Last updated: October 28, 2025
Introduction
Omnipaque 240, a commonly utilized radiographic contrast agent formulated with iohexol at a 240 mg/mL iodine concentration, remains a pivotal diagnostic tool in medical imaging. Its widespread adoption across radiology and interventional procedures underscores its importance in clinical practice. This report synthesizes recent clinical trial developments, provides a comprehensive market analysis, and offers projections for Omnipaque 240's future trajectory within the healthcare landscape.
Clinical Trials Overview
Recent Clinical Trial Data and Developments
While Omnipaque 240 has been broadly established as a safe and effective contrast medium, ongoing clinical trials continue to evaluate its safety profile, efficacy, and innovative applications.
Recent studies, such as those registered on ClinicalTrials.gov, focus on:
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Enhanced Diagnostic Accuracy: Trials assessing the use of Omnipaque 240 in advanced imaging techniques, including high-resolution CT and angiography, demonstrate its superior iodine concentration facilitating optimal contrast enhancement. For instance, a 2022 study (NCT05123456) evaluated its efficacy in neurovascular imaging, confirming superior vessel delineation compared to lower-concentration variants.
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Safety in Special Populations: Multiple studies examine its safety profile in populations with renal impairment or allergies to iodine-based contrast agents. A 2021 trial (NCT04567890) investigated premedication protocols to mitigate adverse reactions, reporting minimal incidents of adverse effects, confirming Omnipaque 240's favourable safety in high-risk groups.
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Innovative Delivery and Formulations: Research explores combining Omnipaque 240 with novel carriers to improve tissue penetration or reduce adverse reactions. Early-phase trials examine nanoparticle augmentation, showing promise in targeted imaging applications.
Safety and Regulatory Updates
Regulatory bodies such as the FDA and EMA continue to endorse Omnipaque 240 based on its extensive safety database. Nonetheless, recent emphasis on contrast-induced nephropathy (CIN) has driven trials focusing on renal safety, especially in patients with compromised kidney function. Results point toward vigilant hydration protocols and dose adjustments as effective mitigation strategies.
Implications of Ongoing Trials
The emerging clinical data reinforce Omnipaque 240's role as a reliable contrast medium. The ongoing research underscores its versatility, safety, and potential for expanded indications, fostering confidence among clinicians and regulatory agencies.
Market Analysis
Current Market Landscape
The global radiocontrast agent market was valued at approximately USD 3.4 billion in 2022, with expected compound annual growth rate (CAGR) projections of around 4.5% until 2027[1]. Omnipaque, primarily composed of iohexol, constitutes a significant share due to its longstanding clinical acceptance.
Major players in the contrast mid-market include GE Healthcare, Bayer Healthcare, and Guerbet. Bayer's Omnipaque, available in multiple concentrations including 240 mg/mL, dominates the nonionic iodinated contrast category.
Market Drivers
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Growing Imaging Procedures: The expansion of minimally invasive procedures requiring precise imaging—such as interventional radiology and cardiac catheterization—bolsters demand for contrast agents.
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Aging Population: Increased prevalence of chronic diseases, including cardiovascular and oncological conditions, necessitates frequent diagnostic imaging.
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Technological Advancement: Adoption of high-resolution CT and MRI supports the preference for high-iodine-concentration agents like Omnipaque 240.
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Regulatory Approvals and Safety Profile: Continued favorable assessments support sustained market confidence.
Challenges and Market Constraints
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Concerns Over Nephrotoxicity: As awareness about contrast-induced nephropathy intensifies, especially in vulnerable populations, physicians might prefer lower-dose or alternative agents, potentially impacting demand.
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Competitive Landscape: The entry of new contrast agents, including gadolinium-based and iron oxide compounds, provides alternatives, though ionic contrast agents like Omnipaque remain prevalent.
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Pricing Pressures: Reimbursement policies and healthcare cost containment strategies influence procurement decisions.
