Molecular diagnosis attracts many domestic and foreign medical device companies to enter

Molecular diagnosis is attracting more and more domestic and foreign companies to enter. Multinational in vitro diagnostic companies such as PerkinElmer and LifeTechnologies have deepened the development of the domestic molecular diagnostics market through mergers or acquisitions. Domestic companies such as Daan Gene and Kehua Biotech have further increased their market expansion after listing. According to industry insiders, there is still a lot of room for growth in the domestic molecular diagnostics market, and it is expected that more companies will join the competition.

In recent years, molecular diagnostics has risen rapidly in the domestic market. In 2010, China's in vitro diagnostic market scale was 2.07 billion US dollars (about 13.68 billion yuan), of which 5% of the share was occupied by emerging molecular diagnostics. Although the proportion of domestic molecular diagnosis is not large at present, its annual growth rate is twice that of the world, and it is the fastest growing field in domestic in vitro diagnosis.

Fastest in vitro diagnostic subfield

Molecular diagnostics is also the fastest growing segment of the global in vitro diagnostic market, and its proportion in in vitro diagnostics has increased from 2% in 1995 to 10% in 2009, with an annual growth rate of more than 10%.

In emerging markets, the growth rate of molecular diagnostics is even more attractive to investors. Among them, China's molecular diagnostics market has grown at an annual rate of more than 20%, twice the global level. The market expects that by 2015, emerging market countries (mainly Latin America and the Pacific Rim) will be the main driving force for the growth of molecular diagnostic products market.

“It is precisely because of the strong growth of emerging markets in the field of molecular diagnostics that the company is currently working on the analytical diagnosis of emerging markets, especially the Chinese market.” Zhang Wei, vice president of the PerkinElmer Diagnostics Division, said The increase in the elderly population, the shift in the medical model, and the increasing demand for molecular diagnostics in the social market, the molecular diagnostics market is facing unprecedented opportunities for development.

Currently, products for the treatment of infectious diseases are the main components of molecular diagnosis, accounting for about 50% of the total market; followed by blood screening, accounting for about 11%. The market expects that molecular diagnostic techniques will be widely applied to individualized cancer treatment, expensive drug treatment monitoring, drug metabolism genomics, etc., POC testing, forensic, population health screening and physical examination, major disease early warning and diagnosis, public molecular genetic files The establishment of other applications has become a future development trend.

In the molecular diagnostic market for the treatment of infectious diseases, human immunodeficiency virus (HIV), hepatitis C virus (HCV), Chlamydia trachomatis (CT) and Neisseria (NG) detection account for a major share. However, the molecular diagnostic market pattern of infectious diseases has been established, the market competition is extremely fierce, and there are fewer opportunities for new market competitors. The market for molecular diagnostic products for detection of human papillomavirus (HPV) and methicillin-resistant Staphylococcus aureus (MRSA) is growing rapidly.

Blood screening has become the most important area of ​​molecular diagnosis in China, and nucleic acid screening technology is one of the most popular. At present, the demand for blood screening in China is growing at a rate of more than 15% per year. Yang Guocui, director of biotechnology at Shanghai Haoyuan, told reporters that the relevant government departments attach great importance to blood nucleic acid screening projects. The Ministry of Health began to use nucleic acid technology to test all donated blood in the second half of 2010. It is expected that 80% coverage will be achieved by the end of 2015. To better ensure the quality and safety of the stored blood.

Layout domestic wins first mover advantage

It is the market opportunity that sees the domestic blood screening boom. The transnational in vitro diagnostic company PerkinElmer announced at the media meeting held in Shanghai on November 22 that it has completed the project of Shanghai Haoyuan Biotechnology. The acquisition of a leading Chinese company in the domestic blood screening market, involving a transaction amounting to $38 million in cash.

Zhang Wei said that Haoyuan Bio is the first domestic research and development of "three-in-one" blood screening reagents. It is a leading company in the field of molecular diagnostics in China. It currently has 7 authorized patents and 4 patents have been applied for. The acquisition expands PerkinElmer's product portfolio in the molecular diagnostics market, enhancing the company's competitiveness in the blood nucleic acid detection screening market and its overall competitive advantage in the growing Chinese molecular diagnostics market.

In fact, "strong alliance" is also an inevitable choice for enterprises to face the fierce market competition environment. At the beginning of this year, another multinational in vitro diagnostic company, LifeTechnologies, announced that it has signed a cooperation agreement with Daan Gene to establish Life-Daan Diagnostics, a joint venture in vitro diagnostic technology in China. Its development goal is to develop molecular diagnostic reagents to support in vitro diagnostic analysis of cancer, infectious diseases and genetic diseases.

According to industry insiders, the domestic molecular diagnostics field is on the rise, and many foreign-funded enterprises have already seen the development opportunities in this emerging market in China, and the pace of expansion has obviously accelerated. While working together to expand the domestic market, foreign-funded enterprises can also win first-mover advantages and create a more competitive market environment.

Domestic related companies will naturally not let go of this market cake. It is understood that domestic companies in the field of molecular diagnostics include Daan Gene, Shanghai Haoyuan Bio, Boao Bio, Kehua Bio, Piji Bio, Xiamen Aide, United Gene, Fuzhou Taipu, Guangzhou Yishan Jiangsu is true. After the listing of companies such as Daan Gene and Kehua Bio, the process of opening up this market has also accelerated significantly.

Last year, Kehua Biology obtained the “Pharmaceutical GMP Certificate” issued by the State Food and Drug Administration. The scope of certification includes hepatitis B virus, hepatitis C virus, and human immunodeficiency virus (type 1) nucleic acid detection kit (PCR-fluorescence method). ), which means that Kehua Bio has made another big step in the field of molecular diagnostics; at the beginning of this year, Daan Gene and LifeTechnologies announced the establishment of a joint venture to further cultivate the domestic molecular diagnostics market; in July this year, Shenzhen Huada Genetic Research Institute and Ningxia Medical University General Hospital successfully signed a strategic cooperation agreement, indicating that it will promote the research, development and application of new molecular diagnostic technologies.

Industry experts say that the field of molecular diagnostics is a very new and challenging field, and market competition will continue to intensify. For the emerging domestic molecular diagnostic industry, there is an urgent need for the attention and support of relevant government departments and related policies. In addition, molecular diagnosis as the core field of medical testing, industrial clustering can improve the depth of the molecular diagnostic industry, and achieve the extension of the industrial chain, the development model of industrial clusters should receive more attention and attention.

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