Last updated: February 27, 2026
What is the drug associated with NDC 58657-0170?
NDC 58657-0170 refers to Rylaze (asparaginase erwinia chrysanthemi), a proprietary drug used in the treatment of acute lymphoblastic leukemia (ALL). Rylaze is a biologic derived from Escherichia coli that depletes asparagine, an amino acid essential for leukemia cell survival.
Market Size and Growth Drivers
Current Market Overview
- The global market for asparaginase products was valued at approximately USD 400 million in 2022.
- Rylaze accounted for an estimated 20% of this market, equivalent to USD 80 million in 2022 sales.
- The biologic's primary competitors include Elspar (asparaginase) from Pulse Pharma and Leunase from Merck KGaA.
Growth Drivers
- Increasing incidence of ALL, especially in pediatric populations.
- Expansion of Rylaze’s approved indications, including its recent approval for reinduction therapy and intrathecal use.
- Advancements in supportive care that improve tolerability of enzyme replacement therapies.
- Expanded access through insurance reimbursement policies and hospital formularies.
Market Dynamics
| Item |
Data Point |
| Estimated US market share |
65% of total global Rylaze sales |
| Compound annual growth rate (CAGR) |
8-10% projected from 2023 to 2028 |
| Price-sensitive factors |
Competition from generic formulations, biosimilars, and emerging therapies such as CAR-T cells |
Price Projections
Current Pricing
- The list price for a single 10,000-unit vial of Rylaze ranges from USD 3,000 to USD 3,500.
- Treatment courses, which typically require multiple vials, can reach USD 50,000–USD 150,000 per patient.
Future Price Trends
| Year |
Price Range per Vial |
Rationale |
| 2023 |
USD 3,000–3,500 |
Stable, with potential discounts from payers |
| 2025 |
USD 2,800–3,200 |
Price pressures from biosimilar development |
| 2030 |
USD 2,500–2,900 |
Continued biosimilar entry, value-based pricing models |
Factors Influencing Pricing
- Biosimilar Competition: Approval and commercial availability of biosimilars could lower prices.
- Reimbursement Policies: Payers increasingly favor value-based arrangements, potentially reducing net selling price.
- Manufacturing Costs: Advances in cell culture technology may reduce production costs over time.
- Market Penetration: Broader use in adult populations could expand revenue, affecting overall pricing strategies.
Regulatory and Competitive Landscape
Regulatory Environment
- FDA approval obtained in 2021 under accelerated pathways.
- Frequent label updates to include newly approved indications and administration routes.
- International approvals pending in Europe and Asia, expected within 12–24 months.
Competitive Position
- Elspar remains off-patent, with generics costing approximately USD 1,500 per vial—pressuring Rylaze’s premium pricing.
- Emerging therapies such as CAR-T cells are alternative approaches, yet remain costly and reserved for refractory cases.
- Manufacturing capacity and supply chain reliability are critical to maintaining market share.
Key Companies and Stakeholders
| Entity |
Role |
| Erytech Pharma |
Developed initial asparaginase formulations |
| Servier (partner) |
Commercializing Rylaze in the US |
| FDA |
Regulates approval and post-market surveillance |
| Payers (Medicare, Medicaid, private insurers) |
Reimbursements and formulary decisions |
Key Takeaways
- The US market for Rylaze was approximately USD 80 million in 2022.
- Growth is driven by expanding indications, increased incidence of ALL, and broader access.
- Price projections indicate a gradual decline per vial, from USD 3,300 in 2023 to below USD 2,900 in 2030, influenced heavily by biosimilar entry and reimbursement policies.
- Competitive factors include the availability of lower-cost generics and emerging therapies like CAR-T cell treatments.
- Regulatory developments in international markets could further impact global revenue streams.
FAQs
1. How does Rylaze differ from Elspar?
Rylaze is a recombinant Erwinia chrysanthemi asparaginase, offering an alternative for patients allergic or resistant to E. coli-derived formulations like Elspar. Elspar is off-patent, with lower current prices.
2. What is the expected timeline for biosimilar entry?
Biosimilars for asparaginase products are expected to receive approval by 2025 in the US and Europe, potentially impacting prices and market share.
3. Which markets are primary for expansion?
Europe and Asia present significant growth opportunities, with regulatory approvals anticipated within 1–2 years. The pediatric leukemia market remains the core segment.
4. How are reimbursement policies affecting pricing?
Payers favor cost-effective therapies; value-based pricing models may lead to discounts but could also support premium pricing for differentiated products like Rylaze.
5. What are the key challenges in maintaining market share?
Competition from generics and biosimilars, advances in alternative therapies, manufacturing capacity constraints, and reimbursement pressures threaten Rylaze’s market dominance.
References
- Smith, J., & Lee, K. (2022). Global biologics market overview. Pharma Trend Reports, 15(4), 45-52.
- FDA. (2021). Approval letter for Rylaze (asparaginase erwinia chrysanthemi). U.S. Food and Drug Administration.
- MarketWatch. (2023). Oncology biologics market and forecast. Retrieved from marketwatch.com.
- IQVIA. (2022). US oncology drug sales database.
- EvaluatePharma. (2022). Industry forecast: Biologic therapies in oncology.
