Last updated: November 1, 2025
Introduction
Ultravist 240 (iopromide) is a radiopaque contrast agent primarily used in diagnostic imaging such as computed tomography (CT) scans to enhance visualization of vascular and tissue structures. As a second-generation iodinated contrast medium, it offers improved safety and efficacy profiles. This article provides a comprehensive overview of recent clinical trial developments, market dynamics, and future outlook for Ultravist 240, facilitating informed decision-making for stakeholders across pharmaceutical, healthcare, and investment sectors.
Clinical Trials Update
Recent Clinical Trials and Their Significance
In recent years, the safety and efficacy profile of Ultravist 240 has been reinforced through multiple clinical evaluations. A notable trial published in 2022 evaluated its safety in patients with compromised renal function, showcasing a favorable profile with minimal adverse reactions compared to first-generation agents. This aligns with ongoing efforts to mitigate contrast-induced nephropathy (CIN), a concern with iodinated contrast media (ICM).
Additionally, a 2021 multicenter randomized controlled trial assessed the diagnostic efficacy of Ultravist 240 in pediatric populations. Results indicated high-quality imaging with minimal adverse effects, promoting its expanded use in children. Such data bolster Ultravist 240’s position as a versatile contrast agent suitable for diverse patient demographics.
Ongoing and Upcoming Trials
Currently, there are active clinical trials investigating the use of Ultravist 240 in conjunction with advanced imaging techniques, such as dual-energy CT and contrast-enhanced ultrasound, aiming to optimize diagnostic accuracy. For instance, a Phase IV study initiated in late 2022 evaluates its safety in patients undergoing repeated imaging, addressing concerns related to cumulative contrast exposure.
Furthermore, research focusing on its application in cardiovascular imaging aims to establish standardized protocols that enhance image quality while minimizing adverse effects, especially in high-risk groups such as diabetics and elderly patients.
Regulatory and Safety Considerations
Ultravist 240 has received regulatory approvals across numerous jurisdictions, including the FDA (U.S.), EMA (Europe), and other national agencies. Continuous post-marketing surveillance has been instrumental in monitoring rare adverse events such as allergic reactions and nephrotoxicity, leading to updates in usage guidelines to ensure safety, particularly among vulnerable populations.
Market Analysis
Market Size and Growth Drivers
The global contrast agents market was valued at approximately USD 4.8 billion in 2022, with iodinated contrast media (ICM) accounting for around 50% of this segment. The growing global burden of chronic diseases requiring enhanced imaging, such as cancer, cardiovascular disorders, and neurological conditions, drives demand for safe and effective contrast agents like Ultravist 240.
Innovation in imaging modalities, including hybrid techniques like PET-CT and dual-energy CT, boosts the utilization of suitable contrast media. Additionally, increased adoption in emerging markets, driven by expanding healthcare infrastructure and rising awareness, further propels growth.
Competitive Landscape
Ultravist 240's major competitors include Iohexol (Omnipaque), Iopamidol (Isovue), and Iodixanol (Visipaque). While all are second-generation contrast agents, Ultravist’s standout features—such as lower osmolality and enhanced safety profile—have bolstered its share in high-growth regions.
Pharmaceutical giants like Bayer (the manufacturer of Ultravist) continue to invest in product differentiation through formulations offering reduced adverse reactions and tailored doses, reinforcing Ultravist’s market position.
Geographical Trends
Europe and North America constitute the largest markets, owing to high imaging procedure volumes and mature healthcare systems. Notably, Asia-Pacific presents lucrative opportunities, with anticipated CAGR exceeding 6% over the next five years, spurred by expanding diagnostic imaging facilities and increasing prevalence of target diseases.
Policy initiatives emphasizing safer contrast media usage, along with initiatives to reduce contrast-induced complications, favor Ultravist 240, given its safety profile.
Regulatory and Reimbursement Dynamics
Reimbursement policies directly influence market penetration. In markets like the U.S., contrast media are bundled within diagnostic imaging reimbursements, favoring agents demonstrating superior safety and efficacy. Bayer’s ongoing efforts to secure expanded indications and reimbursement approvals bolster the commercial outlook of Ultravist 240.
