Last updated: February 12, 2026
Summary:
NDC 00781-7136 is a drug marketed as Kymriah (tisagenlecleucel), a chimeric antigen receptor T-cell (CAR-T) therapy developed by Novartis. It is used for the treatment of certain blood cancers including B-cell acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL). Launched in 2017, Kymriah represents a high-cost biologic with a unique position in immuno-oncology. Its market and pricing dynamics are shaped by regulatory, clinical, and competitive factors.
What is the current market status of Kymriah?
Market Presence:
- Approved in the U.S. for B-cell ALL in patients up to 25 years of age, and for adult DLBCL.
- Approved in the European Union, Japan, and other markets.
- Marketed through a specialty sales force targeting oncology and hematology providers.
- Revenue in 2022: approximately $450 million globally, showing growth driven by expanded indications and approval pathways.
Key competitors include:
- Gilead’s Yescarta (axicabtagene ciloleucel)
- Bristol-Myers Squibb’s Breyanzi (lisocabtagene maraleucel)
- Novartis’ own earlier-developed CAR-T therapies with similar indications.
Market challenges:
- High manufacturing costs
- Complex logistics
- Strict regulatory oversight
- Limited patient population
Market growth drivers:
- Broader approval of indications
- Increasing adoption in second-line settings
- Expansion into earlier lines of therapy and new indications, e.g., multiple myeloma
How does the price of Kymriah compare with similar therapies?
| Therapy |
Typical List Price (per treatment) |
Indications |
Regulatory Notes |
| Kymriah (00781-7136) |
$475,000 |
ALL, DLBCL |
Approved since 2017 |
| Yescarta |
$373,000 |
DLBCL, primary mediastinal B-cell lymphoma |
Approved since 2017 |
| Breyanzi |
$410,000 |
Large B-cell lymphoma, DLBCL |
Approved since 2021 |
Pricing considerations:
- Prices are list prices; actual transaction prices often involve negotiations and rebates.
- Price includes manufacturing, logistical costs, and R&D amortization.
- The high price reflects the personalized nature, complex manufacturing, and significant clinical benefits.
Comparison to traditional therapies:
- Kymriah's list price is significantly higher than traditional chemotherapies ($10,000–$50,000 per cycle).
- Cost-effectiveness assessments are ongoing; reimbursement policies vary by payer.
What are the projections for future pricing and market size?
Market size projections:
- Hematologic cancer market for CAR-T therapies forecasted to reach $8-10 billion globally by 2027 (source: GlobalData, 2023).
- Kymriah's share measured around 25-30% in the CAR-T segment, with potential growth as indications expand.
Price trend projections:
- Initial high prices are likely to stabilize with increased competition and biosimilar/alternative development.
- Expansion into earlier lines of therapy and additional indications could sustain high prices, especially if clinical efficacy remains superior.
- Payer negotiations and value-based agreements may pressure list prices downward, though actual prices may remain high.
Influencing factors on future pricing:
- Patent expirations or challenges could open market access to biosimilars, lowering prices.
- Proven cost-effectiveness and reimbursement policies will impact net pricing.
- Manufacturing innovations reducing costs could enable lower prices while maintaining margins.
What regulatory and policy factors influence pricing?
Pricing regulations:
- U.S.: Medicare and private insurer negotiations heavily influence net prices.
- EU: Reimbursement negotiations vary by country, often based on cost-effectiveness assessments.
- Price control policies in countries like Germany or France could impose caps on reimbursement levels.
Policy developments:
- Value-based pricing models are increasingly adopted.
- Outcome-based agreements are common for CAR-T therapies, linking reimbursement to clinical results.
- Policies encouraging biosimilar entry may affect future competition and pricing.
Key Takeaways
- NDC 00781-7136 corresponds to Kymriah, a leading CAR-T therapy with an approximate list price of $475,000 per treatment.
- Market growth is driven by expanding indications, improved manufacturing efficiencies, and increased adoption, expected to push the global market size toward $10 billion by 2027.
- Price projections suggest stability due to the drug's unique position; however, competition and regulatory pressures could influence future discounts.
- Competitors like Yescarta and Breyanzi share similar pricing and regulatory landscapes, impacting Kymriah's market share.
- Payer strategies emphasizing value-based contracts could modulate the effective price in different jurisdictions.
FAQs
1. Will the price of Kymriah decrease in the future?
Prices may decline due to market competition, biosimilar development, and value-based pricing policies, but high manufacturing and R&D costs will sustain elevated list prices.
2. How does reimbursement impact pricing?
Reimbursement policies often limit the net price hospitals receive; these policies adapt based on clinical outcomes, cost-effectiveness, and negotiations with payers.
3. What are the main factors driving Kymriah's market growth?
Indication expansion, clinical data supporting efficacy, and improved manufacturing processes contribute to growth; reimbursement and regulatory approvals are critical factors.
4. Could biosimilars impact Kymriah's price?
Biosimilars are unlikely in the near term due to personalized manufacturing processes, but future market evolution could change that landscape.
5. How does Kymriah's cost sound compared to other biologics?
It remains considerably more expensive than traditional biologics or chemotherapies, mainly due to personalized manufacturing and its innovative treatment approach.
Citations
- [1] Novartis annual report 2022.
- [2] GlobalData, 2023. CAR-T therapy market forecast.
- [3] U.S. FDA label for Kymriah.
- [4] European Medicines Agency approval documentation.
