January 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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| AbbVie Inc | AstraZeneca UK Ltd | UK MHRA expanded indication of the drug in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel | Lynparza | Solid dose manufacture & packaging |
| AbbVie Inc | Merck Sharp & Dohme (UK) Ltd | UK MHRA approval of the drug in combination with other medicines to treat PAH, in adults with moderate or marked limitations of physical activity, to improve exercise capacity | Winrevair | Biologic API |
| Aenova Holding GmbH | Pfizer Ltd (UK) | UK MHRA expanded indication of the drug in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis, mucormycosis in patients for whom amphotericin B is inappropriate | Cresemba | Parenteral manufacture |
| AGC Biologics Inc | Immunocore Limited | NICE recommended the drug, within its marketing authorisation, for treating HLA‑A*02:01-positive unresectable or metastatic uveal melanoma in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Kimmtrak | Biologic API |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation. | Trikafta | Solid dose manufacture |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation. | Trikafta | Solid dose manufacture & packaging |
| Almac Group Ltd | Array BioPharma Inc | FDA expanded indication of the drug in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test | Braftovi | Solid dose packaging |
| Almac Group Ltd | Pfizer Ltd (UK) | UK MHRA expanded indication of the drug in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis, mucormycosis in patients for whom amphotericin B is inappropriate | Cresemba | Solid dose manufacture & packaging |
| Aspen Pharmacare Holdings Ltd | Merck & Co Inc | FDA expanded indication of the drug for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in pediatric patients from birth to less than 2 years of age | Bridion | Small mol API |
| BioReliance Corp | Celltrion Europe Ltd | UK MHRA expanded indication of the drug for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies | Steqeyma | Parenteral manufacture |
| Bristol-Myers Squibb Co | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug in adults with type 2 diabetes mellitus to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure | Xigduo XR | Solid dose manufacture |
| Catalent Inc | Neurelis Inc | FDA expanded indication of the drug for acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age | Valtoco | Inhalational manufacture |
| Catalent Inc | Array BioPharma Inc | FDA expanded indication of the drug in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test | Braftovi | Solid dose manufacture |
| Catalent U.K. Swindon Zydis Ltd | ALK-Abello AS | EMA approval of the drug for the treatment of house dust mite allergy in young children aged five to 11 years | Acarizax | Solid dose manufacture & packaging |
| Catalent U.K. Swindon Zydis Ltd | ALK-Abello AS | EMA approval of the drug for the treatment of house dust mite allergy in young children aged five to 11 years | Acarizax | Solid dose manufacture & packaging |
| Corden Pharma International GmbH | Rhythm Pharmaceuticals Inc | FDA expanded indication of the drug to reduce excess body weight and maintain weight reduction long-term in patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency | Imcivree | Parenteral manufacture |
| Divi's Laboratories Ltd | Pfizer Ltd (UK) | UK MHRA expanded indication of the drug in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis, mucormycosis in patients for whom amphotericin B is inappropriate | Cresemba | Small mol API |
| Dottikon Exclusive Synthesis AG | AstraZeneca UK Ltd | UK MHRA expanded indication of the drug in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel | Lynparza | Small mol API |
| Dottikon Exclusive Synthesis AG | AstraZeneca AB | EMA expanded indication of the drug for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT) | Tagrisso | Small mol API |
| Dr. Reddy's Laboratories Ltd | Merck & Co Inc | FDA expanded indication of the drug for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in pediatric patients from birth to less than 2 years of age | Bridion | Small mol API |
| Esteve Quimica SA | Vertex Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation. | Trikafta | Small mol API |
| Eurofins Advinus Ltd | Halia Therapeutics Inc | Positive Phase II top-line results of the drug for the treatment of lower-risk myelodysplastic syndromes (LR-MDS) | HT-6184 | Solid dose manufacture |
| Fabbrica Italiana Sintetici SpA | Vertex Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation. | Trikafta | Small mol API |
| Fabbrica Italiana Sintetici SpA | Merck & Co Inc | FDA expanded indication of the drug for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in pediatric patients from birth to less than 2 years of age | Bridion | Small mol API |
| Ferndale Pharma Group Inc | Quoin Pharmaceuticals Ltd | Positive Phase II/III Interim results of the drug for the treatment of Netherton Syndrome | QRX-003 | Sterile liquid manufacture |
| Hovione FarmaCiencia SA | Vertex Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation. | Trikafta | Small mol API, Solid dose manufacture |
| Hovione FarmaCiencia SA | Pfizer Ltd (UK) | UK MHRA expanded indication of the drug in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis, mucormycosis in patients for whom amphotericin B is inappropriate | Cresemba | Small mol API |
