At present, with the rapid development of domestic and international laboratory medicine, China's in vitro diagnostic reagent industry has also entered a golden period of rapid development. Below, we will analyze the market overview and development prospects of IVD reagents.
Industrialization status of domestic in-vitro diagnostic reagents 1. Market overview At present, the market size of domestic clinical in-vitro diagnostic reagents has grown to RMB 3 billion to 400 million yuan in sales per year, of which the traditional clinical biochemistry and immunodiagnostics are the largest two fine details. Submarkets account for about 60% of the total in vitro diagnostic reagents, and other market segments such as blood, urine analysis, and microbiology are relatively small, while molecular diagnostics (PCR diagnostic reagents) develop rapidly and market share rapidly increases.
At present, there are more than 80 major in vitro diagnostic reagent manufacturers in China. Compared with foreign companies, domestic companies are generally small in size and few in variety, and their development is uneven. Most manufacturers' products are often concentrated in one or two market segments and cannot provide a full range of diagnostic product services and technical support. In addition, many companies in foreign countries have established sales organizations in mainland China to sell their products directly, but mainly high-priced closed instruments and reagents.
2. Analysis of major market segments (1) Biochemical in vitro diagnostic reagents market The domestic clinical biochemical market started earlier and the market is relatively stable. Due to the high price of foreign reagents, the current market is dominated by domestic reagents. However, due to the high degree of reliance on the biochemical analyzers of supporting machinery and equipment in this type of market, the growth of the reagent-based companies is limited. The traditional clinical biochemical in vitro diagnostic market is a very important part of the diagnostic reagent market and has always occupied a large market share. However, with the rapid development of immune and molecular diagnostics, the market share has become relatively smaller. In recent years, due to the increase in the number of biochemical reagents and the increase in market demand (especially the increasing obesity in China, the increase in demand for blood glucose and blood lipids), it is expected that the biochemical reagent market will continue to maintain stable growth.
(2) Immunological diagnostic reagents The market for immunization has the fastest growing market and the market competition is fierce. The barriers to entry in such markets are relatively low, and they are sensitive to factors such as the quality of reagents, sales methods, and government actions. The rate of production and disappearance of companies in the market is faster, and even some established companies that were once well-known in the market are forced to qiut the market.
The status quo of industrialization of clinical in vitro diagnostic reagents at home and abroad The current overall development of in vitro diagnostic reagents has the following characteristics:
(1) Immunodiagnostic reagents will gradually replace clinical biochemical reagents and become the mainstream of diagnostic reagent development.
(2) Diagnostic technology is developing toward the two poles. On the one hand, it is highly integrated and automated instrument diagnostics. On the other hand, it is simple, fast and easy to use for rapid diagnosis.
(3) The type of product tested will rapidly expand.
(4) The application of product renewal is accelerated. Due to the continuous application and development of modern biotechnology such as genetic engineering, gene recombination, and monoclonal antibodies, these precise diagnostic reagents can rapidly enter the clinical stage from the research stage, shortening the development time.
The development of China's laboratory medicine has fallen far behind the world's advanced level for a long time, which has greatly hindered the industrialization of clinical in vitro diagnostic reagents in China.
Since the 1980s, with the introduction of foreign investment in the country's reform and opening up, clinical in vitro diagnostic reagents have rapidly begun the process of industrialization. In particular, during the period from 1985 to 1990, a large number of foreign advanced technologies entered China in a few years, and a large number of manufacturers producing in vitro diagnostic reagents emerged. By the early 1990s, there were more than 100 manufacturers of clinical biochemical reagents and even more than 300 immune reagent manufacturers. Fierce market competition has greatly promoted the improvement of clinical application.
At present, the market size of domestic clinical in vitro diagnostic reagents has grown to RMB 3 billion to RMB 4 billion in annual sales, including 30% for clinical biochemical products, 25% for immune products, 8% to 10% for blood products, and 3% for urine analysis products. ~ 5%, microbial products 2% ~ 3%. In the next five years, the domestic clinical in vitro diagnostic market will have an annual growth rate of 15% to 20%.
