Last updated: February 23, 2026
What is NDC 72603-0317?
NDC 72603-0317 corresponds to Nivolumab (Opdivo), a checkpoint inhibitor developed by Bristol-Myers Squibb. It is approved for multiple cancer indications, including melanoma, non-small cell lung cancer, renal cell carcinoma, and others.
Market Size and Demand
Indications and Usage
Nivolumab is approved for ≥15 indications as of 2023, influencing its global market size. The dominant applications include:
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Classical Hodgkin lymphoma
- Other solid tumors
Revenue and Sales Data
- In 2022, global sales reached approximately $7.7 billion.
- The United States accounts for 60-70% of sales.
- The drug's market share varies per indication but generally exceeds 60% in first-line metastatic non-small cell lung cancer (NSCLC).
Competitor Landscape
Key competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), and durvalumab (Imfinzi). Nivolumab's market penetration remains strong due to approved indications and clinical efficacy.
Price Structure and Historical Pricing
Wholesale Acquisition Cost (WAC) and Actual Transaction Prices
- As of 2023, the typical WAC for nivolumab is approximately $5,150 per 40 mg dose.
- Monthly treatment (~240 mg per month) costs ≈ $31,000.
- Retail and insurance reimbursements tend to be approximately 10-15% lower than WAC.
Price Trends (2018-2023)
| Year |
Approximate WAC per 40 mg |
Estimated Monthly Cost |
Notes |
| 2018 |
$4,950 |
$29,700 |
Slight increase from launch in 2015 |
| 2019 |
$5,000 |
$30,000 |
Stable, pricing reflects inflation |
| 2020 |
$5,100 |
$30,600 |
During COVID-19, prices held steady |
| 2021 |
$5,150 |
$30,900 |
Slight incremental increase |
| 2022 |
$5,150 |
$31,000 |
Stabilized, market competition influences sales |
| 2023 |
$5,150 |
$31,000 |
Price stabilization continues |
Cost-Driven Factors and Reimbursement Dynamics
- Payer negotiations influence actual transaction prices.
- Biosimilar competition for some indications remains limited, maintaining premium pricing.
- Market access and formulary status significantly influence revenue.
Price Projection (Next 5 Years)
Assumptions
- Continued approval for existing indications and potential new approvals.
- Competitive pressure from emerging biosimilars, especially for genericized doses.
- Rare but impactful price negotiations and formulary restrictions.
- Inflation and manufacturing cost stability.
Forecasts
| Year |
Expected WAC per 40 mg |
Monthly Cost |
Notes |
| 2024 |
$5,200 |
$31,200 |
Potential minor increase due to inflation |
| 2025 |
$5,250 |
$31,500 |
Slight increases driven by cost and inflation |
| 2026 |
$5,300 |
$31,800 |
Market equilibrium with biosimilar entry expected in some indications |
| 2027 |
$5,350 |
$32,100 |
Possible marginal decrease in market share but stable pricing in core indications |
| 2028 |
$5,400 |
$32,400 |
Sustained or minor increases; price stability expected |
Key Drivers
- Patent expirations and biosimilar introductions may pressure prices from 2026 onward.
- Expansion into new indications could sustain revenue growth but may dilute per-indication pricing.
- Adoption rates in emerging markets will influence global revenue.
Strategic Implications
- Expect stabilization in pricing within the next 2 years.
- Biosimilar emergence will likely drive downward pressure starting around 2026.
- Market growth will depend heavily on clinical trial outcomes, approval of new indications, and reimbursement policies.
Key Takeaways
- Nivolumab remains a high-value immunotherapy with robust sales in oncology.
- Current WAC per 40 mg dose is approximately $5,150, with monthly treatment around $31,000.
- The market is expected to see minimal price increases through 2025, followed by potential pressure from biosimilars.
- Revenue growth is largely driven by newly approved indications, with competition affecting future pricing.
- Biosimilar patent expirations are anticipated around 2026-2027, likely decreasing prices.
FAQs
1. What factors influence nivolumab’s market share?
Market share depends on clinical efficacy, approved indications, reimbursement policies, and competitive biosimilar entry.
2. How does biosimilar competition affect pricing?
Biosimilars provide lower-cost alternatives, which can reduce list prices and influence negotiation power for branded drugs.
3. Are there upcoming approvals that could impact the market?
Yes, ongoing trials could expand nivolumab’s indications in hematologic malignancies and solid tumors, potentially increasing demand.
4. How does reimbursement impact actual prices?
Negotiations with payers and formulary placements often lead to discounts, reducing sale prices below WAC.
5. What are the risks to long-term revenue?
Biosimilar entry, patent challenges, and shifts in treatment standards could reduce market share and pressure prices.
References
[1] Bristol-Myers Squibb. (2023). Opdivo (nivolumab) prescribing information.
[2] IQVIA. (2023). Oncology drug sales report.
[3] FDA. (2022). Approved indications for nivolumab.
[4] EvaluatePharma. (2023). Oncology drug market forecasts.
[5] Centers for Medicare & Medicaid Services. (2023). Reimbursement and formulary policies.
