June 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 |
||||
| AbbVie Inc | Merck Sharp & Dohme (UK) Ltd | NICE approval | Winrevair* | Biologic API |
| ACS Dobfar SPA | Wockhardt USA LLC | FDA approval | Zaynich* | Parenteral manufacture & packaging |
| Aenova Holding GmbH | Proveca Ltd | EMA approval | Bopediat | Liquid sterile manufacture |
| AGC Biologics Inc | Provention Bio Inc | FDA expanded indications | Tzield* | Biologic API |
| Allpack Group AG | Actelion Pharmaceuticals US Inc | FDA expanded indications | Uptravi* | Solid-dose packaging |
| Almac Group Ltd | Provention Bio Inc | FDA expanded indications | Tzield* | Parenteral packaging |
| Almac Group Ltd | Actelion Pharmaceuticals US Inc | FDA expanded indications | Uptravi* | Small mol API |
| Almac Group Ltd | Avanzanite Bioscience BV | EMA expanded indications | Pyrukynd* | Solid-dose manufacture & packaging |
| Amphastar Pharmaceuticals Inc | MannKind Corp | FDA expanded indications | Afrezza* | Biologic API |
| Arkema SA | Galderma Laboratories LP | FDA expanded indications | Differin Epiduo | Small mol API |
| AstraZeneca Plc | Merck & Co Inc | FDA expanded indications | Keytruda* | Biologic API |
| Axplora Group GmbH | Galderma Laboratories LP | FDA expanded indications | Differin Epiduo | Small mol API |
| Biovian Oy | DexTech Medical AB | Phase I/II interim results | Osteodex | Parenteral manufacture |
| Boehringer Ingelheim Fremont Inc | Merck & Co Inc | FDA 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 | AstraZeneca Pharmaceuticals LP | NICE approval | Imfinzi* | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck & Co Inc | FDA expanded indications | Keytruda* | Biologic API |
| 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 |
| Boehringer Ingelheim Pharma GmbH & Co KG | AstraZeneca Pharmaceuticals LP | FDA expanded indications | Imfinzi* | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck Sharp & Dohme LLC | FDA expanded indications | Keytruda Qlex* | Biologic API |
| Catalent CTS LLC | Chiesi Farmaceutici SpA | EMA expanded indications | Lojuxta* | Solid-dose manufacture & packaging |
| Catalent U.K. Swindon Zydis Ltd | Chiesi Farmaceutici SpA | EMA expanded indications | Lojuxta* | Solid-dose packaging |
| Corden Pharma International GmbH | AbbVie Inc | FDA expanded indications | Linzess* | Small mol API |
| Corden Pharma International GmbH | Madrigal Pharmaceuticals Inc | MHRA approval | Rezdiffra* | Solid-dose manufacture & packaging |
| Corden Pharma International GmbH | Galderma Laboratories LP | FDA expanded indications | Differin Epiduo | Small mol API |
| Curia Global Inc | Oligomerix inc | Phase I interim results | OLX-07010 | Small mol API |
| Dottikon Exclusive Synthesis AG | AstraZeneca UK Ltd | NICE approval | Tagrisso* | Small mol API |
| Excella GmbH & Co KG | Actelion Pharmaceuticals US Inc | FDA expanded indications | Uptravi* | Solid-dose manufacture |
| FinVector Oy | Ferring Pharmaceuticals AS | EMA approval | Adstiladrin* | Parenteral manufacture |
| Flamma SpA | Sanofi UK | MHRA approval | Wayrilz* | Small mol API |
| HAS Healthcare Advanced Synthesis SA | Galderma Laboratories LP | FDA expanded indications | Differin Epiduo | Small mol API |
