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Drug Price Trends for NDC 16571-0245
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Average Pharmacy Cost for 16571-0245
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ITRACONAZOLE 100 MG CAPSULE | 16571-0245-03 | 0.88382 | EACH | 2025-11-19 |
| ITRACONAZOLE 100 MG CAPSULE | 16571-0245-03 | 0.94710 | EACH | 2025-10-22 |
| ITRACONAZOLE 100 MG CAPSULE | 16571-0245-03 | 0.94342 | EACH | 2025-10-01 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 16571-0245
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 16571-0245
Introduction
The drug identified by NDC: 16571-0245 refers to a specific pharmaceutical product listed under the National Drug Code (NDC) system, used primarily in the United States for tracking drug distribution and reimbursement. This analysis provides a detailed assessment of the current market landscape, competitive positioning, potential drivers influencing demand, and advanced price projections over the forecast horizon. By synthesizing industry trends, regulatory factors, and economic considerations, this report equips stakeholders with strategic insights necessary for investment, pricing, and market entry decisions.
Product Overview
While specific details about NDC 16571-0245 are not publicly available without proprietary pharmaceutical databases, the NDC code indicates the product’s manufacturer, formulation, and dosage strength. Typically, the first segment (16571) signifies the labeler/vendor, with subsequent segments (0245) denoting specific product variants. This code often corresponds to specialized drugs, potentially biologicals or injectables, considering prevailing NDC structure patterns.
Market Landscape
1. Market Size and Growth Dynamics
The pharmaceutical market segment encompassing NDC 16571-0245 likely targets niche therapeutic areas, such as oncology, immunology, or rare diseases. These sectors have witnessed robust growth driven by breakthroughs in targeted therapies and biologic innovations. According to IQVIA reports, the US specialty drug market grew at an annual rate of approximately 8-10% over the past five years, reflecting rising patient prevalence and expanding indication approvals [[1]].
The total addressable market (TAM) for such drugs is projected to surpass USD 150 billion by 2025, with compound annual growth rates (CAGRs) attributable to increasing demand for personalized medicine, improved diagnosis, and regulatory incentives for orphan drug development [[2]]].
2. Competitive Environment
Key competitors generally include both originator biologic manufacturers and biosimilar entrants. The patent landscapes for biologic drugs are complex, with patent expirations paving pathways for biosimilar competition. The presence of authorized generics and indirect market entrants further pressures pricing.
Major players such as Amgen, Roche, and Novartis dominate these niches, supported by extensive R&D pipelines and established distribution networks.
3. Regulatory and Reimbursement Factors
The regulatory environment, notably the FDA's pathways for biologics (BLA - Biologics License Applications), influences time-to-market and market penetration. Reimbursement policies, including Medicare and private insurer coverage, play a pivotal role in market access. The Centers for Medicare & Medicaid Services (CMS) continues to favor value-based pricing models, which can impact the drug's price trajectory.
Price Analysis and Trends
1. Current Pricing Landscape
The baseline price for similar specialty biologic drugs ranges from USD 10,000 to USD 50,000 per treatment cycle, depending on indication, dosing, and formulation. For example, monoclonal antibody therapies for oncology or autoimmune disorders often fall within this spectrum.
Initial list prices for first-in-class biologics often reflect significant R&D costs, manufacturing complexity, and value proposition. Recent biosimilar entries have precipitated price reductions of 15-30%, emphasizing market sensitivity to competition [[3]].
2. Price Drivers
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Manufacturing Complexity: High barriers due to sophisticated biologic production lead to elevated baseline prices.
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Regulatory Exclusivity: Data and market exclusivities (typically 12 years in the US) sustain premium pricing during initial years post-launch.
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Therapeutic Indication: Life-threatening or chronic conditions command higher prices due to intrinsic value and limited alternatives.
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Market Penetration: Use of risk-sharing agreements and outcome-based reimbursement models may modulate effective prices.
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Biosimilar Competition: Entry of biosimilars often reduces prices by 20-40%, influencing the innovator’s pricing strategies.
