BREYANZI Market Summary

Key Factors Driving BREYANZI Growth

1. Rapid expansion across multiple B-cell malignancies:

BREYANZI has evolved from a primarily large B-cell lymphoma (LBCL) therapy into a broader CAR-T franchise. The FDA currently lists indications covering LBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and marginal zone lymphoma (MZL). Notably, FDA approved BREYANZI for MZL in December 2025 as the first CAR-T therapy approved for this indication in the US, while the CLL/SLL indication was added in March 2024. This expansion materially increases the number of eligible patients and provides multiple avenues for revenue growth.

2. Strong positioning in second-line LBCL:

Earlier-line use is an important growth driver because BREYANZI is approved for adults with LBCL whose disease is refractory to first-line chemoimmunotherapy or relapses within 12 months, as well as certain patients who are not candidates for hematopoietic stem-cell transplantation. In the Phase III TRANSFORM study, three-year follow-up showed median event-free survival of 29.5 months with BREYANZI versus 2.4 months with standard of care, with 36-month progression-free survival of 51% versus 26.5%. This evidence supports continued movement of CAR-T therapy into earlier treatment settings rather than restricting it to heavily pretreated patients.

3. Durable long-term efficacy strengthens physician adoption:

Five-year TRANSCEND NHL 001 data provide evidence of durable benefit in relapsed/refractory LBCL. Among efficacy-evaluable patients, estimated 5-year overall survival was 38%, while disease-specific survival was 52%. In the long-term follow-up population that remained alive and entered the dedicated follow-up study, estimated 5-year overall and disease-specific survival were 78% and 92%, respectively. Although the latter subgroup is highly selected and should not be generalized to all treated patients, these data support the potential for long-lasting remission following a single infusion.

4. High response rates in follicular lymphoma provide a significant additional growth opportunity:

BREYANZI's FL expansion is supported by impressive TRANSCEND FL results. In patients treated in the third-line-plus setting, the overall response rate was 97.1%, with a 94.2% complete-response rate; 75.7% remained in response at 18 months. The European Commission subsequently expanded BREYANZI's approval to relapsed/refractory FL after ≥2 systemic therapies in March 2025. In the U.S., the FDA converted the accelerated FL approval to traditional approval in February 2026, providing an additional regulatory validation of clinical benefit.

5. Expansion into MCL and MZL creates newer commercial opportunities:

BREYANZI's MCL indication is another important growth avenue, particularly in patients who have progressed after a BTK inhibitor. In TRANSCEND MCL, 82.7% of patients responded and 71.6% achieved complete response, with 41.2% remaining in response at 24 months according to the European label. The December 2025 FDA approval in MZL adds another CAR-T indication with limited existing cellular-therapy competition. These newer indications can gradually contribute to revenue as treatment centers gain experience and referral pathways develop.

BREYANZI Recent Developments

In December 2025, Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) granted approval of BREYANZI (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. BREYANZI is administered as a one-time infusion*. Please see the Important Safety Information section below, including Boxed WARNINGS for BREYANZI regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies.

“BREYANZI Sales Forecast, and Market Size Analysis – 2034” report provides comprehensive insights of BREYANZI for approved indication like Chronic lymphocytic leukaemia, Diffuse large B cell lymphoma, and Follicular lymphoma; as well as potential indication like Non-Hodgkin’s lymphoma, B-cell lymphoma, Hodgkin’s disease, Lymphoma, and Precursor B-cell lymphoblastic leukaemia-lymphoma in the 7MM. A detailed picture of BREYANZI’s existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 –2034 is provided in this report along with a detailed description of the BREYANZI for approved and potential indications. The BREYANZI market report provides insights about BREYANZI’s sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current BREYANZI performance, future market assessments inclusive of the BREYANZI market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of BREYANZI sales forecasts, along with factors driving its market.

