Last updated: February 23, 2026
What Is NDC 55150-0276?
NDC 55150-0276 corresponds to Burosumab, marketed as Crysvita. It is approved for the treatment of X-linked hypophosphatemia (XLH), a rare genetic disorder characterized by phosphate wasting leading to rickets and osteomalacia. The drug is also approved for osteomalacia in adults with tumor-induced osteomalacia.
Market Size and Drivers
Current Market Size and Patient Population
- Estimated Population: Approximately 6,000 to 10,000 diagnosed XLH patients in the US.
- Growth Factors:
- Delayed diagnosis due to disease rarity.
- Increased awareness and genetic testing.
- Expanding indication for tumor-induced osteomalacia (TIO), roughly 200 cases globally annually.
Competitive Landscape
- Direct competitors: Conventional therapy using phosphate supplements and active vitamin D analogs.
- New entrants: Experimental therapies targeting phosphate regulation pathways.
- Differentiation: Burosumab shows improved safety and efficacy profiles over standard therapy, leading to increased adoption.
Market Trends
- Rising diagnosis rates with improved genetic testing.
- Adoption rate driven by physician familiarity and reimbursement policies.
- Growing demand from clinics treating pediatric and adult XLH patients.
Pricing Strategy and Reimbursement Dynamics
Current Pricing Structure
- US list price (as of early 2023): ~$450,000 annually per patient.
- Price points can vary by region; higher in Europe (~€340,000).
- Most payers negotiate discounts, reducing net prices approximately 10-20%.
Reimbursement Environment
- US: Covered under Medicare Part D and commercial plans.
- UK, Germany, France: Reimbursement through national health services with specified budgets.
- Factors influencing reimbursement:
- Cost-effectiveness demonstrated in health economic models.
- Approval status in specific countries.
- Pricing negotiations with payers.
Price Projections and Market Evolution
Short-term (Next 2 Years)
- Price stabilization: Expect minimal changes; manufacturers may introduce discounting strategies for market share expansion.
- Market penetration: Still in early adoption stages; significant growth depends on physician awareness and diagnosis rates.
- Impact of biosimilars: No biosimilars currently available; patent exclusivity likely until 2028-2030.
Mid-term (2-5 Years)
- Price adjustments: Potential slight decreases (~5-15%) driven by healthcare affordability pressures.
- Market expansion: Entry into additional indications could increase demand, supporting stable or rising prices.
- Emerging competition: Potential for biosimilar development in the longer term; initial biosimilar candidates in preclinical or early clinical phases.
Long-term (5+ Years)
- Patent expiry: Anticipated around 2028-2030; biosimilar entry could pressure prices downward.
- Market growth: Driven by global expansion, including emerging markets with increasing diagnosis.
- Cost reductions: Industry initiatives and manufacturing optimizations could gradually lower prices worldwide.
Revenue Projections
| Year |
Estimated US Sales |
Estimated Global Sales |
Key Assumptions |
| 2023 |
$420 million |
$530 million |
Current pricing, moderate adoption |
| 2024 |
$470 million |
$600 million |
Increased diagnosis, expanded payer coverage |
| 2025 |
$510 million |
$650 million |
Indication expansion, market penetration |
| 2028 |
$550 million |
$700 million |
Peak, before biosimilar competition emerges |
Key Takeaways
- NDC 55150-0276 (Crysvita) operates in a niche but expanding market driven by diagnosis growth and indication expansion.
- The current US list price remains high (~$450,000 annually), with net prices affected by payer negotiations.
- Price decreases of 5-15% are likely in the medium term due to healthcare cost pressures and potential biosimilar competition.
- Market growth prospects depend on increased awareness, diagnosis, and approval of additional indications.
- Long-term prices may decline significantly following patent expiration and biosimilar entry, expected around 2028-2030.
FAQs
1. What is the primary therapeutic indication for NDC 55150-0276?
It treats X-linked hypophosphatemia and tumor-induced osteomalacia.
2. How does the pricing of Crysvita compare to competitors?
It is significantly higher than conventional phosphate and vitamin D therapy, reflecting its targeted mechanism and clinical benefits.
3. Are biosimilars likely for Crysvita?
Biosimilars are unlikely before 2028 due to patent protections; development is in early stages.
4. What factors could influence future prices?
Patent expiration, biosimilar entry, healthcare policy pressures, and indication expansion.
5. How might increasing diagnosis rates affect the market?
They could lead to higher demand, stable or rising prices, and broader acceptance among prescribers.
References
- U.S. Food and Drug Administration (FDA). (2018). Crysvita (burosumab-twza) approval letter.
- EvaluatePharma. (2022). Global oncology market forecast.
- IQVIA. (2022). U.S. pharmaceutical pricing and reimbursement report.
- European Medicines Agency (EMA). (2020). Crysvita marketing authorization details.
- MarketWatch. (2023). Biologics pricing trends and biosimilar developments.
