Last updated: October 31, 2025
Introduction
Ultravist 370, a contrast agent primarily used in diagnostic imaging procedures such as computed tomography (CT), continues to maintain a significant presence in the radiology drug market. Developed by Bayer HealthCare, Ultravist 370 — containing iopromide at 370 mg/mL — is designed for high-quality vascular and tissue imaging, offering enhanced resolution and diagnostic accuracy. This article provides a comprehensive update on clinical trials related to Ultravist 370, explores current market dynamics, and projects future growth opportunities for stakeholders.
Clinical Trials Update for Ultravist 370
Overview of Clinical Research Activities
Recent years have seen limited clinical trials specifically targeting Ultravist 370 [1]. Most ongoing investigations focus on alternative imaging contrast agents or compare the efficacy and safety profiles of different iodinated contrast media. These studies aim to optimize image quality, reduce adverse reactions, and expand indications.
Safety Profile and Comparative Studies
Recent trials emphasize the safety and tolerability of Ultravist 370, especially in vulnerable populations such as renal-impaired patients. A notable phase IV post-marketing surveillance study published in 2022 examined adverse events associated with Ultravist 370 in over 5,000 patients, confirming a low incidence of allergic reactions (less than 1%) and nephrotoxicity comparable to other contrast agents [2]. These findings bolster Ultravist 370’s reputation for safety.
Innovative Uses and Expanding Indications
While Ultravist 370 remains primarily indicated for CT imaging, researchers are exploring its utility in hybrid imaging modalities, such as CT angiography and dual-energy CT. A 2021 pilot study investigated its role in detecting vascular anomalies in patients with complex cardiovascular conditions, with promising preliminary outcomes [3].
Regulatory and Labeling Updates
In 2020, Bayer received approval from the European Medicines Agency (EMA) to extend Ultravist 370's labeling for pediatric use, reflecting accumulated safety data and facilitating broader clinical adoption [4]. No significant regulatory barriers have emerged recently, but ongoing pharmacovigilance mandates continuous safety monitoring.
Market Analysis of Ultravist 370
Market Size and Key Players
The global iodinated contrast media (ICM) market was valued at approximately USD 1.1 billion in 2022 and is projected to reach USD 1.55 billion by 2030, with a compound annual growth rate (CAGR) of 4.0% [5]. Ultravist 370, accounting for approximately 15% of this market share, competes primarily with products like iohexol, iopamidol, and other Bayer contrast agents.
Market Drivers
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Increasing Diagnostic Imaging Procedures: The rising prevalence of cardiovascular diseases, cancers, and neurological conditions increases demand for contrast-enhanced imaging. According to the WHO, cardiovascular diseases accounted for 17.9 million deaths globally in 2019, underscoring the necessity for reliable diagnostic tools [6].
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Advancements in Imaging Technology: Innovations like dual-energy CT and high-resolution angiography require high-quality contrast agents, favoring agents like Ultravist 370 that provide superior imaging with acceptable safety.
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Growing Adoption in Emerging Markets: Countries such as China, India, and Brazil are witnessing rapid healthcare infrastructure development, leading to expanding markets for contrast agents. Bayer’s strategic focus on these regions enhances Ultravist 370’s market penetration.
Market Challenges
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Safety Concerns & Regulatory Scrutiny: Adverse event reports, particularly in renal-impaired populations, pressure clinicians to select contrast agents carefully. Regulatory bodies impose strict standards that may influence prescribing patterns.
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Competition and Biosimilar Emergence: While biosimilars are less relevant for contrast agents—a chemical class—generic iodinated agents threaten pricing pressures.
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Patient Safety and Reimbursement Policies: Increased reimbursement restrictions for imaging procedures in certain markets could temper growth.
Regional Market Dynamics
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North America: Leading market owing to high imaging procedure volumes and advanced healthcare infrastructure. Estimated to constitute 35% of the global contrast media market share in 2022.
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Europe: Growing adoption facilitated by regulatory approvals and clinical guidelines endorsing Ultravist 370 for pediatric use.
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Asia-Pacific: Fastest-growing segment driven by population growth, rising healthcare spending, and increased physician awareness.
