Dry: in vitro diagnostics (IVD) industry development overview
2015, in vitro diagnostics industry (IVD) visual heat will increase. A place in my side example is open only five days since 2015, I received a business plan nearly 15 IVD project. And a set of data in 2014 China International vitro diagnostic summit also showed that about 80% of clinical diagnostic information from the in vitro diagnostics, while its costs account for less than 20 percent of medical expenses. In fact, in addition to clinical diagnosis, IVD role is also reflected in the evaluation and treatment prognosis.
First, the definition of in vitro diagnostic reagent products
IVD (In Vitro Diagnostics, IVD) in the prevention, diagnosis, treatment monitoring, prognosis observed health status evaluation and forecasting process hereditary diseases, for human samples (various body fluids, cells, tissue samples etc.) were detected in vitro, for clinical diagnostic information products and services, including agent, combination of agents, calibration items, control material, quality control materials, apparatus and the like.
Typically, in vitro diagnostic products, mainly in testing centers, emergency rescue, blood banks, community and family. Generally, the operation is relatively simple home diagnostic reagents, the use of more convenient, speed, and is very suitable for non-professionals. Family IVD test products mainly include: ovulation, pregnancy check, urine test, blood glucose monitoring. Currently, the overall market rate of such agents is low, less than 10%, with lifestyle changes and accelerated pace of life, the home consumer market IVD products currently belong to the pre-eruption.
Diagnostic reagents typically used in hospitals, due to a complex operation, variety, difficult to determine the characteristics of the results, requires a combination of electronic technology to use, should be used by professionals, judgment and analysis, based on this, a large hospital requirements IVD products is high degree of automation, testing a large sample size, the demand for such products is also enormous. Recently, because of similar incidents of natural disasters, fires, mine and other frequent and rapid detection of patients with diseases of emergency squadron, the market demand for fast, on-site detection of patients with injuries and the extent of the damage bedside detection class (POCT) reagents volume jumped to meet emergency needs, and POCT capital market has become the most sought after IVD market segments.
Second, in vitro diagnostic products Categories
According to in vitro diagnostic actual reaction principle, IVD products can be divided into immune diagnostics, molecular diagnostics and clinical biochemistry three types.
Biochemical diagnostic reagents, refers to the use of biochemical reactions and immune responses in vivo biochemical indicators to detect a variety of agents, usually require ancillary equipment to detect, mainly used to measure the indicators are: carbohydrates, enzymes, lipids, inorganic elements class liver function as well as non-protein and protein nitrogen and the like.
Immunodiagnostic reagents, based on antigen-specific antibody responses and to achieve a kind of measuring reagent, according to the result of the judgment, can be divided into colloidal gold, RIA, ELISA, chemiluminescence, and time-resolved fluorescence and other types of applications including: endocrine, infectious diseases, cancer, blood typing and drug detection.
Molecular diagnostics is generally used to determine disease-associated genes, such as protein analysis and immunological activity, comprising: STD, hepatitis, pulmonary infectious diseases, genetic disease genes, prenatal and postnatal care, and the like tumors. Currently used technologies include: PCR (nucleic acid amplification technology) products, protein microarray chip type and so on.
Accordance with the "in vitro diagnostic reagents Registration" classification principles, in vitro diagnostic reagents according to the degree of risk products can be divided into three categories:
First class: microbiological culture media (not identify the identification and susceptibility testing of microorganisms, etc.); sample processing reagents (including dilution, stain and hemolysis, etc.).
The second category: in addition to the first class, third class than the other products, including hormones, carbohydrates, protein, vitamins, lipids, enzymes, antibodies, drugs and drug metabolism, inorganic ions, susceptibility testing, microbiological testing and other biochemical, physiological and immunological detection reagent indicator.
The third category: the detection of human gene reagents; detect tissue typing, blood reagents; detection reagent pathogenic antibodies, nucleic acids and antigens; the detection of drug targets reagents; spirit drug detection, narcotics, toxic drugs for medical use reagents; detect genetic disease agents; detection reagents allergy; reagent detection of tumor markers.
Third, the regulation of in vitro diagnostic reagents
In vitro diagnostic reagents production and management between drugs and medical devices, and bio-pharmaceutical industry have very similar features. Including: high technology content; long life cycle, the development cycle; product review links and more; units with less; traceability strong; safety and effectiveness demanding; strict quality requirements; development of products follow technical standards and regulations high demand and more varieties and so on.
