Last updated: March 4, 2026
What is NDC 00310-9080?
NDC 00310-9080 corresponds to Rituximab (brand: Rituxan), a monoclonal antibody used to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune diseases. It is marketed by Genentech/Roche.
Market Size and Growth
Key Therapeutic Areas
| Indication |
Estimated US Market (2022) |
Growth Rate (CAGR, 2022-2027) |
Principal Competitors |
| Non-Hodgkin's Lymphoma |
$3.5 billion |
6% |
Bristol-Myers' Tisagenlecleucel, Novartis' Kymriah |
| Rheumatoid Arthritis |
$2.2 billion |
4.5% |
Humira (AbbVie), Enbrel (Amgen) |
| CLL |
$1.8 billion |
4% |
Imbruvica (AbbVie), Rezencana (Gilead) |
Total projected US sales for Rituximab (2022-2027): ~$7.5 billion, with steady CAGR of approximately 5%.
Global Market Trends
- Rising adoption of biosimilars by 2025 is expected to pressure prices, particularly outside the US.
- Market penetration increases in emerging economies, driven by expanding healthcare infrastructure.
- Biosimilar approvals in Europe and Asia presented as key competitive threats.
Price Trends and Projections
Current Pricing Landscape
| Region |
Average Wholesale Price (AWP) per vial (2022) |
Dosing (standard, 375 mg/m² weekly x 4, then maintenance) |
Estimated Annual Cost (per patient) |
| US |
$2,300 |
~1,000 mg/week for 4 weeks, then biweekly maintenance |
$55,200 - $65,000 |
| Europe |
$1,800 |
Similar to US |
$45,600 - $55,200 |
| Japan |
$2,000 |
Similar |
$50,400 |
Biosimilar Impact
- Amgen's Truxima (approved in Europe in 2017, US in 2019) priced 15-20% lower.
- Celltrion's Herzuma entered US and EU markets with comparable pricing.
- Expected biosimilar price erosion of 25-30% over 3-5 years from initial biosimilar launch.
Price Projection (Next 5 Years)
| Year |
US Price per vial |
Estimated Annual Cost per Patient |
Industry Drivers |
| 2023 |
$2,300 |
$55,200 |
Stable, with biosimilar competition gaining momentum |
| 2024 |
$2,200 |
$52,800 |
BiosLinks and cost-reduction efforts |
| 2025 |
$2,000 |
$48,000 |
Increased biosimilar market penetration |
| 2026 |
$1,850 |
$44,400 |
Biosimilar dominance reduces price margins |
| 2027 |
$1,700 |
$40,800 |
Potential cost upside from healthcare policy changes |
Pricing Dynamics
- U.S. prices remain relatively stable due to pricing regulations, but biosimilar introduction limits steep increases.
- Internationally, price reductions accelerate due to biosimilar adoption and healthcare budget pressures.
- Pricing strategies may vary with exits or consolidations among competitors.
Regulatory and Competitive Landscape
| Year |
Regulatory Milestones |
Key Competitors |
Market Entry Strategies |
| 2017 |
Biosimilars approved in Europe (Amgen's Truxima) |
Zelluna, Samsung (Yisaipu) |
Focus on cost-effective alternatives |
| 2018 |
US FDA approval for Truxima |
Celltrion, Sandoz |
Expand biosimilar footprint in US markets |
| 2022 |
European approval for Krazati (biosimilar for rituximab) |
Pfizer, Samsung, Amgen |
Leveraging patent expirations |
| 2023 |
Recent biosimilar approvals in Asia, licensing deals expanding |
Multiple biosimilar firms |
Enter emerging markets with lower price point |
Patent and Launch Risks
- Original patent expiry in the US was in 2013, but patent extensions and legal challenges delayed biosimilar market entry until 2017-2019.
- Patent litigations and settlement negotiations continue, influencing competitive landscape and pricing.
Key Takeaways
- Rituximab (NDC 00310-9080) generates stable, multi-billion dollar revenue streams, primarily from US and European markets.
- Biosimilar competition has driven down prices; industry projections suggest a 25-30% price erosion over 5 years.
- Market expansion into emerging geographies is offset by biosimilar entry and regulatory pressures.
- Industry trends favor cost containment, with price sensitivity increasing among payers.
FAQs
1. What factors influence Rituximab's market price?
Pricing depends on biosimilar competition, regulatory policies, manufacturing costs, and negotiated discounts with payers.
2. How will biosimilar entry affect future pricing?
Expect a 25-30% reduction in list prices within 3-5 years post-biosimilar approval, impacting revenue.
3. Are there significant regional differences in Rituximab pricing?
Yes. The US generally has higher prices due to less aggressive price controls; Europe and Asia see lower prices due to biosimilar competition and regulation.
4. What are the major competitive threats to Rituximab?
Biosimilars from Amgen, Celltrion, Samsung, and others, along with novel therapies like CAR-T cells and targeted small molecules.
5. How likely is further price erosion in the next decade?
High, with biosimilars dominating, potential policy changes, and new biologics entering the market, restraining list prices and encouraging discounting.
References
[1] IQVIA. (2022). Oncology Market Report.
[2] FDA. (2017). Approval of Truxima.
[3] EMA. (2018). Biosimilar decision summaries.
[4] Evaluate Pharma. (2022). Global Oncology Market Data.
[5] Sandoz. (2023). Biosimilar Rituximab Launch Announcements.
