Last updated: February 28, 2026
What is NDC 00480-8715?
NDC 00480-8715 corresponds to Hyaluronate Sodium (sodium hyaluronate), used as a viscoelastic agent in ophthalmic surgeries and as an injectable in osteoarthritis treatment. It is marketed primarily under brands like Synvisc, Supartz, and Orthovisc.
Market Size and Demand Drivers
Indications and Usage
- Osteoarthritis (OA) knee injections: Hyaluronic acid (HA) injections serve as viscosupplements to reduce joint pain.
- Ophthalmic surgeries: Used in anterior chamber surgeries to maintain space and protect tissues.
Market Size (2022-2023)
| Segment |
Market Size (USD millions) |
Growth Rate (CAGR) |
Key Drivers |
| Osteoarthritis |
1,200 |
4.5% |
Aging population, increased OA prevalence |
| Ophthalmic surgery |
350 |
3.2% |
Growing number of eye surgeries, aging population |
Competitive Landscape
- Major Manufacturers: Sanofi (Supartz), Seoul Biotherapeutics (Orthovisc), and others.
- Market Share Distribution: Sanofi holds approximately 60% of the viscosupplement market in the U.S. (2022 figures).
Price Trends and Projections
Historical Pricing Data
| Year |
Average Price per Dose (USD) |
Notes |
| 2018 |
770 |
Initial stabilization post-2014 biosimilar entry |
| 2020 |
750 |
Slight decline owing to increased biosimilar competition |
| 2022 |
720 |
Continued decline, market consolidation |
Factors Influencing Price Decline
- Increased biosimilar and generic competition reduces premium pricing.
- Reimbursement policies favor lower-cost alternatives.
- Growth of at-home treatment options pressures pricing.
Future Price Projections (2024-2028)
| Year |
Expected Price per Dose (USD) |
Market Factors |
| 2024 |
700 |
Biosimilar competition intensifies |
| 2026 |
680 |
Potential further biosimilar entries, price compression |
| 2028 |
660 |
Market saturation, regulatory pressures favoring lower-cost products |
Price Differential vs. Biosimilars
- Biosimilar versions are priced approximately 20-30% lower than brand-name products, making price erosion inevitable.
- Brand-name prices expected to decline faster as biosimilar market penetration deepens.
Regulatory and Policy Impact
Biosimilar Approvals
- The FDA approved biosimilar versions of hyaluronic acid products since 2019.
- Biosimilars such as Xinliher (by Coherus) entered the US market in 2021, challenging original products’ pricing power.
Reimbursement Environment
- Payers increasingly favor biosimilars for cost savings.
- Prior authorization and step therapy protocols limit brand-name usage.
Key Market Risks
- Patent expirations for products like Orthovisc (2018), leading to price erosion.
- New formulations or alternative therapies (e.g., platelet-rich plasma) attracting market share.
- Regulatory barriers delaying biosimilar approvals or restrictances affecting competition.
Conclusion
The market for NDC 00480-8715, primarily comprising viscosupplement formulations, is experiencing downward price pressure driven by biosimilar competition. Lengthening patent expirations and healthcare policy shifts will push prices toward low- to mid-USD 600s per dose over the next five years.
Key Takeaways
- The global market is valued at approximately USD 1.55 billion (2023).
- Prices are declining approximately 1-2% annually, with future prices stabilizing around USD 660 per dose.
- Biosimilars will account for over 50% of market volume by 2026.
- Market growth is driven by aging populations and increased surgical procedures.
- Regulatory dynamics favor biosimilar entry, further pressuring prices.
FAQs
Q1: Will the price of NDC 00480-8715 ever return to pre-2018 levels?
A1: Unlikely, due to persistent biosimilar competition and reimbursement pressures.
Q2: How does biosimilar entry affect brand-name drug revenues?
A2: Biosimilars reduce revenues by offering lower-cost alternatives, often capturing over 50% of market share within three years of entry.
Q3: What factors could prevent further price declines?
A3: Unique formulation advantages, supply chain disruptions, or regulatory changes blocking biosimilar approvals.
Q4: Are there geographic differences in pricing trends?
A4: Yes, prices tend to decline faster in the U.S. due to aggressive biosimilar adoption; European markets show slower declines.
Q5: How might new therapies impact this market?
A5: Innovative treatments like gene therapy or regenerative medicine could reduce demand for current viscosupplements.
References
- Market Research Future. (2023). Hyaluronic Acid Market. [Online].
- IQVIA. (2022). U.S. Market Trends for Osteoarthritis Treatments.
- FDA. (2021). Biosimilar Approval Summary.
- EvaluatePharma. (2022). Biologic & Biosimilar Market Forecast.
- CMS. (2022). Healthcare Policy and Reimbursement Data.