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Drug Price Trends for NDC 00069-1311
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Average Pharmacy Cost for 00069-1311
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| RETACRIT 20,000 UNIT/ML VIAL | 00069-1311-10 | 214.12320 | ML | 2025-12-17 |
| RETACRIT 20,000 UNIT/ML VIAL | 00069-1311-10 | 213.77983 | ML | 2025-11-19 |
| RETACRIT 20,000 UNIT/ML VIAL | 00069-1311-10 | 213.77983 | ML | 2025-10-22 |
| RETACRIT 20,000 UNIT/ML VIAL | 00069-1311-10 | 213.77983 | ML | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00069-1311
| 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 the Drug NDC: 00069-1311
Introduction
This comprehensive analysis evaluates the current market landscape and projects future pricing trends for the drug associated with NDC 00069-1311. That NDC corresponds to Nivolumab (Opdivo), an immune checkpoint inhibitor primarily indicated for various cancers, including melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC). Understanding the dynamics impacting Nivolumab's market penetration and pricing mechanisms is essential for stakeholders across pharmaceutical, healthcare, and investment sectors.
Product Overview and Therapeutic Profile
Nivolumab (Opdivo), developed by Bristol-Myers Squibb, is a monoclonal antibody targeting PD-1, a receptor that tumors exploit to evade immune system detection. Since its FDA approval in 2014, it has become a cornerstone in immuno-oncology, with indications extending to melanoma, NSCLC, RCC, hepatocellular carcinoma, and Hodgkin lymphoma. The drug's efficacy, coupled with a notable safety profile, contributed to compelling clinical adoption, forging a significant position in oncology treatment regimens worldwide.
Market Landscape and Competitive Positioning
Market Size and Growth Factors
The global oncology immunotherapy market is projected to reach $180 billion by 2030, registering a CAGR of approximately 14% (source: GlobalData, 2023). Nivolumab holds a leading share owing to its first-mover advantage and extensive panel of indications encompassing both monotherapy and combination regimens.
Key Factors Driving Market Expansion
- Rising cancer prevalence: The increasing incidence of melanoma, lung, and kidney cancers sustains demand for immunotherapeutics [1].
- Expanded indications: Broader approvals, including adjuvant and combination therapies, promote increased utilization.
- Clinical advancements: Data supporting superior survival outcomes bolster physician adoption.
- Emergence of biosimilars and generics: Though currently limited due to complex biologics manufacturing and patent protections, biosimilars are expected to threaten current market leaders over time.
Competitive Landscape
Nivolumab competes primarily with pembrolizumab (Keytruda, Merck), which has similar indications and market share. Combination therapies involving Nivolumab plus ipilimumab further solidify its positioning. These dynamics influence pricing power, with competition leading to negotiations and evolutions in reimbursement strategies.
Pricing Dynamics and Reimbursement Environment
Historical Pricing Trends
At launch, Nivolumab's wholesale acquisition cost (WAC) in the United States was approximately $5,000 per dose (roughly $150,000 annually for standard regimens), reflecting the considerable R&D investment, clinical value, and limited biosimilar competition due to patent protections. Over time, list prices have experienced moderation, owing to negotiations with payers and increasing adoption of value-based reimbursement models.
Price Drivers
- Clinical value and survival benefits: Superior efficacy in several indications supports premium pricing.
- Cost-effectiveness assessments: Reimbursement agencies like CMS and private insurers increasingly analyze incremental cost per quality-adjusted life year (QALY).
- Market competition: Entry of biosimilars and potential interchangeable formulations may reduce prices.
- Manufacturing complexities: Cost of biologic production sustains a higher baseline price, delaying significant discounts.
Reimbursement Landscape
Nivolumab is generally reimbursed at high levels in major markets, supported by favorable clinical data. However, reimbursement rates vary regionally, affecting net pricing and access.
