China's bio-innovative pharmaceutical industry development status quo and future market size forecast.

In 1982, the FDA approved the first gene recombinant biological products, since then opened the beginning of biopharmaceuticals, after the 1990s, biopharmaceuticals entered a high-speed development stage, into the 21st century, biotechnology continued to break through, to promote the biopharmaceutical industry to accelerate the transition from chemical drugs to biopharmaceuticals, bringing the original industrial pattern of deconstruction and reconstruction, the global active layout of biopharmaceuticals, ushered in a bumper harvest of biopharmaceuticals.
the size of the biopharmaceutical industry Biopharmaceuticals is one of the most powerful and promising sub-sectors of the global pharmaceutical market.
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.
1: Global Biopharmaceity Market Share 2018 Source: Firestone Creation Collates China's Biopharmace product market based on public information, although still in its infancy, 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 from 2014 to the present (as of September 23, 2020), a total of 3939 new drugs of the first class are in clinical trials in China, of which 1287 are bio-drugs, accounting 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 Overview of the Number of Clinical Trials of New Drugs in Biologics So Far 2014 (Unit Correction: Individuals) Source: Firestone Creation (as of September 23, 2020) Figure 3: Clinical Trials of New Drugs in Biologics from 2014 to date Quantity 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 of the type approved in China, 64 of which are 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, the number of new drugs approved data sources: Firestone Creation (as of September 23, 2020) Comprehensive analysis, the economically developed areas such as North Shanghai and Guangzhou are still an important gathering area for the research and development and layout of bio-innovative drugs, while Suzhou City, Lianyungang City, Taizhou City and other new drugs in Jiangsu Province, the number of new drug clinical trials 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 overview 2019 biotech companies set off a wave of IPOs, the Hong Kong Stock Exchange IPO of a total of 7 Chinese biopharmaceiters, including 6 layout antibodies, 1 layout recombinant vaccine.
table 1: 2019 HKEx listed biopharmaceiter data source: Firestone creation financing, 2019 biopharmaceiters financing total more than 7 billion yuan, of which antibodies, cell and gene therapy, recombinant protein accounted for the first three, antibody sector financing total more than 60%.
Figure 5: Proportion of financing amount in various sub-sectors of biopharmaceuticals in 2019 Data sources: Firestone Creation Comprehensive analysis, China's bio-innovative drugs in the field of investment and financing has attracted much 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 technology direction and development constraints of the biopharmacedicine industry forecast (i) technical direction One is from the sub-areas, 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 adaptives Photo 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; The market needs to go through the "drug discovery - preclinical research - clinical trials - commercial production" four stages, the process down the average time 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 missing, 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 biopharmaceutical enterprises continue to invest in the research and development of bio-innovative drugs, differentiated development, adaptive choice, joint treatment, external cooperation 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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