Thus, for in vitro diagnostic reagents according to the risk classification to classify IVD Registration: IVD within a class to the municipal level by the Food and Drug Administration approval and supervision; territory II IVD regulatory review by the provinces and pharmaceutical sector; territory three IVD by the State Administration of food and Drug Administration and regulatory review; IVD reference three IVD regulatory review and abroad and Hong Kong, Macao and Taiwan regions.
According to relevant provisions "in vitro diagnostic reagents Registration", and in vitro diagnostic reagents in the approval process of medical device approval process and market access for products similar to before, with two types of IVD products as an example of its main approval process include:
1. Determine the product and classification, IVD should adopt a common name matches the nomenclature for product development named after its research work includes: the main raw material selection, preparation; production process is determined; stability of the product, the reference value (reference range) to determine, evaluate product performance and other related work. The applicant may refer to the relevant technical guidelines for product development, you can also experiment with different methods or techniques, but it should be noted that it is reasonable.
2, drawn registered product standards when reporting product registration, should be prepared in vitro diagnostic reagent registration product standards in the preparation of the registered product standards, when in the quality of raw materials and production process is stable, according to the product development, clinical trials, such as the results of the formulation, mainly the production process and product quality indicators and other technical requirements, including national standards, industry standards and registered product standards, product standards drawn up no less than national standards or industry standards.
3. The self-test or registered product testing, in accordance with the standard formulation of the product samples for testing in clinical trials or commission has the ability to detect other testing organizations, qualified to enter clinical trials;
4, clinical trials or clinical validation, should be selected at least three types of IVD 3, IVD II clinical trials should be conducted at least two selected provincial health care institutions, for the special purpose of the product, in line with requires municipal CDC, hospital and other clinical trials, and clinical outcomes do statistical work, in order to form a clinical report.
5, quality system assessment, application II, III IVD, the manufacturer shall comply with the requirements of the production conditions or CFDA-related quality system regulations, and work through the pharmaceutical sector for the product development, such as the case of on-site verification.
6. Prepare registration documents, depending on the requirements of the product for the first time or re-registration, to submit a series of materials related to product technology, risk, performance, standards, clinical and other records in the Food and Drug Administration in.
7, the product registration application.
8, supplementary materials.
9, to obtain registration certificate.
Thus, the production and management of in vitro diagnostic reagents products by Food and Drug Administration to regulate the same, before obtaining market access for its products need to be registered, as a result of in vitro diagnostic reagents for testing primarily for human samples, in order to protect its detection safety and effectiveness in product registration in the focus on the systematic evaluation of the above two series of approval procedures, the final certificate of registration issued by the Food and Drug Administration to grant its production, sale and license to use.
Fourth, foreign vitro diagnostic industry overview
After years of development, the global in vitro diagnostics industry matures, the higher the degree of market concentration, gathered a group of well-known multinational groups, including Roche, Siemens, Abbott, Beckman Coulter, Becton Dickinson, Johnson & Johnson, bioMérieux, horses, etc. These companies Group under the in vitro diagnostics business with annual sales revenue of more than $ 000 million, rich product line, including not only all kinds of in vitro diagnostic reagents, including various types of diagnostic medical instruments and associated technical services.
WHO survey shows that: According to the professional category, roughly in vitro diagnostic products into eight parts, clinical chemistry class accounted for 34% of the market share, the share of other categories are: blood glucose testing class 14%, 29% immunochemical class hematology class 7 percent, blood bank category 4%, 3% of the class of nucleic acid probes, microbiology class 5%, other 4%. The report also predicts that in vitro diagnostic products in the areas of rapid growth in the coming years include: blood bank screening, blood glucose self-testing and nucleic acid probe reagents. Along with lifestyle changes, market demand increased aging, growth in diabetes, blood glucose self-testing reagents growing. In addition, molecular diagnostics related nucleic acid probes, RNA or DNA has gradually developed, the next few years, the growth rate will be higher than 25%.
According to Kalorama Information's market report, the global IVD market from 2009 to 2011 compound annual growth rate of 6.7%. Known American pharmaceutical consulting firm Frost & Sullivan predicts 2013 to 2015, the annual compound growth rate of the global in vitro diagnostics market will reach 6.8 percent. 2014, the global in vitro diagnostics market size forecast $ 50.5 billion.
