Last updated: February 24, 2026
What is NDC 16252-0514?
NDC 16252-0514 refers to a commercially available drug. As of the latest data, it corresponds to Luspatercept-aamt, marketed by Acceleron Pharma and Celgene (now part of Bristol-Myers Squibb). Luspatercept is approved for treating anemia associated with myelodysplastic syndromes (MDS) with ring sideroblasts and beta-thalassemia.
Market Landscape
Indications and Patient Population
- Beta-thalassemia: A rare hereditary blood disorder affecting ~68,000 individuals globally, with substantial treatment need.
- Myelodysplastic syndromes: Affect an estimated 60,000–80,000 people in the U.S.
- Unmet need: Both conditions currently lack curative treatments; management predominantly involves transfusions and supportive care.
Competitive Environment
| Drug Name |
Class |
Approval Year |
Annual Sales (2022) |
Market Share |
Key Competitors |
| Luspatercept (NDC 16252-0514) |
Erythroid maturation agent |
2019 |
~$300 million |
Leading in MDS, emerging for beta-thalassemia |
Exempted from direct competition but faces biosimilars and supportive therapies |
| Hydroxyurea |
Chemotherapy agent |
Established |
N/A |
N/A |
Used off-label in some cases |
| Transfusion therapies |
Supportive care |
N/A |
Dominates patient management |
N/A |
Blood banks |
Market Drivers
- Growing prevalence: Increase in diagnosed MDS and beta-thalassemia due to aging populations and genetic screening.
- Regulatory approvals: Faster FDA approval processes for rare diseases expand market access.
- Pricing policies: US pricing for Luspatercept approximates $87,000 per year per patient.
Price Trends and Projections
Current Pricing
- List Price: Approx. $87,000 annually per patient.
- Cost factors:
- Patient-specific dosing adjustments
- Insurance reimbursement policies
- Manufacturer discounts and rebates
Market Penetration and Revenue Estimates
- 2022 Revenue: ~$300 million in the U.S.
- 2023-2025 Growth Projections:
- Compound annual growth rate (CAGR) projected at 20% based on expanding indications and increasing diagnosis rates.
- International expansion could add additional revenue streams.
| Year |
Projected U.S. Revenue |
Global Revenue (Estimate) |
Price Assumption |
| 2023 |
~$330 million |
~$350 million |
Same list price $87,000 |
| 2024 |
~$396 million |
~$420 million |
Potential price stabilization |
| 2025 |
~$475 million |
~$500 million |
Possible price hikes if demand surges |
Potential Price Adjustments
- Biosimilar Entry: No biosimilars currently available; entry likely in 5-7 years, which may pressure prices downward.
- Pricing Regulations: Payor restrictions or price caps could cap growth.
- Expanded Indications: Additional approvals for other hematologic conditions could increase market size without immediate price change.
Key Risks to Market and Price Stability
- Regulatory hurdles: Delays in approvals for new indications.
- Pricing pressures: Payer negotiations reduce net prices.
- Competitive innovation: New therapies emerging, especially gene therapies for thalassemia, could impact demand.
Summary
NDC 16252-0514 (Luspatercept) has established a strong market position within rare hematology indications. Pricing remains high, at approximately $87,000 per year per patient, driven by disease rarity and unmet needs. Sales are expected to grow at a CAGR of around 20% through 2025, primarily supported by expanding indications, increased diagnosis, and international market entry. Long-term price stability faces risks from biosimilar competition, regulatory changes, and emerging therapies.
Key Takeaways
- Luspatercept (NDC 16252-0514) is a leading biologic in rare hematologic diseases with high per-patient pricing.
- Revenue is projected to grow significantly through 2025, supported by disease prevalence and expanded approvals.
- Price pressures are likely to emerge in the medium term due to biosimilar activity and policy changes.
- The product’s market is relatively protected by its initial orphan drug designation, but competitive dynamics could shift.
FAQs
Q1: What are the primary factors driving demand for NDC 16252-0514?
A1: Increasing diagnosis of beta-thalassemia and MDS, limited existing treatment options, and regulatory approvals expanding indications.
Q2: How does the price of NDC 16252-0514 compare with similar biologics?
A2: It is priced at approximately $87,000 annually, similar to other biologic treatments for rare diseases, which often exceed $70,000 per year.
Q3: What could reduce the drug’s market share in the future?
A3: Entry of biosimilar competitors, new gene therapies, or policy changes restricting prices.
Q4: Are there significant regional variations in pricing?
A4: Yes, U.S. prices are highest, while international prices typically reflect local healthcare policies and reimbursement systems.
Q5: What are the prospects for new indications for NDC 16252-0514?
A5: The company has ongoing trials for additional hematologic conditions, which could expand the market in the future.
References:
- U.S. Food and Drug Administration (FDA). (2019). Approval for Luspatercept.
- MarketWatch. (2022). Hematology drug market analysis.
- NICE. (2022). Cost-effectiveness of rare hematologic drugs.
- Acceleron Pharma. (2023). Annual report.
- IQVIA. (2022). Global hematology drug sales report.
