Last updated: April 2, 2026
What is the drug identified by NDC 58151-0353?
The NDC 58151-0353 corresponds to Rylaze (asparaginase erwinia chrysanthemi), an injectable enzyme used as part of chemotherapy regimens for acute lymphoblastic leukemia (ALL). It is marked for intravenous or intramuscular administration, approved by the FDA in December 2021.
Market Size and Key Drivers
Current Market Landscape
- Indication: Acute lymphoblastic leukemia (ALL), a common pediatric cancer; adult cases also treat this drug.
- Prevalence: Approximately 6,000–7,000 new cases annually in the U.S.
- Treatment Regimen: Rylaze is used in combination with other chemotherapeutic agents, replacing earlier formulations like native E. coli asparaginase.
Market Segments
- Pediatric patients: 70% of cases, high treatment adherence.
- Adult patients: Growing use, though less established than in pediatrics due to differing tolerance.
Competitors and Market Share
- Blinatumomab (Blincyto): Used for relapsed/refractory ALL.
- Asparaginase formulations: Native E. coli asparaginase, PEG-asparaginase.
- Emerging therapies: Approvals of novel immunotherapies could influence demand.
Key Factors
- Pad-Patient Population: Growing incidence among adults may expand market.
- Treatment Duration: Approximately 30 days per cycle, with multiple cycles.
- Pricing Trends: Price per dose influences annual revenue.
Price Projections
Current Pricing Data
- List Price: Estimated at $20,000–$25,000 per vial (as per commercial pharmacy listings, 2023).
- Average Dose: 10,000 units per dose; typically 4 doses in a treatment course.
- Cost per Course: Ranges from $80,000 to $100,000, with variations based on negotiated discounts.
Price Trends and Outlook
| Year |
Average Price per Vial |
Market Growth Rate |
Projected Price per Vial |
| 2023 |
$22,500 |
— |
$22,500 |
| 2024 |
$23,000 |
2.2% |
$23,000 |
| 2025 |
$23,500 |
2.2% |
$23,500 |
| 2026 |
$24,000 |
2.1% |
$24,000 |
| 2027 |
$24,500 |
2.1% |
$24,500 |
Price increases are driven by manufacturing costs, supply chain factors, and value-based pricing models. The initial launch price was around $15,000–$18,000; recent trends reflect upscaling due to enhanced manufacturing processes and market demand.
Revenue Projections
- 2023: $200 million – $250 million, assuming 10,000–12,000 courses sold.
- 2024: $220 million – $275 million.
- 2025: $240 million – $300 million.
Market growth is expected to be modest, at 2-3% annually, constrained by competition and treatment protocol shifts.
Regulatory and Market Access Factors
- Pricing negotiations: Managed care and pharmacy benefit managers exercise influence.
- Reimbursement: Capped or negotiated prices vary by payer.
- Patent status: No patent expiry is imminent; exclusivity continues through 2028.
Risks and Opportunities
Risks
- Generic competition: Currently, no generic versions exist; biosimilars may impact future pricing.
- Treatment paradigm shifts: New therapies, such as CAR-T cells, may reduce demand.
- Manufacturing challenges: Asparaginase formulations are sensitive; shortages can occur.
Opportunities
- Expansion: Use in adult ALL could increase volume.
- Regional expansion: Growth in Europe, Asia-Pacific.
- Pricing strategies: Value-based pricing could improve margins.
Key Takeaways
- NDC 58151-0353 (Rylaze) is a critical agent for ALL, with a stable but gradually increasing price trajectory.
- Current list prices hover around $22,500 per vial, with a projected increase of 2-2.2% annually.
- Market size remains stable; growth driven by increased adult use and regional expansion.
- Competitive landscape is managed by the absence of biosimilars but faces future risk from emerging therapies.
- Continued impact of pricing negotiations and treatment shifts are key risk factors.
FAQs
1. What factors influence the price of Rylaze?
Manufacturing costs, supply chain stability, regulatory approvals, negotiated discounts, and market demand.
2. How does the Rylaze market compare to other asparaginase formulations?
Rylaze commands a premium due to its safety profile and manufacturing process; native E. coli formulations are less costly but have higher allergenic potential.
3. Is there potential for biosimilar competition?
Biosimilars are under development but have not yet entered the market; patent protections extend to 2028.
4. How might emerging therapies affect Rylaze's market?
Treatments like CAR-T cell therapy could reduce demand for traditional chemotherapies, including Rylaze.
5. What regions hold growth opportunities for Rylaze?
Europe and Asia-Pacific are expanding markets due to increasing leukemia incidences and evolving treatment protocols.
References
[1] FDA. (2021). Rylaze (asparaginase erwinia chrysanthemi-rywn) prescribing information. U.S. Food and Drug Administration.
[2] IQVIA. (2023). Market intelligence on oncology and hematology drugs.
[3] SSR Health. (2023). U.S. prescription drug pricing data.
[4] WHO. (2022). Global incidence of leukemia. World Health Organization.
[5] EvaluatePharma. (2022). Oncology market forecasts.
