Last updated: March 4, 2026
What is NDC 62135-0859?
NDC 62135-0859 refers to Yescarta (axicabtagene ciloleucel), a CAR T-cell therapy developed by Gilead Sciences/Kite Pharma. Approved by the FDA in October 2017, it is used for relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
Market Size and Growth Drivers
Current Market Overview
- Indications: Large B-cell lymphoma in adults, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, and transformed follicular lymphoma.
- Therapeutic demand: Increasing as treatment options for refractory lymphoma remain limited. The therapy is often used as a second-line or later treatment due to its efficacy.
Patient Population
- U.S. prevalence estimates: Approximately 25,000 to 30,000 new cases of DLBCL annually.
- Eligible patients: Estimated at 70–80% of cases due to eligibility criteria for CAR T-cell therapy.
Market Penetration
- Adoption largely driven by demand for personalized immunotherapies.
- The therapy's usage is constrained by logistics, manufacturing time, and cost considerations.
Competitive Landscape
- Authorized competitors include Kymriah (tisagenleucel) from Novartis and Tecartus (brexucabtagene autoleucel) from Gilead/Kite for specific indications.
- Expansion into earlier lines of therapy and new indications could increase market share.
Market Growth Projections
| Year |
Market Size (USD) |
CAGR |
Notes |
| 2022 |
850 million |
— |
Based on FDA approvals, market uptake |
| 2023 |
1.1 billion |
30% |
Increased adoption and expanded indications |
| 2024 |
1.4 billion |
27% |
Broader payer acceptance, geographical expansion |
| 2025 |
1.75 billion |
25% |
Growth driven by manufacturer initiatives |
Price Dynamics and Cost Factors
Current Pricing
- List price: Approximately $373,000 per treatment course in the U.S. (Gilead, 2022).
- Reimbursement considerations: Payers negotiate discounts, potentially lowering net prices by 20–40%.
Cost Factors
- Manufacturing costs: Estimated at $80,000–$120,000 per course.
- Logistics: Cold chain requirements add approximately $10,000–$15,000 per batch.
- Administrative expenses: Cover facility, staffing, and clinical monitoring.
Future Price Trends
| Year |
Estimated List Price (USD) |
Comments |
| 2023 |
$370,000–$390,000 |
Stable, with minor discounts |
| 2024 |
$380,000–$400,000 |
Slight increase expected due to inflation and supply costs |
| 2025 |
$390,000–$410,000 |
Potential premium for expanded uses |
Price Reduction Drivers
- Entry of biosimilar or alternative therapies.
- Payer pressure for value-based pricing.
- Manufacturing innovation reducing costs.
Regulatory and Policy Impact
- Expanded indications: Ongoing trials aim to broaden use to other lymphomas, potentially increasing market size.
- Pricing negotiations: CMS and private insurers scrutinize high-cost therapies; value-based agreements may influence net prices.
Key Takeaways
- The market for NDC 62135-0859 is driven by increasing prevalence of lymphomas and expanding indications.
- The global market size could reach approximately $1.75 billion by 2025.
- The initial list price remains near $370,000–$390,000 per course, with discounts varying by payer and region.
- Manufacturing and logistics costs are significant but could decline with process improvements.
- Competition and policy developments may impact net pricing and market growth trajectories.
FAQs
Q1: What is the main driver for the growth of NDC 62135-0859?
The rising incidence of refractory large B-cell lymphoma and broader approval indications.
Q2: How is the price of Yescarta set?
Primarily based on manufacturing complexity, clinical efficacy, and market competition, with discounts negotiated with payers.
Q3: What factors could lower future prices?
Manufacturing efficiencies, biosimilar entries, and increased competition.
Q4: How does Yescarta compare with other CAR T therapies?
It has similar pricing but varies in approved indications and manufacturing logistics.
Q5: What is the potential for expanding indications?
Significant, as ongoing trials target earlier lines of therapy and additional lymphoma subtypes.
Sources
[1] Gilead Sciences. (2022). Yescarta (axicabtagene ciloleucel) package insert.
[2] IQVIA. (2022). Global Oncology Market Data.
[3] FDA. (2017). Approval announcement for Yescarta.
[4] MarketWatch. (2023). CAR T-cell therapy market analysis.
[5] Statista. (2023). Cost of CAR T-cell therapy in the U.S.
