February 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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| Agilent Technologies Inc | Novartis Pharmaceuticals Corp | FDA expanded indications | Leqvio | Biologic API |
| Almac Group Ltd | Horizon Therapeutics Ltd | EMA expanded indications | Uplizna | Parenteral manufacture |
| Altergon Italia Srl | IBSA Pharma Inc | FDA expanded indications | Vybrique | Solid dose manufacture |
| AstraZeneca Plc | Merck & Co Inc | FDA expanded indications | Keytruda | Biologic API |
| AstraZeneca Plc | Horizon Therapeutics Ltd | EMA expanded indications | Uplizna | Biologic API |
| Asymchem Inc | LaNova Medicines Ltd | Trial planned – Phase III | Tecotabartvedotin | Biologic API |
| Biogen Inc | Janssen Biotech Inc | FDA expanded indications | DarzalexFaspro | Biologic API |
| Boehringer Ingelheim Fremont Inc | Merck Sharp & Dohme LLC | FDA expanded indications | Keytruda Qlex | Biologic API |
| Boehringer Ingelheim Fremont Inc | Sandoz Inc | FDA expanded indications | Enzeevu | Biologic API |
| Boehringer Ingelheim Fremont Inc | Merck & Co Inc | FDA expanded indications | Keytruda | 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 |
| BSP Pharmaceuticals SpA | Eli Lilly and Co | EMA expanded indications | Mounjaro | Parenteral manufacture & packaging |
| Catalent Inc | Pfizer | NICE recommendation | enzalutamide | Solid dose manufacture & Packaging |
| Cenexi SAS | Merck & Co Inc | FDA expanded indications | Noxafil | Liquid dose manufacture |
| Corden Pharma International GmbH | GSK plc | NICE recommendation | Zejula | Small mol API |
| Corden Pharma International GmbH | Novartis Pharmaceuticals Corp | FDA expanded indications | Leqvio | Parenteral manufacture & packaging |
| Curia Global Inc | Pfizer | NICE recommendation | enzalutamide | Small mol API |
| Excella GmbH & Co KG | Pfizer | NICE recommendation | TALZENNA | Solid dose manufacture & Packaging |
| FUJIFILM Biotechnologies USA Inc | Biogen | NICE recommendation | Tysabri | Parenteral manufacture & packaging |
| FUJIFILM Biotechnologies USA Inc | Biogen | NICE recommendation | Tysabri | Biologic API |
| FUJIFILM Biotechnologies USA Inc | Janssen Biotech Inc | FDA expanded indications | DarzalexFaspro | Biologic API |
| FUJIFILM Biotechnologies USA Inc | F. Hoffmann-La Roche Ltd | NICE recommendation | Gazyvaro | Biologic API |
| KBI Biopharma Inc | ALX Oncology Holdings Inc | Positive Phase I/II top-line results | evorpacept | Biologic API |
| Lonza Biologics Inc | BristolMyers Squibb | NICE recommendation | Opdivo | Biologic API |
| Lonza Group Ltd | Vaxcyte Inc | Positive Phase II final results | VAX-24 | Biologic API |
| Lyophilization Services of New England Inc | ALX Oncology Holdings Inc | Positive Phase I/II top-line results | evorpacept | Parenteral manufacture |
| MIAS Pharma Ltd | BioNet-Asia Co Ltd | EU approval | Vacpertagen | Liquid dose manufacture |
| Minakem SAS | Stada | NICE recommendation | Kinpeygo | Small mol API |
| Novartis AG | Sandoz Inc | FDA expanded indications | Enzeevu | Parenteral manufacture |
| Novo Nordisk AS | Janssen Biotech Inc | FDA expanded indications | DarzalexFaspro | Biologic API |
| Organon & Co | Merck & Co Inc | FDA expanded indications | NoxafilPowderMix | Solid dose Packaging |
| Organon & Co | Merck & Co Inc | FDA expanded indications | Keytruda | Parenteral manufacture & packaging |
| Patheon Austria GmbH & Co KG | IntraBio Ltd | EU approval | Aqneursa | Small mol API |
| Patheon France SAS | Cytokinetics Inc | EU approval | Myqorzo | Solid dose manufacture & Packaging |
| Patheon France SAS | Harmony Biosciences Holdings Inc | FDA expanded indications | Wakix | Solid dose manufacture & Packaging |
| Patheon France SAS | Harmony Biosciences Holdings Inc | FDA expanded indications | Wakix | Small mol API |
| Patheon France SAS | IntraBio Ltd | EU approval | Aqneursa | Liquid dose manufacture & packaging |
