Last updated: March 5, 2026
What is NDC 13925-0160?
NDC 13925-0160 corresponds to Tafasitamab in combination with lenalidomide, approved by the FDA in August 2020 for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults who are not eligible for autologous stem cell transplant. The drug is marketed by MorphoSys (in partnership with Incyte) under the brand Monjuvi in the United States.
Market Scope and Therapeutic Landscape
Indication and Patient Population
- The target population comprises approximately 30,000 to 40,000 U.S. patients annually with relapsed/refractory DLBCL who are ineligible for transplant.
- DLBCL is the most common non-Hodgkin lymphoma, with about 72,000 new cases annually in the U.S., of which roughly 55% are diagnosed at relapse.
Competition and Treatment Landscape
- Main alternatives include chemotherapy regimens (e.g., R-CHOP, GemOx), CAR T-cell therapies (e.g., Axicabtagene Ciloleucel, Tisagenlecleucel), and other targeted agents.
- CAR T therapies dominate the relapsed/refractory setting with high efficacy but face issues related to cost, access, and patient eligibility.
- Currently, Monjuvi is positioned as an outpatient, non-cell therapy alternative for patients ineligible for CAR T therapies.
Market Penetration and Adoption Factors
- Prescribing rates depend on physician comfort, patient eligibility, and payer coverage.
- The drug's approval expands options for a niche segment: relapsed/refractory patients ineligible for intensive therapies.
- Commercialization efforts target hematologist/oncologist adoption, with initial uptake gradual due to competition and cost.
Revenue and Price Projections
Pricing History and Current Pricing
- List Price: As of 2023, Monjuvi's wholesale acquisition cost (WAC) is approximately $20,000 to $25,000 per dose.
- Treatment course typically involves 4-6 doses over several months, translating to $80,000 to $150,000 per patient.
Pricing Comparisons
| Drug |
Dosing Cost (Approx.) |
Therapy Duration |
Annual Cost Estimate |
| Monjuvi (NDC 13925-0160) |
$20,000–$25,000 per dose |
4–6 doses |
$80,000–$150,000 |
| CAR T therapies (e.g., Yescarta) |
$373,000 (list price) |
Single infusion |
$373,000 |
| Chemotherapy regimens |
Varies; ~$10,000–$50,000 |
Multiple cycles |
$50,000–$200,000 |
Market Size and Revenue Projections (2023–2028)
- 2023 Market Revenue: Estimated at $150–$250 million, accounting for initial uptake, payer negotiations, and market penetration.
- Growth Drivers: Increasing approval expansions, payer coverage, and physician adoption.
- Forecast (2024–2028): Compound annual growth rate (CAGR) expected between 8–12% due to expanding indications and improved access, reaching $400 million–$500 million by 2028.
Factors Impacting Price Evolution
- Payer Negotiations and Rebates: Insurers may push for discounts, reducing effective prices.
- Market Competition: Entry of biosimilars and alternative therapies could pressure list prices.
- Regulatory Updates: Expansion of indications could increase volume, but also price competition.
Key Market Dynamics
- Adoption is limited by the subset of patients ineligible for CAR T therapies.
- The high cost neutralizes some uptake despite a favorable safety profile.
- Transition to biosimilars or new combination therapies could impact future pricing.
Risks and Opportunities
Risks
- Increased competition from biosimilars and new agents.
- Payer pushback on high prices.
- Slow physician adoption due to established treatment algorithms.
Opportunities
- Expansion into new indications.
- Demonstrating superior outcomes or safety profile.
- Strategic partnerships to broaden distribution.
Summary
NDC 13925-0160 (Monjuvi) has carved a niche in relapsed/refractory DLBCL for patients ineligible for CAR T therapy. Current pricing ranges between $80,000 and $150,000 per course, with revenue projections reaching approximately $400 million by 2028. Market growth hinges on expanding indications, payer coverage, and physician adoption, balanced against competitive pressures and evolving treatment paradigms.
Key Takeaways
- Monjuvi's current market is primarily driven by relapsed/refractory DLBCL patients unsuitable for CAR T.
- The drug's per-treatment cost approximates $80,000 to $150,000.
- Revenue is projected to grow at a CAGR of 8–12%, reaching nearly half a billion dollars by 2028.
- Competitive landscape includes CAR T, chemotherapy, biosimilars, and emerging targeted agents.
- Price dynamics will depend on payer negotiations, biosimilar entry, and approval expansions.
FAQs
-
What is the primary indication for NDC 13925-0160 (Monjuvi)?
It treats relapsed or refractory diffuse large B-cell lymphoma in adults ineligible for stem cell transplant.
-
How does Monjuvi compare cost-wise to CAR T therapies?
Monjuvi costs between $80,000 and $150,000 per course, while CAR T therapies list at approximately $373,000.
-
What factors influence the drug’s market penetration?
Physician adoption, payer coverage, patient eligibility, and competition from CAR T and biosimilars.
-
What is the expected growth rate for the drug’s revenue?
Estimated CAGR of 8–12% through 2028.
-
Are there upcoming regulatory or market changes expected to affect pricing?
Expansion of indications, biosimilar availability, and payer negotiations could influence future prices.
References
[1] U.S. Food and Drug Administration. (2020). FDA approves monotherapy for relapsed or refractory DLBCL.
[2] IQVIA. (2023). U.S. Prescription Drug Market Reports.
[3] MorphoSys. (2023). Product information and pricing.
[4] NIH. (2019). Diffuse large B-cell lymphoma stats.
