Chapter 1 Industry Overview
Biopharmaceutical technology has emerged in the past twenty years, and is a new generation of pharmaceutical technology represented by genetic recombination and monoclonal technology. Modern biopharmaceuticals are the direct product of the biotechnology revolution in the 1970s. Different from traditional biotechnology such as fermentation, it mainly includes drugs produced by biotechnology such as gene recombination technology, cell engineering, antibody engineering, etc. It can usually be divided into several major types according to nature and biotechnology: vaccines, antibodies, blood products, recombinant proteins, polypeptides, , gene therapy drugs, cell therapy drugs, etc. In the field of biopharmaceuticals, therapeutic antibodies, most recombinant proteins and peptides, and some Class II vaccine varieties have the characteristics of large market space and high technical barriers, which are currently the hot topics of domestic research and development and market attention.
Genetic engineering, cell engineering, protein engineering, enzyme engineering and fermentation engineering are collectively called "five major projects of biotechnology". The five major projects are closely related to the preparation and production of biological products. In these five major fields, the role of genetic engineering and cellular engineering is to use conventional bacteria as a receptor for specific genetic material, and by binding foreign genes, it becomes a new species that can express specific polypeptides or proteins - "engineered bacteria" or "engineered cell lines". The role of protein engineering, enzyme engineering and fermentation engineering is to create good growth and reproduction conditions suitable for new species, realize large-scale cultivation, so as to fully utilize the inherent potential of new species and provide huge economic and social benefits to mankind.
map of the pharmaceutical and biological industry chain
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map of the biopharmaceutical industry chain
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Chapter 2 Business model and technology development
In the biotechnology industry chain, the upstream of the industry is product research and development and raw material production, the middle stream of the industry is biopharmaceutical products and biopharmaceutical manufacturers, and the downstream of the industry is various medical businesses and serving terminal consumers through online and offline channels.
Figure Biomedical Industry Chain
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Genetic engineering technology refers to introducing exogenous genes into the receptor cells through in vitro recombination, so that the gene is replicated, transcribed, translated and expressed in the receptor cells, and finally made into the biological agent of the target.
Figure Genetic Engineering Technology Preparation Process
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Figure Gene sequencing industry chain
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Cell engineering refers to the application of theoretical methods of cell biology and molecular biology, and performing genetic operations and large-scale cell and tissue culture at the cell level according to the scientist's design blueprint.
Figure Cell fusion diagram
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Protein engineering refers to obtaining information about the physical and chemical properties and molecular properties of proteins through the study of protein chemistry, protein crystallography and protein dynamics, and on this basis, the gene encoding proteins is designed and modified in a purposeful manner.
diagram Protein engineering flow chart
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Biologics mainly include sub-fields such as antibody drugs, vaccines, blood products, hormones, and cytokines. The upstream of the biological agent industry is raw material suppliers, including animal raw materials, microbial raw materials and cellular raw materials; the midstream is mainly divided into antibody drugs, vaccines, blood products and other fields; the downstream is sales terminals, including medical institutions, pharmacies and e-commerce platforms.
diagram of the biologics industry chain
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Vaccine
Figure Vaccine classification
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Figure Vaccine R&D value maximization strategy
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stem cell
The upstream of the industrial chain of the stem cell industry is umbilical cord blood bank storage, and enterprises engaged in storage business include Zhongyuan Xiehe, Selela, Beike Bio, etc.; the middle of the industrial chain is stem cell drug research and development, mainly involving Guanhao Bio, , Zhongyuan Xiehe, Tianshili and other enterprises; the downstream of the industrial chain is sales terminals, including medical institutions and consumers.
Figure Stem cell industry chain
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Blood products
Plasma is the core raw material of the blood products industry. Blood products refer to biological products for treatment obtained from the plasma of healthy people or the plasma of specific immune populations through isolation and purification, mainly including human albumin, human immunoglobulin, rabies patient immunoglobulin, human coagulation factors, etc.
Figure Single-collecting plasma plasma collection process
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Bio-collecting companies mainly obtain revenue through product sales. Bio-collecting companies have leading products, and more biotechnology groups hope to diversify their product structure.
Table Take Amgen as an example to decompose the revenue structure
Domestic pharmaceutical companies have basically completed the fast follow layout of popular targets, and therapies such as dual antibody and ADC have gradually come to the stage. Compared with monoclonal antibody and small molecule targeting drugs, the dual antibody and ADC product structure is more complex. The dual targeting nature of dual antibody (combining two different antigens or different epitopes of one antigen at the same time), the combination of ADC antibodies and toxins makes these therapies more flexible and diverse, and there are certain differences in the layout of different companies.
