Biological industryresearch report

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The following is the China Biopharmaceutical Industry Research Report 2020 From Entrepreneur recommended by And this article belongs to the classification: Biological industry, research report.

According to the data, among the top 10 best-selling drugs in the world in 2019, 8 are biological drugs; among them, adalimumab ranked first for 8 consecutive years, with sales of nearly 20 billion US dollars in 2019. The field of biopharmaceuticals is the most prone to produce heavy products, and biopharmaceuticals are the most popular pharmaceutical products in the world.

The development of domestic biopharmaceutical industry is in the ascendant, and new Biopharmaceutical Enterprises are emerging. The scale of biopharmaceutical market has been growing strongly, with a compound annual growth rate of more than 20%. The biopharmaceutical industry has entered a stage of rapid development from the initial stage of development. The revolutionary changes brought by biotechnology, such as gene editing and cell engineering, have brought new momentum for the rapid development of biomedical industry. On this occasion, chuangbang Research Center launched the “2020 Research Report on China’s biopharmaceutical industry”.

The report aims to sort out the current situation of domestic biopharmaceutical development by comparing the domestic and global market scale of biopharmaceutical, and hopes to have a further understanding of the development trend of biopharmaceutical industry through the introduction of antibody drugs, cell therapy and vaccines.

The highlights of the report are as follows:

Part 1 overview of biological drugs

Biopharmaceuticals refer to a kind of products for prevention, treatment and diagnosis, which are made by comprehensively utilizing the principles and methods of Microbiology, chemistry, biochemistry, biotechnology, pharmacy and other disciplines. According to the registration classification, drugs can be divided into chemical drugs, biological drugs and traditional Chinese medicine; biological drugs have the characteristics of good efficacy and safety, and less toxic and side effects.

The development of domestic biopharmaceutical industry lags behind the global market and has broad market growth space. In the past few years, the growth rate of domestic biopharmaceutical market is several times that of global biopharmaceutical market, and the market scale is expected to reach more than 640 billion yuan by 2023.

Biopharmaceutical industry is booming, and the primary and secondary capital markets are popular. According to wind data, from this year to August 30, 2020, in the secondary capital market, the secondary sub industries of biological products and medical devices in the pharmaceutical and biological industry have the highest growth rate, with more than 90%, and the investment is popular. In the VC / PE venture capital market, in the first half of 2020, the number and amount of financing in the medical and health field ranked top in all industries. Among them, biotech and pharmaceutical sectors attract more money, accounting for more than half of the financing amount.

Part 2. Acceptance of biopharmaceutical registration application

In 2019, the first domestic biological analogue, rituximab biological analogue (Fuhong Hanlin), was approved to go on the market. The domestic biological analogue research has made rapid progress. At the same time, China’s biological drug industry is also entering a period of rapid development from the initial stage.

Since the State Drug Administration (nmpa) implemented the priority review system, the speed of drug review and approval has been accelerated. Data show that in the first half of this year, 21 biological agents were approved for marketing, and nmpa approved the first time that the antibody drug conjugate – emmetstuzumab (Roche) was listed.

Part. 3. Important segments

The field of biopharmaceuticals is broad, including antibody drugs, cytokines, vaccines, blood products, gene therapy and cell therapy drugs, among which antibody drugs are known as the “Pearl” in the field of biopharmaceuticals. Antibody drugs mainly include monoclonal antibody, antibody drug conjugate, bispecific antibody, Fc fusion protein, antibody fragment and polyclonal antibody.

Since the invention of monoclonal hybridoma technology, after 40 years of continuous development and improvement, the research, preparation and application of monoclonal antibody drugs have reached a relatively mature stage. Nowadays, monoclonal antibody drugs have made great progress in the treatment of tumor, immune diseases and other fields, and the market scale is expected to develop rapidly.

According to the immunogenicity, monoclonal antibodies can be divided into four categories: mouse derived antibody, human mouse chimeric antibody, humanized antibody and fully humanized antibody

In 2017, after the approval of two car-t products yeskarta and kymriah, the global car-t market increased from about US $13 million in 2017 to about US $734 million in 2019, and is expected to further grow to US $4.7 billion in 2024.

Although there are no approved car-t products in China, the domestic car-t market is expected to grow to 600 million yuan in 2021 due to the expected launch of new products. In addition, due to the increase in the number of cancer patients and the improvement of residents’ economic affordability, the domestic car-t market is expected to reach 10 billion yuan in 2026.

Part 4. Development trend and Prospect

The medical and health industry has the characteristics of high investment, high risk, long cycle and high return, which needs huge financial support, especially the research and development of biological innovative drugs. Despite all kinds of favorable policies and increasing financial investment, facing the ever-changing external environment, the biopharmaceutical industry has both opportunities and challenges.

The market scale has expanded. With the continuous development of biotechnology and the gradual improvement of residents’ economic level, the domestic demand for biopharmaceuticals is surging; coupled with the government’s strong support for the biopharmaceutical industry, the market scale of the biopharmaceutical industry is expected to continue to maintain rapid growth.

Market supervision has been strengthened. The domestic biopharmaceutical industry started late, the regulatory needs to be improved, and the regulatory in preclinical, clinical research and production fields is relatively backward. With the increasingly strict examination and approval of regulatory agencies, the biopharmaceutical market will become more and more standardized.

Through new targets or new mechanisms of action, biological innovative drugs can more effectively treat diseases and meet the unmet market demand. Under a variety of favorable conditions, the biopharmaceutical industry is expected to enter a golden period of development, and the future is promising.

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