Present situation and future of in vitro diagnostic industry in China

With the introduction of the new medical reform policy, the public's demand for medical health continues to expand; at the same time, due to the support of the national "Twelfth Five-Year Plan" and the 863 plan, the scientific research achievements of in vitro diagnostic industry continue to emerge, and gradually make industrialization progress. In addition, listed companies and social capital frequently enter the field of in vitro diagnostics, prompting the industry to gradually move from dispersion to concentration, in vitro diagnostics industry to benefit from the reform of primary health care, biochemical and immunodiagnostic market segment potential is huge.

Due to the rising demand for health screening and physical examination, early warning and diagnosis of major diseases, molecular diagnostic technology has also attracted much attention. China has a large population and large differences in medical resources, and POCT products are facing a huge blue ocean market that has not yet been met. In addition, through industry extension and cross-field cooperation, the development of individual treatment, accompanying diagnosis and mobile medicine has gradually deepened. How to grasp the market segmentation opportunities, which in vitro diagnostic enterprise strategic planning and product development put forward higher requirements.

In addition to clinical diagnosis, independent laboratories and physical examination centers in domestic hospitals, more and more Chinese in vitro diagnostic enterprises are trying to expand their overseas business. European and American registration regulations and market access standards have attracted wide attention. At the same time, the quality standards of in vitro diagnostic products are also constantly improving. How to provide better products for the domestic and foreign in vitro diagnostic market will be one of the important factors for the sustainable development of enterprises.

He Yunshao, chairman of Daan Gene, also made a report on the current situation and future of China's in vitro diagnostic industry at the seminar of the medical device professional group of the national "Thousand talents Plan". The following is a summary of the speech.

From 2012 to 2014, the compound annual growth rate of the global in vitro diagnostics market will reach 6.58. By 2014, the global in vitro diagnostics market is expected to increase to US $50.3 billion billion.

The size of the in vitro diagnostics market is related to the total population, medical security level, per capita medical expenditure, medical technology and service level of each region and country. At present, the market size of China's in vitro diagnostic industry is about 18 billion yuan, with an average annual growth rate ranking first in the world (16% VS 6%).

The United States is the world's largest in vitro diagnostic market, with a scale of more than $20 billion billion. U.S. companies produce 80% of the world's IVD products, and the U.S. market has a huge impact on the development of the in vitro diagnostic industry. At present, the global in vitro diagnosis to form a "4 + X" pattern, the first echelon for the old four Roche, Siemens, Abbott, Danaher (the acquisition of Beckman),X includes Syme Fly, BD, Mai-Allier, Hyssenmecom and other in the sub-sector has the advantage of the second echelon.

The domestic in vitro diagnostic market can be roughly divided into two levels. One is the high-end market such as tertiary hospitals. Due to the large number of clinical test samples, the search for faster and more accurate diagnosis requires high integration and automation of the test system, which is basically a foreign monopoly. In addition, secondary hospitals and primary markets pursue cost-effective and easy-to-operate systems for testing products. Domestic enterprise products are mostly concentrated in this market. Domestic enterprises to the three hospitals, foreign-funded enterprises to the grass-roots and other mutual penetration.

At present, CFDA has issued about 18000 domestic in vitro diagnostic product numbers, covering a variety of clinically commonly used in vitro diagnostic reagents and equipment, for China's daily medical and health care.BornThe work has made an important contribution.

The number of domestic enterprises is large, and the small-scale in vitro diagnostic reagent industry is an emerging industry in my country. Compared with European and American countries, it started late and the industrialization development is relatively lagging. According to the data provided by the IVD Special Committee, there are currently about 300-400 in vitro diagnostic reagent manufacturers in my country, of which nearly 200 are above designated size, but only about 20 are companies with annual sales revenue of more than 100 million yuan., Few varieties.

In recent years, China's in vitro diagnostic reagent industry has entered the development period from the introduction period, and the market demand is growing rapidly. Domestic enterprises seize the opportunity to seize the share by virtue of the advantages of high cost performance and closer to the local market, resulting in the market pattern dominated by imported products being gradually broken. With the increase of R & D investment and the improvement of product quality level, a number of strong local enterprises have emerged in China's in vitro diagnostic reagent industry, focusing on biochemistry, immunity (mainly enzyme-linked immunosorbent) and molecular diagnosis, and gradually have the strength to compete with international giants in some product fields.

Generally speaking, the pattern of domestic enterprise market separation competition is more obvious, the strength of the comprehensive enterprise is still less, the industry ranking at the top of the enterprise mainly in a certain field has a competitive advantage.

Compared with foreign countries, China's in vitro diagnosis started late, the industry development time is short and the technical level is limited. The domestic enterprises engaged in the in vitro diagnosis industry are mainly reagent manufacturers, and the market in biochemical reagents and PCR diagnostic reagents has surpassed foreign capital. Diagnostic instruments involve machine photoelectric integration technology has high technical barriers, domestic enterprises diagnostic instrument research and development is a short board, most of the domestic hospital automation detection system for foreign enterprises monopoly, domestic manufacturers are relatively few.