Last updated: December 14, 2025
Executive Summary
NDC 62332-0790 corresponds to Erythropoietin Alfa (Injected), a biologic therapy primarily used for treating anemia associated with chronic kidney disease (CKD), chemotherapy, or surgical blood management. This analysis provides an overview of the current market landscape, competitive positioning, pricing trends, and future projections based on recent data. The report underscores the influence of regulatory shifts, biosimilar entry, and payer dynamics on the commercial prospects of this biologic.
Overview of NDC 62332-0790 and Its Therapeutic Indications
| Attribute |
Details |
| Drug Name |
Erythropoietin Alfa (Injected) |
| Manufacturer |
As of 2023, major suppliers include Amgen (Epogen, Procrit), and others. |
| NDC Code |
62332-0790 |
| Formulation |
Lyophilized powder for injection; often administered intravenously or subcutaneously |
| Indications |
- Anemia in CKD (Chronic Kidney Disease) |
|
- Anemia due to chemotherapy |
|
- Anemia associated with surgical blood management |
Erythropoietin Alfa is a recombinant form of erythropoietin, stimulating erythropoiesis. It remains a standard of care but faces pricing pressures amid biosimilar competition.
Market Landscape and Segment Analysis
Market Size and Demand Dynamics
| Metric |
2022 |
2023 (Projected) |
CAGR (2023-2028) |
Notes |
| U.S. Market Value |
~$1.2 billion |
~$1.4 billion |
4.5% |
Driven by CKD prevalence (~37 million adults in the U.S.) and expanding chemotherapy treatments. |
| Global Market |
~$2.5 billion |
~$3 billion |
6% |
Emerging markets adopting biologics. |
| Treatment Population |
~4 million patients |
+5% annually |
|
Accounts for CKD, oncology, surgical use. |
Competitive Landscape
| Manufacturer |
Products |
Market Share |
Price Position |
Remarks |
| Amgen |
Epogen, Procrit |
~70% |
Premium |
Market leader with established biosimilar competition |
| Hospira |
Retacrit (biosimilar) |
~15% |
Discounted |
Biosimilar entry since 2018 |
| Other biosimilars |
Various |
~10% |
Lower than originator |
Growing competition |
| Remaining players |
Various |
5% |
Niche |
Limited presence |
Key Drivers:
- Biosimilar products (~$50-$70 per dose) are eroding the originator's pricing (~$70-$120 per dose).
- Off-label use and aggressive payer negotiations further pressure margins.
Pricing Trends and Regulatory Impact
Current Pricing Overview
| Product Type |
Approximate Cost per Dose |
Notes |
| Originator (Epogen, Procrit) |
$70 - $120 |
Varies by dosage, administration route, and payer discounts |
| Biosimilars (Retacrit) |
$50 - $70 |
Price competitive, with increased uptake post-approval (2018) |
| Hospital/Buy-and-Bill Settings |
Variable |
Negotiated rebates and rebates crucial to net price |
Regulatory and Payer Dynamics
- FDA Approvals:
- Biosimilar approvals since 2015 have fostered price competition.
- Insurance & Payer Influence:
- Payors favor biosimilars as cost-saving alternatives.
- Prior authorization and step therapy programs are common.
International Pricing
- Developing markets see lower prices (~$30-$50 per dose) due to price controls and biosimilar penetration.
Future Price Projections (2023-2028)
| Year |
Estimated Avg. Price per Dose |
Market Drivers |
Notes |
| 2023 |
$55 - $85 |
Biosimilar competition, inflation |
Slight decline of ~5-10% in originator prices expected |
| 2024 |
$50 - $80 |
Increased biosimilar adoption |
Further price erosion |
| 2025 |
$45 - $75 |
Payer pressure intensifies |
Price stabilization at lower band |
| 2026 |
$45 - $70 |
Market maturation |
Biosimilars constitute >50% of sales |
| 2027 |
$40 - $65 |
Biosimilar proliferation |
Volume-driven growth compensates for lower prices |
| 2028 |
$40 - $60 |
Consolidation, biosimilar dominance |
Stabilization expected |
Key Market Trends and Opportunities
- Biosimilar Penetration: Biosimilars are expected to capture increasing market share (~85% of new prescriptions by 2025).
