Last updated: February 17, 2026
What is NDC 58406-0010?
NDC 58406-0010 corresponds to Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor T-cell (CAR-T) therapy approved by the FDA in October 2017 for relapsed or refractory large B-cell lymphoma after at least two prior therapies. It is manufactured by Gilead Sciences through Kite Pharma.
Market Size and Demand
Key Indications and Patient Population
- Approved for diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and follicular lymphoma (transformed).
- Approximately 25,000 patients in the U.S. annually qualify for CAR-T therapy based on incidence rates of eligible lymphomas.
- Market penetration is growing; estimates project 15-20% of eligible patients currently receive CAR-T treatment, with potential to reach 50% by 2025.
Competitive Landscape
| Product |
Year FDA Approved |
Indications |
Market Share (2022) |
Price (per treatment) |
| Yescarta (Gilead) |
2017 |
LBCL, PMBCL, FC |
60% |
$373,000 [1] |
| Kymriah (Novartis) |
2017 |
LBCL, pediatric ALL |
25% |
$475,000 [2] |
| Breyanzi (Bristol-Myers) |
2021 |
LBCL, relapsed |
10% |
$410,000 [3] |
Market Drivers
- Increasing approval for additional indications.
- Expansion into earlier lines of therapy.
- Growing confidence among physicians guiding more patients toward CAR-T options.
Price Trends and Projections
Current Pricing and Reimbursement Landscape
- Average list price: $373,000 per treatment cycle.
- Post-reimbursement, net prices decline by 25-30% due to discounts, negotiations, and patient assistance programs.
- CMS reimbursement: Approximately $510,000 for inpatient administration, but actual payments often lower due to negotiated discounts.
Cost Trends and Manufacturing Economics
- Manufacturing costs: Estimated at $100,000–$150,000 per dose due to personalized production.
- Cost reduction efforts focus on automation, streamlined logistics, and improved supply chain management.
Future Price Projections (2023–2028)
| Year |
Estimated Price Range |
Rationale |
| 2023 |
$350,000 – $400,000 |
Market stabilization, price competition, and scale-up efficiency |
| 2025 |
$330,000 – $380,000 |
Increased competition, broader indication expansion, manufacturing efficiencies |
| 2028 |
$300,000 – $350,000 |
Potential for further cost reduction and biosimilar entry (if applicable) |
Factors Influencing Future Pricing
- Introduction of biosimilars or generics for similar therapy platforms.
- Pricing negotiations driven by payers regarding total treatment costs.
- Expanded indications leading to increased market size but pressure to reduce per-treatment costs.
- Technological advancements reducing manufacturing costs.
Market Outlook and Growth Potential
- The global CAR-T market is projected to reach $8 billion by 2025, expanding at a CAGR of 25% [4].
- Yescarta maintains a leading position, supported by ongoing clinical trials and expanded indications.
- Entry into solid tumors could diversify revenue streams, although current pipeline focuses mainly on hematologic malignancies.
Summary
| Aspect |
Data Points |
| Current market size |
25,000 eligible patients annually in the U.S. |
| Market penetration |
15–20% presently, with potential to reach 50% in 3–5 years |
| Average treatment cost |
$373,000 (list price), net payment ~$250,000–$280,000 per patient |
| Market share (2022) |
Yescarta: 60%; Kymriah: 25%; Breyanzi: 10% |
| Price trajectory |
Expected to decrease gradually to ~$300,000–$350,000 by 2028 |
| Revenue forecast |
Potential baseline revenue of $7–8 billion annually globally |
Key Takeaways
- Yescarta dominates the CAR-T market for hematologic indications in the U.S.
- Pricing remains high but is expected to decline due to competition and cost efficiencies.
- Market growth depends on indication expansion, reimbursement strategies, and customer acceptance.
- Manufacturing cost reductions could enable further price decreases, expanding access.
FAQs
Q1: How does Yescarta compare with competitors in terms of price?
A: Yescarta's list price is slightly lower than Kymriah’s, though net prices differ due to rebates and negotiations.
Q2: What factors could accelerate price reductions?
A: Biosimilar development, technological improvements reducing production costs, and increased competition.
Q3: What is the main driver of growth in the Yescarta market?
A: Expansion into additional indications and broader patient access.
Q4: How are payers responding to high-cost CAR-T therapies?
A: They negotiate discounts, implement value-based agreements, and restrict access to approved indications.
Q5: Will biosimilars significantly impact Yescarta’s future revenue?
A: Likely if biosimilars prove safe and effective, but current development stages limit near-term impact.
References
[1] Gilead Sciences. (2022). Yescarta product information.
[2] Novartis. (2022). Kymriah product information.
[3] Bristol-Myers Squibb. (2022). Breyanzi product information.
[4] MarketsandMarkets. (2022). CAR-T cell therapy market analysis.
Note: All data is based on public sources as of the knowledge cutoff date in 2023.
