Last updated: February 23, 2026
What is NDC 72266-0199 and its Clinical Use?
NDC 72266-0199 corresponds to Nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor produced by Bristol-Myers Squibb. It is approved for multiple oncology indications including melanoma, non-small cell lung cancer, renal cell carcinoma, and others. Its mechanism involves blocking PD-1 receptors to boost immune response against tumors.
Current Market Size and Penetration
Market Context
Nivolumab's global sales exceeded $7.4 billion in 2022, reflecting broad adoption in oncology. The U.S. accounted for approximately 60% of sales, with growth driven by approvals in new indications and expanded line-access.
Revenue Breakdown by Indication
| Indication |
Revenue (2022) |
% of Total Sales |
Growth Rate (2021-2022) |
| Melanoma |
$2.0B |
27% |
12% |
| Non-small Cell Lung Cancer |
$2.4B |
32% |
15% |
| Renal Cell Carcinoma |
$1.1B |
15% |
10% |
| Others (Hodgkin lymphoma, etc.) |
$1.8B |
26% |
14% |
Market Penetration Trends
- Increased use as first-line therapy in lung and melanoma.
- Accelerated approvals for combination therapies.
- Rising use in earlier stages of cancer, extending sales lifespan.
Competitive Landscape
Key Competitors
- Pembrolizumab (Keytruda): Market leader with over $20 billion annual revenue.
- Atezolizumab (Tecentriq): Competitive for lung and bladder cancers.
- Durvalumab (Imfinzi): Approved for specific thoracic cancers.
Market Share Dynamics
| Drug |
Estimated Market Share (2022) |
Growth Rate |
Notes |
| Nivolumab |
29% |
+5% |
Broad, multi-indication |
| Pembrolizumab |
55% |
+3% |
Dominates lung, melanoma |
Patent Status and Biosimilar Impact
Pending patent expirations are unlikely before 2028. Trademark protections remain in key markets.
Price Trends and Projections
Current Pricing
In the U.S., list prices for Nivolumab have been approximately $5,000 per 10-mg vial and $16,598 for a 240-mg dose, with actual net prices lower after discounts and rebates.
Historical Price Data
| Year |
Average Wholesale Price (AWP) per 240 mg |
Notes |
| 2018 |
$16,598 |
Initial launch price |
| 2019 |
Slight decrease (~2%) |
Market competition pressures |
| 2020 |
Stable |
Reimbursement policies |
| 2022 |
$16,400 |
Slight price stabilization |
Projections (2023-2028)
- Price stability expected through 2024 due to limited competition and high demand.
- Potential price erosion of 10-15% post-2025 driven by biosimilar development in markets outside the U.S.
- Industry estimates suggest net prices could decline to approximately $14,000 for a 240-mg dose by 2028.
Economic and Policy Influences
- Pricing pressure from healthcare payers especially in markets with stringent cost-effectiveness criteria.
- Value-based agreements influencing net prices.
- Patent expirations could introduce biosimilar entries in non-U.S. regions starting around 2028.
Sales Forecast Overview
| Year |
Estimated Global Sales |
Variance Factors |
Comments |
| 2023 |
$7.5B |
New indication approvals |
Slight growth expected |
| 2024 |
$8.0B |
Expanded line-access |
Driven by combination regimens |
| 2025 |
$8.2B |
Patent protections remain intact |
Growth stabilizes |
| 2026 |
$8.3B |
Biosimilar competition emerges |
Potential slowdown |
| 2028 |
$8.5B |
Biosimilar entry in US, EU |
Growth rate declines |
Summary
- Nivolumab (NDC 72266-0199) commands a significant share in oncology markets, with continued expansion in indications.
- Pricing remains relatively stable through 2024, with moderate declines anticipated post-2025 due to biosimilar competition.
- Market shares are concentrated, dominated by Pembrolizumab, but Nivolumab sustains high sales through multiple indications.
- Future growth hinges on new approvals, combination therapies, and regional biosimilar competition.
Key Takeaways
- Nivolumab maintains a leading position with $7.4 billion worldwide sales in 2022.
- Price per dose is approximately $16,000, with net prices likely declining to around $14,000 by 2028.
- Market share growth will depend on approval of new indications and competitive pricing strategies.
- Patent and biosimilar developments are crucial for forecasting long-term pricing and market share.
FAQs
Q1: When are biosimilar versions of Nivolumab expected to enter the market?
A1: Biosimilar entries are projected around 2028 in Europe and the U.S., following patent expirations and regulatory pathways.
Q2: How does Nivolumab compare with Pembrolizumab in pricing?
A2: Both drugs have similar dosing and list prices, though Pembrolizumab's market share is higher, potentially affecting negotiations and discounts.
Q3: What upcoming indications could influence Nivolumab sales?
A3: Potential approvals include additional cancers like gastric and head-and-neck cancers, which could expand its market.
Q4: What are the main drivers influencing Nivolumab pricing?
A4: Payer negotiations, reimbursement policies, biosimilar competition, and value-based pricing models.
Q5: How has the COVID-19 pandemic impacted Nivolumab sales?
A5: Short-term disruptions in healthcare delivery caused temporary sales dips, but long-term outlook remains positive with continued treatment adoption.
References
- Bristol-Myers Squibb. (2023). Opdivo (Nivolumab) Prescribing Information.
- IQVIA. (2023). National Prescription Audit.
- EvaluatePharma. (2022). World Oncology Market Outlook 2022.
- U.S. Food and Drug Administration. (2022). Biologic License Application Approvals.
- Centers for Medicare & Medicaid Services. (2022). Pricing and Reimbursement Data.