Figure The research and development progress of dual anti-anti-products in listed companies in the clinical stage
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In the fields of new therapies such as cell and gene therapy, oncolytic viruses, domestic R&D keeps pace with the world trend and shows a booming development. According to the Journal of Gene Medicine, my country has become the second largest number of clinical trials in cell and gene therapy after the United States, accounting for 7.8% of global clinical trials, and it is a slight position in the global market.
Figure Clinical trial information of gene therapy, cell therapy, and oncolytic virus-related products in my country
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Figure Development of monoclonal antibody technology
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The number of invention patent applications published in 2020 is statistically ranked. The patents of the biopharmaceutical industry involve biotechnology drugs, genetic engineering drugs, vaccines, diagnostic reagents, microecological preparations, blood products and other technical fields. The companies/hospitals listed on the list mainly come from 14 countries, organizations or regions, and there are 3 companies with more than 1,000 patents. Roche ranks first with 2,122 patents, Novartis ranks second with 1,336 patents, and Merck ranks third with 1,222. Hengrui Medicine (471) from China ranked 16th, Zhengda Tianqing (220) ranked 32nd, and WuXi AppTec (165) ranked 47th. Data shows that from 2014 to 2018, the number of biotech patents in academic institutions ranked first in the overall ranking of the University of California system, Stanford University and MIT are the most active universities. Harvard University patents have the highest citation rate.Among non-art colleges and universities, the Chinese University of Hong Kong, the National Taiwan University of Taiwan and the National Successful University of Taiwan have also entered the top ten. In recent years, the rankings of Zhejiang University , the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai Cell Therapy Research Institute, , Shanghai Cell Therapy Group Co., Ltd. , Sun Yat-sen University, Fudan University , Tsinghua University, etc. are also very high.
The domestic raw material pharmaceutical industry is mainly managed by government departments and industry associations respectively, and the specific business and production and operation of related enterprises are operated based on market-oriented methods. The State Administration for Drug Administration under the State Administration for Market Regulation is the administrative department of the pharmaceutical industry, responsible for administrative management and technical supervision of the entire process of drug research, production, circulation and use, including formulating relevant administrative regulations and policies, market supervision, new drug approval (including imported drug approval), drug GMP and GSP certification, implementation of OTC system, drug safety evaluation, etc. The drug supervision and administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for drug supervision and administration within their administrative regions. The laws and regulations related to the supervision of my country's pharmaceutical industry mainly involve drug production license and certification, drug classification management system, drug pricing management system, etc., covering all aspects of drug research, production, circulation, and use.
Figure Related policy excerpts
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Figure Related policies and regulations on gene therapy, cell therapy, and oncolytic viruses in my country
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Chapter 3 Industry valuation, pricing mechanism and global leading enterprises
Figure 2 Figure 3 Industry valuation, pricing mechanism and global leading enterprises
Figure 2 Figure 3 Industry comprehensive financial analysis
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Chart Industry performance and valuation
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Biotechnology industry valuation method can choose price-to-earnings ratio valuation method, PEG valuation method, price-to-book ratio valuation method, price-to-book ratio valuation method, price-to-book ratio valuation method, price-to-book ratio valuation method, EV/Sales market rate valuation method, RNAV revaluation net asset valuation method, EV/EBITDA valuation method, DDM valuation method, DCF cash flow discount valuation method, NAV net asset value valuation method, etc.
Figure Take Kangtai Bio as an example to analyze the main business structure
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China's biopharmaceutical market is in the early stage of development, with strong growth potential, and its growth rate is ahead of the overall situation of the pharmaceutical market. Data shows that in 2019, the scale of China's biopharmaceutical market reached 317.2 billion yuan. With the improvement of affordability, the growth of patient population and the expansion of medical insurance coverage, it is estimated that the size of China's biopharmaceutical market will further expand to 464.4 billion yuan by 2021.
Figure 2015-2019 my country's biomedical market size and growth rate
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Figure 2011-2020Q3 Overview of investment and financing of global medical and health industry
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Figure 2009-19 Total revenue of domestic health institutions
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Figure 2015-2022 Domestic drug development expenditure and forecast (US$100 million)
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Figure Development of various sub-fields of medical devices in my country
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Vaccine
Figure 2 2012-2024E Global vaccine market size and growth rate
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Figure Vaccines account for 3.6% of the total drug market, ranking 5th in the top ten therapeutic areas
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Figure Global vaccine market size and supply distribution
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Figure Market size and growth rate of the vaccine industry from 2014 to 2019
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Figure The momentum and resistance to increase vaccine penetration rate
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Antibody
Figure 2014 to 2020
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Figure 2014-2019 Global monoclonal antibody drug market size (billion US dollars) and year-on-year
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Blood products
Figure 2012-2019 Blood products market size and growth rate
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Figure The proportion of blood products segments in 2019
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Figure Take Amgen as an example to analyze the main business structure
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A few developed countries occupy an absolute proportion in the global biomedical market and dominate the industry. The total number of biotech companies in the world has reached 4,362, of which 76% are concentrated in Europe and the United States. The sales of European and American companies account for 93% of global biotech companies, while the sales of Asia-Pacific region only account for about 3% of the world. The United States is the leader in the biotechnology industry, and its products and market sales account for more than 70% of the world. With the influence of factors such as the development of my country's economy, changes in living environment, changes in people's health concepts, and the acceleration of population aging, the biopharmaceutical industry, which is closely related to human quality of life, has maintained a continuous growth trend in recent years. At present, the industry has become one of the fastest growing industries in the world. As the world's second largest economy, my country has also played a positive role in the field of biopharmaceuticals.
