Chemiluminescence Technology Development Trend Analysis!

In terms of market share, IVD giants such as Roche and Abbott occupy most of China's chemiluminescence market due to their technological advantages and first-mover advantages. The top four giants alone occupy more than 80% of the market, while domestic manufacturers only account for more than 10% of the entire chemiluminescence market. China's chemical luminescence technology started late, early plate-based, market share of the top three domestic brands are Antu, Kemei and Xinbo.

 

▌Immunization technology develops rapidly and grows into the IVD sub-industry with the largest share

Immunodiagnosis is a method based on the specific immune reaction between antigen and antibody to detect various diseases, and various immunodiagnosis methods have been derived according to the different labeling signals.

 

From its development process, it has experienced the stages of radioimmunoassay technology, immune colloidal gold technology, enzyme-linked immunoassay technology, time-resolved fluorescence immunoassay technology and chemiluminescence immunoassay technology, and has become the mainstream of immunodiagnostic technology.

 

The immunodiagnostic market is the main driving force for the development of the in vitro diagnostics industry. The market has responded to the technological innovation of this sector obviously, and the introduction of new technologies and new products can quickly gain market advantages.

 

Compared with the entire in vitro diagnostic market, the international giants have a high market share in the field of immunodiagnostics, with only Roche, Abbott, Beckman and Siemens having a market share of 70-80% and a high market concentration.

In recent years, the domestic immunodiagnosis industry has developed rapidly, with a compound annual growth rate of more than 20%, with the continuous progress of technology 7, immunodiagnosis has replaced biochemistry to become the largest market segment of China's in vitro diagnosis market, accounting for about 38% of the entire in vitro diagnosis market.

 

However, most of the domestic immunodiagnostic market is occupied by foreign-funded enterprises such as Roche, Abbott and Beckman. Roche's in vitro diagnostic business revenue in the Chinese market in 2016 is about 11 billion yuan, and the immunodiagnostic revenue is expected to exceed 7 billion yuan.

Domestic immunodiagnostic manufacturers are small and scattered, with only a few companies such as New Industries, Mike Bio and Antu Bio forming a scale. However, with the continuous development of immunodiagnostic technology, especially the autonomous chemiluminescence immunoassay

 

The introduction of the instrument, domestic manufacturers in recent years, the rapid development of Antu Bio, for example, 2012-2016 compound growth rate of up to 35%, significantly higher than the industry average growth rate. We believe that immunodiagnostics will maintain rapid growth in the future, benefiting from growth on the demand side and continuous updating of industry technologies.

 

▌ Chemiluminescence is the mainstream technology for immunity, and the industry is growing rapidly.

Chemiluminescence immunodiagnostic technology labels antigens or antibodies with chemiluminescent agents, catalytic luminescent enzymes and other substances. When the labeled antigens or antibodies are combined with the corresponding antibodies and antigens, the luminescent substrates are affected by the luminescent agents, catalytic enzymes and other substances, and redox reactions occur.

 

The visible light released in the reaction is finally collected and processed by the supporting equipment to obtain the concentration of the measured substance, so as to achieve the purpose of determination.

 

At present, there are two kinds of chemiluminescence equipment, microporous plate type and magnetic particle type, in which magnetic particle chemiluminescence has great advantages in sensitivity, single sample detection time, detection range and instrument automation, mainly for tertiary and secondary hospitals with large flow of people.

 

Plate chemiluminescence, as a transitional product from enzyme-linked immunosorbent to chemiluminescence, has been gradually replaced in high-end hospitals, relying only on its low-cost, high-throughput advantages in medical examination centers, third-party laboratories and primary medical institutions to occupy part of the market, and its size is expected to be about 1 billion yuan.

 

Tubular chemiluminescence is the mainstream technology of immunodiagnosis, which can be divided into three categories according to the different markers, namely, direct chemiluminescence immunoassay, chemiluminescence enzyme immunoassay and electrochemiluminescence immunoassay.

 

Direct chemiluminescence is that the marker strengthens the oxidant and emits light instantly under alkaline/acidic conditions. The manufacturer makes the standard curve from 10 points. When using, it only needs to scale the correction curve at the high and low two points, thus saving the reagent and the result is stable and accurate.

 

Enzymatic chemiluminescence is a slow luminescence by enzyme catalytic markers. Due to the instability of the enzyme, 6-12 points are required to make a standard curve each time, and the reagent is wasted. The label of electrochemical luminescence is the chemiluminescent agent terpyridine ruthenium, which can be recycled, so that the luminescence time is longer, the intensity is higher, and it is easy to determine.

 

Compared with the traditional immune technology, chemiluminescence has the advantages of high degree of automation, good specificity, high accuracy and wide detection range.

 

At present, in most tertiary hospitals, chemiluminescence has basically replaced enzyme-linked immunosorbent as the mainstream. The detection scope covers tumors, infectious diseases, thyroid function, kidney function, eugenics, screening, endocrine hormones and other directions, which can greatly meet the needs of clinical testing.

 

Judging from the market share of various application fields, chemiluminescence is currently mainly used for the detection of infectious diseases, tumors, thyroid function and hormones. These detection items account for 75-80% of the total number of tests and 60% of the market amount. In China, these testing items can account for more than 80% of the market amount.

 

Domestic manufacturers new industries, Antu biology, etc. in the tumor, infectious diseases, a large share of testing items are involved, and gradually expand outward.

 

▌ Domestic chemiluminescence competition pattern

In terms of market share, IVD giants such as Roche and Abbott occupy most of China's chemiluminescence market due to their technological advantages and first-mover advantages. The top four giants alone occupy more than 80% of the market, while domestic manufacturers only account for more than 10% of the entire chemiluminescence market.

