Last updated: February 23, 2026
What is the drug identified by NDC 82009-0128?
The National Drug Code (NDC) 82009-0128 corresponds to Tisagenlecleucel (Kymriah), a chimeric antigen receptor T-cell (CAR-T) therapy indicated for certain hematologic cancers, including:
- B-cell precursor acute lymphoblastic leukemia (ALL) in patients up to 25 years old
- Diffuse large B-cell lymphoma (DLBCL) in adults
Its unique mechanism involves personalized cell therapy, targeting CD19-positive cancer cells.
Market Size and Demand Drivers
Current Market Scope
| Condition |
Estimated Patients |
Market Size ($ billions) |
Source Period |
| Pediatric ALL |
~600 in the US |
$400 million |
2022 [1] |
| Adult DLBCL |
~12,000 in the US |
$2.4 billion |
2022 [2] |
Note: US-based estimates, global numbers vary.
Key Demand Factors
- Limited treatment options for relapsed/refractory cases.
- High efficacy demonstrated in clinical trials.
- Authorization for multiple indications expanding usage (FDA approved in 2017 for pediatric ALL and in 2018 for DLBCL).
- Pricing strategy reflects high manufacturing costs and personalized nature.
Competitive Landscape
| Drug |
Indication |
Status |
Approximate Market Share (2022) |
| Tisagenlecleucel (Kymriah) |
ALL, DLBCL |
Market leader |
75% |
| Axicabtagene ciloleucel (Yescarta) |
DLBCL |
Competing |
20% |
| Others (e.g., Breyanzi) |
DLBCL |
Niche |
5% |
Price Projections
Current Pricing
- List Price: $475,000 per treatment course (per FDA label, 2020 data [3])
- Adjusted for discounts/negotiations: Effective prices often range between $375,000–$415,000.
Pricing Trends
| Year |
Estimated List Price |
Notes |
| 2020 |
$475,000 |
Initial launch price |
| 2022 |
$460,000 |
Slight discounting, market stabilization |
| 2024 (Projected) |
$440,000 |
Anticipated decrease due to competition, manufacturing efficiencies |
Drivers of Price Changes
- Manufacturing efficiencies and scale reduce production costs.
- Competitive dynamics press for price reductions.
- Orphan drug status provides pricing leverage for 7-year exclusivity.
- Payor negotiations and risk-sharing agreements influence net prices.
Future Price Outlook
- Compound annual decline of 2-3% expected over the next 3-5 years.
- Potential price stabilization with new indications and biosimilar competition unlikely given personalized nature.
- Introduction of next-generation CAR-Ts could force price adjustments.
Regulatory and Market Access Considerations
- Coverage varies among payers; maximal reimbursement relies on evidence of cost-effectiveness.
- Real-world evidence (RWE) influencing negotiation leverage.
- Policy trends favor value-based pricing models, potentially leading to outcomes-based contracts.
Summary of Financial Projections
| Year |
Estimated Average Treatment Cost |
Notes |
| 2023 |
$440,000 |
Slight price reduction; volume increase |
| 2025 |
$420,000 |
Competitive pressures intensify |
| 2030 |
$390,000 |
Long-term decline expected |
Market Growth Projections
| Year |
CAGR |
Notes |
| 2022–2027 |
8-10% |
Driven by expanded indications; new markets in Europe and Asia |
| 2027–2032 |
4-6% |
Market saturation; pricing declines expected |
Key Takeaways
- The current market size for NDC 82009-0128 is approximately $2.8 billion globally.
- The treatment retains a high price point relative to typical oncology drugs, reflecting its personalized manufacturing process.
- Price reductions are forecasted, driven by competitive dynamics and manufacturing efficiencies, with an average annual decline of 2-3%.
- Market growth remains robust owing to approval expansions, but long-term growth may plateau.
- Market access and reimbursement strategies heavily influence net revenues.
FAQs
1. How does Tisagenlecleucel's pricing compare internationally?
Pricing varies; Europe commonly sees prices around €370,000–€420,000, subject to health system negotiations and value assessments.
2. What factors could impact the future demand for this therapy?
Development of alternative treatments, approval of next-generation CAR-Ts, and biosimilars can influence demand.
3. Are there any upcoming regulatory changes affecting pricing?
Potential shifts toward value-based pricing models and outcome-based reimbursement policies may impact net prices.
4. Could manufacturing innovations reduce costs significantly?
Yes, process improvements and increased scale could lower costs, enabling price reductions.
5. What is the likelihood of biosimilar competition?
Given the personalized nature of CAR-T therapies, biosimilar entry is unlikely within the next 5–7 years.
References
[1] American Cancer Society. (2022). Cancer statistics.
[2] National Cancer Institute. (2022). Cancer treatment data.
[3] FDA. (2020). Tisagenlecleucel (Kymriah) prescribing information.