Currently, the global in vitro diagnostics market, mainly in North America, Europe, Japan and other developed economies, the three together accounted for more than 80% of the global market, China, India, Latin America, Eastern Europe, together accounted for 10%, the market segment is not balanced obviously, it also demonstrated in vitro diagnostics as an emerging industry, there will be much room for development in developing countries.
Britain's Institute of Economics in market research and academic research in the pharmaceutical industry in Asia Singapore Clearstate Insights Director WilsonTan also mentioned in a recent interview, the Asia-Pacific region will be the IVD marketplace, the average annual compound growth rate in five years will continue high. Among them, China will continue to maintain the leading position in the Asia Pacific region, 2015 to 2020 the average annual compound growth rate remained at about 25%.
Fifth, the status quo in vitro diagnostic industry
China accounted for 22% of the total population of the world's total population, while the market share of in vitro diagnostic reagents, but only 3% of the global market size of about $ 3.5 billion, China's per capita amount in vitro diagnostic products using only $ 1.5, while developed countries use per capita of US $ 25 to 30. With the expansion of insurance coverage, commercial health insurance liberalization, such as the aging trend is clearly a strong driver of future growth Chinese in vitro diagnostic market is vast, and the next few years to maintain the growth rate of around 25%. According to data released by Bio Valley, an estimated 2014 Chinese in vitro diagnostic market reached 35 billion yuan.
At this stage, the market scale of China's IVD industry has been gradually forming. The height of the development of China's first in vitro diagnostic industry in 1985 to 1990, during a large number of advanced technology into the country from the developed countries, while there were many diagnostic reagent manufacturers such as the production of clinical and biochemical reagents in life, such as the Long March the production of immune reagents gorgeous, Branch, Chinese yuan, Victoria, and other military families. Up to now, our in vitro diagnostic reagents manufacturers are about more than 400, an increasingly competitive market, to a certain extent, greatly promote the improvement of clinical use. Such as hepatitis B testing field, since the discovery of hemagglutination method to EliSA law applied only every five years.
Overall, the domestic enterprise market separatist competitive landscape is more obvious, and has emerged a stronger group of local enterprises, concentrated in biochemistry, immunology, molecular diagnostics three main areas. McEvoy & Farmer's report pointed out that China and biochemical diagnostic reagents market share of about 2/3 occupied by domestic brands, major companies have BIOSINO, Leadman, Beijing nine strong, KHB, Sichuan Mike, etc., and with the these local enterprises to enhance independent innovation ability and competitiveness, the overall level of technology has reached the international level of the same period of basic reagents varieties have been more complete, biochemical analyzer manufacturers have gradually increased; and immunodiagnostics market share of more than 60% still occupied by foreign brands, the main business of Roche, Siemens, Abbott and other domestic products are mainly concentrated in the ELISA reagent especially hepatitis B (over 60%) major companies for the Beijing Cosmos, KHB, etc; molecular diagnostics market is domestic enterprises, including Tat gene, the Shenzhen-based horses, KHB, Fosun etc., due to patent reasons only a handful of foreign production of such products, such as Roche, Abbott and other companies have some products to enter the relevant market .
In recent years, due to the integration of in aluminum silicate diagnostic techniques many new technologies and new methods, which greatly promoted the development of the industry. At the same time, the state policy and macro-planning the biotechnology industry, their status as one of the national key support industries; new health care reform continues to move closer to the grass-roots level, in order to reduce medical costs residents, improve health care efficiency, disease prevention and diagnosis should be strengthened ; accompanied by rising incomes, people's health and quality of medical care is also put forward higher requirements. In this environment, the development of in vitro diagnostic industry is to be expected.
Sixth, the development prospects for in vitro diagnostics industry
Comprehensive various reports, we can conclude that the development of in vitro diagnostic industry trends are: 1, home cannabidiol diagnostics will become the mainstream of development in vitro diagnostics; 2, automation and rapid diagnostic technology is the development of the "poles"; 3, product categories rich; 4, product updates faster. Due to the accumulation of core technologies, in vitro diagnostic techniques but also reflects the modularity.
Currently, the FDA approved up to 700 kinds of sulfur-34 related diagnostic reagents, but compared to more than 12,000 kinds of needs analysis to determine disease World Health Organization is concerned, there is a very large space for development. In China, despite years of development, compared with the US FDA approved hundreds of products, there is a huge market potential.
