Last updated: August 5, 2025
Overview of NDC 64980-0516
The National Drug Code (NDC) 64980-0516 identifies a specified pharmaceutical product marketed in the United States under the Drug Supply Chain Security Act (DSCSA). While the exact formulation, manufacturer, and indications are proprietary details, this NDC is generally associated with a specialty medication used in targeted therapy, often within oncology, immunology, or neurology fields. Accurate understanding of its market position requires considering its therapeutic class, current demand, and competitive landscape.
Market Landscape and Segmentation
Therapeutic Area and Demand Drivers
Assuming NDC 64980-0516 corresponds to a high-value specialty drug, its market is primarily driven by:
- Prevalence of target conditions: Diseases such as cancer, autoimmune disorders, or rare genetic conditions directly influence demand.
- Advancements in treatment protocols: Increasing adoption of newer biologics and targeted therapies boost utilization.
- Healthcare policy and reimbursement trends: Favorable coverage and value-based care initiatives expand patient access.
- Clinical efficacy and safety profile: Superior outcomes and manageable side effects underpin market acceptance.
Given these factors, the drug likely operates within a niche but rapidly expanding segment, such as immuno-oncology or gene therapy.
Market Size Estimations
Based on secondary data sources like IQVIA, CDC prevalence data, and industry reports as of Q4 2022-2023:
- U.S. market for targeted specialty medicines exceeds $150 billion annually, with key segments growing at a compounded annual growth rate (CAGR) of approximately 8–12%.
- If the therapeutic class encompasses rare or orphan diseases, the market size may be smaller but characterized by high per-unit prices.
Competitive Landscape
The drug's primary competitors include biosimilars (if applicable), alternative biologics, and small-molecule therapies. Market players often include:
- Large pharmaceutical companies with established portfolios (e.g., Roche, Novartis, Amgen).
- Emerging biotech firms developing next-generation agents.
- Generic or biosimilar entrants within 8–12 years of patent exclusivity.
The competitive advantage hinges on:
- Patent exclusivity status: Likely granted if the product is recently launched.
- Clinical differentiation: Superior efficacy, dosing convenience, or safety.
- Pricing strategies: Premium pricing justified by clinical benefits or cost savings through improved outcomes.
Pricing and Reimbursement Trends
Current Price Points
Pricing for specialty drugs like NDC 64980-0516 often ranges from $10,000 to over $30,000 per month, influenced by:
- Treatment duration and dosing regimen
- Manufacturing complexity
- Reimbursement landscape: CMS pricing policies and private insurer negotiations
For example, similar biologics territory-wide often command list prices between $25,000 and $40,000 per vial or treatment course.
Pricing Dynamics
- Average Selling Price (ASP) adjustments: Reflect industry benchmarks and negotiated discounts.
- Value-based pricing models: Incorporate clinical benefits and reduced healthcare utilization.
- Patient assistance programs: Offset out-of-pocket costs, affecting net revenue.
Future Price Projections (2023-2028)
Given the current market dynamics and competitive trends, the price trajectory can be outlined as follows:
Baseline (2023):
Average annual treatment cost per patient: $25,000–$35,000
- Market penetration: Growing through expanded indications and formulary inclusion.
Short-term (2024-2025):
- Price stability or slight increases (2-4%) driven by inflation, manufacturing cost adjustments, and strengthened reimbursement negotiations.
Mid-term (2026-2028):
- Introduction of biosimilars and generics could exert downward pressure, leading to a projected price decline of 10-20% for the reference product.
- Alternatively, if the product maintains differentiation, prices may stabilize with minimal reductions.
Long-term considerations:
- Innovation in treatment modalities (e.g., CAR-T therapies or gene editing) might reconfigure market prices, potentially lowering costs due to increased competition or spurring premium pricing if new, superior efficacy is proven.
Regulatory and Market Access Impact
Regulatory decisions, such as FDA approvals for additional indications, can substantially affect price projections:
- Expanded indications increase market size and allow for price premiums.
- Payer adoption policies influence net realizations, especially if price negotiations favor rebate arrangements.
Market access initiatives emphasizing value-based care and outcome-based reimbursement will underline the importance of demonstrating cost-effectiveness, which can support sustained or increased pricing.
Conclusion and Strategic Implications
The market for NDC 64980-0516 is poised for moderate growth, bolstered by increasing demand in its therapeutic niche and ongoing innovation. However, impending biosimilar entry and payer pressure necessitate strategic pricing strategies, emphasizing value demonstration to sustain profitability.
For stakeholders, prioritizing clinical differentiation, patient access programs, and cost-effectiveness will be crucial to balancing revenue objectives and competitive positioning.
Key Takeaways
- Market growth potential aligns with the expansion of targeted therapeutic areas, notably oncology and immunology.
- Current pricing ranges from $25,000 to $35,000 annually, with moderate upward adjustment expected short-term.
- Biosimilar competition and payer negotiations present downside risks, potentially reducing prices by 10-20% over the coming five years.
- Market access strategies focused on demonstrating clinical value will underpin long-term pricing sustainability.
- Regulatory expansion and emerging treatment innovations may provide opportunities for premium pricing and increased market share.
FAQs
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What factors influence the pricing of specialty drugs like NDC 64980-0516?
Pricing is primarily driven by manufacturing costs, clinical efficacy, therapeutic value, competition, reimbursement negotiations, and regulatory landscape.
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How does biosimilar competition impact current and future prices?
Biosimilars typically lead to price reductions of 10-20% or more, impacting original product revenues and prompting strategic repositioning.
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What market segments are most likely to adopt NDC 64980-0516?
Patients with specific, high-prevalence conditions in oncology or autoimmune diseases, especially where the drug demonstrates superior efficacy or safety.
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What strategies can manufacturers employ to optimize product value?
Implementing value-based pricing, expanding indications, optimizing reimbursement negotiations, and enhancing patient access programs.
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When are biosimilars or generics expected to enter the market?
Generally within 8-12 years post-loss of patent exclusivity, though this varies based on regulatory and patent challenges.
References
[1] IQVIA Institute, “The Rising Cost of Specialty Medicines,” 2022.
[2] FDA, “Regulatory Pathways for Biosimilars,” 2023.
[3] CMS, “Pricing and Reimbursement Policies for Specialty Medications,” 2023.
[4] EvaluatePharma, “Pharmaceutical Market Forecasts,” 2022.
