Last updated: February 23, 2026
What is the drug identified by NDC 50458-0607?
NDC 50458-0607 corresponds to Tafasitamab (Monjuvi), a CD19-targeted monoclonal antibody used in the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is marketed by MorphoSys and Incyte.
Current Market Position
Tafasitamab was approved by the FDA in August 2020 under accelerated approval with full approval granted in 2022. It is sold as part of a combination therapy with Lenalidomide.
Market Size
- The global non-Hodgkin lymphoma (NHL) market was valued at approximately USD 13.3 billion in 2021 and is expected to rise at a CAGR of 7% through 2028.
- DLBCL accounts for roughly 30-40% of NHL cases.
- Estimated addressable market for Tafasitamab in DLBCL is USD 4-5 billion annually as of 2023, considering the total DLBCL patient population and treatment rates.
Competitive Landscape
- Other targeted therapies include Rituximab, Polatuzumab Vedotin, and CAR T-cell therapies (e.g., Axicabtagene Ciloleucel, Tisagenlecleucel).
- Tafasitamab’s differentiation relies on its combination with Lenalidomide and its efficacy in relapsed/refractory cases unresponsive to prior therapies.
Pharmacoeconomic and Pricing Dynamics
Current Pricing
- The average wholesale price (AWP) for Tafasitamab is approximately USD 9,300 per 20 mg vial.
- Typical treatment involves 12-20 doses per patient, translating to USD 150,000–USD 250,000 per course.
Reimbursement Policies
- Medicare covers Tafasitamab via standard oncology infusion policies with prior authorization.
- Payer negotiations influence net prices, often reducing list prices by 20-30%.
Cost-Effectiveness
- Cost per quality-adjusted life year (QALY) is estimated around USD 150,000–USD 200,000, depending on study parameters.
- Payers weigh this against benefits over competing therapies, leading to exclusive or limited formulary access in certain markets.
Market Growth Projections
| Year |
Estimated Market Size (USD Billion) |
Drivers |
Risks |
| 2023 |
0.5 |
Adoption in relapsed/refractory DLBCL |
Competition from CAR T therapies and biosimilars |
| 2025 |
0.75 |
Expanded indications, increased market penetration |
Pricing pressure, reimbursement hurdles |
| 2028 |
1.2 |
New combination approvals, pipeline developments |
Patent expirations, payer resistance |
Key Factors Influencing Price and Market Share
- Patent Status: Patents extending until 2030 protect pricing power; biosimilar entries could lower prices.
- Regulatory Approvals: Expansion into earlier lines of therapy or other B-cell malignancies could boost sales.
- Pricing Strategies: Tiered pricing in international markets adjusts to local health economics.
- Clinical Data: Positive pivotal trial results enhance adoption and justify premium pricing.
Risks to Revenue Projections
- Increased competition from next-generation CD19-directed therapies.
- Cost containment measures by payers.
- Potential delays in new trial results or regulatory approvals.
- Market saturation in initial target indication.
Summary of Price and Market Outlook
| Aspect |
Projection |
| Peak Price Per Course |
USD 150,000–USD 250,000 |
| Market Penetration Rate in 2028 |
15-20% of relapsed/refractory DLBCL patients |
| Total Revenue by 2028 |
USD 1.2 billion, assuming current price points and adoption rates |
Key Takeaways
- NDC 50458-0607 (Tafasitamab) holds a significant position in the relapsed/refractory DLBCL market, with potential growth driven by expanded indications and combination therapies.
- Pricing remains relatively stable within USD 150,000–USD 250,000 per treatment course, influenced by competition, reimbursement policies, and biosimilar entry.
- Market size is projected to grow modestly, reaching USD 1.2 billion by 2028, with ongoing risks from emerging therapies and legislative changes.
FAQs
1. How does the price of Tafasitamab compare to similar therapies?
Tafasitamab’s treatment course costs generally range between USD 150,000 and USD 250,000, comparable to other monoclonal antibody therapies like Rituximab but higher than biosimilars due to patent protections.
2. What factors could lower the drug’s price in the future?
Entry of biosimilars, increased market competition, payer negotiations, and patent expirations could all lead to price reductions.
3. Which markets present the highest growth opportunity?
The U.S. remains the largest market, with upcoming approvals and reimbursement policies driving growth. Europe and Asia Pacific are secondary opportunities, particularly with emerging healthcare investments.
4. What are the key barriers to market expansion?
Regulatory delays, high treatment costs, and competition from CAR T-cell therapies affect adoption rates.
5. How might new clinical trial data impact pricing and market share?
Positive data expanding indications could justify higher prices and increase market penetration. Conversely, negative or inconclusive results may suppress growth and reduce pricing power.
References
- Statista. (2022). Global Non-Hodgkin Lymphoma Market Size. https://www.statista.com
- Food and Drug Administration. (2022). Tafasitamab approval archive. https://www.fda.gov
- EvaluatePharma. (2023). Oncology Market Outlook. https://www.evaluate.com
- IQVIA. (2022). Healthcare Market Reports. https://www.iqvia.com
- National Comprehensive Cancer Network. (2022). NCCN Clinical Practice Guidelines for NHL. https://www.nccn.org
