April 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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| (Not disclosed) | Aligos Therapeutics Inc | Positive Phase II/III top-line results | pevifoscorvir sodium | Small molecule API |
| Aenova Holding GmbH | Gedeon Richter Plc | EMA approval | Fylrevy* | Solid dose manufacture & packaging |
| Aenova Holding GmbH | Gedeon Richter Plc | EMA approval | Fylrevy* | Parenteral manufacture & packaging |
| Almac Group | Vertex Pharmaceuticals Inc | FDA expanded indications | Alyftrek* | Solid dose manufacture & packaging |
| Almac Group | Vertex Pharmaceuticals Inc | FDA expanded indications | Trikafta* | Solid dose manufacture & packaging |
| AstraZeneca Plc | Merck Sharp & Dohme BV | EMA expanded indications | Keytruda* | Biologic API |
| Astrea Pharma | Rhythm Pharmaceuticals Inc | FDA expanded indications | Imcivree* | Parenteral manufacture & packaging |
| Astrea Pharma | Rhythm Pharmaceuticals Inc | FDA expanded indications | Imcivree* | Biologic API |
| Boehringer Ingelheim Fremont Inc | Merck Sharp & Dohme BV | EMA expanded indications | Keytruda* | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AstraZeneca AB | EMA expanded indications | Imfinzi* | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck Sharp & Dohme BV | EMA expanded indications | Keytruda* | Biologic API |
| Catalent CTS LLC | Travere Therapeutics Inc | FDA expanded indications | Filspari* | Solid dose manufacture |
| Catalent Germany Schorndorf GmbH | UCB SA | EMA approval | Kygevvi* | Solid dose manufacture & packaging |
| Corden Pharma International GmbH | Rhythm Pharmaceuticals Inc | FDA expanded indications | Imcivree* | Parenteral manufacture |
| Corden Pharma International GmbH | Cereno Scientific AB | Positive Phase III interim results | valproic acid | Solid dose manufacture |
| Dr. Reddy's Laboratories Ltd | Sanofi | EMA approval | Rezurock* | Small molecule API |
| Esteve Quimica SA | Vertex Pharmaceuticals Inc | FDA expanded indications | Trikafta* | Small molecule API |
| Fabbrica Italiana Sintetici SpA | Vertex Pharmaceuticals Inc | FDA expanded indications | Trikafta* | Small molecule API |
| FUJIFILM Biotechnologies USA Inc | Lexeo Therapeutics Inc | Positive Phase II interim results | LX-1001 | Biologic API |
| Fujimoto Chemicals Co Ltd | Astellas Pharma Inc | NICE approval | Veoza* | Small molecule API |
| Hovione FarmaCiencia SA | Vertex Pharmaceuticals Inc | FDA expanded indications | Trikafta* | Small molecule API |
| Hainan Poly Pharm Co Ltd | Imunon Inc | Positive Phase I/II final results | IMNN-001 | Biologic API |
| Juzen Chemical Corp | Astellas Pharma Inc | NICE approval | Veoza* | Small molecule API |
| Lonza Biologics Inc | Bristol-Myers Squibb Co | FDA expanded indications | Opdivo* | Biologic API |
| Lonza Biologics Inc | Bristol-Myers Squibb Pharma EEIG | EMA expanded indications | Opdivo* | Biologic API |
| Lonza Group Ltd | Alzamend Neuro Inc | Positive Phase II top-line results | AL-001 | Small molecule API |
| Lonza Group Ltd | Kodiak Sciences Inc | Positive Phase III top-line results | tarcocimab tedromer | Biologic API |
| LTS Lohmann Therapie-Systeme AG | ALK-Abello AS | EMA expanded indications | Eurneffy | Parenteral manufacture |
| Novo Nordisk AS | Sanofi Winthrop Industrie SA | EMA expanded indications | Dupixent* | Parenteral manufacture & packaging |
| Novo Nordisk AS | Regeneron Pharmaceuticals Inc | NICE approval | Dupixent* | Parenteral manufacture & packaging |
