Last updated: February 15, 2026
What is the current market status of the drug NDC 70954-0668?
NDC 70954-0668 refers to Lisocabtagene maraleucel (liso-cel), a CAR T-cell therapy approved by the FDA in February 2021 for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The drug entered the US market under the brand name Breyanzi.
How is the market for Breyanzi structured?
Breyanzi faces competition primarily from other CAR T-cell therapies approved for similar indications:
- Kymriah (tisagenlecleucel) by Novartis
- Yescarta (axicabtagene ciloleucel) by Gilead Sciences/Kite Pharma
The market comprises hospitals, specialty infusion clinics, and oncologists. Funding sources include private insurance, Medicare, and Medicaid, influencing pricing and reimbursement policies.
What are the current sales and revenue figures?
Since its launch, Breyanzi has experienced rapid adoption. In 2022, Gilead reported $803 million in net product sales for CAR T therapies, with Breyanzi accounting for approximately 40% of this figure.
- Q2 2022: Breyanzi sales totaled approximately $275 million, marking a 37% increase sequentially.
- 2022 full-year forecast: Industry estimates project sales to reach $1.2 billion globally by 2023, driven by approvals in additional indications and broader patient access.
What are the price points for Breyanzi?
Pricing varies by geography and reimbursement policies:
- United States: List price approximates $398,000 per treatment course, with actual costs affected by payer negotiations and patient-level factors.
- Cost components: The price includes cell collection, manufacturing, and administration. Payers often negotiate discounts or value-based agreements.
International prices are typically lower, reflecting different healthcare systems and negotiated discounts.
How are reimbursement policies influencing pricing?
In the US, Medicare reimbursement for CAR T-cell therapies uses the Diagnosis-Related Group (DRG) system, with a bundled payment structure. Manufacturers often negotiate with payers for coverage and payment terms.
References indicate that value-based agreements are increasingly used to manage uncertainties surrounding long-term efficacy and costs.
What future price and market projections exist for Breyanzi?
Industry analysts suggest:
- Steady growth in market share within the large B-cell lymphoma segment.
- Price stabilization due to competitive pressure and value-based reimbursement models.
- Potential for incremental price adjustments driven by manufacturing efficiencies and expanded indications, such as earlier lines of therapy or different hematological malignancies.
Projections indicate that global sales could reach $2 billion by 2025, assuming successful market penetration and approval expansions.
How might regulatory and market developments impact prices?
- Additional approvals in indications like follicular lymphoma could increase demand and justify higher prices.
- Competition from biosimilars or other CAR T-cell therapies may exert downward pressure on prices.
- Policy shifts toward value-based pricing could moderate price increases and influence market share.
Summary table of key data points:
| Metric |
Data |
Source |
| Current list price per course |
~$398,000 |
Gilead (2022) |
| 2022 net sales (globally) |
~$803 million |
Gilead (2022) |
| Estimated 2023 global sales |
~$1.2 billion |
Industry estimate |
| Projected 2025 sales |
~$2 billion |
Industry projection |
Key takeaways
- Breyanzi holds a significant share of the CAR T-cell therapy market for large B-cell lymphoma.
- Price per treatment course remains high but is subject to negotiations and value-based adjustments.
- Market growth depends on expanded indications, competitive dynamics, and reimbursement reforms.
- Competitive pressure from other therapies and potential biosimilar entry may moderate future pricing.
- Sales will likely grow, but prices will stabilize due to cost-control efforts and shifting policy landscape.
FAQs
-
How does Breyanzi’s price compare to other CAR T-cell therapies?
Breyanzi is priced similar to Yescarta, slightly lower than Kymriah. List prices hover around $375,000 to $400,000 per course.
-
What factors influence the final reimbursement amount?
Negotiations between manufacturers and payers, utilization of value-based agreements, and individual healthcare system policies.
-
Are there ongoing efforts to reduce costs of CAR T-cell therapies?
Yes. Manufacturing efficiencies, process innovations, and broader patient access programs aim to lower costs.
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What future indications could expand Breyanzi’s market?
Potential approval for earlier lines of therapy and additional blood cancers could increase eligible patient populations.
-
How could emerging competition impact Breyanzi's market share?
New approvals, biosimilars, and alternative therapies may reduce market share and pressure prices downward.
Citations
- Gilead Sciences, Form 10-K 2022.
- FDA Approval Announcement, February 2021.
- Industry sales projections, EvaluatePharma, 2023.
