Introduction to Gadopiclenol
Gadopiclenol, a macrocyclic gadolinium-based contrast agent (GBCA), has been making significant waves in the field of diagnostic imaging. Developed by Guerbet and further enhanced with intellectual property from Bracco, this agent has shown promising results in various clinical trials and has recently gained FDA approval.
Clinical Trials and Efficacy
PROMISE Study
The PROMISE study, a prospective, multinational, crossover, double-blind trial, compared the safety and efficacy of 0.05 mmol/kg gadopiclenol (VUEWAY) with 0.1 mmol/kg gadobutrol (Gadavist) in 273 adult patients. The study focused on patients suspected of having enhancing abnormalities in the head and neck, thorax, abdomen, pelvis, or musculoskeletal system. The results indicated that gadopiclenol was non-inferior to gadobutrol for all visualization parameters and superior to unenhanced images. This led to the FDA approval of gadopiclenol for use in MRI of the head and neck, thorax, abdomen, pelvis, and musculoskeletal system[2][4].
PICTURE Study
The PICTURE clinical trial, another pivotal study, was a within-patient, crossover, blinded comparison of the safety and efficacy of 0.05 mmol/kg gadopiclenol (VUEWAY) and 0.1 mmol/kg gadobutrol (Gadavist) in adult patients with suspected central nervous system (CNS) disease. The trial included 256 patients and demonstrated that gadopiclenol provided similar morphologic information about CNS lesions and greater contrast enhancement compared to gadobutrol, despite being administered at half the dose. The study also showed a slightly lower adverse event rate with gadopiclenol[4].
Safety Profile
Gadopiclenol has been classified as a Group II agent by the American College of Radiology, indicating it is associated with few, if any, unconfounded cases of nephrogenic systemic fibrosis (NSF), a rare but serious condition linked to some GBCAs. This classification underscores its safety profile, making it a preferable option for patients, especially those with renal impairment[2][4].
Market Analysis
Current Market Size
The global contrast media market, which includes gadopiclenol, was valued at approximately USD 6.28 billion in 2023. This market is driven by the increasing prevalence of complex comorbidities and long-term diseases, leading to a higher demand for diagnostic imaging tests such as MRI and CT scans[5].
Growth Projections
The contrast media market is expected to grow at a compound annual growth rate (CAGR) of 7.98% from 2024 to 2030, reaching an estimated USD 10.74 billion by 2030. This growth is fueled by advancements in imaging technologies, new product launches, and regulatory approvals. The approval of gadopiclenol in September 2022 is a significant contributor to this projected growth[5].
Key Applications
Gadopiclenol is used to identify lesions in various body regions, including the brain, spine, abdomen, and musculoskeletal system. Its high relaxivity and lower gadolinium dosage make it an attractive option for both adult and pediatric patients aged two years and older. The primary applications include:
- Neurological Disorders: Gadopiclenol is effective in visualizing CNS lesions and providing greater contrast enhancement compared to other GBCAs[4].
- Cardiovascular Disorders: Although less commonly mentioned, its use in cardiovascular imaging is also a potential area of application.
- Cancer: Identifying lesions with aberrant vascularity in various body regions.
- Musculoskeletal Disorders: Enhancing the visualization of musculoskeletal abnormalities[5].
Market Trends and Competitive Landscape
Market Drivers
The growing need for advanced diagnostic imaging due to increasing chronic diseases and the aging population is a significant driver for the contrast media market. The approval of new agents like gadopiclenol and other macrocyclic GBCAs, such as Pixxoscan (gadobutrol), further boosts market growth[5].
Competitive Landscape
Key players in the contrast media market are focusing on growth strategies including new product launches, regulatory approvals, expansions, collaborations, and acquisitions. Bracco Imaging, for instance, is commercializing gadopiclenol under the brand name VUEWAY, while GE HealthCare has introduced Pixxoscan, another macrocyclic GBCA, in several European markets[4][5].
Regulatory Approvals and Commercialization
Gadopiclenol received FDA approval in September 2022 for use in adults and pediatric patients aged two years and older. Following this approval, Bracco Imaging began commercializing gadopiclenol as VUEWAY injection and VUEWAY Pharmacy Bulk Package in Q1 2023[4].
Key Takeaways
- Clinical Efficacy: Gadopiclenol has demonstrated non-inferiority to gadobutrol in various body regions and superior contrast enhancement in CNS lesions.
- Safety Profile: Classified as a Group II agent, indicating a low risk of NSF.
- Market Growth: The contrast media market is expected to grow significantly, driven by the increasing demand for diagnostic imaging.
- Applications: Effective in neurological, cardiovascular, cancer, and musculoskeletal imaging.
- Regulatory Approvals: FDA-approved in September 2022, with commercialization underway.
FAQs
What is gadopiclenol used for?
Gadopiclenol is a macrocyclic GBCA used to enhance the visualization of lesions in various body regions, including the brain, spine, abdomen, and musculoskeletal system, during MRI scans.
What are the key findings of the PROMISE and PICTURE studies?
The PROMISE study showed that gadopiclenol is non-inferior to gadobutrol for all visualization parameters in body regions, while the PICTURE study demonstrated that gadopiclenol provides similar morphologic information and greater contrast enhancement compared to gadobutrol in CNS lesions.
What is the safety profile of gadopiclenol?
Gadopiclenol is classified as a Group II agent by the American College of Radiology, indicating it has a low risk of nephrogenic systemic fibrosis (NSF).
How is the contrast media market expected to grow?
The global contrast media market is expected to grow at a CAGR of 7.98% from 2024 to 2030, reaching an estimated USD 10.74 billion by 2030.
Who are the key players in the contrast media market?
Key players include Bracco Imaging, GE HealthCare, and Guerbet, among others, who are focusing on new product launches, regulatory approvals, and other growth strategies.
Sources
- Data Reinforcing Efficacy and Safety of Gadopiclenol in Contrast-Enhanced MRI of Certain Body Regions Published in Radiology - Biospace
- Contrast Media/Contrast Agent Market Set to Surge to US$ 12.28 Billion By 2032 With Exhibiting CAGR of 7.66% | Research by SNS Insider - GlobeNewswire
- Guerbet Releases First Production Batch of Elucirem (Gadopiclenol) Injection, a Novel New Macrocyclic GBCA for Use in Contrast-Enhanced Magnetic Resonance Imaging (MRI) - PR Newswire
- Efficacy and Safety of Gadopiclenol - Bracco
- Contrast Media Market Size & Share | Industry Report, 2030 - Grand View Research
