Last updated: August 6, 2025
Introduction
ISOVUE-250 (iodine-based contrast agent) is a high-concentration agent used primarily in radiology for vascular and tissue imaging. As a critical component in diagnostic imaging, its supply chain stability is vital to healthcare providers and pharmaceutical distributors. Understanding the landscape of suppliers for ISOVUE-250 provides insights into market dynamics, manufacturing capabilities, and potential procurement risks. This report offers a comprehensive overview of the key suppliers, their manufacturing capacity, regulatory standing, and market strategies.
Market Overview of ISOVUE-250 Suppliers
ISOVUE-250 is a product of Bracco Diagnostics Inc., a leading global pharmaceutical company specializing in contrast agents. Its primary production facility is based in Italy, with distribution channels worldwide. The supply chain involves various stakeholders, including raw material suppliers, manufacturing firms, and distribution networks to healthcare providers globally.
Bracco Diagnostics Inc.
Bracco is the sole manufacturer of ISOVUE-250, holding exclusive rights to produce and distribute the contrast agent. The company's manufacturing plant in Italy, complemented by regional distribution centers, ensures widespread availability. Bracco maintains rigorous quality control and compliance with international standards such as FDA and EMA approvals.
Raw Material Suppliers
The key raw material in ISOVUE-250 production is iodine, a critical component of contrast agents. The supply chain for pharmaceutical-grade iodine includes several suppliers globally, with major players in the USA, China, and South Korea. High purity and stable supply are vital to prevent production disruptions.
Notable iodine raw material suppliers include:
- Yunnan Yuntianhua Co., Ltd. (China): A leading producer of pharmaceutical-grade iodine.
- Iofina PLC (UK): Manufactures iodine from brine sources, supplying global markets.
- U.S. Iodine (USA): A prominent domestic producer, contributing significantly to the supply chain.
The availability and pricing of iodine directly impact ISOVUE-250 manufacturing volume.
Manufacturing and Distribution Partners
While Bracco remains the exclusive producer of ISOVUE-250, it collaborates with regional distribution partners to ensure availability. In regions like North America, Europe, and Asia-Pacific, local distributors facilitate timely delivery to healthcare facilities.
Key distribution partnerships include:
- Indivior (North America)
- Alfa Wassim Pharmaceuticals (Middle East and Africa)
- Polpharma (Eastern Europe)
Bracco’s global footprint and strategic partnerships play a significant role in mitigating regional supply disruptions.
Regulatory and Market Considerations
The pharmaceutical supply chain for ISOVUE-250 is heavily regulated. The product holds approvals from agencies such as the FDA (USA), EMA (Europe), and other national health authorities. Regulatory compliance ensures quality but also adds complexity to manufacturing and distribution processes.
Recent market trends show increasing demand driven by rising diagnostic imaging procedures globally, particularly in emerging markets. However, supply constraints may arise due to raw material shortages or manufacturing bottlenecks.
Emerging Suppliers and Market Risks
Given the concentration of raw material sources and manufacturing facilities, the market faces certain risks:
- Raw Material Concentration Risks: Dependence on iodine suppliers from limited regions heightens vulnerability to geopolitical issues, natural disasters, and supply disruptions.
- Regulatory Risks: Changes in international standards could impact manufacturing operations.
- Patent and Exclusivity: Bracco holds exclusive rights to ISOVUE-250, limiting competition but also creating dependency on a single supplier.
Potential emerging suppliers, especially in China and India, are entering the market for generic iodine contrast agents. However, these are typically generic versions rather than exact substitutes of ISOVUE-250.
Key Considerations for Procurement
- Supply Chain Diversification: Relying solely on Bracco increases risk; exploring alternative contrast agents and suppliers can mitigate disruptions.
- Raw Material Monitoring: Establishing relationships with iodine suppliers and monitoring geopolitical and environmental factors influencing iodine availability.
- Regulatory Vigilance: Keeping abreast of regulatory changes ensures compliance and uninterrupted supply.
Conclusion
Bracco Diagnostics remains the exclusive supplier of ISOVUE-250, supported by a global network of regional distributors and a robust manufacturing footprint. The supply chain's vulnerability to raw material sourcing, regulatory shifts, and regional disruptions emphasizes the importance of strategic procurement planning.
Healthcare providers and distributors must maintain active supplier monitoring, diversify alternatives, and stay attuned to raw material market dynamics to ensure consistent availability of ISOVUE-250.
Key Takeaways
- Primary Supplier: Bracco Diagnostics Inc. holds exclusive manufacturing rights for ISOVUE-250.
- Raw Material Dependence: Global iodine supply from limited regional sources, primarily China and the USA, influences production stability.
- Supply Chain Risks: Raw material shortages, geopolitical factors, and regulatory changes can threaten consistent supply.
- Market Trends: Growing demand for diagnostic imaging increases pressure on manufacturing and supply channels.
- Procurement Strategy: Diversification, monitoring raw material markets, and regulatory compliance are vital for supply security.
FAQs
1. Who is the primary supplier of ISOVUE-250?
Bracco Diagnostics Inc. is the exclusive manufacturer and supplier of ISOVUE-250 globally.
2. What raw materials are essential for ISOVUE-250 production?
The key raw material is pharmaceutical-grade iodine, sourced primarily from suppliers in China, the UK, and the USA.
3. Are there any alternative contrast agents to ISOVUE-250?
Yes. Several other iodine-based contrast agents, such as GE Healthcare's Omnipaque and Bayer's Ultravist, serve as alternatives, though they are not interchangeable on a one-to-one basis.
4. What risks threaten the supply of ISOVUE-250?
Risks include raw material shortages, geopolitical tensions affecting iodine supply, regulatory changes, and manufacturing disruptions.
5. How can healthcare providers mitigate supply chain risks for contrast agents like ISOVUE-250?
By diversifying suppliers, maintaining safety stock, monitoring raw material markets, and considering alternative contrast agents where appropriate.
Sources:
[1] Bracco Diagnostics Inc. Official Website, "ISOVUE-250 Product Details".
[2] Iodine Raw Material Market Reports, Global Industry Analysts.
[3] U.S. Iodine LLC. Market Overview.
[4] Regulatory approvals and standards databases (FDA, EMA).
[5] Industry Analysis Reports on Contrast Agents Market.
