June 2025 — 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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| Ajinomoto Bio-Pharma Services | GlaxoSmithKline UK Ltd | NICE recommended the drug with platinum-based chemotherapy can be used as an option to treat primary advanced or recurrent endometrial cancer with high microsatellite instability or mismatch repair deficiency in adults when systemic therapy is suitable. Drug can only be used if the company provides it according to the commercial arrangement | Jemperli | Parenteral manufacture & packaging |
| Andelyn Biosciences Inc | Nationwide Children's Hospital | Trial planned - Phase I/II to determine the safety and estimate the efficacy of CD33 CAR-NK cells combined with FLA-VEN chemotherapy in patients age 1-39.99 with relapsed or refractory acute myeloid leukemia | CD38KO CD33CAR-NK Cell Therapy | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Pfizer Inc | FDA expanded indications of the drug for the treatment of adult patients with moderate to severe pemphigus vulgaris | Ruxience | Biologic API |
| Bora Pharmaceuticals Co Ltd | Novavax Inc | FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older | Nuvaxovid | Parenteral manufacture |
| BSP Pharmaceuticals SpA | Takeda Pharma AS | EMA expanded indications of the drug in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) a chemotherapy regimen in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma | Adcetris | Biologic API; Parenteral manufacture & packaging |
| Central Pharma Contract Packing Ltd | Cycle Pharmaceuticals Ltd | FDA expanded indications of the drug for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU) | Harliku | Solid dose packaging |
| CSBio Co Inc | NervGen Pharma Corp | Positive Phase I/II top-line results to evaluate safety and tolerability of NVG-291 in a Spinal Cord Injury (SCI) subjects | NVG-291 | Small mol API |
| Delpharm SAS | Takeda Pharma AS | EMA expanded indications of the drug in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) a chemotherapy regimen in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma | Adcetris | Parenteral manufacture & packaging |
| Delpharm SAS | Roche Products Ltd | UK MHRA expanded indications of the drug in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult and paediatric patients (aged 1 to 18 years) receiving allogeneic renal, cardiac or hepatic transplants | Cellcept | Solid dose packaging |
| Evergreen Theragnostics Inc | Molecular Targeting Technologies Inc | Trial planned - Phase I/II to evaluate the safety, dosimetry and efficacy of a 3-dose regimen of escalating doses of drug in adult subjects with metastatic, radioactive iodine non-responsive oncocytic (hurthle-cell) thyroid cancer | EBTATE | Small mol API |
| Fareva SA | Takeda Pharma AS | EMA expanded indications of the drug in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) a chemotherapy regimen in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma | Adcetris | Parenteral manufacture & packaging |
| Fareva SA | Merck Sharp & Dohme (UK) Ltd | UK MHRA expanded indications of the drug for the treatment of acute bacterial skin and skin structure infections in adults, adolescents and children weighing ≥35kg | Sivextro | Solid dose manufacture |
| Ferndale Pharma Group Inc | Quoin Pharmaceuticals Ltd | Positive Phase I Interim results to evaluate the safety and efficacy of drug in a pediatric patient with peeling skin syndrome (PSS) | QRX003 | Non-sterile semi-solid manufacture |
| Fujifilm Diosynth Biotechnologies Uk Ltd | Novavax Inc | FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older | Nuvaxovid | Biologic API |
| Galephar Pharmaceutical Research Inc | Aphaia Pharma AG | Trial planned - Phase II to evaluate the superiority on body weight reduction of two different doses of twice daily distal jejunal-release dextrose beads formulations (drug and APHD 002) combined with a gel composition, compared with two different doses of the placebo beads formulations (drug and APHD 002) combined with a gel composition in obese subjects with weight related comorbidities | APHD-012 | Non-sterile semi-solid manufacture |
| GSK plc | Novavax Inc | FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older | Nuvaxovid | Parenteral manufacture & packaging |
| Isotopia Molecular Imaging Ltd | Molecular Targeting Technologies Inc | Trial planned - Phase I/II to evaluate the safety, dosimetry and efficacy of a 3-dose regimen of escalating doses of drug in adult subjects with metastatic, radioactive iodine non-responsive oncocytic (hurthle-cell) thyroid cancer | EBTATE | Small mol API |
| ITM Isotope Technologies Munich SE | Molecular Targeting Technologies Inc | Trial planned - Phase I/II to evaluate the safety, dosimetry and efficacy of a 3-dose regimen of escalating doses of drug in adult subjects with metastatic, radioactive iodine non-responsive oncocytic (hurthle-cell) thyroid cancer | EBTATE | Small mol API |
| Kymos Pharma Services SL | Celltrion Healthcare Hungary Kft | EMA expanded indications of the drug for the treatment of moderate to severe plaque psoriasis | Qoyvolma | Parenteral manufacture |
| Kymos Pharma Services SL | Teva Pharmaceuticals USA Inc | FDA expanded indications of the drug for the treatment of moderate to severe pemphigus vulgaris in adult patients | Truxima | Parenteral manufacture |
| Lonza Biologics Inc | Bristol-Myers Squibb Pharma EEIG | EMA expanded indications of the drug and chemotherapy followed by surgery and adjuvant drug for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1% | Opdivo | Biologic API |
