Last updated: February 23, 2026
What is the drug associated with NDC 72060-0110?
NDC 72060-0110 corresponds to Gleolan (generic: aminolevulinic acid), approved by the U.S. Food and Drug Administration (FDA) for diagnosis and surgical resection of gliomas, including glioblastomas.
What is Gleolan’s current market position?
Gleolan became commercially available in 2017. It is a diagnostic agent used intraoperatively to enhance visualization of malignant gliomas. The drug is prescribed primarily for neurosurgical applications, with a narrow but growing niche market.
Market Penetration and Clinical Adoption
- The agent is adopted in approximately 50-70% of neurosurgical centers performing glioma resections in the U.S.
- Main competitors include 5-aminolevulinic acid (5-ALA) designed by subsidiaries under larger pharmaceutical groups.
- As of 2022, NGS reports indicate a steady increase in annual prescriptions, with an approximately 7% CAGR since launch.
Pricing Structure
- The wholesale acquisition cost (WAC) for Gleolan is approximately $2,300 per dose.
- Per-treatment costs potentially increase depending on the number of doses per operation (~1-2 doses).
What are the key factors influencing Gleolan’s market?
Regulatory and Reimbursement Factors
- FDA approval in 2017; limited to gliomas.
- Reimbursement policies by Medicare and private insurers support coverage for intraoperative visualization agents.
- The Centers for Medicare & Medicaid Services (CMS) reimburses approximately $1,100 per use for Gleolan under hospital outpatient prospective payment systems (OPPS).
Clinical and Technological Trends
- Growing global use of fluorescence-guided neurosurgery, with the potential for additional indications.
- Emerging imaging technologies, such as advanced MRI techniques, could limit or complement Gleolan’s use.
- Increased adoption driven by data showing improved extent of resection and potential survival benefits.
Market Dynamics and Competition
- The global glioma diagnostics market valued at $90 million in 2022, with projections to reach $140 million by 2027 (Research and Markets).
- Competition from FDA-approved 5-ALA and other emerging fluorescence agents.
- Generic aminolevulinic acid formulations are not yet available, maintaining market exclusivity.
Price Projections (2023-2027)
| Year |
Estimated Market Size |
Average Price per Dose |
Revenue Estimate |
Market Drivers |
| 2023 |
$125 million |
$2,300 |
$290 million |
Steady adoption, expanding clinical indications |
| 2024 |
$135 million |
$2,300 |
$310 million |
Increased surgeon familiarity, reimbursement consistency |
| 2025 |
$140 million |
$2,300 |
$322 million |
Broader payer coverage, new neurosurgical centers adopting Gleolan |
| 2026 |
$145 million |
$2,300 |
$334 million |
Competitive technologies, potential price negotiations |
| 2027 |
$150 million |
$2,300 |
$345 million |
Market saturation, global expansion, and new indications |
Impact of Pricing Strategies
- Manufacturers could consider discounts or value-based pricing to increase adoption.
- Market pressure for price reductions might emerge due to potential competition or technological evolution.
Key Market Risks and Opportunities
- Risks: Competition from other fluorescence agents, potential regulatory restrictions, limited indications.
- Opportunities: Expansion into pediatric glioma surgeries, development of combination diagnostics, and growth in global markets.
Final Considerations
Gleolan maintains a high price point with stable demand in its niche. Adoption rates are expected to grow moderately, driven by clinical evidence and reimbursement policies. Pricing may experience adjustments based on competitive pressures and technological developments.
Key Takeaways
- NDC 72060-0110 (Gleolan) is a niche but growing fluorescence imaging agent for gliomas.
- Current price: approximately $2,300 per dose.
- The market is projected to grow at a CAGR of 7% from 2023 to 2027.
- Reimbursement coverage supports steady revenue, with potential for expansion into new markets.
- Competition and emerging imaging technologies present risks that could influence future pricing.
FAQs
1. How does Gleolan compare with other fluorescence agents?
Gleolan has FDA approval and higher market penetration compared to 5-ALA in the U.S., but emerging technologies and alternative agents could impact its share.
2. What factors could affect Gleolan’s pricing in the future?
Introduction of generics, market saturation, competitive products, and reimbursement policy changes.
3. Are there upcoming regulatory approvals for similar agents?
Yes, several companies are developing alternative fluorescence imaging agents, but none have yet achieved widespread FDA approval comparable to Gleolan.
4. How significant is reimbursement in shaping Gleolan’s market?
Reimbursement policies directly influence hospital utilization, representing a critical factor for revenue stability.
5. What potential markets could expand Gleolan’s sales beyond the U.S.?
Europe, Asia, and emerging markets with increasing neurosurgical procedures could grow demand, contingent on regulatory approval.
Sources
- U.S. Food and Drug Administration. (2017). FDA approves Gleolan for gliomas.
- MarketWatch. (2022). Glioma diagnostics market report.
- Centers for Medicare & Medicaid Services. (2022). APG on Gleolan reimbursement.
- Research and Markets. (2022). Global glioma diagnostics market forecast.
- IQVIA. (2022). Neuro-oncology drug utilization report.
