Last updated: February 15, 2026
The drug identified by NDC 00832-0532 is Cytarabine Injection, primarily used in chemotherapy regimens for hematologic cancers such as acute myeloid leukemia (AML) and lymphomas.
Market Overview
Therapeutic Market Size and Usage
- Indications: AML, lymphomas, and other hematologic malignancies.
- Prevalence: Approximately 20,000 new AML cases annually in the U.S. (CDC, 2021).
- Treatment Setting: Primarily administered in hospital infusion centers and oncology clinics.
- Drug Demand Drivers:
- Expansion of indications for hematologic cancers.
- Adoption of combination chemotherapy protocols.
- Growing cancer patient population aged 65+.
Market Players
- Prominent Suppliers:
- EpiCept Pharma.
- Hospira (now part of Pfizer).
- Sandoz.
- Generic manufacturers entering the market due to the drug's patent expiration.
Regulatory Status
- FDA Approval: Approved for medical use.
- Patent and Exclusivity: Multiple generics approved, leading to price erosion.
Pricing Trends
Historical Price Data
| Year |
Average Per-Unit Price (Vials) |
Notes |
| 2018 |
$150 |
Brand (EpiCept) dominant; limited generics |
| 2020 |
$120 |
Increased generics availability |
| 2022 |
$100 |
Price competition intensifies |
Pricing Drivers
- Brand vs. Generic: The presence of multiple generic manufacturers reduces prices.
- Formulation: 100 mg/10 mL vial is standard; newer formulations or concentrated forms command premiums.
- Market Competition: Price declines accelerate as additional generics enter the market.
Price Projection
Forecast Period: 2023-2027
| Year |
Estimated Per-Unit Price |
Rationale |
| 2023 |
$95 |
Continued generic penetration, slight market competition impact |
| 2024 |
$90 |
Incremental price decrease expected |
| 2025 |
$85 |
Market saturation with generics stabilizes prices |
| 2026 |
$80 |
Entry of biosimilars or alternative formulations may influence price |
| 2027 |
$75 |
Pricing pressure persists, and cost reductions persist |
Assumptions
- No major patent litigations or exclusivity extensions.
- Increased adoption of biosimilar options may further drive prices down.
- Manufacturing costs remain stable or decline with market competition.
Market Opportunities and Risks
Opportunities
- Expansion in emerging markets due to rising cancer incidences.
- Development of combination therapies incorporating cytarabine.
- Potential for institutional preferred supplier contracts lowering procurement costs.
Risks
- Price erosion due to increasing generics.
- Competitive pressure from biosimilars or novel agents.
- Regulatory changes affecting reimbursement.
Key Takeaways
- Cytarabine injection faces declining pricing trends driven by generic competition.
- The drug's market size is tied to hematology oncology treatments; growth depends on cancer prevalence and treatment protocols.
- Price projections suggest gradual reductions over the next five years, reaching approximately $75 per vial by 2027.
- Opportunities exist in emerging markets and combination therapies, but market saturation and biosimilar entry pose challenges.
- Cost management and strategic procurement are essential for maintaining margins.
Frequently Asked Questions
1. How does the patent landscape impact future pricing?
The drug is off patent, enabling generic manufacturing, which suppresses prices. No active patent protections are inhibiting generic entry.
2. Are biosimilars expected for cytarabine?
No biosimilars are currently approved for cytarabine as it is a small molecule, not a biologic. However, new chemically similar agents could emerge.
3. What therapies compete with cytarabine in AML?
Alternatives include decitabine, azacitidine, and newer targeted agents such as FLT3 inhibitors; these influence market share and pricing.
4. How does hospital procurement influence prices?
Bulk purchasing and contractual agreements with hospitals can further lower costs below listed wholesale prices.
5. What is the shelf-life of cytarabine vials, and does it impact supply?
Shelf-life typically spans 24-36 months. Supply chain disruptions may influence availability but have limited impact on unit prices unless shortages occur.
Sources
[1] CDC. (2021). Cancer Statistics Data.
[2] SSR Health. (2022). U.S. Branded and Generic Oncology Drug Pricing Data.
[3] FDA Drugs Database. (2023). Cytarabine (FDA Approval).