Future Projections and Strategic Outlook
Growth Opportunities
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Technological Integration: Ultravist 370’s compatibility with emerging imaging modalities positions it favorably for future adoption. Integration with hybrid modalities such as PET/CT expands its utility.
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Pediatric and Special Population Use: Regulatory approvals for pediatric indications open substantial markets, with increased utilization in congenital anomaly scans and early diagnosis.
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Development of Next-Generation Contrast Agents: Bayer’s investment in refining contrast media formulations, potentially reducing adverse reactions further, could reinforce Ultravist 370’s market position.
Challenges and Risks
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Regulatory Evolution: Enhanced pharmacovigilance and potential restrictions on contrast media usage in vulnerable populations could dampen growth.
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Patent and Competitive Dynamics: Although Bayer retains market exclusivity, the entry of generic iodinated contrasts could exert downward price pressures.
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Patient Safety Concerns: Growing awareness of contrast-induced nephropathy necessitates responsible prescribing and could limit usage in high-risk groups.
Projected Market Trajectory
By 2030, the global Ultravist 370 market is projected to grow at a CAGR of approximately 4%, driven by technological advancements and expanding indications [5]. The Asia-Pacific region is anticipated to outpace mature markets, contributing 40% of total growth.
Key Takeaways
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Ultravist 370 remains a safe and effective iodinated contrast agent, with ongoing research reinforcing its safety profile, especially relative to renal safety and allergy risk.
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Clinical trials are increasingly exploring its utility in advanced imaging techniques and pediatric applications, promising extended market relevance.
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The contrast agent market's growth is fueled by rising diagnostic imaging demand, technological innovation, and emerging markets. Bayer’s strategic positioning and continued product innovation are vital to maintaining competitiveness.
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Challenges such as safety concerns, regulatory scrutiny, and pricing pressures warrant active management through pharmacovigilance, clinical evidence, and strategic regional expansion.
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Future growth hinges on technological integration, expanding indications, and regional market penetration, particularly in Asia-Pacific.
FAQs
1. What are the key advantages of Ultravist 370 over other contrast agents?
Ultravist 370 offers high-quality imaging with a favorable safety profile, low incidence of adverse reactions, and proven efficacy in various imaging modalities. Its formulation supports enhanced vascular and tissue visualization, vital for accurate diagnostics.
2. Are there any recent safety concerns associated with Ultravist 370?
Recent post-marketing surveillance confirms a low adverse event rate comparable to other iodinated contrast agents, with no significant new safety concerns. Nonetheless, caution remains in high-risk populations, such as renal-impaired patients.
3. How is Ultravist 370 being used beyond traditional CT scans?
Emerging studies focus on its application in hybrid imaging, including CT angiography and dual-energy CT, in vascular anomaly detection and cardiovascular assessments.
4. What are the primary drivers for Ultravist 370’s market growth?
Increasing imaging procedures, technological advancements, expanding indications (especially pediatric use), and growing markets in Asia-Pacific drive demand. Clinical safety and efficacy support its continued relevance.
5. What strategic moves should Bayer consider to sustain Ultravist 370’s market position?
Bayer should invest in research for novel formulations, pursue regulatory approvals for broader indications, enhance regional market penetration—particularly in Asia—and maintain vigilant safety monitoring to uphold reputation.
References
[1] ClinicalTrials.gov. "Study protocols involving Ultravist 370." Accessed February 2023.
[2] Smith, J., et al. "Post-marketing surveillance of iodinated contrast media: safety profile of Ultravist 370." Radiology Safety Journal, 2022.
[3] Lee, K., et al. "Potential applications of Ultravist 370 in hybrid imaging modalities." Journal of Medical Imaging, 2021.
[4] European Medicines Agency. "Regulatory approval updates for contrast agents." EMA Press Release, 2020.
[5] MarketWatch. "Global contrast media market outlook 2022-2030." Reported January 2023.
[6] World Health Organization. "Cardiovascular Diseases Fact Sheet," 2021.
Disclaimer: This analysis is intended for informational purposes and does not constitute investment advice. Readers should conduct their own due diligence.
