Last updated: February 24, 2026
What is the Identity of NDC 00310-6780?
NDC 00310-6780 corresponds to Rituximab, marketed under the brand name Rituxan. Rituximab is a monoclonal antibody used primarily in the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and certain off-label indications.
Market Size and Growth Dynamics
Current Market Landscape
- Global Rituximab Market (2022): Estimated at $8.5 billion.
- Major Regions: North America (45%), Europe (30%), Asia-Pacific (15%), Rest of World (10%).
- Market Drivers: Increasing prevalence of autoimmune diseases and lymphomas, expanding indications, consolidating treatment protocols.
Key Competitors
| Company |
Rituximab Brand |
Market Share (2022) |
Key Approvals |
| Roche |
Rituxan |
65% |
Non-Hodgkin lymphoma, rheumatoid arthritis |
| Teva/Celltrion |
Truxima |
20% |
Biosimilar to Rituxan |
| Sandoz |
Rixathon |
10% |
Biosimilar to Rituxan |
| Others |
Various |
5% |
Regional biosimilars |
Lifecycle and Patent Status
- The original patent for Rituximab expired in 2018 in the U.S.
- Biosimilars introduced in North America and Europe since 2018 have increased competition.
- Patent litigations and exclusivity extensions may influence future pricing.
Pricing Trends and Projections
Current Pricing (Average Wholesale Price - AWP)
- U.S. Price per 100 mg vial: Approximately $2,200.
- Standard Dose for Indications: 375 mg/m² with a typical treatment course costing around $60,000–$75,000.
Biosimilar Impact
- Biosimilars Price Reduction: 20–35% compared to the originator.
- Price Trend (2018–2022): Decreased by approximately 25% in the U.S., driven by biosimilar competition.
Market Pricing Projections (2023–2028)
| Year |
Estimated Price per 100 mg Vial |
Expected Market Share (Biosimilars) |
Notes |
| 2023 |
$2,150 |
25% |
Continued biosimilar entry |
| 2024 |
$2,050 |
35% |
Increased biosimilar adoption |
| 2025 |
$1,950 |
45% |
Biosimilars deepen market penetration |
| 2026 |
$1,850 |
55% |
Further biosimilar competition |
| 2027 |
$1,750 |
65% |
Market stabilization |
| 2028 |
$1,700 |
75% |
Biosimilar dominance |
Price declines are driven by biosimilar competition, generic manufacturing efficiencies, and healthcare policy shifts favoring cost savings.
Policy and Regulatory Environment
- U.S.: The FDA approved multiple biosimilars post-2018, with ongoing price competition.
- Europe: Biosimilar uptake increased significantly post-2017, impacting prices.
- Emerging Markets: Variable adoption rates; prices remain higher due to limited biosimilar penetration.
Investment and R&D Outlook
- Ongoing development of next-generation CD20-targeting monoclonals.
- Increased interest in biosimilar manufacturing capacity.
- Potential future prices depend on patent litigations and regulatory approvals.
Key Takeaways
- Rituximab's market experienced pressure from biosimilars since 2018, reducing prices.
- Market growth remains steady, driven by expanding approved indications.
- Biosimilar competition will continue to decrease per-unit prices, with deepening market share through 2028.
- Price projections indicate a gradual decline per vial, with significant volume-driven savings expected.
- Future pricing will be impacted by regulatory decisions and patent landscapes in key markets.
FAQs
1. How do biosimilars influence Rituximab prices?
Biosimilars decrease prices by 20–35%, increasing market competition and prompting originator price reductions.
2. What are the primary indications for Rituximab?
Non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune conditions.
3. How does patent expiration affect the Rituximab market?
Patent expiration in 2018 enabled biosimilar entry, leading to reduced prices and increased competition.
4. What are the future growth drivers for the Rituximab market?
New indications, expanding global accessibility, and biosimilar market penetration.
5. Will prices stabilize or continue declining?
Prices are expected to decline gradually through 2028 due to biosimilar competition, with stabilization possible once market saturation is achieved.
References
[1] Evaluate Pharma. (2022). Global Oncology Market Report.
[2] IQVIA. (2022). Biologic and Biosimilar Pricing Trends.
[3] U.S. Food and Drug Administration. (2018). Biosimilar Approvals and Market Entry.
[4] European Medicines Agency. (2021). Biosimilar Market Analytics.
[5] Fitch Solutions. (2022). Biologics and Biosimilars Price Forecasts.
