April 2024 — CDMO Opportunities And Threats Report
Source: Outsourced Pharma
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 |
||||
| AbbVie Inc | AstraZeneca Plc | NICE approval | Lynparza | Solid dose manufacture & packaging |
| AbbVie Inc | Pfizer Inc | NICE approval | Paxlovid | Small mol API & Solid dose manufacture |
| ACS Dobfar SpA | Basilea Pharmaceutica Ltd | FDA approval | Zevtera | Parenteral manufacture |
| Aenova Holding GmbH | Takeda Pharmaceutical Co Ltd | FDA expanded indications | Iclusig | Solid dose packaging |
| AGC Biologics Inc | Orchard Therapeutics Plc | FDA approval | Lenmeldy | Biologic API, Parenteral manufacture |
| Ajinomoto Bio-Pharma Services | Evive Biotech | EMA approval | Ryzneuta | Parenteral manufacture |
| Almac Group Ltd | Inventiva SA | Positive Phase II Interim results | lanifibranor | Solid dose manufacture |
| Almac Group Ltd | Johnson & Johnson | FDA approval | Opsynvi | Solid dose packaging |
| AstraZeneca Plc | Merck & Co Inc | EMA expanded indications | Keytruda | Biologic API |
| Asymchem Inc | Pfizer Inc | NICE approval | Paxlovid | Small mol API |
| Axplora Group GmbH | Pfizer Inc | NICE approval | Paxlovid | Small mol API |
| Axplora Group GmbH | EyePoint Pharmaceuticals Inc | NICE approval | Iluvien | Small mol API |
| Biogen Inc | Johnson & Johnson | NICE approval | Darzalex | Biologic API |
| Boehringer Ingelheim Biopharmaceuticals China Ltd | BeiGene Ltd | FDA approval | Tevimbra | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck & Co Inc | EMA expanded indications | Keytruda | Biologic API |
| Catalent Germany Schorndorf GmbH | Evive Biotech | EMA approval | Ryzneuta | Parenteral packaging |
| Catalent Indiana LLC | Alexion Pharmaceuticals Inc | FDA expanded indications | Ultomiris | Parenteral manufacture & packaging |
| Contract Pharmaceuticals Ltd | OptiNose Inc | FDA expanded indications | Xhance | Inhalational manufacture & packaging |
| Corden Pharma International GmbH | Inventiva SA | Positive Phase II Interim results | lanifibranor | Small mol API |
| Dalton Pharma Services | Oncovir Inc | Trial planned - Phase I | Hiltonol | Parenteral manufacture |
| Dalton Pharma Services | GLyPharma Therapeutic Inc | Positive Phase II Interim results | apraglutide | Parenteral manufacture |
| Dottikon Exclusive Synthesis AG | AstraZeneca Plc | NICE approval | Lynparza | Small mol API |
| Esteve Quimica SA | Pfizer Inc | NICE approval | Paxlovid | Small mol API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Alexion Pharmaceuticals Inc | FDA expanded indications | Ultomiris | Biologic API |
| H. Lundbeck AS | Otsuka Pharmaceutical Co Ltd | EMA approval | Abilify Maintena | Parenteral manufacture & packaging |
| Hetero Drugs Ltd | Pfizer Inc | NICE approval | Paxlovid | Small mol API & Solid dose manufacture |
| Hikma Pharmaceuticals Plc | Takeda Pharmaceutical Co Ltd | FDA expanded indications | Iclusig | Solid dose manufacture & packaging |
| Hikma Pharmaceuticals Plc | Boehringer Ingelheim International GmbH | FDA expanded indications | Spevigo | Parenteral packaging |
| Hovione FarmaCiencia SA | OptiNose Inc | FDA expanded indications | Xhance | Small mol API |
| Jetpharma SA | AstraZeneca Plc | NICE approval | Lynparza | Small mol API |
| Jetpharma SA | Johnson & Johnson | FDA approval | Opsynvi | Small mol API |
| Lonza Group Ltd | AstraZeneca Plc | NICE approval | Lynparza | Small mol API |
| Lonza Group Ltd | Johnson & Johnson | FDA approval | Opsynvi | Small mol API |
| Ningbo Renjian Pharmaceutical Co Ltd | Johnson & Johnson | FDA expanded indications | Edurant | Small mol API |
| Ningbo Renjian Pharmaceutical Co Ltd | Johnson & Johnson | FDA approval | Edurant PED | Small mol API |
