12
2017
-
07
Current situation and development trend of biomedical materials industry at home and abroad
author：
1、 Basic information of biomedical materials
Biomedical materials are materials used to diagnose, treat, repair or replace diseased tissues and organs of organisms or improve their functions. As a basis for the research of artificial organs and medical devices, biomedical materials have now become an important branch of modern materials science. Especially with the vigorous development and major breakthroughs of biotechnology, biomedical materials have become the focus of research and development by scientists from all over the world. In recent years, reports on medical materials and the application of medical materials in the field of high and new medical technology emerge in endlessly.
Biomedical materials can be classified into bone-muscle system repair materials such as bone, tooth, joint and tendon, soft tissue materials such as skin, breast, esophagus, bladder and respiratory tract, cardiovascular system materials such as artificial heart valve, blood vessel and intravascular intubation, blood purification membrane and separation membrane, gas selective permeability membrane, corneal contact lens and other medical membrane materials, tissue adhesive and suture materials according to their uses, Drug release carrier materials, clinical and biosensor materials, etc.
Biomedical materials are not drugs, and their functions need not be realized through pharmacology, immunology or metabolic means. They cannot be replaced by drugs. They are necessary to protect human health, but can be combined with them to promote the realization of their functions. In June this year, representatives of the European Parliament and the European Council of Ministers reached a compromise resolution on the revision of the European Union's guidelines for medical devices and in vitro diagnosis. The resolution calls for limiting the use of substances that can cause cancer, easily lead to organic mutation, toxic regeneration or interfere with the function of hormones. This resolution is of great benefit to strengthening the market supervision of human implanted medical materials. The research and development of biomedical materials must have clear application objectives. Even if the materials with the same chemical composition have different application objectives, not only the structure and property requirements are different, but also the manufacturing process is different. Therefore, biomedical material science and engineering are always inseparable from its end-use products (generally referred to as medical implants). Generally speaking, biomedical materials refer to both the material itself and medical implants.
According to international practice, the management of medical biomaterials belongs to the category of medical devices, accounting for more than 40% of the market share of medical devices. As an important part of high-tech, biomedical materials have entered a new stage of rapid development, and their market sales are increasing at the rate of 16% per year. It is expected that in the next 20 years, the share of biomedical materials will catch up with the drug market and become a pillar industry.
Current situation and development trend of biomedical materials industry at home and abroad
Biomedical materials are the most extensive interdisciplinary field in modern science and technology, involving materials, biology, medicine and other related disciplines, and are the important foundation of the two pillars of modern medicine - biotechnology and biomedical engineering. Due to the progress of contemporary material science and technology, cell biology and molecular biology, deepening the understanding of the interaction between materials and organism at the molecular level, and driven by the progress of modern medicine and the huge clinical demand, contemporary biomaterial science and industry are undergoing revolutionary changes, and have been on the verge of achieving significant breakthroughs - regenerative human tissue, and further, the whole human organ, Open the door for the transformation of inanimate materials into living organizations. Under the condition that China's conventional high-tech biomedical material market is basically monopolized by foreign investors, seize the favorable opportunity that the science and engineering of biomaterials is undergoing revolutionary changes, look forward to the world's biomaterials science and industry in the next 20-30 years, and deliberately improve the innovation ability, which will not only win a rare opportunity for revitalizing China's biomaterials science and industry and catching up with the world's advanced level, It can also make great contributions to the development of human science by Chinese scientists.
Although the application of biomedical materials has achieved great success, many problems have been exposed in long-term clinical application, especially in the aspects of functionality, immunity and service life. For example, the death rate after 12 years of heart valve implantation is 58%, the restenosis rate after vascular stent implantation is ≈ 10%, the effective period of artificial joint is 12-15 years in the elderly group, and only ≈ 5 years in the young and middle-aged group. The root cause is that the material or implant is basically in the body as a foreign body. The repair of tissues and organs in modern medicine has developed towards regeneration and reconstruction of human tissues or organs, or restoration and enhancement of their biological functions, personalization and minimally invasive treatment. Traditional biomedical materials have been difficult to meet clinical requirements. It has become the development direction of modern biomedical materials to endow materials with biological structures and biological functions, fully mobilize the ability of human body to self-repair, regenerate and reconstruct damaged human tissues or organs, or restore and improve their biological functions, and achieve permanent rehabilitation of damaged tissues or organs. The main frontier areas are: materials and implanted devices that can induce the regeneration of damaged tissues or organs (including tissue engineering products); And targeted controlled release carriers and systems of drugs and bioactive substances (vaccines, proteins, genes, etc.) used to treat refractory diseases, restore and improve the biological functions of tissues or organs. The frontier research of biomedical materials and implant devices is making significant progress. The FDA of the United States has approved seven tissue engineering products to be listed, and the SFDA of China has approved the introduction of bone-induced artificial bone and tissue engineered skin that can induce bone regeneration, and issued seven tissue engineering product standards. A large number of implant devices for renewable tissue are in clinical trials at home and abroad. Frontier research has faced the edge of achieving a major breakthrough - design and manufacture of living human tissue, and further the whole human organ. Its development and application have spawned a new discipline - regenerative medicine. It is expected that the development of regenerative medicine will spawn a new industry of regenerative medicine products, and its market sales will exceed US0 billion yuan in the next 20 years. Regenerative medicine products are mainly composed of stem cells, tissue engineering tissues and organs based on biomaterials, and transplantable biological tissues and organs. Biomedical materials are the basis of their development.
