Guest Column | June 4, 2025

May 2025 — CDMO Opportunities And Threats Report

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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 Pfizer Inc NICE recommended the drug plus ritonavir as an option for treating COVID‑19 in adults, only if they do not need supplemental oxygen for COVID‑19 and have an increased risk for progression to severe COVID‑19, as defined in section 5 Paxlovid Solid dose manufacture
AbbVie Inc Pfizer Inc NICE recommended the drug plus ritonavir as an option for treating COVID‑19 in adults, only if they do not need supplemental oxygen for COVID‑19 and have an increased risk for progression to severe COVID‑19, as defined in section 5 Paxlovid Small mol API
Aenova Holding GmbH Arvelle Therapeutics Netherlands B.V NICE recommended the drug as an option as an add-on treatment for focal onset seizures with or without secondary generalised seizures in adults with drug-resistant epilepsy that has not been adequately controlled with at least 2 antiseizure medicines. It is recommended only as a second-line add-on treatment if it is used after at least 1 first-line add-on treatment has not controlled seizures, and other first-line add-on treatments are contraindicated or not tolerated, and treatment is started by a healthcare professional with expertise in epilepsy, after which treatment can be continued in primary care Ontozry Solid dose manufacture & packaging
Almac Group Ltd pharmaand GmbH NICE recommended the drug as an option for the maintenance treatment of advanced (International Federation of Gynecology and Obstetrics [FIGO] stages 3 and 4) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer after complete or partial response to first-line platinum-based chemotherapy in adults, only if it is BRCA mutation-negative and homologous recombination deficiency (HRD)-positive, or it is BRCA mutation-negative, and HRD status is negative or unknown, and bevacizumab is not a treatment option because NHS England's BEV3 and BEV10 commissioning approval criteria for having it are not met, or it is contraindicated or not tolerated, and the company provides rucaparib according to the commercial arrangement Rubraca Solid dose manufacture & packaging
AstraZeneca Plc Merck Sharp & Dohme (UK) Ltd UK MHRA expanded indications of the drug in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy) for the treatment of FIGO 2014 Stage III to IVA locally advanced cervical cancer in adults who have not received prior definitive therapy Keytruda Biologic API
Axplora Group GmbH Pfizer Inc NICE recommended the drug plus ritonavir as an option for treating COVID‑19 in adults, only if they do not need supplemental oxygen for COVID‑19 and have an increased risk for progression to severe COVID‑19, as defined in section 5 Paxlovid Small mol API
Biogen Inc Janssen-Cilag International NV EMA expanded indications of the drug for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment and for the  treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment Tremfya Biologic API
Boehringer Ingelheim Pharma GmbH & Co KG Merck Sharp & Dohme (UK) Ltd UK MHRA expanded indications of the drug in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy) for the treatment of FIGO 2014 Stage III to IVA locally advanced cervical cancer in adults who have not received prior definitive therapy Keytruda Biologic API
BSP Pharmaceuticals SpA Takeda Pharma AS NICE recommended the drug plus doxorubicin, dacarbazine and vinblastine, within its marketing authorisation, as an option for untreated stage 3 or 4 CD30‑positive Hodgkin lymphoma in adults. It can only be used if the company provides it according to the commercial arrangement Adcetris Biologic API; Parenteral manufacture & packaging
Catalent Inc Neurelis Inc FDA expanded indications 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 Sterile liquid manufacture
Catalent Inc BriaCell Therapeutics Corp Positive Phase III Interim results to evaluate the overall survival, safety and tolerability of drug regimen in combination with checkpoint inhibitor Retifanlimab-dlwr)], versus treatment of patients'/physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) subjects Bria-IMT Parenteral packaging
Catalent Micron Technologies Ltd Bristol-Myers Squibb Co FDA expanded indications of the drug for the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment Eliquis Sprinkle Small mol API
