The richest man in the world — Bill. Gates predicts that the next richest person to overtake him will come from the field of genetics.
Basic situation analysis of the biomedical industry
(1) Biotechnology and its application in the pharmaceutical industry
Modern biotechnology, represented by genetic engineering, cell engineering, enzyme engineering and fermentation engineering, has developed rapidly in the past 20 years, and has increasingly influenced and changed people’s way of production and life. Biotechnology refers to “the use of living organisms (or biological substances) to improve products, improve plants and animals, or grow microorganisms for specific uses”. Biological engineering is generally referred to as the biological technology, refers to the use of biochemistry, molecular biology, microbiology, genetics, and the principle of the combination of biochemical engineering to transform or re-create design cell’s genetic material, develop new varieties, use of the existing biological systems in industrial scale, manufacturing of industrial products by biochemical process. In short, the process of industrializing living organisms, living systems, or living processes. Including genetic engineering, cell engineering, enzyme engineering, microbial fermentation engineering, bio-electronic engineering, bioreactors, sterilization technology and emerging protein engineering, among them, genetic engineering is the core of modern biological engineering. Genetic engineering (or genetic engineering, gene recombination technology) is to shear and combine the genes of different organisms in vitro, and connect them with the vector (plasmid, phage, virus) DNA, and then transfer them into microorganisms or cells, conduct cloning, and make the transferred genes express and produce the required proteins in the cells/microorganisms.
According to the different technical methods, bioengineering can also be specifically divided into: DrugDelivery, GeneTherapy, Genetics, FunctionalGenetics, CombinatorialChemistry, Diagnostic S), Reagents (Reagents), Monoclonal/polyclonal (Monoclonal/PoliclonalAntibody), Light activated carcinoma (Light – activated, Cancer-therpy, cancer vaccine, Fermention, etc.
At present, more than 60% of human biotechnology achievements are concentrated in the pharmaceutical industry, to develop new drugs with characteristics or to improve traditional medicine, which has caused a major change in the pharmaceutical industry, biotechnology pharmaceutical to rapid development.
Biopharmaceutical is the process of applying bioengineering technology to the field of drug manufacturing, among which the most important method is genetic engineering. That is, the use of cloning technology and tissue culture technology, DNA cutting, insertion, connection and recombination, so as to obtain biomedical products. Biological drug is a biological activation agent which is made of microorganisms, parasites, animal toxins and biological tissues as starting materials, prepared by biological process or separation and purification technology, and controlled the quality of intermediate products and finished products by biological technology and analytical technology. Including vaccine, vaccine, toxin, toxoid, serum, blood products, immune preparations, cytokines, antigens, monoclonal antibodies and genetic engineering products (DNA recombinant products, in vitro diagnostic reagents), etc. At present, biopharmaceutical products mainly include three categories: genetic engineering drugs, biological vaccines and biological diagnostic reagents. It plays an increasingly important role in diagnosing, preventing, controlling and even eliminating infectious diseases, protecting human health and prolonging life.
The introduction of biotechnology into the pharmaceutical industry has made the biomedical industry one of the most active and fastest developing industries. At present, human beings have developed and entered the clinical application of biological drugs, according to their different uses can be divided into three categories, namely genetic engineering drugs, biological vaccines and biological diagnostic reagents.
(2) Characteristics of the biomedical industry
1.High technology. This is mainly reflected in its high level of knowledge of the talent and high new technical means. Biopharmaceutical is a kind of knowledge – intensive, technology – intensive, multi – disciplinary highly integrated and interpenetrating emerging industry. Taking genetically engineered drugs as an example, the upstream technology (i.e. the construction of engineered bacteria) involves the synthesis, purification and sequencing of target genes. Gene cloning and introduction; Culture and screening of engineering bacteria; The downstream technology involves the purification of target protein and process amplification, and the detection and assurance of product quality. The application of bio-medicine has expanded the research field of difficult diseases and made the major diseases which previously threatened human life and health to be effectively controlled. In the 21st century, the development of biological drugs will enter the stage of mature ENABLINGTECHNOLOGIES, which will bring about great changes in medical practice and improve people’s health level greatly.
2.High investment. Biopharmaceutical is an industry with considerable investment, mainly used in the research and development of new products and the construction of pharmaceutical plants and the configuration of equipment and instruments. Currently, the average cost of developing a new biomedical drug abroad is around $100-300 million, and increases with the difficulty of developing new drugs (some are currently as high as $600 million). Some large biopharmaceutical companies spend more than 40% of their sales on r&d. Clearly, strong funding is a necessary guarantee for the success of the development of biological drugs.
