Last updated: March 1, 2026
What is NDC 49483-0687?
NDC 49483-0687 is a biosimilar product marketed as Omnitrope. It is a biosimilar alternative to Genotropin, a recombinant human growth hormone used in treating growth hormone deficiency, idiopathic short stature, and other growth-related conditions.
Market Overview
Market Size and Demand
The growth hormone (GH) market is valued at approximately $3.8 billion globally in 2022, with a compound annual growth rate (CAGR) of 4.2% projected through 2027 (Valuates Reports, 2022). Biosimilars like Omnitrope have gained market share due to patent expirations and cost-conscious prescribing.
Market Players
Key competitors include:
- Pfizer (Genotropin)
- Novo Nordisk (Norditropin)
- Eli Lilly (Lilly Growth Hormone)
Omnitrope’s main advantage lies in its biosimilar status, which generally enables pricing 15-30% lower than originator brands.
Regulatory Landscape
The FDA approved Omnitrope as a biosimilar in 2006, making it one of the earliest biosimilars approved in the U.S. Biosimilar uptake is constrained by physician prescribing habits and patent litigations, but regulatory approvals support increased adoption.
Pricing Dynamics
Current Price Points
- Average Wholesale Price (AWP): Approximately $1,200 to $1,500 per 10 mg vial (Medicaid and private payers, 2022)
- Average Sale Price (ASP): Slightly lower, around $950 to $1,100
The originator product, Genotropin, averages $1,800 to $2,200 per 10 mg vial, underpinning biosimilar savings.
Reimbursement and Payer Trends
In 2022, Medicare Part B and commercial payers have adopted step therapy policies favoring biosimilars. Reimbursement rates favor lower-priced options, encouraging biosimilar use.
Market Penetration and Adoption
Biosimilar penetration ranges from 25% to 45% within growth hormone therapy, with higher adoption in managed care settings. Price sensitivity and physician familiarity influence dynamics.
Price Projections
Short-term (2023-2025)
- Biosimilar prices are expected to decrease by 5-10% annually due to increased competition.
- Price per vial may range from $850 to $1,050 in 2023, declining toward $800–$950 by 2025.
Long-term (2026 and beyond)
- Continued market penetration could push prices down by an additional 10-15%, reaching $700–$850 per vial by 2030.
- Emerging biosimilar entrants may further drive prices.
Factors Influencing Price Trajectory
- Patent litigations and exclusivities.
- Manufacturing cost reductions.
- Payer policies favoring biosimilar substitution.
- Physician and patient acceptance.
Revenue Projections
Assuming annual sales volume of 2 million units (10 mg equivalent), revenues could be:
| Year |
Average Price per 10 mg vial |
Estimated Revenue (millions USD) |
| 2023 |
$950 |
$1.9 billion |
| 2025 |
$850 |
$1.7 billion |
| 2030 |
$750 |
$1.5 billion |
Growth depends on market share gains and competitive pressures.
Key Takeaways
- NDC 49483-0687 (Omnitrope) functions as a biosimilar to Genotropin, with a market that is expanding via biosimilar adoption.
- Prices are currently approximately $950–$1,100 per vial, with trends indicating reductions of 5-10% annually over the next few years.
- Long-term price projections suggest potential prices of $700–$850 per vial by 2030, driven by increased biosimilar adoption and competitive pricing.
- Market volume remains substantial, with revenue projections around $1.5–$2 billion annually in the medium term.
- Key factors influencing market dynamics include regulatory policies, patent litigation, payer strategies, and physician preferences.
FAQs
1. How does NDC 49483-0687 compare to other biosimilars?
It is among the earliest biosimilars approved for growth hormone therapy, with pricing generally below that of originators. Adoption rate varies, but it benefits from early FDA approval.
2. What determines the future pricing of Omnitrope?
Market competition, manufacturing costs, patent status, and healthcare policies influence prices. Regulatory pressure and market entry of new biosimilars further impact price trends.
3. Who are the primary competitors for this product?
Genotropin (Pfizer), Norditropin (Novo Nordisk), and Lilly Growth Hormone are primary competitors, with biosimilar products like Omnitrope vying for market share.
4. How significant is market penetration for biosimilars like Omnitrope?
Biosimilar penetration is approximately 25-45% in growth hormone markets, with upward potential as physicians and payers favor lower-cost options.
5. What are potential barriers to price reductions?
Patent protections, manufacturing complexities, prescriber inertia, and regulatory hurdles can slow price declines, even as market competition intensifies.
References
- Valuates Reports. (2022). Growth hormone market size, share & trends analysis report. Retrieved from https://www.valuates.com
- U.S. Food and Drug Administration. (2006). Biosimilar approvals. Retrieved from https://www.fda.gov
- Medicare.gov. (2022). Coverage policies for biosimilars. Retrieved from https://medicare.gov
- IQVIA. (2022). Market analysis from IQVIA healthcare data.
- Plumer, S., & Song, Z. (2021). Evolution of biosimilar policy landscape in the United States. BioDrugs, 35(1), 1-11.
