August 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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| Aenova Holding GmbH | Incyte Biosciences UK Ltd | EMA expanded indications | Iclusig | Solid dose manufacture & packaging |
| AGC Biologics SpA | Rocket Pharmaceuticals Inc | Positive Phase II interim results | RPA-501 | Biologic API |
| Alcami Corp | Incyte Biosciences UK Ltd | EMA expanded indications | Iclusig | Solid dose packaging |
| Aldevron LLC | Moderna Inc | EMA expanded indications | Spikevax XFG | Biologic API |
| Astrea Pharma | Rhythm Pharmaceuticals Inc | MHRA expanded indications | Imcivree | Small mol API |
| Astrea Pharma | Rhythm Pharmaceuticals Inc | MHRA expanded indications | Imcivree | Parenteral manufacture & packaging |
| Astrea Pharma | Moderna Inc | EMA expanded indications | Spikevax XFG | Parenteral manufacture & packaging |
| Catalent Inc | DiaMedica Therapeutics Inc | Positive Phase II top-line results | rinvecalinase alfa | Biologic API |
| Chemo Holding SL | Stada Arzneimittel AG | EMA approval | Liraglutide | Parenteral manufacture & packaging |
| Corden Pharma International GmbH | Rhythm Pharmaceuticals Inc | MHRA expanded indications | Imcivree | Parenteral manufacture |
| Delpharm SAS | Ipsen SA | EMA approval | Iqirvo | Solid dose manufacture & packaging |
| Emergent BioSolutions Inc | Sanofi | EMA expanded indications | Nuvaxovid XFG | Parenteral manufacture |
| Fareva SA | Mundipharma International Ltd | FDA expanded indications | Rezzayo | Parenteral manufacture |
| Fujifilm Diosynth Biotechnologies UK Ltd | Sanofi | EMA expanded indications | Nuvaxovid XFG | Biologic API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Outlook Therapeutics Inc | FDA approval | Lytenava | Biologic API |
| GSK plc | Sanofi | EMA expanded indications | Nuvaxovid XFG | Parenteral manufacture & packaging |
| Hainan Poly Pharm Co Ltd | Imunon Inc | Positive Phase I/II interim results | IMNN-001 | Biologic API |
| Halo Pharma Inc | Sun Pharma UK Ltd | NICE approval | Leqselvi | Solid dose manufacture |
| Hikma Pharmaceuticals Plc | Incyte Biosciences UK Ltd | EMA expanded indications | Iclusig | Solid dose manufacture & packaging |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | EMA expanded indications | Spikevax XFG | Biologic API |
| Lonza Biologics Inc | Moderna Inc | EMA expanded indications | Spikevax XFG | Biologic API |
| Lonza Group Ltd | TRACON Pharmaceuticals Inc | Positive Phase I interim results | carotuximab | Biologic API |
| Lonza Group Ltd | Gracell Biotechnologies Inc | Trial planned - Phase III | AZD-0120 | Biologic API |
| Lonza Group Ltd | Moderna Inc | EMA expanded indications | Spikevax XFG | Biologic API |
| Mabion SA | Sanofi | EMA expanded indications | Nuvaxovid XFG | Biologic API |
| Minaris Advanced Therapies LLC | Chimeric Therapeutics Ltd | Positive Phase I/II interim results | CHM-2101 | Biologic API |
| National Resilience Inc | Moderna Inc | EMA expanded indications | Spikevax XFG | Biologic API |
| NorthStar Medical Radioisotopes LLC | Clarity Pharmaceuticals Ltd | Positive Phase I/II interim results | abefolastat tesaroxetan | Small mol API |
| NorthStar Medical Radioisotopes LLC | Clarity Pharmaceuticals Ltd | Positive Phase I/II interim results | abefolastat tesaroxetan | Parenteral manufacture |
| Novo Nordisk AS | Moderna Inc | EMA expanded indications | Spikevax XFG | Parenteral manufacture & packaging |
| Nucleus RadioPharma Inc | Clarity Pharmaceuticals Ltd | Positive Phase I/II interim results | abefolastat tesaroxetan | Parenteral manufacture |
| Par Sterile Products LLC | Sanofi | EMA expanded indications | Nuvaxovid XFG | Parenteral manufacture & packaging |
| Patheon Biologics LLC | Janssen-Cilag International NV | EMA expanded indications | Stelara | Biologic API |
| Patheon France SAS | Cytokinetics Inc | MHRA approval | Myqorzo | Solid dose manufacture & packaging |
| Patheon France SAS | Cytokinetics Inc | NICE approval | Myqorzo | Solid dose manufacture & packaging |
| Patheon Italia SpA | Mundipharma International Ltd | FDA expanded indications | Rezzayo | Parenteral manufacture & packaging |
| Patheon Italia SpA | Moderna Inc | EMA expanded indications | Spikevax XFG | Parenteral manufacture |
| Patheon NV | Incyte Biosciences UK Ltd | EMA expanded indications | Iclusig | Solid dose manufacture & packaging |
| Patheon NV | Moderna Inc | EMA expanded indications | Spikevax XFG | Parenteral manufacture & packaging |
| Patheon UK Ltd | Incyte Biosciences UK Ltd | EMA expanded indications | Iclusig | Solid dose packaging |
| Piramal Pharma Solutions Inc | Incyte Biosciences UK Ltd | EMA expanded indications | Iclusig | Small mol API |