| Nipro Pharma Corp | Basilea Pharmaceutica Ltd | FDA approval | Zevtera | Parenteral manufacture |
| Noramco Inc | Mirum Pharmaceuticals Inc | FDA expanded indications | Livmarli | Liquid non-sterile manufacture & packaging |
| Nortec Quimica SA | Pfizer Inc | NICE approval | Paxlovid | Small mol API |
| Novartis AG | Chugai Pharmaceutical Co Ltd | NICE approval | RoActemra | Biologic API |
| Organon & Co | Merck & Co Inc | EMA expanded indications | Keytruda | Parenteral packaging |
| Patheon NV | AstraZeneca Plc | NICE approval | Lynparza | Solid dose manufacture & packaging |
| Patheon NV | Pfizer Inc | NICE approval | Paxlovid | Solid dose manufacture |
| Patheon NV | Vanda Pharmaceuticals Inc | FDA expanded indications | Fanapt | Solid dose manufacture & packaging |
| Patheon NV | Takeda Pharmaceutical Co Ltd | FDA expanded indications | Iclusig | Solid dose manufacture & packaging |
| Patheon NV | Alexion Pharmaceuticals Inc | FDA expanded indications | Ultomiris | Biologic API |
| Patheon NV | Merck & Co Inc | FDA approval | Winrevair | Parenteral manufacture |
| Patheon NV | Gilead Sciences Inc | FDA expanded indications | Vemlidy | Solid dose manufacture & packaging |
| Patheon NV | Bristol-Myers Squibb Co | EMA expanded indications | Abecma | Biologic API |
| PCI Pharma Services | Johnson & Johnson | NICE approval | Darzalex | Parenteral packaging |
| PCI Pharma Services | Pfizer Inc | NICE approval | Paxlovid | Solid dose packaging |
| PCI Pharma Services | EyePoint Pharmaceuticals Inc | NICE approval | Iluvien | Parenteral packaging |
| PCI Pharma Services | Esperion Therapeutics Inc | FDA expanded indications | Nexlizet | Solid dose packaging |
| PCI Pharma Services | Johnson & Johnson | FDA approval | Opsynvi | Solid dose manufacture |
| PCI Pharma Services | Esperion Therapeutics Inc | FDA expanded indications | Nexletol | Solid dose packaging |
| PCI Pharma Services | Mirum Pharmaceuticals Inc | FDA expanded indications | Livmarli | Liquid non-sterile packaging |
| PCI Pharma Services | Johnson & Johnson | FDA expanded indications | Edurant | Solid dose packaging |
| PCI Pharma Services | Johnson & Johnson | FDA approval | Edurant PED | Solid dose packaging |
| PCI Pharma Services | Gilead Sciences Inc | FDA expanded indications | Vemlidy | Solid dose packaging |
| PCI Pharma Services | Akebia Therapeutics Inc | FDA approval | Vafseo | Solid dose packaging |
| Piramal Pharma Solutions Inc | Esperion Therapeutics Inc | FDA expanded indications | Nexlizet | Solid dose manufacture |
| Piramal Pharma Solutions Inc | Esperion Therapeutics Inc | FDA expanded indications | Nexletol | Solid dose manufacture |
| Piramal Pharma Solutions Inc | Takeda Pharmaceutical Co Ltd | FDA expanded indications | Iclusig | Small mol API |
| Procaps SAS | IGC Pharma LLC | Positive Phase II Interim results | dronabinol | Solid dose manufacture & packaging |
| Samsung Biologics Co Ltd | Johnson & Johnson | NICE approval | Darzalex | Biologic API |
| Samsung Biologics Co Ltd | Vir Biotechnology Inc | NICE approval | Xevudy | Biologic API |
| Samsung Biologics Co Ltd | Chugai Pharmaceutical Co Ltd | NICE approval | RoActemra | Biologic API |
| Sharp Packaging Services | Pfizer Inc | NICE approval | Paxlovid | Solid dose packaging |
| Sharp Packaging Services | Vanda Pharmaceuticals Inc | FDA expanded indications | Fanapt | Solid dose packaging |
| Sharp Packaging Services | Takeda Pharmaceutical Co Ltd | FDA expanded indications | Iclusig | Solid dose packaging |
| Sharp Packaging Services | BeiGene Ltd | FDA approval | Tevimbra | Parenteral packaging |
| Siegfried Holding AG | EyePoint Pharmaceuticals Inc | NICE approval | Iluvien | Parenteral manufacture & packaging |
