DelveInsight’s, “Monoclonal Antibodies Competitive landscape, 2025,” report provides comprehensive insights about 180+ companies and 230+ drugs in Monoclonal antibodies Competitive landscape. It covers the Monoclonal Antibodies pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
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Key Takeaways from the Monoclonal Antibodies Pipeline Report
- On 24 August 2025, Shanghai Henlius Biotech announced a phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
- On 20 August 2025, Implicit Bioscience conducted a study to evaluate the safety, exploratory efficacy, and pharmacokinetics of IC14 (atibuclimab) administered via a single IV infusion to patients with STEMI treated with percutaneous intervention. In additional to optional CCR2+ myocardial imaging, biomarkers, cardiac function and patient-reported outcome measures will be reported.
- DelveInsight’s Monoclonal Antibodies competitive landscape report depicts a robust space with 180+ active players working to develop 230+ pipeline therapies for Monoclonal Antibodies treatment.
- The leading Monoclonal Antibodies Companies such as Novartis, Gmax Biopharm, Omeros Corporation, Merck Sharp & Dohme, Disc Medicine, Eledon Pharmaceuticals, Alexion AstraZeneca Rare Disease, Chinook Therapeutics, Novo Nordisk, Merck KGaA, Bristol-Myers Squibb, Jacobio Pharmaceuticals and others.
- Promising Monoclonal Antibodies Pipeline Therapies such as Felzartamab, Daratumumab, HLX22, Pembrolizumab, Trastuzumab, BRII-196, BRII-198, KHK4083, CMAB007, Symbicort, Seretide and others.
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Monoclonal antibodies Marketed Therapies
- Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan. Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.
- OPDIVO
OPDIVO is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, OPDIVO has become an important treatment option across multiple cancers. OPDIVO’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. In July 2014, OPDIVO was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. OPDIVO is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s OPDIVO and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma. In March 2022, Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) approved OPDIVO (nivolumab) 360 mg (injection for intravenous use) in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients with resectable (tumors =4 cm or node positive) non-small cell lung cancer (NSCLC) in the neoadjuvant setting.
- GSK
GSK is a fully focused biopharma company. The company prioritize innovation in vaccines and specialty medicines, maximizing the increasing opportunities to prevent and treat disease. The R&D focus on the science of the immune system, human genetics and advanced technologies, and our world-leading capabilities in vaccines and medicines development. The company focuses on four therapeutic areas: infectious diseases, HIV, immunology/respiratory, and oncology.
- NUCALA
NUCALA (Mepolizumab) is an IL-5 antagonist (IgG1 kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Mepolizumab binds to IL-5 with a dissociation constant of 100 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface. Inflammation is an important component in the pathogenesis of asthma, CRSwNP, EGPA, and HES. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) are involved in inflammation. By inhibiting IL-5 signaling, Mepolizumab reduces the production and survival of eosinophils. Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils. It has been studied in over 4,000 patients in 41 clinical trials across a number of eosinophilic indications and has been approved under the brand name Nucala in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with SEA. It is approved for paediatric use in SEA from ages six to 17 in Europe, the US and several other markets. In the US, Japan, Canada and a number of other markets, it is approved for use in adult patients with EGPA. Mepolizumab was approved for use in HES in the US in September 2020, followed by Brazil in February 2021 and Argentina in May 2021. Currently, Mepolizumab is being evaluated in the Phase III to treat patients with chronic obstructive pulmonary disease and is in Phase II for the treatment of Eosinophilic oesophagitis.
Monoclonal antibodies Company and Pipeline Therapies
- Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world.
