Last updated: February 13, 2026
What Is the Drug Identified by NDC 51672-4017?
NDC 51672-4017 corresponds to Nivolumab (Opdivo) 240 mg marketed by Bristol-Myers Squibb. As an immune checkpoint inhibitor, nivolumab is used primarily in oncology indications, including melanoma, lung cancer, and other cancers, extending its use to multiple tumor types.
What Is the Current Market Size for Nivolumab?
2022 Revenue
- Global sales of nivolumab amounted to approximately $9.7 billion in 2022, up from around $8.9 billion in 2021, reflecting steady growth driven by expanded indications and increased adoption of immunotherapies.[1]
Key Indications
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Renal cell carcinoma (RCC)
- Hodgkin lymphoma
- Other solid tumors
Market Penetration
- Nivolumab accounts for roughly 22% of the global PD-1/PD-L1 inhibitor market, which was valued at $44.2 billion in 2022.[2]
- Competition includes pembrolizumab (Keytruda), atezolizumab (Tecentriq), and durvalumab (Imfinzi).
What Are the Key Drivers and Barriers?
Drivers
- Broadening indications: approvals for gastric, colorectal, and other cancers.
- Companion diagnostics: PD-L1 testing enhances patient selection.
- Improved survival outcomes: clinical data supports survival benefits in multiple tumor types.
Barriers
- High drug price point: list price in the U.S. ranges around $15,600 per 40 mg vial.
- Reimbursement variability: access depends on payer coverage.
- Competition: emerging biomarkers and newer therapies could limit growth.
What Are the Price Trends and Projections?
Current Price Point (2023)
- Price per 240 mg dose: approximately $37,200 (based on $15,600 per 40 mg vial, requiring six vials per dose).
- Pricing varies by healthcare setting, rebate arrangements, and geographic region.
Future Price Trends
- The drug's list price is unlikely to decrease significantly in the short term due to patent exclusivity and market position.
- Biosimilar competition expected after patent expiration (original patent expires in 2028, with some patents extended to 2033).
- Price reductions due to biosimilar entry could range between 15-25% within 3-5 years post-approval of biosimilars.
Market Volume Forecast
- The number of patients eligible for nivolumab in the U.S. is projected to grow from approximately 200,000 in 2022 to 250,000 by 2027, driven by expanding indications and earlier diagnosis.[3]
- Total market value for nivolumab in the U.S. could reach $4.7 billion annually by 2027.
What Are the Key Regional Differences?
United States
- Highest utilization and pricing.
- Reimbursement via Medicare, Medicaid, private insurers.
- List prices predominantly dictate gross revenue; rebates and discounts are common.
Europe
- List prices are lower, averaging $10,000 to $13,000 per 200-240 mg dose.
- National health systems impose additional discounts and negotiated prices.
Emerging Markets
- Significantly lower prices, often 50-70% below developed markets.
- Greater price sensitivity limits revenue potential.
Market Entry and Competitive Outlook
Biosimilar Landscape
- Amgen and Samsung Bioepis are developing biosimilars of nivolumab, with initial filings expected by 2024.
- Entry expected starting around 2028-2030, potentially reducing prices by 20-30%.
Patent Cliff and Regulatory Changes
- Patent expiry scheduled for 2028, with some patents extending into 2033.
- US Patent and Trademark Office (USPTO) filings indicate forthcoming legal challenges that could impact exclusivity timelines.
Revenue and Price Projection Summary (2023–2027)
| Year |
Estimated Global Sales |
Average Price per Dose |
Market Volume (Patients) |
Notes |
| 2023 |
$9.7 billion |
$37,200 |
200,000 |
List price, high uptake in developed markets |
| 2024 |
$10.4 billion |
$36,000–$37,200 |
215,000 |
Slight price decline; biosimilar approval anticipated |
| 2025 |
$11.1 billion |
$34,000–$36,000 |
230,000 |
Biosimilar market entry negotiations begin |
| 2026 |
$11.8 billion |
$32,000–$35,000 |
240,000 |
Increased biosimilar competition |
| 2027 |
$12.3 billion |
$30,000–$33,000 |
250,000 |
Potential biosimilar impact; market saturation |
Key Takeaways
- Nivolumab (NDC 51672-4017) remains a dominant immunotherapy agent with a revenue generates exceeding $9 billion annually.
- Prices per dose are in the ~$37,200 range in the U.S., with regional variations.
- Market growth driven by expanded indications, with volume increasing from 200,000 to 250,000 patients (2022–2027).
- Biosimilars could emerge post-2028, with potential price reductions up to 25%.
- The patent landscape will heavily influence pricing and market share over the next five years.
FAQs
1. How does the pricing of nivolumab compare to its competitors?
Nivolumab's list price is comparable to pembrolizumab, with both drugs priced around $37,000–$39,000 per 240 mg dose in the U.S. The choice between them often depends on indication approvals and clinical efficacy.
2. What are the main factors influencing future price declines?
Entry of biosimilars, competitive dynamics, and regulatory decisions will influence price reductions. Biosimilar price drops could reach 20-30%, with competition likely to intensify around 2028–2030.
3. Which regions offer the highest profitability?
The U.S. maintains the highest prices and sales volume, making it the most profitable market. Europe offers lower prices but still significant revenue potential, while emerging markets pose both opportunities and challenges due to lower prices.
4. Are there risks that could affect market projections?
Yes. Patent litigation, regulatory changes, or faster-than-expected biosimilar entry could lower revenue forecasts. Conversely, newly approved indications and better market access could push revenues higher.
5. How will the expanding indications impact the market?
Broader approvals will increase patient eligibility, supporting volume growth and potentially stabilizing prices despite biosimilar competition.
Sources
[1] Bristol-Myers Squibb, 2022 Annual Report.
[2] IQVIA, 2022 Oncology Market Reports.
[3] EvaluatePharma, 2023 Outlook for Oncology Drugs.
