November 2025 — CDMO Opportunities And Threats Report
By GlobalData
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
| Contractor | BioPharma Company | Event | Product | Relationship |
POTENTIALLY POSITIVE |
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| Catalent Germany Eberbach GmbH | Bayer HealthCare Pharmaceuticals | FDA approval | Lynkuet | Solid dose manufacturer |
| Catalent Germany Schorndorf GmbH | Bayer AG | FDA approval | Lynkuet | Small mol API |
| Hovione FarmaCiencia SA | Novo Nordisk Inc | FDA expanded indications | Rybelsus | Biologic API |
| Novo Nordisk AS | Celltrion Inc | FDA expanded indications | Yuflyma | Parenteral manufacture & packaging |
| NUVISAN Pharma Holding GmbH | Celltrion Inc | FDA expanded indications | Yuflyma | Parenteral manufacture |
| Patheon Italia SpA | Merck Sharp & Dohme LLC | FDA expanded indications | Winrevair | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Janssen-Cilag Ltd | UK MHRA approval | Darzalex | Parenteral manufacture |
| AbbVie Inc | Merck Sharp & Dohme LLC | FDA expanded indications | Winrevair | Biologic API |
| AstraZeneca Plc | Merck Sharp & Dohme BV | EMA expanded indications | Keytruda | Biologic API |
| Bachem Holding AG | Axon Neuroscience SE | Trial planned - Phase II | AADvac-1 | Small mol API |
| Biogen Inc | Janssen-Cilag Ltd | UK MHRA approval | Darzalex | Biologic API |
| Biogen Inc | Janssen-Cilag International NV | EMA expanded indications | Tremfya | Biologic API |
| Biogen Inc | Janssen Biotech Inc | FDA expanded indications | Darzalex Faspro | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck Sharp & Dohme BV | EMA expanded indications | Keytruda | Biologic API |
| Corden Pharma International GmbH | AbbVie Inc | FDA expanded indications | Linzess | Small mol API |
| Curia Global Inc | Cassiopea SpA | EMA approval | Winlevi | Small mol API |
| Esteve Quimica SA | Bayer AG | FDA approval | Lynkuet | Small mol API |
| FUJIFILM Biotechnologies USA Inc | Janssen-Cilag Ltd | UK MHRA approval | Darzalex | Biologic API |
| FUJIFILM Biotechnologies USA Inc | Janssen Biotech Inc | FDA expanded indications | Darzalex Faspro | Biologic API |
| Ivers-Lee AG | Alvotech SA | FDA expanded indications | Simlandi | Parenteral packaging |
| Lonza Group Ltd | Gracell Biotechnologies Inc | Trial planned - Phase I | AZD-0120 | Biologic API |
| MilliporeSigma | GlaxoSmithKline LLC | FDA expanded indications | Blenrep | Biologic API |
| Novo Nordisk AS | Janssen-Cilag Ltd | UK MHRA approval | Darzalex | Biologic API |
| Novo Nordisk AS | Sanofi UK | UK MHRA expanded indications | Dupixent | Parenteral manufacture |
| Novo Nordisk AS | Regeneron Pharmaceuticals Inc | EU expanded indications | Libtayo | Parenteral manufacture & packaging |
| Novo Nordisk AS | Janssen Biotech Inc | FDA expanded indications | Darzalex Faspro | Biologic API |
| Organon & Co | Merck Sharp & Dohme BV | EMA expanded indications | Keytruda | Parenteral manufacture & packaging |
| Lianhe Chemical Technology Co Ltd | Bayer AG | FDA approval | Lynkuet | Small mol API |
| Patheon NV | AstraZeneca AB | EMA expanded indications | Koselugo | Solid dose manufacturer |
| PCI Pharma Services | Janssen-Cilag Ltd | UK MHRA approval | Darzalex | Parenteral packaging |
| PCI Pharma Services | Janssen-Cilag International NV | EMA expanded indications | Tremfya | Parenteral packaging |
| PCI Pharma Services | Glaukos Corp | FDA expanded indications | Epioxa | Liquid sterile manufacture |
| PCI Pharma Services | Celltrion Inc | FDA expanded indications | Yuflyma | Parenteral packaging |
| Pharmstandard | Genentech Inc | FDA expanded indications | Gazyva | Parenteral manufacture & packaging |
| PolyPeptide Laboratories (Sweden) AB | AbbVie Inc | FDA expanded indications | Linzess | Small mol API |
| PolyPeptide Laboratories Inc | AbbVie Inc | FDA expanded indications | Linzess | Small mol API |
| Samsung Biologics Co Ltd | Janssen-Cilag Ltd | UK MHRA approval | Darzalex | Biologic API |
| Sharp Packaging Services LLC | Bayer HealthCare Pharmaceuticals Inc | NICE approval | Nubeqa | Solid dose packaging |
| Sharp Packaging Services LLC | Bayer AG | FDA approval | Lynkuet | Solid dose packaging |
| Sharp Packaging Services LLC | Regeneron Pharmaceuticals Inc | EU expanded indications | Libtayo | Parenteral packaging |
| Siegfried Holding AG | Intra-Cellular Therapies Inc | FDA expanded indications | Caplyta | Small mol API |
| Simtra US LLC | Janssen-Cilag Ltd | UK MHRA approval | Darzalex | Parenteral manufacture & packaging |
| WuXi Advanced Therapies Inc | Kyverna Therapeutics Inc | Positive Phase II/III interim results | KYV-101 | Biologic API |
| WuXi Biologics Cayman Inc | Apogee Therapeutics Inc | Positive Phase I interim results | APG-333 | Biologic API |
| WuXi Biologics Cayman Inc | Tectonic Therapeutic Inc | Positive Phase I top-line results | TX-45 | Biologic API |
POTENTIALLY NEGATIVE |
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| Curia Global Inc | Glenmark Pharmaceuticals Europe Ltd | NICE unable to recommend | Winlevi | Small mol API |
| Novo Nordisk AS | Regeneron Pharmaceuticals Inc | No NICE recommendation | Libtayo | Parenteral manufacture & packaging |
| Sharp Packaging Services LLC | Regeneron Pharmaceuticals Inc | No NICE recommendation | Libtayo | Parenteral packaging |
Notes:
Source: GlobalData, Pharma Intelligence Center (Accessed November 17, 2025) ©GlobalData
NICE = National Institute for Health and Care Excellence
* New molecular entities are in bold