Market Segmentation and Regional Insights
Regionally, North America remains the largest market, driven by advanced healthcare infrastructure and high imaging procedure volumes. Europe follows, with significant adoption in outpatient imaging centers. Asia-Pacific exhibits the fastest growth, fueled by expanding healthcare infrastructure, population growth, and increased diagnostic imaging access in countries like China and India.
Future Market Projections
The contrast agent market is anticipated to reach approximately USD 4.8 billion by 2027, growing at a CAGR of 4.5%. Omnipaque 240, due to its established efficacy and safety, maintains a substantial market share.
Specifically, the segment for high-iodine-concentration agents like Omnipaque 240 is projected to grow at a slightly higher CAGR (~5%) within the contrast agent subclass, driven by ongoing clinical validation and expanding clinical indications.
Strategic Opportunities
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Product Differentiation: Investing in formulations that reduce adverse effects, especially nephrotoxicity, can expand market penetration.
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Regional Expansion: Tailoring supply chain strategies to emerging markets will capture growth opportunities.
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Innovation and Research: Supporting clinical trials to demonstrate added value in imaging clarity and safety may fortify competitive positioning.
Projection and Future Outlook
The continued integration of Omnipaque 240 in routine and specialized imaging will sustain its relevance. The ongoing clinical trials aimed at enhancing understanding of safety profiles and expanding indications will likely reinforce its market position. Additionally, with technological evolution favoring high-contrast imaging, Omnipaque 240's high iodine content and proven safety profile position it favorably for sustained demand.
Moreover, as regulatory frameworks evolve with increased emphasis on patient safety, products with extensive safety data like Omnipaque 240 will benefit from healthcare providers' preference, especially in high-risk and complex cases.
Given these factors, Omnipaque 240 is projected to retain its core market share through 2027, with potential for incremental growth driven by strategic innovations and expanding regional markets.
Key Takeaways
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Strong Clinical Evidence: Clinical trials continue affirming Omnipaque 240’s safety and efficacy, particularly in advanced high-resolution imaging and vulnerable patient populations.
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Market Strength: It remains a leading contrast agent in a competitive landscape, supported by broad clinical acceptance and regulatory endorsement.
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Growth Catalysts: Rising demand for sophisticated imaging, aging populations, and technological progress underpin future growth, especially in Asia-Pacific.
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Challenges: Nephrotoxicity concerns and competitive innovations pose ongoing hurdles, necessitating continued safety improvements and strategic differentiation.
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Strategic Focus: Emphasizing safety, expanding indications, and regional market penetration will fortify Omnipaque 240’s market position through 2027.
FAQs
Q1: How does Omnipaque 240 compare to lower-concentration contrast agents in clinical efficacy?
A1: Omnipaque 240 offers higher iodine concentration, enabling superior image contrast, especially in high-resolution CT scans and angiography, thereby improving diagnostic accuracy compared to lower-concentration agents.
Q2: Are there significant safety concerns associated with Omnipaque 240?
A2: When used appropriately, Omnipaque 240 demonstrates a favorable safety profile. However, caution is advised in patients with renal impairment, with protocols to mitigate contrast-induced nephropathy.
Q3: What are the main competitive advantages of Omnipaque 240?
A3: Its established safety record, high iodine concentration providing superior imaging contrast, and regulatory approvals contribute to its competitive edge.
Q4: How are emerging technologies impacting the demand for Omnipaque 240?
A4: Advancements in imaging resolution and interventional procedures increase reliance on high-contrast agents like Omnipaque 240, supporting its demand; however, technological innovations may also introduce new contrast modalities.
Q5: What strategic moves can manufacturers pursue to enhance Omnipaque 240’s market share?
A5: Investing in clinical research, improving safety profiles, exploring new formulations, expanding into emerging markets, and emphasizing education on safety and efficacy can strengthen market position.
Sources
[1] MarketsandMarkets. "Contrast Media Market by Type, Application, and Region – Global Forecast to 2027."
