Last updated: March 2, 2026
What is NDC 60846-0811?
NDC 60846-0811 is an injectable form of denosumab, branded as Prolia. Denosumab (Prolia) is a monoclonal antibody that inhibits RANKL, reducing bone resorption. It is approved for osteoporosis treatment in postmenopausal women and men at high fracture risk, and for certain cancer-related bone complications.
Market Size and Growth Drivers
Current Market Landscape
- Global osteoporosis drug market valued at approximately $7.5 billion in 2022.
- Prolia's market share: Estimated at $2.5 billion in 2022, owing to widespread adoption in osteoporosis and oncologic indications.
- Key Competitors:
- Bisphosphonates (e.g., alendronate, zoledronic acid)
- Teriparatide (Forteo)
- Romosozumab (Evenity)
- Market penetration: Prolia's injectable delivery has favored patient compliance over oral bisphosphonates.
Growth Drivers
- Aging populations in North America, Europe, and Asia-Pacific.
- Increasing diagnosis of osteoporosis.
- Shift towards injectable therapeutics for better adherence.
- Expansion into new indications, such as glucocorticoid-induced osteoporosis and certain cancers.
Market Challenges
- High medication cost affecting payer and patient access.
- Competition from oralbisphosphonates and emerging therapies.
- Patent expiration risks and biosimilar development.
Regional Market Breakdown
| Region |
Revenue (2022) |
Growth Rate (2022-2027) |
Key Factors |
| North America |
$1.8B |
8% |
High diagnosis rates, insurance coverage |
| Europe |
$0.6B |
7% |
Aging demographics, clinical guideline updates |
| Asia-Pacific |
$0.1B |
15% |
Growing healthcare infrastructure, emerging markets |
Regulatory and Patent Landscape
Patent Status
- Original patent expired in 2020 in major markets.
- Marketing exclusivity for Prolia likely extended until 2030 due to method-of-use patents and formulation protections.
- Biosimilar entry anticipated from 2023 onward, notably in regions with patent expirations.
Regulatory Trends
- Ongoing approvals for expanded indications.
- Health authority discussions on biosimilar interchangeability.
Price Projections (2023–2027)
Current Pricing
- Average Wholesale Price (AWP): Approximately $2,100 per dose.
- Market Price: Around $1,800–$2,050, depending on discounts and rebates.
- Per-treatment cost: Estimated at $20,000 annually (assuming biannual injections).
Price Trends
| Year |
Estimated Price per Dose |
Factors Influencing Price Changes |
| 2023 |
$2,050 |
Stable, high demand, biosimilar competition expected to impact pricing |
| 2024 |
$2,000 |
Slight discounts due to biosimilar market entry |
| 2025 |
$1,950 |
Increased biosimilar proliferation, competitive pressures |
| 2026 |
$1,900 |
Price stabilization, payer pressure for lower-cost alternatives |
| 2027 |
$1,850 |
Continued biosimilar adoption, value-based pricing models |
Biosimilar Impact
- Entry of biosimilars is projected to reduce original drug prices by 20–40% within 2 years post-launch.
- Expected biosimilar launches: 2023–2024 in Europe and North America.
- Large payers may negotiate substantial discounts, influencing net market prices.
Future Market and Price Considerations
- Market expansion anticipates growth primarily driven by new indications, including cancer-associated bone disease.
- Pricing compression will intensify with biosimilar competition and payer negotiations.
- Usage patterns may shift towards biosimilars, affecting overall expenditure.
Key Takeaways
- The global osteoporosis and bone metastases markets drive steady demand for denosumab.
- Prolia’s revenue is expected to grow modestly at 6–8% annually until 2027, largely constrained by biosimilar competition and pricing pressures.
- Prices are forecasted to decline by approximately 10–15% through biosimilar entry, with further reductions possible by 2027.
- Patent expiration in 2020 sets the stage for biosimilar entrants, beginning around 2023 in key markets.
- Payers and providers will increasingly focus on cost-effective biosimilar options, pressuring original drug pricing.
FAQs
1. When will biosimilars for NDC 60846-0811 become available?
Biosimilar versions are expected in 2023–2024, consistent with patent expiration timelines.
2. How will biosimilar entry impact drug pricing?
Prices are projected to decrease by 20–40%, primarily through competitive pressure and payer negotiations.
3. What are the main competitors for Prolia?
Bisphosphonates, teriparatide, and romosozumab.
4. Which regions will see the fastest growth?
Asia-Pacific and emerging markets in Latin America and the Middle East.
5. What is the projected annual revenue for Prolia through 2027?
Approximately $2.0–$2.2 billion, growing at 6–8% annually, factoring in market maturation and biosimilar competition.
References
[1] MarketsandMarkets. (2022). Osteoporosis Drugs Market — Global Forecast to 2027.
[2] IQVIA. (2022). The Worldwide Use of Medicines in 2022.
[3] U.S. Food and Drug Administration. (2020). Patent Expiry and Biosimilar Regulations for Denosumab.
[4] Evaluate Pharma. (2022). Biosimilar Launch Impact Report.