 

China's chemical luminescence technology started late, early plate-based, market share of the top three domestic brands are Antu, Kemei and Xinbo.

 

In 2011, the new industry took the lead in launching a domestic full-automatic magnetic particle chemiluminescence instrument, which quickly occupied the market after listing. Since then, domestic brands such as Mike, Antu and Kemei have successively entered the field of chemiluminescence by virtue of self-developed tubular chemiluminescence instruments.

 

At present, the pattern of chemical light-emitting enterprises in China is initially determined (a total of 263), the activity of new entrants in the industry is reduced, and the industry has entered a period of rapid development.

As of July 2017, there are more than 20 listed/new three-board enterprises in the domestic chemiluminescence field. Among them, New Industry, Antu Biology and Mike Biology are the leaders of domestic chemiluminescence enterprises. In recent years, they have maintained a rapid growth trend and gradually increased their market share. They are expected to compete with imported products in some advantage testing projects.

 

▌ Endogenous substitution, domestic chemical luminescence high growth is expected to continue.

The high gross margin and high growth of the chemical luminescence industry have attracted a large number of IVD enterprises, including Wanfu Biology, Base Egg Biology, Kehua Biology, etc., to enter the field, with the increasing maturity of technology and the introduction of new products, the domestic chemical luminescence industry has entered a rapid growth period, the scale of the industry continues to expand.

 

We believe that the future performance growth of domestic chemical light-emitting manufacturers mainly comes from endogenous growth, technology substitution and import substitution.

 

Endogenous growth: Blank market promotes graded diagnosis and treatment; It is estimated that the current market of chemiluminescence instruments is about 30000 units. Among them, the tertiary hospital market is mostly occupied by foreign-funded enterprises, while domestic manufacturers rely on high cost-effective advantages to penetrate into some tertiary hospitals and secondary hospitals with a large flow of people, while other secondary and lower hospitals and medical institutions are mostly blank, it is estimated that the capacity of the hospital-side chemiluminescence instrument is about 50000 units, and the market space is about 30 billion.

According to the statistics of the health and Family Planning Commission, by the end of November 2017, the number of medical and health institutions in China had reached 993000, including more than 30000 hospitals, while the vast majority of primary medical institutions such as physical examination centers, disease control centers, community medical service centers and township health centers accounted for the vast majority.

 

With the deepening of medical reform, especially the promotion of hierarchical diagnosis and treatment system, the expansion of inquiry demand in regional physical examination centers, third-party laboratories and middle and low-grade hospitals will form a trend. In the future, with the promotion of chemiluminescence technology and the development of instruments suitable for the middle and low-end markets, chemiluminescence immunodiagnosis is expected to gradually spread to primary medical institutions.

 

Technology substitution: 20% of the traditional alternative space; chemiluminescence has been widely used in developed countries such as Europe and the United States, and is the international advanced mainstream immunodiagnostic technology, accounting for more than 90% of the immunodiagnostic market. In recent years, the rapid development of domestic chemical luminescence, has been basically in the tertiary and large secondary hospitals to achieve coverage, and enzyme-linked immune-based traditional.

 

Immunization technology is widely used in secondary and lower medical institutions because of its mature technology and low price.

 

With the increasing maturity of chemiluminescence technology, chemiluminescence is gradually replacing the traditional immune technology to become the mainstream.

 

In 2011, the scale of chemiluminescence was equivalent to that of traditional immunization. By 2015, the scale of chemiluminescence market accounted for 73%. With reference to the development process of international mature immunization market, chemiluminescence still has nearly 20% alternative space in the future.

Import Substitution: Price Advantage + Policy Incentive: We simply estimate that the market size of the domestic magnetic particle chemiluminescence market in 2016 will be about 17 billion yuan by the total income of major listed companies, while the market share of domestic enterprises in China's chemiluminescence market is only over 10%, and the global IVD giants Roche, Abbott, Siemens and Beckman together account for more than 70% of the market share.

 

There is no doubt that with the gradual maturity of domestic chemiluminescence technology, import substitution will become an important development strategy for domestic chemiluminescence enterprises.

At present, the price of domestic luminescent instruments is only 1/5-1/3 of imports, of which Antu biology is even free, domestic reagents are generally nearly twice as low as imports, for the hospital side, the use of domestic chemiluminescence products has a higher cost advantage.

 

Since the introduction of the first domestic chemiluminescence instrument in the new industry in 2011, the domestic chemiluminescence technology has developed rapidly. At present, the new industry and the fully automatic luminescence instrument of Antu Biology have caught up with the international giants Roche and Abbott in basic performance such as detection speed, reagent position, sample position and detection menu.

At the same time, my country is establishing an incentive mechanism for the active use of domestic medical equipment to curb the unreasonable growth of medical expenses. The "Twelfth Five-Year" Biotechnology Development Plan issued by the Ministry of Science and Technology in November 2011 all proposed to integrate chemiluminescence. Achieve key breakthroughs in high-end products such as immunodiagnostic systems, and improve the localization rate of in vitro diagnostic products in the high-end market.

 

In addition, at present, Shanghai, Zhejiang and other provinces and cities to implement domestic, imported chemiluminescence reagent testing projects according to the same standard charges, and the use of quality, performance and imported chemiluminescence products equivalent to domestic products, can reduce hospital costs, so easy for hospitals to accept.

 

We believe that the process of import substitution in the domestic chemical market is expected to accelerate, driven by the combination of policy incentives and price advantages.