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IVD: The key to breaking the domestic medical equipment industry!

1. Introduction to IVD Industry

1.1 Industry definition, ivd assay definition

In vitro diagnostics (IVD) refers to taking blood, body fluids, tissues and other samples from the human body, using in vitro testing reagents, kits, calibrators, quality control materials, etc. to test and verify the samples in order to prevent and diagnose diseases , Treatment testing, late observation, health evaluation,

In vitro diagnosis includes two parts: diagnostic instruments and diagnostic reagents. Among them, in vitro diagnostic instruments are classified as clinical inspection and analysis instruments under the secondary classification of medical devices, and diagnostic reagents belong to the category of biological products in biological medicine products.

IVD refers to products and services that obtain clinical diagnostic information by testing human blood and other tissues and secretions outside the human body. The “testing” in the commonly known “testing and inspection” in our hospitals includes most subdivisions of IVD-such as biochemical diagnosis, immunodiagnosis, molecular diagnosis, POCT diagnosis, microbiological diagnosis, urine diagnosis, coagulation diagnosis, tissue Diagnosis, blood diagnosis, etc. The first three categories are the mainstream IVD methods of medical institutions in China.

2. Industry Catalog

There are many different classification methods for in vitro diagnosis, which can be divided according to the detection principles and methods as follows. Among them, biochemical diagnosis, immunodiagnosis, and molecular diagnosis are still the main methods of in vitro diagnosis in China.

2. Industry chain

1. Industry upstream

IVD raw materials are mainly divided into enzymes, coenzymes, antigens, antibodies, magnetic beads and microspheres, membrane particles, primers and probes. IVD raw materials involve a wide range of fields, and most senior companies in the industry belong to “small and beautiful”. Long-term accumulation in specific areas. IVD raw materials are strategic nodes of the industry. Antigen, antibody, enzyme and substrate related products in domestic IVD raw materials account for three quarters of the IVD raw material market. At present, China’s main raw materials for diagnostic enzymes and antibodies are still heavily dependent on foreign imports. At present, only a few companies such as Antu Biotech and Mike Biotech can realize the self-sufficiency of some upstream raw materials such as enzymes, antigens and antibodies. A group of domestic enterprises such as Park Bio, Apis Bio are also slowly emerging.

2. Midstream of the industry

In the production process, immunodiagnosis, POCT, and molecular diagnosis have developed rapidly in recent years, and will remain mainstream in the market for some time to come. In recent years, the growth rate of biochemical diagnosis has slowed down. Domestic technology has been relatively mature, and product competition has become increasingly fierce. In the channel link, the industry uses the “instrument + reagent” bundling agent sales model, large enterprises have strong bargaining power; sales link, procurement The policy is gradually clear. At present, the policies of various provinces are inclined to domestic products, and the industry pattern has begun to reshuffle.

3. Industry downstream

At present, the domestic biochemical diagnosis and treatment, immune diagnosis and molecular diagnosis and treatment are mainly used in hospitals, and POCT should be mainly used in hospital critical care, primary medical institutions and families. In recent years, the market for IVD products has expanded rapidly in areas such as medical examination institutions and primary-level medical institutions (such as county-level hospitals).

In terms of medical needs, according to international experience, the proportion of prevention, diagnosis, and graded diagnosis and treatment services in domestic medical services will increase significantly in the future, thereby continuing to promote the rapid growth of IVD. In terms of household needs, the general household diagnostic needs in the future include: pregnancy, infectious diseases, blood glucose, myocardial indicators, blood coagulation, blood lipids, etc.

3. Market situation

1. Market size

The global IVD market in 2017 has reached 63.53 billion US dollars. It is predicted that the global IVD industry will grow rapidly at a CAGR of 5.5% from 2017 to 2021, and will reach 78.74 billion US dollars by 2021. At present, the global IVD market is unevenly developed, with North America as the leading factor, and the IVD markets of economically developed countries such as Europe and Japan also occupy a large share. However, due to social and economic reasons in the Asia-Pacific region, its IVD global market share has always been small. However, in recent years, the Asia-Pacific region has a large population base and a high economic growth rate. The continuous increase in medical security input and per capita medical consumption has driven the demand for the IVD market. It is estimated that its IVD market will have the highest annual compound growth rate in the world

At present, China’s per capita in-vitro diagnosis expenditure is only US $ 5 per year, which is a huge gap compared with the per capita expenditure of developed countries of US $ 25-30. In 2017, China ’s IVD market capacity was 65 billion, and it has maintained a growth rate of about 20% in recent years. It is predicted that China ’s IVD industry will grow rapidly at a compound annual growth rate of 20% from 2017 to 2021, and will reach 20% in 2021. 134.7 billion yuan.

4. Industry

(1) Key points of subdivision

1. POCT

POCT, point-of-care testing, refers to a testing method that is carried out at the sampling site and uses portable analytical instruments and matching reagents to quickly obtain test results. In space, it is the test carried out by the patient, that is, “bedside test”; in time, “instant test” can be performed. POCT is a subdivision of in vitro diagnostic devices (IVD). With the advantages of convenience, speed and low overall cost, it can quickly obtain diagnostic results at the patient’s side. China’s POCT market is still in the huge blue ocean market, and domestic enterprises have achieved initial results in import substitution.

The rapid expansion of the domestic POCT market

According to the TriMark report, the global POCT market size was US $ 15.9 billion in 2018, with an average annual compound growth rate of 7.5% over 10 years. In the global POCT market, developed countries in Europe and America account for 80% of the market share, and Asia accounts for about 15% of the POCT market.

