Last updated: August 10, 2025
Introduction
Analyzing the market landscape and price trajectory for the drug identified by National Drug Code (NDC) 00002-1436 is essential for stakeholders, including pharmaceutical companies, healthcare providers, and investors. NDC 00002-1436 refers to Procrit (epoetin alfa), a recombinant human erythropoietin used primarily to treat anemia associated with chronic kidney disease (CKD), chemotherapy, or surgery. As a mature biologic, Procrit's market dynamics are influenced by regulatory, competitive, and technological factors. This report provides a comprehensive market overview and detailed price projections driven by current data and industry trends.
Market Overview
Product Lifecycle and Revenue Performance
Procrit, marketed by Amgen since its initial approval in 1989, remains a leading erythropoietin-stimulating agent (ESA). Despite the advent of biosimilars, Procrit maintains significant market share due to brand loyalty, established healthcare provider prescribing habits, and patent protections extending into recent years. However, the expiration of key patents in various regions has introduced biosimilar competition, affecting pricing and market share.
Regulatory Landscape
The US FDA has approved several biosimilars to Procrit, including Epogen and Retacrit. The proliferation of biosimilars has introduced price competition, especially since the biosimilars entered the market post-2019, leading to a notable decline in proprietary product revenues and prices.
Market Size and Demand Drivers
The global anemia treatment market, driven by CKD patient populations, chemotherapy recipients, and perioperative care, is valued at approximately $3 billion (2022). In the US, the anemia segment accounts for roughly $1.2 billion, with growth fueled by increasing CKD prevalence and expanding indications for ESA use.
Demand for erythropoietin analogs remains strong but faces pressure from alternative therapies and shifting clinical guidelines advocating for conservative anemia management. Additionally, the COVID-19 pandemic temporarily disrupted supply chains and elective procedures, affecting utilization patterns.
Competitive Environment
The emergence of biosimilars has intensified price competition. Biosimilars such as Retacrit and Binocrit (approved in Europe) are priced 25-50% lower than the reference product, exerting downward pressure on prices of the branded drug.
Furthermore, newer therapeutic modalities, such as hypoxia-inducible factor (HIF) stabilizers (e.g., roxadustat), are promising alternatives, potentially reducing the long-term future demand for traditional ESAs like Procrit.
Price Trends and Projections
Historical Pricing Dynamics
Historically, the wholesale acquisition cost (WAC) of Procrit in the US hovered around $300-$400 per dosage unit [1], with significant discounts applied during healthcare provider negotiations and reimbursement adjustments. Post-biosimilar entry, prices for the brand and biosimilars have converged, with certain biosimilars retailing at approximately 60-70% of the original branded price.
Current Market Prices
As of late 2022, the average wholesale price (AWP) for Procrit's standard dosing is approximately $200-$350 per dose depending on dosage form and supplier agreements. Biosimilar pricing averages around $150-$250, indicating substantial discounting compared to the original brand.
Price Forecast (2023-2030)
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Moderate Decline Due to Biosimilar Competition
Over the next 3-5 years, biosimilar proliferation is expected to continue, driving average prices down by 10-15% annually. By 2025, Procrit prices may decline to approximately $150-$250 per dose for the brand and $100-$180 for biosimilars.
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Market Saturation and Volume Growth
Despite price declines, overall revenue may stabilize due to volume growth, especially as CKD prevalence increases globally. However, growth rates will be moderated by clinical guidelines favoring non-ESA therapies and HIF stabilizers.
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Impact of Biosimilar Market Penetration
In regions with robust biosimilar adoption, prices are projected to decline more sharply, possibly reaching sub-$100 levels per dose in select markets by 2028.
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Long-term Outlook (2027-2030)
The entry of novel therapies could further compress prices and reduce demand for traditional ESAs like Procrit. Prices might stabilize at levels approximately 30-40% lower than current prices, depending on the competitive landscape and regulatory policies incentivizing biosimilar use.
Key Market Influencers
- Regulatory approvals of biosimilars and new biologics, impacting pricing and market share.
- Healthcare policy changes, including reimbursement reforms favoring biosimilars.
- Industry authorization of new therapies like HIF stabilizers, which may replace ESAs in certain indications.
- Global CKD and cancer prevalence, influencing overall market demand.
- Economic factors, such as drug pricing regulations in various jurisdictions.
Risks and Opportunities
Risks:
- Further biosimilar and generic entrants lowering prices.
- Regulatory restrictions or reimbursement caps limiting upside.
- Clinical shifts favoring alternative anemia treatments.
Opportunities:
- Expansion into emerging markets with growing anemia patient populations.
- Strategic collaborations for biosimilar development.
- Innovation in delivery methods reducing costs or improving compliance.
Conclusion
The price of NDC 00002-1436 (Procrit) is likely to continue trending downward over the next decade, predominantly driven by biosimilar competition and regulatory evolution. While demand remains significant due to CKD and oncology indications, new therapeutic options may reshape the market, pressuring traditional ESA prices further. Stakeholders should monitor biosimilar market entries and shifts in clinical guidelines to optimize pricing strategies and market positioning.
Key Takeaways
- Pricing will decline by approximately 10-15% annually through 2025, driven by biosimilar competition.
- Average prices may reach $150-$250 per dose for the original product by mid-decade, with biosimilars potentially under $150.
- Market volume growth due to increasing prevalence could offset some price reductions, maintaining revenue streams.
- Regulatory and technological shifts could further compress prices, especially with innovative therapies like HIF stabilizers.
- Strategic adaptation to biosimilar adoption and global demand is crucial for maximizing value.
FAQs
1. What factors influence the price of Procrit (NDC 00002-1436)?
Pricing is affected by biosimilar competition, regulatory policies, reimbursement frameworks, clinical guidelines, and the entry of new therapeutic options.
2. How will biosimilars impact Procrit's market price?
Biosimilars exert downward pressure by offering comparable efficacy at lower costs, accelerating price declines and market share redistribution.
3. Is Procrit still a profitable option for manufacturers?
Profitability depends on manufacturing costs, market share retention amid biosimilar competition, and regional pricing strategies. While declining, demand remains substantial in certain indications.
4. What are the future alternative therapies that could challenge Procrit?
HIF stabilizers like roxadustat are emerging as promising alternatives, potentially replacing ESAs in anemia management for CKD and other conditions.
5. How should stakeholders prepare for future market changes?
By investing in biosimilar development, monitoring regulatory trends, and exploring innovative delivery methods, stakeholders can sustain competitiveness.
References
[1] SSR Health. "Historical Pricing Data for Erythropoietin-Stimulating Agents." 2022.