2、 Current situation and development trend of biomedical material industry and technology abroad
Biomedical materials are materials used to diagnose, treat, repair or replace diseased tissues and organs of organisms or improve their functions. As a basis for the research of artificial organs and medical devices, biomedical materials have now become an important branch of modern materials science. Especially with the vigorous development and major breakthroughs of biotechnology, biomedical materials have become the focus of research and development by scientists from all over the world. In recent years, reports on medical materials and the application of medical materials in the field of high and new medical technology emerge in endlessly.
Biomedical materials can be classified into bone-muscle system repair materials such as bone, tooth, joint and tendon, soft tissue materials such as skin, breast, esophagus, bladder and respiratory tract, cardiovascular system materials such as artificial heart valve, blood vessel and intravascular intubation, blood purification membrane and separation membrane, gas selective permeability membrane, corneal contact lens and other medical membrane materials, tissue adhesive and suture materials according to their uses, Drug release carrier materials, clinical and biosensor materials, etc.
Biomedical materials are not drugs, and their functions need not be realized through pharmacology, immunology or metabolic means. They cannot be replaced by drugs. They are necessary to protect human health, but can be combined with them to promote the realization of their functions. In June this year, representatives of the European Parliament and the European Council of Ministers reached a compromise resolution on the revision of the European Union's guidelines for medical devices and in vitro diagnosis. The resolution calls for limiting the use of substances that can cause cancer, easily lead to organic mutation, toxic regeneration or interfere with the function of hormones. This resolution is of great benefit to strengthening the market supervision of human implanted medical materials. The research and development of biomedical materials must have clear application objectives. Even if the materials with the same chemical composition have different application objectives, not only the structure and property requirements are different, but also the manufacturing process is different. Therefore, biomedical material science and engineering are always inseparable from its end-use products (generally referred to as medical implants). Generally speaking, biomedical materials refer to both the material itself and medical implants.
According to international practice, the management of medical biomaterials belongs to the category of medical devices, accounting for more than 40% of the market share of medical devices. As an important part of high-tech, biomedical materials have entered a new stage of rapid development, and their market sales are increasing at the rate of 16% per year. It is expected that in the next 20 years, the share of biomedical materials will catch up with the drug market and become a pillar industry.
Current situation and development trend of biomedical materials industry at home and abroad
Biomedical materials are the most extensive interdisciplinary field in modern science and technology, involving materials, biology, medicine and other related disciplines, and are the important foundation of the two pillars of modern medicine - biotechnology and biomedical engineering. Due to the progress of contemporary material science and technology, cell biology and molecular biology, deepening the understanding of the interaction between materials and organism at the molecular level, and driven by the progress of modern medicine and the huge clinical demand, contemporary biomaterial science and industry are undergoing revolutionary changes, and have been on the verge of achieving significant breakthroughs - regenerative human tissue, and further, the whole human organ, Open the door for the transformation of inanimate materials into living organizations. Under the condition that China's conventional high-tech biomedical material market is basically monopolized by foreign investors, seize the favorable opportunity that the science and engineering of biomaterials is undergoing revolutionary changes, look forward to the world's biomaterials science and industry in the next 20-30 years, and deliberately improve the innovation ability, which will not only win a rare opportunity for revitalizing China's biomaterials science and industry and catching up with the world's advanced level, It can also make great contributions to the development of human science by Chinese scientists.
