Last updated: March 3, 2026
What is NDC 51672-2001?
NDC 51672-2001 corresponds to the drug Nivolumab (Opdivo), a monoclonal antibody used as an immunotherapy treatment for various cancers, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and others. It was approved by the FDA in 2015. The drug is marketed by Bristol-Myers Squibb.
Market Size and Dynamics
Therapeutic Area and Indications
Nivolumab targets PD-1, a receptor on T-cells, blocking immune evasion mechanisms in cancer. Its approvals span multiple oncology indications:
- Melanoma (approved in 2015)
- NSCLC (2015; expanded in 2017)
- Renal cell carcinoma (2015)
- Hodgkin lymphoma (2016)
- Other solid tumors, including head and neck squamous cell carcinoma
Market Size and Growth
- The global immune checkpoint inhibitor market was valued at approximately $20 billion in 2022.
- Nivolumab accounts for roughly 60% of this market, with an estimated $12 billion in sales in 2022.
- The compound annual growth rate (CAGR) for this segment is projected at around 11% through 2028.
Competitive Landscape
- Main competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), cemiplimab (Libtayo), and durvalumab (Imfinzi).
- Key differentiators are indications, dosing regimens, and approval timelines.
Prescriber Adoption and Market Penetration
- Adoption varies across cancer types, with NSCLC and melanoma being initial high-volume uses.
- Growth driven by expanded indications and combination therapies.
- Pricing and reimbursement policies influence market penetration levels.
Pricing Trends and Projections
Current Pricing
- The average wholesale price (AWP) for Nivolumab is approximately $5,000 to $6,000 per 40 mg dose.
- The typical treatment regimen involves 240 mg every 2 weeks, equating to over $120,000 annually per patient.
List Prices vs. Net Prices
- List prices for Nivolumab have remained relatively stable since approval.
- Rebates and negotiations reduce net prices but are confidential.
Price Trends
- No significant price reductions have been observed since FDA approval.
- Future price changes are unlikely due to the drug's market dominance and coverage policies.
Factors Influencing Future Prices
- Price negotiations by payers may pressure manufacturers to lower reimbursement levels.
- Introduction and approval of biosimilars or competing agents could incentivize price competition.
- Expansion into earlier lines of therapy may stabilize or increase demand, supporting stable or rising prices.
Price Projections (Next 3-5 Years)
| Year |
Estimated Average Price per 240 mg Dose |
Rationale |
| 2023 |
$5,200 |
Stable, with minor adjustments for inflation and negotiations |
| 2024 |
$5,150 |
Slight downward pressure from payer negotiations |
| 2025 |
$5,100 |
Continued negotiations; demand stable or increasing |
| 2026 |
$5,100 |
Prices stabilize with new indications or combination use |
| 2027 |
$5,200 |
Possible price stabilization or slight increase due to market expansion |
Regulatory and Policy Impact
- The No Surprises Act and Medicare negotiations aim to lower drug prices, potentially impacting net reimbursement.
- The Inflation Reduction Act grants Medicare authority to negotiate prices for certain high-cost drugs, including immunotherapies.
Summary of Financial Outlook
- Market size remains robust due to expanding indications.
- Price stability is expected, with potential slight decreases due to reimbursement policies.
- Revenue growth is primarily driven by increased patient access and combination therapies rather than price increases alone.
Key Takeaways
- Nivolumab commands high, stable list prices with limited downward pressure.
- The market is driven by multiple indications and increased line expansion.
- Competitive dynamics could influence future pricing or biosimilar entry.
- Regulatory policies targeting drug prices may impact net revenue, but the brand's market position provides pricing power.
- Estimated average annual expenditure per patient remains above $120,000, with little expected deviation over the next five years.
FAQs
1. Will biosimilars for Nivolumab enter the market?
Yes. Biologic licensing pathways in the US could enable biosimilar development, though no FDA-approved biosimilars have entered the market as of 2023.
2. How do combination therapies affect Nivolumab pricing?
They increase overall treatment costs, potentially boosting sales volume but complicate pricing negotiations.
3. What impact will Medicare negotiations have on drug pricing?
Potentially lower net reimbursement levels, though list prices may stay stable; effects are uncertain until policies are implemented.
4. Are there emerging competitors likely to impact Nivolumab's market share?
Pembrolizumab remains a primary competitor, with ongoing clinical trials for new indications.
5. How does the expansion into additional indications influence pricing and sales?
It prolongs revenue growth, as broader use sustains demand; pricing generally remains stable unless driven by policy or market pressures.
References
- EvaluatePharma. (2022). Global oncology immunotherapy market report.
- IQVIA. (2023). Medicine usage and expenditure data.
- U.S. Food and Drug Administration. (2015-2022). Approval summaries for Nivolumab.
- Centers for Medicare & Medicaid Services. (2023). Proposals for drug price negotiations.
- Statista. (2023). Immunotherapy market revenue projections.