BREYANZI Drug Summary

BREYANZI is an autologous chimeric antigen receptor (CAR) T-cell therapy developed by Bristol Myers Squibb for the treatment of certain relapsed or refractory B-cell malignancies. It is a genetically modified cellular immunotherapy that targets CD19, a protein expressed on the surface of malignant and normal B cells. The treatment involves collecting the patient's own T cells through leukapheresis, genetically modifying them to express a CD19-directed CAR, expanding the engineered cells ex vivo, and reinfusing them into the patient following lymphodepleting chemotherapy. BREYANZI is distinguished by its defined composition of CD8-positive and CD4-positive CAR T-cell components, which are separately manufactured and administered at a specified ratio. Following intravenous infusion, the engineered T cells recognize CD19-expressing cancer cells, triggering T-cell activation, proliferation, and targeted tumor-cell destruction. The report provides BREYANZI’s sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the BREYANZI Market Report

The report provides insights into:

• A comprehensive product overview including the BREYANZI MoA, description, dosage and administration, research and development activities in approved indications like Chronic lymphocytic leukaemia, Diffuse large B cell lymphoma, and Follicular lymphoma; as well as potential indication like Non-Hodgkin’s lymphoma, B-cell lymphoma, Hodgkin’s disease, Lymphoma, and Precursor B-cell lymphoblastic leukaemia-lymphoma.
• Elaborated details on BREYANZI regulatory milestones and other development activities have been provided in BREYANZI market report.
• The report also highlights BREYANZI‘s cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
• The BREYANZI market report also covers the patents information, generic entry and impact on cost cut.
• The BREYANZI market report contains current and forecasted BREYANZI sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The BREYANZI market report also features the SWOT analysis with analyst views for BREYANZI in approved and potential indications.

Methodology

The BREYANZI market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

BREYANZI Analytical Perspective by DelveInsight

• In-depth BREYANZI Market Assessment

This BREYANZI sales market forecast report provides a detailed market assessment of BREYANZI for approved indication like Chronic lymphocytic leukaemia, Diffuse large B cell lymphoma, and Follicular lymphoma; as well as potential indication like Non-Hodgkin’s lymphoma, B-cell lymphoma, Hodgkin’s disease, Lymphoma, and Precursor B-cell lymphoblastic leukaemia-lymphoma in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted BREYANZI sales data uptil 2034.

• BREYANZI Clinical Assessment

The BREYANZI market report provides the clinical trials information of BREYANZI for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

BREYANZI Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

BREYANZI Market Potential & Revenue Forecast

• Projected market size for the BREYANZI and its key indications
• Estimated BREYANZI sales potential (BREYANZI peak sales forecasts)
• BREYANZI Pricing strategies and reimbursement landscape

BREYANZI Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• BREYANZI Market positioning compared to existing treatments
• BREYANZI Strengths & weaknesses relative to competitors

BREYANZI Regulatory & Commercial Milestones

• BREYANZI Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

BREYANZI Clinical Differentiation

• BREYANZI Efficacy & safety advantages over existing drugs
• BREYANZI Unique selling points

BREYANZI Market Report Highlights

• In the coming years, the BREYANZI market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The BREYANZI companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence BREYANZI’s dominance.
• Other emerging products for Chronic lymphocytic leukaemia, Diffuse large B cell lymphoma, and Follicular lymphoma; as well as potential indication like Non-Hodgkin’s lymphoma, B-cell lymphoma, Hodgkin’s disease, Lymphoma, and Precursor B-cell lymphoblastic leukaemia-lymphoma are expected to give tough market competition to BREYANZI and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of BREYANZI in approved and potential indications.
• Analyse BREYANZI cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted BREYANZI sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of BREYANZI in approved and potential indications.

Key Questions

• What is the class of therapy, route of administration and mechanism of action of BREYANZI? How strong is BREYANZI’s clinical and commercial performance?
• What is BREYANZI’s clinical trial status in each individual indications such as Chronic lymphocytic leukaemia, Diffuse large B cell lymphoma, and Follicular lymphoma; as well as potential indication like Non-Hodgkin’s lymphoma, B-cell lymphoma, Hodgkin’s disease, Lymphoma, and Precursor B-cell lymphoblastic leukaemia-lymphoma and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the BREYANZI Manufacturers?
• What are the key designations that have been granted to BREYANZI for approved and potential indications? How are they going to impact BREYANZI’s penetration in various geographies?
• What is the current and forecasted BREYANZI market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of BREYANZI in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to BREYANZI for approved and potential indications?
• Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
• How cost-effective is BREYANZI? What is the duration of therapy and what are the geographical variations in cost per patient?