May 2026 — 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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| AGC Biologics Inc | AAVantgarde Bio Srl | Positive Phase I/II interim results | AAVB-081 | Biologic API |
| AGC Biologics Inc | Provention Bio Inc | FDA expanded indications | Tzield* | Biologic API |
| Ajinomoto Bio-Pharma Services | MacroGenics Inc | Positive Phase II interim results | lorigerlimab | Parenteral manufacture |
| Almac Group Ltd | Provention Bio Inc | FDA expanded indications | Tzield* | Parenteral packaging |
| Almac Group Ltd | Pierre Fabre Ltd | NICE approval | Braftovi* | Solid dose packaging |
| Ardena Holding NV | Pierre Fabre Ltd | NICE approval | Braftovi* | Solid dose manufacture |
| Aspen Pharmacare Holdings Ltd | AstraZeneca Pharmaceuticals LP | FDA expanded indications | Symbicort Aerosphere | Small mol API |
| Astrea Pharma | Rhythm Pharmaceuticals Inc | EMA expanded indications | Imcivree* | Parenteral manufacture & packaging |
| Astrea Pharma | Rhythm Pharmaceuticals Inc | EMA expanded indications | Imcivree* | Biologic API |
| Avid Bioservices Inc | Argenx SE | FDA expanded indications | Vyvgart Hytrulo* | Biologic API |
| Bachem Holding AG | Swedish Orphan Biovitrum Ltd | MHRA expanded indications | Aspaveli* | Biologic API |
| Baxter International Inc | MacroGenics Inc | Positive Phase II interim results | lorigerlimab | Parenteral manufacture |
| BioSpring GmbH | Transcode Therapeutics Inc | Positive Phase 0 interim results | TTXMC-138 | Small mol API |
| Bora Pharmaceuticals Co Ltd | Swedish Orphan Biovitrum Ltd | MHRA expanded indications | Aspaveli* | Parenteral manufacture |
| Borregaard Synthesis Inc | AstraZeneca Pharmaceuticals LP | FDA expanded indications | Symbicort Aerosphere | Small mol API |
| BSP Pharmaceuticals SpA | Taiho Oncology Inc | FDA expanded indications | Inqovi* | Solid dose manufacture |
| Cambrex Corp | Deciphera Pharmaceuticals Inc | NICE approval | Qinlock* | Small mol API |
| Catalent Inc | Regeneron Pharmaceuticals Inc | FDA approval | Otarmeni* | Liquid sterile manufacture |
| Catalent Inc | X4 Pharmaceuticals Inc | EMA approval | Xolremdi* | Solid dose manufacture & packaging |
| Charles River Laboratories International Inc | Rznomics Inc | Positive Phase I/II interim results | RZ-001 | Biologic API |
| Chemspec-API Inc | Can-Fite BioPharma Ltd | Positive Phase II interim results | namodenoson | Small mol API |
| Eurofins Scientific | Organon & Co | EMA approval | Poherdy | Parenteral manufacture & packaging |
| Forge Biologics Inc | Ray Therapeutics Inc | Positive Phase I/II interim results | RTX-015 | Biologic API |
| Juzen Chemical Corp | Swedish Orphan Biovitrum Ltd | MHRA expanded indications | Aspaveli* | Parenteral manufacture |
| Latina Pharma SpA | Apotex Corp | FDA approval | Evdi | Solid dose manufacture |
| Lek Pharmaceuticals dd | Novartis Pharmaceuticals Corp | FDA expanded indications | Cosentyx* | Parenteral manufacture & packaging |
| Lek Pharmaceuticals dd | Novartis Pharmaceuticals UK Ltd | EMA expanded indications | Mekinist* | Solid dose manufacture & packaging |
| Lonza Biologics Inc | Merck & Co Inc | EMA approval | Enflonsia* | Biologic API |
| Lonza Biologics Inc | Merck Sharp & Dohme (UK) Ltd | MHRA approval | Enflonsia* | Biologic API |
| Lonza Bend Inc | Deciphera Pharmaceuticals Inc | NICE approval | Qinlock* | Solid dose manufacture |
| Lonza Group Ltd | Pheast Therapeutics Inc | Positive Phase I interim results | PHST-001 | Biologic API |
| Lonza Group Ltd | Pheast Therapeutics Inc | Positive Phase I interim results | PHST-001 | Parenteral manufacture |
| Lonza Group Ltd | Shanghai Junshi Biosciences Co Ltd | Positive Phase II interim results | JS-007 | Biologic API |
| Lonza Group Ltd | Argenx SE | FDA expanded indications | Vyvgart* | Biologic API |
| Lonza Group Ltd | Argenx SE | FDA expanded indications | Vyvgart Hytrulo* | Biologic API |
| Lubrizol Life Science Health | Transcode Therapeutics Inc | Positive Phase 0 interim results | TTXMC-138 | Small mol API |
| MilliporeSigma | Glaxo Group Ltd | NICE approval | Blenrep* | Biologic API |
| Miltenyi Biotec BV & Co KG | Verismo Therapeutics Inc | Positive Phase I interim results | SynKIR-110 | Biologic API |
| Minakem SAS | AstraZeneca Pharmaceuticals LP | FDA expanded indications | Symbicort Aerosphere | Small mol API |
| Novo Nordisk AS | Organon & Co | FDA expanded indications | Hadlima | Parenteral manufacture & packaging |
