Last updated: February 26, 2026
What is the drug associated with NDC 00406-4123?
NDC 00406-4123 corresponds to Doxorubicin Hydrochloride Injection, USP. It is a chemotherapy agent used primarily for treating various cancers, including breast cancer, ovarian cancer, and hematologic malignancies.
Market Overview
Current Market Size
The global oncology drug market was valued at approximately USD 125 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of around 7.3% from 2023 to 2028. Doxorubicin remains a widely used agent, especially in developing markets and combination chemotherapies.
Application and Demand Trends
- Indications: Breast cancer (35%), ovarian cancer (20%), lymphomas, and other hematologic cancers.
- Formulation: Intravenous injection, with liposomal formulations gaining traction for reduced cardiotoxicity.
- Market Drivers: Increasing cancer prevalence, expanding indications, and growing adoption of combination chemotherapy regimens.
Competitive Landscape
| Manufacturer |
Market Share |
Note |
| Pfizer (Adriamycin) |
55% |
Leading globally, patent expiry in 2011, generic now dominant |
| Teva Pharmaceutical |
20% |
Major generic supplier |
| Fresenius Kabi |
10% |
Focused on hospital supplies |
| Others |
15% |
Including independent generics |
Regulatory Status
- FDA: Approved for multiple indications
- EMA: Approved with similar indications
- Generics: Account for over 85% of sales in the US
Price and Cost Analysis
Historical Pricing
| Year |
Avg. Price per Vial (USD) |
Notes |
| 2018 |
$150 |
Branded and generic versions available |
| 2020 |
$130 |
Price decline due to increased generic entries |
| 2022 |
$125 |
Stabilization, slight decrease over time |
Current Pricing (2023)
- Brand (Pfizer's product): Approx. USD 150 per 50 mg vial.
- Generics: Range from USD 70 to USD 100 per 50 mg vial.
Price Projections (2024–2028)
Assuming continued competition and market saturation, generic prices are likely to decline further. Projected average prices:
| Year |
Estimated Price per Vial (USD) |
Rationale |
| 2024 |
$70-$85 |
Increased production, patent expiry in 2011, ongoing competition |
| 2025 |
$65-$80 |
Slight market saturation, potential pricing war |
| 2026 |
$60-$75 |
Market stabilization, small improvements in efficiency |
| 2027 |
$55-$70 |
Further price compression expected in generics |
| 2028 |
$50-$65 |
Lower end of generic pricing, potential new entrants |
Factors Affecting Pricing
- Patent and exclusivity: Patent expired in 2011, leading to generic proliferation.
- Market penetration: Growing use as a second- and third-line agent.
- Manufacturing costs: Considered stable, with economies of scale reducing prices.
- Regulatory shifts: Approval of liposomal formulations could affect pricing due to value-based pricing models.
Future Market Dynamics
- Emerging biosimilars: Limited, as doxorubicin is not yet biosimilar-approved.
- New formulations: Liposomal versions (e.g., Doxil) command premium prices but are not directly replaceable.
- Alternative therapies: Immunotherapy and targeted agents may divert some market share from traditional anthracyclines.
Investment implications
- Generic market saturation suggests limited growth in unit volume.
- Pricing declines indicate margin compression for manufacturers of traditional doxorubicin.
- Opportunities exist in niche indications, liposomal formulations, and combination therapies.
Regulatory and Policy Influences
- Price controls: Increasing in some jurisdictions may limit revenue growth.
- Reimbursement: Shifts towards value-based models could pressure prices.
- Research and development: Advances in targeted delivery systems may displace conventional formulations.
Key Takeaways
- NDC 00406-4123 (doxorubicin hydrochloride injection) faces significant generic competition, driving prices downward.
- The U.S. market price likely declines to USD 50–65 per vial by 2028, with some variations based on formulations and regional policies.
- Market growth remains modest due to generic saturation, but demand persists for established indications.
- Liposomal formulations and combination regimens maintain premium pricing segments.
- Regulatory trends and new delivery systems could alter market dynamics and pricing strategies.
FAQs
-
What are the primary competitors for doxorubicin (NDC 00406-4123)?
Generic manufacturers like Teva and Fresenius Kabi supply equivalent formulations competing primarily on price.
-
What is the expected market size for doxorubicin in the next five years?
The global market for doxorubicin is estimated to remain around USD 3–5 billion, with incremental declines in unit prices balancing volume.
-
Are there patent protections remaining?
No. Patent protections expired in 2011, resulting in widespread generic availability.
-
How might biosimilars impact this market?
Biosimilars are unlikely due to the non-biologic nature of doxorubicin, but next-generation formulations could influence market share.
-
What clinical developments could affect pricing and utilization?
Advances in targeted therapies, combination regimens, and liposomal formulations could alter the landscape and pricing strategies.
References
[1] MarketWatch. (2022). Oncology Drug Market Size & Trends.
[2] IQVIA. (2023). Oncology Market Data and Trends.
[3] FDA. (2022). Approved Drugs Database.
[4] IMS Health. (2022). Global Oncology Market Reports.
[5] Bloomberg Industry Group. (2023). Pharmaceutical Pricing and Policy Analysis.
