December 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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| Adragos Pharma Gmbh | Recordati UK Ltd | UK MHRA expanded indications | Cystadrops | Liquid sterile manufacture |
| Almac Group Ltd | Novartis Gene Therapies | FDA expanded indications | Itvisma | Parenteral manufacture & Packaging |
| Almac Group Ltd | Horizon Therapeutics USA Inc | FDA expanded indications | Uplizna | Parenteral manufacture |
| AstraZeneca Plc | Horizon Therapeutics USA Inc | FDA expanded indications | Uplizna | Biologic API |
| Avid Bioservices Inc | Janssen Biotech Inc | FDA approval | Rybrevant Faspro | Biologic API |
| Biogen Inc | Johnson & Johnson | NICE Recommendation | Talvey | Biologic API |
| Boehringer Ingelheim Fremont Inc | Merck Sharp & Dohme LLC | FDA expanded indications | Keytruda Qlex | Biologic API |
| Boehringer Ingelheim Fremont Inc | Merck & Co Inc | FDA expanded indications | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AstraZeneca UK Ltd | FDA expanded indications | Imfinzi | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck & Co Inc | FDA expanded indications | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck Sharp & Dohme LLC | FDA expanded indications | Keytruda Qlex | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Incyte Corp | EMA expanded indications | Minjuvi | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Incyte Corp | EMA expanded indications | Minjuvi | Parenteral manufacture & Packaging |
| Cambrex Corp | BioCryst Pharmaceuticals Inc | FDA expanded indications | Orladeyo | Small mol API |
| Catalent CTS LLC | BioCryst Pharmaceuticals Inc | FDA expanded indications | Orladeyo | Parenteral manufacture & Packaging |
| Catalent Inc | GRI Bio Operations Inc | Positive Phase II top-line results | Tazarotene | Small mol API |
| Catalent Inc | IVERIC bio Inc | Positive Phase I/II trial interim results | OPGx-BEST1 | Biologic API |
| Catalent Inc | Novartis Gene Therapies | FDA expanded indications | Itvisma | Biologic API |
| Esteve Pharmaceuticals SA | Insmed Inc | EMA approval | Brinsupri | Small mol API |
| Esteve Quimica SA | Insmed Inc | EMA approval | Brinsupri | Small mol API |
| Fareva SA | Merck & Co Inc | FDA expanded indications | Recarbrio | Parenteral manufacture |
| FUJIFILM Biotechnologies USA Inc | Roche Registration Ltd | EMA expanded indications | Gazyvaro | Parenteral manufacture & Packaging |
| Jiangsu Jiaerke Pharmaceutical Group Co Ltd | Janssen Biotech Inc | FDA expanded indications | Akeega | Small mol API |
| Lonza Group Ltd | Astellas US LLC | FDA expanded indications | Padcev | Biologic API |
| Lonza Group Ltd | Daiichi Sankyo Inc | FDA expanded indications | Enhertu | Biologic API |
| Organon & Co | Merck & Co Inc | FDA expanded indications | Keytruda | Parenteral manufacture & Packaging |
| Patheon France SAS | Insmed Inc | EMA approval | Brinsupri | Parenteral manufacture & Packaging |
| Patheon NV | BioCryst Pharmaceuticals Inc | FDA expanded indications | Orladeyo | Parenteral manufacture |
| Patheon NV | Insmed Inc | EMA approval | Brinsupri | Parenteral manufacture & Packaging |
| Patheon NV | AstraZeneca Pharmaceuticals LP | FDA expanded indications | Koselugo | Solid dose manufacture |
| Patheon NV | Johnson & Johnson | NICE Recommendation | Talvey | Parenteral manufacture & Packaging |
| PCI Pharma Services | Johnson & Johnson | NICE Recommendation | Talvey | Parenteral packaging |
