Lisocabtagene maraleucel - Biologic Drug Details

Summary for lisocabtagene maraleucel

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for lisocabtagene maraleucel

Recent Clinical Trials for lisocabtagene maraleucel

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
M.D. Anderson Cancer Center	PHASE2
Washington University School of Medicine	PHASE1
NeoImmuneTech	PHASE1

See all lisocabtagene maraleucel 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 brand-side disclosures

These patents were identified from searching 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 lisocabtagene maraleucel Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for lisocabtagene maraleucel 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 lisocabtagene maraleucel Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source

International Patents for lisocabtagene maraleucel

Country	Patent Number	Estimated Expiration
New Zealand	745374
Philippines	12015500325
South Korea	102135239
New Zealand	745372
Denmark	3824905
Canada	2881981
Mexico	2015002101

Market Dynamics and Financial Trajectory of Lisocabtagene Maraleucel

Last updated: February 23, 2026

What are the core attributes of lisocabtagene maraleucel?

Lisocabtagene maraleucel (liso-cel) is a CAR T-cell therapy developed for relapsed or refractory large B-cell lymphoma (R/R LBCL). It belongs to the second-generation CD19-directed CAR T therapies and aims to improve safety profiles with balanced T-cell subsets.

Key features:

• Approved by the FDA in February 2021 for adult R/R LBCL after two or more lines of systemic therapy.
• Administered via an outpatient process.
• Demonstrates overall response rates (ORR) around 80%. Complete response (CR) rates approximate 55%, based on clinical trials.

How does the market landscape look for CAR T therapies?

Major players:

Product	Company	Year of Approval	Target Indication	US Launch Year	Estimated Shift to Commercial Availability
Kymriah (tisagenlecleucel)	Novartis	2017	ALL, NHL	2017	Dominates segment in pediatric hematology
Yescarta (axicabtagene ciloleucel)	Gilead (Kite)	2017	NHL	2017	Leading in adult DLBCL, aggressive NHL
Breyanzi (lisocabtagene maraleucel)	Bristol-Myers Squibb	2021	LBCL, DLBCL	2022	Gaining market share, targeting outpatient care
Tecartus (brexucabtagene autoleucel)	Gilead (Kite)	2020	MCL, ALL	2021	Focused on specific hematologic conditions

Market size estimates:

• The global CAR T-cell therapy market was valued at approximately USD 1.5 billion in 2022.
• Projected compound annual growth rate (CAGR) of 24% from 2023-2028.
• North America accounts for over 80% of sales, driven by high approval rates and reimbursement key.

What are the factors influencing the commercial adoption of lisocabtagene maraleucel?

Regulatory approval trajectory:

• Secured FDA approval based on phase 2 TRANSCEND NHL 001 trial, which showed durable remissions.
• Awaiting additional approvals in the EU, Japan, and other territories.

Pricing and reimbursement:

• List price estimated at USD 373,000 per treatment course.
• Reimbursement is primarily through payers' risk-sharing arrangements, acknowledging high upfront costs.

Clinical factors:

• Demonstrates a favorable safety profile, especially reduced neurotoxicity and cytokine release syndrome (CRS) severity compared to competitors.
• Outpatient administration reduces hospital resource burdens, facilitating broader access.

Market penetration tactics:

• Emphasis on outpatient delivery models.
• Expansion into earlier lines of therapy remains under investigation.
• Investment in logistical infrastructure for manufacturing and distribution.

What are the financial forecasts for lisocabtagene maraleucel?

Revenue estimates:

• Estimated to reach USD 200 million in 2023, growing to USD 1 billion by 2028, assuming increased adoption.
• Growth driven by expanding indications, improved manufacturing capacity, and competitive pricing strategies.

Cost considerations:

• Manufacturing costs are high, approximating USD 150,000 per dose.
• Investment in cell processing facilities reduces unit costs over time.

Profitability prospects:

• BMS and collaborators aim to achieve profitability through increased volume and efficiency.
• The therapy's high price point sustains margins but remains sensitive to payer negotiations and healthcare policy changes.

What are the risks and opportunities moving forward?

Risks:

• Competition from existing CAR T therapies with established market share.
• Regulatory delays or unmet safety expectations.
• Reimbursement restrictions limiting access.

Opportunities:

• Label expansion for earlier treatment lines.
• Development of off-the-shelf allogeneic CAR T products.
• Integration into combination therapy regimens.

Key Takeaways

• Lisocabtagene maraleucel is a CAR T therapy targeting R/R LBCL, with a focus on outpatient delivery.
• It faces competitive pressure from Novartis's Kymriah and Gilead's Yescarta but has gained traction through safety and logistical advantages.
• Market size is expanding rapidly, driven by increasing approvals and adoption.
• Revenue forecasts estimate significant growth, with USD 200 million in 2023 rising to USD 1 billion by 2028.
• Cost pressures, reimbursement hurdles, and competitive dynamics shape its commercial trajectory.

FAQs

1. How does lisocabtagene maraleucel differ from other CAR T-cell therapies?

Liso-cel emphasizes a defined CD4/CD8 T-cell composition, reducing toxicity risks and enabling outpatient administration.

2. When is additional regulatory approval expected?

BMS submitted applications for expanded indications in early line settings; decisions are anticipated within 12-24 months, depending on jurisdiction.

3. What are the main competitive advantages?

Safety profile, outpatient administration, and manufacturing efficiencies position it favorably against competitors with higher toxicity and inpatient requirements.

4. How vulnerable is lisocabtagene maraleucel to pricing pressures?

While high list prices support margins, payer negotiations and value-based reimbursement models may constrain pricing growth.

5. What are the future clinical development plans?

Research focuses on label expansion to earlier lines, as well as combination regimens with immune checkpoint inhibitors and targeted therapies.

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Sources

[1] BioPharm Insight. (2023). CAR T-cell therapy market analysis.
[2] FDA. (2021). Approval announcements for lisocabtagene maraleucel.
[3] Markets and Markets. (2023). CAR T-cell therapy market forecast.
[4] Bristol-Myers Squibb. (2023). Corporate pipeline and financial data.
[5] IQVIA. (2023). Hematologic malignancies treatment landscape.