| Novo Nordisk AS | AstraZeneca Pharmaceuticals LP | FDA expanded indications | Fasenra* | Parenteral manufacture & packaging |
| Novo Nordisk AS | Sanofi-Aventis US LLC | FDA expanded indications | Dupixent* | Parenteral manufacture & packaging |
| Novo Nordisk AS | Argenx SE | FDA expanded indications | Vyvgart Hytrulo* | Biologic API |
| Novo Nordisk AS | Bristol Myers Squibb Co | EMA expanded indications | Sotyktu* | Solid dose packaging |
| Patheon Biologics LLC | Janssen Biotech Inc | FDA expanded indications | Stelara* | Biologic API |
| Patheon NV | Lantern Pharma Inc | Positive Phase II interim results | dimesna | Small mol API |
| Patheon NV | Cantargia AB | Positive Phase I/II interim results | nadunolimab | Biologic API |
| Patheon NV | Argenx SE | FDA expanded indications | Vyvgart* | Parenteral manufacture |
| Patheon NV | Axsome Therapeutics Inc | FDA expanded indications | Auvelity | Solid dose manufacture |
| Patheon NV | Regeneron Pharmaceuticals Inc | FDA approval | Otarmeni* | Liquid sterile packaging |
| Patheon NV | Argenx SE | FDA expanded indications | Vyvgart Hytrulo* | Parenteral manufacture |
| Patheon NV | Merck & Co Inc | EMA approval | Enflonsia* | Parenteral manufacture & packaging |
| Patheon NV | Merck Sharp & Dohme (UK) Ltd | MHRA approval | Enflonsia* | Parenteral manufacture & packaging |
| PCI Pharma Services | Provention Bio Inc | FDA expanded indications | Tzield* | Parenteral manufacture |
| PCI Pharma Services | Deciphera Pharmaceuticals Inc | NICE approval | Qinlock* | Solid dose packaging |
| PCI Pharma Services | Swedish Orphan Biovitrum Ltd | MHRA expanded indications | Aspaveli* | Parenteral packaging |
| Piramal Pharma Solutions Inc | Lantern Pharma Inc | Positive Phase II interim results | dimesna | Parenteral manufacture & Packaging |
| PolyPeptide SA | Rhythm Pharmaceuticals Inc | EMA expanded indications | Imcivree* | Biologic API |
| Quotient Sciences Ltd | Ipsen SA | EMA approval | Ojemda* | Solid dose manufacture |
| ReiThera Srl | AAVantgarde Bio Srl | Positive Phase I/II interim results | AAVB-081 | Biologic API |
| ReiThera Srl | AAVantgarde Bio Srl | Positive Phase I/II interim results | AAVB-081 | Liquid sterile manufacture |
| Renaissance Lakewood LLC | Tiziana Life Sciences Ltd | Positive Phase II interim results | foralumab | Parenteral manufacture |
| Rottendorf Pharma GmbH | Servier Laboratories Ltd | NICE approval | Voranigo* | Solid dose manufacture & packaging |
| Sandoz GmbH | Novartis Pharmaceuticals Corp | FDA expanded indications | Cosentyx* | Biologic API |
| Sandoz GmbH | Novartis Pharmaceuticals Corp | FDA expanded indications | Cosentyx* | Parenteral manufacture |
| Sciarra Laboratories Inc (Inactive) | Tiziana Life Sciences Ltd | Positive Phase II interim results | foralumab | Parenteral manufacture |
| Siegfried Holding AG | Novartis Pharmaceuticals UK Ltd | EMA expanded indications | Tafinlar* | Solid dose manufacture & packaging |
| Simtra US LLC | Janssen Biotech Inc | FDA expanded indications | Stelara* | Parenteral manufacture |
| SK Pharmteco Inc | Rznomics Inc | Positive Phase I/II interim results | RZ-001 | Biologic API |
| Third-party contract manufacturers | Mirum Pharmaceuticals Inc | Positive Phase II top-line results | volixibat potassium | Small mol API |
| Undisclosed CDMO Company | BioAge Labs | Positive Phase I final results | BGE-102 | Small mol API |
| Vetter Pharma-Fertigung GmbH & Co KG | Argenx SE | FDA expanded indications | Vyvgart* | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Argenx SE | FDA expanded indications | Vyvgart Hytrulo* | Parenteral manufacture & packaging |
| Zhejiang Raybow Pharmaceutical Co Ltd | Novartis Pharmaceuticals UK Ltd | EMA expanded indications | Tafinlar* | Small mol API |
POTENTIALLY NEGATIVE |
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| Almac Group Ltd | Amgen Ltd | NICE unable to recommend | Uplizna* | Parenteral manufacture |
| AGC Pharma Chemicals Europe SLU | Bayer AG | Withdrawn (EU) | Kinzalmono* | Small mol API |
| AstraZeneca Plc | Amgen Ltd | NICE unable to recommend | Uplizna* | Parenteral packaging |
| AGC Pharma Chemicals Europe SLU | Bayer AG | Withdrawn (EU) | Pritor* | Solid dose manufacture |
| Delpharm SAS | Bayer AG | Withdrawn (EU) | Kinzalmono* | Small mol API |
| Delpharm SAS | Bayer AG | Withdrawn (EU) | Pritor* | Solid dose manufacture |
Notes:
Source: GlobalData, Pharma Intelligence Center (Accessed May 15, 2026) ©GlobalData
NICE = National Institute for Health and Care Excellence
*New molecular entities are in bold.