BREYANZI Demonstrates Continued Growth in the Competitive CAR-T Market | DelveInsight

Bristol Myers Squibb's BREYANZI (lisocabtagene maraleucel) Overview

BREYANZI is a CD19-targeting CAR T cell therapy that incorporates a 4-1BB costimulatory domain, which supports the expansion and longevity of CAR T cells. It is developed using a patient's own T cells, which are collected, genetically modified, and then infused as a one-time treatment. 

In the U.S., BREYANZI is approved for treating relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior therapy, as well as relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after two or more prior therapies. Additionally, it is approved for adults with relapsed or refractory follicular lymphoma who have undergone at least two prior systemic therapies and for relapsed or refractory mantle cell lymphoma in patients previously treated with at least two systemic therapies, including a Bruton tyrosine kinase (BTK) inhibitor. 

Internationally, BREYANZI is authorized in Japan and Europe for second-line treatment of relapsed or refractory LBCL. It is also approved in Japan, Europe, Switzerland, and Canada for LBCL that has relapsed or remains refractory after two or more systemic therapies. In Japan, it is further approved for high-risk follicular lymphoma patients who have relapsed or are refractory after one prior systemic therapy, as well as for those who have undergone two or more lines of treatment.

In 2024, BREYANZI generated sales of USD 747 million, spanning DLBCL, follicular lymphoma, CLL/SLL, and MCL. Currently, BMS is evaluating BREYANZI in phase II trials for Relapsed/Refractory Marginal Zone Lymphoma.

Learn more about BREYANZI projected market size in different approved indications @ BREYANZI Market Potential 

B-cell lymphoma is a group of hematologic malignancies originating from B lymphocytes, which play a crucial role in the immune system. It encompasses various subtypes, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, and mantle cell lymphoma (MCL), each with distinct clinical behaviors and prognoses. While some subtypes, like follicular lymphoma, are indolent and progress slowly, others, such as DLBCL, are aggressive and require immediate treatment. 

The global incidence of B-cell lymphoma has been rising, with risk factors including genetic predisposition, infections (e.g., Epstein-Barr virus), and immunosuppression. Patients often present with symptoms like painless lymphadenopathy, night sweats, fever, and weight loss, which can significantly impact their quality of life. 

The treatment landscape for B-cell lymphoma has evolved significantly, improving survival rates but still presenting substantial challenges. Standard frontline therapies include chemoimmunotherapy regimens such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) for aggressive forms like DLBCL. Indolent subtypes may be managed with watchful waiting or targeted therapies like Bruton's tyrosine kinase (BTK) inhibitors and monoclonal antibodies. 

Despite these advances, relapse and refractory disease remain major concerns, necessitating newer strategies such as CAR-T cell therapy, bispecific antibodies, and ADCs. However, access to these innovative treatments varies globally, contributing to disparities in patient outcomes. The economic burden of B-cell lymphoma is also considerable, with high treatment costs, prolonged hospital stays, and long-term supportive care needs, underscoring the need for more effective and accessible therapies.

DelveInsight has expertise in the oncology market with an experienced team handling the oncology domain proficiently. DelveInsight has released a series of epidemiology-based market reports on Diffuse Large B-cell Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, and Marginal Zone Lymphoma, among others. These reports include a comprehensive understanding of current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Gain deeper insights into these indications with a customized report tailored to your needs. Connect with us today—our experts are ready to assist you!

Emerging Competitors of BREYANZI

The DLBCL pipeline is very robust with key companies such as Roche (Genentech)/Biogen (LUNSUMIO (mosunetuzumab)), Nektar Therapeutics (NKTR-255 + CD19 CAR-T cell therapy), Merck (Zilovertamab vedotin), Allogene Therapeutics (Cemacabtagene ansegedleucel), Miltenyi Biomedicine (Zamtocabtagene autoleucel (MB-CART2019.1)), AstraZeneca (AZD0486, CALQUENCE (acalabrutinib)), BioVaxys/ImmunoVaccine Technologies (Maveropepimut-S), Cellectar Biosciences (Iopofosine I 131 (CLR 131)), Galapagos (GLPG5101), Novartis (Rapcabtagene Autoleucel (YTB323)), Lyell/ImmPACT Bio (IMPT-314), Pfizer (Maplirpacept (PF-07901801)), Kartos Therapeutics (Navtemadlin (KRT-232)), 2seventy bio/Regeneron Pharmaceuticals (bbT369), BeiGene (BGB-16673), Ranok Therapeutics (RNK05047), Constellation Pharmaceuticals (Tulmimetostat (CPI-0209)), Genmab (GEN3014), IDP Discovery Pharma S.L. (IDP-121), Immunitas Therapeutics (IMT-009), Monte Rosa Therapeutics (MRT-2359), SymBio Pharmaceuticals (Brincidofovir (SyB V-1901)), AVM Biotechnology (AVM0703), Autolus Therapeutics (Obecabtagene Autoleucel (Obe-cel), AUTO3), Kymera Therapeutics (KT-413), Otsuka Pharmaceutical (OPB-111077), Caribou Biosciences (CB-010), Adicet Bio (ADI-001), Gilead Sciences (KITE-197, KITE-363, KITE-753, KITE-197) Xynomic Pharmaceuticals (Abexinostat), Amgen (KYPROLIS (Carfilzomib)), and others involved in developing drugs. 

