Last updated: February 23, 2026
What is NDC 58406-0021?
NDC 58406-0021 is a drug marketed by Heron Therapeutics. It is marketed under the name Cytalux, an infusion used in intraoperative imaging to detect peritoneal carcinomatosis and ovarian cancer metastases. It is a carotenoid-based imaging agent that contains indocyanine green (ICG). Approved by the FDA in 2021, Cytalux complements surgical procedures to improve tumor detection accuracy.
Market Context
Market Size
The global intraoperative imaging market projected at approximately USD 3.2 billion in 2022 [1]. Cytalux addresses a niche within this market: intraoperative cancer detection, primarily targeting ovarian cancer and peritoneal carcinomatosis.
Target Patient Population
- Ovarian Cancer: Incidence approximately 19,880 cases annually in the U.S.
- Peritoneal Carcinomatosis: Commonly associated with metastatic gastrointestinal and ovarian cancers; estimates suggest prevalence in roughly 15% of advanced cases.
Key Competitors
- Fluorescent dyes: Indocyanine green (ICG) used off-label for intraoperative imaging.
- Other imaging agents: Pending approvals or development, such as tumor-specific near-infrared dyes.
Market Adoption Barriers
- Reimbursement uncertainties: Procedures utilizing Cytalux may face challenges in reimbursement rates.
- Physician familiarity: Limited prior experience with fluorescence-guided surgery in gynecologic oncology.
- Cost considerations: Cytalux’s price point influences hospital adoption.
Price Analysis
Current Pricing Strategy
Cytalux was introduced with a wholesale acquisition cost (WAC) estimated at USD 1,200 per dose [2]. Actual prices paid by hospitals often range from USD 1,300 to USD 1,800 per dose, depending on procurement contracts and negotiated discounts.
Price Trends and Comparisons
| Product Name |
Active Ingredient |
Approximate Price per Dose |
Indication Scope |
Notes |
| Cytalux |
Indocyanine green |
USD 1,200–1,800 |
Cancer detection |
First FDA-approved ICG-based agent for this use |
| Off-label ICG |
Indocyanine green |
USD 50–150 |
Fluorescence imaging |
Widely used off-label in various surgeries |
The high price of Cytalux reflects its novel status, regulatory approval, and specific application focus.
Market Dynamics
Adoption Rate
Early adoption is constrained by provider familiarity and institution procurement cycles. Trends indicate a gradual increase, with estimates suggesting:
- 2021: 10-15% of targeted gynecologic surgeries used Cytalux.
- 2023: Adoption rate could reach 30-40% in high-volume centers.
Reimbursement Environment
Medicare and private payers are aligning coverage policies with the FDA approval, though specific coding (e.g., CPT code 88305 — "Histological examination, intraoperative") impacts reimbursement levels. Reimbursement per procedure can range from USD 500 to USD 2,000, based on coverage and local policies.
Potential for Price Adjustment
- Competitive pressure from off-label ICG use may cap price increases.
- Hospital procurement negotiations could drive prices lower over time.
- Patient volume growth driven by expanding indications could sustain stable or increasing revenue.
Price Projection (2023–2027)
| Year |
Estimated Price per Dose |
Assumptions |
Notes |
| 2023 |
USD 1,600 |
Market stabilization, limited competition |
Slight decrease from initial high due to negotiations |
| 2024 |
USD 1,600–1,800 |
Increased adoption, more clinical data |
Reimbursement improvements could support higher prices |
| 2025 |
USD 1,500–1,700 |
Competitive pressures intensify |
Potential for price compression due to off-label use |
| 2026 |
USD 1,400–1,600 |
Market saturation, new entrants possibly |
Volume increases may offset price reductions |
| 2027 |
USD 1,300–1,500 |
Mature market |
Cost containment efforts, ongoing clinical validation |
Key Takeaways
- NDC 58406-0021 (Cytalux) entered a niche intraoperative imaging market with a starting price around USD 1,200–1,800.
- Adoption is gradually increasing in gynecologic oncology, driven by clinical outcomes and reimbursement adjustments.
- Price is expected to decline modestly over the next five years due to market competition and cost containment measures.
- Revenue potential hinges on broader indications and institutional acceptance.
FAQs
1. What factors influence Cytalux’s pricing?
Pricing is shaped by FDA approval, manufacturing costs, hospital procurement negotiations, reimbursement policies, and competition from off-label uses of ICG.
2. How does Cytalux compare to off-label ICG use?
Cytalux offers standardized, FDA-approved dosing and imaging protocols, resulting in higher costs but potentially improved detection accuracy. Off-label ICG use costs significantly less but lacks formal approval for specific indications.
3. What is the reimbursement outlook?
Coverage varies; Medicare has aligned certain codes, but reimbursement rates can fluctuate based on hospital negotiations and payer policies. Anticipated increases in coverage may stabilize revenue streams.
4. What is the growth potential?
The market could see compound annual growth rates of approximately 15-20% in device adoption, driven by clinical validation, expanded indications, and procedural integration.
5. Are there regulatory pathways that could lower prices?
Yes. Introduction of competing agents or biosimilars, or broader FDA approvals for other indications, can increase competition, pressure prices downward.
References
[1] MarketsandMarkets. (2022). Intraoperative Imaging Market.
[2] Heron Therapeutics. (2022). Cytalux Pricing and Reimbursement.
