Last updated: April 1, 2026
What is NDC 62559-0523?
This product corresponds to Nivolumab (Opdivo), marketed by Bristol-Myers Squibb. It is an immune checkpoint inhibitor approved for multiple cancer indications including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and Hodgkin lymphoma.
Market Size and Growth Drivers
Indications and Revenue Drivers
- Approved indications: melanoma, NSCLC, head and neck squamous cell carcinoma, Hodgkin lymphoma, and others.
- Recent approvals expand usage, notably in combination therapies.
- The global immuno-oncology market was valued at $10 billion in 2021; expected to reach approximately $20 billion by 2028, growing at an annual rate of 9.7%[1].
Key Market Factors
- High unmet need in advanced cancers sustains demand.
- Regulatory approvals expanding indications.
- Price adjustments in response to biosimilar entry are limited due to regulatory and patient access barriers.
Competitive Landscape
- Main competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), durvalumab (Imfinzi), and cemiplimab (Libtayo).
- Pembrolizumab dominates with a 45% market share among immune checkpoint inhibitors in 2022.
Pricing Trends
- List price for nivolumab: approximately $17,000 per 100 mg dose in the U.S.[2].
- Price increases occur periodically, often annually, reflecting inflation and market dynamics.
- Biosimilar presence is limited; biosimilars are under development but face regulatory and patent barriers.
Pricing and Reimbursement Landscape
U.S.
- Average sales price per 240 mg vial (dose for most indications): about $40,800.
- Reimbursement is largely through Medicaid, Medicare, private insurers, with negotiations influencing net pricing.
- Medicare policy impacts: Inflation-based rebate adjustments and value-based payment models.
International Markets
- European prices vary from $4,000 to $8,000 per treatment cycle.
- In lower-income countries, prices are negotiated downward or facilitated via voluntary licensing agreements.
Price Projections (Next 3-5 Years)
| Year |
Estimated List Price per 100 mg |
Expected Market Penetration |
Key Factors Influencing Price |
| 2023 |
$17,000 |
85% of eligible patients |
Stable demand, limited biosimilar competition |
| 2024 |
$17,500 |
87% |
Enhanced indications, potential biosimilar entries late 2020s |
| 2025 |
$18,000 |
88% |
Patent protection maintained, possible price adjustments for new indications |
| 2026 |
$18,500 |
89% |
Biosimilar approvals may influence pricing in some regions |
| 2027 |
$19,000 |
90% |
Market saturation, negotiations intensify |
Assumptions:
- Regulatory exclusivity remains intact in the U.S. until at least 2027.
- Biosimilar competition remains limited in the near term.
- Demand continues driven by expanding indications and combination therapies.
Impact of Biosimilar Development
While biosimilars for nivolumab are approved in some regions (e.g., Switzerland, EU), widespread adoption is delayed by patent litigation, regulatory hurdles, and healthcare system inertia. Prices are expected to decline gradually once biosimilars penetrate broadly, potentially reducing costs by 20-30% over five years.
Price Comparisons: Nivolumab vs. Competitors
| Drug |
Indications |
List Price (per 100 mg) |
Market Penetration |
Price Change (2020-2023) |
| Nivolumab |
Multiple |
$17,000 |
85% |
Stable with slight increases |
| Pembrolizumab |
Multiple |
$16,500 |
90% |
Slightly higher, stable |
| Atezolizumab |
Limited |
$13,000 |
45% |
Price stable or slightly declining |
Key Takeaways
- Nivolumab maintains a high market share in immune checkpoint inhibitors with a stable price trajectory.
- Price increases are modest and driven by inflation, indication expansion, and market demand.
- Biosimilar competition is limited but will eventually exert downward pressure over the next five years.
- International pricing varies significantly, influenced by regulatory and economic factors.
FAQs
1. Is Nivolumab likely to see significant price reductions in the next five years?
Significant reductions are unlikely in major markets due to patent protections and limited biosimilar competition in the near term. Incremental price increases are expected.
2. How will biosimilars impact Nivolumab’s market share and pricing?
Biosimilars could reduce prices by 20-30% once fully approved and adopted, potentially causing a gradual erosion in margins and market share in some regions.
3. What are the primary factors influencing Nivolumab’s price stabilization?
Market demand, regulatory protection, and limited biosimilar competition contribute to price stability; indication expansion also supports pricing power.
4. How does Nivolumab’s price compare globally?
Prices in Europe are roughly 50-70% lower than in the U.S. due to different healthcare systems, reimbursement models, and negotiated discounts.
5. Are there upcoming regulatory or patent developments that could influence prices?
Patent protections are expected to last until at least 2027 in key markets; no immediate patent expirations are scheduled. Regulatory approvals for biosimilars are underway in some regions.
References
[1] Grand View Research. (2022). Immuno-oncology Market Size, Share & Trends. Retrieved from https://www.grandviewresearch.com/industry-analysis/immuno-oncology-market
[2] GoodRx. (2023). Nivolumab (Opdivo) Price. Retrieved from https://www.goodrx.com/
[3] IQVIA. (2022). Market Intelligence Report.
[4] FDA. (2022). FDA-approved Biosimilars. Retrieved from https://www.fda.gov/drugs/biosimilars
[5] Evaluate Pharma. (2022). Oncology Market Forecast.
