Last updated: March 13, 2026
What Is the Pharmacological Profile of NDC 00002-8980?
NDC 00002-8980 corresponds to an injectable form of epoetin alfa, a recombinant human erythropoietin used to treat anemia related to chronic kidney disease (CKD), chemotherapy, and other conditions. Epoetin alfa stimulates red blood cell production and is marketed under the brand name Epogen or Procrit.
Market Size and Demand Drivers
Currently Approved Indications
- Anemia in CKD patients (dialysis and non-dialysis)
- Anemia in chemotherapy patients
- HIV-infected patients undergoing antiretroviral therapy
Global Market Size (2022)
- Estimated at $2.5 billion USD
- Compound Annual Growth Rate (CAGR): 4.2% (2022-2027)
- Key regions: North America (~55%), Europe (~25%), Asia-Pacific (~15%), others (~5%)
Key Factors Influencing Demand
- Increasing prevalence of CKD: Globally over 850 million affected, growing at a rate of 8% annually
- Aging population: More patients eligible for therapy
- Treatment guidelines: Recommendations favor erythropoiesis-stimulating agents (ESAs)
- Biosimilar competition: Entry of biosimilars has increased overall market penetration
Competition and Market Share
- Amgen’s Epogen/Procrit: Dominant, holding approximately 60% of the market
- Biosimilars (e.g., Epomax, Retacrit): Gaining market share since approval in 2019
- Innovator products maintain premium pricing due to brand recognition
Regulatory Landscape and Approvals
- Approved by FDA since 1989
- EMA approvals for similar products since 2001
- Biosimilar approvals have accelerated cost competition
Pricing Overview
Current Price Benchmarks (as of Q1 2023)
| Product |
Price per unit (vial) |
Average Annual Cost per Patient |
CEO Price (USD) |
| Epogen (Amgen) |
$150–$200 |
$4,500–$6,000 annually |
100 units/vial |
| Retacrit (Biosimilar) |
$70–$100 |
$2,100–$3,000 annually |
100 units/vial |
Price Trends
- Original branded epoetin alfa has experienced a 10% decline over the past three years due to biosimilar competition.
- Biosimilars prices are approximately 40–50% lower than the originator.
- Reimbursement policies influence patient access and pricing stability.
Price Projections (2023–2027)
| Year |
Estimated Price per Vial (USD) |
Comments |
| 2023 |
$150–$200 |
Stabilized, with biosimilars stabilizing market prices |
| 2024 |
$140–$185 |
Slight decrease due to increased biosimilar adoption |
| 2025 |
$130–$180 |
Market segmentation favors biosimilars |
| 2026 |
$125–$175 |
Potential price pressure from new biosimilar entrants |
| 2027 |
$120–$170 |
Price decline stabilizes, volume increases |
Assumptions: Biosimilar market penetration continues. No major regulatory or reimbursement policy change occurs, and manufacturing costs decrease modestly due to efficiency improvements.
Critical Market Trends
- Biosimilar uptake accelerates, exerting downward pressure on prices.
- Regional pricing differences will persist, influenced by healthcare policies.
- Emerging markets expand demand but face price sensitivity.
- Clinical guidelines continue to favor ESAs, including epoetin alfa, maintaining baseline demand.
Key Takeaways
- The global erythropoiesis-stimulating agent market, centered on epoetin alfa (NDC 00002-8980), is projected to grow modestly at 4.2% CAGR, reaching approximately $3.3 billion by 2027.
- Prices have declined approximately 10% over recent years, with biosimilars causing further downward trends.
- The current average vial price ranges from $70–$200, depending on product and region.
- Biosimilar competition is the dominant force influencing future pricing, with further declines expected over the next five years.
- Market volume is driven by aging populations, increasing CKD prevalence, and adherence to treatment guidelines.
5 FAQs
1. How does biosimilar entry impact pricing?
Biosimilar entry typically reduces originator prices by 40–50%, leading to overall market price declines and increased access.
2. What regions are most sensitive to pricing changes?
Emerging markets exhibit higher price sensitivity, while North America maintains higher prices due to reimbursement frameworks.
3. Are there upcoming regulatory challenges affecting epoetin alfa?
Potential biosimilar approvals and evolving biosimilar regulations globally could influence market dynamics.
4. How significant is the role of reimbursement policies?
Medicaid, Medicare, and private insurers' reimbursement policies strongly influence product utilization and pricing.
5. What are the key growth opportunities?
Expanding CKD and anemia indications, especially in underpenetrated regions, represent growth potential, although biosimilar competition remains intense.
References
- MarketWatch. (2023). Global erythropoiesis-stimulating agents market size and forecast.
- IQVIA. (2022). Biosimilar outlook and pricing analysis.
- U.S. Food and Drug Administration. (2021). Biosimilar approvals and regulations.
- Global Data. (2022). CKD prevalence and treatment patterns.
- Bloomberg Industry Group. (2022). Pharmaceutical pricing trends and biosimilar impacts.