It is worth mentioning that, in vitro diagnostics industry, new product development and innovation activities is no longer a purely scientific activity, is more of an economic activity. A large-scale enterprise projects, investment institutions out of funds, CRO (or SME R & D entity) the mode of action has been slow to emerge in the market.
First, the definition of in vitro diagnostic reagent products
IVD (In Vitro Diagnostics, IVD) in the prevention, diagnosis, treatment monitoring, prognosis observed health status evaluation and forecasting process hereditary diseases, for human samples (various body fluids, cells, tissue samples etc.) were detected in vitro, for clinical diagnostic information products and services, including agent, combination of agents, calibration items, control material, quality control materials, apparatus and the like.
Typically, in vitro diagnostic products, mainly in testing centers, emergency rescue, blood banks, community and family. Generally, the operation is relatively simple home diagnostic reagents, the use of more convenient, speed, and is very suitable for non-professionals. Family IVD test products mainly include: ovulation, pregnancy check, urine test, blood glucose monitoring. Currently, the overall market rate of such agents is low, less than 10%, with lifestyle changes and accelerated pace of life, the home consumer market IVD products currently belong to the pre-eruption.
Diagnostic reagents typically used in hospitals, due to a complex operation, variety, difficult to determine the characteristics of the results, requires a combination of electronic technology to use, should be used by professionals, judgment and analysis, based on this, a large hospital requirements IVD products is high degree of automation, testing a large sample size, the demand for such products is also enormous. Recently, because of similar incidents of natural disasters, fires, mine and other frequent and rapid detection of patients with diseases of emergency squadron, the market demand for fast, on-site detection of patients with injuries and the extent of the damage bedside detection class (POCT) reagents volume jumped to meet emergency needs, and POCT capital market has become the most sought after IVD market segments.
Second, in vitro diagnostic products Categories
According to in vitro diagnostic actual reaction principle, IVD products can be divided into immune diagnostics, molecular diagnostics and clinical biochemistry three types.
Biochemical diagnostic reagents, refers to the use of biochemical reactions and immune responses in vivo biochemical indicators to detect a variety of agents, usually require ancillary equipment to detect, mainly used to measure the indicators are: carbohydrates, enzymes, lipids, inorganic elements class liver function as well as non-protein and protein nitrogen and the like.
Immunodiagnostic reagents, based on antigen-specific antibody responses and to achieve a kind of measuring reagent, according to the result of the judgment, can be divided into colloidal gold, RIA, ELISA, chemiluminescence, and time-resolved fluorescence and other types of applications including: endocrine, infectious diseases, cancer, blood typing and drug detection.
Molecular diagnostics is generally used to determine disease-associated genes, such as protein analysis and immunological activity, comprising: STD, hepatitis, pulmonary infectious diseases, genetic disease genes, prenatal and postnatal care, and the like tumors. Currently used technologies include: PCR (nucleic acid amplification technology) products, protein microarray chip type and so on.
Accordance with the "in vitro diagnostic reagents Registration" classification principles, in vitro diagnostic reagents according to the degree of risk products can be divided into three categories:
First class: microbiological culture media (not identify the identification and susceptibility testing of microorganisms, etc.); sample processing reagents (including dilution, stain and hemolysis, etc.).
The second category: in addition to the first class, third class than the other products, including hormones, carbohydrates, protein, vitamins, lipids, enzymes, antibodies, drugs and drug metabolism, inorganic ions, susceptibility testing, microbiological testing and other biochemical, physiological and immunological detection reagent indicator.
The third category: the detection of human gene reagents; detect tissue typing, blood reagents; detection reagent pathogenic antibodies, nucleic acids and antigens; the detection of drug targets reagents; spirit drug detection, narcotics, toxic drugs for medical use reagents; detect genetic disease agents; detection reagents allergy; reagent detection of tumor markers.
Third, the regulation of in vitro diagnostic reagents
In vitro diagnostic reagents production and management between drugs and medical devices, and bio-pharmaceutical industry have very similar features. Including: high technology content; long life cycle, the development cycle; product review links and more; units with less; traceability strong; safety and effectiveness demanding; strict quality requirements; development of products follow technical standards and regulations high demand and more varieties and so on.