- Emerging Markets: Rapid growth driven by expanding healthcare infrastructure and generic biologic adoption.
- Innovative Delivery: Extended-formulations and biospecific enhancements may influence future pricing and utilization.
- Regulatory Policies: Government policies favoring biosimilar substitution (e.g., U.S. federal and state mandates) will accelerate price compression.
Comparative Analysis: NDC 62332-0790 vs. Competitors
| Attribute |
NDC 62332-0790 |
Key Competitors |
Market Positioning |
| Product Type |
Erythropoietin Alfa |
Erythropoietin Biosimilars |
Originator vs. biosimilar landscape |
| Pricing |
$70 - $120 per dose |
$50 - $70 per dose |
Biosimilars undercut originator |
| Approval Timeline |
2001 (Epogen/Procrit) |
2018 onwards (biosimilars) |
Established presence with newer competitors |
| Market Share |
~70% (originator) |
>25% (biosimilars) |
Declining for originator, growing for biosimilars |
Regulatory and Policy Impacts
| Policy/Regulation |
Impact |
Date |
Source |
| US Biosimilar Pathway |
Facilitates biosimilar entry |
2010 |
[1] |
| CMS Reimbursement Policies |
Favor biosimikars |
2018 |
[2] |
| International Price Caps |
Reduce prices |
2022 |
NCDR, France, Germany |
Conclusion & Recommendations
- Market Outlook: The Erythropoietin Alfa market will experience moderate growth driven by increased demand but faces significant pricing pressure due to biosimilars.
- Pricing Strategy: Manufacturers should focus on biosimilar diversion, competitive pricing, and value-based contracts.
- Investment Perspective: Biosimilar providers are poised to dominate, with originators facing erosion but still holding substantial market share in specific niches.
- Forecast Validity: The projections rely on current biosimilar adoption rates, regulatory policies, and payer negotiations. Sudden policy shifts could accelerate or hinder this trajectory.
Key Takeaways
- The traditional price for erythropoietin alfa was around $70–$120/dose, but bios Mid-2000s: biosimilar options introduced at 50–70%, pushing originator prices downward.
- Biosimilar market share is projected to surpass 85% by 2025, exerting downward pressure on pricing.
- Regulatory policies supporting biosimilar substitution are crucial for future price trajectories.
- The global market will grow at a compound annual rate of 6%, with emerging markets leading growth through lower prices and increased access.
- Competitive differentiation will increasingly depend on formulations, delivery devices, and biosimilar partnerships.
FAQs
1. How will biosimilar entry impact the price of NDC 62332-0790?
Biosimilars are expected to reduce the average price per dose by approximately 20-50% over the next five years, especially after gaining wider payer acceptance, leading to intensified price competition.
2. What are the key factors driving demand for erythropoietin alfa?
Demand is primarily driven by the rising prevalence of CKD (chronic kidney disease), expanding oncology treatments requiring anemia management, and surgical procedures necessitating blood augmentation, with a growing emphasis on outpatient administration.
3. How might regulatory changes influence market dynamics?
Regulations that incentivize biosimilar prescribing, such as federal policies, step therapy programs, and interchangeability designations, could accelerate biosimilar uptake, further pressuring prices and market shares of originator products.
4. What regional differences exist in pricing and market penetration?
In the U.S., prices are somewhat higher owing to rebates and better reimbursement, whereas international markets—especially in Europe and emerging economies—experience lower prices due to price controls and earlier biosimilar uptake.
5. Are there emerging innovations that could affect future pricing?
Yes, novel delivery systems, extended dosing intervals, and biospecific formulations could enhance value, potentially stabilizing prices if they demonstrate significant clinical advantages.
Sources
[1] Food and Drug Administration (FDA). "Biosimilar Development and Approval." 2022.
[2] Centers for Medicare & Medicaid Services (CMS). "Final Rule on Biosimilar Reimbursement." 2018.
[3] Grand View Research. "Erythropoietin Market Size & Share." 2023.
[4] IQVIA. "Biologics & Biosimilars Market Data." 2023.
[5] European Medicines Agency (EMA). "Biosimilar Medicines." 2022.
This comprehensive analysis aims to equip stakeholders with actionable insights into the current and future landscape of NDC 62332-0790, supporting strategic decision-making in manufacturing, investment, and healthcare policy.
