Last updated: February 16, 2026
What is the Drug Associated with NDC 51407-0198?
The National Drug Code (NDC) 51407-0198 is assigned to Nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor. Its primary indication is for treating melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and other cancers.
What is the Current Market Size?
The global immuno-oncology market was valued at approximately USD 12 billion in 2022. Nivolumab accounts for a significant share of this, driven by approvals across multiple indications and geographic regions.
| Parameter |
Data |
| Global market size (2022) |
USD 12 billion |
| Nivolumab's US sales (2022) |
USD 5.5 billion (approximately) |
| Market growth rate |
Compound annual growth rate (CAGR) estimate of 12% (2022–2027) |
The approval of new indications, including combinations with other immunotherapies, has contributed to ongoing sales growth.
How Competitive Is the Market?
Nivolumab faces competition mainly from pembrolizumab (Keytruda), another PD-1 inhibitor, which holds a larger market share in several indications. Key competitors also include atezolizumab (Tecentriq) and durvalumab (Imfinzi).
| Major competitors |
Market share (2022) |
| Pembrolizumab (Keytruda) |
Estimated 60-65% in US immuno-oncology market |
| Nivolumab (Opdivo) |
Estimated 30-35% in same segment |
Pricing dynamics are influenced by these competitive pressures, indications, and patient access programs.
What are Current Pricing Trends?
The list price for Nivolumab varies by indication and dosage but typically ranges between USD 5,000 and USD 7,000 per dose. The average wholesale price (AWP) approaches USD 6,000 per 240 mg dose (standard) in the US.
| Price Range per Dose |
USD |
| Lower boundary |
USD 5,000 |
| Upper boundary |
USD 7,000 |
Discounts, rebates, and patient assistance reduce net prices. Managed care organizations often negotiate substantial discounts, affecting actual reimbursement rates.
What Are the Price Projections for the Next 3–5 Years?
Assuming ongoing approval expansions and increased adoption, sales are expected to grow at a compound annual rate of roughly 8-12% through 2027. The projected market size could reach USD 20-25 billion globally, with US sales accounting for approximately USD 10 billion.
| Year |
Estimated US Sales (USD billions) |
Market Size (USD billions) |
| 2023 |
6.0 |
14.0 |
| 2024 |
6.4 |
15.5 |
| 2025 |
6.8 |
17.0 |
| 2026 |
7.3 |
19.0 |
| 2027 |
8.0 |
20-25 |
Pricing per dose may decrease marginally due to increased competition, biosimilar introductions (although none approved yet for nivolumab), and payer negotiations.
What Variables Could Impact Future Prices?
- Regulatory approval of biosimilars.
- Patent expirations—expected around 2028.
- Uptake of combination therapies.
- Entry of alternative immunotherapies with comparable efficacy.
- Reimbursement policies and formulary decisions.
Key Takeaways
- Nivolumab remains a significant revenue driver in immuno-oncology.
- Current US list prices hover around USD 6,000 per dose.
- Market growth is driven by expanding indications and combination treatments.
- Competition from pembrolizumab and emerging biosimilars could influence pricing.
- Projections suggest a US market size reaching USD 10 billion by 2027, with global sales potentially exceeding USD 20 billion.
FAQs
1. What are the main indications for NDC 51407-0198?
Cancer types including melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, and others.
2. How does Nivolumab’s pricing compare to peers?
It generally aligns with pembrolizumab but can be slightly lower or higher depending on negotiated discounts and dosing regimens.
3. When will biosimilars impact Nivolumab’s market share?
Potential biosimilar entries are expected around 2028, pending approval and market uptake.
4. What factors could increase the drug’s price?
Increased demand, new indications, limited biosimilar availability, or supply constraints.
5. How are payers influencing Nivolumab’s pricing?
Through formulary placement, prior authorization, and negotiated discounts that lower net reimbursement.
References
- EvaluatePharma. (2023). Oncology market report.
- IQVIA. (2022). US Oncology Sales Data.
- FDA. (2022). Nivolumab approval details.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies.
- MarketWatch. (2023). Cancer immunotherapy market forecast.
