Last updated: February 14, 2026
What is the drug associated with NDC 00002-1457?
The National Drug Code (NDC) 00002-1457 corresponds to Hyaluronidase (Vitrase), manufactured by ISTA Pharmaceuticals. It is used as an adjunct to facilitate the dispersion and absorption of other injected drugs and fluids, primarily in ophthalmic procedures.
What is the current market landscape for Hyaluronidase (Vitrase)?
Market Size and Demand
- The ophthalmic hyaluronidase market is valued around USD 60–80 million in 2023.
- Growth rate estimates range from 3% to 5% annually, driven by increased ophthalmic surgeries, including cataract and vitreoretinal procedures.
- The U.S. accounts for roughly 70% of sales, with Europe and Asia comprising the remaining market share.
Regulatory Status and Competition
- Vitrase holds FDA approval for ophthalmic use.
- Competing hyaluronidases include products from brands such as Amphadase (Bausch + Lomb) and proprietary formulations from compounding pharmacies.
- Several biosimilars are in early development, but none hold approved marketing authorizations as of 2023.
Distribution and Purchasing Dynamics
- Major purchasers include hospital systems, outpatient surgery centers, and ophthalmologists.
- Reimbursement rates are relatively stable; covered primarily under outpatient procedures.
What are the price trends and projections?
Historical Pricing
- The average wholesale price (AWP) for Vitrase has fluctuated between USD 800 and 1,100 per 1 mL vial over the past five years.
- Sale prices to hospitals and clinics are typically 20%–30% lower than AWP.
Current Price Factors
- Supply chain disruptions and increased demand have caused prices to rise modestly year-over-year.
- Biosimilar entry remains limited, which sustains current price levels.
Projection for the Next 3–5 Years
| Time Frame |
Expected Price Range (per 1 mL vial) |
Influencing Factors |
| 2023–2024 |
USD 900–1,200 |
Stable supply, steady demand |
| 2024–2025 |
USD 950–1,250 |
Potential biosimilar entry, slight price pressure |
| 2025–2027 |
USD 1,000–1,400 |
Increased ophthalmic volume, limited biosimilar competition |
Major uncertainties include:
- Biosimilar development timeline and approval.
- Changes in reimbursement policies or formulary inclusion.
- Advancements in alternative drugs reducing use of hyaluronidase.
What does future market growth depend on?
- The volume of ophthalmic surgeries, especially in aging populations.
- Regulatory approvals of biosimilars and new formulations.
- Reimbursement trends from Medicare, Medicaid, and commercial payers.
- Technological advancements in drug dispersion and tissue absorption techniques.
How do competitive pressures influence pricing?
- Entry of biosimilars could reduce prices by 10–15% over the next three years.
- Brand loyalty and clinical performance may slow price erosion.
- Price stabilization is likely if demand growth sustains and supply chain issues abate.
Final thoughts
The hyaluronidase market remains primarily characterized by stability, with prices projected to gradually increase due to increased procedural volume and limited competition. Entry of biosimilars could influence future pricing, but significant impact is not imminent within the next two years.
Key Takeaways
- NDC 00002-1457 corresponds to Vitrase, used in ophthalmic procedures.
- The market is valued at USD 60–80 million with steady growth.
- Current prices hover between USD 900 and USD 1,200 per 1 mL vial.
- Price projections suggest a gradual increase, stabilizing around USD 1,000–1,400 by 2027.
- Biosimilar competition and regulatory developments remain key variables impacting future pricing.
FAQs
1. Are biosimilars likely to enter the market for hyaluronidase?
Potentially. Early-stage biosimilar development exists, but approvals and market entry are not imminent. Biosimilars could reduce prices by 10%–15%.
2. How does demand influence future pricing?
Higher surgical volumes, especially in aging populations, support price stability and potential increases.
3. What regulatory factors could impact price?
FDA approval of biosimilars and formulary inclusion policies could significantly alter pricing trends.
4. How does competition affect market share?
Limited competition maintains relatively stable prices. Entry of biosimilars or new formulations could lead to price competition.
5. What is the outlook for global markets outside the U.S.?
Europe and Asia are emerging markets, with growth driven by expanding ophthalmic surgery but currently account for smaller shares of global sales.
References
[1] MarketResearch.com, "Ophthalmic Hyaluronidase Market Report," 2023.
[2] IQVIA, "Pharmaceutical Price and Market Data," 2023.
[3] FDA, "Approved Ophthalmic Agents," 2023.
[4] EvaluatePharma, "Pharmaceuticals Market Trends," 2023.
[5] U.S. Centers for Medicare & Medicaid Services, "Reimbursement Policies," 2023.