Figure China's medical device segmentation share
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Vaccine
Figure Analysis of vaccine companies' batch issuance in 2019
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Figure 2019 domestic vaccine variety category sales (unit: billion yuan)
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Figure Porter Wuli Analysis of overseas vaccine market
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Blood products: The number of Chinese pulp stations and pulp collection volume are lower than the world level. Judging from the number of pulp stations and pulp collection volumes that China and the United States have in 2019, there is still a big gap between the pulp collection level of domestic pulp stations and the United States.
Figure 2005-2019 US pulp volume and number of pulp stations
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Figure 2019 The proportion of pulp stations of major domestic blood product companies
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antibody
Figure Distribution of global monoclonal antibody drugs for the first time
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Figure 19 Clinical development of domestic analogs of various celebrity monoclonal antibodies
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Figure Comparison of plasma therapy and antibody therapy
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Figure SWOT analysis of my country's biotechnology industry
Figure A-share and Hong Kong stock listed companies
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Figure 30 biopharmaceutical industry-related companies on the top 500 list account for various countries
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Figure 2020 Global TOP50 Pharmaceutical Enterprise Ranking
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Figure 2020 Global TOP50 Pharmaceutical Enterprise Ranking
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Figure 2 Figure Ranking of foreign listed companies
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Chapter 4 Future Outlook
The future development trend of the biotechnology industry will be as follows:
At present, China's biotechnology industry has begun to take shape, industrial agglomeration layout has been initially formed, and various sub-sectors have developed rapidly. The scale of the biopharmaceutical industry continues to expand, and the economic and social effects of bioagriculture continue to increase.
Currently, China's population aging is accelerating, the environmental pollution situation is severe, and the reduction of cultivated land area has increased the society's demand for the biotechnology industry. Population aging increases the incidence of chronic diseases, the demand for medical products is increasing, and the biopharmaceutical industry is showing a rapid growth momentum.
Technology is the most basic driving force for the development of the biotechnology industry and a necessary condition for the growth of the bioeconomic. The ability to continuously technological innovation is the core competitiveness of biotechnology enterprises. At present, China's lack of independent innovation capabilities in biotechnology restricts the process of technological industrialization. Improving the international competitiveness of China's biotechnology industry, strengthening technological research and development, and enhancing the industry's independent innovation capabilities are the key to the future development of the industry. In the future, biotechnology represented by gene sequencing, synthetic biotechnology, liquid biopsy, cell immunotherapy, biological big data, biosimilars, etc. will promote a new round of industrial transformation.
Biotechnology research and development is a complex system project that integrates knowledge and technologies in disciplines such as molecular biology and genomics. It has the characteristics of high investment, high returns, high risks and long cycles. Biological enterprises need to continuously increase their investment in scientific research, but they cannot achieve revenue in the short term and face the problem of difficulty in financing.
The biological industry chain involves a wide range of technology and complexity, strong professionalism, and high industry barriers. With the expansion of the scale of the biological industry, market competition is becoming increasingly fierce, and there is a clear division of labor in the industrial chain. For example, in the biopharmaceutical industry, in order to maintain the sustainability of new drug research and development, improve operational efficiency, and save costs, many large pharmaceutical companies outsource some non-core R&D links, and contracts entrusted R&D companies to be born due to the luck. In addition, biomedical production, market sales and other links are gradually provided with relevant supporting services by emerging CMO and CSO companies. Through contract research and development, contract production and other forms, the division of labor in the biological industry is becoming increasingly refined, and a complete industrial chain is gradually formed.
The biological industry has the characteristics of high investment, high returns, high risks and long cycles, and high investment is required as a condition for the entry and sustainable development of the industry. In order to cope with the increasingly fierce competition in the industry and enhance their competitiveness and market share, more and more powerful companies have acquired new technologies and new products through mergers and acquisitions. As the scale of the biological industry increases, inter-enterprise mergers and acquisitions will be an inevitable trend.
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