Due to the late start of the domestic market and the long-term lag in industrialization, compared with foreign companies, domestic companies generally have small scale, few varieties, and unbalanced development. There are very few in vitro diagnostic reagent manufacturers with annual sales of domestic companies exceeding or close to 100 million. , with sales of more than 50 million yuan no more than 10 companies. At the same time, as a result of vicious competition, the average profitability of all companies has dropped significantly, from the initial 40% to 50%, to the current 10% to 20%.
There are also many companies in China that sell sales products directly in mainland China. The current sales of diagnostic reagents are about 300 million yuan, accounting for 10% of the total market in China. From the perspective of the distribution of clinical diagnostic reagent manufacturers, the market can basically be divided into four categories: clinical biochemical markets, immunodiagnostic markets, molecular diagnostic markets, and other reagent markets.
In 2000, the purchasing power of the global in vitro diagnostic reagent market was approximately 18 to 20 billion U.S. dollars (including equipment, reagents, and other consumer products). Divided by profession, the entire diagnostic product market consists of roughly 8 parts, with the largest clinical chemistry, with a market share of 34%, followed by 29% for immunochemistry, 14% for blood glucose, 7% for hematology, 5% for microbiology, and blood bank 4%, nucleic acid probe 3%, other (including coagulant) 4%. Larger diagnostic reagents in the future will belong to self-monitoring blood glucose, nucleic acid probes, and blood bank reagents. The self-testing blood sugar part of the global annual sales of about 5 billion US dollars, the external environment in the next few years will promote the market's annual growth rate of 10% to 12%. Another rapidly emerging diagnostic reagent is the use of DNA, RNA, or nucleic acid probes. This technique, also known as molecular diagnostics, involves the use of specific short-range nucleic acid sequences to bind and detect the presence of genetic material. The current size of the nucleic acid probe market is almost $1.3 billion, and the growth rate in the next few years is expected to exceed 25%. The blood bank market business is now US$1.059 billion per year, and it is estimated that the future annual growth rate will be about 6%. In 2002, sales of global diagnostic reagents reached US$7.3 billion. According to conservative estimates, by 2007, the global sales of diagnostic reagents will reach US$15.7 billion, and the annual growth rate will reach 16.6%. The emergence of new diagnostic methods will further accelerate and expand the development of clinical diagnostic reagents and chip industries.
The demand for immunological diagnostic reagents in the market The market demand for viral hepatitis diagnostic reagents is greatest. China is a country with a high incidence of hepatitis virus, including hepatitis B virus carriers as high as 120 million people or more, and the market has huge capacity. With the increase in the prevention and control of hepatitis virus in China in the past few years, the incidence of viral hepatitis has stabilized at the beginning of the 20th century, but the incidence in 2004 has also increased substantially. It is expected that the incidence rate in 2005 will still be 20%. Increase.
The other growing demand for immunological diagnostic reagents will mainly come from the AIDS and syphilis diagnostic kits. According to statistics from the Ministry of Health, the statutory incidence of Class A and B communicable diseases in the country in 2004, syphilis and AIDS were among the highest. With the expansion of the AIDS patient population and the increase in the number of STD patients, the market demand for in vitro diagnostic kits for syphilis and AIDS will continue to rise.
In addition, the tumor has become one of the major diseases of human death, and the market for tumor in vitro diagnostic reagents has thus grown rapidly. Hepatitis virus diagnostic reagents are still expected to be the most important immunological diagnostic reagent products, but the demand growth rate is relatively flat. Since the 1980s, with the introduction of foreign investment in the country's reform and opening up, clinical in vitro diagnostic reagents have rapidly begun the process of industrialization. In particular, during the period from 1985 to 1990, a large number of foreign advanced technologies entered China in a few years, and a large number of manufacturers producing diagnostic reagents emerged.