Although the application of biomedical materials has achieved great success, many problems have been exposed in long-term clinical application, especially in the aspects of functionality, immunity and service life. For example, the death rate after 12 years of heart valve implantation is 58%, the restenosis rate after vascular stent implantation is ≈ 10%, the effective period of artificial joint is 12-15 years in the elderly group, and only ≈ 5 years in the young and middle-aged group. The root cause is that the material or implant is basically in the body as a foreign body. The repair of tissues and organs in modern medicine has developed towards regeneration and reconstruction of human tissues or organs, or restoration and enhancement of their biological functions, personalization and minimally invasive treatment. Traditional biomedical materials have been difficult to meet clinical requirements. It has become the development direction of modern biomedical materials to endow materials with biological structures and biological functions, fully mobilize the ability of human body to self-repair, regenerate and reconstruct damaged human tissues or organs, or restore and improve their biological functions, and achieve permanent rehabilitation of damaged tissues or organs. The main frontier areas are: materials and implanted devices that can induce the regeneration of damaged tissues or organs (including tissue engineering products); And targeted controlled release carriers and systems of drugs and bioactive substances (vaccines, proteins, genes, etc.) used to treat refractory diseases, restore and improve the biological functions of tissues or organs. The frontier research of biomedical materials and implant devices is making significant progress. The FDA of the United States has approved seven tissue engineering products to be listed, and the SFDA of China has approved the introduction of bone-induced artificial bone and tissue engineered skin that can induce bone regeneration, and issued seven tissue engineering product standards. A large number of implant devices for renewable tissue are in clinical trials at home and abroad. Frontier research has faced the edge of achieving a major breakthrough - design and manufacture of living human tissue, and further the whole human organ. Its development and application have spawned a new discipline - regenerative medicine. It is expected that the development of regenerative medicine will spawn a new industry of regenerative medicine products, and its market sales will exceed US0 billion yuan in the next 20 years. Regenerative medicine products are mainly composed of stem cells, tissue engineering tissues and organs based on biomaterials, and transplantable biological tissues and organs. Biomedical materials are the basis of their development.
2、 Current situation and development trend of biomedical material industry and technology abroad
1. Industry status, scale, competitive advantage and development trend
According to statistics, the composite growth rate (CAGR) of biomedical materials in the global market reached more than 22% in 2000-2010, and the global market reached US2 billion yuan in 2010. It is estimated that the CAGR of the market in 2009-2020 will remain about 15%, the world market will reach US5 billion yuan in 2015, and more than US4 billion yuan in 2020. At the same time, it will drive the new output value of related industries (excluding medical treatment) to about 3 times, and the total direct and indirect sales will reach 4% in 2015 and 2020 respectively × US $5 billion ≈ US $20 billion, and US $56 billion. The world's largest producer and consumer of medical devices is the United States. In 2010, it accounted for about 40% of the global market, and consumed 37% of global products, with an annual growth rate of about 8%; Due to the developed economy and sound social medical security system, the EU has become the second largest medical device market in the world, accounting for 29% of the global market share; The Asia-Pacific region is the third largest market in the world, accounting for 18% of the market share. Japan is the country with the most advanced and fastest development of medical technology in the Asia-Pacific region, and the third largest consumer of medical devices in the world. China and India have the most growth potential and space. Due to the largest population, and their health care system is still in the process of development and not yet mature, the health care system of Southeast Asian countries also has great room for improvement, Therefore, the market will continue to grow; Latin America is another region with the fastest growth. Mexico, Brazil, Argentina, Chile and other countries are gradually developing towards industrialized countries. It is estimated that the demand for medical devices will also maintain a relatively rapid growth in the future. (The value of medical technology companies in a competities environment connections，2011.07.03)。
Biomedical materials and implantable devices industry is a high-tech industry with the most interdisciplinary and knowledge-intensive industries. Its development needs the support of upstream and downstream knowledge, technology and relevant environment. Therefore, the industry is highly concentrated (monopolistic), and product diversification or diversification is another feature and trend of the development of biomedical materials industry. In 2010, the world medical device industry was composed of 27000 medical device companies, of which more than 90% were small and medium-sized enterprises. Small and medium-sized enterprises in developed countries are mainly engaged in research and development of new products and technologies, and maintain their survival by transferring technology to large companies or being merged by large companies. Large-scale product production and market operation are basically carried out by large companies. Unlike the situation of "many, small and scattered" medical device enterprises in China, the medical device industry in developed countries has formed a situation of "oligarchy" domination, and the global market has also presented a similar pattern. In 2009, the top 50 multinational companies accounted for 88% of the global medical device market, of which the top 25 companies accounted for 75%; In 2008, six American and British companies: DePuy, Zimmer, Stryker, Biomet, Medtronic, SynthesMathys and Smith&Nephew accounted for ≈ 75% of the global orthopedic material and device market, of which the top four American companies and Smith&Nephew of the United Kingdom accounted for 90% of the artificial joint market; Six major companies: Johnson&Johnson, Abbott, Boston Scientific, Medtronic, CRBard (USA) and Terumo (Japan) account for 80-90% of the market of cardio-cerebrovascular system repair materials and implant (implant) devices; Five major companies: Baxter International (USA), Fresenius (Germany), Gambro (Sweden), Terumo and AsahiMedia (Japan) account for 80% of the market of blood purification and extracorporeal circulation system materials and devices; The market of dental implants and dental materials is basically monopolized by large companies such as Straumann (Switzerland), Dentsply International (USA), Nobel Biocare (Germany) and Osstem (Korea). In order to improve market competitiveness and maintain advantages, mergers and integration of the world's medical device industry has been ongoing. During 1998-2009 alone, the average annual mergers and acquisitions of the United States industry reached 200. The increasing concentration or monopoly of the industry is an important trend in the development of the biomedical material industry.
