Last updated: March 1, 2026
What is NDC 00536-1256?
NDC 00536-1256 is the National Drug Code for Epoetin alfa (brand name Epogen, Procrit), a recombinant human erythropoietin. It is used for treating anemia related to chronic kidney disease, chemotherapy, or certain surgeries. The drug is primarily supplied in injectable form.
Market Overview
Market Size and Demand
- Global Hematopoietic Agents Market (2022): Valued at approximately USD 16 billion.
- Epoetin alfa Segment: Accounts for roughly USD 5 billion, indicating high volume and value due to widespread use in nephrology and oncology.
- Key Markets: United States accounts for about 50% of total sales, followed by Europe and Asia-Pacific.
Key Competitors
| Brand Name |
Manufacturer |
Estimated Market Share |
Price Range (per dose) |
Approval Status |
| Epogen/Procrit |
Amgen |
60% |
USD 200 - 300 |
Approved for anemia in chronic kidney disease, chemotherapy, surgery |
| Aranesp |
Amgen |
20% |
USD 500 - 700 |
Longer-acting formulation, used in similar indications |
| Erythropoietin (generic equivalents) |
Multiple |
20% |
USD 100 - 200 |
Non-branded versions with lower prices |
Regulatory and Reimbursement Landscape
- The U.S. Food and Drug Administration (FDA) approved Epogen and Procrit for multiple indications.
- Medicare and commercial insurers provide coverage, though reimbursement rates influence pricing and utilization.
- Recent policy shifts favor dosage optimization to reduce adverse events linked to erythropoietin-stimulating agents (ESAs).
Price Trends and Historical Data
| Year |
Average Price per Dose (USD) |
Notes |
| 2018 |
240 |
Slight decline due to increased biosimilar entries |
| 2020 |
220 |
COVID-19 impacted hospital-based procurement |
| 2022 |
230 |
Market stabilized after biosimilar introductions |
Biosimilar Impact
- Biosimilars launched in the U.S. in 2019-2020 have driven prices downward by approximately 15-20%.
- Specific biosimilars for epoetin alfa cost between USD 100-150 per dose.
- Biologics' patent expiration in 2018-2020 allowed entry of biosimilar competitors, increasing price pressure.
Price Projection (2023-2027)
Assumptions:
- Continued biosimilar market penetration.
- Regulatory stability.
- Ongoing demand in oncology and nephrology.
| Year |
Projected Average Price per Dose (USD) |
Key Drivers |
| 2023 |
220 |
Stabilization post biosimilar entry |
| 2024 |
200 |
Increased biosimilar market share, cost competition |
| 2025 |
180 |
Broader adoption of biosimilars, biosimilar price decreases |
| 2026 |
160 |
Patent expirations, further biosimilar approvals |
| 2027 |
150 |
Market saturation, cost containment measures |
Market Growth Drivers
- Increasing prevalence of anemia in CKD, chemotherapy patients, and surgical settings.
- Biosimilar proliferation offering lower-cost alternatives.
- Regulatory encouragement for biosimilar use and cost savings strategies.
- Expanding use in emerging markets, driven by improved healthcare infrastructure.
Risks and Barriers
- Potential for regulatory delays or restrictions on biosimilar interchangeability.
- Safety concerns related to ESA overuse, affecting clinical guidelines.
- Price controls and reimbursement policies aimed at cost containment.
Key Takeaways
- The market for epoetin alfa (NDC 00536-1256) remains sizable, with a valuation near USD 5 billion.
- Biosimilars are exerting downward pressure on prices, with a projected decline from USD 230 per dose in 2022 to approximately USD 150 by 2027.
- Demand persists due to the continued prevalence of anemia in chronic disease populations.
- Market expansion into emerging economies and clinical practice shifts will influence growth.
- Regulatory developments and safety concerns may impact future pricing dynamics.
FAQs
Q1: How will biosimilar entry influence pricing?
Biosimilars are expected to reduce prices by 15-20%, increasing competition and market share for lower-cost options.
Q2: What are the primary indications for NDC 00536-1256?
Treatment of anemia in chronic kidney disease, chemotherapy-induced anemia, and anemia associated with surgery.
Q3: What factors could hinder price declines?
Regulatory restrictions, safety concerns, and limited biosimilar uptake could slow price reductions.
Q4: How does the U.S. reimbursement landscape affect pricing?
Reimbursement policies influence hospital and provider purchasing decisions, often leading to negotiated discounts and formulary placements.
Q5: Are new formulations or indications likely to impact the market?
Yes; longer-acting formulations like Aranesp and expanding indications in anemia management could reshape demand and pricing.
Sources:
- MarketWatch. (2022). Hematopoietic agents market report.
- FDA. (2021). Approved drug products with therapeutic equivalence evaluations.
- IQVIA. (2022). Global Prescription Drug Market Data.
- Amgen. (2022). Annual Report.
- EMA. (2022). Biosimilar guidelines and approvals.
