January 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 | Sanofi Winthrop Industrie SA | EU approval | Teizeild | Biologic API |
| Almac Group Ltd | Agios Pharmaceuticals Inc | FDA expanded indications | Aqvesme | Solid dose manufacture & packaging |
| Bachem Holding AG | Swedish Orphan Biovitrum AB | EMA expanded indications | Aspaveli | Biologic API |
| Bio Elpida | Brenus Pharma SAS | Positive Phase I/II trial top-line results | STC-1010 | Biologic API |
| Bionovis SA | Fresenius Kabi USA LLC | FDA expanded indications | Idacio | Biologic API |
| Bora Pharmaceuticals Co Ltd | Swedish Orphan Biovitrum AB | EMA expanded indications | Aspaveli | Parenteral manufacture |
| BSP Pharmaceuticals SpA | Eli Lilly and Co | FDA expanded indications | Mounjaro | Parenteral manufacture & packaging |
| Catalent Inc | AOP Health | Positive Phase II trial top-line results | Besremi | Parenteral manufacture |
| Chime Biologics Ltd | Hope Medicine Inc | Trial planned – Phase III | HMI-115 | Parenteral manufacture |
| Corden Pharma International GmbH | Eli Lilly and Co | FDA expanded indications | Mounjaro | Biologic API |
| Corden Pharma Switzerland LLC | Eli Lilly and Co | Positive Phase I/II trial top-line results | Mounjaro | Biologic API |
| EMD Serono Inc | Fresenius Kabi USA LLC | FDA expanded indications | Idacio | Parenteral manufacture & Packaging |
| EMD Serono Inc | Fresenius Kabi USA LLC | FDA expanded indications | Idacio | Biologic API |
| Flamma SpA | Sanofi | EU approval | Wayrilz | Small-molecule API |
| FUJIFILM Biotechnologies USA Inc | F. Hoffmann-La Roche Ltd | NICE recommendation | Gazyvaro | Biologic API |
| FUJIFILM Biotechnologies USA Inc | Biogen Inc | EMA expanded indications | Spinraza HD | Parenteral manufacture |
| FUJIFILM Biotechnologies USA Inc | Roche | NICE recommendation | Venclyxto | Biologic API |
| Juzen Chemical Corp | Swedish Orphan Biovitrum AB | EMA expanded indications | Aspaveli | Parenteral manufacture |
| Lonza Biologics Inc | Genzyme Corp | FDA expanded indications | Cerezyme | Biologic API |
| MIAS Pharma Ltd | SpringWorks Therapeutics Inc | MHRA approval | Ogsiveo | Solid dose manufacture |
| Patheon France SAS | Shield TX (UK) Ltd | FDA expanded indications | Accrufer | Solid dose manufacture |
| Patheon Italia SpA | Ablynx NV | FDA expanded indications | Cablivi | Parenteral manufacture & packaging |
| Patheon NV | Biogen Inc | EMA expanded indications | Spinraza HD | Parenteral manufacture |
| Patheon NV | Sanofi | EU approval | Wayrilz | Solid dose manufacture & packaging |
| Patheon NV | Novimmune SA | Positive Phase II trial top-line results | Gamifant | Parenteral manufacture & packaging |
| PCI Pharma Services | Biogen Inc | EMA expanded indications | Spinraza HD | Parenteral packaging |
| PCI Pharma Services | Eli Lilly and Co | FDA expanded indications | Mounjaro | Parenteral manufacture & packaging |
| PCI Pharma Services | Takeda Pharmaceutical Co Ltd | Positive Phase II trial top-line results | Fruzaqla | Solid dose packaging |
| PCI Pharma Services | MorphoSys US Inc | Positive Phase III trial top-line results | Monjuvi | Parenteral packaging |
| PCI Pharma Services | Eli Lilly and Co | Positive Phase I/II trial top-line results | Mounjaro | Parenteral manufacture & packaging |
| PCI Pharma Services | Swedish Orphan Biovitrum AB | EMA expanded indications | Aspaveli | Parenteral packaging |
| PharmaKorell GmbH | Idorsia Pharmaceutical Ltd | Positive Phase III trial top-line results | Quviviq | Solid dose packaging |
| Piramal Pharma Solutions Inc | Shield TX (UK) Ltd | FDA expanded indications | Accrufer | Solid dose manufacture & packaging |
| ProBioGen AG | Zymeworks Inc | Positive Phase III trial top-line results | Ziihera | Biologic API |
| Richter-Helm BioLogics GmbH & Co KG | Ablynx NV | FDA expanded indications | Cablivi | Biologic API |
| Rottendorf Pharma GmbH | Bayer AG | NICE recommendation | Beyonttra | Solid dose manufacture |
| Sharp Packaging Services LLC | Ablynx NV | FDA expanded indications | Cablivi | Parenteral packaging |
| Sharp Packaging Services LLC | BeOne Medicines AG | Positive Phase III trial top-line results | Tevimbra | Parenteral packaging |
| Undisclosed | Hutchmed China Ltd | Positive Phase II trial top-line results | Fruzaqla | Small-molecule API |
| Vetter Pharma-Fertigung GmbH & Co KG | Biogen Inc | EMA expanded indications | Spinraza HD | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Janssen Biotech Inc | Positive Phase II trial top-line results | Imaavy | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AOP Health | Positive Phase III trial top-line results | Besremi | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Eli Lilly and Co | FDA expanded indications | Mounjaro | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Eli Lilly and Co | Positive Phase I/II trial top-line results | Mounjaro | Parenteral manufacture & packaging |
| WuXi Biologics Co Ltd | Janssen Biotech Inc | Positive Phase II trial top-line results | Imaavy | Biologic API |
| WuXi Biologics Co Ltd | Jazz Pharmaceuticals Inc | Positive Phase III trial top-line results | Ziihera | Parenteral manufacture |
| WuXi STA (Shanghai) Co Ltd | Gyre Therapeutics Inc | Planned Phase III trials | F-351 | Small-molecule API & solid dose manufacture |
POTENTIALLY NEGATIVE |
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| Carbogen Amcis AG | F. Hoffmann-La Roche Ltd | NICE unable to recommend | Rozlytrek | Small-molecule API |
| Catalent Inc | F. Hoffmann-La Roche Ltd | NICE unable to recommend | Rozlytrek | Solid dose manufacture |
| Quotient Sciences Ltd | Shionogi & Co Ltd | Withdrawn | Mulpleta | Solid dose manufacture |
Notes:
Source: GlobalData, Pharma Intelligence Center (Accessed January 19, 2026) ©GlobalData
NICE = National Institute for Health and Care Excellence
* New molecular entities are in bold