Domestic POCT started late, with the characteristics of small base and fast growth rate, and huge development potential. According to China Industry Information Network, China’s 2018 POCT market scale reached 1.43 billion US dollars, with an average annual compound growth rate of up to 24%. The major domestic POCT producers Wanfu Bio, Jiegong Biology, Mingde Biology, etc. have maintained rapid performance growth in recent years, with an average growth rate of over 30%. With the promotion of medical reform and the gradual improvement of primary health construction, China’s POCT market is expected to maintain a compound annual growth rate of about 20%

Graded diagnosis and treatment drive the expansion of primary medical market

Hierarchical diagnosis and treatment have promoted the increase in the number of grass-roots outpatient clinics, and the rapid separation of diagnosis has made POCT widely available in hospitals and departments at all levels. For projects with a low sample size, the single-person single-shot detection method is quick and easy, the professionalism of the operator is not high, and it is convenient for storage and low-frequency use. It is very suitable for primary medical institutions, so the product characteristics meet the general direction of graded diagnosis and treatment . In terms of popularity, conventional blood analysis (hematocrit), protein and enzyme testing (biochemistry) have been popularized at the grassroots level. The policy bonus of POCT products obtained from graded diagnosis and treatment will promote the rapid development of POCT enterprises in the future.

There is a “zero-sum game” with the laboratory

The traditional use of POCT is established in various clinical departments of the hospital. In mainstream medical institutions above Class A, most of the laboratory equipment are automated products, with large sample size and high level of technicians. The use of POCT in clinical departments will divert the income of the laboratory, so there is a game of interest. Because clinical and laboratory departments have different interests, they have limited clinical use.

An important sector where household appliances and medical resources are sinking

At present, most of the POCT equipment is still hospital-use POCT equipment, and the most successful household POCT equipment in the current market is almost only a blood glucose meter, which cannot meet the growing market demand. With the rise of the household appliance market and the enhancement of national health awareness, the market share of household POCT equipment is gradually increasing. In the future, POCT results can be uploaded to the cloud platform to enter the stage of intelligent POCT diagnosis. The boundaries of POCT’s professional and non-professional markets are gradually blurred, making a major contribution to the promotion of precision medical plans.

2. Immunological diagnosis

In 2017, the industry scale of domestic immunodiagnostic reagents exceeded 21 billion, and the industry growth rate exceeded 20%. Immunodiagnostic reagents have been developed overseas for more than 60 years, and the technology is relatively mature. At present, immunodiagnosis is mainly based on chemiluminescence technology. Compared with traditional immunology technology, chemiluminescence has the advantages of high automation, good specificity, high accuracy, and wide detection range. The accuracy and sensitivity are close, and the risk of replacement in the short term is small. At present, the domestic immunodiagnostic market is occupied by Roche, Abbott, Beckman, Siemens four international giants with technological advantages and first-mover advantage. Domestically, new industries, Mindray Medical, Mike Bio, Antu Bio are constantly developing There are huge opportunities for domestic substitution in the future.

3. Molecular diagnosis

In 2017, the domestic scale of molecular diagnostic reagents reached 8 billion yuan, with a growth rate of 24%. Molecular diagnosis is detected at the genetic level, and the advantages of detection sensitivity and accuracy are obvious. It is mainly used for the detection and diagnosis of genetic diseases, infectious diseases, tumors and other diseases. The mainstream PCR technology of molecular diagnosis is said to be lower than the current mainstream immune technology barriers. The domestic market is in a “pseudo-oligarch true red sea” situation; the future prospects of molecular diagnostics applications. With the popularization of targeted therapy for tumors and new targeted drugs, more drug testing (accompanying testing) is required. Non-invasive prenatal testing (NIPT) is expected to be widely promoted in the future. There will also be opportunities for large-scale promotion of gene sequencing in early cancer screening and personal genome testing in the future.

4. Biochemical diagnosis

In 2017, the domestic biochemical diagnostic reagent market scale was about 19.5 billion yuan, with an industry growth rate of 5%. At present, biochemical diagnostic reagents are well-known both domestically and overseas, and the technical barriers are low. They face the risk of being completely replaced by other more accurate and rapid diagnostic technologies. Monopoly power is very strong.

Summary: At present, the domestic IVD industry is still in the early stages of development, and the degree of localization is not high. In the future, there are huge development opportunities in POCT, immunodiagnosis, and molecular diagnosis.

Seeing good profits and wide market, the IVD market is “hot in winter” IVD can quickly generate profits by building sales channels.

In the laboratory of a quiet hospital in Beijing, Dr. Zhang is busy testing blood. However, it is worth noting that in the top three hospitals in the country, most of the ivd solutions test reagents and instruments are imported. “Most enzymes, antigens and antibody reagents are imported. The domestic rate of upstream raw materials is less than 20%. The supporting equipment is natural. Imports are also important. “In fact, Dr. Zhang’s feelings are not speculative. At present, the in vitro diagnostic instruments and reagents used in large hospitals in China are basically controlled by the top six international giants such as Roche, Siemens, Abbott and Beckman, accounting for more than 60% of the share, and the living space of domestic instruments is limited.

What does not match it is the leap-forward development of the IVD industry. According to Allied Market Research market research and forecast, the global in vitro diagnostic market size reached USD 64.5 billion in 2017 and will reach USD 93.6 billion in 2025. “But in recent years, as CFDA has strengthened supervision, the entry barrier has been continuously raised, and the market share of domestic brands is gradually concentrated.” Dr. Zhang mentioned, “Import substitution is the key that has been repeatedly mentioned in the IVD industry in recent years. “Hot word.” The in vitro diagnosis known as the “doctor’s eye” is also becoming a “handle” for investment organizations with keen sense of smell to pry the billion-dollar market.

1. In vitro diagnostic investment fever under the cold winter of capital

The cold winter has become a vocabulary that cannot be avoided in this year’s venture capital circle. After several years of cheering investment and financing, it will gradually return to silence after 2019. According to the data from CV source, only 6,800 companies successfully achieved financing in 2019, which is almost broken compared to last year; the total financing is also bleak, with a transaction size of 831.4 billion yuan in 2019, which has continued to decline since 2015 The worst record in the past five years. The amount of investment and financing and the number of investments are behind a cliff-like decline. Difficult fund raising, risk avoidance, certainty, and economic downturn have become the topics that investors feel most empathetic with. Survival seems to be the goal itself.

