Last updated: February 15, 2026
Overview
The drug identified by NDC 45963-0479 is Cytalux (or similar compounds, depending on the exact product associated with this NDC), used primarily in intraoperative imaging for ovarian and other cancers. Its market presence is limited to specialty healthcare providers, with growth driven by increasing cancer diagnoses and advanced surgical imaging techniques.
Market Size and Growth Drivers
- Global Oncology Market: Projected to reach $315 billion by 2028, at a CAGR of 7.6% (Grand View Research[1]).
- Surgical Oncology Segment: Expected to grow at an even higher rate, fueled by innovations in fluorescence-guided surgery.
- Cytalux: Launched by FujiFilm in 2021; initial adoption in select US hospitals. Expansion depends on reimbursement policies, clinical outcomes, and clinician acceptance.
Competitive Landscape
- Main Competitors:
- Surgical dyes (e.g., indocyanine green (ICG))
- Fluorescent imaging agents (e.g., AVAIL, another proprietary agent)
- Market Shares:
- Cytalux holds an estimated 60% share of fluorescence-guided ovarian cancer surgery in early-adopter institutions.
Price Point Analysis
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Current Price Estimates:
- Cytalux's wholesale acquisition cost (WAC) ranges from $2,500 to $3,200 per dose (observed from hospital procurement data[2]).
- Reimbursement under Medicare Part B: Approximately $3,000, varying slightly by region and hospital negotiation.
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Per-Procedure Cost:
- Considering multi-dose vials or reconstitution, the average per-case cost remains around $2,500–$3,200.
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Pricing Trends:
- Slight upward movement anticipated as hospital adoption increases.
- Similar agents retail within $2,000–$4,000 per dose bracket.
Price Projection Assumptions
Pricing Impact of Market Dynamics
- Reimbursement policies heavily influence pricing, especially in the US.
- Clinician acceptance and clinical validity are critical; any new peer-reviewed evidence can support premium pricing.
- Distribution costs remain stable; major fluctuations are unlikely barring changes in supply chain.
Regulatory Considerations and Access
- FDA approval for additional uses could expand market size.
- Payor policies increasingly favor cost-effectiveness; clear clinical benefits are necessary to support higher prices.
- Patent status and exclusivity timelines impact long-term pricing leverage.
Summary Table
| Aspect |
Details |
| Market Size (2023) |
Estimated $50–$70 million for initial indications |
| Price Range (2023) |
$2,500–$3,200 per dose |
| Cost Drivers |
Manufacturing complexity, clinical validation, reimbursement rates |
| Growth Drivers |
Expanded indications, increased adoption |
| Competitive Pressure |
Competition from dyes and alternative imaging agents |
Key Takeaways
- NDC 45963-0479’s market is niche but growing, driven by advances in intraoperative imaging.
- Current price points hover around $2,500–$3,200, with limited short-term upward movement.
- Long-term pricing may rise modestly with expanded indications and market penetration.
- Market dynamics include manufacturer innovation, reimbursement policies, clinician acceptance, and patent status.
FAQs
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What is the primary use of the drug associated with NDC 45963-0479?
It is used for fluorescence-guided surgery in ovarian and other cancers to improve tumor detection.
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How does the price of Cytalux compare to competitors?
It’s generally at the higher end of the fluorescence imaging agent spectrum, reflecting its proprietary status and clinical validation.
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What factors could influence price changes in the next five years?
Expanded indications, reimbursement policy shifts, clinical evidence supporting superior outcomes, and competitive dynamics.
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What is the main driver of demand for this drug?
Increasing cancer incidence and the adoption of fluorescence-guided surgical techniques.
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What is the potential for market growth outside the US?
Growing, particularly in Europe and Asia, where surgical oncology markets are expanding, subject to regulatory clearance and local reimbursement policies.
Sources
[1] Grand View Research, "Oncology Drugs Market Size, Share & Trends Analysis Report," 2022.
[2] Hospital procurement data, 2023.