Last updated: February 25, 2026
What is the Drug with NDC 49702-0242?
NDC 49702-0242 corresponds to Crysvita (burosumab-twza). It is a monoclonal antibody indicated for the treatment of X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO).
Market Overview
Indications and Market Size
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X-linked hypophosphatemia (XLH): A rare, inherited disorder affecting approximately 1 in 20,000 individuals. The disease results in phosphate wasting, leading to rickets, osteomalacia, and bone deformities.
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Tumor-induced osteomalacia (TIO): A rare paraneoplastic syndrome characterized by phosphate wasting due to mesenchymal tumors. Incidence rates are estimated at 1-2 cases per million annually.
Competitive Landscape
| Drug |
Class |
Approved Indications |
Market Share |
Pricing (approximate) |
| Crysvita (burosumab) |
Monoclonal antibody |
XLH, TIO |
Leading in rare bone disorders |
$350,000-$370,000 per year (USA) |
| Conventional Therapy |
Phosphate, vitamin D analogs |
XLH alternative, less effective, lower cost |
N/A |
$2,000-$5,000 annually |
| Off-label options |
Various drugs |
General bone health |
N/A |
Varies |
Market Drivers
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Increased diagnosis rates of XLH due to better awareness and genetic testing.
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Expanding use in TIO, with growing recognition among specialists.
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Patent exclusivity and pricing strategies influence revenue potential.
Price Projections and Revenue Potential
Current Pricing Analysis
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Pricing: Approximately $350,000 to $370,000 annually in the United States.
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Pricing trends: Stable; manufacturers have maintained high prices given orphan status and limited competition.
Revenue Projections (2023-2028)
| Year |
Estimated Prescriptions |
Revenue (USD million) |
Notes |
| 2023 |
1,200 |
420 |
Stable demand; market penetration |
| 2024 |
1,500 |
525 |
Increased clinician adoption |
| 2025 |
1,800 |
630 |
Expansion into TIO indications |
| 2026 |
2,200 |
770 |
Potential entry of biosimilars unlikely in near term |
| 2027 |
2,600 |
910 |
Pricing remains stable; volume growth continues |
| 2028 |
3,000 |
1,050 |
Market maturation, steady demand |
Key Assumptions
- Market penetration increases gradually.
- No significant price erosion due to biosimilar emergence within forecast period.
- Off-label or expanded indications do not substantially alter demand.
Risks to Price and Market Growth
- Biosimilar entrants or generic competitors could reduce prices.
- Insurance reimbursement policies may impact access and revenue.
- Regulatory changes could alter approved indications or pricing.
Regulatory and Reimbursement Landscape
- FDA approval: Granted for XLH and TIO.
- Pricing policies: Orphan drug status limits references to generic competition but emphasizes high pricing.
- Reimbursement: Typically covered by Medicare and private insurers, with prior authorization required.
Key Takeaways
- NDC 49702-0242 (Crysvita) is a leader in rare bone disorder treatments with stable high pricing.
- Market growth correlates with increased diagnosis, expanding indications, and continued clinician awareness.
- Revenue projections suggest consistent growth through 2028, with potential risks from biosimilars and policy shifts.
- Pricing remains high due to orphan status and limited competition, but long-term viability depends on patent life and market dynamics.
FAQs
1. When is Crysvita expected to face biosimilar competition?
Biosimilar development for monoclonal antibodies typically occurs 8-12 years post-approval. As Crysvita was approved in 2018, biosimilar activity could begin around 2026-2030, depending on regulatory approval and market factors.
2. What are the main geographical markets for Crysvita?
The U.S. is the primary market with the highest revenue, followed by the European Union. Other markets include Japan and Canada, with limited adoption in developing regions.
3. How does the price of Crysvita compare to other orphan biologics?
Crysvita's price exceeds many other orphan biologics, often due to its rare indication and high treatment costs. Prices can range from $200,000 to over $400,000 annually.
4. Are there ongoing trials for expanded indications?
Yes. Clinical trials are ongoing for potential new indications such as other phosphate-wasting disorders. Expansion could increase market size and revenue.
5. What is the impact of insurance on Crysvita access?
High cost necessitates prior authorization and reimbursement negotiations. Insurance coverage impacts patient access significantly.
References
[1] U.S. Food and Drug Administration. (2018). FDA approval letter for Crysvita.
[2] EvaluatePharma. (2022). Orphan drugs market analysis.
[3] IQVIA. (2022). Global pharmaceutical market data.
[4] National Organization for Rare Disorders. (2021). XLH overview.
