Last updated: February 20, 2026
What Is NDC 61314-0044?
NDC 61314-0044 is a drug identified as Nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor manufactured by Bristol-Myers Squibb. It is used primarily for the treatment of various cancers, including melanoma, non-small cell lung cancer, and renal cell carcinoma.
Market Overview
Market Size and Growth
- The global immuno-oncology market was valued at approximately USD 10 billion in 2021.
- It is projected to grow at a compound annual growth rate (CAGR) of 12% through 2030.
- Nivolumab accounts for roughly 45% of the PD-1/PD-L1 inhibitor market revenue.
Indications and Approvals
- Approved indications include melanoma, lung cancer, kidney cancer, and others.
- Additional approvals are ongoing for head and neck cancers, liver cancers, and colon cancers.
- The drug's versatility drives sustained demand across multiple oncology segments.
Competitive Landscape
- Main competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), and durvalumab (Imfinzi).
- Pembrolizumab holds the largest market share, but Nivolumab maintains a significant presence due to earlier approvals and established patient data.
Key Market Drivers
- Broadening indications and line extensions.
- Rising cancer incidence globally.
- Increasing adoption of immunotherapy over chemotherapy.
- Patent protections and exclusivities in key markets extending into the late 2020s and early 2030s.
Patent and Regulatory Timeline
- Patents protecting Nivolumab extend until 2028-2030 in key territories, subject to extension or litigation outcomes.
- Regulatory approvals vary by country but generally extend up to 2028 in the U.S. and Europe.
Price Analysis and Projections
Current Pricing
- Average wholesale price (AWP) per vial (approx. 240 mg) is USD 8,000–9,000.
- Dosing typical: 240 mg every 2 weeks; annual treatment costs estimate USD 200,000–USD 400,000 per patient.
- Prices have marginally decreased since launch due to biosimilar developments and market competition but remain high.
Historical Price Trends
| Year |
Average Price per Vial (USD) |
Notable Changes |
| 2017 |
USD 8,000 |
Launch year, stable pricing, limited biosimilar competition |
| 2019 |
USD 8,500 |
Slight increase attributed to inflation and R&D recovery |
| 2021 |
USD 8,800 |
Market stabilization, patent protections intact |
| 2022 |
USD 8,900 |
Introduction of biosimilar options in Asia affecting some pricing segments |
Future Price Trajectory
- Base Scenario: Prices are projected to decline gradually by 5–10% over the next 5 years due to biosimilar entry, especially in Asia and Europe.
- Optimistic Scenario: Price reductions of up to 15% could accelerate if biosimilar approval in the U.S. occurs before patent expiration.
- Pessimistic Scenario: Limited biosimilar impact, prices remain stable through patent protections until 2028, followed by a 20–30% reduction post-patent expiry.
Biosimilar Impact
- Biosimilars for Nivolumab are in development, with several candidates awaiting regulatory approval in Europe and Asia.
- U.S. biosimilar approval is expected around 2025–2026, potentially causing a 30% decline in price within 2 years of launch.
Revenue Projections
| Year |
Estimated Market Revenue (USD billion) |
Notes |
| 2023 |
USD 4.2 |
Assume steady growth driven by expanding indications |
| 2025 |
USD 4.8 |
Biosimilar market entries begin, modest price drops |
| 2028 |
USD 3.2 |
Near patent expiration, biosimilar competition intensifies |
| 2030 |
USD 2.5 |
Market stabilizes with biosimilar uptake |
Strategic Considerations
- Market share could decline with biosimilar adoption, particularly outside the U.S.
- Continued expansion into new indications often supports revenue stability.
- Pricing negotiations with payers are likely to favor discounts, especially outside U.S.
Key Takeaways
- Nivolumab remains a leading immunotherapy agent, driven by broad approval and multiple indications.
- Prices are stable but expected to decline gradually as biosimilars enter the market.
- Patent expiration around 2028-2030 will significantly impact pricing and revenue.
- Competitive pressure, particularly from pembrolizumab, influences market dynamics.
- Emerging combination therapies and expanding indications could offset price declines.
FAQs
1. When do biosimilars for Nivolumab typically enter the market?
Biosimilar approvals expected between 2025 and 2026 in the U.S., with earlier launches in Europe and Asia.
2. How does the price of Nivolumab compare to competitors?
It is similar in cost to pembrolizumab; however, pricing varies by region and biosimilar competition.
3. What are the key factors influencing Nivolumab's future revenue?
Market expansion, biosimilar entry, patent duration, and new indications.
4. Will price reductions significantly affect profitability?
Potentially, especially post-biosimilar entry, but revenue loss may be offset by increased patient volume and broader indications.
5. How might new therapies impact Nivolumab’s market share?
Emerging treatments, combination therapies, and incoming biosimilars could reduce Nivolumab’s market dominance.
References
[1] MarketsandMarkets. (2022). Immuno-oncology market growth and forecasts.
[2] IQVIA Institute. (2021). The Global Oncology Market Report.
[3] FDA. (2022). Approval timeline for biosimilar agents.
[4] Bristol-Myers Squibb. (2022). Opdivo product information.
[5] EvaluatePharma. (2022). Oncology drug price and revenue analysis.
