Last updated: February 23, 2026
What is the drug associated with NDC 16714-0059?
NDC 16714-0059 is associated with Nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor used for treating various cancers, including melanoma, non-small cell lung cancer, renal cell carcinoma, and others.
What is the current market position of Nivolumab?
Nivolumab is a leading immunotherapy drug with a significant presence in oncology. It is marketed by Bristol-Myers Squibb under the brand name Opdivo. Its sales revenue exceeds $7 billion annually worldwide, with steady growth driven by expanding indications and global approval.
What are the key factors influencing market size?
Market size
- Global oncology drug market was valued at approximately $166 billion in 2022, with immunotherapies accounting for about 25%, or nearly $42 billion.
- Nivolumab captures a significant market share within immunotherapy, estimated at 30-40% in key indications.
Market growth drivers
- Expansion of indications into earlier lines of therapy
- Increasing prevalence of target cancers
- Regulatory approvals in emerging markets
- Combination therapy approvals, expanding use cases
Competitive landscape
- Key competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), durvalumab (Imfinzi), and a variety of biosimilars.
- Pembrolizumab holds a larger share in some indications, but Nivolumab remains a core therapy.
What are the pricing trends?
Current pricing
- List Price: Approximately $11,000–$13,000 per infusion, with dosing based on body weight (e.g., 240 mg every 2 weeks).
- Average Wholesale Price (AWP): Slightly higher than the list price, factoring in discounts.
Reimbursement and discounts
- Actual transaction prices often include negotiated discounts, with net prices 20%-30% below list prices.
- Payer negotiations and value-based pricing models influence net revenue.
Pricing vs. competition
| Drug |
Approximate Weekly Cost |
Indication Focus |
| Nivolumab (Opdivo) |
$11,000–$13,000 |
Multiple cancers |
| Pembrolizumab (Keytruda) |
$10,500–$13,500 |
Multiple cancers |
| Atezolizumab ( Tecentriq) |
$10,000–$12,000 |
Lung, bladder, breast |
What are smart projections for future prices?
Factors impacting future prices
- Price pressure from biosimilars (expected to enter the market within 3-5 years for some indications)
- Increasing competition from other immunotherapies
- Impact of biosimilar uptake and payer negotiations
- Regulatory and formulary decisions favoring cost-effective options
Price projection estimates (next 3-5 years)
| Year |
Price Range (per infusion) |
Key Drivers |
| 2023 |
$11,000–$13,000 |
Stable pricing, ongoing demand |
| 2024 |
$10,500–$12,500 |
Price negotiations, initial biosimilar entry |
| 2025 |
$10,000–$12,000 |
Biosimilar market penetration, increased competition |
Projected net prices are expected to decline by approximately 10-15% over five years as biosimilars and generics gain market share.
What is the forecast for biosimilar impact?
- Biosimilar approval for nivolumab is anticipated between 2024 and 2026.
- Biosimilar prices may be 30-50% lower than the originator, pushing homologous competition.
- Market share for biosimilars could reach 20-30% within three years of entry, leading to pricing pressures.
Final summary
- Nivolumab remains a dominant immunotherapy agent with high revenue.
- List prices are approximately $11,000–$13,000 per infusion.
- Market growth is driven by expanded indications, but price erosion is probable due to biosimilar competition.
- Price projections over the next five years estimate a gradual decline to about $10,000–$12,000 per infusion.
Key Takeaways
- Nivolumab (NDC 16714-0059) holds a significant market share in oncology immunotherapies with stable revenue.
- Current retail prices are around $11,000–$13,000 per dose, with net prices impacted by payer negotiations.
- Biosimilar competition will exert downward pressure on prices, with a 10–15% reduction projected over five years.
- Market expansion into new indications and regions supports continued revenue growth despite pricing pressures.
- Strategic partnerships and value-based pricing approaches will influence future pricing negotiations.
FAQs
-
When are biosimilars for nivolumab expected to hit the market?
Biosimilars are projected to receive approval between 2024 and 2026, with initial market entry possibly occurring shortly thereafter.
-
How does pricing of nivolumab compare to other immunotherapies?
It is similar in list price to pembrolizumab and atezolizumab, though actual transaction prices vary based on negotiations and discounts.
-
What are opportunities for cost reduction through biosimilar adoption?
Biosimilars can reduce per-infusion costs by 30-50%, leading to increased affordability and access.
-
What indications most influence nivolumab revenue growth?
Melanoma, non-small cell lung cancer, renal cell carcinoma, and combination therapies are primary drivers.
-
How might regulatory changes affect future pricing?
Price controls and value-based reimbursement policies in major markets could further pressure prices downward.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] Bloomberg Intelligence. (2023). Immunotherapy Market Trends.
[3] FDA. (2022). Biosimilar Approval Timeline.
[4] Bristol-Myers Squibb. (2023). Opdivo Price and Usage Data.
[5] Centers for Medicare & Medicaid Services. (2023). Drug Reimbursement Policies.
