"Small and beautiful" IVD or sudden rise

The rising IVD (in vitro diagnostics) industry in China should be given enough attention as a new industry.

The in vitro diagnostic industry refers to products that obtain clinical diagnostic information by testing human samples, such as blood, body fluids, tissues, etc., outside the human body. In vitro diagnosis is fast, convenient, high penetration and high effectiveness, which can be called "doctor's eye". At present, more than 80% of clinical disease diagnosis is completed by in vitro diagnosis.

The in vitro diagnostics industry has developed with the development of biochemistry, immunology, molecular biology and other fields, and can be divided into three stages of development. In the first stage, some traditional medical diagnostic techniques were used in the embryonic period before the 20th century; in the second stage, in the early 20th century, with the development of modern medicine and the discovery of enzyme catalytic reaction and antigen antibody reaction, in vitro diagnosis gradually emerged; in the third stage, after 1953, the application of DNA double helix structure, monoclonal antibody technology, macromolecular labeling technology and other technologies promoted the leapfrog development of the whole in vitro diagnosis industry.

China's IVD industry is still in the early stage of industrial development, showing a small base, fast growth and other characteristics. In 2013, the scale of China's in vitro diagnostic market was nearly 20 billion billion yuan, up 20% year-on-year, which was much higher than the growth rate of the international market in the same period. Hospital market demand accounts for more than 90% of the total demand for in vitro diagnostics. In the future, China's in vitro diagnostics industry will benefit from the increase in the number of patients and per capita inspection costs, and the scale growth rate is expected to remain at a high level of 16% to 18%. According to this average growth rate, the scale of China's in vitro diagnostic industry will be around 31.6 billion yuan by 2015.

Growing up in the context of the Internet, China's "scattered, small, chaotic" IVD industry, is expected to take off first with the help of the Internet wind, and the birth of a segment of the leading enterprises and even overlord.

In vitro diagnosis is an important emerging industry in China, which has been strongly supported by policies during the "Twelfth Five-Year Plan" period. In this context, more companies have begun to get involved in the in vitro diagnosis industry. In the first half of 2015, nearly 20 traditional pharmaceutical companies entered the in vitro diagnostics industry through or about to acquire joint ventures. The increasingly fierce competition will prompt enterprises to continuously improve their competitiveness, so as to improve the level of domestic in vitro diagnosis as a whole. Since the issuance of the "Notice on Organizing the Implementation of the Special High-tech Industrialization of Biological Vaccines and Diagnostic Reagents" in December 2005, the state has always encouraged and supported biological high-tech including in vitro diagnostics, and issued relevant supporting documents in 9 years More than ten.

With the improvement of technology, the domestic in vitro diagnostic market has gradually shifted from biochemical diagnosis to immunodiagnosis and molecular diagnosis. According to statistics, from 2010 to 2014, the market share of biochemical diagnosis decreased from 27% to 19%, the market share of immunochemistry increased from 33% to 38%, and molecular diagnosis increased from 5% to 15%. Bedside diagnosis (POCT) developed rapidly and approached the share of molecular diagnosis in 2014.

In the field of biochemical diagnostic reagents, domestic enterprises have occupied about 2/3 of the market share. The mature technology, serious homogenization and shrinking space for localization of products have led to a slowdown in growth rate, with a compound annual growth rate of about 7%. The focus of the development of biochemical diagnosis field will shift to the competition of cost, channel, marketing means and quality control. On this basis, biochemical enterprises with self-produced raw materials, reagent instrument linkage sales and channel advantages will have more advantages.

Chemiluminescence is the current mainstream direction of immunodiagnostic products, with high sensitivity, strong specificity, high degree of automation, detection speed and other advantages, gradually replace the domestic enzyme-linked immunodiagnostic products. At present, China's chemiluminescence products are mainly imported, and the detection cost is high. The environment of medical insurance cost control and the independent research and development of chemical luminescence products will make immune diagnosis usher in explosive growth, and domestic enterprises with technical advantages and price advantages will be the first to benefit.

Release date: 2015-12-11 01:22:28 Source: China Securities Journal Author: Anonymous Responsible Editor: Robert