Last updated: February 24, 2026
What is the drug associated with NDC 82249-0747?
The National Drug Code (NDC) 82249-0747 corresponds to Nivolumab (Opdivo), a monoclonal antibody used in oncology indications. It is approved for metastatic melanoma, non-small cell lung cancer, and other cancers.
What is the current market status for Nivolumab?
Nivolumab is a leading immune checkpoint inhibitor with high market penetration since its FDA approval in 2014. It is marketed primarily by Bristol-Myers Squibb (BMS). The drug has established a strong presence across multiple indications globally, with competitive offerings including pembrolizumab (Keytruda).
How large is the current market size?
Estimates based on recent reports show:
| Metric |
Value |
Notes |
| 2022 global sales |
$8.94 billion |
Source: EvaluatePharma |
| U.S. market share |
55-60% |
Approximate, based on regional sales data |
| Major indications |
Melanoma, lung cancer, renal cell carcinoma |
Key revenue contributors |
The market has seen steady growth, driven by expanding indications and increased clinical adoption.
What are the competitive dynamics?
Key competitors include pembrolizumab (Keytruda) from Merck. As of 2022, Keytruda surpasses Nivolumab in global sales with approximately $16 billion. Nivolumab maintains a significant share due to early entry, established efficacy, and combination approvals.
What are the projected market trends?
Growth Drivers:
- Approval of new indications (e.g., gastric, hepatocellular carcinoma)
- Expanded biomarkers (e.g., PD-L1 expression)
- Combination therapies enhancing efficacy
Potential Challenges:
- Patent expirations
- Pricing pressures from payers
- Competition from biosimilars (post-patent expiration, expected around 2029)
Revenue Projections:
| Year |
Estimated Revenue |
Compound Annual Growth Rate (CAGR) |
Source |
| 2023 |
$9.4 billion |
5-7% |
Based on recent growth trends |
| 2025 |
$10.5 billion |
|
|
| 2030 |
$14-16 billion |
|
|
These estimates account for increased utilization in expanded indications and geographic expansion.
What pricing trends are projected?
Current list prices:
- Price per 100 mg vial: approximately $10,000-$15,000
- Compounded weekly/monthly therapy costs: approximately $200,000/year
Future Pricing Outlook:
- With competitive pressures, prices may decline marginally over the next 3-5 years.
- The introduction of biosimilars (upcoming around 2029) could reduce costs by an estimated 15-25% upon market entry.
Reimbursement landscape:
- Payer negotiations are increasingly aggressive, emphasizing value-based agreements and outcome-based pricing models.
What are the key regulatory and policy factors impacting market and prices?
- US FDA approval for additional indications is expected to drive sales.
- The European Medicines Agency (EMA) continues to approve expanded indications.
- Price controls and value-based pricing initiatives may temper revenue growth.
- Biosimilar pathways are actively incentivized by policy to foster competition.
Conclusion
Nivolumab (NDC 82249-0747) remains a dominant immunotherapy with a large and growing market. Revenue projections suggest steady growth fueled by new indications and geographic expansion, although prices are likely to face downward pressure with biosimilar competition in the late 2020s.
Key Takeaways
- Nivolumab, marketed as Opdivo, had global sales of approximately $8.94 billion in 2022.
- The competitive landscape is dominated by pembrolizumab, but Nivolumab maintains significant market share.
- Projected revenues will grow at a CAGR of about 5-7% through 2025.
- Pricing is expected to decline slightly with biosimilar entry and payer negotiations.
- Expanded indications and regulatory approvals are primary drivers of future growth.
FAQs
1. When will biosimilars for Nivolumab enter the market?
Biosimilars are expected around 2029, following patent expiration.
2. What are the primary indications for Nivolumab?
Metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, and others, with ongoing expansion.
3. How does Nivolumab compare to Pembrolizumab in sales?
Pembrolizumab leads with approximately $16 billion in 2022, surpassing Nivolumab.
4. Are there recent regulatory updates affecting its market?
Yes, approvals for additional indications and ongoing label expansions continue to support growth.
5. How are pricing strategies evolving?
Increase in value-based and outcome-based agreements is likely, with potential slight price declines due to biosimilar competition.
References
[1] EvaluatePharma. (2023). World Preview 2023: Outlook to 2028.
[2] U.S. Food and Drug Administration (FDA). (2014). Nivolumab approval.
[3] European Medicines Agency (EMA). (2022). Evaluation reports for Opdivo.
[4] IQVIA. (2023). Healthcare Data and Market Trends.
[5] BMS annual report. (2022). Market and Revenue Data.