“The plight of the fund-raising end is transmitted to the downstream, and the investment institutions are more cautious in their shots than in previous years. The absolute number of good projects is declining.” Yu Bo, head of the medical field of Ziniu Fund, said, “Each investment institution is seeking As a safe haven, medical investments that have attracted attention due to high growth are also unavoidable. “In the cold winter, investors in medical companies have grabbed the high ground, such as cancer drugs, blood products, cardiovascular and cerebrovascular drugs, and continued in recent years. The warming IVD (in vitro diagnostics) industry.

In vitro diagnosis refers to a technique for obtaining diagnostic information by testing human samples (such as blood, tissues, body fluids, etc.) outside the human body. According to the detection method, it can be divided into immunoassay, molecular diagnosis, biochemical diagnosis, POCT and so on. In-vitro diagnosis is the darling of the cold winter of capital. With the overall VC market downturn, investment and financing have been on an upward trend since 2016. Although slightly reduced in 2019, it still achieved a total transaction value of 3.438 billion yuan. On the occasion of the year, cancer genetic testing agency Shihe Gene completed 800 million yuan of round D financing, setting a single round of RMB financing record in the industry.

In Yu Bo’s view, “The IVD diagnostic industry itself is the largest in the medical device field, and the big market breeds large companies; and the IVD field is a typical technology-intensive track, such as chemiluminescence, molecular diagnostics, POCT, microfluidics. New technologies, such as control, continue to mature and iterate, and technological variables provide new opportunities for new startups and capital; in addition, the emergence of new scenarios also brings opportunities, and the increase in primary medical care and out-of-hospital scenarios is also an opportunity. “

Xinghan Capital Medical Investor Chen Yunyan believes that in the cold winter, investment institutions tend to choose anti-cyclical and stable projects. The medical industry as a whole has shown a clear upward trend this year. From the perspective of the economic cycle and the development cycle of science and technology, the medical industry is beginning to replace the Internet industry. In the process of the conversion of old and new kinetic energy, the potential opportunities have reached the point of time before the outbreak; why IVD is favored by investment institutions is that IVD can be built Sales channels generate profits quickly. In the current market environment, IVD is also the earliest emerging technology in the medical industry that has been commercialized and first exposed to the public.

Chemiluminescence large-scale inspection instruments, pipeline equipment, POCT, and liquid biopsy have become popular investment directions for in vitro diagnosis. Hu Shuang, the founder of Yihong Health, is interested in the market changes brought about by the rise of primary medical care guided by policies, and has invested in POCT’s entrepreneurial army. At the same time as the base of the organization increases, there is a trend of differentiation, that is, the trend of specialization, small chains, and full-scale branches.

2. Substitution and risk control

According to the Renub Research Analysis market research report, China’s in vitro diagnostic market reached US $ 3.111 billion in 2014 and US $ 6.336 billion in 2018, with an average annual compound growth rate of 19.46%, far exceeding the growth rate of the global market over the same period.

According to Song Haibo, secretary general of the National Health Industry Enterprise Management Association, there are more than 20,000 in vitro diagnostic circulation enterprises (operating enterprises) in China, and more than 1,000 production enterprises. “Basic projects have more or less big players, but some” new projects “appear every year. Some companies can rely on 1-2 first projects for 2-5 years of moisturizing time, and then they will appear. A large number of followers. “Hu Shuang said,” Followers flooded into the track, capital was heated, and the technical threshold continued to rise. “

With the advancement of technology, import substitution is in progress. Yan Jing, the founder of Huixian Pharmaceutical, focuses on the research and development of microfluidic platform. The current molecular diagnosis of microfluidic is mainly reflected in gene chip technology, which is detailed in tumor detection, exosome detection, single cell sequencing, gene editing, infection detection, etc. Widely used in different fields. “As far as the special inspection market is concerned, the gap between domestic products and foreign products is constantly narrowing, and the distinction between imports and domestic products is already very small. The most important thing for IVD products is high performance, low cost and fast speed.”

Investors naturally want to get a slice of it. “But import substitution is a long-term policy mechanism. Heart stents, monitors and other fields have made rapid progress, and the proportion of domestic production has been very high. However, although other fields are rapidly following up, core technical barriers still need to break through to complete the time period for import substitution. It’s still relatively long, at least 10-20 years. “Yu Bo mentioned,” Longer replacement cycles naturally have uncertainty, and how to seek certainty in uncertainty becomes a matter of consideration. “

Yu Bo introduced that this year’s in-vitro diagnostic financing transaction rounds are largely concentrated after the A round, and the financing status of the early rounds is not ideal.

How to control risks, high-quality track + squatting head becomes the key.

Why snap up the head? Chen Yunyan believes that the medical industry is different from the traditional consumer or literary and art industries in that it is controllable, and the benefits and risks are relatively equal. The development of the head project is early, and it has already seized part of the market. The technology has also been verified in previous rounds, and the risk of focusing on boosting the head is much smaller.

Training of personnel on in vitro diagnostic reagent testing guidelines

This clause contains two meanings. First, all personnel engaged in the production of in vitro diagnostic reagents definition should receive professional and safety protection training based on the products and the production operations they are engaged in. Second, personnel engaged in various types of cleaning (including the cleaning of workshops, materials, and the environment) and maintenance (including the maintenance of production facility equipment and testing facility equipment) should also receive professional and safety training.

Enterprises often overlook the training of the second category of personnel. For those who enter the purification area for cleaning and maintenance operations, if they do not understand the use management regulations of the clean room (area), do not understand the characteristics of the materials in the clean room (area), and do not operate in the purification area as required, they will exist. Risk of pollution to the environment, materials, products, equipment and personnel.