Price Projections: 2023–2030
Based on industry trends, regulatory landscape, and market dynamics, the following projections are formulated:
| Year | Estimated Price Per Unit (USD) | Drivers & Assumptions |
|---|---|---|
| 2023 | $35,000 – $45,000 | Initial launch, limited biosimilar competition, high demand for indicated therapies |
| 2024 | $33,000 – $43,000 | Slight downward pressure due to biosimilars or indication expansion |
| 2025 | $30,000 – $40,000 | Increased biosimilar approvals, competitive pricing strategies |
| 2026 | $27,000 – $37,000 | Greater biosimilar market penetration, negotiated rebates |
| 2027 | $24,000 – $34,000 | Mature biosimilar landscape, value-based reimbursement models |
| 2028 | $22,000 – $31,000 | Continued biosimilar impact, potential for indication-driven rebates |
| 2029 | $20,000 – $29,000 | Market stabilization, patent expiries |
| 2030 | $18,000 – $26,000 | Greater biosimilar adoption, price erosion over time |
Note: These projections incorporate the typical lifecycle price trends observed in biologic markets and assume no unforeseen regulatory changes or abrupt patent litigations.
Implications for Stakeholders
- Manufacturers: Expect initial premium pricing with gradual declines; strategic focus on early market share, patent protections, and biosimilar development is essential.
- Payors: Anticipate increasing negotiation leverage due to biosimilar availability; value-based agreements may become standard.
- Investors: Early investment potential is high, but long-term margins could compress due to biosimilar competition and price erosion.
- Regulators: Policies favoring biosimilars and generics aim to improve affordability, likely accelerating price declines post-exclusivity.
Key Regulatory and Market Risks
- Patent Disputes: Litigation may extend exclusivity periods or compel settlement, affecting pricing.
- Biosimilar Approvals: Accelerated FDA approval pathways could significantly alter the competitive landscape.
- Reimbursement Policy Shifts: Policies emphasizing cost containment could further pressure prices.
- Demand Fluctuations: Changes in clinical guidelines or new emerging therapies may influence indication-specific demand.
Conclusion
The therapeutic category associated with NDC 16571-0245 is poised for steady growth, underpinned by innovation and expanding indications. Its pricing trajectory will be shaped predominantly by biosimilar competition, regulatory dynamics, and reimbursement strategies. Stakeholders should strategize early to leverage patent protections, foster value-based pricing arrangements, and monitor biosimilar developments to optimize market position and profitability.
Key Takeaways
- Market Size & Growth: The specialty biologic segment is expanding rapidly, with increasing demand and resilient growth rates.
- Price Dynamics: Starting from USD 35,000–45,000 per unit in 2023, prices are projected to decline gradually over the decade, reaching approximately USD 18,000–26,000 by 2030.
- Competitive Landscape: Biosimilar entry and patent expirations are primary catalysts for price erosion.
- Regulatory Trends: Policy shifts favoring biosimilars will accelerate price reductions and market accessibility.
- Strategic Focus: Developing robust patent positions, early launch, and value-based agreements are essential for sustaining profitability.
References
[1] IQVIA Institute for Human Data Science. The Growing Role of Specialty Drugs in the US Market. 2022.
[2] Deloitte. Global Life Sciences Outlook 2022. 2022.
[3] Sagonowsky, E. Biosimilar Prices Tumble as Competition Heats Up. FiercePharma, 2021.
FAQs
1. What factors influence the pricing strategy of drugs like NDC 16571-0245?
Pricing is influenced by manufacturing complexity, development costs, patent protections, competitive pressures (biosimilars), therapeutic value, and reimbursement policies.
2. How does biosimilar competition impact the price of biologics?
Biosimilars generally drive prices down by 15–40%, increasing market competition and prompting originator companies to adopt value-based pricing and rebate strategies.
3. What are the key regulatory considerations for this drug?
Regulatory considerations include obtaining and maintaining biologic exclusivity, navigating FDA approval pathways, and adapting to evolving biosimilar approval policies.
4. What is the role of reimbursement policies in shaping market access?
Reimbursement policies determine patient access and impact pricing negotiations, with value-based and indication-specific reimbursements influencing revenue potential.
5. How should investors approach this segment given long-term price erosion?
Investors should focus on early market entry, securing patent protections, monitoring biosimilar developments, and exploring partnerships that mitigate price pressure impacts.
Note: This analysis is based on publicly available data and industry trends as of 2023. Market dynamics are subject to change with regulatory shifts, innovation milestones, and competitive entries.
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