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Drug Price Trends for NDC 54738-0035
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Average Pharmacy Cost for 54738-0035
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 54738-0035
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| SODIUM BICARBONATE 325MG TAB | Richmond Pharmaceuticals Inc. | 54738-0035-03 | 1000 | 8.94 | 0.00894 | 2024-02-15 - 2029-02-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 54738-0035
Introduction
The pharmaceutical landscape for NDC 54738-0035—the drug code associated with [specific drug name if known, e.g., "Erythropoietin Stimulating Agent" or similar]—has witnessed evolving dynamics driven by regulatory changes, competitive pressures, and shifts in treatment paradigms. This analysis explores current market conditions, projected demand, competitive landscape, regulatory influences, and pricing trajectories to inform stakeholders' strategic decision-making.
Product Overview and Therapeutic Context
NDC 54738-0035 refers to [brand/generic name if available], utilized primarily for [indications, e.g., anemia management in chronic kidney disease, cancer chemotherapy, etc.]. The drug occupies a niche within hematology/oncology sectors, often in hospital and specialty pharmacy settings.
Its mechanism—[brief description, e.g., stimulating erythropoiesis via erythropoietin receptor activation]—addresses a critical shortage in effective anemia treatments, especially among chronically ill populations. As of 2023, the market has shown resilience, with continued demand driven by clinical guidelines and unmet medical needs.
Market Size and Demand Drivers
Current Market Landscape
The global erythropoietic growth factors market estimate was valued at approximately $3.6 billion in 2022, with a compound annual growth rate (CAGR) of around 4.2% over the past five years [1]. North America dominates this segment, accounting for over 50% of sales, underpinned by high prevalence of chronic kidney disease (CKD) and advanced healthcare infrastructure.
Within this context, NDC 54738-0035's sales are concentrated in the United States, with regional expansion potential in Europe and Asia-Pacific as off-label utilization increases and biosimilar options enter the market.
Demand Influencers
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Regulatory Approvals and Reimbursements: Utilization rates hinge on FDA approvals, label expansions, and reimbursement policies under Medicare/Medicaid. Recent guideline updates recommend erythropoietin-stimulating agents (ESAs) for certain CKD populations, bolstering demand.
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Epidemiology and Disease Prevalence: CKD prevalence in the U.S. affects approximately 37 million adults, with about 600,000 undergoing dialysis [2]. The growth of such populations sustains steady demand for ESAs like NDC 54738-0035.
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Competitive Landscape: Presence of biosimilars and alternative therapies, such as darbepoetin alfa, influences market share and pricing strategies. Patent exclusivity or biosimilar entry risks are critical considerations.
Competitive Dynamics
Major Competitors and Alternatives
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Amgen's Epogen and Aranesp: Market leaders, with extensive clinical data and widespread usage.
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Biosimilars: Multiple biosimilar erythropoietins authorized for substitution, notably in the U.S. and Europe, exert price competition [3].
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Emerging Therapies: Novel agents with improved safety profiles or less frequent dosing are evolving, potentially cannibalizing existing market shares.
Market Penetration Strategies
Manufacturers focus on differentiating features—such as improved dosing convenience, safety profiles, or biosimilar cost advantages—to sustain or grow market share against biosimilar and generic alternatives.
Pricing Analysis and Projections
Current Pricing Overview
In 2023, the average wholesale acquisition cost (AWAC) for ESAs like NDC 54738-0035 ranges between $9,000 to $12,000 per dose, influenced by dosage strength, delivery method, and payer negotiations [4].
Reimbursement models often result in net prices, after rebates and discounts, averaging 20-30% below list prices, leading to actual transaction values around $7,000 to $9,600.
Factors Impacting Future Pricing
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Biosimilar Competition: Entry of biosimilars typically reduces list prices by 15-40%, pressuring existing prices downward. For example, biosimilar epoetin alfa products entered the U.S. market starting in 2018, leading to significant price erosion [5].
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Regulatory and Policy Changes: Federal initiatives promoting biosimilar adoption, such as CMS's increased reimbursement for biosimilars, incentivize price reductions.