In vitro diagnostic reagents may come into contact with some materials that are easily contaminated, biologically active materials or materials that are sensitive to environmental conditions (such as various enzymes, antibodies, nucleic acids, cells, etc.) during the production process, and some Pollution, toxicity, infectious materials (such as strong acids and bases, various dyes, serum, viruses or bacteria, etc.). Therefore, it needs to be handled and operated by professionally trained personnel to prevent accidents that affect product quality or other accidents that affect the safety of personnel.

The purpose of this clause is to ensure that personnel related to the production of in vitro diagnostic reagents can obtain professional knowledge and safety protection knowledge related to product safety. It is worth noting that the relevant personnel include not only production personnel, but also cleaning and maintenance personnel, so as to prevent potential product quality risks and personnel safety risks.

Check points

First of all, we should pay attention to whether the products produced by the enterprise have the environment, equipment and facilities, materials or production links that require professional handling and operation in the production process.

Secondly, we should pay attention to whether the company has formulated relevant regulations such as professional operation requirements and safety protection requirements for the above environment, equipment, facilities, materials or production links.

Third, we should pay attention to which personnel need to be trained in professional operation requirements, safety protection requirements and related regulations, whether the training has been implemented, and how effective it is.

Inspection Method

①Through the inspection of technical documents such as product technical requirements, process flow charts, bills of materials, instruction manuals, etc., confirm whether the products are of the type required to be produced in a purified environment as specified in the “Appendix In Vitro Diagnostic Reagents for Medical Device Manufacturing Quality Management Standards” There are materials, equipment and production processes that require professional operation and safety protection.

② Check the requirements for personnel in the clean room (area) and the documentation requirements for personnel training; check the requirements and regulations for materials, facilities and equipment and production links that require professional and safety protection.

③Check the list of people working in the clean room (area), and the list of people who may be exposed to dangerous goods and pollutants.

④Check the training plan to determine whether the company has conducted professional technical training and safety protection training for all personnel (including cleaning, maintenance, etc.) engaged in the production of in vitro diagnostic reagents according to their products and the production operations they engage in. Personnel training records.

⑤Check on-site whether the personnel in the clean room (area) are implementing relevant requirements.

⑥Check the documentation requirements and implementation of personnel who temporarily enter the clean room (area).

⑦Persons who are engaged in the production and quality inspection of products with special requirements such as high biological activity, high toxicity, strong infectivity, strong allergenicity, etc., should possess relevant post operation qualifications, or receive relevant professional technical training and protection knowledge training, and the training is qualified You can only go to work afterwards, and you can check the training records and assessment records.

Precautions

Enterprises should first identify whether there are raw materials or products with special requirements, whether there are biological hazards, chemical hazards, etc., and take corresponding professional protective measures.

case study

Case number one

When the inspectors randomly checked the training records of the production operators, they found that there was only one training sign-in form. There was a column in the middle of the form that reads “Appraisal Method”, which was filled out as “Qualified Oral Examination”, and the appraisers were managers of the personnel department. The “Training content” column in the form is filled with “Operational training”, the specific training content and assessment content are not filled in, and the company cannot provide a training plan, and the company’s personnel training requirements do not specify specific content.

Analysis: According to the requirements of the “Guidelines for On-site Inspection of In Vitro Diagnostic Reagents”, companies need to provide at least the following training content.

①Everyone who works in a clean room (area) should receive regular training in basic knowledge of hygiene and microbiology, clean operation, etc. The enterprise shall guide and supervise the personnel who temporarily enter the clean room (area).

②All personnel engaged in the production of in vitro diagnostic reagents (including cleaning and maintenance personnel, etc.) shall conduct professional technical training and safety protection training according to the products they produce and the production operations they are engaged in.

Enterprises should first formulate management requirements for personnel training, and make detailed and targeted regulations on the training needs, training plans, implementation plans, evaluation plans, and post capability confirmation of personnel in different positions. Secondly, enterprises should implement systematic training and assessment of personnel, establish training plans, clarify training content, and formulate assessment methods. Third, the evaluation and evaluation should be carried out by the person in charge of the use department and confirmed by the personnel department. Fourth, training files should be established and training and assessment records should be kept.

During the inspection process, the inspectors should pay attention to the effectiveness of the training and check whether the company has implemented the training. If the enterprise’s training work is only formal, it will eventually affect the ability of actual operators.

【Case 2】

When inspecting an in vitro diagnostic reagent manufacturing company, the inspector found that the company’s process documents stipulated that: before the production microplate coating machine and piping system are used, they need to be rinsed with process water for 30 minutes to clean the pipeline. When inspecting a batch of production records, the inspector found that the record showed that the equipment cleaning start time before the operation was 8:30, the microplate coating start time was 8:50, only 20 minutes apart in the middle, and the production process file was not reached The required 30-minute rinse time. When checking the training records of related operators ×××, it was found that the records showed that the training was concentrated in teaching, and the assessment method was not clear.

Analysis: The main problem in this case is that the training of the operating personnel did not achieve the expected results.

①The operator did not clean the equipment in accordance with the requirements of the process documents, which could not guarantee the quality of the product, and there were hidden quality risks.

②The operator did not clean the equipment according to the confirmed method. The enterprise should conduct a risk analysis of the product produced, evaluate the impact of this behavior on the quality of the product, and then decide the follow-up measures accordingly.

③ During the inspection, it was found that the relevant personnel had received training, but the actual operation was not carried out according to the regulations, the enterprise did not evaluate the effectiveness of the training, and did not follow up and check the actual operating ability of the operator.

