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Current Situation and Development Trend of Biomedical Materials Industry at Home and Abroad

Current Situation and Development Trend of Biomedical Materials Industry at Home and Abroad

(Summary description)Biomedical Materials are materials that are used to diagnose, treat, repair or replace damaged tissues, organs or enhance the function of living organisms. As a basis for the study of artificial organs and medical devices, biomedical materials have now become an important branch of contemporary materials science, especially with the vigorous development and major breakthroughs of biotechnology, biomedical materials have become a research topic for scientists from all over the world. In recent years, there have been endless reports on the application of medical materials and medical materials in the field of high-tech medical technology.

Current Situation and Development Trend of Biomedical Materials Industry at Home and Abroad

(Summary description)Biomedical Materials are materials that are used to diagnose, treat, repair or replace damaged tissues, organs or enhance the function of living organisms. As a basis for the study of artificial organs and medical devices, biomedical materials have now become an important branch of contemporary materials science, especially with the vigorous development and major breakthroughs of biotechnology, biomedical materials have become a research topic for scientists from all over the world. In recent years, there have been endless reports on the application of medical materials and medical materials in the field of high-tech medical technology.

1. Basic situation of biomedical materials

Biomedical Materials are materials that are used to diagnose, treat, repair or replace damaged tissues, organs or enhance the function of living organisms. As a basis for the study of artificial organs and medical devices, biomedical materials have now become an important branch of contemporary materials science, especially with the vigorous development and major breakthroughs of biotechnology, biomedical materials have become a research topic for scientists from all over the world. In recent years, there have been endless reports on the application of medical materials and medical materials in the field of high-tech medical technology.

Biomedical materials can be classified into skeletal-muscular system repair materials such as bones, teeth, joints, tendons, etc., soft tissue materials such as skin, breast, esophagus, bladder, and respiratory tract, and artificial heart valves, blood vessels, and intravascular catheters. Vascular system materials, blood purification membranes and separation membranes, gas selective permeation membranes, medical membrane materials such as corneal contact lenses, tissue adhesives and suture materials, drug release carrier materials, clinical and biosensor materials, etc.

Biomedical materials are not drugs, and their functions do not have to be achieved through pharmacological, immunological or metabolic means, and 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 of this year, representatives of the EU Parliament and the EU Council of Ministers reached a compromise resolution on the revision of EU guidelines for medical devices and in vitro diagnostics. The resolution calls for restricting the use of substances that can cause cancer, easily lead to organic mutations, toxic regeneration, or interfere with hormonal functions. The research and development of biomedical materials must have clear application goals. Even if the materials with the same chemical composition have different application purposes, not only the structure and property requirements are different, but the manufacturing process is also different.

Therefore, the science and engineering of biomedical materials are always inseparable from their end-use products (generally referred to as medical implants), and when it comes to biomedical materials, it refers not only to the materials themselves, but also to medical implants.

According to international practice, the management of medical biomaterials belongs to the category of medical devices, accounting for >40% of the medical device market. As an important part of high technology, biomedical materials have entered a new stage of rapid development, and their market sales are increasing at an annual rate of 16%. It is expected that in the next 20 years, the share of biomedical materials will catch up with drugs market and become a pillar industry.

Biomedical materials are the most extensive interdisciplinary fields in contemporary science and technology, involving materials, biology and medicine and other related disciplines. Due to the progress of contemporary materials science and technology, cell biology and molecular biology, the understanding of the interaction between materials and the body has been deepened at the molecular level, coupled with the progress of modern medicine and the drive of huge clinical needs, contemporary biomaterials science and industry Revolutionary changes are taking place and are already on the verge of achieving a significant breakthrough - regenerating human tissue, and further, whole human organs, opening the door to the transformation of inanimate materials into living tissue. Under the circumstance that my country's conventional high-tech biomedical materials market is basically monopolized by foreign investors, seize the favorable opportunity of the revolutionary changes in biomaterial science and engineering, look forward to the world biomaterial science and industry in the next 20-30 years, and deliberately improve Innovation ability can not only win rare opportunities for revitalizing my country's biomaterial science and industry and catch up with the world's advanced level, but also make great contributions to the development of human sciences by Chinese scientists.