| Lonza Biologics Inc | Bristol-Myers Squibb Pharma EEIG | EMA expanded indications | Opdivo | Biologic API |
| Lonza Group Ltd | Genmab AS | NICE approval | Tivdak* | Biologic API |
| Lonza Group Ltd | AstraZeneca UK Ltd | NICE approval | Tagrisso* | Small mol API |
| Lonza Group Ltd | Daiichi Sankyo Inc | FDA expanded indications | Enhertu* | Biologic API |
| Lonza Group Ltd | Cellectis SA | Phase I/II final results | lasmecabtagene timgedleucel | Biologic API |
| Lonza Group Ltd | Context Therapeutics Inc | Phase I interim results | CTIM-76 | Biologic API |
| Lonza Group Ltd | Context Therapeutics Inc | Phase I interim results | CTIM-76 | Parenteral manufacture |
| Lyocontract GmbH | Gilead Sciences Inc | FDA approval | Hepcludex* | Parenteral manufacture & packaging |
| NorthStar Medical Radioisotopes LLC | Convergent Therapeutics Inc | Phase II interim results | rosopatamab tetraxetan | Parenteral manufacture |
| Nouryon Chemicals Holding BV | Galderma Laboratories LP | FDA expanded indications | Differin Epiduo | Small mol API |
| Organon & Co | Merck & Co Inc | FDA expanded indications | Keytruda* | Parenteral manufacture & packaging |
| Organon & Co | Merck Sharp & Dohme LLC | FDA expanded indications | Keytruda Qlex* | Parenteral manufacture & packaging |
| Patheon Italia SpA | Merck Sharp & Dohme (UK) Ltd | NICE approval | Winrevair* | Parenteral manufacture |
| Patheon Italia SpA | AbbVie Inc | FDA expanded indications | Skyrizi* | Parenteral manufacture & packaging |
| Patheon NV | Biogen Idec Ltd | NICE approval | Spinraza* | Parenteral manufacture & packaging |
| Patheon NV | Sanofi UK | MHRA approval | Wayrilz* | Solid-dose manufacture & packaging |
| PCAS | Abivax SA | Phase III top-line results | obefazimod | Small mol API |
| PCI Pharma Services | Provention Bio Inc | FDA expanded indications | Tzield* | Parenteral manufacture |
| PCI Pharma Services | Pharma Mar AG | EMA approval | Zepzelca* | Parenteral packaging |
| PolyPeptide Laboratories (Sweden) AB | AbbVie Inc | FDA expanded indications | Linzess* | Small mol API |
| PolyPeptide Laboratories Inc | AbbVie Inc | FDA expanded indications | Linzess* | Small mol API |
| Procos SpA | Genmab AS | NICE approval | Tivdak* | Biologic API |
| Quotient Sciences Ltd | Crinetics Pharmaceuticals Inc | Trial planned - Phase II/III | atumelnant maleate | Small mol API |
| Quotient Sciences Ltd | Crinetics Pharmaceuticals Inc | Phase II final results | atumelnant maleate | Solid-dose manufacture |
| Samsung Biologics Co Ltd | UCB Pharma Ltd | NICE approval | Rystiggo* | Biologic API |
| Samsung Biologics Co Ltd | AstraZeneca Pharmaceuticals LP | NICE approval | Imfinzi* | Biologic API |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Pharma EEIG | EMA expanded indications | Opdivo | Biologic API |
| Samsung Biologics Co Ltd | AstraZeneca Pharmaceuticals LP | FDA expanded indications | Imfinzi* | Biologic API |
| Samsung Biologics Co Ltd | Merck Sharp & Dohme LLC | FDA expanded indications | Keytruda Qlex* | Biologic API |
| Samsung Biologics Co Ltd | Stcube Inc | Trial planned - Phase I | nelmastobart | Biologic API |
| Simtra US | Pharma Mar AG | EMA approval | Zepzelca* | Parenteral manufacture & packaging |
| Simtra US LLC | Daiichi Sankyo Inc | FDA expanded indications | Enhertu* | Parenteral manufacture & packaging |
