Last updated: February 20, 2026
What Is NDC 57894-0651?
NDC 57894-0651 identifies the drug Blinatumomab (trade name: Blincyto). It is a bispecific T-cell engager (BiTE) antibody designed to treat B-cell precursor acute lymphoblastic leukemia (ALL). Approved by the FDA in 2014, Blincyto is indicated for Philadelphia chromosome-negative relapsed or refractory (r/r) B-cell precursor ALL and for minimal residual disease-positive (MRD+) B-cell precursor ALL.
Current Market Status
Market Segments
- Oncology drugs targeting hematologic malignancies dominate the market segment.
- Primary competitors include CAR T therapies (e.g., Novartis' Kymriah, Gilead's Yescarta), and other antibody-based treatments.
- Market size: The global hematologic oncology drug market was valued at approximately USD 11.4 billion in 2021, with an expected CAGR of 8% through 2028 [1].
Market Drivers
- Increasing incidence of B-cell ALL.
- Rising adoption of immunotherapies.
- Broadened indications for Blincyto.
- Expanding treatment in relapsed/refractory cases.
Market Barriers
- Treatment costs.
- Limited durability of response.
- Manufacturing complexities of biologics.
- Competition from emerging therapies.
Price History and Pricing Elements
Pricing in the U.S.
- Average Wholesale Price (AWP): Historically, Blincyto’s AWP has been approximately USD 27,600 per vial.
- First-year cost estimate: For a typical treatment course requiring 4 doses at 38 mcg, the total cost is around USD 110,400 [2].
Pricing Trends
- Pricing has remained relatively stable over the last 3-4 years.
- Recent negotiations and formulary inclusion have influenced net prices downward.
Price Comparison with Competitors
| Therapy |
Indication |
Cost (USD) |
Approval Year |
Key Differentiator |
| Blincyto (NDC 57894-0651) |
ALL |
~$27,600 per vial |
2014 |
First BiTE antibody in its class |
| Kymriah (NDC 60760-0011) |
ALL, DLBC |
~$475,000 (per CAR T dose) |
2017 |
Autologous CAR T, one-time infusion |
| Yescarta (NDC 60760-0450) |
DLBC |
~$373,000 |
2017 |
CAR T cell therapy |
Future Price Projections
Short-Term (Next 2 Years)
- Prices are expected to stabilize due to established manufacturing costs and market penetration.
- Payer negotiations are likely to continue reducing net prices.
- Entry of biosimilars or biosimilar-like products is unlikely in the near term due to complexity.
Long-Term (3-5 Years)
- Price reductions of 5-10% could materialize with increased competition from generic biologics or biosimilar entrants.
- Potential bundling or value-based agreements could affect effective pricing.
Factors Influencing Future Pricing
- Patent expirations or legal challenges.
- Repurposing for additional indications.
- Leverage from payer negotiations and formulary placement policies.
- Innovation in manufacturing that reduces costs.
Market Outlook
- The drug is positioned in a niche with high unmet needs.
- The high cost limits broad payer coverage but is offset by the lack of alternatives in relapsed/refractory cases.
- The increasing prevalence of B-cell malignancies and expanding indications could sustain or grow revenue streams.
Key Takeaways
- NDC 57894-0651 (Blinatumomab) remains a core immunotherapy in relapsed/refractory ALL with prices around USD 27,600 per vial.
- The market for hematologic cancer biologics is valued over USD 11 billion, with steady growth.
- Competitive pressures from CAR T therapies and biosimilars may influence future pricing downward.
- Projections suggest modest price reductions over the next 2-5 years, influenced by payer negotiations and market dynamics.
- The drug’s niche position and limited competition support maintained pricing despite high costs.
FAQs
Q1: Is there potential for biosimilars to reduce Blincyto’s price?
A1: Biosimilar development faces biological complexity, with no biosimilars approved or in advanced development as of 2023. Significant price reductions via biosimilars are unlikely soon.
Q2: How does Blincyto compare to CAR T-cell therapies in terms of cost?
A2: Blincyto’s per-treatment cost is approximately USD 110,400, whereas CAR T therapies like Kymriah can cost over USD 475,000 per dose, reflecting differences in manufacturing, administration, and durability.
Q3: What is the fiscal impact of Blincyto's pricing on healthcare payers?
A3: The high per-course cost contributes to substantial expenditure for payers, especially in high-incidence settings. Cost-effectiveness analyses weigh its benefits against expenses.
Q4: Are new indications expected to alter the market for Blincyto?
A4: Expanding indications, such as use in minimal residual disease (MRD)-positive ALL, could increase demand, stabilizing or increasing revenue streams.
Q5: What regulatory or patent changes could affect future pricing?
A5: Patent exclusivity extends until around 2030, barring legal or regulatory challenges. Any patent challenges or regulatory approvals of biosimilars could shift pricing dynamics.
References
[1] Grand View Research. (2022). Hematologic Oncology Market Size, Share & Trends Analysis Report.
[2] Red Book. (2022). Pharmaceutical Pricing and Cost Data.