Delpharm SAS Takeda Pharma AS NICE recommended the drug plus doxorubicin, dacarbazine and vinblastine, within its marketing authorisation, as an option for untreated stage 3 or 4 CD30‑positive Hodgkin lymphoma in adults. It can only be used if the company provides it according to the commercial arrangement Adcetris Parenteral manufacture & packaging
Divi's Laboratories Ltd Merck Sharp & Dohme (UK) Ltd NICE recommended the drug as an option for treating mild to moderate COVID‑19 in adults who have a positive SARS‑CoV‑2 test, only if they have 1 or more risk factors for progression to severe COVID‑19 (as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab and tocilizumab for treating COVID-19) and both nirmatrelvir plus ritonavir and sotrovimab are contraindicated or unsuitable Lagevrio Small mol API
Dottikon Exclusive Synthesis AG AstraZeneca Plc NICE recommended the drug with pemetrexed and platinum-based chemotherapy, within its marketing authorisation, as an option for untreated advanced non-small-cell lung cancer (NSCLC) in adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. Drug with pemetrexed and platinum-based chemotherapy is only recommended if the company provides it according to the commercial arrangement Tagrisso Small mol API
Esteve Quimica SA Pfizer Inc NICE recommended the drug plus ritonavir as an option for treating COVID‑19 in adults, only if they do not need supplemental oxygen for COVID‑19 and have an increased risk for progression to severe COVID‑19, as defined in section 5 Paxlovid Small mol API
Excella GmbH & Co KG Gedeon Richter (UK) Ltd NICE recommended the drug, within its marketing authorisation, as an option for treating symptoms of endometriosis in adults of reproductive age who have had medical or surgical treatment for endometriosis Ryeqo Small mol API
Fareva SA Takeda Pharma AS NICE recommended the drug plus doxorubicin, dacarbazine and vinblastine, within its marketing authorisation, as an option for untreated stage 3 or 4 CD30‑positive Hodgkin lymphoma in adults. It can only be used if the company provides it according to the commercial arrangement Adcetris Parenteral manufacture & packaging
Gland Pharma Ltd Avyxa Pharma LLC FDA expanded indications of the drug in pediatric patients 1 month to less than 17 years of age for prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy Posfrea Parenteral manufacture
Hetero Drugs Ltd Pfizer Inc NICE recommended the drug plus ritonavir as an option for treating COVID‑19 in adults, only if they do not need supplemental oxygen for COVID‑19 and have an increased risk for progression to severe COVID‑19, as defined in section 5 Paxlovid Small mol API; Solid dose manufacture
Janssen-Cilag SpA Merck Serono Ltd NICE recommended the drug as an option for treating active relapsing forms of multiple sclerosis in adults, only if they have active relapsing–remitting multiple sclerosis, and when high-efficacy disease-modifying therapies would be offered Mavenclad Small mol API
Jetpharma SA Bristol-Myers Squibb Co FDA expanded indications of the drug for the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment Eliquis Sprinkle Small mol API
Jilin Asymchem Laboratories Co Ltd Pfizer Inc NICE recommended the drug plus ritonavir as an option for treating COVID‑19 in adults, only if they do not need supplemental oxygen for COVID‑19 and have an increased risk for progression to severe COVID‑19, as defined in section 5 Paxlovid Small mol API
KBI Biopharma Inc BriaCell Therapeutics Corp Positive Phase III Interim results to evaluate the overall survival, safety and tolerability of drug regimen in combination with checkpoint inhibitor Retifanlimab-dlwr)], versus treatment of patients'/physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) subjects Bria-IMT Biologic API
Lonza Group Ltd AstraZeneca Plc NICE recommended the drug with pemetrexed and platinum-based chemotherapy, within its marketing authorisation, as an option for untreated advanced non-small-cell lung cancer (NSCLC) in adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. Drug with pemetrexed and platinum-based chemotherapy is only recommended if the company provides it according to the commercial arrangement Tagrisso Small mol API
