Introduction: In the view of the industry, the ICL industry is a huge investment, just to establish a medical laboratory requires huge capital expenditure. With the development of technology, the proportion of special test items gradually increased, which puts forward higher technical requirements for inspectors, but also for research and development personnel to put forward higher requirements. Investment, talent introduction and training ICL industry companies.
ICL is a subsidiary of the listed company Rundle Medical. on May 11, Rundle Medical released an announcement that the company attaches great importance to the above public opinion, and has asked ICL to initiate internal self-examination and cooperate with the relevant departments in the investigation.
The nucleic acid testing accident of Runda Medical's subsidiary has drawn the public's attention back to the third-party medical testing industry. In fact, in recent years, with the continuous spread of new crown pneumonia, nucleic acid testing was once considered one of the most accurate testing methods. The third-party medical testing business has also ensured steady growth in the performance of many companies.
However, on the one hand, the quality and safety of many newly built third-party medical laboratories are a concern; on the other hand, after a brief outbreak of demand for neococcal pneumonia testing, it has become worth thinking about how these companies can promote the long-term development of their main business in the future.
Management chaos appeared
Eye search shows that Shanghai Zhongke Runda Laboratory was established in September 2017, the registered address is located in Hongkou District, Shanghai, by Shanghai Zhongke Runda Medical Laboratory Co. 100% holding, the latter by the Chinese Academy of Sciences, Runda Medical, Superstar Healthcare*** with the building.
Pharmaceutical marketing expert Shi Lichen told Observer.com that there could be two reasons for false positives. One is that the nucleic acid kit itself is inaccurate, such as having quality issues. On the other hand, there could be a problem with the lab.
Shi Lichen told Observer.com that the nucleic acid lab at CKRD was not built for a long time, and its management may not be standardized. In addition, unfamiliar operations by staff could have led to contaminated samples. "Or the inside of the lab has been contaminated, and many utensils or equipment have been infected with positive viruses."
"If the technicians are unfamiliar, you need to find some skilled technicians, but in any case, if there are false positives in this lab, you have to stop the test and then completely strangle it internally." Schlissel said.
On April 23 this year, the Hefei Epidemic Prevention and Control Emergency Response Command issued a notice warning two nucleic acid testing labs to suspend cooperation. The notice pointed out that on April 22, Hefei Hehe Medical Laboratory, Hefei Novel Medical Laboratory in Shu District nucleic acid testing contracted 11 tests, seriously exceeding the commitment time to issue test reports, affecting Hefei City, the timely study and judgment of the epidemic. More seriously, similar situations have occurred many times before, and some even issued several "false positive" report, seriously interfering with the prevention and control of the epidemic in Hefei.
Earlier this year, Xuchang City Public Security Bureau issued a police bulletin, pointing out that due to Zhengzhou Jinyu Clinical Laboratory Center Co., Ltd. regional head Zhang Moudong violation of the "Prevention and Control of Infectious Diseases Act", the implementation of the new coronavirus pneumonia caused by the spread of the spread of the new coronavirus or the spread of the act of a serious risk, the Yuzhou City Public Security Bureau on January 10, 2023 to suspected of a criminal offense on the Zhang Moudong investigation and to take coercive measures. . Subsequently, GTC Medical issued an official statement in response, saying that the group is actively cooperating with the investigation of the incident.
The rise of the ICL market
Publicly available information shows that third-party medical laboratories, also known as independent medical laboratories (ICLs), are medical institutions that are licensed by the health administrative department, have independent legal personality, are engaged in clinical testing or pathological diagnosis and services, and are able to independently assume responsibility.
According to the Basic Standards for Medical Testing Laboratories (for Trial Implementation) issued by the Ministry of Health in 2009, medical laboratories perform clinical tests on human specimens, including clinical blood and body fluid tests, clinical chemistry tests, clinical immunology tests, clinical microbiology tests, clinical cytomolecular genetics tests, and clinical pathology tests, with the aim of providing diagnosis-related information
These organizations include Goldcorp Medical Laboratories (GML) and Goldcorp Medical Laboratories (GML). >This type of organization includes Goldcorp Medical, Dean Diagnostics, Edgecomb, GoldQuest Genetics and so on, which are well known to the public. In recent years, due to the surge in demand for nucleic acid testing, the number of third-party medical laboratories has greatly increased and the performance of related companies has soared.
For example, in 2021, GTC Medical's operating revenue was 11.943 billion yuan, up 44.88% year-on-year; net profit attributable to shareholders of listed companies was 2.189 billion yuan, up 47.03% year-on-year. Among them, the third-party medical diagnostic services revenue of 11.303 billion yuan, accounting for 94.64%. It is understood that at present, GTC Pharmaceuticals has established 39 medical laboratories in the mainland, Hong Kong and Macao.
Dian Diagnostics, another leading third-party medical laboratory company, has also achieved rapid growth. in 2021, Dean Diagnostics' operating revenue was 13.083 billion yuan, an increase of 22.85% year-on-year; net profit attributable to shareholders of listed companies was 1.163 billion yuan, an increase of 44.83% year-on-year.
It is understood that Dean Diagnostics has laid out a chain of 40 laboratories across the country, with a service network covering more than 90% of the country's population, and providing more than 2,800 medical tests for more than 20,000 medical institutions.
The third-ranked ICL market is Adicon, which will realize revenue of 1.729 billion yuan, 2.742 billion yuan and 3.380 billion yuan from 2019 to 2021, corresponding to annual profits of 70.443 million yuan, 289 million yuan and 323 million yuan, respectively.
Many third-party medical testing companies are in the "horse race" stage. In March this year, Keppel Bio announcement mentioned that according to the third-party medical testing business needs, the company plans to expand the new third-party medical laboratory in Chongqing, Nanchang, Wuhan, Hangzhou. Keppel Bio secretary previously responded to investors that the company has key provinces and cities in the country layout of 35 third-party medical laboratories, of which 30 third-party medical laboratories to obtain a license to practice in medical institutions and formal operation, can carry out related medical testing services.
From the point of view of market size, according to Jost Sullivan's report, including the new crown pneumonia test, China's ICL market size has grown from 11.7 billion yuan in 2016 to 30.7 billion yuan in 2020, with a compound annual growth rate of 27.2%, and is expected to reach 47.9 billion yuan by 2025. By March 2020, there are 1,570 independent medical laboratories in China.
The initial stage of capital accumulation is always to go through the stage of building rules and regulations from disorder to order, and this year has been exposed one after another to overcapacity contract testing and overtime.
The issuance of the report, and even out of the Bureau of a number of "false-positive" report, are signaling that the rapid rise of the industry at the same time, but also need to further standardization and management.
In addition, in the view of industry insiders, ICL industry investment, simply set up a medical testing laboratory requires huge capital expenditure, with the development of technology, special testing program gradually increase the proportion of the test personnel, thus putting forward higher technical requirements, but also for the ICL industry, the company's investment in research and development, the introduction of talent and training put forward a higher demand.
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Related Q&A: Who is the boss of ICLICL's boss is Yue Zhaofeng.
Yue Zhaofeng, who serves as the legal representative of Beijing Zhongke Runda Investment Ltd. and other companies, serves as a shareholder of Beijing Zhongke Runda Investment Ltd. and other companies, and serves as an executive of Beijing Zhongke Runda Investment Ltd.
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