Thus, for in vitro diagnostic reagents according to the risk classification to classify IVD Registration: IVD within a class to the municipal level by the Food and Drug Administration approval and supervision; territory II IVD regulatory review by the provinces and pharmaceutical sector; territory three IVD by the State Administration of food and Drug Administration and regulatory review; IVD reference three IVD regulatory review and abroad and Hong Kong, Macao and Taiwan regions.
According to relevant provisions "in vitro diagnostic reagents Registration", and in vitro diagnostic reagents in the approval process of medical device approval process and market access for products similar to before, with two types of IVD products as an example of its main approval process include:
1. Determine the product and classification, IVD should adopt a common name matches the nomenclature for product development named after its research work includes: the main raw material selection, preparation; production process is determined; stability of the product, the reference value (reference range) to determine, evaluate product performance and other related work. The applicant may refer to the relevant technical guidelines for product development, you can also experiment with different methods or techniques, but it should be noted that it is reasonable.
2, drawn registered product standards when reporting product registration, should be prepared in vitro diagnostic reagent registration product standards in the preparation of the registered product standards, when in the quality of raw materials and production process is stable, according to the product development, clinical trials, such as the results of the formulation, mainly the production process and product quality indicators and other technical requirements, including national standards, industry standards and registered product standards, product standards drawn up no less than national standards or industry standards.
3. The self-test or registered product testing, in accordance with the standard formulation of the product samples for testing in clinical trials or commission has the ability to detect other testing organizations, qualified to enter clinical trials;
4, clinical trials or clinical validation, should be selected at least three types of IVD 3, IVD II clinical trials should be conducted at least two selected provincial health care institutions, for the special purpose of the product, in line with requires municipal CDC, hospital and other clinical trials, and clinical outcomes do statistical work, in order to form a clinical report.
5, quality system assessment, application II, III IVD, the manufacturer shall comply with the requirements of the production conditions or CFDA-related quality system regulations, and work through the pharmaceutical sector for the product development, such as the case of on-site verification.
6. Prepare registration documents, depending on the requirements of the product for the first time or re-registration, to submit a series of materials related to product technology, risk, performance, standards, clinical and other records in the Food and Drug Administration in.
7, the product registration application.
8, supplementary materials.
9, to obtain registration certificate.
Thus, the production and management of in vitro diagnostic reagents products by Food and Drug Administration to regulate the same, before obtaining market access for its products need to be registered, as a result of in vitro diagnostic reagents for testing primarily for human samples, in order to protect its detection safety and effectiveness in product registration in the focus on the systematic evaluation of the above two series of approval procedures, the final certificate of registration issued by the Food and Drug Administration to grant its production, sale and license to use.
Fourth, foreign vitro diagnostic industry overview
After years of development, the global in vitro diagnostics industry matures, the higher the degree of market concentration, gathered a group of well-known multinational groups, including Roche, Siemens, Abbott, Beckman Coulter, Becton Dickinson, Johnson & Johnson, bioMérieux, horses, etc. These companies Group under the in vitro diagnostics business with annual sales revenue of more than $ 000 million, rich product line, including not only all kinds of in vitro diagnostic reagents, including various types of diagnostic medical instruments and associated technical services.
WHO survey shows that: According to the professional category, roughly in vitro diagnostic products into eight parts, clinical chemistry class accounted for 34% of the market share, the share of other categories are: blood glucose testing class 14%, 29% immunochemical class hematology class 7 percent, blood bank category 4%, 3% of the class of nucleic acid probes, microbiology class 5%, other 4%. The report also predicts that in vitro diagnostic products in the areas of rapid growth in the coming years include: blood bank screening, blood glucose self-testing and nucleic acid probe reagents. Along with lifestyle changes, market demand increased aging, growth in diabetes, blood glucose self-testing reagents growing. In addition, molecular diagnostics related nucleic acid probes, RNA or DNA has gradually developed, the next few years, the growth rate will be higher than 25%.
According to Kalorama Information's market report, the global IVD market from 2009 to 2011 compound annual growth rate of 6.7%. Known American pharmaceutical consulting firm Frost & Sullivan predicts 2013 to 2015, the annual compound growth rate of the global in vitro diagnostics market will reach 6.8 percent. 2014, the global in vitro diagnostics market size forecast $ 50.5 billion.
Currently, the global in vitro diagnostics market, mainly in North America, Europe, Japan and other developed economies, the three together accounted for more than 80% of the global market, China, India, Latin America, Eastern Europe, together accounted for 10%, the market segment is not balanced obviously, it also demonstrated in vitro diagnostics as an emerging industry, there will be much room for development in developing countries.
