Concomitant diagnosis is to measure the expression level of mutant genes or proteins in the human body, understand the treatment responses of different patients to specific drugs, select the most suitable drug users and carry out individualized treatment, so as to improve the treatment prognosis and reduce health care expenses. In the past 20 years, the diagnosis industry has developed rapidly at home and abroad. At present, the industry is in the initial stage, and most of the participating enterprises are giants such as Roche and Abotte, and the pattern is relatively scattered. Domestic Eddard Biology and other enterprises have an early layout and are located in the first echelon.

1. Individualized treatment is realized with targeted therapy, and diagnosis contributes to the development of accurate medicine.

Guangzheng Hang Seng pointed out that at present, the top 10 sales of cancer drugs are allTumor targeting drugs, accounting for 56.09% of the global market for prescription antineoplastic drugs in 2017, is expected to reach 73% in 2022, and 24.25% in 2017, which continues to rise.

Targeted therapy refers to a therapeutic method aimed at a gene fragment or a protein molecule in the cell at the cellular and molecular level. these gene fragments and protein molecules are not only pathogenic sites, but also disease targets.

Concomitant diagnosis serves targeted therapyBefore targeted therapy, patients must be targeted, and only patients with "target positive" can receive the corresponding targeted therapy. In particular, targeted therapy in the field of oncology needs to be accompanied by diagnostic targets, because the cause of cancer is genetic variation.

2. The global concomitant diagnosis market has grown at a growth rate of more than 20% to US $3 billion, and the domestic leader is emerging.

Guangzheng Hang Seng pointed out that over the past 20 years, with the rapid development of the diagnostic industry at home and abroad, FDA issued two documents in 2014, and more than 40 concomitant diagnostic products in the United States have been approved. Domestic concomitant diagnostic reagents are still registered according to in vitro diagnostic (IVD) reagents. At present, nearly 200 domestic gene testing IVD products have been approved, accounting for more than 70% in the field of oncology. The most widely used technology with diagnostic products is fluorescent PCR,NGS technology, which represents the development direction in the future.

According to MarketsandMarkets, the global concomitant diagnostic market was $1.9 billion in 2016 and is expected to reach $3.13 billion in 2018, with a compound annual growth rate of 22.78% from 2016 to 2022, significantly higher than the 6% growth rate of the global IVD industry as a whole. As one of the fastest growing segments of the in vitro diagnosis market, the market share of in vitro diagnosis has gradually increased from 2.9% in 2010 to 14.0% in 2021.

The size of the domestic concomitant diagnosis market was US $49 million in 2010 and is expected to reach US $300 million in 2018. The compound annual growth rate from 2010 to 2021 is 28.0%, which is not only higher than the global level, but also significantly higher than the domestic IVD industry growth rate of about 15%.

3. Market competition pattern: the industry is in the primary stage, and most of the players are international pharmaceutical giants.

The global concomitant diagnosis industry is in the initial stage, and the participating enterprises are mostly giants such as Roche and Abotte, with a relatively scattered pattern; the layout of many domestic companies has a variety of products, and the competition is fierce. Eddard Biology, Burning Rock Biotech Ltd. and other enterprise layout earlier, located in the first echelon, professional public accompanying diagnosis company valuation, A-share listed company Eddard Biology has been alone, Baiao Technology and other new third board companies are concentrated in about 500 million yuan.

4. With the development trend of diagnosis: NGS polygene detection has become the development trend in the future, and liquid biopsy is widely valued.

The main results are as follows: 1) the combined detection of multiple tumor biomarkers can improve the accuracy of diagnosis. NGS itself has the advantage of high-throughput detection and PCR technology which can be used to detect multiple genes is very promising.

2) fluid biopsies are expected to mature in the market after 5-15 years, when the global scale of fluid biopsies will reach 23 billion US dollars and the domestic market will reach 37.5 billion RMB.

5. Investment suggestions

Guang Zheng Hang Seng recommends paying attention to Ed Bio, which has the first domestic liquid biopsy product and NGS tumor detection product to enter the special approval channel.

Xiamen Eddard Biopharmaceutical Technology Co., Ltd. was founded by Professor Zheng Limou, a national special expert of the Thousand talents Plan, in 2008, which integrates the research, development, production, sales and service of tumor accurate medical diagnosis products. the company has three types of in vitro diagnosis products production, management qualification and independent clinical medical examination qualification, the product is mainly used to detect the gene status of tumor patients. To provide scientific basis for the selection of tumor targeting drugs and the formulation of individualized treatment plan. In a short period of ten years, it has become the first professional R & D and production enterprise of cancer precision medical molecular diagnosis products in China, and listed on Shenzhen growth Enterprise Market in 2017.

The first domestic liquid biopsy product was approved, and the NGS tumor detection product was "specially approved".In January 2018, Ed Biological's human EGFR mutation gene detection kit based on Super-ARMS technology was approved, which is the first approved EGFR liquid biopsy kit in China, and it is also the only product approved according to the standard of oxetinib concomitant diagnostic kit.