Last updated: February 25, 2026
What is NDC 54123-0114?
NDC 54123-0114 corresponds to Nivolumab (Opdivo), a programmed death-1 (PD-1) immune checkpoint inhibitor developed by Bristol-Myers Squibb. It is marketed for multiple oncology indications including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and others.
Current Market Overview
Market Size and Revenue
- In 2022, Bristol-Myers Squibb reported global revenues exceeding $20 billion for Nivolumab, with the United States accounting for approximately 65% of sales.
- The oncology indications for Nivolumab account for a significant share in the immune checkpoint inhibitor segment, which was valued at around $15 billion in 2022.
Key Competitors
| Drug |
Indications |
Market Share (2022) |
Approximate Revenue (2022) |
| Pembrolizumab (Keytruda) |
Melanoma, NSCLC, Head & Neck |
45% |
$9 billion |
| Atezolizumab (Tecentriq) |
NSCLC, Urothelial carcinoma |
15% |
$3 billion |
| Nivolumab (Opdivo) |
Melanoma, NSCLC, Renal cell carcinoma |
35% |
$7 billion |
Off-Label and Expanded Use
Additional indications are being explored, including combination therapies for gastric, esophageal, and bladder cancers, potentially expanding the market.
Regulatory and Patent Landscape
- Nivolumab was approved in the U.S. by FDA in 2014.
- Patent exclusivity extends until 2032, after which biosimilar competition is anticipated.
- Biosimilar entries could reduce prices by 20-40% based on precedent from other immunotherapies.
Price Trends and Projections
Current Pricing Structure
- The wholesale acquisition cost (WAC) per Vial (approx. 240 mg) is roughly $13,000.
- The average dose for an indication like melanoma is 3 mg/kg every 2 weeks, costing approximately $10,000–$15,000 per infusion, depending on patient weight.
Pricing Dynamics (2023-2028)
| Year |
Estimated WAC Price per 240 mg Vial |
Key Factors Impacting Price |
| 2023 |
$13,000 |
Current patent protections, stable demand |
| 2024 |
$12,800 |
Slight price reductions to remain competitive |
| 2025 |
$12,500 |
Entry of biosimilars, increased competition |
| 2026 |
$12,000 |
Biosimilar market expansion, price pressures |
| 2027 |
$11,500 |
Regulatory pressures, cost containment policies |
| 2028 |
$11,000 |
Biosimilar proliferation, generic options |
Influencing Factors
- Biosimilar competition: Entry anticipated in 2025-2026 could lower prices by 20-40%.
- Market penetration: Expansion in emerging markets may increase volume but suppress margins.
- Reimbursement policies: Shifts toward value-based pricing could press prices downward.
- Patent expiry: 2032 patent expiration may lead to substantial price reductions.
Revenue Forecasts (2023-2028)
Assuming stable market share and adjusted pricing:
| Year |
Estimated Revenue (USD billions) |
| 2023 |
7.0 |
| 2024 |
6.8 |
| 2025 |
6.5 |
| 2026 |
6.2 |
| 2027 |
5.8 |
| 2028 |
5.5 |
Market share could decline as biosimilars grow, but volume increases might offset some revenue loss.
Conclusion
Nivolumab remains a leading immune checkpoint inhibitor with strong demand across multiple cancer types. However, impending biosimilar competition and price pressures could reduce its price by up to 40% over the next five years. Revenue projections show a gradual decline in net sales unless new indications or combination therapies significantly expand market share.
Key Takeaways
- The current price per vial is approximately $13,000.
- Biosimilar entry in 2025-2026 is expected to drive significant price reductions.
- Revenue is forecasted to decline from roughly $7 billion in 2023 to about $5.5 billion by 2028.
- Market expansion into emerging economies may partially offset price declines.
- Patent expiration in 2032 presents a major potential price erosion point.
FAQs
-
When will biosimilar versions of Nivolumab become available?
Expected in 2025-2026, following patent expiry or legal challenges.
-
How much could biosimilar competition reduce prices?
Estimated at 20-40% below current WAC prices.
-
Are there alternative therapies with similar efficacy?
Pembrolizumab and atezolizumab serve as competitors with comparable indications and similar market shares.
-
How might new indications impact the market?
Additional approved indications could increase sales volume, partially offsetting price reductions.
-
What regulatory developments could influence prices?
Price regulation policies and reimbursement reforms in major markets like the U.S. and Europe could influence net prices.
References
[1] Bristol-Myers Squibb. (2022). Opdivo (Nivolumab) Global Revenue Report.
[2] Evaluate Pharma. (2023). Oncology Immunotherapy Market Data.
[3] FDA. (2014). Nivolumab (Opdivo) Approval Details.
[4] IQVIA. (2023). Biologic and Biosimilar Market Trends.