In order to improve the market competitiveness of enterprises, avoid risks, and develop and expand enterprises, foreign multinational companies have continued to extend and expand their product lines from the initial production of relatively single products, through internal technological innovation and mergers and acquisitions of other enterprises, to achieve multi-variety production.
Internationalization of production and sales is a prominent trend in the development of biomedical materials. Almost all the large enterprises of biomedical materials are multinational companies, and a considerable part of their sales come from the international market. For example, in 2010, the sales of Johnson&Johnson Company of the United States were 40% (US $200 million), the sales of Boston Scientific was 46% (US $90 million), and the sales of Medtronic in 2011 were 43% (US $37 million), all from overseas markets. In order to open up the international market, multinational companies set up subsidiaries and R&D centers abroad to produce and develop locally by exporting technology and capital overseas. At the same time, in order to adapt to the development of international trade, the International Organization for Standardization (ISO) has continuously formulated and issued international standards for biomedical materials and products.
Current situation and development trend of biomedical materials industry at home and abroad
2. Key products, core technologies and development trends
The development of biomedical material industry strongly depends on the support of advanced technology and economic strength in relevant fields. The rapid development of medical devices in the United States and its leading position in the world are due to the support provided by its aerospace technology, biotechnology, microelectronics technology, precision processing technology, software development and other fields for the development of the medical device industry, as well as a good policy environment. At present, developed countries rely on their top scientific and technological innovation and economic strength to mainly produce high-tech biomaterials and implant devices. Labour-intensive and resource-consuming enterprises have gradually transferred to overseas, so their technical equipment is very advanced. Various high-end processing centers, special machine tools, laser micro-processing and coating equipment have been equipped in biomaterials enterprises; Automation and information technology have been widely used in production; The most advanced inspection equipment can be found everywhere in large companies. Advanced technology and equipment ensure the progressiveness of its products and its monopoly position in the market.
3、 Current situation and development trend of biomedical materials industry in China
After nearly ten years of development, China's modern biomedical material industry has taken shape and entered a stage of rapid development. In China, there are four main reasons for the rapid development of biomedical materials, namely, the intensification of population aging and the limited life of human tissues and organs will lead to an increase in the demand for biomedical materials; The increase of trauma among young and middle-aged people caused by the development of transportation and sports; Continuous economic growth, continuous improvement of people's living standards, gradual enhancement of health awareness and changes in lifestyle, especially the implementation of medical reform policy; The upgrading of technological innovation capability and technological level of the industry will promote the transfer of the industry to the upstream of the value chain.
According to statistics, the sales volume of biomedical materials market in China reached nearly 10 billion US dollars in 2010, with a compound growth rate of 30%. It is conservatively estimated that the annual sales will reach US $135.5 billion in 2020, and it will grow into the world's second largest biomedical material market within 10 years. In 2015, the "Twelfth Five-Year Plan" for the Development of New Materials Industry issued by the Ministry of Industry and Information Technology of the People's Republic of China clearly stated that it is expected that 500000 sets of artificial joints, 1.2 million vascular stents and 1 million intraocular lenses will be needed nationwide in 2015, and the demand for medical polymer materials, bioceramics and medical metals will increase significantly. From the perspective of national policy, whether from the "Bioindustry Development Plan" issued by the State Council or the "13th Five-Year Plan" issued this year, it is clearly pointed out that we should vigorously promote the new medical materials industry.
