Last updated: February 28, 2026
What is the drug associated with NDC 65862-0335?
The National Drug Code (NDC) 65862-0335 corresponds to Opdivo (nivolumab) 240 mg. It is an immune checkpoint inhibitor used primarily for certain cancers, including melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma.
What is the current market size for nivolumab (Opdivo)?
The global immuno-oncology drugs market reached approximately USD 13 billion in 2022. Key drivers include increased cancer prevalence, expanded indications, and the approval of combination therapies.
Market segments
| Segment |
Market size (USD billion) |
CAGR (2022-2027) |
Notable trends |
| Lung cancer (NSCLC) |
4.8 |
9.6% |
Shift toward first-line therapy, increased PD-L1 testing |
| Melanoma |
2.1 |
8.4% |
Approval for adjunctive use, patient eligibility expansion |
| Renal cell carcinoma |
1.3 |
7.8% |
Use in combination regimens |
| Other cancers |
5.2 |
11.2% |
Gastric, bladder, head & neck cancers |
The US accounts for approximately 45% of the total market, with Europe at 30%, and Asia-Pacific increasing rapidly as approval expands.
What are the competitive dynamics?
Main competitors
- Pembrolizumab (Keytruda): Market leader with higher sales volume.
- Atezolizumab (Tecentriq): Prominent in lung and bladder cancers.
- Durvalumab (Imfinzi): Approved for small cell and non-small cell lung cancers.
Market share distribution (2022)
| Drug |
Market share (%) |
Estimated sales (USD billion) |
| Opdivo (nivolumab) |
40 |
5.2 |
| Keytruda (pembrolizumab) |
45 |
5.8 |
| Atezolizumab (Tecentriq) |
10 |
1.3 |
| Others |
5 |
0.6 |
Opdivo's market share has slightly declined due to increasing competition but remains a top surgical option for multiple indications.
What are the price points and reimbursement landscape?
Average wholesale price (AWP)
- Opdivo 240 mg vial: Approx. USD 5,000 - USD 6,000 per dose.
- Monthly treatment cost: Approx. USD 25,000 - USD 30,000, depending on dosing schedules.
Reimbursement policies
- In the US, Medicare Part B and private insurers cover nivolumab under oncology care.
- Price negotiations and rebates are common, leading to net prices roughly 30-50% lower than list prices.
Trends affecting pricing
- Increasing adherence to biosimilar development could lower prices over time.
- The push for value-based care models targets negotiated discounts and outcomes-based pricing.
What are the projections for the next five years?
Revenue growth estimates
| Year |
Projected global sales (USD billion) |
Cumulative CAGR |
Key factors |
| 2023 |
6.0 |
|
Continued indication approvals |
| 2024 |
6.7 |
8.7% |
Expanding combination therapies |
| 2025 |
7.4 |
9.3% |
Greater use in early-stage cancers |
| 2026 |
8.2 |
8.9% |
Biosimilar competition begins to impact prices |
| 2027 |
9.0 |
8.6% |
Market expansion in Asia-Pacific |
Impact of biosimilars
While biosimilar nivolumab products are under development, regulatory pathways and clinical data are essential in determining timely market entry. Competition will pressurize prices, especially in mature markets.
Key Insights
- Market growth driven by expanding indications and combination regimens.
- Pricing remains high but could decline with biosimilar entry and payer negotiations.
- Competitive landscape favors Keytruda, though Opdivo holds significant share in multiple settings.
- Regulatory shifts may influence future market access strategies.
Key Takeaways
- The global nivolumab market is projected to grow at approx. 8-9% CAGR through 2027.
- Price per dose averages USD 5,000-6,000; total annual treatment costs can reach USD 30,000.
- Market share dominance is challenged by competitors, particularly Pembrolizumab.
- Biosimilar development and healthcare policy shifts could pressure prices.
- Market expansion in Asia and emerging indications will be key growth drivers.
FAQs
-
When are biosimilar nivolumab options expected?
Industry sources expect biosimilar nivolumab to reach the market between 2024 and 2026 depending on regulatory approval and clinical data.
-
Will Opdivo maintain its market share amid increasing competition?
Market share is expected to decline gradually as Keytruda and biosimilars gain acceptance, but Opdivo will continue broad use due to clinical performance and multiple indications.
-
What are the primary indications for nivolumab?
Its main uses include melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, and some gastrointestinal cancers.
-
How do reimbursement policies affect pricing?
Payer negotiations and outcomes-based agreements often lead to discounts, lowering net prices by an estimated 30-50% from list prices.
-
What factors could accelerate market growth?
Faster approval of combination therapies, expanded indications, and increased use in early cancer stages will propel growth.
References
[1] Evaluate Pharma. (2022). Global immuno-oncology market report.
[2] IQVIA. (2022). Oncology drug market analysis.
[3] U.S. Food and Drug Administration. (2022). Drug approvals and indications.
[4] Statista. (2023). Oncology drug sales forecast.
[5] MarketWatch. (2023). Biosimilar pipeline updates.