| PolyPeptide SA | Rhythm Pharmaceuticals Inc | MHRA expanded indications | Imcivree | Small mol API |
| Richter-Helm BioLogics GmbH & Co KG | MoonLake Immunotherapeutics | Positive Phase III top-line results | sonelokimab | Biologic API |
| Richter-Helm BioLogics GmbH & Co KG | Athera Biotechnologies AB (Inactive) | Positive Phase II interim results | vanexin | Biologic API |
| ROVI Pharma Industrial Services SAU | Moderna Inc | FDA approval | Mflusiva | Parenteral packaging |
| ROVI Pharma Industrial Services SAU | Moderna Inc | FDA approval | Mflusiva | Parenteral manufacture & packaging |
| ROVI Pharma Industrial Services SAU | Moderna Inc | EMA expanded indications | Spikevax XFG | Parenteral manufacture & packaging |
| Samsung Biologics Co Ltd | Moderna Inc | EMA expanded indications | Spikevax XFG | Parenteral manufacture & packaging |
| SEQENS | Ipsen SA | EMA approval | Iqirvo | Small mol API |
| Sharp Packaging Services LLC | Incyte Biosciences UK Ltd | EMA expanded indications | Iclusig | Solid dose packaging |
| Sharp Packaging Services LLC | Bayer Plc | NICE approval | Kerendia | Solid dose packaging |
| Siegfried Holding AG | Sanofi | EMA expanded indications | Nuvaxovid XFG | Parenteral manufacture & packaging |
| Simtra US LLC | Sanofi | EMA expanded indications | Nuvaxovid XFG | Parenteral manufacture |
| Simtra US LLC | Moderna Inc | EMA expanded indications | Spikevax XFG | Parenteral manufacture & packaging |
| Simtra US LLC | Janssen-Cilag International NV | EMA expanded indications | Stelara | Parenteral manufacture |
| SK Bioscience Ltd | Sanofi | EMA expanded indications | Nuvaxovid XFG | Biologic API |
| SpectronRx | Clarity Pharmaceuticals Ltd | Positive Phase I/II interim results | abefolastat tesaroxetan | Small mol API |
| Vetter Pharma-Fertigung GmbH & Co KG | MoonLake Immunotherapeutics | Positive Phase III top-line results | sonelokimab | Parenteral manufacture & packaging |
| Viral Vector Manufacturing Facility Pty Ltd | Chimeric Therapeutics Ltd | Positive Phase I/II interim results | CHM-2101 | Biologic API |
| Zhejiang Hisun Pharmaceutical Co Ltd | Imunon Inc | Positive Phase I/II interim results | IMNN-001 | Biologic API |
| Zhejiang Hisun Pharmaceutical Co Ltd | Imunon Inc | Positive Phase I/II interim results | IMNN-001 | Parenteral manufacture & packaging |
| Zhejiang Raybow Pharmaceutical Co Ltd | Novartis UK Ltd | EMA expanded indications | Kisqali | Small mol API |
POTENTIALLY NEGATIVE |
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| Bausch & Lomb Pharmaceuticals Inc | Santen UK Ltd | NICE unable to recommend | Rhokiinsa | Parenteral manufacture & packaging |
| Cellipont Bioservices | Wugen Inc | Trial Suspended - Phase I | soficabtagene geleucel | Biologic API |
| Chime Biologics Ltd | EOC Pharma Ltd | Trial Terminated - Phase II/III | eftilagimod alfa | Parenteral manufacture |
| Hovione FarmaCiencia SA | Vifor-Fresenius Medical Care Renal Pharma Ltd | Withdrawn (EU) | Tavneos | Small mol API |
| KBI Biopharma Inc | ALX Oncology Holdings Inc | Trial Terminated - Phase II | evorpacept | Biologic API |
| Lonza Group Ltd | Athersys Inc | Trial Terminated - Phase II/III | invimestrocel | Parenteral manufacture |
| Lonza Group Ltd | Shanghai Junshi Biosciences Co Ltd | Trial Terminated - Phase II | roconkibart | Biologic API |
| Lyophilization Services of New England Inc | ALX Oncology Holdings Inc | Trial Terminated - Phase II | evorpacept | Parenteral manufacture |
| Nikon CeLL innovation Co Ltd | Athersys Inc | Trial Terminated - Phase II/III | invimestrocel | Biologic API |
| Oxford BioMedica Plc | Novartis AG | Trial Withdrawn - Phase I | CTL-119 | Biologic API |
| Patheon NV | Vifor-Fresenius Medical Care Renal Pharma Ltd | Withdrawn (EU) | Tavneos | Solid dose manufacture & packaging |
| Patheon NV | Xencor Inc | Trial Terminated - Phase II/III | obexelimab | Parenteral manufacture |
| Siegfried Holding AG | Novartis UK Ltd | Withdrawn (EU) | Enurev Breezhaler | Inhalational manufacture & packaging |
| WuXi AppTec Co Ltd | Immutep Ltd | Trial Terminated - Phase II/III | eftilagimod alfa | Parenteral manufacture |
| WuXi Biologics (Hong Kong) Ltd | Zenas BioPharma Inc | Trial Terminated - Phase II/III | obexelimab | Parenteral manufacture |
| WuXi Biologics (Hong Kong) Ltd | Zenas BioPharma Inc | Trial Terminated - Phase II/III | obexelimab | Biologic API |
| WuXi Biologics Cayman Inc | Immutep Ltd | Trial Terminated - Phase II/III | eftilagimod alfa | Biologic API |
Notes:
Source: GlobalData, Pharma Intelligence Center ©GlobalData
NICE = National Institute for Health and Care Excellence
*New molecular entities are in bold.