Britain's Institute of Economics in market research and academic research in the pharmaceutical industry in Asia Singapore Clearstate Insights Director WilsonTan also mentioned in a recent interview, the Asia-Pacific region will be the IVD marketplace, the average annual compound growth rate in five years will continue high. Among them, China will continue to maintain the leading position in the Asia Pacific region, 2015 to 2020 the average annual compound growth rate remained at about 25%.
Fifth, the status quo in vitro diagnostic industry
China accounted for 22% of the total population of the world's total population, while the market share of in vitro diagnostic reagents, but only 3% of the global market size of about $ 3.5 billion, China's per capita amount in vitro diagnostic products using only $ 1.5, while developed countries use per capita of US $ 25 to 30. With the expansion of insurance coverage, commercial health insurance liberalization, such as the aging trend is clearly a strong driver of future growth Chinese in vitro diagnostic market is vast, and the next few years to maintain the growth rate of around 25%. According to data released by Bio Valley, an estimated 2014 Chinese in vitro diagnostic market reached 35 billion yuan.
At this stage, the market scale of China's IVD industry has been gradually forming. The height of the development of China's first in vitro diagnostic industry in 1985 to 1990, during a large number of advanced technology into the country from the developed countries, while there were many diagnostic reagent manufacturers such as the production of clinical and biochemical reagents in life, such as the Long March the production of immune reagents gorgeous, Branch, Chinese yuan, Victoria, and other military families. Up to now, our in vitro diagnostic reagents manufacturers are about more than 400, an increasingly competitive market, to a certain extent, greatly promote the improvement of clinical use. Such as hepatitis B testing field, since the discovery of hemagglutination method to EliSA law applied only every five years.
Overall, the domestic enterprise market separatist competitive landscape is more obvious, and has emerged a stronger group of local enterprises, concentrated in biochemistry, immunology, molecular diagnostics three main areas. McEvoy & Farmer's report pointed out that China and biochemical diagnostic reagents market share of about 2/3 occupied by domestic brands, major companies have BIOSINO, Leadman, Beijing nine strong, KHB, Sichuan Mike, etc., and with the these local enterprises to enhance independent innovation ability and competitiveness, the overall level of technology has reached the international level of the same period of basic reagents varieties have been more complete, biochemical analyzer manufacturers have gradually increased; and immunodiagnostics market share of more than 60% still occupied by foreign brands, the main business of Roche, Siemens, Abbott and other domestic products are mainly concentrated in the ELISA reagent especially hepatitis B (over 60%) major companies for the Beijing Cosmos, KHB, etc; molecular diagnostics market is domestic enterprises, including Tat gene, the Shenzhen-based horses, KHB, Fosun etc., due to patent reasons only a handful of foreign production of such products, such as Roche, Abbott and other companies have some products to enter the relevant market .
In recent years, due to the integration of in aluminum silicate diagnostic techniques many new technologies and new methods, which greatly promoted the development of the industry. At the same time, the state policy and macro-planning the biotechnology industry, their status as one of the national key support industries; new health care reform continues to move closer to the grass-roots level, in order to reduce medical costs residents, improve health care efficiency, disease prevention and diagnosis should be strengthened ; accompanied by rising incomes, people's health and quality of medical care is also put forward higher requirements. In this environment, the development of in vitro diagnostic industry is to be expected.
Sixth, the development prospects for in vitro diagnostics industry
Comprehensive various reports, we can conclude that the development of in vitro diagnostic industry trends are: 1, home cannabidiol diagnostics will become the mainstream of development in vitro diagnostics; 2, automation and rapid diagnostic technology is the development of the "poles"; 3, product categories rich; 4, product updates faster. Due to the accumulation of core technologies, in vitro diagnostic techniques but also reflects the modularity.
Currently, the FDA approved up to 700 kinds of sulfur-34 related diagnostic reagents, but compared to more than 12,000 kinds of needs analysis to determine disease World Health Organization is concerned, there is a very large space for development. In China, despite years of development, compared with the US FDA approved hundreds of products, there is a huge market potential.
It is worth mentioning that, in vitro diagnostics industry, new product development and innovation activities is no longer a purely scientific activity, is more of an economic activity. A large-scale enterprise projects, investment institutions out of funds, CRO (or SME R & D entity) the mode of action has been slow to emerge in the market.
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