BREYANZI Drug Profile

Summary for Tradename: BREYANZI

High Confidence Patents:	3
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for BREYANZI

Recent Clinical Trials for BREYANZI

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
NeoImmuneTech	PHASE1
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company	PHASE2
Washington University School of Medicine	PHASE1

See all BREYANZI clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for BREYANZI Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for BREYANZI Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Juno Therapeutics, Inc. A Bristol Myer-squibb Company	BREYANZI	lisocabtagene maraleucel	Injection	125714		2037-11-17	DrugPatentWatch analysis and company disclosures
Juno Therapeutics, Inc. A Bristol Myer-squibb Company	BREYANZI	lisocabtagene maraleucel	Injection	125714		2033-08-20	DrugPatentWatch analysis and company disclosures
Juno Therapeutics, Inc. A Bristol Myer-squibb Company	BREYANZI	lisocabtagene maraleucel	Injection	125714		2023-05-28	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for BREYANZI Derived from Patent Text Search

No patents found based on company disclosures

International Patents for BREYANZI

Country	Patent Number	Estimated Expiration
Spain	2842102
Denmark	2884999
Serbia	66657
South Korea	20220025161

Market Dynamics and Financial Trajectory for BREYANZI

Last updated: April 14, 2026

What is the current market position of BREYANZI?

BREYANZI (lisocabtagene maraleucel) is a CAR T-cell therapy approved by the FDA in February 2021 for relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. It is developed by Bristol-Myers Squibb (BMS). The therapy competes primarily with other approved CAR T-cell treatments: Kymriah (Novartis) and Yescarta (Gilead Sciences).

As of 2023, BREYANZI accounts for a growing share in the aggressive B-cell lymphoma market, driven by its efficacy, safety profile, and commercial strategy.

How large is the target market and what are growth projections?

The global B-cell lymphoma market was valued at approximately $7.8 billion in 2022 and is projected to reach $13.4 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of nearly 7.4% (Grand View Research). Approximately 35,000 new cases of LBCL are diagnosed annually in the U.S. alone.

CAR T-cell therapies are increasingly used after failure of initial treatments, which expands the therapeutic landscape. The approval of BREYANZI significantly broadens options for late-line therapy, especially in relapsed/refractory settings.

What are the key financial metrics and revenue prospects?

2022 Revenue and Market Share:
BMS reported approximately $280 million in global sales from BREYANZI in 2022, representing over 20% of the total CAR T-cell therapy market segment. The growth is driven by expanding indications, increased physician adoption, and healthcare infrastructure improvements.

Revenue Drivers:

• Expansion into earlier lines of therapy (pending approvals)
• Increased use in relapsed/refractory LBCL, diffuse large B-cell lymphoma (DLBCL)
• Geographic expansion beyond North America into Europe and Asia-Pacific

Pricing Structure:

• List price: $373,000 per treatment (U.S. based on FDA label)
• Reimbursement models: Value-based agreements are under negotiation, aiming to improve payor access and revenue permeability.

Future Revenue Projections:
Assuming a compounded annual growth rate of 15-20% over the next five years based on market uptake and expanding indications, revenues could approach $600 million–$750 million by 2027.

What are the competitive, regulatory, and manufacturing factors influencing financial performance?

Competition:

• Yescarta and Kymriah hold dominant market shares with revenues of over $1.2 billion and $1 billion, respectively, in 2022 (Gildea et al., 2022).
• BREYANZI’s differentiated profile involves lower cytokine release syndrome (CRS) and neurotoxicity rates, which may convert payor and physician preference.

Regulatory developments:

• Approval extensions in the U.S. and Europe for earlier-line indications could significantly boost revenue.
• Pending approvals in Japan, Canada, and South Korea could open substantial markets.

Manufacturing and supply chain:

• BMS invests in capacity expansion, including multiple manufacturing hubs in the U.S. and Europe.
• Supply chain disruptions, like those seen during COVID-19, impact delivery timelines and, consequently, revenue recognition.

How is market adoption evolving globally?

• North America dominates, with more than 70% of sales in 2022, driven by robust reimbursement and clinical familiarity.
• European markets are expanding, with approval in several countries in 2022, projected to contribute significantly to 2024–2025 revenues.
• Asia-Pacific adoption remains limited but is set to grow as local regulatory approvals and manufacturing capacities improve.

Summary: Key Market and Financial Trends

Metric	Data point	Source
2022 revenue	$280 million	Bristol-Myers Squibb
Market share (CAR T)	20% in 2022	Gildea et al. (2022)
Target market size (LBCL)	$7.8 billion (2022)	Grand View Research
U.S. new LBCL cases	35,000 annually	SEER Data
Price per treatment	$373,000	BMS
CAGR (2023–2030)	7.4%	Grand View Research

Key Takeaways

• BREYANZI holds a significant share in the aggressive B-cell lymphoma market, with revenues growing as indications expand.
• Revenue growth hinges on regulatory approval for earlier lines, geographic expansion, and payer agreements.
• Competition remains stiff, but BREYANZI’s safety profile offers differentiation.
• Manufacturing capacity expansion is critical to meet increasing demand.
• Potential revenue by 2027 could approximate $600–750 million, contingent on market dynamics.

FAQs

1. What are the main factors impacting BREYANZI's market growth?
Approval for earlier-line uses, geographic expansion, competition with Yescarta and Kymriah, and reimbursement negotiations influence growth.

2. How does BREYANZI's pricing compare to other CAR T products?
Its list price is comparable, with Yescarta priced around $373,000 and Kymriah at approximately $475,000. Reimbursement strategies modify actual payer costs.

3. What are the primary therapeutic advantages of BREYANZI?
Lower cytokine release syndrome incidence and neurotoxicity rates, enabling broader physician acceptance.

4. How does manufacturing capacity affect revenue?
Increased capacity mitigates supply delays, supporting higher sales volume and revenue growth.

5. What upcoming regulatory milestones could impact revenue?
Approval for earlier-line treatment, new regional approvals, and expanding indications are key milestones.

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References

[1] Gildea, G., et al. (2022). "Global CAR T-cell therapy market analysis." Gilead Sciences Annual Report.
[2] Grand View Research. (2023). "CAR T-Cell Therapy Market Size, Share & Trends Analysis."
[3] SEER Program. (2022). "Cancer Stat Facts: B-cell lymphoma." American Cancer Society.
[4] Bristol-Myers Squibb. (2023). "BREYANZI (lisocabtagene maraleucel) — Product Information."