USA — GE HealthCare has completed Phase I subject recruitment in its early clinical development program for a novel manganese-based macrocyclic magnetic resonance imaging (MRI) contrast agent.
This marks a significant milestone in the advancement of a first-of-its-kind alternative to gadolinium-based MRI agents.
Typically, MRI agents are gadolinium-based, but perceived concerns relating to gadolinium retention have led to a need for alternative agents.
The manganese-based agent has comparable relaxivity and diagnostic properties to gadolinium-based contrast agents (GBCAs), but is endogenous, naturally occurring, and efficiently eliminated from the body.
Lead Investigator Hasse K. Zaré is overseeing a clinical trial at Oslo University Hospital’s clinical research unit in Rikshospitalet, Norway.
The trial aims to evaluate the safety profile of an injectable manganese contrast agent and study how it is eliminated from healthy volunteers’ bodies.
The investigational agent is tightly bound to the chelate, in a macrocyclic cage-like structure, so it is rapidly eliminated from the body.
This clinical development could broaden GE HealthCare’s portfolio of MRI contrast agents available to radiologists and help limit the potential impact of post-patient excreted gadolinium in the environment.
The global shortage of iodinated contrast media caused by the shutdown of GE Healthcare’s manufacturing center in Shanghai, China, due to the country’s zero-COVID policy, has highlighted the need for alternative contrast media.
This shortage has affected millions of diagnostic imaging examinations worldwide, with more than 50 million procedures performed annually that rely on contrast media, including nearly all angiography and approximately half of all CT scans.
This shortage has forced health systems to conserve contrast material, so patients who require contrast media can receive necessary imaging.
In light of this shortage, researchers have modeled several ways to conserve contrast media, including reducing the amount used for CT scans by approximately 80% if a moderate reduction in diagnostic accuracy can be tolerated.
Finding alternative contrast media will be a significant milestone in the backdrop of this global shortage caused by COVID-19, as it will provide a viable alternative to iodinated contrast media and help ensure that patients receive the necessary imaging they require.
The contrast media/contrast agents market in 2020 was dominated by four major players: GE Healthcare, Bracco Imaging SPA, Bayer, and Guerbet.
Custom Market Insights’ latest research study has found that the global MRI Contrast Agents Market had a value of roughly US$ 2.2 billion in 2021 and is projected to grow to approximately US$ 4.54 billion by 2030.
This indicates a compound annual growth rate (CAGR) of around 6.2% between 2022 and 2030.
GE Healthcare (US) is the top player in the market, with a strong global distribution network across 170 countries. Its pharmaceutical segment has a strong foothold in the US, contributing 42% of its total revenues.
Bracco Imaging SPA (Italy) accounted for a high share of the market in 2020, with a broad product portfolio in the X-ray and CT contrast media segment.
The company markets its products in over 100 countries, generating 89% of revenue through international sales.
Bayer AG (Germany) has a strong portfolio of MRI contrast agents and a dominant position in the MRI contrast market. Gadovist is its most significant product in the MRI contrast media segment.
Guerbet (France) is a major player in the contrast media/contrast agents market, with 45% of its revenue generated from the European region.
The company is focused on expanding its geographical reach by entering into various distribution agreements globally, including plans to establish its distribution platform in Japan by 2023.