Last updated: February 24, 2026
What is the drug associated with NDC 21922-0029?
The National Drug Code (NDC) 21922-0029 corresponds to Voxzogo (vosoritide), a medication approved by the U.S. Food and Drug Administration (FDA) in August 2021 for the treatment of achondroplasia in pediatric patients aged 2 years and older. It is an injectable peptide that enhances bone growth by inhibiting C-type natriuretic peptide receptor (NPR2) signaling.
What is the market size for Voxzogo?
The global market for growth disorder treatments, particularly achondroplasia, is expected to grow significantly over the next decade. Key drivers include increased diagnosis rates, expanding indications, and ongoing development of related therapies.
Current market estimates (2023)
| Metric |
Figure |
Notes |
| Estimated global prevalence of achondroplasia |
1 in 15,000 to 40,000 live births |
Population-dependent; approximately 250,000 affected globally assuming 130 million births annually. |
| US prevalence |
4,000–5,000 pediatric patients |
Based on US birth rate (~3.6 million/year) and prevalence. |
| US treatment-eligible population |
~2,000–3,000 children aged 2+ |
Based on age distribution and diagnosis rates. |
Revenue potential
Projected for initial years based on:
- Prescriber adoption rates: modest initially, increasing as awareness grows.
- Pricing: Voxzogo is priced at approximately $372,000 annually per patient in the U.S. (as per recent pricing disclosures).
Total addressable market (TAM) in the U.S.: approximately $3.7 billion annually, assuming full penetration in eligible patients.
What are the current pricing models?
| Price Point |
Approximate Annual Cost |
Notes |
| U.S. retail price |
$372,000 |
Listed estimates, based on CMS and commercial plans. |
| Wholesale acquisition cost (WAC) |
Slightly lower |
Used for formulary negotiations. |
| Patient out-of-pocket |
Varies |
Co-pays and insurance deductibles influence actual costs. |
Pricing compares with other rare disease therapies such as Zolgensma ($2.1 million one-time) and Spinraza ($750,000 initial, then ~$125,000 annually).
What are the competitive options?
| Therapy |
Treatment Type |
Indication |
Status |
Price |
| Biomarin's Asfotase alfa |
Enzyme replacement |
Hypophosphatasia |
Approved |
~$425,000/year |
| Pfizer's Vosoritide (NDC 21922-0029) |
Peptide therapy |
Achondroplasia |
Approved |
~$372,000/year |
| Future drugs |
Under development |
Various growth disorders |
Clinical trials |
Not yet established |
The market has limited licensed therapies targeting achondroplasia directly, with many companies developing experimental agents.
What factors influence pricing and reimbursement?
- Regulatory status: Approval in key markets (US, EU) increases adoption.
- Pricing policies: Payers are scrutinizing high-cost orphan drugs, often demanding negotiated discounts.
- Clinical adoption: Physician awareness and cross-border prescribing practices impact utilization.
- Manufacturing costs: Peptide drug manufacturing costs are relatively high due to synthesis complexity.
Concurrently, insurers may implement risk-sharing agreements or outcomes-based pricing to manage high expenses.
What are price projection trends?
Short-term (1-2 years)
- Initial prices will likely remain stable at around $372,000 annually.
- Early adoption limited to specialized centers; pricing pressures minimal.
- Negotiated discounts or patient assistance programs may reduce effective costs.
Medium-term (3-5 years)
- As competition emerges or biosimilars are considered, prices may decline 10–20%.
- Expanded indications or approved dosing regimens could influence price adjustments.
- Payer negotiations could lead to value-based agreements, incentivizing outcome-based discounts.
Long-term (5+ years)
- Market entry of alternative therapies may generate price competition.
- Generic or biosimilar development unlikely due to peptide complexity.
- Prices might stabilize within 10–15% of current levels unless new competitors or therapies reduce overall costs.
Key market dynamics
- The orphan drug status extends exclusivity periods, delaying generic entry.
- Pricing in international markets varies significantly, with many countries negotiating confidential discounts.
- Market growth depends heavily on clinical outcomes, reimbursement policies, and prescriber acceptance.
Conclusion
Price projections for NDC 21922-0029 (Voxzogo) suggest stable high prices over the short term, tapering slowly as competition and policy pressures evolve. The US market's revenue potential remains significant owing to unmet demand, with total annual sales potentially reaching $3.7 billion if full coverage is realized among eligible pediatric patients.
Key Takeaways
- Voxzogo's current annual price is approximately $372,000, with a total market size around $3.7 billion in the US.
- Market expansion hinges on increased diagnosis and prescriber acceptance.
- Price reductions are possible over 3–5 years through negotiated discounts or new therapeutic entrants.
- Durable exclusivity due to orphan drug status limits immediate competition.
- International pricing varies considerably, influenced by local reimbursement frameworks.
FAQs
-
How does Voxzogo compare in price to other rare disease therapies? It is priced lower than gene therapies like Zolgensma but comparable to other peptide-based orphan drugs, typically in the $300,000–$400,000 range annually.
-
What are the main barriers to market growth? Limited awareness, high costs, reimbursement negotiations, and the slow diagnosis rate for achondroplasia.
-
Could biosimilars impact Voxzogo's price? Biosimilar development is unlikely due to the nature of peptide synthesis and patent protections, though future innovations could influence pricing dynamics.
-
What is the potential for global expansion? Countries with national health services and price negotiations may see lower prices, but overall market size abroad remains limited compared to the US.
-
Will the pricing trend change with new therapies? Competition from emerging therapies, especially those with different mechanisms or shorter administration schedules, could reduce prices over time.
References
- Food and Drug Administration. (2021). FDA approves Voxzogo to treat achondroplasia.
- Evaluate Pharma. (2022). Orphan drug market outlook.
- IQVIA. (2023). US prescription drug pricing data.
- American Society of Human Genetics. (2022). Achondroplasia prevalence estimates.
[1] U.S. Food and Drug Administration. (2021). FDA approves Voxzogo (vosoritide) to treat achondroplasia. https://www.fda.gov/news-events/press-announcements/fda-approves-voxzogo-vosoritide-treat-achondroplasia
