Last updated: March 5, 2026
What is NDC 00245-1074?
NDC 00245-1074 corresponds to Rituximab, a monoclonal antibody indicated for non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune conditions. Produced by various manufacturers under different brand names such as Rituxan (Genentech/Biogen) and biosimilar versions.
Market Size Overview
The Rituximab market historically surpassed $4 billion globally in 2022. Key drivers include:
- Expanding indications, especially in autoimmune diseases such as rheumatoid arthritis (RA).
- Increasing adoption of biosimilars post patent expiration.
- Growing prevalence of hematologic and autoimmune conditions.
Market Segments
| Segment |
2022 Revenue |
Growth Rate (2022-2027) |
Key Products |
| Oncology (non-Hodgkin's) |
$2.2 billion |
8% annually |
Rituxan, biosimilars |
| Autoimmune diseases |
$1.2 billion |
9% annually |
Rituxan, biosimilars |
| Biosimilars |
$1.0 billion |
20% annually |
Truxima, Ruxience, others |
Competitive Landscape
- Original patent expiry was in 2016.
- Multiple biosimilars launched from 2017 onward, capturing significant market share.
- Leading biosimilars include Truxima (Celltrion/ Teva), Ruxience (Pfizer), and others.
Market Share Distribution (2022)
| Product |
Brand/Origin |
Estimated Market Share |
Price Range (per dose) |
| Rituxan |
Genentech/Biogen |
70% |
$6,600 - $8,000 |
| Truxima |
Celltrion |
20% |
$4,300 - $5,000 |
| Ruxience |
Pfizer |
10% |
$4,100 - $4,800 |
Pricing Dynamics
Original brand Rituxan prices range from $6,600 to $8,000 per infusion. Biosimilars have reduced effective prices by approximately 30-45%, accelerating market penetration. The typical dose is 375 mg/m² weekly for four weeks, with variations based on condition.
Factors Influencing Price
- Biosimilar competition lowers prices.
- Negotiations with payers impact reimbursement rates.
- Manufacturing costs for biosimilars are generally 20-35% lower than brand-name versions.
Future Price Projections
Short-Term (2023-2025)
- Biosimilar prices will stabilize at 40-50% discounts to the originator.
- Reimbursement pressures will limit price increases.
- Expect initial price erosion to plateau by 2024 as biosimilar penetration peaks.
Long-Term (2026-2030)
- Biosimilar market share could reach 60-70% in hematologic indications.
- Prices may decline an additional 15-20% as biosimilars become more prevalent.
- Innovative pricing models, such as drug bundling and outcome-based pricing, may influence net costs.
| Year |
Average Price (per infusion) |
Estimated Market Share of Biosimilars |
Notes |
| 2023 |
$5,800 |
25% |
Entry phase for biosimilar intensification |
| 2025 |
$5,200 |
50% |
Bios cialissolidify market share |
| 2028 |
$4,700 |
70% |
Mature biosimilar competition |
| 2030 |
$4,500 |
75% |
Further price stabilization or decline |
Regulatory and Policy Impacts
- FDA continues approvals for biosimilars, with 20 approved as of 2023.
- Payer rebates and formulary placements favor biosimilars.
- Market access varies globally, with some countries implementing price caps.
Conclusion
The Rituximab market faces a transition driven by biosimilar entry, leading to declining prices and increased competition. Original brand prices are expected to decline by 20-30% by 2030. Market share will continue shifting toward biosimilars, stabilizing overall revenue growth but reducing per-unit profitability for original manufacturers.
Key Takeaways
- Biosimilar competition drives significant price reductions.
- Market share for biosimilars is projected to surpass 70% in hematologic indications by 2030.
- Prices are expected to stabilize at 40-50% lower than the originator.
- Growing indications and expanded payer acceptance support market volume growth.
- Regulatory trends favor biosimilar approval, enabling further price erosion.
FAQs
Q1: How does the entry of biosimilars impact the pricing of NDC 00245-1074?
Biosimilar entry causes a typical price decline of 30-45% relative to the originator, with additional downward pressure as market share shifts.
Q2: What are the primary factors influencing the future price of Rituximab?
Market share of biosimilars, payer negotiations, manufacturing costs, and regulatory policies primarily influence future prices.
Q3: Which biosimilars are the most competitive in this space?
Truxima, Ruxience, and subsequent biosimilars from several manufacturers dominate, with pricing significantly below the originator.
Q4: Are there regions where Rituximab prices are more stable?
Prices tend to be more stable in regions with regulatory price controls, such as parts of Europe and Canada, versus the more flexible U.S. market.
Q5: What is the expected timeline for biosimilar market dominance?
Biosimilars will likely account for 60-70% of the market within five years (2028-2030), depending on regional adoption rates.
References
- IQVIA. (2022). Global Oncology Market Report.
- FDA. (2023). Approved Biosimilar Products.
- PhRMA. (2022). Biologic and Biosimilar Competition.
- EvaluatePharma. (2023). World Market for Oncology and Immunology Drugs.
- Centers for Medicare & Medicaid Services. (2023). Drug Reimbursement and Formularies.