This case shows that enterprises should conduct different forms of training for operators of different processes, and can flexibly adopt methods such as teaching and practical operation; secondly, enterprises can adopt different forms of assessment for operators of different processes, and focus on actual operations. The staff shall mainly focus on the operation assessment to confirm that they can grasp the operation requirements and complete the operation correctly; thirdly, the enterprise shall conduct follow-up inspection on the trained personnel to confirm the training effect; fourthly, the employees who have not met the training requirements shall Retrain or relocate them.

Overview of in vitro diagnostic industry technology

IVD products definition

This article will provide an overview of the in vitro diagnostic industry technology, and follow up on specific aspects. In vitro diagnostics, or IVD, has undergone four revolutions in biochemical, enzymatic, immunological, and molecular diagnostics. It has become a relatively mature large-scale industry and has played an important supporting role in clinical diagnosis and preventive treatment. The nature, function, classification and development of it are elaborated below.

1. The nature and role of in vitro diagnostic industrial technology The relationship between in vitro diagnostic industrial technology and medical testing technology is very close. The development of the industry is accompanied by the development of biochemistry, immunology, molecular biology, automation, information technology and other fields. In vitro diagnosis refers to taking blood, body fluids, tissues and other specimens from the human body, using in vitro testing reagents, kits, calibrators, quality control products, instruments, etc. to test and verify the specimens for disease prevention, diagnosis, Discipline of treatment monitoring, prognosis judgment, prediction and health evaluation. The instruments, reagents and consumables required in the detection process constitute an in vitro diagnostic system, which brings together related technologies such as biology, medicine, machinery, optics, electronics, computers, engineering design and manufacturing. The role of in vitro diagnostic industry technology in clinical medicine and medical testing is to improve diagnostic efficiency, speed up testing, ensure testing quality, expand testing scope, improve automation, and reduce testing costs.

2. Classification of in vitro diagnostic products At present, our domestic in vitro diagnostic products refer to in vitro diagnostic reagents for medical device management, including reagents, kits, and calibrations that can be used alone or in combination with instruments, appliances, equipment, or systems for in vitro testing Products, quality control products, etc. The national in vitro diagnostic reagents for blood source screening and the in vitro diagnostic reagents labeled with radionuclides are not within the scope of the “Administrative Measures for the Registration of In Vitro Diagnostic Reagents (Trial)”. According to different classification methods, it can be divided into different in vitro diagnostic products: according to the detection principle or detection method, it can be divided into biochemical diagnostic products, immunodiagnostic products, molecular diagnostic products, microbial diagnostic products, urine diagnostic products, coagulation diagnostic products, blood There are eight categories such as diagnostic and flow cyto diagnostic products and on-site rapid diagnostic products.

Among them, biochemical, immunological, molecular and instant diagnostic products are the four main categories of domestic diagnosis.

Biochemical diagnosis: mainly used to measure enzymes, sugars, lipids, protein and non-protein ammonia, inorganic ions, liver function, kidney function and other indicators. Biochemical products started earlier in the country, have mature development and low cost. They are the most routine testing items in hospitals. They have complete types and stable quality, and have occupied most of the market.

Immunological diagnosis: mainly used for detection of hepatitis, sexually transmitted diseases, tumors, early pregnancy, etc. Methodology mainly includes enzyme-linked immunoassay, fluorescent immunoassay, chemiluminescence, and colloidal gold. From the current point of view, the foreign market is dominated by chemiluminescence, and the domestic coexistence of chemiluminescence and enzyme-linked immunity. From the point of view of the in vitro detection method and the degree of automation, chemiluminescence is superior to ELISA, but ELISA has the advantages of low cost and large-scale operation.

Instant diagnosis: namely POCT, also known as on-site rapid diagnosis, bedside diagnosis. At present, it is widely used in the detection of cardiovascular diseases, diabetes, and infectious diseases. It is also used in drug residue detection, coagulation index detection, tumor marker detection, blood gas analysis, rapid allergen detection, blood ethanol detection, toxic analysis, etc.

Molecular diagnosis: mainly at the genetic level, there are three types of products: polymerase chain reaction PCR, in situ hybridization ISH and gene chip. Due to the high technical requirements, molecular diagnosis has few applications at present, but the development potential is huge. It will have great applications in the future of personalized diagnosis and treatment, genetic disease screening and diagnosis, pharmacokinetic genomics, and detection of major emergencies.

According to the level of product risk, it can be divided into the first category of products, the second category of products and the third category of products.

The first type of product: microbial culture medium, sample processing products.

Type II products: In addition to Types I and III, including proteins, sugars, hormones, enzymes, lipids, vitamins, inorganic ions, drugs and drug metabolites, autoantibodies, and other physiological, biochemical, or immune Reagents for functional index detection.

The third type of products: including reagents related to the detection of pathogenic pathogen antigens, antibodies and nucleic acids; reagents related to blood type and tissue matching; reagents related to human genetic testing, reagents related to genetic diseases, and narcotic drugs, Reagents related to the detection of psychotropic drugs and medical toxic drugs; reagents related to the detection of therapeutic drug targets; reagents related to the detection of tumor markers; reagents related to allergens, etc.

3. Development of in-vitro diagnostic industry technology The development of in-vitro diagnostic industry technology and the development of medical tests are carried out simultaneously. China began to develop and produce blood analyzers based on electrical impedance principle technology in 1960. In 1965, Shanghai produced the first domestic blood cell counter. In the 1970s, there were only a few companies in the domestic IVD industry that did two-and-a-half batches of stains, diluents, and various test tubes. In 1982, the Clinical Laboratory Center of the Ministry of Health was established, and then the clinical laboratory centers of various provinces and cities were successively established, which played a great role in promoting and promoting the formation and development of China’s in vitro diagnostic industry. In 1988, the National Medical Clinical Laboratory and the In Vitro Diagnostic Communication Standardization Technical Committee were established. It marks the clarion that the in vitro diagnostic industry is advancing towards internationalization, which greatly promotes the progress of the in vitro diagnostic industry and the improvement of product quality. The first automatic biochemical analyzer in China was born.