Industrialization status of domestic in-vitro diagnostic reagents 1. Market overview At present, the market size of domestic clinical in-vitro diagnostic reagents has grown to RMB 3 billion to 400 million yuan in sales per year, of which the traditional clinical biochemistry and immunodiagnostics are the largest two fine details. Submarkets account for about 60% of the total in vitro diagnostic reagents, and other market segments such as blood, urine analysis, and microbiology are relatively small, while molecular diagnostics (PCR diagnostic reagents) develop rapidly and market share rapidly increases.
At present, there are more than 80 major in vitro diagnostic reagent manufacturers in China. Compared with foreign companies, domestic companies are generally small in size and few in variety, and their development is uneven. Most manufacturers' products are often concentrated in one or two market segments and cannot provide a full range of diagnostic product services and technical support. In addition, many companies in foreign countries have established sales organizations in mainland China to sell their products directly, but mainly high-priced closed instruments and reagents.
2. Analysis of major market segments (1) Biochemical in vitro diagnostic reagents market The domestic clinical biochemical market started earlier and the market is relatively stable. Due to the high price of foreign reagents, the current market is dominated by domestic reagents. However, due to the high degree of reliance on the biochemical analyzers of supporting machinery and equipment in this type of market, the growth of the reagent-based companies is limited. The traditional clinical biochemical in vitro diagnostic market is a very important part of the diagnostic reagent market and has always occupied a large market share. However, with the rapid development of immune and molecular diagnostics, the market share has become relatively smaller. In recent years, due to the increase in the number of biochemical reagents and the increase in market demand (especially the increasing obesity in China, the increase in demand for blood glucose and blood lipids), it is expected that the biochemical reagent market will continue to maintain stable growth.
(2) Immunological diagnostic reagents The market for immunization has the fastest growing market and the market competition is fierce. The barriers to entry in such markets are relatively low, and they are sensitive to factors such as the quality of reagents, sales methods, and government actions. The rate of production and disappearance of companies in the market is faster, and even some established companies that were once well-known in the market are forced to qiut the market.
The status quo of industrialization of clinical in vitro diagnostic reagents at home and abroad The current overall development of in vitro diagnostic reagents has the following characteristics:
(1) Immunodiagnostic reagents will gradually replace clinical biochemical reagents and become the mainstream of diagnostic reagent development.
(2) Diagnostic technology is developing toward the two poles. On the one hand, it is highly integrated and automated instrument diagnostics. On the other hand, it is simple, fast and easy to use for rapid diagnosis.
(3) The type of product tested will rapidly expand.
(4) The application of product renewal is accelerated. Due to the continuous application and development of modern biotechnology such as genetic engineering, gene recombination, and monoclonal antibodies, these precise diagnostic reagents can rapidly enter the clinical stage from the research stage, shortening the development time.
The development of China's laboratory medicine has fallen far behind the world's advanced level for a long time, which has greatly hindered the industrialization of clinical in vitro diagnostic reagents in China.
Since the 1980s, with the introduction of foreign investment in the country's reform and opening up, clinical in vitro diagnostic reagents have rapidly begun the process of industrialization. In particular, during the period from 1985 to 1990, a large number of foreign advanced technologies entered China in a few years, and a large number of manufacturers producing in vitro diagnostic reagents emerged. By the early 1990s, there were more than 100 manufacturers of clinical biochemical reagents and even more than 300 immune reagent manufacturers. Fierce market competition has greatly promoted the improvement of clinical application.
At present, the market size of domestic clinical in vitro diagnostic reagents has grown to RMB 3 billion to RMB 4 billion in annual sales, including 30% for clinical biochemical products, 25% for immune products, 8% to 10% for blood products, and 3% for urine analysis products. ~ 5%, microbial products 2% ~ 3%. In the next five years, the domestic clinical in vitro diagnostic market will have an annual growth rate of 15% to 20%.