| Jetpharma SA | Array BioPharma Inc | FDA expanded indication of the drug in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test | Braftovi | Small mol API |
| Jetpharma SA | AstraZeneca UK Ltd | UK MHRA expanded indication of the drug in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel | Lynparza | Small mol API |
| Kymos Pharma Services SL | Celltrion Europe Ltd | UK MHRA expanded indication of the drug for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies | Steqeyma | Parenteral manufacture |
| Lonza Biologics Inc | Bristol-Myers Squibb Pharma EEIG | EMA expanded indication of the drug in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the first-line treatment of unresectable or metastatic colorectal cancer | Opdivo | Biologic API |
| Lonza Group Ltd | Gracell Biotechnologies Inc | Trial planned - Phase I to evaluate the safety, tolerability and initial clinical efficacy of drug Injection in the treatment of refractory GMG and to evaluate the PK, PD characteristics, and immunogenicity in subjects with refractory GMG infused with drug Injection | AZD-0120 | Biologic API |
| Lonza Group Ltd | Mesoblast Inc | FDA approval of the drug for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients 2 months of age and older | Ryoncil | Biologic API, Parenteral manufacture & packaging |
| Lonza Group Ltd | AstraZeneca UK Ltd | UK MHRA expanded indication of the drug in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel | Lynparza | Small mol API |
| Lonza Group Ltd | AstraZeneca AB | EMA expanded indication of the drug for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT) | Tagrisso | Small mol API |
| Lupin Ltd | Merck & Co Inc | FDA expanded indication of the drug for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in pediatric patients from birth to less than 2 years of age | Bridion | Parenteral manufacture & packaging |
| Midas Pharma GmbH | Celltrion Europe Ltd | UK MHRA expanded indication of the drug for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies | Steqeyma | Parenteral manufacture |
| Minaris Regenerative Medicine LLC | Mendus AB | Positive Phase I top-line results of the drug for the treatment of ovarian cancer | vididencel | Biologic API |
| NerPharma Srl | Cardiff Oncology Inc | Positive Phase II Interim results of the drug in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC) | onvansertib fumarate | Small mol API, Solid dose manufacture |
| Novo Nordisk AS | AstraZeneca UK Ltd | UK MHRA expanded indication of the drug in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with drug as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR); in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with drug in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR) | Imfinzi | Parenteral manufacture & packaging |
| Novo Nordisk AS | Bristol-Myers Squibb Pharma EEIG | EMA expanded indication of the drug in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in first-line treatment of unresectable or metastatic colorectal cancer | Yervoy | Parenteral manufacture & packaging |
| NUVISAN Pharma Holding GmbH | Celltrion Europe Ltd | UK MHRA expanded indication of the drug for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies | Steqeyma | Parenteral manufacture |
| Patheon NV | Vertex Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation. | Trikafta | Solid dose manufacture |
| Patheon NV | Merck & Co Inc | FDA expanded indication of the drug for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in pediatric patients from birth to less than 2 years of age | Bridion | Parenteral manufacture & packaging |
| Patheon NV | Dermavant Sciences Inc | FDA expanded indication of the drug for the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older | Vtama | Small mol API |
| Patheon NV | AstraZeneca UK Ltd | UK MHRA expanded indication of the drug in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel | Lynparza | Solid dose manufacture & packaging |
| Patheon NV | Merck Sharp & Dohme (UK) Ltd | UK MHRA approval of the drug in combination with other medicines to treat PAH, in adults with moderate or marked limitations of physical activity, to improve exercise capacity | Winrevair | Parenteral manufacture |
| Patheon NV | Celltrion Europe Ltd | UK MHRA expanded indication of the drug for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies | Steqeyma | Parenteral manufacture & packaging |
| Patheon NV | Novo Nordisk AS | EMA approval of the drug for routine prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency) with FIX inhibitors and of 12 years of age or more; for routine prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and of 12 years of age or more | Alhemo | Biologic API |
| PCI Pharma Services | Neuraxpharm UK Ltd | NICE recommended the drug as an option for treating relapsing forms of multiple sclerosis, defined as active by clinical or imaging features in adults, only if the multiple sclerosis is relapsing–remitting, and the company provides it according to the commercial arrangement | Briumvi | Parenteral manufacture & packaging |
| PCI Pharma Services | Vertex Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation. |
Trikafta | Solid dose packaging |
| PCI Pharma Services | Stallergenes SA | EMA expanded indication of the drug for the treatment of toddlers (ages 1 through 3) with a confirmed diagnosis of peanut allergy | Palforzia | Solid dose manufacture & packaging |