| PCI Pharma Services | BioCryst Pharmaceuticals Inc | FDA expanded indications | Orladeyo | Parenteral packaging |
| PCI Pharma Services | Incyte Corp | EMA expanded indications | Minjuvi | Parenteral packaging |
| PCI Pharma Services | GSK plc | NICE Recommendation | Jemperli | Parenteral manufacture & Packaging |
| Pfizer Inc | Janssen Biotech Inc | FDA expanded indications | Akeega | Solid dose manufacture & Packaging |
| Rentschler Biopharma SE | Genmab US Inc | FDA expanded indications | Epkinly | Biologic API |
| Samsung Biologics Co Ltd | Janssen Biotech Inc | FDA approval | Rybrevant Faspro | Biologic API |
| Samsung Biologics Co Ltd | AstraZeneca UK Ltd | FDA expanded indications | Imfinzi | Biologic API |
| Sandoz GmbH | Novartis Gene Therapies | FDA expanded indications | Itvisma | Biologic API |
| Sharp Packaging Services LLC | Bayer USA LLC | FDA approval | Hyrnuo | Solid dose packaging |
| Sharp Packaging Services LLC | CStone Pharmaceuticals Co Ltd | EMA expanded indications | Cejemly | Parenteral packaging |
| Sharp Packaging Services LLC | Beigene USA Inc | FDA expanded indications | Tevimbra | Parenteral packaging |
| Simtra US LLC | Astellas US LLC | FDA expanded indications | Padcev | Parenteral manufacture & Packaging |
| Simtra US LLC | Daiichi Sankyo Inc | FDA expanded indications | Enhertu | Parenteral manufacture & Packaging |
| Societal CDMO Inc | BioCorRx Inc | Trial planned - Phase I | Naltrexone | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Alnylam Pharmaceuticals Inc | NICE Recommendation | Amvuttra | Parenteral manufacture & Packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Janssen-Cilag International NV | EMA approval | Imaavy | Parenteral manufacture & Packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca UK Ltd | FDA expanded indications | Imfinzi | Parenteral manufacture |
| WuXi Biologics Co Ltd | GSK plc | NICE Recommendation | Jemperli | Biologic API |
| WuXi Biologics Co Ltd | Janssen-Cilag International NV | EMA approval | Imaavy | Biologic API |
| WuXi Biologics Co Ltd | CStone Pharmaceuticals Co Ltd | EMA expanded indications | Cejemly | Biologic API |
| WuXi STA | Janssen Biotech Inc | FDA expanded indications | Akeega | Small mol API |
| WuXi XDC Cayman Inc | Janssen Biotech Inc | FDA expanded indications | Akeega | Small mol API |
| WuXi XDC Cayman Inc | Janssen Biotech Inc | FDA expanded indications | Akeega | Solid dose manufacture |
| WuXi XDC Cayman Inc | Janssen-Cilag International NV | EMA approval | Imaavy | Biologic API |
| Zhejiang Xianju Junye Pharmaceutical Co Ltd | Janssen Biotech Inc | FDA expanded indications | Akeega | Small mol API |
POTENTIALLY NEGATIVE |
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| Bora Pharmaceuticals Co Ltd | Roche Registration GmbH | Withdrawn | Ronapreve | Parenteral packaging |
| Catalent Germany Eberbach GmbH | Boehringer Ingelheim International GmbH | NICE unable to recommend | Ofev | Solid dose manufacture |
| Hikma Pharmaceuticals Plc | Boehringer Ingelheim International GmbH | NICE unable to recommend | Ofev | Solid dose packaging |
| Lonza Group Ltd | Daiichi Sankyo Co Ltd | NICE unable to recommend | Enhertu | Biologic API |
| Novo Nordisk AS | Roche Registration GmbH | Withdrawns | Ronapreve | Parenteral manufacture & Packaging |
| Simtra US LLC | Daiichi Sankyo Co Ltd | NICE unable to recommend | Enhertu | Parenteral manufacture & 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