Due to the late start of the domestic market and the long-term lag in industrialization, compared with foreign companies, domestic companies generally have small scale, few varieties, and unbalanced development. There are very few in vitro diagnostic reagent manufacturers with annual sales of domestic companies exceeding or close to 100 million. , with sales of more than 50 million yuan no more than 10 companies. At the same time, as a result of vicious competition, the average profitability of all companies has dropped significantly, from the initial 40% to 50%, to the current 10% to 20%.
There are also many companies in China that sell sales products directly in mainland China. The current sales of diagnostic reagents are about 300 million yuan, accounting for 10% of the total market in China. From the perspective of the distribution of clinical diagnostic reagent manufacturers, the market can basically be divided into four categories: clinical biochemical markets, immunodiagnostic markets, molecular diagnostic markets, and other reagent markets.
In 2000, the purchasing power of the global in vitro diagnostic reagent market was approximately 18 to 20 billion U.S. dollars (including equipment, reagents, and other consumer products). Divided by profession, the entire diagnostic product market consists of roughly 8 parts, with the largest clinical chemistry, with a market share of 34%, followed by 29% for immunochemistry, 14% for blood glucose, 7% for hematology, 5% for microbiology, and blood bank 4%, nucleic acid probe 3%, other (including coagulant) 4%. Larger diagnostic reagents in the future will belong to self-monitoring blood glucose, nucleic acid probes, and blood bank reagents. The self-testing blood sugar part of the global annual sales of about 5 billion US dollars, the external environment in the next few years will promote the market's annual growth rate of 10% to 12%. Another rapidly emerging diagnostic reagent is the use of DNA, RNA, or nucleic acid probes. This technique, also known as molecular diagnostics, involves the use of specific short-range nucleic acid sequences to bind and detect the presence of genetic material. The current size of the nucleic acid probe market is almost $1.3 billion, and the growth rate in the next few years is expected to exceed 25%. The blood bank market business is now US$1.059 billion per year, and it is estimated that the future annual growth rate will be about 6%. In 2002, sales of global diagnostic reagents reached US$7.3 billion. According to conservative estimates, by 2007, the global sales of diagnostic reagents will reach US$15.7 billion, and the annual growth rate will reach 16.6%. The emergence of new diagnostic methods will further accelerate and expand the development of clinical diagnostic reagents and chip industries.
The demand for immunological diagnostic reagents in the market The market demand for viral hepatitis diagnostic reagents is greatest. China is a country with a high incidence of hepatitis virus, including hepatitis B virus carriers as high as 120 million people or more, and the market has huge capacity. With the increase in the prevention and control of hepatitis virus in China in the past few years, the incidence of viral hepatitis has stabilized at the beginning of the 20th century, but the incidence in 2004 has also increased substantially. It is expected that the incidence rate in 2005 will still be 20%. Increase.
The other growing demand for immunological diagnostic reagents will mainly come from the AIDS and syphilis diagnostic kits. According to statistics from the Ministry of Health, the statutory incidence of Class A and B communicable diseases in the country in 2004, syphilis and AIDS were among the highest. With the expansion of the AIDS patient population and the increase in the number of STD patients, the market demand for in vitro diagnostic kits for syphilis and AIDS will continue to rise.
In addition, the tumor has become one of the major diseases of human death, and the market for tumor in vitro diagnostic reagents has thus grown rapidly. Hepatitis virus diagnostic reagents are still expected to be the most important immunological diagnostic reagent products, but the demand growth rate is relatively flat. Since the 1980s, with the introduction of foreign investment in the country's reform and opening up, clinical in vitro diagnostic reagents have rapidly begun the process of industrialization. In particular, during the period from 1985 to 1990, a large number of foreign advanced technologies entered China in a few years, and a large number of manufacturers producing diagnostic reagents emerged.
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