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Contrast agent, also known as contrast agent, is a subsidiary industry of medical imaging equipment
.
When the differential diagnosis of some diseases is difficult through routine imaging examinations, contrast agents will be injected into the human body to enhance the contrast of the images, so that tumors and some cardiovascular diseases can be differentially diagnosed
.
As one of the drugs frequently used in interventional radiology operations, the market size of contrast agents is showing a rapid upward trend in recent years
.
Affected by this, more and more companies are beginning to increase their entry into this field
.
Recently, the CDE website showed that Hunan Kelun Pharmaceutical's gadobutrol injection was accepted for production of imitation 4 types
.
It is understood that gadobutrol injection is used for diagnosis and is for intravenous administration only
.
Contrast-enhanced magnetic resonance imaging (MRI) of the brain and spinal cord Contrast-enhanced magnetic resonance angiography (CE-MRA)
.
The drug will have a scale of more than 15 billion yuan in China's urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) in 2020
.
It is worth noting that there are currently 8 types of gadolinium-based contrast agents approved in China, including gadopentetate meglumine, gadolinium meglumine, gadoterate meglumine, gadolinium disodium gadolinium, and gadolinium meglumine ( Symbol expired), Gadolinium Diamine, Gadoteriol, Gadobutrol
.
Among them, only gadopentetate meglumine injection, gadobeme meglumine injection, gadoxetate disodium injection, and gadoterate meglumine injection have generic drugs approved
.
The only manufacturer of gadobutrol injection approved by Kelun Pharmaceutical this time was Bayer
.
However, at present, Jiangsu Hengrui Pharmaceutical, Beijing Beilu Pharmaceutical, Yangzijiang Pharmaceutical Group, Guangzhou Hairui Pharmaceutical|Yangzijiang Pharmaceutical Group and Jiangsu Zilong Pharmaceutical have submitted the application for listing in generic 4 categories and are under review and approval for this product
.
The industry predicts that in the future in this field, market competition will continue to intensify
.
In fact, compared with most pharmaceutical subdivisions, there are fewer original research and imitation manufacturers in the contrast agent industry, and most of the product patents have expired for many years and there is still only one original research, or a small number of imitations, so in recent years More and more domestic companies have begun to pay attention to this market prospect.
In addition to gadobutrol injection, iodine, barium and microbubble contrast agents have also become the focus of many pharmaceutical companies
.
It is reported that Kelun Pharmaceutical issued an announcement on June 22 that the subsidiary Shandong Kelun Pharmaceutical's iopamidol injection was approved for listing and passed the consistency evaluation, becoming the first Kelun Pharmaceutical approved to enter.
Drugs in the field of diagnostic imaging
.
In addition, in February of this year, Chengdu Better Pharmaceuticals also issued an announcement stating that its application for imitation listing of Category 4 iopromide injection was accepted, and it became the company's first contrast agent to apply for listing
.
According to public information, the original research company of this product is Bayer, with sales of more than 300 million euros in 2019, and terminal sales in China's public medical institutions have exceeded 1.
3 billion yuan.
Currently, only the original research is imported in China
.
In general, with the rapid development of the contrast agent market in the past ten years, the market scale has become larger and larger, and the battle of pharmaceutical companies for the contrast agent market is constantly being fought
.
However, it should be noted that although the contrast agent market is becoming larger, its market structure has basically taken shape
.
Therefore, pharmaceutical companies still need to be cautious if they want to enter the contrast agent market.
Unless they have certain determination and strength, it is better not to enter the market lightly
.
.
When the differential diagnosis of some diseases is difficult through routine imaging examinations, contrast agents will be injected into the human body to enhance the contrast of the images, so that tumors and some cardiovascular diseases can be differentially diagnosed
.
As one of the drugs frequently used in interventional radiology operations, the market size of contrast agents is showing a rapid upward trend in recent years
.
Affected by this, more and more companies are beginning to increase their entry into this field
.
Recently, the CDE website showed that Hunan Kelun Pharmaceutical's gadobutrol injection was accepted for production of imitation 4 types
.
It is understood that gadobutrol injection is used for diagnosis and is for intravenous administration only
.
Contrast-enhanced magnetic resonance imaging (MRI) of the brain and spinal cord Contrast-enhanced magnetic resonance angiography (CE-MRA)
.
The drug will have a scale of more than 15 billion yuan in China's urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) in 2020
.
It is worth noting that there are currently 8 types of gadolinium-based contrast agents approved in China, including gadopentetate meglumine, gadolinium meglumine, gadoterate meglumine, gadolinium disodium gadolinium, and gadolinium meglumine ( Symbol expired), Gadolinium Diamine, Gadoteriol, Gadobutrol
.
Among them, only gadopentetate meglumine injection, gadobeme meglumine injection, gadoxetate disodium injection, and gadoterate meglumine injection have generic drugs approved
.
The only manufacturer of gadobutrol injection approved by Kelun Pharmaceutical this time was Bayer
.
However, at present, Jiangsu Hengrui Pharmaceutical, Beijing Beilu Pharmaceutical, Yangzijiang Pharmaceutical Group, Guangzhou Hairui Pharmaceutical|Yangzijiang Pharmaceutical Group and Jiangsu Zilong Pharmaceutical have submitted the application for listing in generic 4 categories and are under review and approval for this product
.
The industry predicts that in the future in this field, market competition will continue to intensify
.
In fact, compared with most pharmaceutical subdivisions, there are fewer original research and imitation manufacturers in the contrast agent industry, and most of the product patents have expired for many years and there is still only one original research, or a small number of imitations, so in recent years More and more domestic companies have begun to pay attention to this market prospect.
In addition to gadobutrol injection, iodine, barium and microbubble contrast agents have also become the focus of many pharmaceutical companies
.
It is reported that Kelun Pharmaceutical issued an announcement on June 22 that the subsidiary Shandong Kelun Pharmaceutical's iopamidol injection was approved for listing and passed the consistency evaluation, becoming the first Kelun Pharmaceutical approved to enter.
Drugs in the field of diagnostic imaging
.
In addition, in February of this year, Chengdu Better Pharmaceuticals also issued an announcement stating that its application for imitation listing of Category 4 iopromide injection was accepted, and it became the company's first contrast agent to apply for listing
.
According to public information, the original research company of this product is Bayer, with sales of more than 300 million euros in 2019, and terminal sales in China's public medical institutions have exceeded 1.
3 billion yuan.
Currently, only the original research is imported in China
.
In general, with the rapid development of the contrast agent market in the past ten years, the market scale has become larger and larger, and the battle of pharmaceutical companies for the contrast agent market is constantly being fought
.
However, it should be noted that although the contrast agent market is becoming larger, its market structure has basically taken shape
.
Therefore, pharmaceutical companies still need to be cautious if they want to enter the contrast agent market.
Unless they have certain determination and strength, it is better not to enter the market lightly
.