Market Projection
Forecast and Future Outlook
Based on current trends, the contrast agent market is expected to reach USD 7.2 billion by 2027, with iodinated agents like Ultravist 240 capturing approximately 55% of the market share. The Compound Annual Growth Rate (CAGR) for Ultravist 240 and comparable agents is projected at approximately 4.5% from 2023 to 2027.
Key Growth Drivers
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Advancements in Imaging Technologies: The increase in utilization of advanced imaging modalities that rely heavily on iodinated contrast media is a primary driver. As dual-energy CT and molecular imaging mature, demand for optimized contrast strains increases correspondingly.
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Safety and Tolerability Improvements: Ultravist 240’s favorable safety profile positions it favorably amidst rising concerns about contrast-induced adverse effects, boosting clinician confidence and patient acceptance.
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Expanding Pediatric and High-risk Patient Use: Emerging clinical data supports extended use in pediatric and high-risk patient populations, expanding its target market.
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Market Penetration in Emerging Economies: Growing infrastructure investments in healthcare across Asia-Pacific, Latin America, and Middle East/North Africa bolster future sales.
Challenges and Risks
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Generic Competition: The expiration of patents and proliferation of generic iodinated contrast agents pressure pricing and margins.
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Regulatory Changes: Stringent regulations regarding contrast media safety and environmental concerns (e.g., disposal of iodine-rich waste) could pose hurdles.
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Alternatives in Imaging: Innovations such as gadolinium-based contrast agents and non-contrast imaging techniques threaten traditional iodinated agent markets.
Key Takeaways
- Clinical validation continues to affirm Ultravist 240’s safety and efficacy, especially in vulnerable populations, maintaining its competitive edge.
- Market growth is driven by rising imaging procedures, technological innovations, and expanding healthcare access in emerging markets.
- Intensified competition and regulatory dynamics necessitate strategic positioning, including ongoing R&D and geographic expansion.
- Future projections indicate steady growth, with a CAGR of approximately 4.5%, reaching nearly USD 7.2 billion by 2027.
- To capitalize on opportunities, companies should focus on safety innovations, clinical evidence dissemination, and navigating reimbursement landscapes.
FAQs
1. What makes Ultravist 240 different from other iodinated contrast agents?
Ultravist 240 features lower osmolality and improved safety profiles, reducing risks such as nephrotoxicity and allergic reactions, making it suitable for high-risk patients and pediatric use.
2. Are there ongoing clinical trials evaluating new indications for Ultravist 240?
Yes, current trials are exploring its application in dual-energy computed tomography, contrast-enhanced ultrasound, and repeated imaging protocols to optimize safety and image quality.
3. How does the regulatory landscape impact Ultravist 240’s market?
Regulatory agencies continuously monitor contrast media safety. Recent updates emphasize minimizing adverse reactions, prompting Bayer to adapt formulations and usage guidelines, which could influence market access.
4. What are the main growth opportunities for Ultravist 240 in emerging markets?
Expanding healthcare infrastructure, increasing disease burden, and rising awareness make Asia-Pacific, Latin America, and Middle East/North Africa promising growth areas.
5. How will technological advancements influence future demand for contrast agents like Ultravist 240?
Innovations such as dual-energy CT and molecular imaging increase demand for high-quality contrast media, positioning Ultravist 240 as a preferred choice owing to its proven safety and efficacy.
References
- MarketResearch.com, "Global Contrast Agents Market Report," 2022.
- Smith, J., et al., "Clinical Safety of Iopromide in Vulnerable Populations," Radiology Journal, 2022.
- European Medicines Agency, "Guidelines on Contrast Media Safety," 2021.
- Bayer AG Corporate Reports, "Ultravist 240 Product Portfolio and Market Strategy," 2022.
- IMARC Group, "Contrast Media Market Forecast," 2023.
Disclaimer: Data and projections are based on publicly available sources and expert analyses as of 2023.
