July 2026 — CDMO Opportunities And Threats Report
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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| 3P Biopharmaceuticals SLU | Buzzard Pharmaceuticals AB | Trial planned - Phase I/II | isunakinra | Biologic API |
| Aenova Holding GmbH | Incyte Biosciences UK Ltd | EMA expanded indications | Iclusig | Solid-dose manufacture & packaging |
| AGC Biologics Inc | Aventis Pharma Ltd | NICE approval | Tzield | Biologic API |
| Alcami Corp | Incyte Biosciences UK Ltd | EMA expanded indications | Iclusig | Solid-dose packaging |
| Almac Group Ltd | Pierre Fabre Medicament SA | EMA expanded indications | Braftovi | Solid-dose packaging |
| Almac Group Ltd | AbbVie Ltd | NICE approval | Elahere | Parenteral manufacture & packaging |
| Almac Group Ltd | Novartis AG | EMA expanded indications | Itvisma | Parenteral manufacture & packaging |
| Almac Group Ltd | Aventis Pharma Ltd | NICE approval | Tzield | Parenteral packaging |
| Ardena Holding NV | Pierre Fabre Medicament SA | EMA expanded indications | Braftovi | Solid-dose manufacture |
| AstraZeneca Plc | Merck Sharp & Dohme (UK) Ltd | NICE approval | Keytruda | Biologic API |
| AstraZeneca Plc | Merck & Co Inc | FDA expanded indications | Keytruda | Biologic API |
| AstraZeneca Plc | Merck Sharp & Dohme BV | EMA expanded indications | Keytruda | Biologic API |
| Biogen Inc | Janssen-Cilag Ltd | NICE approval | Darzalex | Biologic API |
| Boehringer Ingelheim Fremont Inc | Merck Sharp & Dohme (UK) Ltd | NICE approval | Keytruda | Biologic API |
| Boehringer Ingelheim Fremont Inc | Merck & Co Inc | FDA expanded indications | Keytruda | Biologic API |
| Boehringer Ingelheim Fremont Inc | Merck Sharp & Dohme BV | EMA expanded indications | Keytruda | Biologic API |
| Boehringer Ingelheim Fremont Inc | Merck Sharp & Dohme LLC | FDA expanded indications | Keytruda Qlex | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AbbVie Ltd | NICE approval | Elahere | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck BV | EMA expanded indications | Erbitux | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck BV | EMA expanded indications | Erbitux | Parenteral manufacture & packaging |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck Sharp & Dohme (UK) Ltd | NICE approval | 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 BV | EMA 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 | AbbVie Deutschland GmbH & Co KG | EMA expanded indications | Skyrizi | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AbbVie Deutschland GmbH & Co KG | EMA expanded indications | Skyrizi | Parenteral manufacture |
| Boehringer Ingelheim Pharma GmbH & Co KG | AbbVie Inc | FDA expanded indications | Skyrizi | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AbbVie Inc | FDA expanded indications | Skyrizi | Parenteral manufacture |
| BSP Pharmaceuticals SpA | AbbVie Ltd | NICE approval | Elahere | Parenteral manufacture & packaging |
| BSP Pharmaceuticals SpA | AbbVie Ltd | NICE approval | Elahere | Biologic API |
| BSP Pharmaceuticals SpA | Moleculin Biotech Inc | Phase II/III interim results | naxtarubicin | Parenteral manufacture |
| BSP Pharmaceuticals SpA | Gilead Sciences Europe Ltd | EMA expanded indications | Trodelvy | Parenteral manufacture |
| BSP Pharmaceuticals SpA | Gilead Sciences Europe Ltd | EMA expanded indications | Trodelvy | Biologic API |
| BSP Pharmaceuticals SpA | Immunomedics Inc | FDA expanded indications | Trodelvy | Parenteral manufacture |
| BSP Pharmaceuticals SpA | Immunomedics Inc | FDA expanded indications | Trodelvy | Biologic API |
| Catalent Inc | Avecho Biotechnology Ltd | Phase III interim results | cannabidiol | Solid-dose manufacture |
| Catalent Inc | Novartis AG | EMA expanded indications | Itvisma | Biologic API |
| Catalent Inc | Elpida Therapeutics | Trial planned - Phase II | Melpida | Biologic API |
