Last updated: February 17, 2026
What is NDC 57664-0655?
NDC 57664-0655 refers to Doxorubicin Hydrochloride injection, a chemotherapeutic agent primarily used in the treatment of various cancers, including breast, bladder, and ovarian cancers. It is supplied in a sterile, injectable form, often administered intravenously. The drug is marketed by various pharmaceutical companies, with its patent status, manufacturing, and pricing varying across regions.
Market Size and Demand
Global Cancer Treatment Market Overview
- The oncology drug market reached $150 billion globally in 2022[1].
- Doxorubicin remains a key component in chemotherapy regimens, especially in the US, Europe, and emerging markets.
- The demand for Doxorubicin is expected to sustain compound annual growth rate (CAGR) of approximately 5% through 2030[2].
Key Market Drivers
- Rising cancer incidence rates. Globally, cancer cases increased from 19.3 million in 2020 to an estimated 24.5 million by 2030[3].
- Advances in combination chemotherapy protocols incorporating doxorubicin.
- Patent expiries of competing agents pushing demand for generic options.
Competitive Landscape
| Company |
Market Share (2022) |
Key Products |
Notes |
| Hisun Pharmaceuticals |
~25% |
Doxorubicin HCl injection |
Major supplier in the US |
| Pfizer |
~20% |
Doxorubicin (various formulations) |
Generic and branded drugs |
| Teva Pharmaceuticals |
~15% |
Doxorubicin products |
Expanding presence in emerging markets |
| Others |
~40% |
Multiple regional suppliers |
Fragmented across different regions |
Note: Sum may not total 100% due to rounding and regional differences.
Price Trends and Projections
Current Price Range (U.S. Market)
- The average wholesale acquisition cost (WAC) for Doxorubicin HCl injection is approximately $10 to $20 per vial of 10 mg[4].
- Generic versions dominate the market, exerting downward pressure on pricing.
Price Drivers
- Patent expirations for branded forms have increased generic availability.
- Manufacturing costs influence retail prices, with economies of scale lowering per-unit costs.
- Regulatory approval and quality standards impact market entry barriers.
Price Projections (Next 5 Years)
| Year |
Wholesale Cost / Vial (10 mg) |
Expected Market Factors |
| 2023 |
$10 - $20 |
Stable with slight downward pressure from generics |
| 2025 |
$8 - $18 |
Increased generic competition, possible price erosion |
| 2027 |
$7 - $15 |
Further generic penetration, manufacturing efficiencies |
| 2030 |
$6 - $12 |
Market saturation, supply chain improvements |
Projection assumptions include continued generic price erosion, stable demand, and no major regulatory or manufacturing disruptions.
Regulatory and Patent Considerations
- Doxorubicin's original patents expired in the late 1990s; however, some formulations or delivery patents might extend exclusivity.
- The FDA approved various biosimilars and generics from 2010 onward, increasing market competition[5].
- Price reductions are correlated with the approval of biosimilars, which can be up to 30% lower than branded counterparts.
Financial and Market Impact
- For manufacturers, production costs ranging from $1 to $4 per vial enable healthy margins (assuming scale and manufacturing efficiencies).
- For healthcare providers and payers, increased generic availability reduces treatment costs, influencing formulary inclusion.
- Price sensitivity is high in emerging markets, where affordability impacts access and adoption rates.
Key Takeaways
- The drug is a mainstream chemotherapeutic agent with consistent demand in oncology.
- The market is highly competitive, dominated by generics, with prices trending downward.
- Price projections suggest a decline of approximately 40-50% over the next decade, driven by generic competition and market saturation.
- Market size is sizable, with annual global revenue estimated around $2-3 billion for doxorubicin products.
- Price reduction trajectories are influenced by regulatory, manufacturing, and patent expirations.
FAQs
1. What factors most influence Doxorubicin pricing?
Price is driven primarily by generic competition, manufacturing costs, patent status, and regional regulatory approval.
2. How does patent expiration affect market price?
Patent expiration enables generics entry, lowering prices by 30-50%, especially in mature markets.
3. Are biosimilars involved in this market?
No, Doxorubicin is a small molecule chemotherapeutic, not a biologic; biosimilar development does not apply.
4. What are major regional market differences?
Pricing tends to be higher in the US due to higher healthcare costs, with lower prices in emerging markets driven by price controls and local manufacturing.
5. How might future regulatory changes impact prices?
Streamlined approval processes for generics/biosimilars can accelerate price declines, while stricter quality standards could increase costs.
References
[1] MarketWatch, 2022. Global Oncology Drugs Market Report.
[2] Grand View Research, 2022. Cancer Therapeutics Market Analysis.
[3] WHO, 2021. Cancer Burden and Statistics.
[4] IQVIA, 2022. Pharmaceutical Pricing Data.
[5] FDA, 2022. Approvals of Oncology Biosimilars and Generics.
End of Report
