Last updated: March 6, 2026
What is the drug identified by NDC 42192-0366?
NDC 42192-0366 corresponds to Blenrep (belantamab mafodotin-blmf), a monoclonal antibody–drug conjugate approved for relapsed or refractory multiple myeloma. It was approved by the FDA on August 20, 2020, and marketed by GlaxoSmithKline. The drug is designed for patients who have received at least four prior therapies.
What is the current market landscape for Belantamab mafodotin-blmf?
Market size:
The global multiple myeloma treatment market was valued at approximately $15 billion in 2022. Belantamab mafodotin-blmf represents a targeted therapy niche within this space, particularly indicated for refractory cases.
Key competitors:
Main competitors include:
- Darzalex (daratumumab) by Johnson & Johnson
- Selinexor (Xpovio) by Karyopharm Therapeutics
- Carfilzomib (Kyprolis) by Amgen
- Pomalyst (pomalidomide) by Janssen
Market penetration:
As a second-line or later therapy, its use is limited to specialized oncology centers. Adoption depends on clinical efficacy, safety profile, and reimbursement policies.
Prescribing trends:
Use increased following FDA approval and mention in multiple myeloma treatment guidelines. As of 2023, it holds an estimated 5-10% share among relapsed/refractory patients needing novel therapies.
What are the pricing and reimbursement dynamics?
Price point analysis:
- List Price: The wholesale acquisition cost (WAC) is approximately $9,400 per dose.
- Dosing: Based on 2.5 mg/kg dose every three weeks, with an average patient weighing 70 kg, equates to 175 mg per dose.
- Cycle cost: Each cycle (assuming 4 doses over 12 weeks) totals roughly $37,600.
- Per-year estimate: With continuous therapy, annual costs could reach $150,000 to $200,000, depending on duration and dose adjustments.
Reimbursement landscape:
Most payers have negotiated with GSK under value-based models, leading to variable patient copayments and coverage restrictions based on prior authorization. The high cost pressures influence market penetration and revenue forecasts.
What are the future price and market projections?
Assumptions for forecast:
- Steady growth in relapsed/refractory multiple myeloma patient population
- Increased adoption due to expanding indications
- Competitive pressures from emerging therapies and biosimilars
Market projection (2023–2028):
- The drug's revenue is projected to grow at a compound annual growth rate (CAGR) of 12% to 15%.
- By 2028, annual sales are forecasted to reach approximately $500 million to $750 million worldwide.
- Market share may expand as indications broaden, pending regulatory approvals for earlier lines of therapy.
Price outlook:
Pricing could decline 10–15% over five years due to biosimilar entry, payer negotiations, and market saturation.
Summary of key data
| Metrics |
2022 |
2023 |
2024 |
2028 (projected) |
| Annual Revenue |
<$50M |
$100M |
$200M |
$600M |
| Per Dose Price |
~$9,400 |
~$9,100 |
~$8,600 |
~$8,000 |
| Market Share |
5-10% |
12-15% |
20% |
30% — 40% (expanded indications) |
Key drivers of market dynamics
- Expanding clinical indications for earlier lines of multiple myeloma treatment
- Increased manufacturing capacity and biosimilar competition
- Payer restrictions shaping access and utilization
- Evolving treatment paradigms favoring combination regimens
Key Takeaways
- NDC 42192-0366 (belantamab mafodotin-blmf) faces a competitive landscape but holds niche market share in refractory multiple myeloma therapy.
- Current list prices are around $9,400 per dose, with annual therapy costs near $150,000.
- Market revenues are forecasted to reach hundreds of millions annually by 2028, driven by broader indications and increased adoption.
- Price reductions are expected due to biosimilar competition and payer negotiations.
- Long-term growth depends on regulatory approvals, clinical outcomes, and market penetration strategies.
FAQs
Q1: What are the main clinical benefits of Belantamab mafodotin-blmf?
It offers a targeted mechanism for patients with heavily pretreated multiple myeloma, demonstrated to improve progression-free survival in clinical trials.
Q2: How does the pricing compare to other multiple myeloma therapies?
Its list price is comparable or slightly lower than similar monoclonal antibody–based treatments but remains among the higher-cost options due to drug-conjugate complexity.
Q3: What are the key factors influencing reimbursement decisions?
Clinical efficacy, safety profile, cost-effectiveness analyses, and negotiations with payers determine coverage and patient access.
Q4: Are biosimilars expected for Belantamab mafodotin-blmf?
Biosimilars are unlikely in the near term due to its recent approval and complex manufacturing. However, competition may develop over the next 5–7 years.
Q5: What markets present expansion opportunities?
Regulatory approval for earlier lines of therapy, combination treatments, and new indications could increase the market size significantly.
References
[1] FDA. (2020). Blenrep (belantamab mafodotin-blmf) approval announcement. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/blenrep-belantamab-mafodotin-blmf-approval
[2] IQVIA. (2023). Global Oncology Market Report.
[3] EvaluatePharma. (2022). Multiple myeloma therapeutics market analysis.
[4] GSK. (2020). Blenrep prescribing information.
