Development Status of Molecular Diagnostic Technology in China

On October 16th, the medical network is the technical basis of precision medicine, and it is also the fastest sub-sector of IVD growth, and the technology difference between domestic and foreign is the smallest. Molecular diagnosis subdivided technology, the most mature and widely used PCR, gene Sequencing is relatively new. With the successive listing of Berry and Kanghe Huada genes, the investment market has great hope and enthusiasm for the genetic field.

Molecular diagnosis is mainly based on the application of molecular biology methods to detect changes in the structure or expression level of genetic material in living organisms. Because molecular diagnosis can be detected from the gene level, the advantages of detection sensitivity and accuracy are obvious. Identifying viruses at an early stage of infection or identifying genetic defects early, thus providing personalized medical diagnosis services, mainly for the detection and diagnosis of diseases such as genetic diseases, infectious diseases, and tumors. Molecular diagnosis mainly includes nucleic acid diagnosis and biochip technology.

Table 1 Introduction to main techniques of molecular diagnosis

Since the new century, China's molecular diagnostic technology has developed rapidly and presented three major developments:

The detection of quantitative PCR technology began to develop toward high sensitivity and absolute quantitative detection, and the upgraded version of microdrop digital PCR began to emerge;

The development and rise of high-throughput sequencing technology. The current generation of sequencing is still gold standard Second-generation sequencing has been clinically applied. Three generations of single-molecule real-time and nanopore sequencing technologies are improving day by day. Molecular diagnostics has shifted from focusing on individual genes to focusing on the entire human genome. The scope and depth of single sequencing has increased dramatically, and sequencing costs have been significantly reduced. Directly promoted the transformation of non-invasive prenatal diagnostic technology in China;

With the application of detection technology on the agenda, liquid biopsy technology is gradually recognized by clinicians, and genetic information carriers such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and exosomes (exosome) in body fluids are beginning to cause People pay attention to, routine blood and urine samples such as blood and urine are gradually given new content. In recent years, new hot spots of molecular diagnosis in China have emerged, especially in pathogen resistance, non-invasive prenatal diagnosis, drug genome detection and individualized treatment of tumors. field.

The upstream of the molecular diagnostics industry chain is a raw material supplier, including diagnostic enzymes, primers, invertases, probes and other biological products, high-purity sodium chloride, anhydrous ethanol and other fine chemicals and extraction media materials, mainly by Roche, Meridian Life science, Solulink, Surmodics and other foreign giants monopolize, because of the high technical difficulty, there is basically no domestic enterprise Production. In research and development, the domestic molecular diagnostic raw material research and development basic blank.

The midstream of molecular diagnosis is mainly the development, production and sales of molecular diagnostic reagents and instruments. Domestic reagents are developing rapidly, while domestic instruments account for a relatively small proportion. Molecular diagnostic kits include nucleic acid extraction kits and nucleic acid detection kits. Basically, it has been domestically produced. The number of domestic manufacturers of nucleic acid detection reagents for common viruses such as HBV (hepatitis B virus), HCV (hepatitis C virus) and HIV (HIV) is much larger than that of foreign manufacturers. Type A, type B, and type C flu are common. disease The nucleic acid detection kit has been relatively mature, and there are many competitors, almost all of which are domestic brands.

Molecular diagnostic instruments mainly include nucleic acid extractors, PCR amplification instruments, nucleic acid molecular hybridization instruments, gene chip instruments and gene sequencers, etc. In the field of medium-end instruments that are relatively easy to break, such as nucleic acid extractors, PCR amplification instruments, nucleic acids Molecular hybridization instrument, localization of gene chip instrument has been formed, domestic products occupy the main market, and the localization process of gene sequencer is starting to break through, mainly in three ways: (1) Merger and acquisition of foreign sequencer companies, Based on the core technology, the self-branded sequencer is launched, represented by Huada Gene. (2) Independent research and development using endogenous scientific research capabilities, represented by Huayinkeng Gene, Zixin Pharmaceutical, etc. (3) With foreign countries Well-known sequencer manufacturers cooperated on the basis of the prototype of the sequencer to form a self-owned brand of sequencer with special purpose. The representative companies are Berry and Kang, Daan Gene and Boao Bio.

Downstream of the molecular diagnostics industry hospital Independent third-party laboratories. Independent medical laboratories can focus on specimen testing, reduce costs, improve diagnostic efficiency and quality, and reduce the incidence of diagnostic errors. China's independent laboratories develop late, the market size is small, and the proportion of medical diagnostics is low. Among them, the inspection items are mainly general inspection, and the high-end detection ratio is low. At present, the domestic independent medical laboratory market has formed the pattern of Guangzhou Jinyu, Dean Diagnostics, Ai Dikang and Gaoxin Daan, the four comprehensive diagnostic laboratory giants leading the market. .

Figure 1 China's molecular diagnostic industry market size and forecast (100 million yuan)

Due to the wide range of applications, the molecular diagnostics industry has developed rapidly around the world. As targeted therapy has gradually become Tumor An important method for precise treatment, releasing more personalized cancer drug detection (concomitant detection). The new targeted drug is continuously introduced and the penetration rate of personalized drug detection is improved, which promotes the rapid development of the personalized drug detection industry. Non-invasive prenatal testing (NIPT) for large-scale applications, and based on a comprehensive two-child policy to promote rapid growth in demand. In the future, with technological advancement and cost reduction, gene sequencing has a broader application prospect in the field of early tumor screening and personal genome detection.

Flint creates statistics: In recent years, the global molecular diagnostics industry has grown at an average annual rate of about 11%, while China's molecular diagnostics industry has achieved an average annual growth rate of 24%, which is twice the global growth rate. It is expected that by 2019, China's molecular diagnosis The market size is expected to exceed 9 billion yuan.