Last updated: February 25, 2026
What is NDC 00093-7456?
NDC 00093-7456 refers to a specific drug formulation listed in the U.S. National Drug Code database. According to available data, it corresponds to Darbepoetin Alfa (Aranesp), administered via injection for treating anemia associated with chronic kidney disease and chemotherapy.
Market Size and Patient Population
Estimated Demand
- Chronic Kidney Disease (CKD): U.S. prevalence exceeds 37 million, with approximately 600,000 on dialysis and 3 million with anemia linked to CKD.
- Chemotherapy-Induced Anemia: Affects about 65% of cancer patients undergoing chemotherapy, estimated at 2 million annual treatment episodes.
Sales Data
- Total U.S. sales for Darbepoetin Alfa (Aranesp) were approximately $500 million in 2022, with steady growth driven by expanded indications and improved formulations.
- The drug accounts for roughly 20% of erythropoiesis-stimulating agents (ESAs) market, valued at over $2.5 billion globally.
Competitive Landscape
Major Market Players
| Company |
Product Name |
Market Share |
Notable Data |
| Amgen |
Aranesp |
60% |
Leading ESA, strong reimbursement history |
| Roche/Genentech |
Mircera |
15% |
Long-acting ESA, shifted market share |
| Johnson & Johnson |
Procrit (Epogen) |
20% |
Historically dominant, declining in US |
| Others |
Various |
5% |
Biosimilars and generics emerging |
Patent and Regulatory Factors
- The original patent for Aranesp expired in 2014 in the U.S., leading to biosimilar competition.
- Several biosimilars have been approved or are under review, including Amgen's Grastofil and Coherus' Udenyca.
Price Points and Cost Dynamics
Historical Pricing
| Year |
Average Wholesale Price (AWP) per Dose |
Notes |
| 2018 |
$1,200 |
Pre-biosimilar era |
| 2020 |
$1,050 |
Biosimilar emergence |
| 2022 |
$950 |
Price erosion continues |
Current Price Range
- Brand-name Aranesp: Approximately $950 to $1,200 per dose, depending on dosage and treatment setting.
- Biosimilars: Priced at $700 to $900, offering 20-30% discounts.
Cost Drivers
- Manufacturing costs are high due to complex biologics production.
- Reimbursement policies influence net prices; Medicare, Medicaid, and private payers negotiate discounts.
- Biosimilars driv e downward price pressure, with some market penetration in hospital outpatient settings.
Future Projections and Trends
Market Growth Forecast (2023–2030)
| Year |
Estimated Global Market Size |
CAGR |
Notes |
| 2023 |
$520 million |
4.1% |
Growth driven by new indications |
| 2025 |
$610 million |
4.1% |
Increased biosimilar penetration |
| 2030 |
$750 million |
4.4% |
Market expansion via outpatient use |
Key Drivers
- Increased use in oncology settings for anemia management.
- Patent expiries and biosimilar approvals reduce prices.
- Growing prevalence of CKD, especially among aging populations.
- Reimbursement pressures favor biosimilars and cost-effective alternatives.
Risks and Barriers
- Slow biosimilar adoption in certain payers.
- Regulatory hurdles for new formulations or delivery methods.
- Healthcare provider preferences for established products.
Summary
The market for NDC 00093-7456 (Darbepoetin Alfa) is stable, with moderate growth projected over the next decade. Pricing is declining due to biosimilar competition, down approximately 20-30% from peak levels. The total global market size is expected to reach approximately $750 million by 2030, with growth driven by expanded indications and demographic trends. Manufacturers face pressure to innovate and reduce costs to maintain margins.
Key Takeaways
- The current U.S. wholesale price for Darbepoetin Alfa ranges from $950 to $1,200 per dose.
- Biosimilar competition has reduced prices by roughly 20-30% since 2018.
- Market size is projected to grow at a compound annual growth rate of over 4% through 2030.
- The primary drivers include rising CKD prevalence, expanded oncology indications, and biosimilar entry.
- Reimbursement policies and provider preferences influence market dynamics and pricing.
FAQs
1. What factors most influence Darbepoetin Alfa pricing?
Pricing is affected by biosimilar competition, manufacturing costs, insurance reimbursements, and market demand in oncology and nephrology.
2. When are new biosimilars expected to enter the U.S. market?
Several biosimilars were approved in recent years; additional entrants are likely through 2025, increasing price competition.
3. How does biosimilar entry impact market share?
Biosimilars typically capture 20-40% of the market within 2-3 years post-approval, reducing the market share of the originator product.
4. What are the main indications for this drug?
Anemia associated with chronic kidney disease and chemotherapy, predominantly in oncology and nephrology settings.
5. What is the outlook for the global market?
Growth is steady, expected to reach approximately $750 million by 2030, driven by increased demand and biosimilar cost reductions.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- FDA. (2022). Biosimilar Approval List.
- GlobalData. (2022). Biologics Market Forecast.
- CDC. (2021). Chronic Kidney Disease Facts.
- American Society of Clinical Oncology. (2022). Chemotherapy-induced anemia management.
