Market Dynamics and Financial Trajectory for Indium In-111 Pentetate Disodium
Overview of Indium In-111 Pentetate Disodium
Indium In-111 Pentetate Disodium, commonly known as Indium DTPA In 111, is a radioactive diagnostic agent used primarily in radionuclide cisternography. This drug is indicated for studying the flow of cerebrospinal fluid (CSF) in the brain, diagnosing abnormalities in CSF circulation, assessing and localizing CSF leakage, and testing the patency of or localizing blocks in CSF shunts[3][4].
Market Approval and Regulation
Indium In-111 Pentetate Disodium was first approved in the United States on February 18, 1982. It is marketed by GE Healthcare Ltd. (United Kingdom) and distributed by various subsidiaries, including GE Healthcare Canada Inc. and Medi-Physics, Inc. in the U.S.[2][4].
Clinical Use and Indications
The drug is administered intrathecally and is available as a sterile, pyrogen-free, isotonic aqueous solution. It is used to visualize the brain and spinal column through gamma camera imaging, leveraging the decay of In-111 by electron capture[3][4].
Market Demand
The demand for Indium In-111 Pentetate Disodium is driven by the need for accurate diagnostic tools in neurology and neurosurgery. Conditions such as hydrocephalus, CSF leaks, and blockages in CSF shunts require precise imaging, making this drug a valuable asset in clinical practice.
Competitive Landscape
The market for radioactive diagnostic agents is niche but competitive. Indium In-111 Pentetate Disodium competes with other radionuclide-based imaging agents, although its specific indications and long-standing approval give it a strong market position. GE Healthcare's dominance in the diagnostic imaging sector also contributes to the drug's market stability[2].
Pricing and Revenue
The pricing of Indium In-111 Pentetate Disodium is influenced by several factors, including production costs, regulatory approvals, and market demand. Given its specialized use and the high cost of radionuclide production, the drug is typically priced at a premium. Revenue is generated through sales to hospitals and diagnostic centers, with pricing varying by region and market conditions.
Financial Performance
The financial performance of Indium In-111 Pentetate Disodium is tied to the broader financial health of GE Healthcare and the demand for diagnostic imaging services. As a well-established product, it contributes steadily to GE Healthcare's revenue stream. However, specific financial figures for this product are not publicly disclosed, as they are often bundled within the company's overall financial reports.
R&D and Innovation
GE Healthcare continues to invest in research and development to enhance diagnostic imaging technologies. While Indium In-111 Pentetate Disodium itself is an approved product, ongoing R&D in related areas such as new radionuclides and imaging techniques can impact its market position and future revenue potential[2].
Regulatory Environment
The regulatory environment for radioactive diagnostic agents is stringent due to safety and efficacy concerns. Indium In-111 Pentetate Disodium must comply with strict guidelines set by regulatory bodies such as the FDA and Health Canada. Compliance with these regulations ensures the drug's continued market presence but also presents ongoing costs and challenges[1][4].
Safety and Adverse Reactions
The safety profile of Indium In-111 Pentetate Disodium includes rare but serious adverse reactions such as aseptic meningitis, pyrogenic reactions, and skin reactions. These risks are managed through careful dosing and administration protocols. The drug's safety profile is closely monitored by regulatory agencies, and any significant changes could impact market dynamics[4].
Geriatric Use and Special Populations
The drug's use in elderly patients requires careful consideration due to potential renal function impairment. This demographic factor can influence prescribing practices and may affect market demand to some extent[4].
Supply Chain and Distribution
Indium In-111 Pentetate Disodium is supplied in single-dose glass vials, each containing 1.5 mL of solution, packaged in individual lead shields with plastic outer containers. The distribution network is managed by GE Healthcare and its subsidiaries, ensuring timely and secure delivery to healthcare facilities[4].
Future Outlook
The future outlook for Indium In-111 Pentetate Disodium is stable, driven by its established clinical use and the ongoing need for precise diagnostic imaging in neurology. Advances in imaging technologies and potential new indications could further enhance its market position.
Key Takeaways
- Established Market Presence: Indium In-111 Pentetate Disodium has been approved and marketed for over four decades.
- Specialized Use: It is used specifically for radionuclide cisternography to study CSF flow and diagnose related abnormalities.
- Competitive Landscape: The market is niche but competitive, with GE Healthcare holding a strong position.
- Financial Stability: The drug contributes steadily to GE Healthcare's revenue, though specific figures are not publicly disclosed.
- Regulatory Compliance: Strict regulatory guidelines must be adhered to, ensuring safety and efficacy.
- Safety Profile: Rare but serious adverse reactions are managed through careful administration protocols.
FAQs
Q: What is the primary use of Indium In-111 Pentetate Disodium?
A: The primary use is for radionuclide cisternography to study the flow of cerebrospinal fluid (CSF) in the brain and diagnose related abnormalities.
Q: Who is the primary manufacturer and distributor of Indium In-111 Pentetate Disodium?
A: The primary manufacturer and distributor is GE Healthcare Ltd. (United Kingdom) and its subsidiaries.
Q: What are the potential adverse reactions associated with Indium In-111 Pentetate Disodium?
A: Potential adverse reactions include aseptic meningitis, pyrogenic reactions, skin reactions, and vomiting, although these are rare.
Q: How is Indium In-111 Pentetate Disodium administered?
A: It is administered intrathecally as a sterile, pyrogen-free, isotonic aqueous solution.
Q: What is the regulatory status of Indium In-111 Pentetate Disodium?
A: It was first approved in the U.S. on February 18, 1982, and is currently marketed with ongoing regulatory compliance.
Sources
- Drug and Health Products Portal: Details for: INDIUM DTPA IN 111[1]
- Patsnap: Indium In-111 Pentetate Disodium - Drug Targets, Indications, Patents[2]
- Inxight Drugs: INDIUM IN-111 PENTETATE DISODIUM[3]
- DailyMed: INDIUM DTPA IN 111- indium in-111 pentetate disodium solution[4]
- DailyMed: In-111 DTPA (In-111 Pentetate Disodium)[5]