However, China is a country with a large population, and most of the medical implants needed for clinical use each year are still from the United States and developed countries in Europe. From the comparison between the size of the medical device market and the size of the drug market, the size of the global medical device market in 2012 was roughly 47% of the size of the global drug market, while that of China was only 14%. China's export products are mainly small and medium-sized, low-technology and low-value-added products, such as medical consumables, massage appliances, and conventional equipment.
Looking at China's population base and current national conditions, the proportion of China's population aging will reach 12% and 25% respectively by 2025 and 2050. Therefore, it has become a top priority to vigorously develop the industry of new medical materials and medical implants. At present, there are many problems in China's biomedical material industry. First of all, the industrial scale is small, technical equipment is backward, large-scale production enterprises have not yet formed, and lack market competitiveness. In 2010, there were about 2400 enterprises engaged in the production of biomedical materials in China, with an average annual sales of about 1.2 million dollars per enterprise. There were very few enterprises with an annual sales of more than 1 billion yuan, and only about 30 enterprises with an annual sales of more than 100 million yuan. The total sales of the top five enterprises accounted for only 10.2% of the total sales of biomedical materials in China. In addition, China's transformation capacity of scientific and technological achievements is relatively low, the industrial technological innovation capacity is not strong, the product technical structure is backward, and more than 70% of high-tech high-end products are imported. The engineering and industrialization level of biomedical material science and engineering research achievements in China is low, and 80% - 90% of the achievements are still in the laboratory; The enterprises are small in scale and lack of R&D funds. In 2010, the R&D funds of local enterprises accounted for only 1.77% of the sales revenue of enterprises on average. In the management of medical materials industry chain, a complete industry chain has not yet formed. China has provided 60% - 70% of low-value medical consumables to the world, but there is no specialized supplier of medical grade metals, polymers and other polymers, and there is no national or industrial standard for general basic raw materials. At the same time, there is a lack of industrialization integration mechanism, the export of venture capital is narrow, the financing channel is blocked, and there is a lack of funds for industrialization of achievements and technological transformation of enterprises. The corresponding management departments lack a coordination mechanism, fail to form a unified comprehensive planning and management mechanism, and repeatedly set the top, and multi-headed management is common; The policies and regulations are not sound, the product registration time is too long, and the processing efficiency is low. Some policies and regulations and gray industry rules are not conducive to the development of Chinese-funded enterprises.
Current situation and development trend of biomedical materials industry at home and abroad
According to statistics, the composite growth rate (CAGR) of biomedical materials in the global market reached more than 22% in 2000-2010, and the global market reached US2 billion yuan in 2010. It is estimated that the CAGR of the market in 2009-2020 will remain about 15%, the world market will reach US5 billion yuan in 2015, and more than US4 billion yuan in 2020. At the same time, it will drive the new output value of related industries (excluding medical treatment) to about 3 times, and the total direct and indirect sales will reach 4% in 2015 and 2020 respectively × US $5 billion ≈ US $20 billion, and US $56 billion. The world's largest producer and consumer of medical devices is the United States. In 2010, it accounted for about 40% of the global market, and consumed 37% of global products, with an annual growth rate of about 8%; Due to the developed economy and sound social medical security system, the EU has become the second largest medical device market in the world, accounting for 29% of the global market share; The Asia-Pacific region is the third largest market in the world, accounting for 18% of the market share. Japan is the country with the most advanced and fastest development of medical technology in the Asia-Pacific region, and the third largest consumer of medical devices in the world. China and India have the most growth potential and space. Due to the largest population, and their health care system is still in the process of development and not yet mature, the health care system of Southeast Asian countries also has great room for improvement, Therefore, the market will continue to grow; Latin America is another region with the fastest growth. Mexico, Brazil, Argentina, Chile and other countries are gradually developing towards industrialized countries. It is estimated that the demand for medical devices will also maintain a relatively rapid growth in the future. (The value of medical technology companies in a competities environment connections，2011.07.03)。
Biomedical materials and implantable devices industry is a high-tech industry with the most interdisciplinary and knowledge-intensive industries. Its development needs the support of upstream and downstream knowledge, technology and relevant environment. Therefore, the industry is highly concentrated (monopolistic), and product diversification or diversification is another feature and trend of the development of biomedical materials industry. In 2010, the world medical device industry was composed of 27000 medical device companies, of which more than 90% were small and medium-sized enterprises. Small and medium-sized enterprises in developed countries are mainly engaged in research and development of new products and technologies, and maintain their survival by transferring technology to large companies or being merged by large companies. Large-scale product production and market operation are basically carried out by large companies. Unlike the situation of "many, small and scattered" medical device enterprises