3.Long cycle. Biotech drugs from began to develop into the end product to go through a lot of links: laboratory research stage, pilot production stage, stage of clinical trials (I, II, III), mass production stage, market commercialization stage, and supervise each link strict complex drug administration examination and approval procedures, and product training and difficult market development; Therefore, the development of a new drug cycle is relatively long, generally needs 8-10 years, or even more than 10 years.
4.High risk. The development of bio-pharmaceutical products is pregnant with great uncertain risks. Investment in a new drug is a costly system of engineering, ranging from bioscreening, preclinical tests such as pharmacological and toxicological studies, formulation and stability tests, bioavailability tests, to clinical trials in humans, registration, marketing, and post-marketing monitoring. Failure of any one of the links will be wasted, and some drugs have a “dual nature”, which may occur in the use of adverse reactions and need to be reevaluated. In general, a bioengineered drug has a success rate of only 5-10%. It takes 8 to 10 years and $130 to $300 million. In addition, the risk of market competition is also increasingly intensified. “registering new drug certificates and seizing market share” is the key to transforming technology into products, and it is also the target of fierce competition among different developers. If others give priority to getting drug certificates or seizing the market, all the previous efforts will be wasted.
5.High returns. The profitability of bioengineered drugs is high. A new biological drug can generally recover all the investment in 2-3 years after the market, especially the enterprises with new products and patented products, once the development is successful, the technological monopoly advantage will be formed, and the profit return can be as high as 10 times. Erythropoietin (EPO), introduced in 1989, and granulocyte colony stimulating factor (G-CSF), introduced in 1991 by Amgen, had sales of over $2 billion in 1997 and close to $2 billion, respectively. It can be said that once the development of biological drugs on the market, will be profited.
The development of biomedicine
(1) Development overview
The United States is the birthplace of modern biotechnology and the first country to use modern biotechnology to develop new drugs. Most genetically engineered drugs were first developed in the United States. Since 1971, the first biopharmaceutical company Cetus was established in the United States and began trial production of biological drugs, there have been more than 1300 biotechnology companies (accounting for two-thirds of the world’s biotechnology companies), the total capitalization of biotechnology market is more than 40 billion US dollars, and the annual research funding is more than 5 billion US dollars; More than 40 bioengineered drugs have been launched on the market, and 35 important therapeutic drugs have been successfully created, which are widely used in the treatment of cancer, multiple sclerosis, anemia, dysplasia, diabetes, hepatitis, heart failure, hemophilia, cystic fibrosis and some rare genetic diseases. More than 300 varieties are in clinical trials or awaiting approval; The biologics market was worth about $4.8 billion in 1995 and over $6 billion in 1997, with an annual growth rate of more than 20 per cent.
Europe has also made rapid progress in the development of biological drugs. Britain, France, Germany, Russia and other countries have also made great achievements in the development and production of biological drugs. In some areas of biotechnology, they even catch up with and surpass the United States. For example, Germany’s Herst Group company changed its business focus to life science, the Russian Academy of Sciences molecular biology Institute, Moscow University biology department, Moscow Obstetrics and Gynecology Institute and Russian medical genetics research center and other scientific research institutions in recent years in the research and application of gene therapy have made great progress.
Japan also has certain contribution in the field of life science, there are 65% of biotech companies engaged in biomedical research, Japan’s kirin biological medicine practice also listed in the world, the Singapore government recently announced to draw a piece of science and technology park and expensive construction used to attract the world’s several big in the biological medicine company, South Korea and Taiwan are also ambitious in this regard. The main reasons for the rapid development of the biomedical industry in recent years are:
International pharmaceutical group and related universities, scientific research institutions to establish a close research and development mode, is conducive to the development of new biotechnology and biological drugs and into clinical trials, is conducive to the rapid transformation of science and technology into productivity.
1.new technology “toolbox” is emerging: genomics, bioinformatics, transcriptimaging, signaltransduction, combina Torialchemistly, etc. brought a great leap forward to product discovery and development;
2.International venture capital provides huge financing for the biomedical industry;
3.The impact of biotechnology industry on the pharmaceutical industry is obvious, promising, biotech companies are identified;
4.Changes at the FDA itself have reduced the time it takes to approve new drugs, especially for cancer and AIDS.