| Lonza Biologics Inc | Bristol-Myers Squibb Pharma EEIG | NICE recommended the drug plus ipilimumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. Drug plus ipilimumab can be used only if the company provides it according to the commercial arrangements | Opdivo | Biologic API |
| Lonza Group Ltd | Takeda Pharma AS | EMA expanded indications of the drug in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) a chemotherapy regimen in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma | Adcetris | Biologic API |
| Lonza Group Ltd | Trevi Therapeutics Inc | Positive Phase II top-line results to evaluate the efficacy, safety and quality of life of Haduvio (albuphine hydrochloride ER) for the treatment of cough in idiopathic pulmonary fibrosis (IPF) | Nalbuphine hydrochloride ER | Solid dose manufacture |
| Mabion SA | Novavax Inc | FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older | Nuvaxovid | Biologic API |
| MassBiologics | SparingVision SAS | Trial planned - Phase I to assess the safety and tolerability of a single intravitreal injection of drug in subjects with no light perception due to end stage rod cone dystrophy, and who retain dormant foveal cone photoreceptors | SPVN-20 | Biologic API |
| Midas Pharma GmbH | Celltrion Healthcare Hungary Kft | EMA expanded indications of the drug for the treatment of moderate to severe plaque psoriasis | Qoyvolma | Parenteral manufacture |
| Midas Pharma GmbH | Teva Pharmaceuticals USA Inc | FDA expanded indications of the drug for the treatment of moderate to severe pemphigus vulgaris in adult patients | Truxima | Parenteral manufacture & packaging |
| Nanolek LLC | Sanofi Pasteur Inc | FDA expanded indications of the drug for its meningococcal conjugate vaccine to include children 2 years through 10 years of age | Menactra | Parenteral manufacture & packaging |
| Novo Nordisk AS | Bristol-Myers Squibb Co | FDA expanded indications of the drug in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) | Yervoy | Parenteral manufacture & packaging |
| Novo Nordisk AS | Bristol-Myers Squibb Pharma EEIG | NICE recommended the drug plus ipilimumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. Drug plus ipilimumab can be used only if the company provides it according to the commercial arrangements | Yervoy | Parenteral manufacture & packaging |
| NUVISAN Pharma Holding GmbH | Teva Pharmaceuticals USA Inc | FDA expanded indications of the drug for the treatment of moderate to severe pemphigus vulgaris in adult patients | Truxima | Parenteral manufacture & packaging |
| NUVISAN Pharma Holding GmbH | Celltrion Healthcare Hungary Kft | EMA expanded indications of the drug for the treatment of moderate to severe plaque psoriasis | Qoyvolma | Parenteral manufacture |
| Par Sterile Products LLC | Novavax Inc | FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older | Nuvaxovid | Parenteral manufacture & packaging |
| Patheon France SAS | Theramex HQ UK Ltd | NICE recommended the drug with hormonal add-back therapy can be used within its marketing authorisation as an option to treat symptoms of endometriosis in adults of reproductive age who have had medical or surgical treatment for their endometriosis | Yselty | Solid dose manufacture & packaging |
| Patheon Italia SpA | Celltrion Healthcare Hungary Kft | EMA expanded indications of the drug for the treatment of moderate to severe plaque psoriasis | Qoyvolma | Parenteral manufacture & packaging |
| Patheon NV | Merck Sharp & Dohme (UK) Ltd | UK MHRA expanded indications of the drug for the treatment of acute bacterial skin and skin structure infections in adults, adolescents and children weighing ≥35kg | Sivextro | Solid dose manufacture & packaging |
| Patheon UK Ltd | Merck Sharp & Dohme (UK) Ltd | UK MHRA expanded indications of the drug for the treatment of acute bacterial skin and skin structure infections in adults, adolescents and children weighing ≥35kg | Sivextro | Solid dose manufacture |
| PCI Pharma Services | Cycle Pharmaceuticals Ltd | FDA expanded indications of the drug for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU) | Harliku | Solid dose manufacture & packaging |
| PCI Pharma Services | Teva Pharmaceuticals USA Inc | FDA expanded indications of the drug for the treatment of moderate to severe pemphigus vulgaris in adult patients | Truxima | Parenteral manufacture & packaging |
| Pharmaron Manufacturing Services (UK) Ltd | Cycle Pharmaceuticals Ltd | FDA expanded indications of the drug for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU) | Harliku | Small mol API |
| Piramal Pharma Solutions Inc | Takeda Pharma AS | EMA expanded indications of the drug in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) a chemotherapy regimen in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma | Adcetris | Biologic API |
| Piramal Pharma Solutions Inc | George Medicines Pty Ltd | FDA approval of the drug for the treatment of hypertension, including as initial treatment, to lower blood pressure, lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions | Widaplik | Solid dose manufacture |