in China, the medical device industry in developed countries has formed a situation of "oligarchy" domination, and the global market has also presented a similar pattern. In 2009, the top 50 multinational companies accounted for 88% of the global medical device market, of which the top 25 companies accounted for 75%; In 2008, six American and British companies: DePuy, Zimmer, Stryker, Biomet, Medtronic, SynthesMathys and Smith&Nephew accounted for ≈ 75% of the global orthopedic material and device market, of which the top four American companies and Smith&Nephew of the United Kingdom accounted for 90% of the artificial joint market; Six major companies: Johnson&Johnson, Abbott, Boston Scientific, Medtronic, CRBard (USA) and Terumo (Japan) account for 80-90% of the market of cardio-cerebrovascular system repair materials and implant (implant) devices; Five major companies: Baxter International (USA), Fresenius (Germany), Gambro (Sweden), Terumo and AsahiMedia (Japan) account for 80% of the market of blood purification and extracorporeal circulation system materials and devices; The market of dental implants and dental materials is basically monopolized by large companies such as Straumann (Switzerland), Dentsply International (USA), Nobel Biocare (Germany) and Osstem (Korea). In order to improve market competitiveness and maintain advantages, mergers and integration of the world's medical device industry has been ongoing. During 1998-2009 alone, the average annual mergers and acquisitions of the United States industry reached 200. The increasing concentration or monopoly of the industry is an important trend in the development of the biomedical material industry.
In order to improve the market competitiveness of enterprises, avoid risks, and develop and expand enterprises, foreign multinational companies have continued to extend and expand their product lines from the initial production of relatively single products, through internal technological innovation and mergers and acquisitions of other enterprises, to achieve multi-variety production.
Internationalization of production and sales is a prominent trend in the development of biomedical materials. Almost all the large enterprises of biomedical materials are multinational companies, and a considerable part of their sales come from the international market. For example, in 2010, the sales of Johnson&Johnson Company of the United States were 40% (US $200 million), the sales of Boston Scientific was 46% (US $90 million), and the sales of Medtronic in 2011 were 43% (US $37 million), all from overseas markets. In order to open up the international market, multinational companies set up subsidiaries and R&D centers abroad to produce and develop locally by exporting technology and capital overseas. At the same time, in order to adapt to the development of international trade, the International Organization for Standardization (ISO) has continuously formulated and issued international standards for biomedical materials and products.
Current situation and development trend of biomedical materials industry at home and abroad
2. Key products, core technologies and development trends
The development of biomedical material industry strongly depends on the support of advanced technology and economic strength in relevant fields. The rapid development of medical devices in the United States and its leading position in the world are due to the support provided by its aerospace technology, biotechnology, microelectronics technology, precision processing technology, software development and other fields for the development of the medical device industry, as well as a good policy environment. At present, developed countries rely on their top scientific and technological innovation and economic strength to mainly produce high-tech biomaterials and implant devices. Labour-intensive and resource-consuming enterprises have gradually transferred to overseas, so their technical equipment is very advanced. Various high-end processing centers, special machine tools, laser micro-processing and coating equipment have been equipped in biomaterials enterprises; Automation and information technology have been widely used in production; The most advanced inspection equipment can be found everywhere in large companies. Advanced technology and equipment ensure the progressiveness of its products and its monopoly position in the market.
3、 Current situation and development trend of biomedical materials industry in China
After nearly ten years of development, China's modern biomedical material industry has taken shape and entered a stage of rapid development. In China, there are four main reasons for the rapid development of biomedical materials, namely, the intensification of population aging and the limited life of human tissues and organs will lead to an increase in the demand for biomedical materials; The increase of trauma among young and middle-aged people caused by the development of transportation and sports; Continuous economic growth, continuous improvement of people's living standards, gradual enhancement of health awareness and changes in lifestyle, especially the implementation of medical reform policy; The upgrading of technological innovation capability and technological level of the industry will promote the transfer of the industry to the upstream of the value chain.
According to statistics, the sales volume of biomedical materials market in China reached nearly 10 billion US dollars in 2010, with a compound growth rate of 30%. It is conservatively estimated that the annual sales will reach US $135.5 billion in 2020, and it will grow into the world's second largest biomedical material market within 10 years. In 2015, the "Twelfth Five-Year Plan" for the Development of New Materials Industry issued by the Ministry of Industry and Information Technology of the People's Republic of China clearly stated that it is expected that 500000 sets of artificial joints, 1.2 million vascular stents and 1 million intraocular lenses will be needed nationwide in 2015, and the demand for medical polymer materials, bioceramics and medical metals will increase significantly. From the perspective of national policy, whether from the "Bioindustry Development Plan" issued by the State Council or the "13th Five-Year Plan" issued this year, it is clearly pointed out that we should vigorously promote the new medical materials industry.