| Charles River Laboratories International Inc | Vertex Pharmaceuticals Inc | FDA expanded indications | Casgevy | Biologic API |
| Chemo Holding SL | Stada Arzneimittel AG | EMA approval | Ablymico | Parenteral manufacture & packaging |
| EirGenix Inc | HCW Biologics Inc | Phase I interim results | HCW-9302 | Parenteral manufacture |
| FUJIFILM Diosynth Biotechnologies USA Inc | Janssen-Cilag Ltd | NICE approval | Darzalex | Biologic API |
| Halo Pharma Inc | Sun Pharma UK Ltd | NICE approval | Leqselvi | Solid-dose manufacture |
| IDT Biologika GmbH | Merz Pharmaceuticals LLC | FDA expanded indications | Xeomin | Parenteral manufacture & packaging |
| Jetpharma SA | Pierre Fabre Medicament SA | EMA expanded indications | Braftovi | Small mol API |
| Kymos Pharma Services SL | Intas Pharmaceuticals Ltd | EMA approval | Rexatilux | Parenteral manufacture |
| Lonza Group Ltd | TRACON Pharmaceuticals Inc | Phase I interim results | carotuximab | Biologic API |
| Lonza Group Ltd | Vertex Pharmaceuticals Inc | FDA expanded indications | Casgevy | Biologic API |
| Lonza Group Ltd | Vertex Pharmaceuticals Inc | FDA expanded indications | Casgevy | Parenteral manufacture & packaging |
| Lonza Group Ltd | Daiichi Sankyo Co Ltd | EMA expanded indications | Enhertu | Biologic API |
| Lonza Group Ltd | Astellas US LLC | FDA expanded indications | Padcev | Biologic API |
| LTS Lohmann Therapie-Systeme AG | Hikma Pharmaceuticals USA Inc | FDA expanded indications | Ryaltris | Parenteral manufacture |
| MIAS Pharma Ltd | Arrowhead Pharmaceuticals Inc | EMA approval | Redemplo | Parenteral manufacture & packaging |
| Novo Nordisk AS | Janssen-Cilag Ltd | NICE approval | Darzalex | Biologic API |
| Novo Nordisk AS | AstraZeneca AB | EMA expanded indications | Fasenra | Parenteral manufacture & packaging |
| Novo Nordisk AS | Regeneron UK Ltd | NICE approval | Libtayo | Parenteral manufacture & packaging |
| NTP Radioisotopes SOC Ltd | ITM Isotope Technologies Munich SE | Phase I interim results | ITM-31 | Small mol API |
| Organon & Co | Merck Sharp & Dohme (UK) Ltd | NICE approval | Keytruda | Parenteral manufacture & packaging |
| Organon & Co | Merck & Co Inc | FDA expanded indications | Keytruda | Parenteral manufacture & packaging |
| Organon & Co | Merck Sharp & Dohme BV | EMA expanded indications | Keytruda | Parenteral manufacture & packaging |
| Organon & Co | Merck Sharp & Dohme LLC | FDA expanded indications | Keytruda Qlex | Parenteral manufacture & packaging |
| Patheon Italia SpA | AbbVie Deutschland GmbH & Co KG | EMA expanded indications | Skyrizi | Parenteral manufacture & packaging |
| Patheon Italia SpA | AbbVie Inc | FDA expanded indications | Skyrizi | Parenteral manufacture & packaging |
| Patheon NV | Incyte Biosciences UK Ltd | EMA expanded indications | Iclusig | Solid-dose manufacture & packaging |
| Patheon NV | Novo Nordisk Ltd | MHRA expanded indications | Wegovy | Parenteral packaging |
| PCI Pharma Services | Janssen-Cilag Ltd | NICE approval | Darzalex | Parenteral packaging |
| PCI Pharma Services | Gilead Sciences Ltd | NICE approval | Livdelzi | Solid-dose manufacture |
| PCI Pharma Services | Aventis Pharma Ltd | NICE approval | Tzield | Parenteral manufacture & packaging |
| Piramal Pharma Solutions Inc | Incyte Biosciences UK Ltd | EMA expanded indications | Iclusig | Small mol API |
| Piramal Pharma Solutions Inc | Daiichi Sankyo UK Ltd | NICE approval | Nilemdo | Solid-dose manufacture & packaging |
| Piramal Pharma Solutions Inc | Daiichi Sankyo UK Ltd | NICE approval | Nustendi | Solid-dose manufacture & packaging |
| Rechon Life Science AB | Novo Nordisk Inc | FDA expanded indications | Zegalogue | Parenteral manufacture & packaging |
| Rentschler Biopharma SE | AbbVie Inc | EMA expanded indications | Tepkinly | Biologic API |
| Roslin Cell Therapies Ltd | Vertex Pharmaceuticals Inc | FDA expanded indications | Casgevy | Biologic API |