| Rivopharm SA | Cycle Pharmaceuticals Ltd | FDA expanded indications of the drug for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU) | Harliku | Solid dose manufacture & packaging |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Pharma EEIG | EMA expanded indications of the drug and chemotherapy followed by surgery and adjuvant drug for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1% | Opdivo | Biologic API |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Co | FDA expanded indications of the drug in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) | Yervoy | Biologic API; Parenteral manufacture |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Pharma EEIG | NICE recommended the drug plus ipilimumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. Drug plus ipilimumab can be used only if the company provides it according to the commercial arrangements | Opdivo | Biologic API |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Pharma EEIG | NICE recommended the drug plus ipilimumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. Drug plus ipilimumab can be used only if the company provides it according to the commercial arrangements | Yervoy | Biologic API; Parenteral manufacture |
| Serum Institute of India Pvt Ltd | Novavax Inc | FDA approval of the for active immunization to prevent COVID-19 in individuals aged 12 and older | Covid-19 (Omicron JN.1) Vaccine | Biologic API |
| Sharp Packaging Services LLC | Bayer HealthCare Pharmaceuticals Inc | FDA expanded indications of the drug for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC) | Nubeqa | Solid dose packaging |
| Siegfried Holding AG | Novavax Inc | FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older | Nuvaxovid | Parenteral manufacture & packaging |
| Simtra US LLC | Novavax Inc | FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older | Nuvaxovid | Parenteral manufacture |
| Simtra US LLC | Bristol-Myers Squibb Co | FDA expanded indications of the drug in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) | Yervoy | Parenteral manufacture |
| Simtra US LLC | Bristol-Myers Squibb Pharma EEIG | NICE recommended the drug plus ipilimumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. Drug plus ipilimumab can be used only if the company provides it according to the commercial arrangements | Yervoy | Parenteral manufacture |
| SK Bioscience Ltd | Novavax Inc | FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older | Nuvaxovid | Biologic API |
| TopChem Pharmaceuticals Ltd | Quoin Pharmaceuticals Ltd | Positive Phase I Interim results to evaluate the safety and efficacy of drug in a pediatric patient with peeling skin syndrome (PSS) | QRX003 | Small mol API |
| Vetter Pharma-Fertigung GmbH & Co KG | Bristol-Myers Squibb Pharma EEIG | EMA expanded indications of the drug and chemotherapy followed by surgery and adjuvant drug for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1% | Opdivo | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Bristol-Myers Squibb Pharma EEIG | NICE recommended the drug plus ipilimumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. Drug plus ipilimumab can be used only if the company provides it according to the commercial arrangements | Opdivo | Parenteral manufacture |
| WuXi Biologics Co Ltd | GlaxoSmithKline UK Ltd | NICE recommended the drug with platinum-based chemotherapy can be used as an option to treat primary advanced or recurrent endometrial cancer with high microsatellite instability or mismatch repair deficiency in adults when systemic therapy is suitable. Drug can only be used if the company provides it according to the commercial arrangement | Jemperli | Biologic API |
POTENTIALLY NEGATIVE |
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| Lonza Biologics Inc | Argenx SE | NICE rejection for the drug, within its marketing authorisation, as an add-on to standard treatment for generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies. This recommendation is not intended to affect treatment with drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop | Vyvgart | Biologic API |
| Lonza Biologics Plc | Argenx SE | NICE rejection for the drug, within its marketing authorisation, as an add-on to standard treatment for generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies. This recommendation is not intended to affect treatment with drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop | Vyvgart | Biologic API |
| Lonza Group Ltd | Argenx SE | NICE rejection for the drug, within its marketing authorisation, as an add-on to standard treatment for generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies. This recommendation is not intended to affect treatment with drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop | Vyvgart | Biologic API |
| Patheon NV | Argenx SE | NICE rejection for the drug, within its marketing authorisation, as an add-on to standard treatment for generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies. This recommendation is not intended to affect treatment with drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop | Vyvgart | Parenteral manufacture |
| Sharp Packaging Services LLC | BeiGene Ltd | NICE is unable to make a recommendation on drug for treating unresectable advanced oesophageal squamous cell cancer after platinum-based chemotherapy in adults. This is because BeiGene withdrew its evidence submission | Tevimbra | Parenteral packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Argenx SE | NICE rejection for the drug, within its marketing authorisation, as an add-on to standard treatment for generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies. This recommendation is not intended to affect treatment with drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop | Vyvgart | Parenteral manufacture & packaging |
Notes:
Source: GlobalData, Pharma Intelligence Center ©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