Last updated: February 13, 2026
What is NDC 71699-0100?
NDC 71699-0100 corresponds to Mecasermin (Increlex), a recombinant human insulin-like growth factor-1 (IGF-1) used for treating growth failure due to severe primary IGF-1 deficiency or secondary to growth hormone gene deletion. It is approved for pediatric patients below 18 with specific growth hormone deficiencies who do not respond adequately to growth hormone therapy.
Current Market Landscape
Market Size and Patient Population
- Target Patients: Estimated 1,800 to 2,200 children in the U.S. with severe primary IGF-1 deficiency.
- Diagnosis: Rare disorder, classified as an ultra-orphan with limited treatment options.
- Market Penetration: Limited due to exclusivity, administration complexity, and high costs.
Competitive Environment
- Existing Therapies: Only Mecasermin approved for IGF-1 deficiency with no direct biosimilars or alternative therapies.
- Orphan Drug Status: Granted by FDA, providing market exclusivity until at least 2030 and potential for seven years of market monopoly post-approval.
Revenue Trends
- Historical Sales: Estimated $60-$80 million annually in the U.S., driven predominantly by pediatric endocrinologists.
- Growth Factors: Increased diagnosis rates, expanding awareness, and potential label expansions for other indications.
Price Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $50,000 per 3-mg vial.
- Average Treatment Cost: Estimated at $120,000 - $150,000 annually per patient, considering average dosing of 0.04-0.12 mg/kg/day for a 20 kg child.
Price Comparisons to Similar Drugs
| Product |
Dosage Form |
WAC per unit |
Annual Treatment Cost |
Indication |
| Mecasermin (Increlex) |
3 mg vial |
~$50,000 |
$120,000 - $150,000 |
Severe IGF-1 deficiency in children |
| Growth Hormone (Genentech, Norditropin) |
Vials (multiple doses) |
~$8,000 per 5 mg |
$50,000 - $70,000 |
Growth hormone deficiency, broader population |
| Biosimilar IGF-1 |
Not yet available |
N/A |
N/A |
Pending regulatory approvals |
Price Projections
Short-term (Next 2 years)
- Stable Pricing: WAC remains around $50,000 per vial due to market exclusivity.
- Market Penetration: Slow growth expected due to diagnostic challenges, limited patient pool, and high treatment costs.
- Reimbursement: Likely to remain high, with insurance coverage largely comprehensive given orphan status.
Medium to Long-term (3-10 years)
- Potential Price Adjustment: Price erosion unlikely without biosimilar entry, which is not currently on the horizon for rare biologics.
- Regulatory Impact: Any label expansion is unlikely to influence pricing dramatically unless additional indications or enhanced efficacy are demonstrated.
- Market Expansion: Possible growth if new formulations or delivery methods improve adherence and reduce costs.
Factors Influencing Future Pricing
- Regulatory Approvals: Broader indications could expand the eligible patient pool, impacting volume more than price.
- Policy Changes: Value-based pricing or cost-containment policies could pressure prices down.
- Biosimilar Entry: No biosimilars anticipated before 2030, maintaining current pricing structure.
- Manufacturing Costs: Stable, considering advances in bioprocessing reduce costs over time.
Key Takeaways
- NDC 71699-0100 (Mecasermin) remains a high-cost orphan drug with stable pricing at approximately $50,000 per vial.
- Market size is limited, with an estimated 2,000 eligible patients in the U.S.
- Revenue projections are steady, with minimal change expected over the next two years barring regulatory or market shifts.
- Price erosion is unlikely until biosimilar competition appears, potentially beyond 2030.
- Future expansion of indications or improvements in treatment administration could influence volume but have limited impact on per-unit price.
FAQs
1. What is the main driver of Mecasermin's high price?
Market exclusivity granted by orphan drug status shields it from competition, enabling high pricing to recoup development costs for a rare disease.
2. Are biosimilars expected for Mecasermin?
No biosimilars are currently approved or in late-stage development for IGF-1 therapies, suggesting sustained exclusivity until at least 2030.
3. How does Mecasermin compare with growth hormone therapies in pricing?
Mecasermin costs approximately twice as much annually compared to growth hormone therapies due to its orphan status, specialized use, and manufacturing complexity.
4. What factors could influence the price in the next decade?
Regulatory changes, potential generic or biosimilar entry, broader indications, and healthcare policy reforms could impact pricing.
5. How has the COVID-19 pandemic affected Mecasermin’s market?
Disruptions in clinical visits and delays in diagnosis may have slowed market growth minimally; however, demand for orphan biologics remains stable.
References
- FDA Drug Database. Increlex. https://www.accessdata.fda.gov/scripts/cder/daf/
- IQVIA. US Orphan Drug Market Data, 2022.
- EvaluatePharma. Volume and Pricing Trends for Rare Disease Biologics, 2022.
- Regulatory Affairs Professionals Society. Orphan Drug Designation and Incentives, 2022.
- Commercial Data Providers. Current Pricing and Reimbursement Status of Mecasermin, 2023.
Disclaimer: Data and projections are based on publicly available sources and estimates; actual market dynamics may vary.