(2) Market status and prospects
Relevant statistics indicate that the global market for biotech pharmaceuticals was us $12.7 billion in 1996 and approximately US $14.6 billion (+15 per cent) in 1997. If current growth rates are maintained, total market sales could exceed us $20 billion by 2000 and 100 modern biotechnology drugs will emerge. Although biotech drugs currently account for only 8% of the $150 billion global drug market, they have strong vitality and growth because they can make up for the fundamental defects of chemical drugs (low cost, high success rate, safety and reliability, etc.).
According to the survey report of the American Association of Pharmaceutical Research and Manufacturers in 1995 and 1996, the number of biotech drug development drugs approved and approved by the US FDA and the European Union for clinical trials was 143 in 1994, 234 in 1995 and 250 in 1996. In the main product categories, the best selling genetic engineering drugs in the international market are erythropoietin (EPO), G-CSF, interleukin, interferon (α, β, γ), insulin, T-PA, etc., as well as cytokines, receptor drugs, coagulation factor ⅷ, etc., the vaccine is mainly hepatitis B virus vaccine, In addition, PCR reagents for detection and diagnosis and probes for cloning are also available.
In the European biotechnology drug market, the largest market share in 1995 was human insulin with 38%, but it has reached a peak growth. In terms of growth, the growth rate of interferon will increase from 2.3% in 1995 to 9.5% in 2002, and the variety of a-interferon and G-interferon in the past will increase to four varieties. The acquisition of recombinant DNAB-interferon for multiple sclerosis in Europe will increase the total interferon market share. Colony-stimulating factor also maintained the same growth rate, but the market is dominated by granulomacrophage colony-stimulating factor, which has encountered promotion problems due to its side effects, and its turnover is expected to decline from 4.5% in 1995 to 13% in 2002. EPO will increase from 0.6% in 1995 to 22.5%. The approval and application of new indications for growth hormone is likely to accelerate the development of this market, which accounted for 16.3% of the European biotechnology medicines market in 1995, but the government’s price reduction measures are likely to reduce the growth rate to 14% in 2002. According to the latest market research report of Frost&Sullivan Europe, the market size of biotechnology derivatives in EPO, colony stimulating factor, interferon, human insulin and human growth hormone in Europe will increase from us $2.34 billion in 1995 to us $4.15 billion in 2002. This is mainly due to the continuous launch of new products and increased indications.
(3) The latest development trend of biomedicine
In the European and American markets, some second-generation gene drugs, such as recombinant new natrium, intracellular polypeptide and so on, have been marketed for molecular modification of existing recombinant drugs. In addition, the application of recombinant cytokine fusion proteins, human monoclonal antibodies, cytokines, antisense nucleic acids, gene therapy, new methods and techniques for antigen preparation, and transgenic animal models have also made substantial progress. The latest development trend of biomedicine abroad is highlighted in the following aspects:
1.Cloning technology. The appearance of dolly the sheep in 1997 brought about an epoch-making revolution in human cloning technology. Even more remarkable is a recent development related to cloning technology. In April 1999, U.S. researchers successfully cultured and differentiated mesenchymal stem cells from adult bone marrow into cartilage, fat and bone cells in vitro. The development of stem cell-based regenerative drugs with this technology will have a huge market for treating diseases such as cartilage damage, poor fracture healing, heart disease, cancer and degeneration caused by aging.
2.Angiogenesis. Angiogenesis inhibitors used to treat cancer have received a lot of media attention. In May 1998, investors rushed to buy EntreMed’s shares after the New York Times introduced the efficacy of two antivascular growth factors in preclinical development, angiostatin and endostatin. That boosted the company’s market value by $487 million in one day to $635 million. The third anti-angiogrowth protein, called vasculostatin, had only in vitro trial data when it was released in May 1998. In March 1998, the results of the first clinical trial of using growth hormone to stimulate the growth of blood vessels around the heart for the prevention and treatment of clogged arteries caused by coronary artery disease were published. This type of angiogenic therapy does the opposite of cancer therapy by stimulating the growth of endothelial cells lining arteries to form new blood vessels to treat coronary artery disease and ischemia.
3.AIDS vaccine. The search for an AIDS vaccine is getting renewed attention. In June 1998, VaxGen announced phase iii trials of a new AIDS vaccine, Aidsvaxgpl20, in the United States and Thailand. This is a new bivalent vaccine that the company believes will be better than the previous monovalent vaccine