| Samsung Biologics Co Ltd | Janssen-Cilag Ltd | NICE approval | Darzalex | Biologic API |
| Samsung Biologics Co Ltd | Merck Sharp & Dohme (UK) Ltd | NICE approval | Keytruda | Biologic API |
| Samsung Biologics Co Ltd | Merck Sharp & Dohme LLC | FDA expanded indications | Keytruda Qlex | Biologic API |
| Samsung Biologics Co Ltd | Gilead Sciences Europe Ltd | EMA expanded indications | Trodelvy | Biologic API |
| Samsung Biologics Co Ltd | Immunomedics Inc | FDA expanded indications | Trodelvy | Biologic API |
| Sandoz GmbH | Novartis AG | EMA expanded indications | Itvisma | Parenteral manufacture & packaging |
| Shanghai Obio Technolgy Group Corp Ltd | Beijing Chinagene Tech Co Ltd | Trial planned - Phase III | puliretgene parvec | Biologic API |
| Sharp Packaging Services LLC | Regeneron UK Ltd | NICE approval | Libtayo | Parenteral packaging |
| Simtra US LLC | Janssen-Cilag Ltd | NICE approval | Darzalex | Parenteral manufacture & packaging |
| Simtra US LLC | Daiichi Sankyo Co Ltd | EMA expanded indications | Enhertu | Parenteral manufacture & packaging |
| Simtra US LLC | Astellas US LLC | FDA expanded indications | Padcev | Parenteral manufacture & packaging |
| Undisclosed CDMO | TRACON Pharmaceuticals Inc | Phase I interim results | carotuximab | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Janssen-Cilag Ltd | NICE approval | Darzalex | Parenteral manufacture |
| Viralgen Vector Core SL | Elpida Therapeutics | Trial planned - Phase II | Melpida | Biologic API |
| WuXi Biologics Co Ltd | HanchorBio Inc | Phase I/II interim results | HCB-101 | Biologic API |
| WuXi Biologics Co Ltd | HanchorBio Inc | Phase I/II interim results | HCB-101 | Parenteral manufacture |
| WuXi Biologics Co Ltd | Viridian Therapeutics Inc | FDA approval | Lumvoa | Parenteral manufacture |
| WuXi Biologics Co Ltd | Viridian Therapeutics Inc | FDA approval | Lumvoa | Biologic API |
| WuXi XDC Cayman Inc | AbbVie Ltd | NICE approval | Aquipta | Solid-dose manufacture |
POTENTIALLY NEGATIVE |
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| Catalent Inc | BriaCell Therapeutics Corp | Trial Withdrawn - Phase I | Bria-IMT | Parenteral packaging |
| Catalent Inc | Vaccinex Inc | Trial Suspended - Phase I | pepinemab | Biologic API |
| FUJIFILM Cellular Dynamics Inc | Cynata Therapeutics Ltd | Phase II interim results | CYP-001 | Biologic API |
| FUJIFILM Cellular Dynamics Inc | Cynata Therapeutics Ltd | Phase III top-line results | CYP-004 | Biologic API |
| Jubilant HollisterStier LLC | AIM ImmunoTech Inc | Trial Withdrawn - Phase I/II | rintatolimod | Parenteral manufacture |
| Jubilant HollisterStier LLC | AIM ImmunoTech Inc | Trial Withdrawn - Phase I/II | rintatolimod | Small mol API |
| KBI Biopharma Inc | BriaCell Therapeutics Corp | Trial Withdrawn - Phase I | Bria-IMT | Parenteral packaging |
| Lonza Group Ltd | Ankyra Therapeutics Inc | Trial Withdrawn - Phase I | tolododekin alfa | Biologic API |
| Lonza Group Ltd | Ankyra Therapeutics Inc | Trial Withdrawn - Phase I | tolododekin alfa | Parenteral manufacture |
| Nitto Avecia Pharma Services Inc | AIM ImmunoTech Inc | Trial Withdrawn - Phase I/II | rintatolimod | Parenteral manufacture & packaging |
| Patheon NV | Tricida Inc | Trial Terminated - Phase II | veverimer | Solid-dose manufacture |
| PCI Pharma Services | Tricida Inc | Trial Terminated - Phase II | veverimer | Solid-dose manufacture |
| Pharmaceutics International Inc | AIM ImmunoTech Inc | Trial Withdrawn - Phase I/II | rintatolimod | Parenteral manufacture |
| Recipharm AB | Eli Lilly Group Limited | NICE unable to recommend | Inluriyo | Solid-dose manufacture & packaging |
| WuXi AppTec Co Ltd | Cabaletta Bio Inc | Trial Withdrawn - Phase I/II | rintatolimod | Biologic API |
Notes:
Source: GlobalData, Pharma Intelligence Center ©GlobalData
NICE = National Institute for Health and Care Excellence
*New molecular entities are in bold.