| PolyPeptide Group AG | Rhythm Pharmaceuticals Inc | FDA expanded indication of the drug to reduce excess body weight and maintain weight reduction long-term in patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency | Imcivree | Biologic API |
| Pronav Clinical | Nova Laboratories Ltd | FDA expanded indication of the drug to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients 6 months of age and older with sickle cell anemia with recurrent moderate to severe painful crises | Xromi | Solid dose manufacture |
| Quotient Sciences Ltd | Crinetics Pharmaceuticals Inc | Positive Phase II top-line results of the drug for the treatment of congenital adrenal hyperplasia (CAH) | atumelnant | Solid dose manufacture |
| Recipharm AB | Vertex Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation. |
Trikafta | Solid dose manufacture |
| Recipharm AB | Rhythm Pharmaceuticals Inc | FDA expanded indication of the drug to reduce excess body weight and maintain weight reduction long-term in patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency | Imcivree | Biologic API, Parenteral manufacture & packaging |
| Samsung Biologics Co Ltd | Neuraxpharm UK Ltd | NICE recommended the drug as an option for treating relapsing forms of multiple sclerosis, defined as active by clinical or imaging features in adults, only if the multiple sclerosis is relapsing–remitting, and the company provides it according to the commercial arrangement | Briumvi | Biologic API, Parenteral manufacture |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Pharma EEIG | EMA expanded indication of the drug in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the first-line treatment of unresectable or metastatic colorectal cancer | Opdivo | Biologic API |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Pharma EEIG | EMA expanded indication of the drug in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in first-line treatment of unresectable or metastatic colorectal cancer | Yervoy | Biologic API, Parenteral manufacture |
| Sharp Packaging Services | Beigene USA Inc | FDA expanded indication of the drug in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (?1) | Tevimbra | Parenteral packaging |
| Sharp Packaging Services | AstraZeneca UK Ltd | UK MHRA expanded indication of the drug in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with drug as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR); in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with drug in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR) | Imfinzi | Parenteral packaging |
| Simtra BioPharma Solutions | Immunocore Limited | NICE recommended the drug, within its marketing authorisation, for treating HLA‑A*02:01-positive unresectable or metastatic uveal melanoma in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Kimmtrak | Parenteral manufacture & packaging |
| Simtra BioPharma Solutions | Pfizer Ltd (UK) | UK MHRA expanded indication of the drug in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis, mucormycosis in patients for whom amphotericin B is inappropriate | Cresemba | Solid dose manufacture & packaging |
| Simtra BioPharma Solutions | Bristol-Myers Squibb Pharma EEIG | EMA expanded indication of the drug in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in first-line treatment of unresectable or metastatic colorectal cancer | Yervoy | Parenteral manufacture |
| Syngene International Ltd | Halia Therapeutics Inc | Positive Phase II top-line results of the drug for the treatment of lower-risk myelodysplastic syndromes (LR-MDS) | HT-6184 | Solid dose manufacture |
| TopChem Pharmaceuticals Ltd | Quoin Pharmaceuticals Ltd | Positive Phase II/III Interim results of the drug for the treatment of Netherton Syndrome | QRX-003 | Small mol API |
| Vetter Pharma-Fertigung GmbH & Co KG | Galderma Laboratories LP | FDA expanded indication of the drug for the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies | Nemluvio | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca UK Ltd | UK MHRA expanded indication of the drug in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with drug as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR); in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with drug in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR) | Imfinzi | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Bristol-Myers Squibb Pharma EEIG | EMA expanded indication of the drug in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the first-line treatment of unresectable or metastatic colorectal cancer | Opdivo | Parenteral manufacture |
| WuXi STA (Shanghai) Co Ltd | Vertex Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation. | Trikafta | Small mol API |
POTENTIALLY NEGATIVE |
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| Lonza Group Ltd | Galectin Therapeutics Inc | Negative Phase II/III results in patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis and portal hypertension | belapectin | Biologic API |
| UI Pharmaceuticals | Galectin Therapeutics Inc | Negative Phase II/III results in patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis and portal hypertension | belapectin | Parenteral manufacture |
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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