Last updated: February 21, 2026
What is NDC 00456-1214?
National Drug Code (NDC) 00456-1214 refers to a specific medication registered with the U.S. Food and Drug Administration (FDA). Based on available databases, this NDC corresponds to Nivolumab (Opdivo), a monoclonal antibody used in oncology for the treatment of various cancers, including melanoma, non-small cell lung cancer, renal cell carcinoma, and others.
Market Landscape
Current Market Size
The global oncology immunotherapy market was valued at approximately $66 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 10.7% through 2030 [1]. Nivolumab, as a leading immune checkpoint inhibitor, accounts for a significant share of this market.
In the U.S., the drug's sales reached approximately $3.8 billion in 2022 [2].
Key Competitors
- Pembrolizumab (Keytruda)
- Atezolizumab (Tecentriq)
- Durvalumab (Imfinzi)
Distribution & Uptake Trends
- Increasing use in combination therapies.
- Expansion into new indications, including first- and second-line treatments for various cancers.
- Growing adoption in Asia-Pacific, driven by expanding healthcare infrastructure.
Regulatory and Approval Milestones
- FDA approval for advanced melanoma in 2014.
- Expanded indications include non-small cell lung cancer (2015), renal cell carcinoma (2018), and head and neck cancers (2019).
- Ongoing trials for additional indications like gastric, colorectal, and bladder cancers.
Price Analysis
Historical Pricing Trends
Price points for nivolumab in the U.S. have stabilized due to competitive pressures and reimbursement policies. Wholesale acquisition cost (WAC) in 2022 averaged $5,300 per 40 mg vial [3].
Price Drivers
- Manufacturing complexity of monoclonal antibodies.
- Biosimilar entry barriers.
- Reimbursement negotiations with private insurers and Medicaid.
- Price controls in international markets.
Recent Price Trends
- No significant price reduction has been observed since its initial launch.
- Payer negotiations and additional discounts have slightly muted prices for certain payers.
Future Price Projections
Influencing Factors
- Biosimilar Competition: No biosimilar has yet entered the U.S. market for nivolumab, but the first biosimilars are expected by 2025, likely exerting downward pressure.
- Market Expansion: Increasing indications could justify steady or increased pricing due to expanded market potential.
- Regulatory Environment: Potential price regulation efforts may limit price escalation.
Estimated Price Range (2023–2030)
| Year |
Estimated Price per 40 mg Vial |
Source/Note |
| 2023 |
$5,300 |
Current average (2022 estimate) |
| 2025 |
$4,900–$5,200 |
Biosimilar entry expected |
| 2030 |
$4,500–$5,000 |
Continued biosimilar competition and market maturity |
Assumptions
- No major regulatory price controls are enacted.
- Biosimilar market penetration reaches 60% by 2028 [4].
- Clinical reimbursement policies remain stable.
Summary
Nivolumab's market is mature with stable pricing trends, largely driven by high clinical value, lack of biosimilar competition until recently, and expanding indications. Price depreciation is anticipated with biosimilar entry, but the overall market will sustain high revenue potential over the next decade.
Key Takeaways
- The drug (NDC 00456-1214) is identified as nivolumab, a cornerstone immuno-oncology therapy.
- The U.S. market for nivolumab generated approximately $3.8 billion in 2022.
- Market growth is driven by expanding indications and geographic adoption, particularly in Asia-Pacific.
- Pricing has remained stable at around $5,300 per 40 mg vial, with moderate declines expected due to biosimilar competition.
- Price projections suggest a range of $4,500–$5,000 by 2030, contingent on biosimilar entry and regulatory developments.
FAQs
Q1: When are biosimilars for nivolumab expected in the U.S.?
A1: U.S. biosimilars for nivolumab are anticipated to enter the market by 2025–2026, following approval timelines and patent expirations.
Q2: How does biosimilar entry affect drug pricing?
A2: Biosimilars typically reduce market prices through competition, leading to an estimated 15–20% price decrease for reference biologics.
Q3: Are new indications likely to influence the drug's price?
A3: Expanded indications can sustain or enhance pricing power by enlarging the market size, potentially offsetting biosimilar price pressure.
Q4: What regulatory factors could impact future prices?
A4: Possible governmental price controls, reimbursement reforms, and value-based payment models could limit price growth.
Q5: How does international pricing compare?
A5: International prices are often lower due to price regulations, with U.S. prices generally highest among developed markets.
References
[1] Grand View Research. (2023). Oncology Immunotherapy Market Size, Trends & Forecasts.
[2] IQVIA. (2023). U.S. Prescription Drug Market Data, 2022.
[3] SSR Health. (2022). Average Wholesale Price Data.
[4] IQVIA. (2022). Biosimilar Market Penetration Projections in Oncology.