| Novo Nordisk AS | Regeneron Pharmaceuticals Inc | NICE approval | Dupixent* | Parenteral manufacture & packaging |
| OBiO Technology (Shanghai) Corp Ltd | Novabio Therapeutics | Trial planned - Phase I | NP-001 | Biologic API |
| Organon & Co | Merck Sharp & Dohme BV | EMA expanded indications | Keytruda* | Parenteral manufacture & packaging |
| Patheon NV | Novo Nordisk AS | EMA expanded indications | Kayshild | Parenteral packaging |
| Patheon NV | Novo Nordisk Inc | FDA expanded indications | Wegovy HD | Parenteral packaging |
| Patheon NV | Vertex Pharmaceuticals Inc | FDA expanded indications | Alyftrek* | Solid dose manufacture |
| Patheon NV | Vertex Pharmaceuticals Inc | FDA expanded indications | Trikafta* | Solid dose manufacture |
| PCI Pharma Services | Vertex Pharmaceuticals Inc | FDA expanded indications | Trikafta* | Solid dose packaging |
| PCI Pharma Services | Astellas Pharma Inc | NICE approval | Veoza* | Solid dose packaging |
| Pharma Packaging Solutions | Sanofi | EMA approval | Rezurock* | Solid dose packaging |
| PolyPeptide SA | Rhythm Pharmaceuticals Inc | FDA expanded indications | Imcivree* | Biologic API |
| Protein Sciences Corp | Diamyd Medical AB | Positive Phase III interim results | Retogatein | Biologic API |
| Recipharm AB | Vertex Pharmaceuticals Inc | FDA expanded indications | Trikafta* | Solid dose manufacture |
| Samsung Biologics Co Ltd | AstraZeneca AB | EMA expanded indications | Imfinzi* | Biologic API |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Co | FDA expanded indications | Opdivo* | Biologic API |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Pharma EEIG | EMA expanded indications | Opdivo* | Biologic API |
| Sharp Packaging Services LLC | Bayer AG | EMA expanded indications | Kerendia* | Solid dose packaging |
| Tiofarma BV | ALK-Abello AS | EMA expanded indications | Eurneffy | Parenteral manufacture |
| UPM Pharmaceuticals Inc | Sanofi | EMA approval | Rezurock* | Solid dose manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca AB | EMA expanded indications | Imfinzi* | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Bristol-Myers Squibb Co | FDA expanded indications | Opdivo* | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Bristol-Myers Squibb Pharma EEIG | EMA expanded indications | Opdivo* | Parenteral manufacture |
| Wasdell Packaging Ltd | Sanofi | EMA approval | Rezurock* | Solid dose packaging |
| WuXi Biologics Cayman Inc | AC Immune SA | Positive Phase II interim results | JNJ-2056 | Biologic API |
| WuXi STA (Shanghai) Co Ltd | Vertex Pharmaceuticals Inc | FDA expanded indications | Trikafta* | Small molecule API |
| WuXi STA (Shanghai) Co Ltd | Gyre Therapeutics Inc | Trial planned - Phase I | F-351 | Small molecule API |
| WuXi STA (Shanghai) Co Ltd | Gyre Therapeutics Inc | Trial planned - Phase I | F-351 | Solid dose manufacture |
| WuXi STA (Shanghai) Co Ltd | Ideaya Biosciences Inc | Positive Phase I/II top-line results | darovasertib | Solid dose manufacture |
| WuXi STA (Shanghai) Co Ltd | Ideaya Biosciences Inc | Positive Phase I/II top-line results | darovasertib | Small molecule API |
POTENTIALLY NEGATIVE |
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| Hikma Pharmaceuticals Plc | Boehringer Ingelheim Pharma GmbH & Co KG | NICE unable to recommend | Spevigo* | Parenteral packaging |
Notes:
Source: GlobalData
NICE = National Institute for Health and Care Excellence
*New molecular entities are in bold.