Introduction to Ultravist 370
Ultravist 370, an iodine-based contrast agent developed by Bayer, is widely used in various radiological procedures to enhance the visibility of internal body structures. Here, we will delve into the clinical trials, market analysis, and future projections for this versatile medical product.
Clinical Trials and Efficacy
Diagnostic Efficacy
In double-blind clinical trials, Ultravist 370 has demonstrated diagnostic efficacy comparable to other nonionic and ionic radiographic contrast agents. These trials included evaluations in excretory urography, renal arteriography, cerebral arteriography, peripheral arteriography, and coronary arteriography, among others[4].
Specific Trial Outcomes
- Coronary Arteriography and Left Ventriculography: Clinical trials involving Ultravist 370 mgI/mL showed excellent visualization ratings in patients with altered coronary artery perfusion and ventricular function. The results were comparable to those of iohexol and iopamidol[5].
- Peripheral Venography: Trials evaluating Ultravist 240 mgI/mL in patients with venous disorders reported good or excellent visualization ratings in 99% of the patients, similar to the outcomes with iohexol and iopamidol[5].
Safety Profile
While Ultravist 370 has shown strong diagnostic efficacy, it is not without potential risks. It is contraindicated in patients with known hypersensitivity to the drug or manifest hyperthyroidism. Special caution is advised in patients with cyanotic and acyanotic heart disease, congestive heart failure, or elevated serum creatinine levels[4].
Market Analysis
Global Usage and Approval
Ultravist 370 is approved for use in over 100 countries and is applied more than 18 million times annually. It has recently received approval for use in contrast-enhanced mammography (CEM) in the European Union, expanding its portfolio in breast imaging[2].
Export and Trade Data
According to Volza's global export data, Ultravist 370 exports have shown a growth rate of 4% from March 2023 to February 2024 compared to the preceding year. Germany leads the world in Ultravist exports, followed by India and Turkey. Key importers include Argentina, India, and Colombia[3].
Revenue and Sales
Bayer's radiology products, including Ultravist, generated €1.8 billion in sales in 2021. The approval for CEM and other indications is expected to further boost sales and market presence[2].
Market Projections
Emerging Modalities
The approval for contrast-enhanced mammography (CEM) is a significant milestone, as CEM is an emerging modality that combines digital mammography with contrast agents to enhance breast cancer diagnosis and treatment planning. This expansion is likely to increase the demand for Ultravist 370 in the coming years[2].
Global Market Growth
Given the widespread use and continuous expansion of indications, Ultravist 370 is projected to maintain its strong market position. The global contrast agents market is expected to grow, driven by advancements in imaging technologies and increasing diagnostic needs.
Competitive Landscape
Ultravist 370 competes with other iodine-based contrast agents such as iohexol and iopamidol. However, its broad range of approved indications and recent expansion into CEM position it favorably in the market.
Regulatory and Approval Updates
Recent Approvals
The recent approval for CEM in the EU through the European Workshare Procedure is a significant regulatory update. This approval is expected to lead to national approvals in the EU in the first quarter of 2023, further solidifying Ultravist 370's presence in the European market[2].
Pharmacokinetics and Safety Considerations
Distribution and Elimination
Ultravist 370 is characterized by a steady-state volume of distribution of 16 L and minimal plasma protein binding (1%). It is primarily excreted through the renal route (97%), with only 2% excreted via the fecal route[1][4].
Special Populations
Special caution is advised when administering Ultravist 370 to children, especially those with asthma, cyanotic and acyanotic heart disease, or immature renal function. In elderly patients and those with severe cutaneous reactions, careful consideration is necessary[1][4].
Key Takeaways
- Clinical Efficacy: Ultravist 370 has demonstrated strong diagnostic efficacy in various radiological procedures.
- Market Presence: It is widely used globally, with recent approvals expanding its indications.
- Safety Profile: While effective, it requires careful administration, especially in special populations.
- Market Projections: Expected to grow with the increasing demand for advanced imaging modalities like CEM.
- Regulatory Updates: Recent EU approval for CEM is a significant milestone.
FAQs
What is Ultravist 370 used for?
Ultravist 370 is an iodine-based contrast agent used in various radiological procedures, including CT scans, angiography, excretory urography, and recently approved for contrast-enhanced mammography (CEM).
What are the contraindications for Ultravist 370?
Ultravist 370 is contraindicated in patients with known hypersensitivity to the drug or manifest hyperthyroidism. It should not be used in myelography, cerebral ventriculography, or cisternography.
How is Ultravist 370 excreted from the body?
Ultravist 370 is primarily excreted through the renal route (97%), with only 2% excreted via the fecal route.
What are the recent market developments for Ultravist 370?
Ultravist 370 has recently been approved for use in contrast-enhanced mammography (CEM) in the European Union, expanding its portfolio in breast imaging.
Who are the major exporters of Ultravist 370?
Germany leads the world in Ultravist exports, followed by India and Turkey.
What is the projected market growth for Ultravist 370?
The market for Ultravist 370 is expected to grow, driven by the increasing demand for advanced imaging modalities and the recent approval for CEM.
Sources
- ULTRAVIST 370 Prescription & Dosage Information - MPR
https://www.empr.com/drug/ultravist-370/
- Ultravist™ by Bayer now approved for contrast-enhanced mammography in EU
https://www.bayer.com/media/en-us/ultravist-by-bayer-now-approved-for-contrast-enhanced-mammography-in-eu/
- Ultravist Exports from World - Volza.com
https://www.volza.com/p/ultravist/export/
- ULTRAVIST - Product Monograph
https://pdf.hres.ca/dpd_pm/00054785.PDF
- ULTRAVIST - accessdata.fda.gov
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020220s027lbl.pdf
Last updated: 2025-01-07
