In 2017, thanks to the rapid development of precision medicine, the progress of the medical industry has also progressed by leaps and bounds. The publication of results of a number of promising scientific research and clinical trials caused people to have much expectation on the development of gene sequencing, liquid biopsy, and immunotherapy in 2018.The development of these technologies is also driving the continuous development of the in vitro diagnostic market. As the largest market segment in the global medical device industry, in vitro diagnosis of this fatty meat has attracted the attention of people in the industry.

　　In Vitro Diagnosis,Namely IVD,IVD refers to the products and services that determine the disease or body functions by acquiring clinical diagnostic information from human samples (blood, body fluids, tissues, etc.) outside the human body.

　　IVD has become an increasingly important component of human disease prevention, diagnosis and treatment, and it is an increasingly important component of safeguarding human health and building a harmonious society. With the gradual integration of diagnosis and treatment, Pan-IVD's molecular-based, concomitant, and gene-based diagnostic technologies are also booming and are gradually shifting from scientific research to the broader clinical market.

　　The traditional IVD market has entered a stable and mature competition in the Red Sea. New detection technologies and big data must be the commanding heights of the industry in the future!

　　Precision Medical Brings Development Opportunities for IVD

　　At present, the size of the global market of precision medicine has exceeded 60 billion U.S. dollars, of which the field of precision diagnosis is approximately 10 billion U.S. dollars. It is expected that by 2030, the relevant market scale is expected to exceed the trillion-billion mark, and precision medicine will provide a 100-billion-level blue ocean diagnostic market.

　　As of August 2017, a total of 17 in vitro diagnostic companies have been listed in China. The field of biochemical diagnosis in China is basically mature. Because of its low technical barriers, most in vitro diagnostic companies can participate in it. About two-thirds of the companies have many products in the field.At present, most companies are also deeply pursuing different subdivisions in molecular diagnostics, such as tumor molecular diagnosis, nucleic acid molecular diagnosis, and so on.

　　Under the trend of “integration of diagnosis and treatment”, the constant update of drugs and treatment methods has promoted the development of the in vitro diagnostic market. For example, in May 2017, Merck's PD-1 inhibitor Keytruda was approved by the FDA for the positive treatment of MSI-H/dMMR. This is the first new drug approved by humans for the treatment of all tumors.

　　Prior to this, cancer treatment was based on the origin of cancer in the body, such as lung cancer and gastric cancer. The therapeutic basis of the PD-1 inhibitor Keytruda is that no matter what the cancer is, it can be used as long as it is positive for MSI-H/dMMR.

　　In 2017, the FDA approved multiple gene detection technologies for clinical use, paving the way for the development of precision medical and in vitro diagnostics.

　　In May, "Natural Medicine" magazine published the world's first million people late cancer sequencing results, which is based on second-generation sequencing technology big data genetic mutation project of cancer, help to open a new model of cancer treatment.

　　In June, the FDA approved Thermo Fisher's first NGS-based assay for NGS concomitant diagnosis of a variety of new non-small cell tumor neoplasms, allowing doctors to find a match for patients within a few days.

　　In December, the FDA approved the listing application of the Foundation Medicine CD, FoundationOne CDx, which is a milestone event for genetic testing and in vitro diagnostics. It also clarified the FDA's determination to promote the marketization of genetic testing.

　　Breakthroughs in treatment methods are gradually realizing the precise medical concept of “the same disease of different treatments, different diseases of different treatments”, and the “premature” era of cancer has slowly come. As we all know, the market for early diagnosis of cancer is very large, the cure rate of early cancer is very high, and the perfect early diagnosis and early treatment of tumor ecological chain becomes an urgent need.

　　IVD industry development can not be separated from hot technology progress

　　In the field of genetic testing, the most fierce current includes, of course, gene sequencing and liquid biopsy diagnostics.

　　Gene Sequencing

　　Gene sequencing is a hot topic in the field of molecular diagnostics for the past five years and is the fastest growing sub-sector in molecular diagnostics. Gene sequencing can be used to analyze gene sequences and predict the possibility of multiple diseases.

　　Gene sequencing technology can lock individual diseased genes, advance prevention and treatment, and combine big data to lock in more disease characteristics. In recent years, the cost of molecular diagnostics (especially NGS) has been greatly reduced, meaning that more patients will be exposed to molecular diagnostics.

　　At present, the clinical application of gene detection is very extensive, including reproductive health, tumor prevention and control, pathogen analysis, transplantation matching, complex diseases, among which non-invasive prenatal detection NIPT is currently the most mature gene detection technology.

　　Many companies in the genetic industry have devoted themselves to the clinical application and development of gene sequencing. Representative companies abroad include Illumina, Thermo Fisher, and Roche, while domestic companies use BGI, Boau Bio, and Golden Domain.In 2015, the global gene sequencing market was 5.9 billion U.S. dollars, and it is expected to reach 13.8 billion U.S. dollars by 2020, with a compound annual growth rate of 18.7%. It is expected that the disease-precision medical companies with AIDS treatment in 2018 will become overlord.

　　Liquid biopsy

　　Liquid biopsy is the most exciting breakthrough in the field of tumor diagnosis. Because there is no need to organize punctures, but through non-invasive specimens such as blood or urine, diseases such as high-throughput sequencing are used to diagnose and evaluate the disease. Compared with traditional tissue biopsy, liquid biopsy has the advantages of small side effects, simple operation, and repeated sampling.

　　In addition, the medical cost of liquid biopsy is also relatively low. At present, the main tests for liquid biopsy include CTCs, ctDNA, and exosomes. In addition, new studies have found that blood components such as platelets can also be used for detection. Clinically, it is mainly used for cancer screening, companion diagnosis, postoperative detection, and non-invasive screening.

　　The field of liquid biopsy has gathered a lot of "unicorn" type companies, such as Grail, Ideas, Ed Bio, Berry and Kang, WuXi Mingde and so on. In January 2018, Ade Bio, a representative of liquid biopsy companies in China, announced that its Super-ARMS® EGFR test kit became China's first ctDNA test kit approved by the companion diagnostic reagent standard and can be used to detect late-stage non-small The EGFR gene mutation status of cell lung cancer to screen for patients with EGFR-targeted drugs.

　　Kalorama Information estimated that the global liquid biopsy market in 2016 was 394 million U.S. dollars, and the market size in 2021 is expected to be 1.398 billion U.S. dollars, with a compound annual growth rate of 28.8%.

　　Since liquid biopsy has the advantage of clinical diagnosis and drug monitoring, precise treatment will effectively promote the application of liquid biopsy. At the same time, as the cost of genetic testing decreases, the diagnostic cost of liquid biopsy will also decrease.

　　Although the accuracy of the results of liquid biopsy is still in doubt, a truly wide range of clinical applications, technological breakthroughs and standard specifications still have a long way to go, but liquid biopsy will undoubtedly bring cancer patients and researchers new hope.