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Wen: In 1982, the FDA approved the first gene recombinant biological products, which opened the curtain on biopharmaceuticals, and after the 1990s, biopharmaceuticals entered a high-speed development stage, and since the 21st century, biotechnology has continuously broken through, promoting the biopharmaceutical industry to accelerate the transition from chemical drugs to biopharmaceuticals, bringing the deconstruction and reconstruction of the original industrial pattern, and actively layout the biopharmaceutical field around the world, ushering in a bumper biopharmaceutical harvest period.
biopharmaceutical industry market size profile biopharmaceuticals is the global pharmaceutical market development momentum of the most rapid, the best prospects for development of sub-areas.
the global biopharmaceus market growth rate has remained above 5% in recent years, with market share divided mainly by antibodies, recombinant protein drugs and recombinant vaccines, of which the antibody market accounted for more than 50% in 2018.
Figure 1: Global Biopharmaceers Market Share 2018 Figure 1: Global Biopharmaceons Market Share Data Source: Firestone Creation Collates China's Biopharmace products market based on public information, although still in its early stages of development, has strong growth potential.
2018, China's biopharmaceutical market reached 262.2 billion yuan, accounting for about 17.1% of the overall pharmaceutical market, according to public data.
With the growth of the patient population, the improvement of affordability and the expansion of health insurance coverage, china's biopharmaceity market is expected to expand further to RMB641.2 billion by 2023, with a compound annual growth rate of 19.6% over the same period.
The research and development and layout of bio-innovative drugs in China since 2014 (as of September 23, 2020), a total of 3939 new drugs of the first class are in clinical trials, of which 1287 biopharmaceons accounted for 32.7%.
In terms of regional distribution, Jiangsu Province, Shanghai, Beijing and Guangdong Province are the four provinces with the largest number of clinical trials of new drugs such as biopharmaceons, accounting for about 74% of the total;
Figure 2: Regional profile of the number of clinical trials of new drugs such as biologic drugs from 2014 to date (unit correction: individuals) Data source: Firestone Creation (as of September 23, 2020) Figure 2: Regional profile of the number of clinical trials of new drugs such as biologic drugs from 2014 to date (unit correction: one) Figure 3:1 From 2014 to now, the number of clinical trials of new drugs such as biological drugs city layout data source: Firestone Creation (as of September 23, 2020) 2014 to date (as of September 23, 2020), a total of 227 new drugs approved in China, of which 64 belong to biological drugs.
regional distribution, Shanghai and Beijing are still the provinces with the largest number of new drug approvals, more than one-third of the total.
In the distribution of sub-sectors, recombinant proteins (42), vaccines (16) and antibodies (11) were the three most involved segments in new drug batches such as biological drugs, accounting for 92.2% of the total.
figure 4: 2014 to date, biological drugs such as the number of approved data sources: Firestone Creation (as of September 23, 2020) comprehensive analysis, the economically developed areas such as North Shanghai and Guangzhou is still an important gathering area for the research and development and layout of bio-innovative drugs, and Jiangsu Province, Suzhou City, Lianyungang City, Taizhou City and other new drug clinical trials ranked in the forefront of the country, the future will become the development of bio-innovative drugs new engine, new power.
from the sub-sectors, recombinant proteins, vaccines, antibodies are currently popular in the field of bio-innovative drugs, all kinds of drugs have been listed, and will enter the outbreak period.
2019 China's biopharmaceian companies listed and financing profile 2019 biotech companies set off a wave of IPOs, the Hong Kong Stock Exchange IPO of a total of 7 Chinese biopharmaceian enterprises, of which 6 layout antibodies, 1 layout recombinant vaccine.
table 1: 2019 HKEx listed biopharmaceiter data source: Firestone creative financing, 2019 total financing in the biopharmaceiter sector of more than 7 billion yuan, of which antibodies, cell and gene therapy, recombinant protein accounted for the first three, antibody sector financing total of more than 60%.
figure 5: 2019 Biopharmaceuticals in various sub-sectors of financing amount of data sources: Firestone creation comprehensive analysis, China's bio-innovative drugs in the field of investment and financing has attracted attention, industrial capital in the domestic bio-innovative pharmaceutical industry development process has played a role that can not be ignored.
from the HONG Kong Stock Exchange IPO and financing data, the antibody field is highly sought after by capital and hot speculation, while cell therapy and gene therapy gradually emerged as the capital market "scent."
the future technical direction and development constraints of the biopharmacedicine industry forecast (i) the technical direction is from the sub-sector, antibodies, cell therapy and gene therapy, recombinant proteins, etc. are the mainstream of the future.
monoantibodies will usher in the industrialization explosion stage, humanized antibodies, nanoantibodies, antibody association drugs (ADCs), dual-specific antibodies and so on become an important technical direction of antibodies;
second is from the point of view of adaptive diseases, the field of bio-innovative drug treatment focuses on tumors and infectious diseases.
Biotherapy is the fourth generation of tumor therapy after surgery, radiotherapy and chemotherapy, and antibodies, recombinant proteins, tumor vaccines, cell therapy and gene therapy provide new therapeutic ideas for tumor therapy, the largest application of tumor therapy drugs or future bio-innovative drugs.
figure 6: Clinical trials of new drugs such as biopharmaceuses involve adaptive image Source: Firestone Creation (ii) Development constraints One is from the industrial chain, upstream biological reagents, model animals and other test materials and test equipment are heavily dependent on imports, domestic research and development and supply is seriously inadequate; Drug market needs to go through the "drug discovery - preclinical research - clinical trials - commercial production" four stages, the process took an average of 9.5-15 years, time costs, human and material resources are huge investment;
Second, policy supervision is not perfect, at present, bio-innovative drugs, especially for cell therapy and gene therapy research guidelines and other normative documents are lacking, insufficient legal supervision, the future to build a sound macro-system of laws and regulations and micro-guidance operating rules.
is the shortage of high-end talent, bio-innovative drugs as a technology-oriented industry, the need for professional high-end talent to lead the development of the industry.
Small knot bio-innovative drugs will become a must-win for biopharmaceutical enterprises, domestic bio-pharmaceutical enterprises continue to invest in the research and development of bio-innovative drugs, differentiated development, adaptive choice, joint treatment, external cooperation, etc. has become an important way to enhance the competitiveness of new drug research and development enterprises, but also the main way for domestic pharmaceutical companies to go a country to participate in global competition.
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