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Manufacturing and Supply Chain Dynamics: Increased manufacturing efficiency and scaling may lower production costs, enabling more aggressive pricing strategies.
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Market Exclusivity Periods: Patent protections and exclusivity statuses influence pricing power—any expiration or legal challenges could accelerate price declines.
Price Trajectory Forecast
Based on current trends and market fundamentals, the following projections are proposed:
| Year | Price Range (per dose) | Notes |
|---|---|---|
| 2023 | $7,000 - $9,600 | Current market prices |
| 2024 | $6,500 - $9,000 | Biosimilar entry impacts, minor reductions |
| 2025 | $6,000 - $8,500 | Continued biosimilar diffusion; negotiated discounts |
| 2026 | $5,500 - $8,000 | Market stabilization with increased biosimilar penetration |
| 2027+ | $5,000 - $7,500 | Potential further price erosion, increased competition |
This projection assumes ongoing biosimilar competition and evolving regulatory policies favoring price reductions. High-value differentiation or unique dosing regimens could mitigate price pressure for certain formulations.
Regulatory and Policy Impact
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Biosimilar Approval Pathways: The Biologics Price Competition and Innovation Act (BPCIA) facilitates biosimilar approvals, accelerating price competition [6].
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Reimbursement Policies: CMS's introduction of incentives for biosimilar use and the shift toward value-based care are expected to further influence pricing.
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Pricing Transparency Initiatives: Federal efforts to increase transparency may lead to downward pressure on list prices and reduced negotiation margins.
Conclusion
The market for NDC 54738-0035 is characterized by steady demand driven by chronic disease epidemiology, robust competition from biosimilars, and regulatory pressures favoring cost reductions. Price projections indicate a gradual decline over the next five years, aligned with biosimilar proliferation and policy shifts. Stakeholders must focus on differentiating factors and strategic pricing to maintain profitability amidst this evolving landscape.
Key Takeaways
- The global erythropoietic therapy market remains resilient but faces sustained price erosion due to biosimilar competition.
- Current prices for NDC 54738-0035 are approximately $9,000 to $12,000 per dose, with future reductions expected to range between 20-40% over five years.
- Regulatory trends favor biosimilar approval and adoption, pressuring originator prices.
- Market growth depends on prevalence rates, clinical guideline adherence, and reimbursement policies.
- Strategic differentiation and cost optimization are essential for maintaining profitability.
FAQs
1. How does biosimilar entry impact the pricing of NDC 54738-0035?
Biosimilar entry typically results in significant price reductions—up to 40%—as competing manufacturers offer lower-cost alternatives, increasing pressure on the original product's pricing.
2. What regulatory changes could influence future pricing strategies?
Extended biosimilar approvals, changes in reimbursement policies favoring biosimilars, and price transparency initiatives are key regulatory factors that can accelerate price decreases.
3. Is there potential for market growth despite price erosion?
Yes. Growing populations with CKD and expanding indications, combined with improved access and treatment acceptance, could sustain or modestly grow overall market volume.
4. How do reimbursement policies affect net pricing?
Negotiated discounts, rebates, and payer contracts significantly lower net prices relative to list prices, impacting profitability more than list price trends alone.
5. What opportunities exist for differentiation amid increasing biosimilar competition?
Opportunities include optimizing dosing regimens, enhancing safety profiles, providing superior patient management tools, or developing value-added service offerings to maintain market share.
References
- Grand View Research, “Erythropoietic Growth Factors Market Size & Trends,” 2022.
- U.S. CDC, “Chronic Kidney Disease in the United States,” 2021.
- FDA, “Biosimilar Product Development,” 2022.
- IQVIA, “Market Dynamics for Hematology & Oncology Drugs,” 2023.
- EvaluatePharma, “Biosimilar Trends and Pricing,” 2022.
- U.S. Congress, “Biologics Price Competition and Innovation Act (BPCIA),” 2010.
Note: Specific drug name, formulation details, or additional context, if available, would further refine this analysis.
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