Last updated: February 25, 2026
What is NDC 62135-0271?
NDC 62135-0271 corresponds to Nivolumab (OPDIVO), a programmed death-1 (PD-1) immune checkpoint inhibitor developed by Bristol-Myers Squibb. Approved for multiple cancers, including non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma, it generated significant revenue since its 2015 market entry.
Current Market Position
- Indications: NSCLC, melanoma, renal cell carcinoma, Hodgkin lymphoma, other solid tumors.
- Market Share: Nivolumab holds approximately 20-25% of the global checkpoint inhibitor market (IQVIA, 2022).
- Competitive Landscape: Competes with pembrolizumab (Keytruda), atezolizumab (Tecentriq), cemiplimab (Libtayo).
Market Size and Growth
| Year |
Global Oncology Immunotherapy Market (USD billions) |
Nivolumab's Market Share |
Nivolumab's Estimated Revenue (USD billions) |
| 2020 |
35 |
20% |
7 |
| 2021 |
42 |
22% |
9.24 |
| 2022 |
50 |
23% |
11.5 |
| 2023 |
58 |
24% |
13.92 |
The market exhibits a compound annual growth rate (CAGR) of approximately 12.5%.
Pricing Overview
- Average Wholesale Price (AWP) per 40 mg dose: $14,000
- Typical treatment course (e.g., NSCLC): 6-8 doses
- Average per patient: $84,000 - $112,000
Pricing is comparable across regions, with slight discounts in managed markets and discounts for bundled therapies.
Price Trends and Projections
- Historical trend: Nivolumab prices have remained relatively stable, with modest inflation-adjusted increases (~3-5% annually).
- Impact of biosimilars: As biosimilar approvals increase (e.g., CT-P10 in Europe), price erosion of 15-25% over 5 years is anticipated.
- Market dynamics: Increased competition from pembrolizumab and emerging combination therapies could put downward pressure on prices.
Short-term projections (2023-2025):
- Price per dose may decrease by 3-5% annually due to biosimilar entry.
- Average treatment course costs could decline to $80,000–$100,000 by 2025.
Revenue projections (2023-2027):
| Year |
Estimated Global Revenue (USD billions) |
Assumptions |
| 2023 |
13.9 |
Stable market share, price erosion |
| 2024 |
12.9 |
Market share declines, price drops |
| 2025 |
11.8 |
Increased biosimilar competition |
| 2026 |
10.8 |
Further biosimilar adoption |
| 2027 |
9.8 |
Market saturation, price stabilization |
Key Factors Affecting Market and Pricing
- Regulatory approvals for new indications can expand market access.
- Patent expiry in major markets in the late 2020s could introduce biosimilars.
- Combination therapies (e.g., nivolumab + ipilimumab) may shift treatment paradigms, impacting single-agent pricing.
- Cost containment policies and payer negotiations can drive discounts.
Strategic Implications
- Manufacturers should monitor biosimilar development and regulatory filings.
- Investors should consider patent expiration risks and emerging competitors.
- Pharmaceutical companies may explore pricing strategies tied to combination regimens.
Key Takeaways
- Nivolumab remains a leading immune checkpoint inhibitor, with steady revenue contributions driven by expanding indications.
- The market is projected to decline gradually in revenue due to biosimilar price competition, despite increasing approval scope.
- Average treatment costs are likely to decrease slightly over the next three years, impacting profitability and market dynamics.
- The trajectory depends on regulatory developments, biosimilar uptake, and combination therapy trends.
FAQs
1. When are biosimilars for nivolumab expected to enter major markets?
Expected approval around 2025-2027, with European biosimilars established earlier than U.S. counterparts.
2. How does the pricing of nivolumab compare to pembrolizumab?
Prices are similar, with pembrolizumab sometimes slightly cheaper due to different negotiation strategies and biosimilar availability.
3. What are the primary drivers for nivolumab market growth?
Expanding indications, new combination regimens, and FDA approvals for additional cancers.
4. How will biosimilar competition affect the revenue of nivolumab?
Exact impact depends on biosimilar market penetration; estimates suggest a 15-25% price reduction over five years, reducing revenue accordingly.
5. Are there emerging therapies that could replace nivolumab in key indications?
Yes; targeted therapies and novel immunotherapies are under development, potentially impacting nivolumab's market share.
References
[1] IQVIA (2022). Global Oncology Market Data.
[2] U.S. FDA (2022). Nivolumab (OPDIVO) Approval history.
[3] MarketResearch.com (2023). Oncology Immunotherapy Market Forecasts.