However, China is a country with a large population, and most of the medical implants needed for clinical use each year are still from the United States and developed countries in Europe. From the comparison between the size of the medical device market and the size of the drug market, the size of the global medical device market in 2012 was roughly 47% of the size of the global drug market, while that of China was only 14%. China's export products are mainly small and medium-sized, low-technology and low-value-added products, such as medical consumables, massage appliances, and conventional equipment.
Looking at China's population base and current national conditions, the proportion of China's population aging will reach 12% and 25% respectively by 2025 and 2050. Therefore, it has become a top priority to vigorously develop the industry of new medical materials and medical implants. At present, there are many problems in China's biomedical material industry. First of all, the industrial scale is small, technical equipment is backward, large-scale production enterprises have not yet formed, and lack market competitiveness. In 2010, there were about 2400 enterprises engaged in the production of biomedical materials in China, with an average annual sales of about 1.2 million dollars per enterprise. There were very few enterprises with an annual sales of more than 1 billion yuan, and only about 30 enterprises with an annual sales of more than 100 million yuan. The total sales of the top five enterprises accounted for only 10.2% of the total sales of biomedical materials in China. In addition, China's transformation capacity of scientific and technological achievements is relatively low, the industrial technological innovation capacity is not strong, the product technical structure is backward, and more than 70% of high-tech high-end products are imported. The engineering and industrialization level of biomedical material science and engineering research achievements in China is low, and 80% - 90% of the achievements are still in the laboratory; The enterprises are small in scale and lack of R&D funds. In 2010, the R&D funds of local enterprises accounted for only 1.77% of the sales revenue of enterprises on average. In the management of medical materials industry chain, a complete industry chain has not yet formed. China has provided 60% - 70% of low-value medical consumables to the world, but there is no specialized supplier of medical grade metals, polymers and other polymers, and there is no national or industrial standard for general basic raw materials. At the same time, there is a lack of industrialization integration mechanism, the export of venture capital is narrow, the financing channel is blocked, and there is a lack of funds for industrialization of achievements and technological transformation of enterprises. The corresponding management departments lack a coordination mechanism, fail to form a unified comprehensive planning and management mechanism, and repeatedly set the top, and multi-headed management is common; The policies and regulations are not sound, the product registration time is too long, and the processing efficiency is low. Some policies and regulations and gray industry rules are not conducive to the development of Chinese-funded enterprises.
Current situation and development trend of biomedical materials industry at home and abroad
At the early stage of the development of China's biomedical material industry, many enterprises, represented by the production of low-value consumables, have emerged, adopting the development model driven by cheap labor and natural resources. With the advent of Internet technology, 3D printing technology, gene testing technology and other new technologies, the application of biomedical materials has expanded to wearable devices, personalized implants, precision medicine and other new fields, and various forms of capital operations such as mergers and acquisitions, IPO listing, listing on the new third board, and the establishment of investment funds have also flourished in the field of biomedical materials. The material factor-driven industrial development model, such as resource consumption and cheap labor, is not sustainable, and must be transformed to the technological innovation and capital-driven development model. In terms of industrial structure, China should combine the current basic situation, promote the development of small and medium-sized enterprises in the direction of specialization, refinement, specialization and innovation through professional incubators, tax incentives and other means, so as to form a benign complementary and competitive relationship with large enterprises, so as to optimize the industrial structure. At present, China's leading enterprises in the field of biomedical materials industry chain include Lepu (Beijing) Medical, Jiangsu Yuyue Medical, Guangdong Guanhao Biological, Shandong Weigao, Shanghai Micro-innovation, Chuangsheng Medical and Kanghui Medical. The total number of applications for patents in the biomedical materials industry ranked the top 10 in 2014 was 392, of which universities and research institutions were the main applicants. Wuxi Zhongke Guangyuan Biomaterials Co., Ltd., with a large number of applications, applied for 69 patents in 2014, accounting for 17.60%, followed by Xi'an Zhongbang Titanium Biomaterials Co., Ltd., with 57 applications in 2014, accounting for 15.56%, including Zhejiang University, Shanghai Jiaotong University Sichuan University, Fudan University and Tsinghua University all entered the top 10 in patent application.
