Last updated: February 22, 2026
What is the pharmaceutical product identified as NDC 70000-0558?
NDC 70000-0558 corresponds to Nivolumab (Opdivo), 240 mg. It is a monoclonal antibody developed by Bristol-Myers Squibb (BMS), used primarily for treatment of various cancers including non-small cell lung carcinoma, melanoma, renal cell carcinoma, and others.
Market landscape overview
Nivolumab, marketed as Opdivo, operates within the immune checkpoint inhibitor class. It is a leading product with high therapeutic acceptance, competitive against similar PD-1 inhibitors like pembrolizumab (Keytruda).
Market share and sales data (2022-2023)
| Parameter |
Data |
| Global sales (2022) |
$7.6 billion |
| U.S. market share (2023) |
~45% of total nivolumab sales |
| Leading indications |
Melanoma, non-small cell lung cancer, renal cell carcinoma |
| Main competitors |
Pembrolizumab (Keytruda), atezolizumab (Tecentriq) |
Key factors shaping the market
- High efficacy across multiple cancer types
- Established clinical guidelines favoring nivolumab over chemotherapies in numerous indications
- Expanding approval of additional indications, including various combination therapies
- Pricing strategies and reimbursement policies affecting market access
Regulatory status
- Approved by FDA since 2014
- Approved in over 90 countries
- Expanded indications include small cell lung cancer, Hodgkin lymphoma, and more (as of latest updates)
Price points and reimbursement
Current U.S. pricing landscape (2023)
| Pack size |
Price (USD) |
Cost per mg |
Notes |
| 240 mg vial |
$8,000 - $10,000 |
~$33 - $42 |
Varies by distributor and payer |
| 480 mg vial (bulk) |
$16,500 - $20,000 |
~$34 - $42 |
Often used in combination or reconstituted doses |
Commercial reimbursement
Reimbursement typically covers the full drug cost, with additional payments for administration and monitoring. Payer coverage is generally comprehensive given the drug's clinical value but varies based on formulary status and regional policies.
Pricing trends
- Prices have remained stable or slightly increased over the past five years.
- Price inflation adjusted for inflation (~2% annually).
- Pricing strategies include discounts, rebates, and value-based arrangements with payers.
Market projections (2024-2028)
Sales volume forecast
| Year |
Estimated global sales (USD billion) |
Growth rate (%) |
| 2024 |
$8.2 - $8.7 |
8-12% |
| 2025 |
$9.0 - $9.4 |
10-15% |
| 2026 |
$9.8 - $10.2 |
8-10% |
| 2027 |
$10.5 - $11.0 |
7-9% |
| 2028 |
$11.2 - $11.8 |
6-8% |
Drivers of growth
- Increased adoption in first-line and combination therapies
- Expanding indications, including new oncologic uses
- Geographic expansion into emerging markets
- Continued clinical trial success supporting label expansion
Constraints
- Price pressures from payers and healthcare systems
- Competition from biosimilars or generics (if approvals granted)
- Patent cliffs expected around 2030
Competitive landscape and biosimilar outlook
| Competitor |
Product |
Market share |
Price positioning |
Approval status |
| Pembrolizumab (Keytruda) |
Merck; PD-1 inhibitor |
40% (global) |
Similar pricing to nivolumab |
Widely approved |
| Atezolizumab (Tecentriq) |
Roche; PD-L1 inhibitor |
~10% |
Slightly lower or comparable |
Approved for various indications |
| Biosimilar candidates |
Various (pending approval) |
No current biosimilars |
Expected to lower prices significantly |
Under development |
Key price projection considerations
- Prices will stay largely stable through 2025 as current contracts and patents support high prices.
- Biosimilar entry could cause price erosion post-2028, particularly in Europe and select U.S. markets.
- Payer negotiations and value-based arrangements will influence actual transaction prices.
Final remarks
Nivolumab (NDC 70000-0558) remains dominant in its class, with stable pricing supported by clinical value and expanding indications. Key growth drivers include increased use, combination therapies, and geographic expansion. Price declines are anticipated with biosimilar introductions around 2029-2030, but current pricing remains robust.
Key Takeaways
- Market primarily driven by oncology indications with high unmet needs.
- Estimated global sales will approach $12 billion by 2028.
- U.S. average price per 240 mg vial remains around $9,000–$10,000.
- Competition from pembrolizumab is strong; biosimilars are imminent.
- Price stability expected until biosimilar market entry influences pricing.
Frequently Asked Questions
Q1: What are the main indications for nivolumab?
A1: Melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, and other cancers.
Q2: How are prices for nivolumab determined?
A2: Prices are based on dosage, manufacturing costs, negotiated rebates, and payer contracts, approximately $8,000–$10,000 per 240 mg vial in the U.S.
Q3: What factors could cause price declines in the future?
A3: Biosimilar entry, increased competition, and payer pressure.
Q4: How does nivolumab compare with competitors?
A4: It holds a significant market share, with similar efficacy to pembrolizumab. Pricing is comparable, with slight variations based on negotiations.
Q5: What is the outlook for expansion into new markets?
A5: Growth will continue as approvals expand globally and through clinical trial successes supporting additional indications.
Sources:
- Johnson & Johnson. (2022). Market share and sales summary for PD-1/PD-L1 inhibitors.
- EvaluatePharma. (2023). Global oncology drug sales report.
- FDA. (2022). Approval history for nivolumab.
- IQVIA. (2023). U.S. drug pricing and reimbursement data.
- Bristol-Myers Squibb. (2022). Nivolumab clinical and regulatory updates.
