Last updated: March 13, 2026
What is NDC 68180-0463?
NDC 68180-0463 corresponds to Hyaluronate Sodium/Chondroitin Sulfate (brand name: Euflexxa), a viscosupplement used to treat osteoarthritis of the knee. It is a biologic injectable, designed to supplement synovial fluid and improve joint function.
Market Overview
Market Size and Demand
The global osteoarthritis therapeutics market was valued at approximately $6.5 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 4.5% through 2030 [1].
Key Drivers
- Increasing prevalence of osteoarthritis, particularly among aging populations.
- Preference for minimally invasive procedures like intra-articular injections.
- Rising adoption of viscosupplements over oral NSAIDs, due to fewer systemic side effects.
Market Penetration
Euflexxa's market share has been growing within the viscosupplement segment, amid competition from products like Hyalgan, Synvisc, and Supartz. Its use is supported by its physician preference and insurance coverage policies favoring viscosupplementation.
Geographic Markets
- United States: Largest market, with an estimated 30% of global sales.
- Europe: Expanding market, slower adoption due to regulatory hurdles.
- Asia-Pacific: Emerging market with high growth potential; increasing diagnosis and treatment rates.
Competitive Landscape
| Product Name |
Manufacturer |
Approval Year |
Key Features |
Price Point (per injection) |
Market Share (US, estim.) |
| Euflexxa |
Fidia Pharma |
2010 |
Biological, natural hyaluronate |
$600 - $700 |
35% |
| Hyalgan |
Fidia Pharma |
1994 |
Bovine hyaluronate |
$500 - $600 |
25% |
| Synvisc |
Genzyme (Sanofi) |
2009 |
Cross-linked hyaluronate |
$700 - $800 |
20% |
| Supartz |
Otsuka |
1997 |
Hyaluronate from rooster combs |
$400 - $500 |
10% |
Price Projections
Current Pricing
- Average price per injection: $600 - $700 in the US.
- Total treatment course: 3-5 injections, total cost of $1,800 - $3,500.
Short-Term Projections (2023-2025)
- Prices are expected to remain stable or slightly decline due to payer pressure and increased competition.
- Anticipated stabilization at $550 - $700 per injection, with slight discounts for bundled packages.
- Launch of biosimilar versions could pressure prices downward by 5-10%.
Long-Term Outlook (2026-2030)
- As new formulations and delivery methods enter the market, prices may decline 10-15%.
- Adoption of biosimilars could result in price reductions of up to 20% by 2030.
- Market growth driven by broader acceptance and expanding indications may offset price declines, maintaining revenue stability.
Price Sensitivity Factors
- Regulatory approvals influencing reimbursement.
- Manufacturer branding and provider preferences.
- Insurance coverage policies and payer negotiations.
- Introduction of biosimilars or alternative technologies.
Regulatory and Reimbursement Environment
- In the US, Euflexxa has FDA approval via 510(k), benefiting from clear regulatory pathways.
- Medicare and private insurers cover viscosupplementation, typically reimbursing between $600 - $750 per injection.
- Reimbursement policies influence provider prescribing behaviors and product pricing strategies.
Key Takeaways
- The osteoarthritis viscosupplement market is growing steadily, with Euflexxa currently holding approximately 35% of U.S. market share.
- Prices per injection are stable but face downward pressure from biosimilar competition and payer negotiations.
- Short-term prices are projected to stay within $550 - $700, with potential declines of up to 20% through 2030 due to biosimilars.
- Market expansion in Asia-Pacific and Europe offers opportunities but is tempered by regulatory challenges.
FAQs
-
What factors influence Euflexxa’s price stability?
Regulatory approval, insurance coverage, brand loyalty, and provider preferences.
-
How might biosimilar competition impact prices?
Biosimilars could reduce prices by 10-20%, prompting brand-price adjustments to maintain market share.
-
What is the typical treatment course for Euflexxa?
Three to five injections over several weeks, with total costs ranging from $1,800 to $3,500.
-
Are new formulations expected to change the market?
Yes; innovations such as long-acting formulations may influence future pricing and adoption.
-
What is the growth outlook for viscosupplementation?
The market is expected to grow at a CAGR of 4.5% through 2030, driven by aging populations and preference for minimally invasive treatments.
References
[1] Grand View Research. (2023). Osteoarthritis Therapeutics Market Size, Share & Trends Analysis.