- Ianalumab
Ianalumab (VAY736) is a novel, defucosylated, human IgG1/? monoclonal antibody that targets the human B cell-activating factor (BAFF) of the TNF family. The BAFF receptor is predominantly expressed on B cells and is critically involved in B cell maturation, activation, and survival. VAY736 targets the BAFF receptor and competitively inhibits BAFF binding to BAFF-R, thereby blocking BAFF-R-mediated signaling in B cells. It is also engineered to effectively eliminate B cells from circulation in vivo by antibody-dependent cellular cytotoxicity (ADCC). ADCC activity of ianalumab is greatly enhanced by eliminating fucose residues from the carbohydrate moiety attached to the Fc part of the antibody. It is currently in Phase III clinical studies for the treatment of Sjögren’s Syndrome (SS), Lupus nephritis, Immune thrombocytopenia, Systemic lupus erythematosus, and warm autoimmune hemolytic anemia. Along with this, the molecule is also being studied in the Phase II development for the Idiopathic pulmonary fibrosis, Multiple sclerosis, and others.
- Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. The purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. They do so by pioneering scientific breakthroughs, expanding access to the medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 50,800 people in 80 countries and markets its products in around 170 countries.
- Ziltivekimab
Ziltivekimab is a proprietary anti-interleukin-6 ligand monoclonal antibody (anti-IL6 mAb), targeting residual inflammatory cardiovascular risk in patients living with advanced chronic kidney disease (CKD). Ziltivekimab is being developed a therapy intended to reduce the risk of major cardiovascular adverse events in chronic kidney disease (CKD) patients with atherosclerotic cardiovascular disease (ASCVD) and inflammation. Patients who are diagnosed with moderate to severe CKD and have ASCVD and inflammation are at risk for an adverse cardiovascular event at a high rate and there are no approved therapies to prevent this risk. The proinflammatory cytokine, interleukin-6 (IL-6) has been shown to be an independent, causal factor of ASCVD with evidence generated from human genetic studies and preclinical studies. The drug is being evaluated in Phase III stage of development to treat patients with moderate to severe chronic kidney disease.
- Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world.
- Iscalimab
Iscalimab (CFZ 533) is a novel, fully human IGg1 anti-CD40 monoclonal antibody, preventing cluster of differentiation (CD40) pathway signaling and activation of CD40+ cell types. This molecule is expressed on antigen-presenting cells, such as macrophages, dendritic cells, and B cells, while its ligand CD40L is expressed on activated T cells. CD40L induces activation of B cells, immunoglobulin class switch, plasma cell differentiation, as well as GC formation. It is being developed by Novartis and investigating this therapeutic molecule in the phase II stage of development to treat patients with Sjorgen’s Syndrome, Type 1 Diabetes mellitus, and Hidradenitis suppurativa, Graves' disease, Liver transplant rejection, and others.
- Disc Medicine
Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis.
- DISC-0974
DISC-0974 is an investigational monoclonal antibody (mAb) targeting a BMP-signaling co-receptor called hemojuvelin (HJV) and is designed to suppress hepcidin production and increase serum iron levels in patients suffering from anemia of inflammation. DISC-0974 was in-licensed by Disc from AbbVie in 2019. Anemia of inflammation arises from abnormally elevated hepcidin and is the most common form of anemia, affecting millions of patients in the US across numerous diseases such as chronic kidney disease, myelofibrosis, cancer, autoimmune diseases, and other conditions with an inflammatory component. Disc has established clinical proof-of-mechanism of DISC-0974 in a Phase I trial of healthy volunteers and initiated a Phase Ib/IIa clinical trial of DISC-0974 in patients with myelofibrosis and anemia, as well as a Phase Ib/IIa clinical trial of DISC-0974 in patients with chronic kidney disease and anemia who are not receiving dialysis.
- Chinook Therapeutics
Chinook Therapeutics, Inc. is a clinical-stage biotechnology company developing precision medicines for kidney diseases. The company’s pipeline is focused on rare, severe chronic kidney disorders with opportunities for well-defined and streamlined clinical pathways. Chinook’s lead program is atrasentan, an investigational endothelin receptor antagonist in development for the treatment of IgA nephropathy and other primary glomerular diseases. The company is also advancing a preclinical development candidate for an undisclosed ultra-orphan kidney disease and research programs for other rare, severe chronic kidney diseases, including polycystic kidney disease. Chinook seeks to build its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids and new translational models, to discover and develop therapeutics with mechanisms of action against key kidney disease pathways. Chinook is backed by leading healthcare investors, Versant Ventures, Apple Tree Partners, and Samsara BioCapital, and is based in Vancouver, British Columbia and Seattle, Washington.
