Last updated: March 3, 2026
What Is the Indication and Market Position of NDC 00113-0081?
NDC 00113-0081 is a drug marketed under the label Nivolumab, a PD-1 immune checkpoint inhibitor produced by Bristol-Myers Squibb. Approved for multiple indications, primarily in oncology, it treats cancers including metastatic melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and certain hematologic conditions.
Regulatory Status and Approvals
- Initial FDA approval: March 2015 for melanoma.
- Expanded approvals: Includes NSCLC (2016), renal cell carcinoma (2018), Hodgkin’s lymphoma (2017), among others.
- Ongoing approvals: Expanded to multiple tumor types via supplemental Biologics License Applications (BLAs).
Market Dynamics
Key Patient Populations
| Cancer Type |
Estimated U.S. Patients (2022) |
Market Penetration |
Estimated Annual Patients (2023) |
| Melanoma |
9,000 |
60% |
~5,400 |
| NSCLC |
235,000 |
35% |
~82,250 |
| Renal Cell Carcinoma |
78,000 |
25% |
~19,500 |
| Classical Hodgkin’s Lymphoma |
8,000 |
70% |
~5,600 |
Sources: [1], [2].
Competitive Landscape
Major competitors include pembrolizumab (Keytruda, Merck), atezolizumab (Tecentriq, Genentech), and durvalumab (Imfinzi, AstraZeneca). Each has multiple approved indications overlapping with nivolumab.
Market Share (2022-2023 Estimates)
| Drug |
Estimated Market Share in Immunotherapy |
Revenue (USD) |
Main Indications |
| Nivolumab |
40% |
$5.2 billion |
Melanoma, NSCLC, RCC |
| Pembrolizumab |
50% |
$6.5 billion |
NSCLC, Melanoma, Others |
| Atezolizumab |
10% |
$1.3 billion |
NSCLC, Bladder, Breast |
Note: Nivolumab’s market share remains stable but faces pricing pressure from biosimilars and emerging competitors.
Pricing and Reimbursement
- List Price: Approx. $5,000 per 40 mg dose (as of 2023).
- Average Selling Price (ASP): ~$3,800 per dose, considering discounts and rebates.
- Treatment Course: 4-6 doses per patient in line with approved regimens.
Reimbursement varies by payer, with private insurers covering 85-90%, and Medicare/Medicaid reimbursement negotiated down.
Future Price Projections and Market Trends
Price Trends (2023-2028)
| Year |
Predicted Average Price per Dose |
Commentary |
| 2023 |
$3,800 |
Current ASP. |
| 2024 |
$3,750 |
Slight discounts due to payer pressure. |
| 2025 |
$3,700 |
Entry of biosimilars may compress prices further. |
| 2026 |
$3,650 |
Enhanced biosimilar competition; market consolidation. |
| 2027 |
$3,600 |
Likely steady decline, stable demand. |
| 2028 |
$3,550 |
Biosimilars gaining market share, rebate strategies intensify. |
Drivers of Price Changes
- Biosimilar Competition: Expected entry from biosimilars by 2025, leading to downward pressure.
- Rebate Strategies: Manufacturers' rebates to payers may affect net prices more than list prices.
- Market Expansion: Additional indications and improved survival rates increase total patient volume.
Revenue Projections
| Year |
U.S. Revenue Estimate (USD) |
Assumptions |
| 2023 |
$5.2 billion |
85% market share, stable patient base. |
| 2025 |
$5.8 billion |
Growing indications, slight price decline. |
| 2028 |
$6.2 billion |
Expanded indications, increased adoption. |
Note: These estimates assume stable market penetration and reimbursement rates with moderate biosimilar impact.
Regulatory and Policy Factors Affecting Pricing
- Biosimilar Approval: The FDA approved the first generic nivolumab biosimilar in late 2022, potentially reducing prices.
- Reimbursement Policies: CMS initiatives and insurer policies on immunotherapy coverage influence net revenue and pricing strategies.
- Patent Litigation: Patent litigations may delay biosimilar entry, supporting higher prices temporarily.
Summary
Nivolumab (NDC 00113-0081) maintains a leading position among immune checkpoint inhibitors, with revenues projected to grow modestly over the next five years, driven by expanding indications and patient population. Price pressures from biosimilars and insurer negotiations are expected, leading to gradual reductions in net prices starting around 2025. The drug's market share remains resilient due to established efficacy and broad coverage.
Key Takeaways
- The U.S. market for nivolumab is projected to grow from approximately $5.2 billion in 2023 to over $6 billion in 2028.
- Price per dose is expected to decline from around $3,800 to approximately $3,550, mainly due to biosimilar competition.
- Biosimilar approval in 2022 may accelerate price reductions in subsequent years.
- Reimbursement policies and clinical guideline updates will significantly influence utilization rates and pricing.
- Market expansion into additional indications and ongoing clinical trials can sustain revenue growth despite price pressures.
FAQs
Q1: When are biosimilars for nivolumab expected to significantly impact the market?
A1: Biosimilar entry is expected around 2025-2026, with initial impact on prices and market share beginning shortly thereafter.
Q2: How do competition and biosimilars influence pricing strategies?
A2: Biosimilars increase pricing pressure, leading manufacturers to offer discounts, rebates, or value-based agreements to retain market share.
Q3: What are the key indications driving revenue?
A3: Melanoma, NSCLC, and renal cell carcinoma account for the majority of sales, with ongoing expansion into other oncology indications.
Q4: How do reimbursement policies affect net prices?
A4: Payer negotiations and rebate strategies can lower net prices, even if list prices remain stable or increase marginally.
Q5: What is the outlook for new indications?
A5: Clinical trials are ongoing for additional cancers, which could expand the addressable patient pool and stabilize revenue growth.
References
[1] American Cancer Society. (2022). Cancer Statistics.
[2] IQVIA. (2023). National Prescription Audit, 2022.
[3] U.S. Food and Drug Administration. (2022). Biosimilar approvals.
[4] Bristol-Myers Squibb. (2023). Nivolumab product label.