Although the application of biomedical materials has achieved great success, long-term clinical application has also exposed many problems. For example, the mortality rate after 12 years of heart valve implantation is 58%, and the vascular restenosis rate after vascular stent implantation is ≈10%. It is a material or implant that is essentially present in the body as a foreign body. The repair of tissues and organs in contemporary medicine has developed in the direction of regeneration and reconstruction of human tissues or organs, or restoration and enhancement of their biological functions, and personalized and micro-trauma treatment. Traditional biomedical materials have been difficult to meet clinical requirements. Endows materials with biological structure and biological functions, fully mobilizes the human body's self-healing ability, regenerates and rebuilds damaged human tissues or organs, or restores and enhances its biological functions, and achieves permanent recovery of damaged tissues or organs. It has become a modern biological The development direction of medical materials. The main frontiers focus on: materials and implantable devices (including tissue engineered products) that can induce regeneration of damaged tissues or organs; and drugs and biological activities for the treatment of incurable diseases, restoration and enhancement of biological functions of tissues or organs Substances (vaccines, proteins, genes, etc.) target controlled release carriers and systems, etc. The cutting-edge research on biomedical materials and implanted devices is making significant progress. The US FDA has approved 7 tissue engineering products for the market, and the Chinese SFDA has approved the introduction of osteoinductive artificial bone and tissue engineered skin that can induce bone regeneration. Seven tissue engineering product standards have been passed, and a large number of implantable devices for regenerating tissue are in clinical trials at home and abroad. Frontier research is already on the verge of achieving a major breakthrough—the design and manufacture of living human tissue, and further whole human organs. Its development and application have given birth to 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 US$0 billion in the next 20 years. Regenerative medicine products are mainly composed of stem cells, tissue-engineered tissues and organs with biological materials as scaffolds, and biological tissues and organs for transplantation. Biomedical materials are the basis for their development.

2. Status and development trend of foreign biomedical material industry and technology

1. Industry status, scale, competitive advantage and development trend

According to statistics, the compound growth rate (CAGR) of the global market for biomedical materials from 2000 to 2010 was as high as 22%. In 2010, the global market reached US2 billion. It can reach more than US5 billion yuan, and it will reach more than US4 billion yuan in 2020. At the same time, it will drive the new output value of related industries (excluding medical treatment) by about three times. In 2015 and 2020, the total direct and indirect sales will reach 4 × US5 billion respectively. Yuan ≈ US20 billion yuan, and US56 billion yuan. The world's largest medical device producing and consuming country 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 its developed economy and a sound social medical security system, the European Union has become a global market. The second largest medical device market, 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, of which Japan is the most advanced and fastest-growing country in the Asia-Pacific region for medical technology, and The third largest consumer of medical devices in the world, my country and India have the most growth potential and space, because they have the largest population, and their healthcare systems are developing and not yet mature, and the healthcare systems in Southeast Asian countries are also greatly improved. Therefore, the market will continue to grow; Latin America is another fastest-growing region, and countries such as Mexico, Brazil, Argentina and Chile are gradually developing into industrialized countries, and it is estimated that the demand for medical devices will also remain large in the future. speed growth.

The biomedical materials and implantable device industry is a high-tech industry with the most interdisciplinary and knowledge-intensive industries. Its development requires the support of upstream and downstream knowledge, technology and related environments. Therefore, the industry is highly concentrated (monopoly), and product diversification or diversification is a biological issue. Another characteristic and trend of the development of medical materials industry. In 2010, the world medical device industry consisted of 27,000 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 the research and development of new products and new technologies, and survive by transferring technology to large companies or being merged by large companies. Large-scale product production and market operations are basically carried out by large companies. Different from the "many, small and scattered" situation of medical device enterprises in my country, the medical device industry in developed countries has formed a situation of "oligarchic" rule, and the global market also presents 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, 6 American and British companies: DePuy, Zimmer, Stryker, Biomet, Medtronic, Synthes Mathys and Smith & Nephew hold ≈ 75% of the global orthopaedic materials and devices market, of which the top 4 US companies and British Smith & Nephew hold 90% of the artificial joint market; 6 large companies: Johnson & Johnson, Abbott, Boston Scientific, Medtronic, CRBard (US) , Terumo (Japan) company occupies 80-90% of the cardiovascular and cerebrovascular system repair materials and implant (interventional) devices market; 5 large companies: Baxter International (United States), Fresenius (Germany), Gambro (Sweden), Terumo and AsahiMedia (Japan) holds 80% of the market of materials and devices for blood purification and extracorporeal circulation systems; the market for dental implants and dental materials is basically dominated by large companies such as Straumann (Switzerland), Dentsply International (United States), NobelBiocare (Germany) and Osstem (South Korea) monopolized. In order to improve market competitiveness and maintain advantages, mergers and integrations in the world's medical device industry have been going on. During the period from 1998 to 2009, the average annual merger and acquisition in the US industry reached 200, and the industry concentration or monopoly continued to increase. an important trend in development.

In order to enhance the market competitiveness of enterprises, avoid risks, and develop and expand enterprises, foreign multinational companies have been expanding and expanding their product lines from the initial production of a single product, through internal technological innovation and mergers and acquisitions of other enterprises, to achieve multi-variety production.

The internationalization of production and sales is a prominent trend in the development of biomedical materials. Almost all large enterprises of biomedical materials are multinational companies, and a considerable part of their sales come from the international market. 900 million yuan), Medtronic's sales in 2011 were 43% (US.37 billion yuan), all from overseas markets. In order to open up the international market, multinational companies have established subsidiaries and R&D centers abroad by exporting technology and capital abroad to produce and develop locally. At the same time, in order to adapt to the development of international trade, the International Organization for Standardization (ISO) continuously formulates and publishes international standards for biomedical materials and products.

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