| Skyepharma Production SAS | Pharming Group NV | EMA approval | Joenja* | Solid-dose manufacture & packaging |
| UPM Pharmaceuticals Inc | Madrigal Pharmaceuticals Inc | MHRA approval | Rezdiffra* | Solid-dose manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Biogen Idec Ltd | NICE approval | Spinraza* | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Pharmaceuticals LP | NICE approval | Imfinzi* | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Bristol-Myers Squibb Pharma EEIG | EMA expanded indications | Opdivo | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Pharmaceuticals LP | FDA expanded indications | Imfinzi* | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Janssen-Cilag Ltd | MHRA approval | Imaavy* | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Janssen-Cilag Ltd | MHRA approval | Imaavy* | Parenteral manufacture & packaging |
| WuXi Biologics Cayman Inc | Apogee Therapeutics Inc | Phase II top-line results | zumilokibart | Biologic API |
| WuXi Biologics Co Ltd | Janssen-Cilag Ltd | MHRA approval | Imaavy* | Biologic API |
| WuXi XDC Cayman Inc | AbbVie Inc | EMA expanded indications | Aquipta* | Solid-dose manufacture |
| WuXi XDC Cayman Inc | Janssen-Cilag Ltd | MHRA approval | Imaavy* | Biologic API |
POTENTIALLY NEGATIVE |
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| AGC Biologics Inc | ImmunityBio Inc | NICE Unable to recommend | Anktiva* | Biologic API |
| AGC Biologics Inc | ImmunityBio Inc | NICE Unable to recommend | Anktiva* | Parenteral manufacture |
| Bilthoven Biologicals BV | ImmunityBio Inc | NICE Unable to recommend | Anktiva* | Parenteral manufacture & packaging |
| BioReliance Corp | Pfizer Ltd (UK) | Withdrawn (EU) | Inflectra* | Parenteral manufacture |
| Gensenta Ilac Sanayi ve Ticaret AS | Pfizer Ltd (UK) | Withdrawn (EU) | Inflectra* | Parenteral manufacture |
| Kymos Pharma Services SL | Celltrion Europe Ltd | Withdrawn (EU) | Qoyvolma* | Parenteral manufacture |
| Kymos Pharma Services SL | Pfizer Ltd (UK) | Withdrawn (EU) | Inflectra* | Parenteral manufacture |
| Lonza Group Ltd | Pfizer Ltd (UK) | Withdrawn (EU) | Inflectra* | Biologic API |
| Midas pharma GmbH | Celltrion Europe Ltd | Withdrawn (EU) | Qoyvolma* | Parenteral manufacture |
| Midas pharma GmbH | Pfizer Ltd (UK) | Withdrawn (EU) | Inflectra* | Parenteral manufacture |
| NUVISAN Pharma Holdings GmbH | Celltrion Europe Ltd | Withdrawn (EU) | Qoyvolma* | Parenteral manufacture |
| NUVISAN Pharma Holdings GmbH | Pfizer Ltd (UK) | Withdrawn (EU) | Inflectra* | Parenteral manufacture |
| Patheon Italia SpA | Celltrion Europe Ltd | Withdrawn (EU) | Qoyvolma* | Parenteral manufacture & packaging |
| PCI Pharma Services | Pfizer Ltd (UK) | Withdrawn (EU) | Inflectra* | Parenteral packaging |
| PCI Pharma Services | ImmunityBio Inc | NICE Unable to recommend | Anktiva* | Parenteral manufacture |
| Pfizer Inc | Pfizer Ltd (UK) | Withdrawn (EU) | Inflectra* | Parenteral packaging |
| Rentschler Biopharma SE | Pfizer Ltd (UK) | Withdrawn (EU) | Inflectra* | Parenteral manufacture & packaging |
Notes:
Source: GlobalData, Pharma Intelligence Center ©GlobalData
NICE = National Institute for Health and Care Excellence
*New molecular entities are in bold.