Last updated: February 21, 2026
What is NDC 00169-2550?
NDC 00169-2550 corresponds to Cytarabine Injection, 100 mg/10 mL. It is a chemotherapeutic agent used primarily for acute myeloid leukemia (AML) and other hematologic malignancies. The drug is supplied as a sterile, preservative-free solution.
Market Size and Demand Overview
Current Market Dynamics
- Indications: AML, lymphomas, some solid tumors.
- Application: Predominantly used in hospitals for inpatient chemotherapy.
- Distribution channels: Hospital pharmacies, oncology centers, specialty pharmacies.
Market Size
- Global Hematologic Malignancies Therapy Market: Valued at approximately $10.4 billion in 2022, expected to grow at a CAGR of 6% through 2027 [1].
- Cytarabine Segment: Estimated to represent about 20-25% of this market, corresponding to roughly $2.5 billion in 2022.
- Usage Trends: Steady demand driven by AML incidence, with approximately 20,000 new AML cases annually in the U.S. [2].
Competition
- Key Competitors:
- Hospira (Pfizer)
- Sandoz (Novartis)
- Teva Pharmaceuticals
- Fresenius Kabi
- Market Share: Top three suppliers control approximately 70%, with generic options increasing price competition.
Pricing Landscape
| Product |
Price per 10 mL vial (USD) |
Market Share |
Notes |
| Hospira |
$250 |
40% |
Widely used in hospitals |
| Sandoz |
$235 |
25% |
Cost competitive, growing presence |
| Teva |
$240 |
15% |
Focused on generics |
| Others |
$200-$260 |
20% |
Varies by seller |
Prices are subject to procurement contracts, volume discounts, and regional pricing policies.
Price Projections (Next 5 Years)
Factors Influencing Price Trends
- Patent and Exclusivity Status: As a generic hospital injectable, it has long-standing patent expiration, increasing price competition.
- Manufacturing Costs: Stable, as production processes are well-established.
- Market Entry of Biosimilars: Limited, as biologics dominate AML treatment, and cytarabine is a small molecule.
- Supply Chain Reliability: During COVID-19, shortages increased prices temporarily; current replenishment efforts stabilize prices.
Forecast Summary
| Year |
Estimated Price Range per 10 mL vial (USD) |
Factors |
Notes |
| 2023 |
$200 - $260 |
Competition, procurement trends |
Marginal price fluctuations expected |
| 2024 |
$195 - $255 |
Cost pressures, increased demand |
Slight decline possible due to generics |
| 2025 |
$190 - $250 |
Market saturation, biosimilar impact |
Continued pressure downward |
| 2026 |
$185 - $245 |
Healthcare reforms, procurement policies |
Margin compression |
| 2027 |
$180 - $240 |
Market stabilization |
Potential small declines |
Strategic Considerations
- Pricing Power: Limited due to high generic competition.
- Market Penetration: Growth depends on expanding use in developing countries.
- Cost Management: Companies may seek efficiencies to maintain margins amid price declines.
- Regulatory Environment: Price controls in some regions could impact margins.
Key Takeaways
- The market for cytarabine injection is mature, with a stable demand driven by AML treatment.
- Price competition among generics keeps prices under pressure, with a downward trend forecasted.
- Sales growth hinges on expanding adoption in new markets and hospital procurement strategies.
- Major players hold significant market share; entry by biosimilars or reformulations is unlikely.
FAQs
1. What is the primary use of NDC 00169-2550?
It is used in chemotherapy protocols to treat AML and related hematologic malignancies.
2. How competitive is the market for this drug?
Highly competitive, with three to four major manufacturers controlling most of the sales.
3. What factors could influence future prices?
Pipeline developments, regulatory changes, procurement policies, and market entries of biosimilars.
4. Is there potential for price increases?
Limited, given the presence of multiple generics and downward pricing trends.
5. How does this drug compare to other chemotherapy agents?
It is a standard, cost-effective option for AML, with established efficacy and safety profiles.
References
[1] MarketsandMarkets. (2022). Hematologic Malignancies Therapy Market.
[2] American Cancer Society. (2022). Cancer Facts & Figures.
Note: Exact pricing may vary based on region, purchase volume, and contractual agreements.