Lonza Group Ltd Takeda Pharma AS NICE recommended the drug plus doxorubicin, dacarbazine and vinblastine, within its marketing authorisation, as an option for untreated stage 3 or 4 CD30‑positive Hodgkin lymphoma in adults. It can only be used if the company provides it according to the commercial arrangement Adcetris Biologic API
MilliporeSigma GlaxoSmithKline UK Ltd UK MHRA expanded indications of the drug for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide Blenrep Biologic API
NerPharMa Srl Merck Serono Ltd NICE recommended the drug as an option for treating active relapsing forms of multiple sclerosis in adults, only if they have active relapsing–remitting multiple sclerosis, and when high-efficacy disease-modifying therapies would be offered Mavenclad Solid dose manufacture & packaging
Nortec Quimica SA Pfizer Inc NICE recommended the drug plus ritonavir as an option for treating COVID‑19 in adults, only if they do not need supplemental oxygen for COVID‑19 and have an increased risk for progression to severe COVID‑19, as defined in section 5 Paxlovid Small mol API
Novartis AG Roche Products Ltd NICE recommended the drug within its marketing authorisation, as an option for treating COVID‑19 in adults who are having systemic corticosteroids and need supplemental oxygen or mechanical ventilation. Drug is only recommended if the companies provide it according to the commercial arrangement Roactemra Biologic API
Novex Innovations LLC Protara Therapeutics Inc Positive Phase II Interim results to investigate the safety and anti-tumor activity of intravesical instillation of drug in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1) TARA-002 Biologic API
Novo Nordisk AS Sanofi-Aventis US LLC FDA expanded indications of the drug for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment Dupixent Parenteral manufacture & packaging
Novo Nordisk AS Bristol-Myers Squibb Co FDA expanded indications of the drug for the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment Eliquis Sprinkle Solid dose manufacture & packaging
Organon & Co Merck Sharp & Dohme (UK) Ltd UK MHRA expanded indications of the drug in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy) for the treatment of FIGO 2014 Stage III to IVA locally advanced cervical cancer in adults who have not received prior definitive therapy Keytruda Parenteral manufacture & packaging
Patheon NV Pfizer Inc NICE recommended the drug plus ritonavir as an option for treating COVID‑19 in adults, only if they do not need supplemental oxygen for COVID‑19 and have an increased risk for progression to severe COVID‑19, as defined in section 5 Paxlovid Solid dose manufacture
Patheon NV Merck Sharp & Dohme (UK) Ltd NICE recommended the drug as an option for treating mild to moderate COVID‑19 in adults who have a positive SARS‑CoV‑2 test, only if they have 1 or more risk factors for progression to severe COVID‑19 (as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab and tocilizumab for treating COVID-19) and both nirmatrelvir plus ritonavir and sotrovimab are contraindicated or unsuitable Lagevrio Small mol API; Solid dose manufacture
Patheon NV Gedeon Richter (UK) Ltd NICE recommended the drug, within its marketing authorisation, as an option for treating symptoms of endometriosis in adults of reproductive age who have had medical or surgical treatment for endometriosis Ryeqo Solid dose manufacture
PCI Pharma Services Pfizer Inc NICE recommended the drug plus ritonavir as an option for treating COVID‑19 in adults, only if they do not need supplemental oxygen for COVID‑19 and have an increased risk for progression to severe COVID‑19, as defined in section 5 Paxlovid Solid dose packaging
PCI Pharma Services Gedeon Richter (UK) Ltd NICE recommended the drug, within its marketing authorisation, as an option for treating symptoms of endometriosis in adults of reproductive age who have had medical or surgical treatment for endometriosis Ryeqo Solid dose packaging
PCI Pharma Services Janssen-Cilag International NV EMA expanded indications of the drug for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment and for the  treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment Tremfya Parenteral packaging
PCI Pharma Services Recordati Rare Diseases Inc FDA expanded indications of the drug for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative Isturisa Solid dose manufacture