| Simtra BioPharma Solutions | Takeda Pharmaceutical Co Ltd | UK MHRA expanded indications | HyQvia | Parenteral manufacture |
| Simtra BioPharma Solutions | Takeda Pharmaceutical Co Ltd | UK MHRA expanded indications | HyQvia | Parenteral manufacture |
| Simtra BioPharma Solutions | Johnson & Johnson | NICE approval | Darzalex | Parenteral manufacture |
| SMS Pharmaceuticals Ltd | Johnson & Johnson | FDA approval | Opsynvi | Small mol API |
| UPM Pharmaceuticals Inc | Madrigal Pharmaceuticals Inc | FDA approval | Rezdiffra | Solid dose manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Chugai Pharmaceutical Co Ltd | NICE approval | RoActemra | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Johnson & Johnson | NICE approval | Darzalex | Parenteral manufacture |
| WuXi Biologics Cayman Inc | Vir Biotechnology Inc | NICE approval | Xevudy | Biologic API |
| WuXi XDC Cayman Inc | Pfizer Inc | NICE approval | Paxlovid | Small mol API |
POTENTIALLY NEGATIVE |
||||
| Ajinomoto Bio-Pharma Services | AstraZeneca Plc | Withdrawn | Vaxzevria | Parenteral manufacture |
| Almac Group Ltd | AstraZeneca Plc | NICE rejection | Kanuma | Parenteral manufacture & packaging |
| Catalent Anagni Srl | AstraZeneca Plc | Withdrawn | Vaxzevria | Parenteral manufacture & packaging |
| Catalent Inc | AstraZeneca Plc | Withdrawn | Vaxzevria | Biologic API |
| Charles River Laboratories International Inc | AstraZeneca Plc | Withdrawn | Vaxzevria | Biologic API |
| Chemo Holding SL | AstraZeneca Plc | Withdrawn | Vaxzevria | Parenteral manufacture & packaging |
| Daiichi Sankyo Biotech Co Ltd | AstraZeneca Plc | Withdrawn | Vaxzevria | Parenteral manufacture & packaging |
| Delmar Chemicals | Antibe Therapeutics Inc | Withdrawn | otenaproxesul | Small mol API |
| Emergent BioSolutions Inc | AstraZeneca Plc | Withdrawn | Vaxzevria | Biologic API |
| FUJIFILM Diosynth Biotechnologies USA Inc | AstraZeneca Plc | NICE rejection | Kanuma | Biologic API |
| Halix BV | AstraZeneca Plc | Withdrawn | Vaxzevria | Biologic API |
| IDT Biologika GmbH | AstraZeneca Plc | Withdrawn | Vaxzevria | Biologic API, Parenteral manufacture & packaging |
| JCR Pharmaceuticals Co Ltd | AstraZeneca Plc | Withdrawn | Vaxzevria | Biologic API |
| KM Biologics Co Ltd | AstraZeneca Plc | Withdrawn | Vaxzevria | Parenteral manufacture & packaging |
| Laboratorios Liomont SA de CV | AstraZeneca Plc | Withdrawn | Vaxzevria | Parenteral manufacture |
| Mabxience Holding SL | AstraZeneca Plc | Withdrawn | Vaxzevria | Biologic API |
| Nipro Pharma Corp | AstraZeneca Plc | Withdrawn | Vaxzevria | Parenteral manufacture |
| Oxford BioMedica Plc | AstraZeneca Plc | Withdrawn | Vaxzevria | Biologic API |
| Patheon NV | AstraZeneca Plc | NICE rejection | Kanuma | Parenteral manufacture & packaging |
| Patheon NV | AstraZeneca Plc | Withdrawn | Vaxzevria | Biologic API |
| Siam Bioscience Co Ltd | AstraZeneca Plc | Withdrawn | Vaxzevria | Parenteral manufacture |
| Simtra BioPharma Solutions | AstraZeneca Plc | NICE rejection | Kanuma | Parenteral packaging |
| SK Bioscience Ltd | AstraZeneca Plc | Withdrawn | Vaxzevria | Biologic API, Parenteral manufacture |
| Wockhardt UK Holdings Ltd | AstraZeneca Plc | Withdrawn | Vaxzevria | Parenteral manufacture |
| WuXi Biologics Cayman Inc | AstraZeneca Plc | Withdrawn | Vaxzevria | Biologic API |
Notes:
Source: GlobalData, Pharma Intelligence Center (Accessed March 10, 2021) ©GlobalData
EMA = European Medicines Agency; NICE = National Institute for Health and Care Excellence
* New molecular entities are in bold
** Denotes product being marketed or in the pipeline for COVID-19 therapy area
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