Last updated: March 3, 2026
What is NDC 63824-0175?
NDC 63824-0175 corresponds to a specific drug product. As of the latest available data, the drug identified by this NDC is injectable denosumab (Prolia) used for osteoporosis treatment in adult women at high risk of fracture.
Market Overview
Market Size and Demand
- Global osteoporosis market counted approximately $13 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 4% over the next five years.
- The U.S. osteoporosis therapy market was valued at around $3.2 billion in 2022, driven by increasing aging populations and osteoporosis prevalence.
Key Drivers
- Rising aging demographic with osteoporosis prevalence increasing from 10 million (2000) to over 54 million Americans (2020).
- Introduction of biosimilars and patent expirations increasing market competition.
- Greater awareness and diagnosis leading to higher prescription rates.
Competitors
- Bisphosphonates: Alendronate, Risedronate
- Monoclonal antibodies: Denosumab (Prolia/Xgeva)
- New entrants: Potential biosimilars poised to impact pricing and market share
Regulatory Status
- Approved by the FDA in 2010 for postmenopausal osteoporosis in women at high risk.
- Patent protections largely expired or expiring, opening the market to biosimilar competition.
- Biosimilars for denosumab are in advanced stages, with multiple candidates submitted or approved in various markets.
Price Analysis
Current Pricing
In the U.S., the Wholesale Acquisition Cost (WAC) for Denosumab (Prolia) is approximately $1,600 to $1,800 per dose, with dosing typically every six months (two doses annually).
Factors Influencing Price
- Brand vs. biosimilar: The brand Prolia remains dominant, with biosimilars expected to reduce prices by 15-30%.
- Reimbursement policies: Payers favor biosimilars for cost savings, potentially lowering overall prices.
- Market penetration: Increased competition could push prices downward over time.
Price Trends and Projections
| Year |
Estimated Price per Dose |
Comments |
| 2022 |
$1,750 |
Current average for the brand |
| 2023 |
$1,700–$1,750 |
Slight decline expected with biosimilar entry |
| 2024 |
$1,500–$1,650 |
Increased biosimilar competition, potential discounting |
| 2025 |
$1,400–$1,600 |
Biosimilars capturing larger market share |
Projected Market Penetration
- Biosimilar approval expected by 2024–2025 in key markets.
- Biosimilar adoption could make up 20-40% of the osteoporosis denosumab market within the next three years.
- Price reductions could reach 20% for biosimilars, with brand prices remaining stable initially but declining as market share shifts.
Revenue Projections
- Total U.S. market volume (~1 million doses annually).
- Assuming brand market share decreases from 80% to 50% over three years.
- Pricing adjustments yield potential revenue shifts:
| Year |
Estimated Annual Revenue (USD) |
Key assumptions |
| 2022 |
$1.7 billion |
Brand dominance; stable pricing |
| 2023 |
$1.4 billion |
Biosimilar entry; 10% price reduction |
| 2024 |
$1.2 billion |
Increased biosimilar uptake; further price reduction |
| 2025 |
$1.0 billion |
Biosimilar market share exceeds 30%, prices stabilize at lower levels |
Key Market Risk Factors
- Regulatory delays: Biosimilar approval processes vary.
- Reimbursement policies: Changes could impact pricing strategies.
- Market response: Physician and patient acceptance of biosimilars influences market share.
Conclusion
Market growth for denosumab (NDC 63824-0175) remains steady; however, impending biosimilar competition may exert downward pressure on prices by 2024–2025. The product's longevity in the market is contingent upon regulatory approvals, payer acceptance, and market share shifts.
Key Takeaways
- The U.S. osteoporosis drug market is projected to grow at 4% CAGR through 2027.
- Current denosumab prices hover around $1,700 per dose.
- Biosimilars could reduce prices by approximately 20-30%, threatening the brand's market dominance.
- Market share for biosimilars could reach 40% within three years post-approval.
- Revenue projections indicate a potential 40% decline in revenue from 2022 to 2025 due to price compression and market share shifts.
Frequently Asked Questions
1. When are biosimilars for denosumab expected to enter the market?
Biosimilar applications are under review or have been approved in multiple regions, with US approvals possibly occurring between 2023 and 2024.
2. How will biosimilar entry affect overall drug pricing?
Biosimilars typically reduce prices by 15–30%, increasing market competition and decreasing revenue for the branded product.
3. What is the primary driver of demand for denosumab?
The aging population and increased diagnosis of osteoporosis. Physicians are switching from bisphosphonates to monoclonal antibodies for high-risk patients.
4. Are there any regulatory barriers to biosimilar approval for denosumab?
Yes, biosimilar approval requires demonstration of similarity in efficacy, safety, and immunogenicity. Regulatory timelines vary, but no major barriers are currently expected.
5. How does payer policy influence the price of denosumab?
Payers favor biosimilars to reduce costs, which can lead to preferential reimbursement of cheaper biosimilar options and pressure on brand pricing.
References
- Evaluate Pharma. (2023). Osteoporosis Market Analysis.
- U.S. Food and Drug Administration. (2022). Biologics License Application Approvals.
- IQVIA. (2022). U.S. Prescription Drug Market Trends.
- IMS Health. (2022). Biosimilar Adoption and Pricing Trends.
- Grand View Research. (2022). Osteoporosis Therapeutics Market Size, Share & Trends.
