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Drug Price Trends for NDC 72064-0130
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Average Pharmacy Cost for 72064-0130
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Best Wholesale Price for NDC 72064-0130
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Market Analysis and Price Projections for NDC 72064-0130
Introduction
NDC 72064-0130 corresponds to Nivolumab, a pioneering immune checkpoint inhibitor marketed under the brand name Opdivo by Bristol-Myers Squibb. Approved by the FDA in 2014, Nivolumab has revolutionized oncology treatment, offering significant advancements in managing various cancers, including melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma. This review examines the current market landscape, competitive dynamics, patient access, pricing trends, and forecasts future price movements for Nivolumab.
Market Landscape and Therapeutic Segment
Nivolumab represents a critical asset in the rapidly expanding immuno-oncology sector. The immunotherapy market has experienced exponential growth, driven by the proven efficacy of immune checkpoint inhibitors across an array of malignancies. As of 2023, the global oncology immunotherapy market was valued at approximately US$61 billion, with a projected compound annual growth rate (CAGR) of around 12% through 2030 [1].
Nivolumab holds FDA approvals for over ten indications, including melanoma, NSCLC, Hodgkin lymphoma, and head and neck cancers. It is often used as a monotherapy or in combination with other agents. The drug has established a strong foothold in first- and second-line treatment settings, contributing to sustained revenue streams.
Competitive Landscape
Nivolumab's primary competitors include pembrolizumab (Keytruda, Merck), atezolizumab (Tecentriq, Roche), and durvalumab (Imfinzi, AstraZeneca). Pembrolizumab, in particular, has shown comparable efficacy across several indications and often rivals Nivolumab in market share.
The competitive intensity has led to aggressive pricing strategies, patent litigations, and biosimilar developments. Despite patent protections expiring in some jurisdictions—most notably the U.S. patent expiration was anticipated around 2028—the market remains highly competitive because of ongoing patent litigations, formulation patents, and new indication approvals.
Market Penetration and Patient Access
The adoption rate of Nivolumab is rapidly increasing, attributed to its proven survival benefits and favorable safety profile relative to chemotherapy. However, access remains uneven globally, influenced largely by reimbursement policies, healthcare infrastructure, and price sensitivity.
In developed markets like the U.S. and Europe, payers often negotiate with manufacturers to secure formulary inclusion, which influences net pricing. In emerging markets, tariffs, import taxes, and economic constraints limit utilization.
The overall patient population eligible for Nivolumab is expanding with ongoing clinical trials and newly approved indications. The increasing prevalence of cancers amenable to immunotherapy continues to fuel demand.
Pricing Trends and Historical Data
List Price and Negotiated Prices
As of 2023, the list price for Nivolumab in the U.S. hovers around $10,000 per infusion, typically administered every two weeks, translating to an annual cost of approximately $260,000 for a full treatment course; however, actual net prices after discounts and rebates are substantially lower [2].
In Europe, similar price ranges are observed, although government negotiations often reduce the effective price.
Factors Affecting Price Dynamics
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Patent litigation and biosimilar entry: Patent disputes could delay biosimilar proliferation; however, once biosimilars enter, competition could reduce prices by 30-50%.
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Reimbursement negotiation power: Payers leverage formulary placements to secure discounts, especially amid budget constraints.
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Manufacturing and R&D costs: Continuing innovation, such as novel combination regimens or biomarker-driven indications, influences R&D investments and, consequently, pricing strategies.
Projected Price Trends
Given current market dynamics, we anticipate the following trends:
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Gradual price erosion in mature markets: Biosimilar competition and increased negotiations are likely to reduce net prices over the next five years by 10-20%.
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Increased unit utilization: As indications expand and clinical guidelines favor immunotherapy, volume-driven growth may offset price declines.
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Premium pricing for combination therapies: Combination regimens incorporating Nivolumab and other agents could command higher prices, though payers may push for discounts.
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Global pricing divergence: Lower-income regions may witness significant price reductions due to affordability constraints, possibly with tiered pricing models.
Future Market and Pricing Projections (2023–2030)
| Year | Estimated Global Market Value | Expected Net Price Change | Rationale |
|---|---|---|---|
| 2023 | US$8.5 billion | Baseline | Current market conditions |
| 2025 | US$11.2 billion | -10% to -15% | Biosimilar entry in mature markets, increased negotiations |
| 2027 | US$14.5 billion | -15% to -20% | Biosimilar competition intensifies, patent expirations occur |
| 2030 | US$20.0 billion | Stabilization or slight decrease | Expansion to new indications, emerging markets, pricing stabilization |
Note: These projections depend heavily on the pace of biosimilar development, regulatory approvals, and market access negotiations.
Regulatory and Patent Outlook
Patent fortifications are set to expire across various jurisdictions between 2028 and 2030, opening the market for biosimilars. Companies like Samsung Bioepis and Biocon are advancing biosimilar candidates, which are expected to enter the market at a significant discount [3].
Regulatory agencies continue to prioritize biosimilar pathways to enhance affordability, which will impact Nivolumab's pricing landscape considerably in the upcoming decade.
Conclusion and Business Implications
Nivolumab remains a high-value immuno-oncology agent with substantial growth prospects. The current high list prices are under pressure from biosimilar developments and payer negotiations. However, the overall market expansion driven by new indications, combination therapies, and global accessibility ensures continued revenue growth.
Producers and investors should monitor patent statuses, biosimilar pipelines, and regulatory pathways meticulously. Strategic collaborations and innovation in combination regimens could also help sustain pricing power.
Key Takeaways
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Market Expansion: The immuno-oncology sector, with Nivolumab as a cornerstone, is poised for significant growth through expanded indications and combination therapies.
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Price Erosion Expectations: Biosimilar competition will likely reduce net prices by approximately 10–20% by 2030 in mature markets.
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Global Access Dynamics: Lower-income countries and emerging markets will play a key role in volume growth, often with lower pricing.
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Strategic Considerations: Key patent expirations approaching in 2028–2030 will reshape market competition landscape, necessitating proactive strategies.
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Investment Opportunities: Companies advancing biosimilars and novel combination regimens could disrupt current pricing norms, providing investment avenues.
FAQs
1. What is the current market size for Nivolumab?
The global oncology immunotherapy market, including Nivolumab, is valued at over US$61 billion, with Nivolumab accounting for a significant share due to its approval for multiple indications and high adoption rates.
2. How do biosimilars impact the pricing of Nivolumab?
Biosimilars introduce price competition, which is expected to reduce Nivolumab’s net price by approximately 30–50% upon entry, depending on regulatory and market acceptance.
3. What are the main indications driving Nivolumab’s revenue growth?
Key indications include melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, and head and neck cancers, with ongoing expansion into additional cancer types.
4. Will Nivolumab’s price stabilize or decline in the future?
Pricing is projected to decline gradually due to biosimilar competition and negotiation pressures, but overall revenue growth is sustained by increasing volume and new indications.
5. How are global healthcare policies influencing Nivolumab pricing?
Health policies favoring affordability and access, especially in emerging markets, are pushing for lower patient prices, influencing manufacturers to adopt tiered and flexible pricing models.
References
[1] Grand View Research. Oncology Immunotherapy Market Size & Share Analysis, 2023.
[2] U.S. Department of Health and Human Services, Medicare pricing data, 2023.
[3] Biosimilar Development Pipeline Report, Biosimilar Market News, 2022.
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