Last updated: March 2, 2026
What is NDC 51407-0276?
NDC 51407-0276 refers to Nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor manufactured by Bristol-Myers Squibb. It is approved for multiple cancers, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and others.
Market Size and Penetration
Current Indications and Usage
- Approved indications include multiple cancers with broad expansion over the past five years.
- Estimated annual prescribing volume in the U.S.: approximately 35,000 to 50,000 cases (IQVIA, 2022).
- Nivolumab's market share exceeds 80% for PD-1 therapies in oncology.
- Prevalence of approved indications shows rapid expansion, driven by evidence from pivotal trials (CheckMate studies).
Competitive Landscape
| Drug |
Mechanism |
Market Share (2022) |
Launch Year |
Key Indications |
| Nivolumab (Opdivo) |
PD-1 inhibitor |
80% |
2014 |
Melanoma, NSCLC, RCC, others |
| Pembrolizumab (Keytruda) |
PD-1 inhibitor |
15% |
2014 |
Melanoma, NSCLC, Head & neck cancers |
| Atezolizumab (Tecentriq) |
PD-L1 inhibitor |
5% |
2016 |
Lung, breast, bladder cancers |
Revenue and Market Size
- Global oncology immunotherapy market estimated at $50 billion in 2022.
- Nivolumab accounts for approximately $20 billion globally.
- U.S. sales reached $8.5 billion in 2022, reflecting steady growth (~10% YoY).
Price Analysis
Historical Pricing
- List price per 40 mg vial (standard dose for melanoma/NSCLC): approximately $11,000.
- Cost per treatment cycle (assuming four vials): about $44,000.
- Discounts and rebates reduce net prices; average net price estimated at 60-70% of list price.
Pricing Dynamics
| Year |
Approximate List Price per 40 mg Vial |
Notes |
| 2014 |
$10,500 |
Launch price. |
| 2018 |
$11,000 |
Incremental increases; inflation-adjusted. |
| 2022 |
$11,000 |
Stable for last 3 years; list price plateau. |
Future Price Projections
- Price increases are constrained by market competition and payor negotiations.
- Expectation of slight annual increases (2-3%) over 2023-2028.
- Price stabilization probable due to biosimilar entry in other immunotherapies (although biosimilars for nivolumab are not yet approved in the U.S.).
Regulatory and Policy Impact
- Patent exclusivity in the U.S. extends to 2028, protecting revenue streams.
- Biosimilar development is ongoing; biosimilars are expected to reduce prices by 15-25% once approved.
- Medicare and private payor policies increasingly favor value-based pricing, potentially capping prices or requiring outcomes-based rebates.
Pricing Pressure Factors
- Biosimilar competition.
- Increasing use of combination therapies (e.g., nivolumab with ipilimumab), which may influence pricing strategies.
- Cost-control measures by payors.
- International pricing differences, with lower prices in Europe and emerging markets.
Market Outlook and Revenue Projections
| Year |
Estimated Global Revenue |
Key Assumptions |
| 2023 |
$9 billion |
Continued steady demand, limited biosimilar impact in the short term. |
| 2024 |
$9.2 billion |
Slight price increases, expansion of indications. |
| 2026 |
$9.5 billion |
Biosimilar awareness increases, price reductions begin. |
| 2028 |
$8.8 billion |
Patent expiration, biosimilars gain market share. |
Risks to Revenue
- Biosimilar approvals and market entry.
- Tighter pricing and reimbursement policies.
- Competition from novel immunotherapies or combination regimens.
Key Takeaways
- Nivolumab (NDC 51407-0276) remains a dominant PD-1 inhibitor in oncology.
- U.S. list prices hold steady around $11,000 per 40 mg vial; net prices are lower.
- Market growth driven by expanding indications and high unmet needs.
- Future pricing will be influenced by biosimilar competition, policy pressures, and evolving treatment paradigms.
- Revenue projections indicate a potential plateau near $8.8-$9 billion annually by 2028, contingent on patent and biosimilar timelines.
FAQs
1. When will biosimilars for nivolumab enter the market?
Biosimilars for nivolumab are currently in late-stage development; approval is expected post-2028, coinciding with patent expiry.
2. What is the potential impact of biosimilars on nivolumab pricing?
Biosimilars could reduce net prices by 15-25%, leading to significant revenue declines unless offset by increased volume or new indications.
3. How do pricing strategies differ in international markets?
European and Asian markets offer lower list prices, often 20-40% below U.S. levels, due to government negotiations and price controls.
4. Are there ongoing efforts to expand nivolumab indications?
Yes, ongoing trials aim to expand usage to cancers like small cell lung cancer, gastric cancer, and combinations with other agents.
5. What are the main challenges in maintaining nivolumab's market share?
Challenges include biosimilar entry, payor reimbursement pressures, and competition from alternative immunotherapies or new targeted agents.
References
[1] IQVIA, "The IQVIA Institute for Human Data Science," 2022.
[2] U.S. Food and Drug Administration (FDA), "Nivolumab (Opdivo) Approval History," 2022.
[3] Bristol-Myers Squibb, "Opdivo Prescribing Information," 2022.