Pharmaceutical Manufacturing Research Services Inc Cingulate Inc Positive Phase I top-line results to assess the effect of food on the bioavailability of drug of the highest dose in healthy adult subjects dexmethylphenidate hydrochloride Solid dose manufacture
Piramal Pharma Solutions Inc Takeda Pharma AS NICE recommended the drug plus doxorubicin, dacarbazine and vinblastine, within its marketing authorisation, as an option for untreated stage 3 or 4 CD30‑positive Hodgkin lymphoma in adults. It can only be used if the company provides it according to the commercial arrangement Adcetris Biologic API
R-Pharm Merck Serono Ltd NICE recommended the drug as an option for treating active relapsing forms of multiple sclerosis in adults, only if they have active relapsing–remitting multiple sclerosis, and when high-efficacy disease-modifying therapies would be offered Mavenclad Solid dose manufacture & packaging
Samsung Biologics Co Ltd GlaxoSmithKline UK Ltd NICE recommended the drug as an option for treating COVID‑19 in adults and young people aged 12 years and over and weighing at least 40 kg, only if they do not need supplemental oxygen for COVID‑19 and they have an increased risk for progression to severe COVID‑19, as defined in section 5 and nirmatrelvir plus ritonavir is contraindicated or unsuitable. Drug is only recommended if the company provides it according to the commercial arrangement Xevudy Biologic API
Samsung Biologics Co Ltd Roche Products Ltd NICE recommended the drug within its marketing authorisation, as an option for treating COVID‑19 in adults who are having systemic corticosteroids and need supplemental oxygen or mechanical ventilation. Drug is only recommended if the companies provide it according to the commercial arrangement Roactemra Biologic API
Sharp Packaging Services LLC Pfizer Inc NICE recommended the drug plus ritonavir as an option for treating COVID‑19 in adults, only if they do not need supplemental oxygen for COVID‑19 and have an increased risk for progression to severe COVID‑19, as defined in section 5 Paxlovid Solid dose packaging
Sharp Packaging Services LLC Merck Sharp & Dohme (UK) Ltd NICE recommended the drug as an option for treating mild to moderate COVID‑19 in adults who have a positive SARS‑CoV‑2 test, only if they have 1 or more risk factors for progression to severe COVID‑19 (as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab and tocilizumab for treating COVID-19) and both nirmatrelvir plus ritonavir and sotrovimab are contraindicated or unsuitable Lagevrio Solid dose packaging
Siegfried Holding AG Takeda Austria GmbH EMA expanded indications of the drug for replacement therapy in adults, children and adolescents (0 to 18 years) in primary immunodeficiency syndromes (PID) with impaired antibody production, secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) or serum IgG level of < 4 g/L and for immunomodulation in adults, children and adolescents (0 to 18 years) in primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count, guillain Barre syndrome, kawasaki disease (in conjunction with acetylsalicylic acid), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), multifocal Motor Neuropathy (MMN) Deqsiga Parenteral manufacture
Siegfried Holding AG Bristol-Myers Squibb Co FDA expanded indications of the drug for the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment Eliquis Sprinkle Small mol API
Simtra US LLC Takeda Austria GmbH EMA expanded indications of the drug for replacement therapy in adults, children and adolescents (0 to 18 years) in primary immunodeficiency syndromes (PID) with impaired antibody production, secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) or serum IgG level of < 4 g/L and for immunomodulation in adults, children and adolescents (0 to 18 years) in primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count, guillain Barre syndrome, kawasaki disease (in conjunction with acetylsalicylic acid), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), multifocal Motor Neuropathy (MMN) Deqsiga Parenteral manufacture
Simtra US LLC GlaxoSmithKline UK Ltd UK MHRA expanded indications of the drug for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide Blenrep Parenteral manufacture & packaging
