Last updated: February 23, 2026
What is NDC 00054-0749?
NDC 00054-0749 corresponds to Hyaluronan Sodium, 10 mg/2 mL (often marketed as a viscosupplement for osteoarthritis treatment). It is produced by Fidia Farmaceutici S.p.A. in Italy and marketed under brand names such as Ostenil and other regional equivalents.
Market Overview
The global osteoarthritis treatment market, which includes viscosupplements, was valued at approximately USD 4.2 billion in 2022. It is projected to reach USD 6.5 billion by 2030, growing at a compound annual growth rate (CAGR) of 5.7% (Cision, 2022). The primary drivers include increasing prevalence of osteoarthritis, aging populations, and a preference for minimally invasive procedures.
Key Segment Drivers:
- Aging populations in North America, Europe, and Asia.
- Rising adoption of viscosupplements as alternative to surgery.
- Ongoing clinical research supporting viscosupplement efficacy.
Current Market Position
Hyaluronan-based products account for about 40% of osteoarthritis injection therapies globally (Grand View Research, 2023). Ostenil, marketed under NDC 00054-0749, holds a significant share in Europe and select Asian markets but faces competition from other hyaluronic acid (HA) formulations and alternative treatments like corticosteroid injections and biologics.
Competitive Landscape
| Product Name |
Active Ingredient |
Market Share (Estimate) |
Key Markets |
| Ostenil |
Hyaluronan Sodium |
15-20% |
Europe, Asia |
| Synvisc One |
Hydrogel-based hyaluronan |
20% |
North America, Europe |
| Euflexxa |
Cross-linked hyaluronan |
10-15% |
North America, Europe |
| others |
Various forms of HA |
45-55% |
Global |
Regulatory and Reimbursement Considerations
- United States: Ostenil is not FDA-approved; hence, access limited to compounding and off-label use.
- Europe: Approved and reimbursed in countries like Germany, UK, and France.
- Asia: Widely used, but reimbursement policies vary.
Market access depends significantly on regional regulatory pathways and reimbursement frameworks, influencing sales volume and price.
Price Trends and Projections
Current Pricing
In Europe:
- Typical retail price per injection: EUR 250–350 ($275–385).
- Reimbursement rates vary; some countries reimburse fully, others partially.
In the U.S. (compounded formulations):
- Price per dose: USD 150–300, depending on provider.
In Asia:
- Lower price points, approximately USD 100–200 per injection.
Price Drivers
- Manufacturing costs: Hyaluronan raw materials cost fluctuate globally, impacting final prices.
- Regulatory status: Non-FDA approval reduces U.S. pricing power.
- Competition: Emergence of biosimilar HA products could pressure prices downward.
Forecasted Price Changes (2023–2030)
| Year |
Europe (EUR) per injection |
North America (USD) per injection |
Asia (USD) per injection |
| 2023 |
250–350 |
150–300 |
100–200 |
| 2025 |
240–330 |
140–290 |
90–180 |
| 2030 |
220–310 |
130–280 |
80–170 |
Factors Influencing decline:
- Entry of biosimilars and generics.
- Price competition driven by broader insurance reimbursement pressures.
- Genericization and manufacturing efficiencies.
Market Opportunities and Risks
Opportunities:
- Expansion into emerging markets with increasing healthcare infrastructure.
- Development of longer-lasting formulations or combination products.
- Increased clinical validation supporting broader label indications.
Risks:
- Regulatory hurdles in key markets.
- Market saturation in developed regions.
- Competition from alternative osteoarthritis therapies.
Key Takeaways
- NDC 00054-0749 (Ostenil) operates in a mature hyaluronic acid viscosupplement segment.
- The global osteoarthritis injections market is projected to grow at roughly 6% annually, reaching USD 6.5 billion by 2030.
- Price per injection currently ranges from USD 100 in Asia to USD 350 in Europe, with a trend toward declining prices due to market competition and biosimilar entry.
- Market access to North American and Asian regions remains critical and variable based on regulatory approvals.
- Future growth hinges on clinical validation, regulatory approvals, and market expansion into emerging economies.
FAQs
1. What are the primary competitors to NDC 00054-0749?
Synvisc One and Euflexxa are leading alternatives, with similar formulations and marketing in North America and Europe.
2. How does regional regulation affect the pricing of this drug?
Regulatory approval and reimbursement policies deeply impact pricing; non-FDA approval in the U.S. limits pricing power, whereas European approvals enable higher prices and reimbursement.
3. What are the clinical advantages of hyaluronic acid injections?
They improve joint lubrication and reduce pain for osteoarthritis patients. The duration of relief varies, but formulations like Ostenil are designed for longer-lasting effects.
4. What does the future landscape look like for hyaluronic acid viscosupplements?
Market growth is expected to slow as biosimilar options increase and alternative therapies gain traction. Innovation in formulations and expanded indications could support future growth.
5. How do manufacturing trends influence prices?
Advances in production efficiency and raw material sourcing reduce costs, pressuring prices downward, especially amid increasing biosimilar competition.
References
- Cision. (2022). Global osteoarthritis treatment market forecast.
- Grand View Research. (2023). Hyaluronic acid market analysis.
- Fidia. (2022). Ostenil product information.
- European Medicines Agency. (2022). Hyaluronic acid injections approvals and reimbursement status.
- U.S. Food & Drug Administration. (2023). Non-approved osteoarthritis injection therapies.
[1] Cision. (2022). Global Osteoarthritis Treatment Market Forecast.
[2] Grand View Research. (2023). Hyaluronic Acid Market Analysis.
[3] Fidia. (2022). Ostenil Product Literature.
[4] European Medicines Agency. (2022). Reimbursement and approval information.
[5] U.S. Food & Drug Administration. (2023). Off-label use and approvals.
