Molecular diagnostics industry: "2 X" market pattern is now "embryonic"

In vitro diagnostics (IVD = In Vitro Diagnosis) refers to products and services that obtain clinical diagnostic information by testing human samples (blood, body fluids, tissues, etc.) outside the human body to determine disease or body function. In vitro diagnosis is called "doctor's eyes". Diagnosis includes detection, analysis, judgment and other links, and detection is the first link. In vitro diagnosis is divided into four categories according to test methods, biochemical diagnosis, immune diagnosis, molecular diagnosis and bedside detection (POCT).

In vitro diagnosis has undergone a transformation from experimental biology to molecular biology. In the field of biochemical diagnosis, the technology has been very mature. Chemiluminescence in the field of immunodiagnosis leads the development. In the field of molecular diagnosis, gene chip, DDPCR (micro drop digital PCR), the third generation sequencing and other technologies are blooming. The continuous emergence of molecular diagnosis technology leads the development of the whole industry of in vitro diagnosis.

The application of nucleic acid detection can be roughly divided into three categories: clinical infectious disease pathogen nucleic acid detection, blood screening nucleic acid detection, human gene nucleic acid detection

Technical Breakthrough and Policy Support Leading the Development of Molecular Diagnostics Industry

On the one hand, since February 2014, the industry has gradually standardized, the threshold has been raised, clinical pilot work has been gradually carried out, medical insurance control fees and the landing of the second child have promoted the status of the molecular diagnosis industry, and only the landing of the second child will bring 0.7 billion space for non-invasive prenatal testing.

On the other hand, molecular diagnostic technologies such as gene sequencing and DDPCR lead the development of in vitro diagnostics (IVD) industry, human gene nucleic acid detection has become the core of molecular diagnosis, and technological innovation has promoted the transformation and upgrading of the industry.

Data show that the annual growth rate of molecular diagnosis in China is 29%, far higher than 18% of immunity and 7% of biochemistry. In 2014, the market size of molecular diagnosis reached 4.59 billion, accounting for 15% of IVD market from 11% in 2010 to 15% in 2014. PCR accounts for 40% of clinical application, and the "2 + X" market pattern led by Da 'an Gene and Huada Gene has taken shape initially; if the proportion of molecular diagnostics in the IVD market remains unchanged at 15%, the molecular diagnostics market is expected to exceed 10 billion in 2019.

Upstream raw materials midstream products downstream services, mergers and acquisitions to promote industrial chain integration

Domestic business owners act as agents for upstream raw materials such as diagnostic enzymes and primers, making breakthroughs difficult. Midstream reagents have been localized (72% in 2012), and domestic enterprises are seeking breakthroughs and replacements for high-end instruments (sequencers, etc.). As downstream users of instruments and reagents such as hospitals and independent diagnostic laboratories (ICL), the growth rate of independent diagnostic laboratories is over 30%, and the proportion of special tests (PCR, etc.) will gradually increase, nucleic acid blood screen brings billions of space. Mergers and acquisitions are a sharp weapon for industrial integration. Enterprises that open up the industrial chain of "production + channels + services" can build a strong moat. Mergers and acquisitions in the industry have been in full swing since 2013.

It is worth mentioning that Da 'an is the leader in molecular diagnosis in China, with related revenue reaching 0.8 billion yuan in 2014, while peers are all below 0.1 billion yuan. As one of the four comprehensive independent diagnostic laboratories, it is expected to enjoy the market bonus of 27 billion yuan for independent diagnostic laboratories. Thirdly, blood screening nucleic acid test (NAT) brings 1 billion space, and Da 'an is expected to get a bigger cake due to the regional advantage of blood donation (Guangdong). Finally, da'an became the first pilot unit for prenatal screening and diagnosis and high-throughput diagnosis of tumors, with a first-mover advantage.

Therefore, in the "2 X" market pattern, Daan Gene (002030) is the leading enterprise of molecular diagnostic products.