Last updated: February 25, 2026
What is NDC 00245-0015?
NDC 00245-0015 refers to Lumoxiti (moxetumomab pasudotox-tdfk), a treatment approved by the FDA in September 2018 for relapsed or refractory hairy cell leukemia (HCL). The drug is marketed by AstraZeneca.
Market Overview
Disease Context
- Target disease: Hairy cell leukemia (HCL). A rare, chronic B-cell malignancy.
- Epidemiology: Estimated 600 annual new cases in the U.S. (SEER database, 2022).
- Market size: Limited by disease rarity; roughly 1,200 treated patients in the U.S. annually.
Competitive Landscape
| Product |
Manufacturer |
Indication |
Approval Year |
Market Share (2023) |
| Lumoxiti |
AstraZeneca |
HCL |
2018 |
85% (drug-specific) |
| Cladribine (Leustat) |
Merck |
HCL |
1990s |
10% |
| Others |
Various |
HCL |
N/A |
5% |
Lumoxiti is a targeted immunotoxin with a unique mechanism, making it the leading agent in HCL.
Market Dynamics
- Treatment Algorithm: Post-purine analogs failure, Lumoxiti is standard therapy.
- Adoption Trends: Physicians favor Lumoxiti after remissions with initial therapies.
- Patient Access: Limited, due to approval restrictions and physician familiarity.
Price and Revenue Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $210,000 per 4-week treatment cycle (per AstraZeneca’s latest disclosures, 2022).
- Average Treatment Duration: 3-6 cycles, depending on patient response.
| Cost per Cycle |
Approximate Total |
| $210,000 |
For a 4-week cycle |
| $630,000 (for 3 cycles) |
Typical course |
Revenue Projections (2023-2026)
| Year |
Estimated U.S. Patients |
Total Revenue |
Notes |
| 2023 |
1,200 |
$250 million |
Market penetration at 85% of total (based on current market share and patient count) |
| 2024 |
1,300 |
$275 million |
Slight increase in patient pool, potential price increase of 5%. |
| 2025 |
1,400 |
$290 million |
Price holds, steady growth. |
| 2026 |
1,500 |
$310 million |
Continued growth and market stabilization. |
Price Sensitivity
- A 10% price reduction could decrease revenue by approximately $25 million annually.
- Price increases are limited by payor contracts and market acceptance; a 3-5% annual increase is plausible amid inflation and R&D costs.
Market Entry Barriers and Potential Growth
Barriers
- Limited patient population due to rarity.
- Physician familiarity and experience with alternative treatments.
- Cost reimbursement constraints in Medicare and commercial payors.
- Competition from emerging therapies or biosimilars, though biosimilars are unlikely for this specific immunotoxin within the forecast period.
Opportunities
- Expansion into second-line or combination therapy protocols.
- Use in other B-cell malignancies if clinical trials demonstrate efficacy.
- Increased diagnosis rates with improved awareness.
Price Projection Factors
- Regulatory environment: No imminent patent expiry.
- Pricing pressure: Moderate, constrained by the rare disease market.
- Market growth: Driven primarily by diagnosis rates and physician adoption.
- R&D pipeline: No competing drugs with similar mechanisms expected within five years.
Summary
Lumoxiti (NDC 00245-0015) remains the dominant therapy for relapsed/refractory HCL with a stable price around $210,000 per cycle. Revenue estimates suggest growth modestly driven by incremental patient numbers and potential price increases, reaching approximately $310 million globally by 2026. Market barriers and payor negotiations moderate pricing expansion.
Key Takeaways
- Lumoxiti is a targeted immunotoxin for a niche indication with limited competition.
- Current U.S. market share is around 85% with consistent price points.
- Revenue projections for 2023-2026 range from $250 million to $310 million.
- The primary growth driver is increased diagnosis and utilization, constrained by market size.
- Price sensitivity is moderate due to payor controls and disease rarity.
FAQs
1. How does Lumoxiti compare to other HCL treatments?
Lumoxiti has a targeted mechanism with a higher response rate in refractory cases, whereas traditional chemotherapies like cladribine are older but still used.
2. Are there any upcoming competitors for Lumoxiti?
No approved drugs for HCL with a similar mechanism are imminent within the next five years, though pipeline candidates are ongoing.
3. What are the main factors influencing Lumoxiti’s pricing?
Market size, reimbursement policies, competition, and manufacturing costs.
4. Can Lumoxiti be used for other indications?
Currently, its approval is limited to HCL; experimental use in other B-cell malignancies is under investigation.
5. What is the potential impact of biosimilars or generics?
Due to its complex biologic nature, a biosimilar development is unlikely within this period, limiting price pressure from generics.
References
[1] FDA. (2018). Lumoxiti approval fact sheet. U.S. Food and Drug Administration.
[2] AstraZeneca. (2022). Revenue and pricing disclosure. Annual report.
[3] SEER. (2022). Cancer Statistics Review. National Cancer Institute.
[4] Market Data Forecast. (2023). Oncology drug market analysis.
