Last updated: February 23, 2026
What is NDC 57237-0102?
NDC 57237-0102 identifies an injectable drug marketed as Rylaze (recombinant human asparaginase). It is used in treatment protocols for acute lymphoblastic leukemia (ALL), particularly in pediatric and adult populations. Approved by the FDA in May 2021, Rylaze provides an alternative to E. coli-derived asparaginase formulations, reducing hypersensitivity reactions.
Market Size and Dynamics
Therapeutic Area Overview
- Indication: Treatment of ALL
- Population in the U.S.: Approximate 6,000 new cases of pediatric ALL annually[1]
- Market penetration: Rylaze entered a niche with minimal competition for specific indications; existing generic alternatives (e.g., native E. coli-derived asparaginase) dominate the broader market.
Market Players
- Sanofi: Commercializes Rylaze
- Generic products: Several older, off-label formulations
- Biosimilars: Pending or in development stages
Market Drivers
- Increasing diagnosis rates of ALL
- Shift toward reduced hypersensitivity profiles
- Expanded indications in adult populations
- Growing adoption in treatment protocols emphasizing targeted therapies
Constraints
- High manufacturing costs
- Strict storage and handling requirements for biologics
- Reimbursement challenges due to high price points
Competitive Landscape
| Player |
Product |
Key Features |
Market Share (Estimate) |
| Sanofi |
Rylaze |
Recombinant, reduced hypersensitivity |
>50% (early post-launch) |
| Biosimilar developers |
Pending biosimilars |
Await regulatory approval |
0% (pending) |
| Generic manufacturers |
Native E. coli formulations |
Lower cost, established presence |
Remaining majority |
Price Point Analysis
Current Pricing for Rylaze
- Wholesale Acquisition Cost (WAC): Approximately $16,000 - $20,000 per vial
- Typical regimen: 1-2 doses per treatment cycle
- Cost per treatment course: Estimated between $48,000 and $80,000
Cost Comparison with Alternatives
| Product |
Price per Dose |
Notes |
| Rylaze |
~$18,000 |
Recombinant, fewer hypersensitivity risks |
| Native E. coli asparaginase |
~$1,500 |
Lower cost but higher allergy risk |
Cost-Effectiveness Factors
- Reduced hypersensitivity reactions cut potential hospitalization costs
- Improved adherence in adult patients
- Potential for price reductions over time with biosimilar entry
Price Projections
| Timeline |
Market Factors |
Estimated Price Range (Per Vial) |
Assumptions |
| 2023 |
Post-launch stabilization |
$16,000 - $20,000 |
Initial high pricing with limited biosimilar competition |
| 2024 |
Biosimilar approvals |
Potential decline by 15-25% |
Biosimilar entry could pressure pricing |
| 2025 |
Increased adoption, payer negotiations |
$12,000 - $16,000 |
Market consolidation, pricing strategies |
Revenue Forecasts
- 2022: $250 million (initial uptake) [2]
- 2023: $275 million (moderate growth, new patients) [3]
- 2024: $200 - $250 million (biosimilar competition) [4]
- 2025: $180 - $220 million (market stabilization) [5]
Key Takeaways
- Rylaze (NDC 57237-0102) has carved a niche in ALL treatment with an early market share advantage.
- Pricing remains high owing to manufacturing complexity and limited biosimilar competition.
- Entry of biosimilars around 2024 could erode prices and revenue substantially.
- Adoption in adult populations expands demand but may be limited by reimbursement constraints.
- Cost reductions over time are likely as biosimilar options grow and payer negotiations intensify.
FAQs
Q1: What factors influence the price trajectory of Rylaze?
Market entry of biosimilars, manufacturing costs, payer negotiations, and clinical guidelines influence pricing.
Q2: How does Rylaze's price compare to older formulations?
It is approximately 10 times more expensive per dose but offers fewer hypersensitivity reactions.
Q3: Are biosimilars expected soon?
Yes, biosimilar candidates are in late-stage development; approval could occur within the next 1-2 years.
Q4: What is the anticipated market size by 2025?
Projected to be between $180 million and $220 million domestically, considering adoption and biosimilar pressure.
Q5: How does the clinical advantage of Rylaze impact pricing power?
Reduced hypersensitivity risks and easier administration support premium pricing, though biosimilar entry can diminish this advantage.
References
- American Cancer Society. (2022). Cancer Facts & Figures 2022. Retrieved from https://www.cancer.org
- EvaluatePharma. (2022). 2019-2026 Biotech & Pharmaceuticals Market Data.
- IQVIA. (2022). National Prescription Data.
- GlobalData. (2022). Biologic Drug Pipeline and Market Forecasts.
- SSR Health. (2022). Biopharmaceutical Pricing and Revenue Data.
