Last updated: March 24, 2026
What is NDC 25021-0662?
The National Drug Code (NDC) 25021-0662 corresponds to Nivolumab (Opdivo) 240 mg. It is an immune checkpoint inhibitor used primarily in oncology to treat various cancers, including non-small cell lung carcinoma (NSCLC), melanoma, renal cell carcinoma, and other tumor types.
Market Landscape Overview
Current Market Size
The global immunotherapy market for cancer treatment, including nivolumab, was valued at approximately $20 billion in 2022. The segment has experienced compound annual growth rates (CAGR) of around 15% due to expanding indications and approval of new combination therapies.
In the U.S., nivolumab sales accounted for roughly $5 billion in 2022, representing a significant proportion of the PD-1/PD-L1 inhibitor market, which itself is projected to reach $10 billion globally by 2025. The drug’s top-selling indications include NSCLC, melanoma, and renal cell carcinoma.
Competitive Landscape
Major competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), and durvalumab (Imfinzi). Key drivers of competitiveness are:
- Approved indications and line of therapy
- Combination therapy approvals
- Regulatory actions, such as new indications or dosing guidance
Recent Approvals and Indication Expansion
- Approved in 2015 for metastatic melanoma.
- Expanded to NSCLC in 2017.
- Recently received FDA approvals for combination regimens, broadening market reach.
- Ongoing trials aim at earlier stage cancers and other tumor types, likely to further expand use.
Price Dynamics
Current Wholesale Price
As of Q1 2023, the average list price (ALP) for nivolumab 240 mg is approximately $15,000 per 240 mg vial (source: Medicare Part B pricing data [1]).
Actual Transaction Price
Medicare and private payers typically negotiate discounts, reducing the effective transaction price to $9,000-$11,000 per vial.
Cost-Effectiveness and Reimbursement
Reimbursement policies favor high-cost immunotherapies due to their clinical benefit, leading to sustained high prices, especially in oncology settings. Price sensitivity remains for biosimilars, which are in development but have yet to significantly impact the market.
Price Projections (2023-2028)
| Year |
Estimated Average Price per 240 mg Vial |
Key Factors |
| 2023 |
$10,500 |
Negotiated discounts, market saturation |
| 2024 |
$10,000 |
Increasing biosimilar development, competitive pressure |
| 2025 |
$9,500 |
Biosimilars entering markets, reimbursement changes |
| 2026 |
$9,000 |
Wider biosimilar adoption, price erosion |
| 2027 |
$8,500 |
Cost containment policies, generic biosimilars |
| 2028 |
$8,000 |
Market maturity, biosimilars fully integrated |
Key Assumptions:
- Biosimilars for nivolumab will enter the market between 2024-2026.
- Payer negotiations and healthcare policies will impose downward pressure.
- Clinical advancements will sustain demand despite price erosion.
Market Drivers & Risks
Drivers:
- Growing cancer prevalence and aging population.
- Expanded labeling for earlier-stage cancers.
- Combination regimens boosting overall sales volume.
Risks:
- Price reductions driven by biosimilar competition.
- Regulatory or reimbursement policy shifts.
- Competition from other immunotherapy classes or alternative treatments.
Summary
Nivolumab 240 mg (NDC 25021-0662) remains a high-value immunotherapy with an evolving pricing landscape. The market is expected to witness steady price declines, influenced primarily by biosimilar entry and healthcare policies aimed at cost containment. Sales growth will likely continue due to indication expansion and increased adoption, but margin pressures will persist.
Key Takeaways
- The current list price is approximately $15,000 per vial; effective transaction prices are lower.
- Market size is around $5 billion in the U.S. with global growth projections of 15% CAGR.
- Biosimilar competition predicted to lower prices to ~$8,000-$9,000 per vial by 2028.
- Growth driven by new indications and combination therapy approvals.
- Price erosion anticipated with increased biosimilar approval and healthcare cost controls.
Frequently Asked Questions
Q1: When are biosimilars for nivolumab expected to enter the market?
A1: Biosimilars are anticipated to launch between 2024 and 2026, depending on regulatory approvals.
Q2: How might approval of new indications impact sales?
A2: Expanded indications, especially in earlier-stage cancers, could significantly increase patient access and sales volume.
Q3: What are the key regulatory challenges facing nivolumab?
A3: Regulatory focus on biosimilar approval, reimbursement policies, and guidance on combination therapy dosing.
Q4: How does nivolumab compare price-wise to competitors?
A4: Prices are similar among PD-1 inhibitors, with slight variations based on negotiations and discounts. Key competitors like pembrolizumab have comparable list prices.
Q5: What is the outlook for healthcare systems?
A5: Growing demand balanced against cost containment measures will shape pricing and market access strategies.
References
- CMS.gov. (2023). Medicare Part B Drug Pricing Data. Available at: https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeeschedule/search
- IQVIA. (2023). The Global Oncology Market Report.
- EvaluatePharma. (2023). Oncology Drug Market Forecast.
- FDA. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
- BioPharmAdvisors. (2023). Biosimilar Landscape in Oncology.
[1] Centers for Medicare & Medicaid Services. (2023). Medicare Part B Drug Pricing Data.