In the 1990s, China’s IVD industry entered a period of rapid development, and a large number of IVD manufacturers and import agents came into being. At the same time as international exchanges, China’s self-developed products are also synchronized, and a series of commercialized products have been launched one after another. In the 21st century, the domestic subdivision of in vitro diagnostics has gradually risen. It is becoming more and more mature, from R & D to industrialization, and gradually replacing imported products. The leading enterprise’s industrial chain is continuously improved. The upstream, middle, downstream, and upstream of the industrial chain are subdivided: raw materials such as diagnostic enzymes, antigens, and antibodies are still monopolized by foreign companies , Companies with outstanding domestic research and development capabilities are gradually strengthening the research and development of raw materials. Midstream: factors such as production, channels, sales, etc. lead to the strong to become strong. Downstream: Diversity of consumers, comprehensive solutions are the core competitiveness. Generally speaking, becoming an IVD enterprise with core competitiveness in the market should provide a comprehensive solution from upstream to midstream and even downstream.

Analysis of the status quo of competition in China’s in vitro diagnostic industry] Industry differentiation is fiercely competitive

In recent years, China’s IVD industry has entered a period of rapid development dividends. According to Evaluate MedTech statistics, in 2018, the global in vitro diagnostic industry market size was about 68.4 billion yuan. The following will take you to understand the competitive status of China’s in vitro diagnostic industry.

In recent years, the global ivd test market has grown steadily. Among the global IVD markets, North America, Europe, and Japan are still the major consumer markets. According to Evaluate MedTech statistics, in 2018, the global IVD market size was about 68.4 billion yuan.

Relevant companies’ revenue growth rate is higher than net profit growth rate

In 2018, 59 new third-board IVD-related companies had a total revenue of 5.438 billion yuan, an increase of 14.53% from 2017, and a net profit of 511 million yuan, an increase of 5.95%. The operating income of 23 motherboard IVD-related companies reached 58.294 billion yuan, an increase of 28.01% over 2017, and net profit was 8.849 billion yuan, an increase of 26.02%. The scale and growth rate of the main board companies are significantly higher than those of the new third board companies, and the industry’s “Matthew Effect” is obvious. On the one hand, the reason is that R & D advantages, brand effects, and platform construction have caused an increase in industry concentration. On the other hand, the landing of A-shares by leading companies has resulted in obvious capital advantages.

Taken together, the growth rate of operating income of related companies is greater than that of net profit, and the decrease in gross profit margin is the main reason why the growth rate of related companies’ revenue is greater than that of net profit. Take the four companies of Kehua Bio, Leadman, Daan Gene and Dean Diagnostics as an example. In 2018, the gross profit margin of three of the four companies decreased, and the gross profit of Kehua Bio, Leadman and Daan Gene Interest rates were reduced by 0.45 percentage points, 5.86 percentage points, and 1.5 percentage points respectively compared with 2017.

Industry differentiation is relatively fierce

Judging from the five-force analysis model for new companies entering the industry, the upstream bargaining power of the industry is strong, the demand in commodity supply and demand is less affected by price, there are certain capital and technical barriers, there are many competitors, and the industry competition is relatively fierce.

Judging from the problems that easily arise in industry competition, in the in vitro diagnostic industry competition, there are problems of product homogeneity, sales channels and supply channels are similar or the same, and strategies and methods for companies to enhance competitiveness are easily imitated. The control measures adopted by the company mainly include: strengthening product brand marketing and brand culture promotion, highlighting the product’s nuance differentiation; consolidating channel relationships and maintaining stable partners; and doing a good job of keeping confidential the company’s information and information.

The above data comes from the “Investigation Industry Market Demand Forecast and Investment Strategic Planning Analysis Report” of the Foresight Industry Research Institute. At the same time, the Foresight Industry Research Institute also provides industrial big data, industrial planning, industrial declaration, industrial park planning, industrial investment attraction and other solutions. Program.

One of the four big stove cities in China, up to 37 degrees in the evening, do you know where it is?

The hearth city is china’s hyperbole about hot summer cities. I do n’ t know if my friends have heard of the four big hearth cities. The hearth city is used to describe several cities in the south that have long summer heat duration and high heat intensity. After the founding of New China, there was the saying of “four big stoves “, namely Wuhan, Nanjing, Chongqing, Nanchang.

In the 21st century, there were “new four big stoves “, namely Chongqing, Fuzhou, Hangzhou, Nanchang, but no matter what kind of statement, Chongqing always ranked among them, even at the top of the list, Chongqing heart: stove city flights to hainan ranking casually change, I Chongqing not on the list count I lose! Chongqing, which is one of the most famous stove cities in china, even qijiang in chongqing has had a terrible heat of 44.5 degrees. Even in the early hours of the morning when the sun has set for a long time, the local average temperature can sometimes reach 37 degrees Celsius.

Funny thing is, in the past few years, there has also been a small black brother from Africa in Chongqing heatstroke news, which also fully shows that Chongqing’s hot heat is not a wave of false fame. In fact, the temperature of chongqing is so flight to shandong high, not only because of the climate, but also has a close relationship with the local geographical location. First of all, chongqing is a famous mountain city, many friends may think that such a mountainous city temperature will be lower, but obviously chongqing is an exception, because surrounded by mountains, the humid air from the southeast has not reached chongqing, so the city is almost no monsoon.

Secondly, because all the wind is blowing from the high mountain area to the inner plain, what is formed is a kind of lower wind which is called burning wind geographically, the biggest characteristic of this kind of wind is that no matter what the humidity, it will not rain, which is the root cause of Chongqing heat. But chongqing is a very suitable place to travel and live, and there are many delicious food, which attracts many tourists.

