Last updated: February 20, 2026
What is NDC 00093-2026?
NDC 00093-2026 corresponds to Gleolan (aminolevulinic acid hydrochloride), used primarily in photodynamic therapy for resection of malignant gliomas. Approved by the FDA in 2017, Gleolan is a specialty drug with a targeted market focus.
Market Size and Key Drivers
Current Market Scope
- Market Launch Date: June 2017 (FDA approval for glioma resection)
- Primary Indicated Use: High-grade gliomas, including glioblastoma multiforme
- United States Market Size (2022): Estimated at $80–100 million
- Global Market: Approximate $150 million, with growth in Europe and Asia-Pacific
Key Drivers
- Incidence of Malignant Gliomas: U.S. estimates report 12,000 new cases annually
- Surgical Adoption Rates: Growing use in neurosurgical centers, driven by improved tumor visualization
- Reimbursement Policies: Medicare and private insurers increasingly cover Gleolan, facilitating broader adoption
- Competitive Landscape: Limited to a few photodynamic agents; standard of care still evolving
Market Trends
| Trend |
Impact |
| Increased surgical usage |
Expanding patient pool |
| Regulatory approvals in other countries |
Boosts global market potential |
| Introduction of competing agents |
May cause price pressure in the next 2–3 years |
Pricing Overview
Current Price Points
- Average Wholesale Price (AWP): Approximately $6,500–$8,000 per dose
- Per-Procedure Cost: Estimated at $10,000–$15,000, factoring dose and administration
Pricing Comparison with Similar Drugs
| Drug |
Price Range (per dose) |
Indication |
Market Notes |
| Gliolan (5-ALA) (EU) |
€5,000–€6,500 |
Glioma surgery |
Slightly lower due to regional pricing |
| Photofrin (porfimer sodium) |
$1,200–$1,500 |
Photodynamic therapy |
Used in other cancers, more established |
Factors Influencing Price
- Manufacturing Costs: Specialty drug synthesis with high purity requirements
- Regulatory Costs: Costs associated with FDA approval and post-market commitments
- Market Exclusivity: Patent expiration not until 2025–2027, potentially affecting future prices
- Reimbursement Dynamics: Coverage limits may influence negotiated prices
Price Projections (2023–2028)
| Year |
Projected Average Price (per dose) |
Market Penetration |
Estimated Revenue (US) |
Key Assumptions |
| 2023 |
$7,500 |
70% adoption |
$100 million |
Steady adoption in key centers |
| 2024 |
$7,500 |
80% adoption |
$125 million |
Increased awareness, insurance coverage |
| 2025 |
$7,200 |
85% adoption |
$130 million |
Slight price reduction expected due to competition |
| 2026 |
$6,800 |
90% adoption |
$140 million |
Patent expiry considerations |
| 2027 |
$6,500 |
90% adoption |
$135 million |
Entry of biosimilars or generics |
Key Assumptions:
- Continued growth in neurosurgical utilization.
- No significant supply disruptions or regulatory hurdles.
- Reimbursement policies remain favorable or improve.
- Entry of competing agents remains limited during this period.
Competitive and Regulatory Outlook
Expected Competitive Dynamics
- Patent Lifecycle: Patent expires around 2025–2027; biosimilar entry possible thereafter.
- Alternative Agents: Currently, no direct biosimilar competitors for Gleolan.
- New Technologies: Advances in intraoperative imaging and other photodynamic agents may impact market share.
Regulatory Changes
- Expansion into Other Indications: Clinical trials for additional tumor types could expand market size.
- International Approvals: Regulatory approvals in the EU, Japan, and China can unlock new revenue streams.
Summary
Gleolan (NDC 00093-2026) remains a niche but growing high-margin asset in glioma surgery. Price points are projected to decline slightly post-patent expiry, while market penetration advances with increased adoption in neurosurgical centers. Competitive and regulatory factors are key drivers of future pricing and market size.
Key Takeaways
- Current US market size ranges $80–$100 million with prices averaging $7,500 per dose.
- Market growth tied to glioma incidence and surgical adoption.
- Price projections suggest a gradual decline to approximately $6,500–$7,000 per dose by 2026.
- Patent expiration around 2025–2027 could influence pricing and market share.
- Limited competition currently exists, but biosimilar entry and new therapies could impact long-term prospects.
FAQs
1. What is the main clinical advantage of Gleolan?
It improves tumor visualization during glioma resection, potentially leading to more complete surgeries.
2. How does Gleolan compare to traditional surgical methods?
It adds fluorescence-guided surgery, increasing the likelihood of complete tumor removal compared to white-light surgery alone.
3. What are the main barriers to market expansion?
Limited awareness among neurosurgeons and reimbursement challenges, especially outside the US.
4. How might patent expiry impact pricing?
Patent expiry around 2025–2027 could enable biosimilar or generic competition, leading to price reductions.
5. Are there ongoing clinical trials impacting Gleolan’s market?
Yes. Trials exploring Gleolan for other tumor types and indications could open future markets.
References
[1] U.S. Food and Drug Administration. (2017). FDA approves Gleolan for malignant gliomas.
[2] IQVIA. (2022). U.S. Pharmaceutical Market Analysis.
[3] European Medicines Agency. (2020). Summary of product characteristics: Gleolan.
[4] Generic and Biosimilar industry reports. (2022). Impact of patent expirations.
