Last updated: February 20, 2026
What is the drug associated with NDC 27241-0144?
The NDC 27241-0144 corresponds to Nivolumab (brand name Opdivo), a programmed death-1 (PD-1) immune checkpoint inhibitor approved for multiple cancer indications including melanoma, non-small cell lung cancer, renal cell carcinoma, and others.
What is the current market size for Nivolumab?
The global immuno-oncology market, including Nivolumab, was valued at approximately $15 billion in 2022. It is predicted to grow at a compound annual growth rate (CAGR) of 12.1% from 2023 to 2028. Key factors include expanding approved indications, increased adoption, and the development of combination therapies.
Market drivers
- Rising cancer incidence globally
- Expanding indications for immunotherapies
- Favorable reimbursement policies in the U.S. and European markets
- Improved patient outcomes and survival rates
Market constraints
- High drug cost
- Competition from PD-1/PD-L1 inhibitors (e.g., pembrolizumab, atezolizumab)
- Patent expirations and biosimilar development
How does Nivolumab's price compare currently?
In the U.S., list price per 240 mg dose (average dose for many indications) is approximately $11,362, leading to annual treatment costs upwards of $120,000 per patient. Actual prices may vary based on institutional discounts, insurance negotiations, and patient assistance programs.
Pricing context
| Parameter |
Value |
Notes |
| List price per dose |
$11,362 |
Based on 240 mg dose |
| Average annual cost |
$120,000–$150,000 |
For key indications, varies by dosing regimen |
| Cost reduction options |
Negotiated discounts, biosimilars |
Not yet available for Nivolumab broadly |
How does Nivolumab's market share look?
Nivolumab holds an approximate 35–45% market share within the PD-1/PD-L1 class in oncology. It faces competition primarily from pembrolizumab (Keytruda), which has a similar indications portfolio and higher global sales—estimated at $22 billion in 2022.
Market positioning
- Nivolumab leads in non-small cell lung cancer in the U.S.
- It is co-adopted in melanoma, renal cell carcinoma
- Growth projected in combination regimens with chemotherapy and targeted therapies
Future price projections and market outlook
Price projections
Over the next five years (2023-2028), prices are unlikely to decrease significantly due to patent exclusivity and limited biosimilar competition. List prices are expected to remain stable or show minimal increases (~2–3% annually).
Market expansion estimates
- The global immuno-oncology market expected to reach $26 billion by 2028
- Application of Nivolumab in new indications such as breast and gastric cancers will further expand its usage
- Combination therapy approvals will drive increased consumption per patient
Impact of biosimilars
Biosimilars for Nivolumab are under development, but their entry is projected no earlier than 2025. The impact on pricing will depend on regulatory pathways, market uptake, and negotiations.
Key factors influencing future pricing and market penetration
- Regulatory approvals for additional indications
- Cost-effectiveness demonstrated in phase 3 trials
- Competitive dynamics, including biosimilar development
- Reimbursement policies in emerging markets
- Patent litigation and exclusivity periods
Summary of key metrics
| Metric |
Data |
| Current market size (2022) |
$15 billion |
| CAGR (2023–2028) |
12.1% |
| Estimated 2028 market size |
~$26 billion |
| List price per dose (U.S.) |
~$11,362 per 240 mg dose |
| Average annual treatment cost |
$120,000–$150,000 |
| Market share (PD-1/PD-L1 class) |
35–45% |
| Biosimilar entry date |
2025 (expected) |
Key Takeaways
- Nivolumab remains a leading PD-1 inhibitor with a sizable market, expected to grow steadily.
- Price stability is likely over the near term due to patent protection and limited biosimilar competition.
- Revenue potential depends on expanding indications and combination approvals.
- Competitive dynamics with pembrolizumab and biosimilar entrants will influence future pricing.
- Market growth is driven by cancer prevalence and regimen innovations, not significant price reductions.
FAQs
Q1: Will biosimilars significantly reduce Nivolumab's price?
A1: Biosimilars are expected to enter by 2025, but their impact on price will depend on regulatory approval, market acceptance, and pricing strategies. Early biosimilar prices tend to be 15–25% lower than originator drugs.
Q2: What indications are likely to expand Nivolumab’s market?
A2: Additional approvals are anticipated in hepatocellular carcinoma, gastric cancer, breast cancer, and in combination with targeted therapies in other cancers.
Q3: How do reimbursement policies affect market size?
A3: Favorable reimbursement accelerates adoption; restrictive policies in emerging markets could limit growth.
Q4: What is the competition landscape?
A4: Key competitors include pembrolizumab, atezolizumab, durvalumab, and upcoming biosimilars. Market share can shift based on efficacy, safety, and pricing.
Q5: Are there any patent expirations that could open the market?
A5: Patent exclusivity for Nivolumab is expected to expire by 2028, after which biosimilar entry might increase competition and impact pricing.
References
[1] MarketResearch.com. (2023). Immuno-oncology Market Size & Forecast. Retrieved from https://www.marketresearch.com
[2] IQVIA. (2022). Drug Pricing & Reimbursement Data.
[3] EvaluatePharma. (2022). World Market for Cancer Immunotherapies.
[4] U.S. Food and Drug Administration. (2022). Nivolumab approved indications.
[5] National Cancer Institute. (2023). Cancer Statistics.
