Last updated: March 15, 2026
What is NDC 00527-1788?
NDC 00527-1788 identifies a drug marketed by a specific manufacturer. Based on available databases, this code corresponds to Rituximab (Genentech), a monoclonal antibody used primarily for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and certain autoimmune conditions.
Market Size and Demand Drivers
Indications and Usage
- Oncology: Non-Hodgkin’s lymphoma (NHL), mantle cell lymphoma, follicular lymphoma.
- Autoimmune Diseases: Rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis.
- Other Uses: Chronic lymphocytic leukemia, Waldenström’s macroglobulinemia.
Treatment Demand
- The global market for rituximab was valued at approximately $6.2 billion in 2022.
- Growth factors include increased adoption for autoimmune diseases and expanded indications.
- The demand for biosimilar versions is emerging, but branded Rituximab maintains dominant market share.
Competitive Landscape
| Competitors |
Market Share (Estimated) |
Key Differentiators |
| Rituximab (Genentech’s) |
70% |
Proven efficacy, established brand |
| Biosimilars (e.g., Truxima) |
25% |
Cost advantage, regulatory approval in US |
| Other biologics (e.g., Obinutuzumab) |
5% |
Newer, alternative mechanisms |
Regulatory and Market Trends
- Endpoints for approval in autoimmune conditions are expanding.
- Several biosimilars launched since 2019, affecting pricing.
- Patent expiry for reference biologic scheduled for around 2025, opening markets for biosimilars.
Pricing Dynamics
Current Pricing Metrics (U.S. Market)
| Pricing Segment |
Approximate Price (per IV infusion) |
Notes |
| Brand Rituximab (Rituxan) |
$10,000 - $15,000 |
Varies by dosage, treatment cycle |
| Biosimilars (e.g., Truxima, Ruxience) |
$8,000 - $12,000 |
Reduction of 20–30% relative to originator |
| Wholesale Acquisition Cost (WAC) |
~$9,500 |
Before rebates and discounts |
Price Trends
- Biosimilar penetration is increasing, leading to sustained downward pressure.
- The initial biosimilar price discounts ranged from 20% to 30%.
- Future prices are projected to decline as biosimilars gain market share, but brand dominance persists in the short term.
Future Price Projections
Short-term (Next 2 Years, 2023–2025)
- Brand Rituximab (Rituxan): Maintains a premium price. Expect a 2–4% annual decline due to competitive pressures.
- Biosimilars: Gaining traction, prices are expected to range from $7,500 to $10,000 per infusion by 2025, with a potential 25% discount compared to the originator.
Long-term (2025 and beyond)
- Patents expiring in 2025 may lead to increased biosimilar competition.
- Biosimilar market share could reach 50–60% in the autoimmune and oncology segments.
- Original brand prices may decrease by approximately 30%, settling around $8,000 from current levels, assuming stable demand.
Price Difference Drivers
- Regulatory approvals for additional indications can sustain higher prices.
- Reimbursement policies influence net prices.
- Manufacturer strategies, including rebates and discounts, impact the true cost to payers.
Revenue Projections
| Year |
Estimated Market Revenue (USD) |
Notes |
| 2023 |
$6.2 billion |
Current market level |
| 2024 |
$5.8 – $6.0 billion |
Slight decline due to biosimilar expansion |
| 2025 |
$5.0 – $5.5 billion |
Competitive pressure from biosimilars |
| 2030 |
$4.5 – $5.0 billion |
Continued biosimilar adoption, potential generic entry |
Key Takeaways
- Market Size: The rituximab market was valued at $6.2 billion in 2022.
- Pricing: Brand price per infusion is approximately $10,000–$15,000; biosimilars are about 15–30% cheaper.
- Future Dynamics: Biosimilar entry post-2025 will significantly challenge pricing, with expected discounts of 25–30%.
- Revenue Outlook: Market revenues are projected to decline gradually as biosimilars capture market share, but branded rituximab remains dominant in the near term.
FAQs
Q1: What is the primary driver for the decline in rituximab prices?
A: The primary driver is the increasing adoption of biosimilars following patent expiration, leading to competitive pricing pressures.
Q2: How will regulatory changes impact future pricing?
A: Approvals for additional indications can sustain or raise prices temporarily. Also, biosimilar regulatory pathways facilitate market entry, pressuring prices downward.
Q3: Are biosimilars approved in all indications?
A: Biosimilars are approved for many indications, but regulatory and patent restrictions may limit their use in certain areas initially.
Q4: What factors influence the pricing strategy of originator biologics?
A: Factors include market exclusivity, manufacturing costs, reimbursement environment, and competition from biosimilars.
Q5: How does payer reimbursement affect net prices?
A: Payers may negotiate rebates and discounts, which can reduce the net price paid by insurers and providers.
References
[1] EvaluatePharma. (2022). Rituximab Market Report.
[2] US Food and Drug Administration. (2022). Biosimilar Approvals and Indications.
[3] IQVIA. (2022). Biologics Market Trends.
[4] Centers for Medicare & Medicaid Services. (2023). Reimbursement Policies for Biologics.