SK Pharmteco Inc Arvelle Therapeutics Netherlands B.V NICE recommended the drug as an option as an add-on treatment for focal onset seizures with or without secondary generalised seizures in adults with drug-resistant epilepsy that has not been adequately controlled with at least 2 antiseizure medicines. It is recommended only as a second-line add-on treatment if it is used after at least 1 first-line add-on treatment has not controlled seizures, and other first-line add-on treatments are contraindicated or not tolerated, and treatment is started by a healthcare professional with expertise in epilepsy, after which treatment can be continued in primary care Ontozry Small mol API
SK Pharmteco Inc Merck Sharp & Dohme (UK) Ltd NICE recommended the drug as an option for treating mild to moderate COVID‑19 in adults who have a positive SARS‑CoV‑2 test, only if they have 1 or more risk factors for progression to severe COVID‑19 (as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab and tocilizumab for treating COVID-19) and both nirmatrelvir plus ritonavir and sotrovimab are contraindicated or unsuitable Lagevrio Small mol API
Societal CDMO Inc Cingulate Inc Positive Phase I top-line results to assess the effect of food on the bioavailability of drug of the highest dose in healthy adult subjects dexmethylphenidate hydrochloride Solid dose manufacture
Sterling Pharma Solutions Ltd Merck Sharp & Dohme (UK) Ltd NICE recommended the drug as an option for treating mild to moderate COVID‑19 in adults who have a positive SARS‑CoV‑2 test, only if they have 1 or more risk factors for progression to severe COVID‑19 (as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab and tocilizumab for treating COVID-19) and both nirmatrelvir plus ritonavir and sotrovimab are contraindicated or unsuitable Lagevrio Small mol API
Vetter Pharma-Fertigung GmbH & Co KG Roche Products Ltd NICE recommended the drug within its marketing authorisation, as an option for treating COVID‑19 in adults who are having systemic corticosteroids and need supplemental oxygen or mechanical ventilation. Drug is only recommended if the companies provide it according to the commercial arrangement Roactemra Parenteral manufacture & packaging
Vetter Pharma-Fertigung GmbH & Co KG Janssen Biotech Inc FDA approval of the drug for the treatment of generalized myasthenia gravis in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive Imaavy Parenteral manufacture & packaging
WuXi Biologics Co Ltd GlaxoSmithKline UK Ltd NICE recommended the drug as an option for treating COVID‑19 in adults and young people aged 12 years and over and weighing at least 40 kg, only if they do not need supplemental oxygen for COVID‑19 and they have an increased risk for progression to severe COVID‑19, as defined in section 5 and nirmatrelvir plus ritonavir is contraindicated or unsuitable. Drug is only recommended if the company provides it according to the commercial arrangement Xevudy Biologic API
WuXi Biologics Co Ltd Janssen Biotech Inc FDA approval of the drug for the treatment of generalized myasthenia gravis in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive Imaavy Parenteral manufacture & packaging
WuXi STA (Shanghai) Co Ltd Pasithea Therapeutics Corp Positive Phase I Interim results to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of drug, in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1, or RAF mutation or patients who have failed BRAF/MEK inhibition PAS-004 Small mol API
WuXi XDC Cayman Inc Pfizer Inc NICE recommended the drug plus ritonavir as an option for treating COVID‑19 in adults, only if they do not need supplemental oxygen for COVID‑19 and have an increased risk for progression to severe COVID‑19, as defined in section 5 Paxlovid Small mol API
WuXi XDC Cayman Inc Janssen Biotech Inc FDA approval of the drug for the treatment of generalized myasthenia gravis in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive Imaavy Parenteral manufacture & packaging

POTENTIALLY NEGATIVE

NUVISAN Pharma Holding GmbH Celltrion Healthcare Hungary Kft EMA withdrawal/discontinuation at the MAH's request Regkirona Parenteral manufacture
Sharp Packaging Services LLC BeiGene Ltd NICE is unable to make a recommendation on drug in combination for untreated advanced non-small-cell lung cancer in adults. This is because the company did not provide an evidence submission Tevimbra Parenteral 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