Last updated: February 16, 2026
Overview
NDC 00591-2805 corresponds to Thyrogen (thyrotropin alfa), a recombinant form of human thyroid-stimulating hormone used primarily for diagnostic purposes in thyroid cancer management. It is manufactured by Fresenius Kabi and approved by the FDA.
Market Size and Trends
The primary end-use involves patients with differentiated thyroid carcinoma undergoing radioactive iodine therapy or diagnostic testing. The market is influenced by the following factors:
- An estimated 62,000 new thyroid cancer cases annually in the U.S. (CDC, 2022).
- Thyrogen is an alternative to thyroid hormone withdrawal, leading to increased use due to reduced patient discomfort.
- Healthcare provider adoption has increased, driven by improved patient outcomes and convenience.
Competitive Landscape
Thyrogen competes mainly with traditional hormone withdrawal protocols and other diagnostic agents like recombinant human TSH (Thyrotropin Alfa), with no direct biosimilar competition yet. The key competitors are:
- Thyrogen (Fresenius Kabi)
- Off-label use of recombinant TSH agents in contrast with traditional methods
Pricing Overview
The wholesale acquisition cost (WAC) for Thyrogen in 2023 has been approximately $3,600 to $4,200 per 0.9 mg dose (typical single-use vial). Price variations depend on payer negotiations, pharmacy markup, and regional factors.
Historical Price Trends
- Since FDA approval in 2002, prices have been relatively stable with minor increases.
- No significant price erosion observed; limited biosimilar introduction constrains downward pressure.
- Reimbursement policies and hospital procurement practices influence final prices.
Market Drivers
- Expanding indications for post-treatment diagnostic testing.
- Increasing thyroid cancer diagnosis rates.
- Shift toward outpatient administration, reducing overall costs.
- Insurance coverage favors non-hormonal methods due to patient comfort and shorter recovery times.
Pricing Projections (Next 3-5 Years)
| Year |
Estimated Average Price per Dose |
Key Assumptions |
| 2023 |
$3,600 |
Stable with minimal competition |
| 2024 |
$3,700 |
Slight inflation, steady demand |
| 2025 |
$3,800 |
Possible new payer agreements, no biosimilar case |
| 2026 |
$3,850 |
Continued stable pricing, potential off-label growth |
Potential Price Pressures
- Entry of biosimilars is unlikely within the next 3–5 years due to high development costs and FDA biosimilar pathway complexity.
- Changes in reimbursement policies could modestly influence net prices.
- Increased adoption of alternative diagnostic protocols could reduce demand growth, exerting downward pressure.
Regulatory and Policy Impact
- FDA's guidance on biosimilar approval could alter the competitive landscape post-2024.
- CMS reimbursement adjustments, especially under the Hospital Outpatient Prospective Payment System (OPPS), influence hospital procurement strategies.
Key Market Challenges
- Limited pipeline for biosimilar entrants.
- Potential shifts in clinical guidelines promoting alternative approaches.
- Cost-effectiveness debates concerning recombinant vs. traditional methods.
Summary
The Thyrogen NDC 00591-2805 market remains relatively stable with pricing in the $3,600–$4,200 range per dose. Market growth aligns with rising thyroid cancer diagnoses and evolving diagnostic standards, but limited biosimilar activity constrains downward price pressure. Demand is driven by clinical preference for non-hormonal methods, with minor price inflation expected over the forecast horizon.
Key Takeaways
- The primary value of NDC 00591-2805 lies in its convenience and safety profile, reinforcing stable demand.
- Prices are expected to stay within current levels unless significant biosimilar competition emerges.
- The market remains susceptible to regulatory policy changes and shifts in clinical practice guidelines.
- Market expansion hinges on increasing thyroid cancer incidence and adoption of recombinant TSH over traditional protocols.
- The absence of biosimilars in the near term supports limited pricing fluctuations.
FAQs
1. What factors influence the price of Thyrogen (NDC 00591-2805)?
The price depends on manufacturing costs, payer negotiations, hospital procurement strategies, and the absence of biosimilar competition.
2. Will biosimilars reduce the price of Thyrogen?
Potentially after biosimilar approval, prices could decline due to increased competition. Currently, no biosimilars for Thyrogen are approved or in late-stage development.
3. How does demand for Thyrogen compare to traditional thyroid testing methods?
Demand has increased due to patient comfort and reduced recovery time. It is replacing hormone withdrawal protocols in many practices.
4. What are key regions influencing market sales besides the U.S.?
Europe and select Asia-Pacific countries show rising adoption. Regional pricing varies depending on healthcare policies.
5. Could new indications influence future pricing or demand?
Yes, expanding use in other diagnostic or therapeutic areas could increase demand, potentially affecting pricing strategies.
References
- Centers for Disease Control and Prevention (CDC). Thyroid Cancer Statistics. 2022.
- FDA. Approval details for Thyrogen. 2002.
- IQVIA. Market data on Thyrogen pricing and utilization. 2023.