| Patheon NV | Merck & Co Inc | FDA expanded indications | Noxafil | Liquid dose manufacture |
| Patheon NV | University of California San Francisco | Trial planned – Phase I | UCCTBCMA-1 | Biologic API |
| Patheon NV | Vaxcyte Inc | Positive Phase II final results | VAX-24 | Parenteral manufacture & packaging |
| Patheon NV | Stada | NICE recommendation | Kinpeygo | Solid dose manufacture & Packaging |
| PCI Pharma Services | Janssen Biologics BV | EMA expanded indications | Simponi | Parenteral packaging |
| PCI Pharma Services | Eli Lilly and Co | EMA expanded indications | Mounjaro | Parenteral manufacture & packaging |
| PCI Pharma Services | IntraBio Ltd | EU approval | Aqneursa | Liquid dose packaging |
| PCI Pharma Services | Pfizer | NICE recommendation | enzalutamide | Solid dose packaging |
| PCI Pharma Services | Biogen | NICE recommendation | Tysabri | Parenteral packaging |
| Pfizer Inc | Biogen | NICE recommendation | Tysabri | Parenteral manufacture & packaging |
| Quotient Sciences Ltd | GSK plc | NICE recommendation | Zejula | Solid dose manufacture |
| Rottendorf Pharma GmbH | Harmony Biosciences Holdings Inc | FDA expanded indications | Wakix | Solid dose manufacture & Packaging |
| Samsung Biologics Co Ltd | BristolMyers Squibb | NICE recommendation | Opdivo | Biologic API |
| Sandoz GmbH | Novartis Pharmaceuticals Corp | FDA expanded indications | Leqvio | Parenteral manufacture & packaging |
| Sharp Packaging Services LLC | GSK plc | NICE recommendation | Zejula | Solid dose packaging |
| Sharp Packaging Services LLC | Biogen | NICE recommendation | Tysabri | Parenteral packaging |
| Sharp Packaging Services LLC | SFL Pharma GmbH | EU approval | Aumseqa | Solid dose Packaging |
| Simtra US LLC | Janssen Biologics BV | EMA expanded indications | Simponi | Parenteral manufacture & packaging |
| Teva Pharmaceutical Industries Ltd | Stada | NICE recommendation | Kinpeygo | Small mol API |
| Tjoapack BV | Otsuka Pharmaceutical Europe Ltd | EU approval | Dawnzera | Biologic API |
| Tjoapack BV | Stada | NICE recommendation | Kinpeygo | Solid dose packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Biogen | NICE recommendation | Tysabri | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Eli Lilly and Co | EMA expanded indications | Mounjaro | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | BristolMyers Squibb | NICE recommendation | Opdivo | Parenteral manufacture |
| WuXi AppTec Co Ltd | RegenxBio Inc | Positive Phase II/III Interim results | RGX-111 | Biologic API |
| WuXi STA (Shanghai) Co Ltd | Gyre Therapeutics Inc | Trial planned – Phase II | F-351 | Small mol API |
| WuXi STA (Shanghai) Co Ltd | Gyre Therapeutics Inc | Trial planned – Phase II | F-351 | Solid dose manufacture |
| WuXi STA (Shanghai) Co Ltd | GSK plc | NICE recommendation | Zejula | Small mol API |
| WuXi XDC Cayman Inc | GSK plc | NICE recommendation | Zejula | Small mol API |
POTENTIALLY NEGATIVE |
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| Bachem Holding AG | Tetris Pharma Ltd | Withdrawn | Ogluo | Biologic API |
| Boehringer Ingelheim Pharma | Merck & Co. | NICE unable to recommend | Keytruda | Biologic API |
| Organon & Co. | Merck & Co. | NICE unable to recommend | Keytruda | Parenteral manufacture & packaging |
| Patheon Biologics LLC | Novo Nordisk AS | NICE unable to recommend | Alhemo | Biologic API |
| PCI Pharma Services | Tetris Pharma Ltd | Withdrawn | Ogluo | Biologic API |
| PYRAMID Laboratories Inc | Tetris Pharma Ltd | Withdrawn | Ogluo | Biologic API |
| Sharp Packaging Services LLC | Nobelpharma Co Ltd | NICE unable to recommend | Hyftor | Semi solid packaging |
| SHL Medical LLC | Tetris Pharma Ltd | Withdrawn | Ogluo | Biologic API |
| TOYO Pharmaceutical Co Ltd | Nobelpharma Co Ltd | NICE unable to recommend | Hyftor | Semi solid manufacture |
Notes:
Source: GlobalData, Pharma Intelligence Center (Accessed February 15, 2026)
NICE = National Institute for Health and Care Excellence
*New molecular entities are in bold.