Last updated: February 17, 2026
What is NDC 51407-0555?
NDC 51407-0555 refers to Blincyto (blinatumomab), an immunotherapy used in treating certain kinds of B-cell precursor acute lymphoblastic leukemia (ALL). Approved by the FDA in 2014, Blincyto is a bi-specific T-cell engager (BiTE), designed to target CD19+ malignant cells while activating T-cells.
Market Overview
Indications and Usage
- Approved for adults and pediatric patients with relapsed or refractory B-cell precursor ALL.
- Also approved for minimal residual disease (MRD)-positive ALL in adults.
- Consensus estimates indicate annual U.S. prescriptions range between 2,000 and 3,000 units, reflecting its niche position within oncology.
Competitive Landscape
- Other targeted therapies for ALL, such as CAR T-cell therapies (Kymriah, Tecartus), compete in the same indication.
- Manual therapies for relapsed ALL include chemotherapy and stem cell transplant, though less targeted.
Market Drivers
- Increasing incidence of ALL (approximate global incidence: 1-1.5 per 100,000).
- Rising adoption in relapsed/refractory settings.
- Growing approval for MRD-positive cases.
- Market penetration influenced by physician familiarity and reimbursement policies.
Regional Market Dynamics
- U.S. accounts for primary revenue, driven by FDA approval and reimbursement.
- Growth potential exists in Europe and Asia, contingent on approval and local pricing negotiations.
Price Analysis and Projections
Pricing Setting
- Wholesale acquisition cost (WAC) for Blincyto in the U.S. stands at approximately $3,500 to $4,000 per 50 mcg vial.
- Treatment course typically involves 3-4 vials, based on patient weight and dosing schedule.
- Average retail treatment cost per course estimated between $112,000 and $150,000.
Reimbursement Factors
- Reimbursement hinges on insurance coverage, hospitals’ formulary inclusion, and manufacturer contracts.
- Cost-effectiveness is debated; studies suggest a cost per quality-adjusted life year (QALY) around $150,000, within acceptable thresholds for oncology drugs.
Price Trend Analysis
- No significant recent price reductions; price remains stable since approval.
- Potential for price adjustments contingent on biosimilar development or competition.
- Price inflation expected to remain under 2% annually for the foreseeable future.
Future Price Projections
| Year |
Estimated WAC per Course |
Assumed Prescription Volume |
Projected Revenue |
| 2023 |
$135,000 |
2,500 |
$337.5 million |
| 2024 |
$137,700 |
3,000 |
$413.1 million |
| 2025 |
$140,454 |
3,200 |
$449.4 million |
| 2026 |
$143,263 |
3,500 |
$501.4 million |
Prices assume slight annual inflation; actual revenue depends on volume, payer policies, and market competition.
Investment and R&D Outlook
- No biosimilars approved yet; biosimilar development is ongoing, with potential launches in late 2024 or 2025.
- advances in CAR-T therapies may influence market share but are unlikely to displace Blincyto entirely due to different logistical requirements and indications.
- Manufacturer continued investment in combination therapies and expanded indications could sustain or increase pricing power.
Key Takeaways
- NDC 51407-0555 (Blincyto) holds a niche market within relapsed and MRD-positive ALL.
- Base-case price remains around $135,000-$150,000 per treatment course.
- Revenue projections suggest growth aligned with increased prescription volume.
- Biosimilar competition anticipated post-2024 could pressure pricing.
- Market expansion depends on approval in other regions and evolving treatment guidelines.
FAQs
1. How is the price of Blincyto determined?
The price is set based on manufacturing costs, comparable therapies, and market willingness to pay, with monthly inflation kept below 2%. Reimbursement negotiations and value-based assessments influence final pricing.
2. What factors could drive Blincyto’s price down?
The development and approval of biosimilars and newer therapies such as CAR T-cells could introduce price competition, impacting Blincyto’s market share and revenue.
3. Is the market for Blincyto expected to grow?
Yes, driven by increased indications, usage in earlier lines, and expanding approvals for MRD. However, growth is restrained by competition and its niche position.
4. How significant is the impact of biosimilar entry?
Biosimilars are likely to reduce market prices by 20-30%, impacting revenue and potentially leading to price adjustments by originators.
5. What is the outlook for global sales?
Europe and Asian markets offer growth opportunities, contingent on local regulatory approvals and reimbursement policies.
References
[1] FDA. "Blincyto (blinatumomab) Label." 2014.
[2] IQVIA. "Market Trends & Prescription Data." 2022.
[3] EvaluatePharma. "Worldwide Oncology Market Estimates." 2023.
[4] National Cancer Institute. "B-cell Precursor Acute Lymphoblastic Leukemia." 2022.
[5] Research on biosimilar development and market entry timelines.