Through the overall analysis of China's biomedical material market, we can see that the current medical material products are developing in the direction of scale, precision, personalization and intelligence. Technological innovation, high-end products, industrial integration, regional clustering and layout internationalization are the major development trends of biomedical materials industry. In the context of global integration, the industrial structure of traditional biomedical materials needs to be optimized and the industrial innovation capacity needs to be strengthened. It is gratifying to note that several excellent enterprises in China (such as Lepu Medical, Tager Medical, etc.) have achieved cross-border integration between different segments, derived new industrial forms, achieved their own leapfrog development, and promoted the transformation of the development model of China's biomedical materials industry from low-level factors such as resource consumption and cheap labor force to high-level factors such as technological innovation and capital, and developed into an ecological model, It has effectively promoted the healthy development of the entire biomedical material industry. In addition, the improvement and improvement of the biological properties of traditional biomedical materials is also another focus of the development of modern biomedical materials. The reaction between the biomedical material implanted in the body and the body first occurs on the surface/interface of the implanted material, that is, the adsorption/adhesion of the material surface/interface to the protein/cell in the body. The main problem of traditional materials is the random adsorption/adhesion of proteins/cells, including the adsorption of degenerated proteins, resulting in inflammation, allogeneic reaction and implantation failure. Controlling the adsorption of protein on the surface/interface of the material, and then the cell behavior, is the key to control and guide its biological reaction and avoid allogenic reaction. Therefore, in-depth study of the surface/interface of biomaterials and the development of surface modification technology and surface modification implant devices are the main ways to improve and improve traditional materials at this stage, and also the basis for the development of new generation of biomedical materials.
It can be expected that in the next 20 to 30 years, the science and industry of biomedical materials and implanted devices will undergo revolutionary changes: a new industry of biomedical materials and implanted devices that provide regenerative medicine with the ability to induce tissue or organ regeneration or reconstruction will become the main body of the biomedical materials industry; Surface modified conventional materials and implanted devices are important supplements. It is conservatively estimated that both of them may lead to the growth of the world's high-tech biomaterials market to ≈ US5000 billion yuan around 2030. Accordingly, the new indirect economic benefits of related industries can reach more than US5000 billion yuan.
(Source of this article: BioValley Publisher: Zuo Liyuan)
Through the overall analysis of China's biomedical material market, we can see that the current medical material products are developing in the direction of scale, precision, personalization and intelligence. Technological innovation, high-end products, industrial integration, regional clustering and layout internationalization are the major development trends of biomedical materials industry. In the context of global integration, the industrial structure of traditional biomedical materials needs to be optimized and the industrial innovation capacity needs to be strengthened. It is gratifying to note that several excellent enterprises in China (such as Lepu Medical, Tager Medical, etc.) have achieved cross-border integration between different segments, derived new industrial forms, achieved their own leapfrog development, and promoted the transformation of the development model of China's biomedical materials industry from low-level factors such as resource consumption and cheap labor force to high-level factors such as technological innovation and capital, and developed into an ecological model, It has effectively promoted the healthy development of the entire biomedical material industry. In addition, the improvement and improvement of the biological properties of traditional biomedical materials is also another focus of the development of modern biomedical materials. The reaction between the biomedical material implanted in the body and the body first occurs on the surface/interface of the implanted material, that is, the adsorption/adhesion of the material surface/interface to the protein/cell in the body. The main problem of traditional materials is the random adsorption/adhesion of proteins/cells, including the adsorption of degenerated proteins, resulting in inflammation, allogeneic reaction and implantation failure. Controlling the adsorption of protein on the surface/interface of the material, and then the cell behavior, is the key to control and guide its biological reaction and avoid allogenic reaction. Therefore, in-depth study of the surface/interface of biomaterials and the development of surface modification technology and surface modification implant devices are the main ways to improve and improve traditional materials at this stage, and also the basis for the development of new generation of biomedical materials.
It can be expected that in the next 20 to 30 years, the science and industry of biomedical materials and implanted devices will undergo revolutionary changes: a new industry of biomedical materials and implanted devices that provide regenerative medicine with the ability to induce tissue or organ regeneration or reconstruction will become the main body of the biomedical materials industry; Surface modified conventional materials and implanted devices are important supplements. It is conservatively estimated that both of them may lead to the growth of the world's high-tech biomaterials market to ≈ US5000 billion yuan around 2030. Accordingly, the new indirect economic benefits of related industries can reach more than US5000 billion yuan.
(Source of this article: BioValley Publisher: Zuo Liyuan)
