Last updated: March 13, 2026
What is the drug associated with NDC 00054-0622?
NDC 00054-0622 corresponds to Doxorubicin Hydrochloride Injection, USP, produced by Pfizer. It is a chemotherapeutic agent used primarily for treating breast cancer, ovarian cancer, and different types of lymphomas. Doxorubicin's mechanism involves intercalating DNA, inhibiting topoisomerase II, and generating free radicals, leading to apoptosis of cancer cells.
Market Size and Dynamics
Current Market Overview (2023)
| Metric |
Data |
Source |
| Estimated global oncology drug market |
$228 billion in 2023; projected to reach $366 billion by 2030 |
[1] |
| Doxorubicin-specific market share |
Approximately 2.5% of oncology drugs; roughly $5.7 billion in 2023 |
Industry estimates |
| Doxorubicin volume sales (US, 2023) |
Approx. 2.5 million vials annually, with some recent decline |
IQVIA [2] |
| Main competitors |
Liposomal formulations (e.g., Doxil), biosimilars, other topoisomerase inhibitors |
Market reports [3] |
Market Drivers
- Growing cancer prevalence: Rising incidence of breast, ovarian, and hematologic cancers increases demand.
- Shift towards targeted therapies: Doxorubicin remains standard for many regimens but faces competition from newer agents.
- Patent expiry and biosimilars: The original patent expired, leading to biosimilar entries that reduce prices and expand access.
- Regulatory considerations: Stringent safety protocols, given known cardiotoxicity.
Market Constraints
- Cardiotoxicity risks limit long-term use.
- Declining use due to alternative therapies.
- Reimbursement challenges related to high toxicity profile.
Price Trends and Projections
Current Pricing Landscape (2023)
- Brand-name Doxorubicin (Pfizer): Approx. $50–$100 per 20 mg vial.
- Biosimilars and generics: Prices range from $10–$25 per vial.
| Price Point |
Source |
Notes |
| US average retail price |
$75 per 20 mg vial (brand), $15 per vial (generic) |
Market data, MediSpan [4] |
| International prices |
Vary: $20–$80 per vial (developed countries); lower in emerging markets |
WHO databases [5] |
Price Dynamics (2018–2023)
- The entry of biosimilars led to a 60% reduction in median prices.
- Brand price remained relatively stable but faced volume declines.
- Snavig fluctuations influenced by supply chain and regulatory policies.
Future Price Projections (2024–2028)
| Year |
Expected Average Price (US) |
Drivers of Price Change |
Source |
| 2024 |
$68–$75 per vial |
Market stabilization, biosimilar competition |
Industry forecasts |
| 2025 |
$65–$70 per vial |
Increasing biosimilar penetration, pricing pressure |
Market analysts |
| 2026 |
$60–$65 per vial |
Continued biosimilar rollouts, reduced manufacturing costs |
Industry reports |
| 2027 |
$55–$60 per vial |
Mature biosimilar market, patent-related price declines |
Industry projections |
| 2028 |
$50–$55 per vial |
Volume growth, international expansion |
Market forecasts |
(Note: Prices are per 20 mg vial and subject to regional variations.)
Regulatory and Manufacturing Trends Affecting Price and Market
- Manufacturing improvements: Cost reductions in biosimilar production with high-volume batch processing.
- Regulatory approvals: Increasing approvals of biosimilars in key markets (US, EU, Asia) drive price competition.
- Supply chain stability: Critical for maintaining consistent pricing, especially in emergent markets.
Summary of Competitive Landscape
| Product Type |
Major Players |
Market Share |
Price Range (2023) |
Notable Features |
| Brand (Doxil) |
Pfizer, generic manufacturers |
~40% |
$50–$100 per vial |
Patent expiry in 2014; limited exclusivity |
| Biosimilars |
Teva, Celltrion, Sandoz, Mylan, Fresenius |
~30% |
$10–$25 per vial |
Cost-effective, widely adopted |
| Alternatives |
Liposomal formulations, targeted agents |
~30% |
Varies |
Different mechanisms, often costlier |
Key Takeaways
- The market for doxorubicin injection is mature with declining prices driven by biosimilar entry.
- The overall market remains stable due to high cancer prevalence but is facing competition from targeted and immunotherapies.
- Prices are expected to decline gradually over the next five years, stabilizing around $50 per 20 mg vial.
- International markets, especially emerging economies, will play a significant role in volume expansion despite lower prices.
- Regulatory approvals and manufacturing efficiencies will influence pricing trajectories.
FAQs
1. How does biosimilar entry impact doxorubicin prices?
Biosimilars lead to significant price reductions, with median prices dropping by approximately 60% post-approval, increasing market competition.
2. What are the primary factors influencing doxorubicin prices?
Market dynamics, patent status, biosimilar competition, manufacturing costs, and regional regulations.
3. Are there upcoming regulatory changes that could affect pricing?
Yes. Increased approval pathways for biosimilars in the US and EU encourage competition, likely reducing prices further.
4. How significant is international market expansion for doxorubicin?
International markets, especially in Asia and Latin America, offer volume growth opportunities despite lower per-unit prices.
5. What is the outlook for doxorubicin's market share?
While still essential, its market share is gradually shrinking due to evolving oncology treatments, but volume remains steady driven by existing indications.
References
[1] Grand View Research. (2023). Oncology Drugs Market Size, Share & Trends Analysis.
[2] IQVIA. (2023). Drug Sales Data.
[3] Market Watch. (2023). Oncology Drug Competition Reports.
[4] MediSpan. (2023). Drug Pricing Database.
[5] WHO. (2022). Essential Medicines and Pricing Data.
Note: All figures are estimates based on industry reports and market analyses, pending further regional-specific data.
