Last updated: February 19, 2026
What is NDC 00093-3123?
NDC 00093-3123 corresponds to Nivolumab (Opdivo), a monoclonal antibody approved for multiple cancer indications. It functions as an immune checkpoint inhibitor targeting PD-1 proteins to enhance immune response against tumors.
Market Overview
Indications and Approved Uses
Nivolumab is approved for:
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Renal cell carcinoma
- Classical Hodgkin lymphoma
- Other solid tumors
Market penetration is high in developed countries, especially in the US, Europe, and Japan.
Current Market Size and Growth
- The global immuno-oncology market was valued at approximately $30 billion in 2022.
- Nivolumab accounts for about 50-55% of this segment.
- CAGR estimated at 11.5% from 2023 to 2028, driven by expanded indications and increasing oncology treatment adoption.
Competitive Landscape
Major competitors include:
- Pembrolizumab (Keytruda)
- Atezolizumab (Tecentriq)
- Durvalumab (Imfinzi)
Nivolumab's leading position persists due to early approval and broad label.
Price Analysis
Current Pricing
United States average wholesale price (AWP):
- Per 40 mg dose: approximately $1,200-$1,300
- Per 240 mg vial: around $7,200-$7,800
Pricing varies by indication, dosing schedules, and payor negotiations.
Pricing Trends
- Prices have remained relatively stable from 2020 to 2023.
- Discounting practices are common, with net prices reduced by rebates and discounts.
Cost Drivers
- Manufacturing costs are high due to complex biologic production.
- Maturation of biosimilars is limited; no biosimilar versions are FDA-approved for nivolumab to date.
- Payer negotiations impact actual transaction prices.
Price Projections (2023–2028)
| Year |
Estimated Wholesale Price per 240 mg vial |
Key Factors |
| 2023 |
$7,200-$7,800 |
Stable pricing; market dominance maintained |
| 2024 |
$7,200-$7,800 |
No biosimilar introduction; demand growth in expanded indications |
| 2025 |
$7,150-$7,750 |
Possible slight decrease; inflation control |
| 2026 |
$7,100-$7,700 |
Biosimilar approval anticipated; potential for discounts |
| 2027 |
$7,000-$7,600 |
Biosimilar market entry begins, exerting downward pressure |
| 2028 |
$6,900-$7,500 |
Increased biosimilar competition; price reductions expected |
Assumptions underpinning projections:
- No major regulatory changes impacting pricing.
- Biosimilar entry occurs in 2026–2027.
- Continued demand due to expanded indications, including neoadjuvant/younge adult uses.
- Market stability barring supply chain disruptions or policy reforms.
Regulatory and Policy Factors
- Ongoing patent protections until at least 2030.
- Changes in Medicare and Medicaid reimbursement policies could influence net prices.
- Biosimilar pathway regulation by FDA heavily influences future pricing.
Key Takeaways
- Nivolumab holds a dominant position in immuno-oncology, with high market share.
- Prices have plateaued but may decline marginally as biosimilars emerge.
- Market expansion into additional oncologic indications supports continued revenue.
- Competitive pressure from biosimilars could reduce prices by approximately 10–15% over the next five years.
- Overall market size is expected to grow at double-digit rates through 2028.
FAQs
1. When are biosimilars for nivolumab expected to enter the market?
Likely approval in the 2026–2027 timeframe, based on biosimilar development timelines and FDA approval patterns.
2. How will biosimilar entry affect nivolumab pricing?
Biosimilar competition will exert downward pressure, potentially reducing prices by 10–15%, depending on market uptake and payor negotiations.
3. Are there any upcoming regulatory changes that could impact prices?
No major regulatory reforms impacting nivolumab pricing are imminent, but policy shifts, especially in Medicare/Medicaid, could influence net reimbursement.
4. How do prices vary internationally?
Prices are generally lower outside the US, often reflecting national negotiation, approval, and reimbursement frameworks. European prices typically range 30–50% below US levels.
5. What is the potential for label expansion impacting revenues?
Expansion into new indications, such as earlier-stage cancers or combination therapies, can significantly boost sales volume, offsetting pressure from price reductions.
References
- IQVIA. (2023). Top Immuno-Oncology Drugs Market Data.
- FDA. (2022). Biologics License Application Approvals.
- EvaluatePharma. (2023). Global Oncology Market Forecast.
- Centers for Medicare & Medicaid Services. (2022). Drug Payment Policies.
- Pharmaceutical Research and Manufacturers of America. (2023). Biologics and Biosimilars Regulatory Environment.
