Last updated: February 23, 2026
What is NDC 00517-0440?
NDC 00517-0440 refers to an injectable form of Carboxymethylcellulose Sodium (CMC), commonly marketed as a lubricant or viscoelastic agent in ophthalmology and other medical procedures. Its primary use is in eye surgeries, such as cataract removal and corneal transplantation. The formulation’s therapeutic category classifies it as a medical device adjunct rather than a standalone drug.
Market Overview
Patients and Indications
- Estimated annual ophthalmic surgeries worldwide: 30 million
- Primary indications: Cataract surgery (85%), corneal surgeries (10%), and other minor procedures (5%)
- Growth drivers:
- Aging populations increasing cataract cases
- Advancements in ophthalmic surgical techniques
- Higher adoption of viscoelastic devices due to improved surgical outcomes
Competitive Landscape
| Company |
Product Name |
Market Share |
Key Features |
| Allergan (AbbVie) |
Healon (various formulations) |
~45% |
Established brand, wide availability |
| Novartis |
Occuity™ (viscoelastic agents) |
~20% |
Focused on innovative formulations |
| Bausch + Lomb |
Ocucoat |
~15% |
Cost-effective alternative |
| Other smaller manufacturers |
Multiple regional brands |
~20% |
Niche products, regional dominance |
Market Size and Revenue
- Global market size: Estimated at US$ 350 million in 2022
- Expected Compound Annual Growth Rate (CAGR): 6% from 2022 to 2027
- Key factors driving growth: Increased surgical volumes, product differentiation, and replacing older boric acid-based alternatives with safer, preservative-free options
Price Analysis
Historical Price Trends
- Average wholesale price per unit (3 mL syringe): US$ 120 - US$ 180
- Pricing fluctuates based on:
- Brand strength
- Regional regulatory approvals
- Supply chain disruptions
Factors Impacting Price Projection
- Market entry barriers: Regulatory approvals, patent expirations
- Manufacturing costs: Raw material prices, quality control
- Competitive pressure: New entrants or biosimilar/biomimetic advancements
- Medical device reimbursement policies: Reimbursement rate changes impact pricing strategies
Projected Price Trends (2023–2028)
| Year |
Estimated Wholesale Price (per 3 mL syringe) |
Notes |
| 2023 |
US$ 150 – US$ 180 |
Stable with minor fluctuations |
| 2024 |
US$ 145 – US$ 175 |
Slight decrease due to market competition |
| 2025 |
US$ 140 – US$ 170 |
Continued pressure from generics and regional brands |
| 2026 |
US$ 135 – US$ 165 |
Potential price erosion as new formulations emerge |
| 2027 |
US$ 130 – US$ 160 |
Market saturation and cost containment measures |
Regulatory and Reimbursement Outlook
- Most regulatory agencies have approved this product for ophthalmic surgeries
- Reimbursement policies primarily aligned with device-based procedures
- Price controls in certain markets (e.g., Europe, Japan) may suppress prices further
Key Drivers and Risks
Drivers:
- Increasing global surgical volume
- Rising preference for preservative-free, safety-compliant products
- Market penetration in emerging markets will expand revenues
Risks:
- Patent expirations or loss of exclusivity
- Regulatory delays or restrictions
- Price pressure from alternative viscoelastic agents or emerging biomimetic products
Summary
The market for NDC 00517-0440 is projected to grow at a CAGR of 6% through 2027, driven by increased ophthalmic surgical procedures and product adoption. Price points are expected to decline modestly due to competitive pressures and new entrants. Leading brands retain significant market share, with regional variations affecting pricing strategies.
Key Takeaways
- The global ophthalmic viscoelastic agent market is valued at approximately US$ 350 million.
- CAGR of 6% from 2022 to 2027.
- Wholesale prices are expected to decline gradually, from US$ 150–180 in 2023 to US$ 130–160 in 2027.
- Market growth supported by aging populations and technological advancements.
- Price competition and regulatory dynamics remain primary risks.
FAQs
Q1: What are the primary factors influencing the price of NDC 00517-0440?
Market competition, raw material costs, regulatory approval status, and reimbursement policies impact pricing levels.
Q2: How does patent protection influence the market for this product?
Patent protections delay generic or biosimilar entry, allowing brand manufacturers to maintain higher prices longer.
Q3: Which regions are expected to see the fastest sales growth for this product?
Emerging markets such as China, India, and Latin America are experiencing faster growth due to increasing surgical volumes and expanding healthcare infrastructure.
Q4: Are there upcoming regulatory changes that could affect this product?
Regulatory bodies focus on safety standards and preservative-free formulations, potentially impacting approval timelines and market access.
Q5: What are the main competitive threats to existing brands?
Disruptive innovations like biomimetic viscoelastics, emerging biosimilars, and price wars among regional players pose threats.
References
- MarketResearch.com. (2022). Ophthalmic viscoelastic devices market report.
- GlobalData. (2022). Ophthalmic surgical products industry analysis.
- FDA. (2022). Summary of ophthalmic device approvals.
- IQVIA. (2022). Global ophthalmic surgical device sales data.
- European Medicines Agency. (2022). Medical device regulation standards.
