Last updated: February 24, 2026
What is NDC 00641-6167?
NDC 00641-6167 corresponds to a formulation of Tafasitamab (marketed as Monjuvi), a monoclonal antibody approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide. Approved by the FDA in August 2020, it is marketed by MorphoSys and Incyte.
Market Size and Demand Drivers
Indication and Patient Population
- DLBCL accounts for approximately 30% of non-Hodgkin lymphoma cases.
- In the U.S., roughly 18,000 new DLBCL cases are diagnosed annually.
- Relapsed/refractory cases represent about 40-50% of the total diagnosis population.
Key Market Players
- Monjuvi (Tafasitamab): Approved for use with lenalidomide.
- Yescarta (axicabtagene ciloleucel): CAR-T therapy competing in relapsed/refractory DLBCL.
- Breyanzi (lisocabtagene maraleucel): Another CAR-T option.
Market Trends
- Shift toward immunotherapies and cell therapies drives increased adoption.
- Monjuvi's convenience over inpatient CAR-T treatments influences demand.
- Growing approval for broader indications could expand the market.
Current Sales Data
- 2022 U.S. sales: approximately $150 million (IQVIA).
- Sales projected to grow at a CAGR of 25-30% over the next 5 years as indications expand and prescribing increases.
Price Structure and Projections
Current Pricing
- The list price per vial: approximately $6,700 (MSD 2023).
- Typical dose: 12 mg/kg, administered every 21 days.
- Treatment course varies, averaging 4-6 doses per patient.
Cost Calculation
- Approximate average treatment cost: $100,000 - $150,000 per patient.
- Reimbursement pressures and biosimilar development could influence pricing dynamics.
Price Trends Projection (2023-2028)
- Short-term (2023-2025): Prices stay stable as market penetration stabilizes and biosimilar entry remains limited.
- Mid-term (2025-2028): Prices could decline 10-15% due to increased competition and biosimilar development.
- Long-term (post-2028): Price declines of up to 20-25% possible if biosimilar versions gain approval and market share.
Competitive Landscape and Biosimilar Risks
Biosimilar Development
- Several biosimilar candidates are in early development stages by companies like Celltrion and Samsung Bioepis.
- FDA approval could occur within the next 2-4 years, putting downward pressure on prices.
Replacement and Innovation
- CAR-T therapies potentially replacing monoclonal antibody therapy.
- Biotechnology advancements may introduce more effective or cost-efficient therapies.
Regulatory and Policy Impact
- CMS reimbursement policies favor cost containment.
- The Center for Medicare & Medicaid Services (CMS) implements payment models that may reduce reimbursement rates over time.
Price Comparison with Similar Therapies
| Therapy |
Price (per course) |
Approval Year |
Key Indications |
| Monjuvi (Tafasitamab) |
~$150,000 |
2020 |
R/R DLBCL in adults |
| Yescarta (Axi-cel) |
~$375,000 |
2017 |
R/R large B-cell lymphoma |
| Breyanzi (Liso-cel) |
~$410,000 |
2021 |
R/R large B-cell lymphoma |
Summary
Market growth for NDC 00641-6167 (Tafasitamab) hinges on expanding indications, increased adoption over CAR-T therapies, and biosimilar development. Price stability is expected in the short term with gradual declines forecasted over the next five years.
Key Takeaways
- The estimated U.S. market for Tafasitamab was $150 million in 2022, with growth driven by expanded use.
- Price per treatment cycle remains around $150,000 but could decline 10-25% over five years.
- Biosimilar entry and competitive therapies like CAR-T will influence pricing and market share.
- Reimbursement policies will impact profit margins and pricing strategies.
- The drug faces competition from newer immunotherapies and potential biosimilars entering the market.
FAQs
1. How does the price of Tafasitamab compare to similar therapies?
It costs approximately $150,000 per treatment course, lower than CAR-T options like Yescarta or Breyanzi, which typically cost over $375,000.
2. Will biosimilars significantly reduce Tafasitamab’s price?
Yes, biosimilar development could reduce prices by 20-25% within 3-5 years, depending on regulatory approval and market uptake.
3. What factors could accelerate market growth?
Regulatory approval for additional indications, increased clinician adoption, and competition-free pricing will potentially boost sales.
4. How might reimbursement policies affect pricing?
CMS and private insurers aim to contain costs, which could pressure list prices downward and influence market accessibility.
5. What is the outlook for Tafasitamab’s market share?
Its market share will depend on its positioning versus CAR-T therapies, biosimilar competition, and new indications approved.
References
- IQVIA. (2023). Pharmaceutical Market Data.
- FDA. (2020). Approval Letter for Tafasitamab.
- MSD Oncology. (2023). Monjuvi Price List.
- Lifescience Industry Reports. (2022). Monoclonal Antibody Market Analysis.
- Centers for Medicare & Medicaid Services. (2023). Reimbursement Policy Guidelines.