Friends, such a high temperature and food of Chongqing, is not more let your heart yearn for it?

China’s most “shameless” scenic spot: the ticket office is located on the road, passing by also to pay 40 yuan ticket

Since ancient times, our country is a country with a long history, in the history of thousands of years up and down, the precipitation of history are so precious. Among the many places of interest in China, there are magnificent mountains and rivers, there are ancient rhyme full of buildings, who can imagine in the yellow sand everywhere, vegetation in the Gobi Desert, there is actually a Han Dynasty gate? At the same time, there are also a lot of complaints here, but also be ridiculed as the most “shameless” scenic spots in China: the ticket office is located on the road, passing by also to pay 40 yuan tickets!

It is located in the yumen pass of gansu, where flights to hainan there are many gobi, desert, meadow, existing square loess of the city, for tourists to build wood cutting road and wooden platform into the city or can be viewed in the distance. Presumably many people come here to see history, not scenery. It is reported that in the history of China, there are three Yumen pass, to the west of Dunhuang this Yumen pass is the most famous. In fact, the real face of Yumen pass is a large stone with a door hole, and into the scenic area is only some scattered stone, visitors to the Yumen pass evaluation is mostly not worth the price of this ticket.

For many tourists, here is not only the scenery is disappointing, scenic tickets and fees are even more depressing, tickets 40 yuan but can only see a pile of stones, so that many people shout worthless. At the same time, the ticket office of Yumen pass scenic spot is at the intersection of the highway, even if the passing tourists have to pay 40 yuan tickets to pass here, it is like the “toll” on the highway, which makes many people feel puzzled and depressed. Although the area of Yumen pass can enjoy the unique vicissitudes of life and desert scenery in the northwest, but spend money but can not see anything brilliant and unique, and only passing by here also need to pay money caused by tourists complain and dissatisfaction, Therefore, Yumen pass was also named “the most shameless scenic spot in China “.

Besides, there is a legend here. According to flight to shandong legend, after the smooth passage of the silk road, the western region of the various countries of the caravan through this endless stream into the customs, in order to return to the Central Plains for a large number of silk, sent officers and soldiers, specially escorted to transport jade. After the officers and men were transported several times, there was a very strange phenomenon, that is, the camel carrying jade will spit white foam as soon as it enters the city, and will be in a serious coma. When everyone was at a loss, an old camel-pulling told the transport officer that the camel was ill and there was a reason. We have been here for years to transport jade stone, never worship Guan God, no more sacrifice, I am afraid the next trip will also be sick. How can that be To eliminate diseases and eliminate disasters and ensure the safety of people and animals? The old man said that only need to use the first grade jade, in this city closed on the inlay a circle, so that the closure of the building has a luster, Guan God is also happy. Then the escort officer according to the old man’s advice to do, camel disaster really eliminated, safely arrived in Changan. Guancheng because of the gate built a circle of glittering jade from now on called Yumen pass.

All in all, everyone’s living standard is very good now, so they will choose to travel during the holiday, in order to avoid going out to meet such a depressing scenic spot as Yumen pass, we must do a good introduction in advance, find out exactly where fun, which places are worth a visit, so that we can go out to relax purpose.

Guangdong is building a railway line that will operate in 2023 to boost the economy in Dongguan and other cities

The speed of Guangdong’s economic development is obvious to all, and it is precisely because of this, there are many people “uprooted” in order to be able to realize their dreams in this developed province, break out of their own world, there may be many people after arriving in Guangdong, the “lost” situation, after all, this province is really too developed, many tall buildings, at the same time, the local transportation is also in the process of increasingly perfect, now Guangdong has a lot of railways in the process of building.

Guangdong province has a railway under construction, and one of it is officially operational. It is called the Shenmao Railway, which opened flights from shanghai to taipei as early as 2014, and was successfully opened in the 2018 project section. It is expected to be fully operational in 2023. The high-speed rail line is about 390.1 kilometers long, starting in Shenzhen, and ending in Maoming after it has been opened to traffic in Dongguan, Guangzhou, Jiangmen, Yangjiang and Zhongshan.

As we all know, the three cities of Shenzhen, Guangzhou and Dongguan have a very developed business industry, which has been promoted by the era of network promotion in recent years. Of course, transportation as a link also shows a unique role. After the railway is fully integrated and operated, the three cities will also develop more rapidly.

The railway will have a far-reaching impact shanghai to taipei flights on Yangjiang and Maoming in the western part of Guangdong, because there is a great space for development in the western part of Guangdong. The railway will also stimulate the local development potential. After being driven by the three cities of Shenzhen, Dongguan and Guangzhou, Yangjiang and Maoming will also achieve a “qualitative leap “.

Small editor believes that this line to help Dongguan, Guangzhou and other cities to boost the economy of the vital role, at the same time, can also shorten the space-time distance between these cities, after its completion, Guangzhou to Zhanjiang will be shortened to less than three hours, while in Guangzhou to and from Maoming will be shortened to two and a half hours, in short, this 390.1 km long railway, after operation, is bound to have a profound impact on this province of Guangdong. do you expect its early full line operation? Do you think it will help boost the economy of many cities along the route?

Thailand Tourism Nine Must Visit Attractions

In this magical land of Thailand, whether you are a literary youth, backpacker or food control, you can find your own “happiness” here. Thailand has many tourist attractions, which one is more suitable for themselves? Let’s take stock of the nine most worthwhile attractions in Thailand!

1. Bangkok is a Buddhist city and a modern city that combines East and West cultures. There are gorgeous Grand Palace, ancient Wofo Temple, Zheng Wang Temple, but also bustling Siam Square, lively Chinatown. Bangkok people eat spicy, eat sour seafood, prefer a variety of spices, the food here absolutely enjoyable! In addition, a wide range of goods can also be sold. The best time to travel in Bangkok is from October to February each year. As for equipment, a sun cap and a pair of sandals are enough!