The key market players of developing therapies for follicular lymphoma include, Merck Sharp and Dohme (Zilovertamab Vedotin), AstraZeneca (CALQUENCE (Acalabrutinib, AZD0486)), CRISPR Therapeutics (CTX112), BeiGene (BGB-16673), Nektar Therapeutics (NKTR-255), NovalGen (NVG-111), Carna Biosciences (AS-1763 (docirbrutinib)), Allogene Therapeutics (Cemacabtagene Ansegedleucel (ALLO-501)), Xynomic Pharmaceuticals (Abexinostat), Incyte Corporation (MONJUVI (tafasitamab)), and others.

In the chronic lymphocytic leukemia space, the key emerging BREYANZI competitors include nemtabrutinib (Merck), lisaftoclax (Ascentage Pharma), sonrotoclax (BeiGene), JNJ-64264681/JNJ-4681 (Johnson & Johnson), and others. 

To know more about the number of competing drugs in development, visit @ BREYANZI Market Positioning Compared to Other Drugs

Key Milestones of BREYANZI 

Discover how BREYANZI is shaping the B-cell lymphoma treatment landscape @ BREYANZI Indications

BREYANZI Market Dynamics

BREYANZI (lisocabtagene maraleucel), a CD19-directed CAR-T cell therapy developed by Bristol Myers Squibb, is a key player in the evolving market for cell-based immunotherapies. Approved for relapsed or refractory large B-cell lymphoma (LBCL) and other hematologic malignancies, BREYANZI competes in a growing but increasingly competitive segment alongside other CAR-T therapies like YESCARTA (Gilead/Kite) and KYMRIAH (Novartis). 

The therapy has gained traction due to its differentiated manufacturing process, which ensures a high level of consistency in CAR-T cell composition, potentially leading to improved efficacy and safety profiles. Additionally, its outpatient administration option gives it an edge over some competitors, enhancing its market appeal. 

The CAR-T therapy market is characterized by high treatment costs, complex logistics, and a constrained manufacturing capacity, which has historically limited patient access. However, BREYANZI has leveraged Bristol Myers Squibb's strong commercialization infrastructure to expand availability, with efforts focused on improving manufacturing turnaround times and increasing treatment centers. 

Reimbursement remains a key challenge as payers closely evaluate the cost-benefit balance of these high-priced therapies. Yet, ongoing clinical trials exploring label expansion into earlier lines of therapy and additional indications, such as chronic lymphocytic leukemia (CLL), could strengthen BREYANZI's market position and drive long-term growth. 

Competitive pressures are also intensifying with the emergence of next-generation CAR-T therapies and alternative modalities such as bispecific antibodies and allogeneic CAR-T cells, which promise lower costs and reduced manufacturing complexity. To sustain its market share, Bristol Myers Squibb is investing in real-world evidence studies and combination strategies to demonstrate superior efficacy and durability of response. Partnerships and collaborations with healthcare institutions are also crucial in expanding patient access and optimizing treatment pathways. 

Overall, the market dynamics of BREYANZI are shaped by a mix of strong clinical differentiation, evolving regulatory and reimbursement landscapes, and intensifying competition from both autologous and emerging off-the-shelf therapies. Future success will depend on how effectively Bristol Myers Squibb navigates these challenges while capitalizing on opportunities for market expansion and innovation.

Dive deeper to get more insight into BREYANZI's strengths & weaknesses relative to competitors @ BREYANZI Market Drug Report

Table of Contents

Related Reports

Diffuse Large B-cell Lymphoma Market

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