Last updated: February 28, 2026
What is NDC 00178-0615?
NDC 00178-0615 identifies a specific medication: Hyaluronic Acid (HA) injection, 1.5% (15 mg/mL), in a 2.0 mL prefilled syringe. It is marketed under the name Synvisc One by Sanofi Genzyme. This product is used primarily for osteoarthritis knee pain management.
Market Overview
Market Size and Growth
-
The global osteoarthritis (OA) treatment market was valued at approximately $6 billion in 2022, with a compounded annual growth rate (CAGR) of 4.5% from 2023 to 2028 (Grand View Research, 2023).
-
Hyaluronic acid injections account for about 25% of the OA treatment market, with a market size near $1.5 billion as of 2022.
-
The North American segment dominates with 70% market share, driven by high OA prevalence and insurance coverage.
Competitive Landscape
Major competitors include:
- Euflexxa (Ferring Pharmaceuticals)
- Orthovisc (Zimmer Biomet)
- Supartz (Sciquus)
- Gel-One (Zimmer Biomet)
Market share distribution mirrors pricing strategies and brand recognition. Synvisc One historically held about 20-25% market share but has seen market share erosion due to biosimilar entries and generics.
Regulatory Environment
-
Synvisc One holds FDA approval for intra-articular treatment of osteoarthritis knee pain.
-
Biosimilar and generic versions are increasingly approved or awaiting approval, pressuring prices.
Price Trends and Projections
Current Pricing
-
Average wholesale price (AWP) for Synvisc One per 2 mL syringe hovers around $750–$950.
-
Medicaid and commercial insurance reimbursement tends to be $600–$800, influenced by negotiated contracts.
Recent Pricing Trends
-
Over the past five years, list prices have declined by approximately 10-15% due to biosimilar competition and payer pressures.
-
Post-pandemic market dynamics emphasize cost-effectiveness, impacting price stability.
Future Price Projections (2023-2028)
| Year |
Estimated Average Wholesale Price (per syringe) |
Comment |
| 2023 |
$850 |
Stable, with slight downward pressure. |
| 2024 |
$820 |
Introduction of biosimilar options begins impacting pricing. |
| 2025 |
$790 |
Increased biosimilar market entries, further discounting. |
| 2026 |
$760 |
Competitive pressures drive prices down. |
| 2027 |
$720 |
Smaller premium products gain share. |
| 2028 |
$700 |
Expected stabilization at sub-$700 levels. |
Factors Influencing Price Movement
- Biosimilar approvals: Expected to gain market share, exert downward pressure.
- Insurance negotiations: Payers push for lower prices.
- Manufacturing costs: Technological advances may reduce costs, enabling discounts.
- Regulatory developments: Patent expirations could open markets for generics.
Market Entry and Revenue Potential
Market penetration assumptions:
-
Initial adoption rate of 10% of the total OA hyaluronic acid market (~$375 million for 2023).
-
Growth driven by increased OA prevalence, now affecting approximately 32 million Americans.
-
With improved access and insurance coverage, sales could reach $500–$700 million annually by 2028.
Pricing impact:
Key Takeaways
-
NDC 00178-0615 corresponds to Synvisc One, a leading HA injection for osteoarthritis knee pain.
-
Market size in 2022 approximates $1.5 billion, with a steady growth trajectory projected at 4.5% CAGR.
-
Pricing currently averages $850 per syringe with a downward trend expected to 2028, reaching around $700.
-
Competition from biosimilars is the main driver of pricing pressure but also expands total addressable market volume.
-
The revenue potential hinges on market penetration, insurance coverage, and biosimilar adoption rates.
FAQs
1. What factors are driving price decreases for HA injections?
Biosimilar and generic competitors, payer negotiations, and increased market volume are the primary factors.
2. How does biosimilar entry impact Synvisc One's market share?
It creates price competition and reduces market share, but also expands the overall size of the HA injection market.
3. What is the likelihood of significant price reductions by 2028?
High, given biosimilar approvals and increasing payer pressure; prices could fall below $700 per syringe.
4. Which geographic markets are most profitable for this drug?
North America dominates due to higher OA prevalence and insurance coverage, followed by Europe.
5. Will new formulations or innovations affect the market?
Yes. Longer-acting formulations or alternative delivery methods could disrupt current pricing and market dynamics.
References
[1] Grand View Research. (2023). Osteoarthritis (OA) Treatment Market Size, Share & Trends Analysis. https://www.grandviewresearch.com/industry-analysis/osteoarthritis-treatment-market
[2] IQVIA. (2023). US Prescription Drug Market Data.
[3] U.S. Food and Drug Administration (FDA). (2022). Approved Biosimilars and Interchangeable Products. https://www.fda.gov/drugs/biosimilars/biosimilar-approvals
[4] Medtrack. (2023). Hyaluronic Acid Injectables Pricing and Market Data.
