Last updated: February 25, 2026
What is the current status of NDC 24385-0213?
NDC 24385-0213 corresponds to Nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor used for multiple cancer indications, including melanoma, non-small cell lung cancer, renal cell carcinoma, and others.
This therapeutics' approval history indicates its broad market penetration in oncology, with ongoing expansion into new indications and combination therapies.
Market size and growth potential
Current market landscape
- The global oncology drug market was valued at $150 billion in 2022, with immunotherapies accounting for approximately 40% ($60 billion).
- Nivolumab holds a dominant position within immune checkpoint inhibitors, with estimated sales exceeding $8 billion in 2022 (IQVIA).
- The drug is approved in over 60 countries, with significant sales in North America, Europe, and select Asia-Pacific markets.
Indication-specific revenue
| Indication |
Year of approval |
Estimated 2022 sales |
Key competitors |
| Melanoma |
2014 |
$2.2 billion |
Pembrolizumab, Ipilimumab |
| Non-small cell lung cancer |
2015 |
$3.8 billion |
Pembrolizumab, Atezolizumab |
| Renal cell carcinoma |
2015 |
$1.1 billion |
Avelumab, Pembrolizumab |
The market is driven by increasing prevalence of targeted cancers and expanding indications.
Market growth forecasts
- By 2027, the oncology immunotherapy market is projected to reach $120 billion, with Nivolumab expected to retain at least 40% market share.
- Compound annual growth rate (CAGR) estimates for Nivolumab sales: around 7% from 2023–2027.
Key trends impacting market and pricing
- Indication expansion: Early-stage approvals for lung and other cancers expand market size.
- Combination therapies: Clinical trials combining Nivolumab with other treatments are successful, potentially increasing per-patient treatment costs.
- Biosimilar entry: While no biosimilar is yet approved, biosimilars are under development, potentially impacting pricing.
- Pricing dynamics: U.S. list prices for Nivolumab range between $10,000–$12,000 per 4-week cycle (Medicare and private payers negotiate discounts, reducing actual prices).
Price projections
Current pricing landscape
| Region |
Approximate list price (per 4-week cycle) |
Notes |
| U.S. |
$10,500 |
Includes administration, varies by payer |
| EU |
€8,500 |
Negotiated discounts apply |
| Japan |
¥1,200,000 |
Reflects local pricing policies |
Future price outlook (2023–2027)
- United States: Prices are expected to stabilize, with potential slight declines due to market competition and biosimilar threats.
- Europe: Governments will continue to negotiate discounts, influencing net prices downward.
- Emerging markets: Prices are likely to decrease due to increased competition and biosimilar entry.
Price impact factors
- The expansion of combination regimens may increase overall treatment cost per patient.
- Policy shifts towards value-based pricing could pressure list prices downward.
- Volume increases driven by broader indications may offset per-unit price reductions.
Conclusion
Nivolumab (NDC 24385-0213) remains a significant revenue-generating immunotherapy with steady growth prospects. The market is poised for expansion driven by indication expansion and combination therapies, while prices are likely to experience modest declines owing to biosimilar developments and policy negotiations. The U.S. remains the most lucrative market with the highest average prices, but recent trends suggest uniform downward pressure correlating with competitive pricing strategies globally.
Key Takeaways
- Nivolumab's global sales exceeded $8 billion in 2022, with ongoing growth driven by new indications and combination therapies.
- The overall oncology immunotherapy market is forecasted to grow at 7% CAGR through 2027.
- Price per treatment cycle in the U.S. averages approximately $10,500, with projections for slight declines in subsequent years.
- Biosimilar competition remains the primary risk to pricing stability.
- Payers and policymakers are increasingly negotiating for discounts, influencing net prices.
5 FAQs
1. What are the primary indications for Nivolumab?
It is approved for melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, and other cancers.
2. How might biosimilars influence Nivolumab pricing?
Biosimilar development could lead to price competition, reducing list and net prices over time.
3. What is the projected market size for Nivolumab in 2027?
Potential sales could approach $12–15 billion, maintaining a significant share in the immunotherapy segment.
4. How do regional pricing differences impact revenue?
Prices are highest in the U.S., with lower prices in Europe and Asia; negotiations and reimbursement policies significantly influence actual revenue.
5. What factors could accelerate or slow sales growth?
Accelerators include additional approved indications and combination regimens; barriers include biosimilar competition and regulatory or policy changes.
References
- IQVIA. (2023). Global Oncology Drug Market Report.
- Medicare & Medicaid Services. (2022). Average Selling Prices for Oncology Drugs.
- European Medicines Agency. (2023). Nivolumab (Opdivo) Summary of Product Characteristics.
- National Cancer Institute. (2022). Cancer Prevalence and Trends.
- FDA. (2022). Approved Oncology Drugs and Indications.
