Last updated: February 27, 2026
What is NDC 42291-0125?
NDC 42291-0125 corresponds to Retacrit (epoetin alfa-epbx) injection. It is a biosimilar to Epogen and Procrit, used to treat anemia caused by chronic kidney disease, chemotherapy, or other medical conditions. Approved in the U.S. by the FDA in October 2019, it is marketed by Pfizer under the brand Retacrit.
Market Size and Penetration
Key Market Drivers
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Prevalence of Anemia: Globally, anemia affects approximately 1.8 billion people, with chronic kidney disease (CKD) and cancer as primary conditions requiring erythropoietin-stimulating agents (ESAs).
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Treatment Landscape: The biosimilar market for ESAs expanded post-2019 due to patent expirations. Retacrit's entry has targeted hospitals and outpatient clinics.
Competitive Position
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Brand vs. Biosimilar: Retacrit is priced approximately 20-30% lower than originator products (Epoetin alfa, Darbepoetin alfa).
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Market Share: As of early 2023, Retacrit's market share in biosimilar ESAs in the U.S. stands at approximately 35%, with growth driven by hospital formulary acceptance.
Market Segmentation
| Segment |
Share (2023) |
Growth Rate (2022-2023) |
Notes |
| Hospitals |
50% |
12% |
Major channel, preferred for biosimilars |
| Oncology clinics |
25% |
8% |
Used for chemotherapy-induced anemia |
| Chronic outpatient settings |
25% |
10% |
Increasing use as biosimilar options expand |
Price Projections
Current Pricing
- Average Wholesale Price (AWP): Retacrit's AWP ranges from $3.00 to $4.00 per unit (dose), approximately 25-30% lower than originators.
- Reimbursement: Medicare and private insurers typically reimburse at 150% of AWP, with negotiated discounts reducing actual payer prices.
Short-term Projections (2023-2025)
- Price Trend: Prices are expected to stabilize with minor fluctuations (+2-3%) due to manufacturer rebates and contracting dynamics.
- Reimbursement Pressure: Payor negotiations will influence net prices, potentially reducing gross prices by an additional 10% over two years.
Long-term Outlook (2026-2030)
- Biosimilar market saturation may lead to further price erosion. Expected average prices could decline by 15-20% from 2025 levels as more biosimilar competitors enter.
Benchmark Comparison
| Product |
Manufacturer |
Launch Year |
Average Price (per dose) |
Market Share (2023) |
| Retacrit |
Pfizer |
2019 |
$3.50 |
35% |
| Epogen (originator) |
Amgen |
1989 |
$5.00 |
Declining |
| Aranesp |
Amgen |
2001 |
$6.50 |
10% (used for anemia of CKD) |
Regulatory and Policy Impact
- Interchangeability: No federal designation as interchangeable, limiting substitution to pharmacy level.
- Reimbursement Policies: CMS has implemented policies favoring biosimilar use through alternative payment models, potentially reducing prices.
Market Risks and Opportunities
Risks
- Market Saturation: Increased biosimilar availability may drive prices down further.
- Patent Litigation: Originator companies may challenge biosimilar patents, delaying market entry or price erosion.
- Supply Chain Disruptions: Manufacturing issues could reduce supply, affecting price and market stability.
Opportunities
- Expanding Indications: Ongoing research into additional indications could increase use.
- International Markets: Growth potential in Europe and Asia where biosimilar adoption accelerates.
- Value-based Contracts: Payers offered discounts tied to outcomes, affecting net pricing strategies.
Key Takeaways
- NDC 42291-0125 (Retacrit) has gained significant market share since 2019 but faces increasing competition.
- Prices are relatively stable but subject to decline due to market saturation and enhanced payor bargaining.
- The biosimilar segment for ESAs is projected to see a 15-20% price reduction by 2030.
- Market expansion into international territories and new indications offers growth avenues.
- Regulatory policies and payer strategies will remain critical price influencers.
FAQs
1. What factors influence biosimilar pricing?
Manufacturers’ rebate strategies, payer negotiations, market competition, and regulatory policies significantly impact biosimilar prices.
2. How does Retacrit compare to originator products?
Retacrit is priced 20-30% lower than originators (Epoetin alfa, Procrit) and has gained market share through cost savings for providers.
3. What is the outlook for biosimilar ESAs beyond 2023?
Prices are expected to decline by 15-20% by 2030 due to increased competition, improved manufacturing, and payor policies.
4. Which market segments are primary for Retacrit?
Hospitals and oncology clinics are the main channels, with outpatient settings showing increasing adoption.
5. How might regulatory changes affect biosimilar prices?
Designations like interchangeability could foster substitution at pharmacy level, potentially driving prices lower.
References
[1] Food and Drug Administration (FDA). (2019). FDA approves first biosimilar for epoetin alfa.
[2] IQVIA. (2023). U.S. pharmaceutical market analysis.
[3] EvaluatePharma. (2023). Biosimilars market projections.
[4] Centers for Medicare & Medicaid Services (CMS). (2022). Policy updates on biosimilar reimbursement.
[5] CDC. (2022). Global anemia prevalence and causes.
Please note that market prices and figures are based on public sources, industry reports, and projections as of early 2023.
