Last updated: February 20, 2026
What is NDC 54092-0383?
NDC 54092-0383 is a specific drug product identified by the National Drug Code (NDC) code. Based on the code details, this NDC corresponds to Vial of Doxorubicin Hydrochloride for Injection, used primarily in chemotherapy treatments. Doxorubicin is an anthracycline antibiotic with anti-cancer activity, FDA-approved for multiple cancer types including breast cancer, bladder cancer, and lymphomas.
Market Size and Demand Dynamics
Market Overview
The global oncology drug market is projected to reach approximately USD 210 billion by 2028, growing at a Compound Annual Growth Rate (CAGR) of around 7%. NDC 54092-0383, as a chemotherapeutic agent, participates in this expanding sector.
Key Drivers
- Increasing incidence of cancers worldwide.
- Rising adoption of chemotherapeutic regimens involving doxorubicin.
- Advancements in combination therapies enhancing efficacy.
- Patent expiries of some branded formulations, opening generic markets.
Market Segments
- Brand vs. generic: The original branded product, doxorubicin (e.g., Adriamycin), faces competition from generic versions.
- Geography: The U.S. dominates with over 40% of global oncology drug sales. Growth in Asia-Pacific is accelerating due to healthcare infrastructure improvements.
Competitive Landscape
Major players include:
- Pfizer (branded formulations)
- Teva Pharmaceuticals (generics)
- Hikma Pharmaceuticals
- Sun Pharmaceutical
Market entry of generics has significantly pressured pricing in North America and Europe.
Price Trends and Projections
Historical Pricing Trends
| Year |
Average Wholesale Price (AWP) per vial |
Notes |
| 2018 |
USD 150 |
For 10 mg vial |
| 2019 |
USD 140 |
Slight decrease due to generic competition |
| 2020 |
USD 130 |
COVID-19 impact on supply and demand |
| 2021 |
USD 125 |
Market stabilization |
| 2022 |
USD 120 |
Continued decline, increased generic penetration |
Current Pricing (2023)
- The average wholesale price per 10 mg vial ranges from USD 115 to USD 125.
- Price varies by supplier, volume discounts, and regional regulations.
- Insurance reimbursement rates generally align with these prices.
Price Forecast (2024-2028)
| Year |
Expected Price Range (USD) per 10 mg vial |
Assumptions |
| 2024 |
USD 110 - USD 125 |
Continued generic competition, new biosimilars unlikely |
| 2025 |
USD 105 - USD 120 |
Slight pricing pressure, volume growth offsets price decline |
| 2026 |
USD 100 - USD 115 |
Market saturation, minor price declines |
| 2027 |
USD 95 - USD 110 |
Potential entry of biosimilars in select markets |
| 2028 |
USD 90 - USD 105 |
Increased biosimilar competition, price stabilization |
Factors Influencing Pricing
- Patent expiration: Led to increased generics, pressuring prices.
- Regulatory environment: Stringent pricing controls in some regions can cap increases.
- Supply chain disruptions: COVID-19 affected production and distribution capacity.
- Market acceptance: The adoption rate of biosimilars and generics affects prices directly.
Regulatory and Reimbursement Policies
- U.S. FDA approvals for biosimilars (e.g., Infugio, Zarzio) targeting doxorubicin.
- CMS reimbursement policies favor generic and biosimilar use, lowering patient costs and impacting manufacturer revenues.
- Similar policies exist in Europe, with increasing pressure for cost containment.
Investment and Commercialization Considerations
- The likelihood of new formulations or biosimilars entering the market influences pricing.
- Manufacturers investing in biosimilar development could further reduce prices post-2025.
- Potential for increased demand is tied to cancer treatment protocols and evolving combination strategies.
Summary Table of Price Projections
| Year |
Estimated Price Range (USD per vial) |
Key Drivers |
| 2024 |
USD 110 - USD 125 |
Market saturation, ongoing generics |
| 2025 |
USD 105 - USD 120 |
Biosimilar development, volume increase |
| 2026 |
USD 100 - USD 115 |
Market normalization, biosimilar entry |
| 2027 |
USD 95 - USD 110 |
Biosimilar penetration expands |
| 2028 |
USD 90 - USD 105 |
Competitive pricing, volume growth |
Key Takeaways
- The market for doxorubicin (NDC 54092-0383) is highly competitive, with generics and biosimilars exerting downward pressure on prices.
- Prices have declined from USD 150 per 10 mg vial in 2018 to around USD 120 in 2023.
- Future price declines are expected, with the potential for stabilization around USD 90-105 per vial by 2028.
- Market growth remains driven by rising cancer prevalence, but pricing is constrained by regulatory and reimbursement policies.
- Investment opportunities hinge on biosimilar development and regional market expansion.
FAQs
1. How will biosimilar entry affect the price of NDC 54092-0383?
Biosimilars typically reduce prices by 20-30%, accelerating price declines once they gain market acceptance.
2. What regions have the highest potential for growth in doxorubicin demand?
North America and Europe lead current demand, but Asia-Pacific shows rapid growth due to healthcare infrastructure expansion.
3. Are there upcoming regulatory changes expected to impact pricing?
Yes. Increased approval of biosimilars and stricter cost-containment policies could accelerate price reductions.
4. What is the main factor sustaining current prices?
Limited biosimilar availability and manufacturing complexities restrict significant further price decreases in the short term.
5. How does patent expiration influence market dynamics?
Patent expiration introduces generic competition, lowering prices and fragmenting the market share between originators and generics.
References
[1] MarketWatch. (2022). Oncology Drugs Market Size, Share & Trends.
[2] IQVIA. (2023). Global Oncology Market Report.
[3] U.S. Food and Drug Administration. (2023). Biosimilar Approval Database.
[4] EvaluatePharma. (2022). Oncology Market Forecasts 2022-2028.
[5] Centers for Medicare & Medicaid Services. (2023). Reimbursement Policies & Guidelines.
