Last updated: March 5, 2026
What is NDC 68462-0406?
NDC 68462-0406 identifies a specific drug within the United States National Drug Code system. It corresponds to Nivolumab (Opdivo) Injection, 240 mg. Nivolumab is an immune checkpoint inhibitor indicated for various cancers, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and Hodgkin lymphoma.
Market Overview
Market Size and Revenue
The global cancer immunotherapy market, which includes nivolumab, was valued at approximately USD 14.8 billion in 2022 and is projected to grow at a CAGR of around 11.3% through 2030. Nivolumab holds a significant share in this space, driven by approvals for multiple indications and expanding usage.
Key Markets
- United States: Largest market, driven by high approval rates, established reimbursement pathways, and early adoption due to extensive clinical evidence. Estimated sales reached USD 4.5 billion in 2022.
- European Union: Second-largest market, with growth supported by expanding indications and uptake.
- Asia-Pacific: Fastest growth rate (CAGR ~15%) owing to increased cancer prevalence, emerging healthcare infrastructure, and local approvals.
Competitive Landscape
Major competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), and durvalumab (Imfinzi). Nivolumab's market share is approximately 40% among these agents for approved indications as of 2022.
Prescription Trends
Post-approval expansion into additional indications and combination regimens increases demand. The drug is administered every 2-4 weeks, with dosing depending on the indication.
Price Point and Cost Trends
Current Pricing
- United States: Average wholesale price (AWP) for a 240 mg vial ranged from USD 15,000 to 16,000 in 2022.
- Per-Patient Cost: For an average dose (240 mg), yearly treatment costs can reach USD 360,000, assuming monthly administrations.
Price Dynamics
- List Prices: Generally stable, with slight fluctuations driven by manufacturing costs, pricing negotiations, and market competition.
- Rebates and Discounts: Significant discounts are common through insurance arrangements and patient assistance programs, which reduce effective net prices.
Reimbursement and Insurance Policies
Most insurers reimburse based on negotiated rates, often below list prices. The Centers for Medicare & Medicaid Services (CMS) formulary decisions influence access and pricing flexibility.
Future Price Projections
Factors Influencing Price Trends
- Patent Expiry: Nivolumab's patent protection extends until around 2028, after which biosimilars could enter the market, pressuring prices.
- Biosimilar Competition: Expected to reduce prices by 20-50%, potentially lowering patient costs and expanding access.
- Regulatory and Policy Changes: Proposed Medicare negotiations and value-based pricing models might result in price adjustments.
- Indication Expansion: Approvals for additional cancer types could increase volume but may also lead to negotiated price reductions.
Predicted Pricing Outlook (2023–2030)
| Year |
Estimated Average Wholesale Price (USD) |
Notes |
| 2023 |
15,500 |
Stable; no biosimilar competition yet |
| 2025 |
15,000–14,000 |
Slight decline as biosimilars approach approval |
| 2028 |
12,000–14,000 |
Entry of biosimilars expected; prices to decrease further |
| 2030 |
10,000–12,000 |
Biosimilar market stabilizes; prices plateau |
Projection based on historical drug pricing trends and biosimilar entry patterns.
Key Competitive and Regulatory Developments
- The FDA has approved several nivolumab indications, including non-small cell lung cancer and Hodgkin lymphoma.
- Biosimilar candidates are in late-phase development; their approval could influence pricing estimates.
- Ongoing clinical trials expand indications, potentially increasing volume but also pressuring prices due to competition.
Summary
Nivolumab (NDC 68462-0406) remains a high-value, widely used immunotherapy with stable to slightly declining prices projected over the next seven years due to biosimilar competition and regulatory influences. Market expansion into additional indications and larger geographic regions will sustain growth, but pricing pressures are imminent post-2028.
Key Takeaways
- US market sales for nivolumab are approximately USD 4.5 billion as of 2022.
- Pricing has remained stable, with current wholesale prices around USD 15,500 per 240 mg dose.
- Biosimilar entry expected around 2028 will likely reduce prices by 20-50%.
- Growing indications and approval in emerging markets will support revenue growth despite competitive pressures.
- Regulatory policies and reimbursement strategies significantly influence net pricing and access.
FAQs
Q1: When will biosimilars for nivolumab likely enter the market?
A: Biosimilars are expected to gain approval around 2028, after patent expiration.
Q2: How much could biosimilars reduce nivolumab prices?
A: Prices could decrease by 20% to 50%, depending on market competition and regulatory factors.
Q3: What are the main indications for nivolumab?
A: Melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, and others.
Q4: How does price vary across markets?
A: Prices are highest in the US (~USD 15,000), lower in Europe, and variable in emerging markets.
Q5: Are there any emerging therapies that threaten nivolumab's market share?
A: Yes; other checkpoint inhibitors and novel immuno-oncology agents are in development and gaining approval.
References
[1] Grand View Research. (2022). Cancer immunotherapy market size, share & trends analysis.
[2] IQVIA. (2022). US oncology drug sales data.
[3] U.S. Food and Drug Administration. (2022). Nivolumab approval and indications.
[4] Biosimilar Development. (2022). Market forecast for biosimilar entry into immuno-oncology space.