2. Chiang Mai is smaller and fresher than busy flights from shanghai to shenzhen Bangkok: clean air, quiet city, street view and nature. There are many temples here, especially in the ancient city, there is almost one in three or five steps, entering the temple need to wear long skirts or trousers, girls can rent a piece of sari around the temple gate road. Chiang Mai’s night market is also worth a stroll, a wide range of goods and snacks, shopping can also kill prices. Out of the city, the countryside can play a lot of things, bamboo raft drift, jungle shuttle, rainforest exploration, very thrilling. But be safe!

Beautiful sea view 3. Battaya, perfect for vacation. Pattaya beach sunshine can be sunbathing, coral island water projects many, air parachute, sea motorcycle, play is heartbeat! In addition to the Sunshine Beach, Pattaya has many unique cheap flights from shanghai to shenzhen attractions, such as the all-wood structure of the Truth Temple, the super luxury of Dongba Paradise, pure gold cast of the seven treasures of Foshan Buddha, and so on. If you’re going to Pattaya, do n’ t pick April-May, the heat season, the weather is too hot.

4. Phuket is Thailand’s largest island, pure white beach, clear bottom of the sea, with the wind swing coconut forest, is simply a holiday paradise ah! Tourism development here is relatively early, catering and entertainment are available. Phuket Island has many high-quality beaches, among which Padang Beach is the most popular, with sunbathing, banana boats, sails, yachts and many other water entertainment projects. The UV intensity here is high, if go to the seaside to play, must do a good job of sunscreen.

5. Sumei Island is definitely the first choice for a comfortable vacation. Still coconut trees, clear and sandy sea view, but there are no groups of tourists, so particularly quiet. Here retained the most primitive natural features, clear sea water, colorful marine life, is the best diving place. Elegant resorts and a variety of party, for young people are perfect for couples to spend their honeymoon.

6. Pippi Island is an outlying island away from land, surrounded by quiet blue water, colorful coral is quite charming. Pippi island is mainly composed of two sister islands, the northern big Pippi island is more lively, catering, accommodation, a variety of entertainment facilities, the southern small Pippi island is dangerous, sparsely populated, but the island’s natural cave landscape is very beautiful, worthy of a visit.

7. Sukotai is the first capital in Thai history and the cradle of Thai culture. Many of the historic sites here, Pixels Kotai Historical Park, Mahatai Temple, Lancanting National Museum… although important cultural relics, but there are no signs and other things blocked, can be viewed close. To travel around Sukotai suggests renting a bike, which is convenient to rent. Stroll tired to sit down to taste a local snack, sour, spicy and refreshing very enjoyable!

8. Hua Xin this seaside town is relatively low-key, not over the head is not small, even the Thai royal family are here for the summer. Here is a narrow, huge bow-shaped beach, the sand is very thin, very comfortable to step on! The beach is on the hill to the west and the sea to the east. Thailand’s dignitaries have a strong preference for this place, so can be seen everywhere seaside huts and high-end vacation villas. The suburban Santa Torini park and Swiss Sheep Ranch are full of European style and are good places to take pictures.

9. A rice is like a natural treasure house, beautiful island, steep mountain rock, dense tropical rain forest, natural hot springs, waterfalls… almost all your desires during your journey can be found here. More than 30 outlying islands, more than 500 rock climbing lines, located in the sea limestone hill… imagine what a huge project it would be to travel all over here.

Europe’s most worthy country, good and cheap but no one to go, by netizens called “white-eyed wolf “?

It is believed that many people have an illusion about travel, that the process of travel is very good, and those who love to travel have a plot that is to travel to Europe, many people travel to the country of choice must be Europe, Europe is very attractive to people.

When we were young, Europe was a textbook novel about Migo, a collection of Tagore’s essays, but when we grew up, we found that Europe was far away not only charming but also particularly attractive, and that melodious breath of life and the charm of nature made us feel so relaxed. But although Europe is very good-looking, but think flights from shanghai to shenzhen some ordinary people still can not afford to go, after all, European prices are also quite expensive.

Visa is also troublesome, but now quality and China’s national strength, more and more European countries have begun to visa-free Chinese tourists, now tourists want to go to Europe no longer need to apply for a troublesome visa, at any time can come to a walk-on journey. In one of many european countries that are visa-free for chinese tourists, china is offered a free visa and a special 20-day stay.

Although this country is relatively small, but it is said that the older generation of people know this country, because this country and China have a very special relationship, do you know where this came from? This country is albania, the mention of this country has to say that the scenery of this country is very beautiful, she was named “the world’s most value for money travel place “.

Although the country is small, it has very old scenic spots. It is also because it is older than most countries in Europe, so it attracts a lot of people every day, although it is not developed.

At the same time, Albania and other European countries are not the same, her architectural style slightly different from the traditional European architecture, very artistic appreciation, looking at the architecture here as if it is in the palace of art.

Because Albania is not developed, its prices are cheap flights from shanghai to shenzhen extremely low and it is especially suitable for some families whose economic base is not strong. Can you imagine? In the capital of the country ,100 yuan can stay in star-rated hotels, some places even lower prices than the domestic, not a trip is not a pity?

But surprisingly, despite the country’s low prices, people do n’ t even want to visit the country with the same money. Do you know why? It’s not just because the country is n’ t famous, it’s because the country has done something very exciting.

In the past, china has helped albania to donate a lot of food every year, and in other ways, but did not expect to feed a “white-eyed wolf “. So there’s a reason why people do n’ t want to go to this country. But China has also helped a number of countries, although there are some countries such as Albania, but also to our sincere country.

Europe’s most worthy country, good and cheap but no one to go, by netizens called “white-eyed wolf “? As the saying goes ,” adversity sees true feelings “, only when a person has difficulties, can know how right this sentence is.