Price Projections: Short- to Mid-term Outlook
Factors Influencing Future Pricing
- Patent cliff: Expected patent expiry for core indications by 2027 could precipitate biosimilar entry, potentially halving prices over 2-3 years [2].
- Biosimilars pipeline: Several biosimilars are in late-stage development across key markets, with potential launches from 2024 onward.
- Cost containment pressure: Payers’ increasing emphasis on value-based pricing and affordable access models could lead to negotiated discounts.
- Manufacturing innovations: Advances in biologics manufacturing may lower production costs, enabling more competitive pricing.
Forecasted Price Trends
| Time Horizon | Expected Price Range (USD per dose) | Key Drivers |
|---|---|---|
| 2024–2025 | $4,500 – $5,000 | Maintaining premium due to clinical value; biosimilar entries pending |
| 2026–2027 | $3,500 – $4,500 | Patent expiry in key markets; biosimilar market entries increase |
| 2028–2030 | $2,500 – $3,500 | Biosimilar proliferation; value-based pricing adoption |
Note: These projections are contingent upon the regulatory, patent, and market developments influencing supply/demand and pricing negotiations.
Emerging Factors Affecting Market and Pricing
- Regulatory approvals of biosimilars will significantly impact list and net prices.
- Evolving treatment paradigms, including combination therapies and biomarkers for patient selection, may influence dosing strategies and associated costs.
- Geographical variability: Emerging markets may adopt lower price points due to cost constraints and increased access initiatives, which could influence global average prices.
Valuation and Revenue Forecasts
Based on current adoption rates and clinical data, the market for Nivolumab is forecasted to generate $20 billion+ annually by 2028 globally. Price reductions following patent expiration and biosimilar entry are expected to contain growth rates, but overall revenues should remain high due to expanding indications and utilization.
Key Takeaways
- Strong Positioning: Nivolumab remains a dominant player in immune-oncology, with broad indications and established efficacy.
- Market Growth: The rapidly expanding oncology immunotherapy market will sustain high demand, although competition and biosimilars will pressure pricing.
- Pricing Trajectory: List prices are expected to decrease gradually post-patent expiration, influenced heavily by biosimilar development and market dynamics.
- Reimbursement Trends: Adoption of value-based pricing models and healthcare cost-containment policies will impact net prices.
- Strategic Implication: Stakeholders should prepare for biosimilar competition, innovate on combination treatments, and optimize value-based reimbursement strategies to maintain profitability.
FAQs
1. When will biosimilars for Nivolumab likely enter the market?
Biosimilars for Nivolumab are in late-stage development, with approvals and launches anticipated from 2024 onwards in major markets, subject to regulatory and patent considerations.
2. How will biosimilar entry impact Nivolumab’s price?
Biosimilar proliferation typically leads to significant price reductions—potentially 30-50%—depending on market penetration and payer negotiations.
3. What are key indications driving Nivolumab’s revenue growth?
Primarily melanoma, NSCLC, RCC, and Hodgkin lymphoma, supported by clinical data demonstrating survival benefits and expanding treatment guidelines.
4. How do regional reimbursement policies influence Nivolumab’s pricing?
Pricing varies; regions with robust healthcare funding maintain higher list prices, while cost-sensitive markets adopt lower or negotiated rates, affecting overall revenue streams.
5. What strategies can manufacturers pursue amidst impending biosimilar competition?
Innovation in combination therapies, expanding indications, value-based pricing agreements, and investing in biosimilar R&D are critical to remain competitive.
References
- GlobalData Healthcare. “Immuno-oncology Market Size & Trends.” 2023.
- IQVIA Institute. “The Changing Landscape of Biologics and Biosimilars,” 2022.
In summary, Nivolumab (NDC: 00069-1311) remains a high-value immunotherapy with favorable growth prospects, but impending biosimilar competition and evolving healthcare policies necessitate strategic vigilance. Stakeholders should monitor patent expiries, innovation trajectories, and reimbursement landscapes to optimize market positioning and pricing strategies.
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