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

BREYANZI has significant market potential due to its innovative approach as a CD19-directed chimeric antigen receptor (CAR) T-cell therapy. The growing prevalence of hematologic malignancies and increasing adoption of CAR-T therapies, along with BREYANZI's promising efficacy and safety profile, position it for strong demand.

LAS VEGAS, March 11, 2025 /PRNewswire/ -- DelveInsight's 'BREYANZI Market Size, Forecast, and Market Insight Report' highlights the details around BREYANZI, a CD19-directed CAR T-cell therapy with a 4-1BB co-stimulatory domain, which enhances the expansion and persistence of the CAR T cells. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of BREYANZI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

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 

• In February 2025, Bristol Myers Squibb reported that the Phase 2 TRANSCEND FL trial assessing BREYANZI in adults with relapsed or refractory indolent B-cell non-Hodgkin lymphoma achieved its primary endpoint in the marginal zone lymphoma (MZL) cohort. The findings revealed that Breyanzi delivered a statistically significant and clinically meaningful overall response rate (ORR) in these patients.
• In January 2025, Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended approving BREYANZI for adult patients with relapsed or refractory follicular lymphoma who have undergone at least two previous systemic therapies. The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use across the European Union (EU).
• In November 2024, Bristol Myers Squibb presented long-term analyses reinforcing the durable efficacy and well-established safety profile of BREYANZI in LBCL and new ctDNA data from the Phase III TRANSFORM study supporting the superiority of BREYANZI to achieve deeper responses over the former standard of care in second-line LBCL at ASH 2024.
• In May 2024, Bristol Myers Squibb announced that the FDA has approved BREYANZI for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have undergone at least two previous systemic treatments, including a Bruton tyrosine kinase (BTK) inhibitor.
• In May 2024, Bristol Myers Squibb announced that the FDA had granted accelerated approval for BREYANZI to treat adult patients with relapsed or refractory follicular lymphoma who have undergone at least two previous systemic therapies.
• In March 2024, Bristol Myers Squibb announced that the FDA had granted accelerated approval for BREYANZI for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have undergone at least two prior treatments, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
• In May 2023, Bristol Myers Squibb announced that the EC had granted approval for BREYANZI for the treatment of adult patients with DLBCL, HGBCL, PMBCL, and follicular lymphoma Grade 3B who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
• In June 2022, Bristol Myers Squibb announced that the FDA had approved BREYANZI (lisocabtagene maraleucel) for the treatment of adult patients with LBCL, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), HGBCL, primary mediastinal large B-cell lymphoma, and follicular lymphoma Grade 3B for the patients who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for HSCT due to comorbidities or age.
• In June 2022, Bristol Myers Squibb announced that the EMA had validated its Type II variation application for an extension of the indication for BREYANZI. The extension is to treat adult patients with DLBCL, HGBCL, PMBCL, and follicular lymphoma Grade 3B who are refractory or have relapsed within 12 months of initial therapy and are candidates for HSCT.
• In April 2022, Bristol Myers Squibb announced that the EC had granted marketing authorization for BREYANZI (for the treatment of adult patients with R/R DLBCL, PMBCL, and follicular lymphoma Grade 3B after two or more lines of systemic therapy. The Marketing Authorization approves BREYANZI for use in all EU member states.
• In March 2022, Bristol Myers Squibb announced that the MHLW had accepted the supplemental New Drug Application for BREYANZI for the second-line treatment of patients with R/R LBCL. BREYANZI is not approved in any region for the second-line treatment of LBCL (Bristol Myers Squibb, 2022b). This is the first CAR T-cell therapy application filed for the second-line treatment of R/R LBCL in Japan.
• In March 2021, Bristol Myers Squibb announced that Japan's MHLW approved BREYANZI for the treatment of patients with R/R LBCL and R/R follicular lymphoma.
• In February 2021, Bristol Myers Squibb announced that the FDA had approved BREYANZI (lisocabtagene maraleucel; liso-cel) for the treatment of adult patients with R/R LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma Grade 3B.
• In November 2019, Bristol Myers Squibb completed the acquisition of US-based biotechnology company Celgene in a cash-cum-stock deal worth around USD 74 billion. With the closing of the acquisition, Celgene became a wholly owned subsidiary of Bristol Myers Squibb. Under the deal, Celgene shareholders secured a 1.00 share of BMS common stock and USD 50 in cash without interest. As per the terms of this agreement, Celgene also gained full global rights to JCAR017. At the time of the agreement, Celgene was expecting the addition of JCAR017 and other cellular immunotherapy products in Juno's pipeline to accelerate revenue diversification with meaningful growth drivers from 2020 and beyond.
• In October 2017, lisocabtagene maraleucel was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA for DLBCL.
• In April 2016, lisocabtagene maraleucel was granted ODD in the US and the EU (July 2017) for treating DLBCL.

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

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