced receipt of an FDA complete response letter in August 2026 citing CMC and third-party commercial facility-related items. The company reported that the FDA did not identify concerns with the clinical or nonclinical data package or the safety profile. | Suggests that manufacturing and partner-facility readiness may affect the approval path even when clinical data are not at issue. |
| PeptiDream / PDRadiopharma | Macrocyclic peptide discovery platform partnered with Novartis; the company also reports an internal peptide radiopharmaceutical program. | Macrocycles often include non-natural amino acids and ring-closing steps, which may raise synthesis and analytical requirements when a program moves into GMP. |
| Bicycle / Oncopeptides | Bicycle reported deprioritizing its lead conjugate program in 2026 while continuing next-generation programs; melflufen remains approved in the EU after its US approval was withdrawn in 2024. | Suggests demand for conjugate capacity may remain program-specific. Capacity plans may be more robust when based on qualified pipeline demand rather than modality labels alone. |
What It May Mean for CDMO Capacity Planning
- Planning in grams, pricing for risk. Revenue from oncology peptide programs may not come mainly from reactor utilization. Small, high-value campaigns can carry demanding release criteria, and planning models built only on kilograms per year could understate both the requirements of the category and the cost of a failed batch.
- Small-scale GMP suites may be a key asset. Relevant capabilities may include gram-scale GMP synthesis, preparative purification sized for small lots, containment for potent conjugates and analytical methods suited to peptide-chelator and peptide-drug molecules. At sites scaling for GLP-1, these suites could compete for the same quality, release and engineering resources.
- Reliability may need to be scheduled around the patient. In radioligand supply, precursor readiness sits within a chain organized around treatment dates. Stability data, safety stock and dual sourcing could therefore become part of supply planning.
- Inspection status may be on the critical path. The ITM example suggests that sponsors could benefit from requesting inspection history and site-readiness information earlier in supplier selection.
Diligence Questions Sponsors May Want to Ask
- Precursor specification. What are the limits for trace metals and chelator content, and is labeling performance tested as part of release or characterization?
- Regulatory definition of the precursor. How is the precursor described in the regulatory filing (for example, as a starting material, intermediate or drug substance), and how might that affect GMP requirements, change control and qualification of a second source?
- Scale fit. What is the typical GMP batch size for peptides in the 1–50 gram range, and how is that suite protected from being displaced by larger metabolic campaigns at the same site?
- Stability and stock. What retest period is supported by real-time data under the sponsor's storage and shipping conditions, and how much safety stock can be held?
- Complex chemistry at GMP. How many non-natural amino acid and cyclic-peptide projects have been run under GMP, not only at research scale?
- Potent handling. For conjugates, what containment level, conjugation-suite availability and cleaning validation apply to cytotoxic payloads?
- Inspection record. Which FDA, EMA or PMDA inspections has this specific site and relevant suite had, and with what outcome?
- Ownership and priority. Who owns the site, and how are external customer programs prioritized against the parent company's own radioligand or conjugate pipeline?
The CDMO Hub View
In CDMO Hub's view, peptide-based oncology medicines are unlikely to change the overall tonnage picture of peptide manufacturing. GLP-1 and other metabolic peptides appear likely to remain the main drivers of large-scale reactor planning, and established hormone analogs are expected to remain largely a cost-per-kilogram business. Targeted peptide therapeutics in oncology may add a distinct market with different requirements: small GMP suites that remain available, specifications designed for labeling or conjugation, appropriate analytical and containment capability, and a quality record that supports regulatory review.
For mid-sized and specialist peptide CDMOs that do not compete on multi-tonne capacity, this segment could represent a route to growth, particularly where they can provide evidence of relevant experience rather than listing a capability. For sponsors, a practical consideration may be that a site with the technical capability might still not be the right fit if the required suite, scale or schedule is not available.
A Note on Scope
This briefing covers peptide-based oncology medicines and what they may mean for outsourced peptide manufacturing. It uses selected non-peptide radioligand examples where they help illustrate the wider radiopharmaceutical manufacturing and supply-chain context. It does not assess the clinical merits of any product, or the overall quality, capacity or commercial terms of any company, and inclusion or omission is not a recommendation. Per-patient peptide quantities are CDMO Hub calculations from published product information and exclude manufacturing losses; manufacturers do not generally publish radioligand precursor volumes. Deal values are as announced and may include contingent payments where stated. Descriptions of regulatory decisions reflect company announcements and FDA communications available at the time of writing.
CDMO Hub Insight
In CDMO Hub's view, capacity is rarely a single number. A supplier may have peptide capability and still not be the right fit for a specific oncology program. A more useful question may be whether a specific site can manufacture a given molecule, at the required scale, to the required specification, on the required schedule, with the regulatory evidence to support the program.
Capability, qualification, availability and program fit are related, but they may not always align. We believe that distinction is important for evidence-based supplier matching.
Looking for peptide manufacturing partners? CDMO Hub helps biotech and pharmaceutical companies identify and evaluate peptide manufacturing partners using structured capability information, facility-level evidence, regulatory experience, scale and therapeutic modality. The aim is to help assess whether a relevant site and its capabilities fit a specific program requirement, not only whether a company lists peptide manufacturing. Explore verified suppliers and peptide manufacturing capabilities.
Inside Peptide Manufacturing is a CDMO Hub series on the industrial side of the peptide category: capacity, chemistry, cost of goods, and the decisions that sit behind them.
Notes and Sources
- Novartis: Q4 and full-year 2025 results, 4 February 2026; Q2 2026 results, 21 July 2026; radioligand manufacturing announcements of 10 November 2025, 9 January 2026, 25 February 2026 and 7 May 2026.
- FDA: approval of lutetium Lu 177 vipivotide tetraxetan with ARPI therapy, 31 July 2026; Lutathera US prescribing information (vial volume, half-life).
- Lutathera Australian product information, Therapeutic Goods Administration (peptide concentration of about 10 µg/mL). Per-dose and per-course totals are CDMO Hub calculations.
- Wegovy US prescribing information (semaglutide 2.4 mg weekly maintenance dose).
- ITM: press releases of 13 November 2025 (NDA acceptance) and 10 August 2026 (complete response letter received 7 August 2026).
- Lantheus: announcement of FDA tentative approval for generic lutetium Lu 177 dotatate, March 2026; disclosures on the Evergreen Theragnostics acquisition. Curium and Lantheus joint announcement, 3 August 2026.
- Lutathera patent litigation: Novartis Q2 2026 results disclosures, 21 July 2026.
- Transactions: Eli Lilly announcement of completion of the POINT Biopharma acquisition, 27 December 2023; Bristol Myers Squibb and AstraZeneca disclosures on the RayzeBio and Fusion Pharmaceuticals acquisitions.
- Isotope supply: Fierce Pharma, 3 June 2024 (RayzeBio Phase III enrollment pause).
- Peptide-drug conjugates: FDA final decision on withdrawal of Pepaxto (melflufen) approval, 23 February 2024; Oncopeptides disclosures; Bicycle Therapeutics full-year 2025 results, 17 March 2026, and subsequent company disclosures.
- PeptiDream: company disclosures on the Novartis collaboration and internal programs.
Figures and characterizations are current as of September 2026. CDMO Hub analysis is identified where interpretation extends beyond company-stated facts. Corrections are welcome and will be noted in a following issue.
CDMO Hub is a sourcing intelligence platform helping pharmaceutical and biotech companies identify and evaluate CDMOs, CROs and specialist manufacturing partners.
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