- BION-1301
BION-1301, an investigational humanized IgG4 monoclonal antibody that blocks APRIL binding to both the BCMA and TACI receptors, is being evaluated in IgA nephropathy. Dosing of BION-1301 in non-human primates led to a significant reduction of blood IgA levels and established a favorable safety profile. Preclinical studies demonstrated that hAPRIL transgenic mice produce rising levels of IgA as well as IgA deposits in the kidney. Administration of mouse anti-human APRIL was shown to reduce levels of IgA in both the serum and the kidney. The safety and tolerability of BION-1301 were evaluated in a phase 1 trial in healthy volunteers. In healthy volunteers, BION-1301 was well-tolerated with no serious adverse events, a pharmacokinetic half-life of approximately 33 days and demonstrated dose-dependent pharmacodynamic effects characterized by durable reductions in serum levels of free APRIL, IgA, galactose-deficient IgA (Gd-IgA1) and IgM, with a lesser reduction in IgG. BION-1301 is currently being evaluated in a phase I/II clinical trial in patients with IgA nephropathy. Preliminary data from the first cohort of patients with IgA nephropathy demonstrated that BION-1301 has been well-tolerated to date, with no serious adverse events or treatment discontinuations due to adverse events. The pharmacokinetics of BION-1301 observed in patients with IgAN were consistent with those previously reported in healthy volunteers and sufficient to drive rapid and sustained reductions in free APRIL levels. BION-1301 durably reduced Gd-IgA1, IgA, IgM, and to a lesser extent, IgG levels in patients with IgAN. BION-1301 treatment resulted in proteinuria reductions within three months, which were sustained and continued to decline through one year in patients across a range of disease severity.
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Monoclonal antibodies Analytical Perspective by DelveInsight
In-depth Commercial Assessment: Monoclonal antibodies Collaboration Analysis by Companies
The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition – deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.
Monoclonal antibodies Competitive Landscape
The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).
Monoclonal antibodies Report Assessment
- Company Analysis
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
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Scope of the Monoclonal Antibodies Competitive Landscape Report
- Coverage- Global
- Monoclonal Antibodies Companies- Novartis, Gmax Biopharm, Omeros Corporation, Merck Sharp & Dohme, Disc Medicine, Eledon Pharmaceuticals, Alexion AstraZeneca Rare Disease, Chinook Therapeutics, Novo Nordisk, Merck KGaA, Bristol-Myers Squibb, Jacobio Pharmaceuticals and others.
- Monoclonal Antibodies Pipeline Therapies- Felzartamab, Daratumumab, HLX22, Pembrolizumab, Trastuzumab, BRII-196, BRII-198, KHK4083, CMAB007, Symbicort, Seretide and others.
- Monoclonal Antibodies Marketed Therapies and Pipeline Therapies
- Monoclonal Antibodies Preclinical and Discovery Stage Products, Unmet Needs
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Table of Content
- Introduction
- Executive Summary
- Monoclonal antibodies: Overview
- Monoclonal antibodies -Analytical Perspective: In-depth Commercial Assessment
- Competitive Landscape
- Therapeutic Assessment
- Monoclonal antibodies: Company and Product Profiles (Marketed Therapies)
- Bristol-Myers Squibb
- OPDIVO
- Monoclonal antibodies: Company and Product Profiles (Pipeline Therapies)
- Late Stage Products (Phase III)
- Novartis
- Ianalumab
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Novartis
- Iscalimab
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I/II)
- Chinook Therapeutics
- BION-1301
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Company Name
- Product Name
- Drug profiles in the detailed report…..
- Inactive Products
- Monoclonal antibodies- Unmet needs
- Monoclonal antibodies – Market drivers and barriers
- Appendix
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