Last updated: February 13, 2026
What is NDC 00078-0911?
NDC 00078-0911 identifies a form of Denosumab (Prolia), indicated for osteoporosis treatment in postmenopausal women and osteoporosis in men at increased risk of fractures. It is marketed by Amgen Inc. The strength is 60 mg per prefilled syringe, with multiple dosing options.
Market Overview
Size and Demand
- The global osteoporosis drug market was valued at approximately USD 11 billion in 2022.
- The United States accounts for roughly 45% of the market, with an estimated USD 5 billion in sales annually.
- Demand drivers include increasing osteoporosis prevalence driven by aging populations and rising awareness.
Competitive Landscape
- Main competitors include: Fraxi (Raloxifene), Ibanda (Ibandronate), Tymlos (Abaloparatide), and Romosozumab (Evenity).
- Denosumab retains a significant market share, estimated at 40% of anti-resorptive osteoporosis drugs in the U.S., due to its efficacy and dosing schedule.
Regulatory Status
- Approved by the FDA since 2010 for osteoporosis.
- Approved across multiple countries, including the EU and Japan.
- Recent approvals for additional indications, such as bone metastases, expand potential markets.
Pricing Trends
- U.S. retail price typically ranges from USD 1,300 to USD 1,900 per dose, depending on payor contracts and discounts.
- Commercial insurance pays approximately USD 1,000 — USD 1,500 per dose after negotiated discounts.
- Medicaid and government programs pay lower rates, around USD 800 — USD 1,200.
Price Projections
Factors Influencing Price Trends
- Patent exclusivity: Expected expiry around 2030, after which biosimilar competition will exert downward pressure.
- Biosimilar entry: Anticipated biosimilar launches in the U.S. starting from 2025, potentially reducing prices by 25-40%.
- Reimbursement policies: Increasing price negotiations and cost-effectiveness assessments could constrain future prices.
- Manufacturing costs: Stable due to the complex biotech processes, but scale-up can reduce unit costs.
Forecasts (2023-2028)
| Year |
Estimated Average Price Per Dose (USD) |
Notes |
| 2023 |
USD 1,300 – USD 1,600 |
Current rates with minor declines expected as market saturates |
| 2024 |
USD 1,200 – USD 1,500 |
Increased competition from biosimilars uncertainty |
| 2025 |
USD 1,000 – USD 1,300 |
Potential entry of biosimilars in early 2025 |
| 2026 |
USD 900 – USD 1,200 |
Biosimilar market penetration accelerating |
| 2027 |
USD 800 – USD 1,100 |
Greater biosimilar adoption and negotiated discounts |
| 2028 |
USD 750 – USD 1,000 |
Further price erosion possible due to increased biosimilar availability |
Market Risks
- Biosimilar competition dropping retail prices.
- Changing reimbursement and formulary policies.
- Patent litigation delaying biosimilar market entry.
- Shifts toward alternative therapies with improved efficacy or dosing profiles.
Market Opportunities
- Expanding indication labels, such as for prevention in broader populations.
- Developing combination therapies to enhance adherence and outcomes.
- Entering emerging markets with rising osteoporosis prevalence and fewer treatment options.
Key Takeaways
- NDC 00078-0911 (Denosumab Prolia) commands high pricing in the U.S., around USD 1,300–USD 1,900 per dose.
- Market is mature, with significant competition from biosimilars expected from 2025.
- Prices are projected to decline gradually over the next five years, with reductions of approximately 30% by 2028.
- Price declines are influenced heavily by biosimilar entry, reimbursement policies, and patent expirations.
- Future growth depends on expanding indications and global market penetration.
FAQs
1. When will biosimilars for Denosumab become available?
Biosimilars are expected to launch in the U.S. around 2025, following patent expirations and regulatory approvals.
2. How much can prices drop post-biosimilar entry?
Analysts estimate a 25-40% reduction in list prices once biosimilars are available and widely adopted.
3. What is the primary market driver for Denosumab?
The increasing incidence of osteoporosis in aging populations and high treatment adherence drive demand.
4. Are there regulatory barriers affecting cost reductions?
Patent litigation and regulatory delays can postpone biosimilar market entry, impacting price trends.
5. How does US pricing compare globally?
Pricing is generally higher in the U.S., with European prices typically 20-30% lower due to different reimbursement systems and negotiations.
References
- MarketWatch. "Osteoporosis Drugs Market Size in 2022."
- EvaluatePharma. "Global Osteoporosis Market Forecast 2023–2028."
- FDA. "Denosumab (Prolia) Approval History."
- Amgen. "Prolia Product Details."
- IQVIA. "U.S. Prescription Drug Prices and Trends."
