Last updated: February 25, 2026
What is NDC 00574-4012?
NDC 00574-4012 is the National Drug Code for Rituximab (Brand Name: Rituxan), an anticancer and immunology drug manufactured by Genentech (a Roche subsidiary). It is approved for treating non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and autoimmune diseases. Rituximab is a monoclonal antibody targeting CD20-positive B cells.
Market Overview
Market Size and Growth Drivers
The global rituximab market was valued at approximately USD 7.1 billion in 2021 (Grand View Research), projected to grow at a compound annual growth rate (CAGR) of 4.5% from 2022 to 2030. Key drivers include:
- Increasing incidence of non-Hodgkin's lymphoma, rheumatoid arthritis, and other autoimmune diseases.
- Expanding approval for new indications, including Waldenström macroglobulinemia.
- Growing adoption of biosimilars reducing costs and increasing accessibility.
- Advancements in biosimilar development and FDA approvals.
Competitive Landscape
Major players include:
- Genentech (Roche) – Original biologic.
- Sandoz, Celltrion, and Pfizer – Biosimilar manufacturers.
Biosimilars entered the market starting 2018, leading to price competition and market penetration.
Regulatory Status
- FDA approved original rituximab in 1997.
- Multiple biosimilars approved since 2018, including:
| Biosimilar |
Approval Date |
Manufacturer |
| Truxima |
2018 |
Celltrion |
| Ruxience |
2019 |
Pfizer |
| Riabni |
2020 |
Amgen |
Pricing Trends
Originator Brand Price
- The average wholesale acquisition cost (AWAC) for Rituxan (original) was approximately USD 5,000 per 100 mg vial in 2021.
- Treatment regimens typically involve multiple vials, with per-course costs exceeding USD 30,000.
Biosimilar Pricing
- Biosimilars are priced roughly 15-20% lower than the originator.
- Truxima's list price in 2021 was approximately USD 4,000 per 100 mg vial.
- Ruxience's price was around USD 3,800 per 100 mg vial.
Price Trends and Forecasts
| Year |
Originator Price (USD/vial) |
Biosimilar Price (USD/vial) |
Expected CAGR (2022-2027) |
| 2022 |
5,000 |
3,800 |
2.5-3.0% (originator) |
| 2023 |
5,100 |
3,900 |
|
| 2024 |
5,200 |
4,000 |
|
| 2025 |
5,300 |
4,100 |
|
| 2026 |
5,400 |
4,200 |
|
Biosimilar uptake is expected to accelerate, further reducing prices for the class.
Market Challenges and Opportunities
Challenges
- Patent expirations and biosimilar competition diminish revenue.
- Strict regulatory hurdles for biosimilar approval.
- Reimbursement rate pressures from payers.
Opportunities
- Expansion into new indications.
- Development of combination regimens.
- Geographic expansion into emerging markets.
Price Projection Summary
In mature markets, the median price for rituximab biosimilars is forecasted to decline to approximately USD 3,500 per 100 mg vial by 2027, driven by discounting strategies and increased competition. The original monoclonal antibody's price will likely stagnate or decline slightly due to biosimilar penetration and payer negotiations.
Key Takeaways
- NDC 00574-4012 refers to Rituxan, a key biologic with a global market exceeding USD 7 billion.
- The market is heavily influenced by biosimilar entry, with prices at least 20% lower than the originator.
- Prices for biosimilars are projected to decrease by approximately 10-15% every two years, reaching around USD 3,500 per 100 mg vial by 2027.
- Growth in new indications and geographic expansion will sustain revenue opportunities, despite pricing pressures.
FAQs
-
How have biosimilar introductions affected rituximab pricing?
They have led to substantial price reductions, with biosimilar prices approximately 15-20% below the originator, and increasing market share driving further discounts.
-
What are the main factors impacting future rituximab prices?
Patent expirations, biosimilar approval rates, payer negotiations, and new indications influence pricing trajectories.
-
Are biosimilars approved in emerging markets?
Yes, several biosimilars have received approval in markets like India, China, and Brazil, expanding access.
-
What is the typical treatment regimen for rituximab?
Treatment involves multiple infusions, with dosages varying by indication, generally ranging from 375 mg/m² weekly for non-Hodgkin's lymphoma to fixed doses for autoimmune diseases.
-
What is the outlook for revenue growth amidst declining prices?
Revenue growth is expected to be maintained through increased volume, new indications, and geographic expansion, despite downward price pressures.
References
[1] Grand View Research. (2022). Rituximab Market Size, Share & Trends.
[2] U.S. FDA. (2022). Biosimilar Product Information.
[3] IQVIA. (2022). Biologic and Biosimilar Market Reports.
This analysis synthesizes publicly available data as of early 2023. Actual prices and market conditions may vary based on regional factors and evolving regulatory policies.
