echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > The era of large varieties of domestic vaccines has opened! Analysis and research on the development of vaccine industry at home and abroad

    The era of large varieties of domestic vaccines has opened! Analysis and research on the development of vaccine industry at home and abroad

    • Last Update: 2021-01-09
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    First, the vaccine industry introduction Vaccine refers to all kinds of pathogenic microorganisms (such as viruses, bacteria, etc.) and their metabolites, through artificial detoxification, inactivation or the use of genetic engineering and other methods made of a medical biological products, through the active exposure of inoculators to re-safe and controllable antigens, trigger body immune skills and leave immune memory, and ultimately achieve the prevention of a particular disease or class.
    With the rapid development of immunology, biochemistry, biotechnology and molecular microorganisms, the technical path of vaccines has been iterative for nearly a hundred years, from the first generation of traditional vaccines, including detoxification vaccines, inactivated vaccines, to the second generation of vaccines, including pathogen cleavage. Sub-unit vaccines and recombinant protein vaccines that recombine components that stimulate immune responses, to gene vaccines currently represented by DNA vaccines, mRNA vaccines, recombinant vector vaccines, etc., a new generation of vaccine varieties will continue to be available in the future to meet clinical needs. Table
    1 Classification of vaccines by technical path Source: According to public information, vaccines are generally classified as one and two vaccines according to our policy (the new 2019 Vaccine Act calls them "included in the national immunization programme vaccine" and "not included in the national immunization programme vaccine").
    First class of vaccines for the state mandatory vaccination varieties, the government provided free of charge to citizens, including hepatitis B vaccine, cardy seed, polio vaccine, cell-free white-crack vaccine and other 11 kinds of children routine vaccination and haemorrhagic fever vaccine, hook vaccine, carbon 3 key groups of people vaccinated, such as anthrax vaccine, can prevent hepatitis B, tuberculosis, polio, whooping cough and other 15 infectious diseases, due to the implementation of national tender procurement, usually low pricing, profitability in general, manufacturers to plan immunization period of state-owned enterprises.
    second-class vaccines for the voluntary vaccination of citizens at their own expense varieties, to adopt a completely market-oriented pricing model, more profitable, in recent years the growth rate is significantly faster, "explosive varieties" frequently.
    , the current state of the global vaccine industry Since 2000, the global vaccine market has continued to grow at a high rate, and then gradually leveled off around 2010.
    According to EvaluatePharma WorldPreview 2020, the global vaccine market will be about $32.5 billion in 2019, ranking fourth in all therapeutic sectors, with a market share of about 3.6%, and with more multi-priced vaccines and new vaccines coming on the market, the future growth potential of the global vaccine market is huge, with a projected global vaccine market size of $56.1 billion in 2026 and a compound annual growth rate of about 8.1%.
    Figure 1 Global Vaccine Market Size and Growth Data 2017-2026 Source: EvaluatePharma, Firestone Creation According to PublicLy Collated Global Vaccine Market has formed an oligopoly competitive landscape, 2019 GlaxoSmithKline (GSK), Mercadon, Pfizer and Sanofi's four vaccine giants combined to account for more than 90 percent of the global vaccine market with revenues of $8,481 million, $7,967 million, $6,716 million and $6.504 billion, respectively.
    sales growth in the vaccine business in 2019 was faster than in previous years, mainly due to GSK's recombined shingles vaccine and a significant increase in sales of Mercedon's HPV vaccine after its launch in China.
    the rankings among the world's top four vaccine companies have changed slightly over the past few years as new varieties are released, the overall top four have been solid for a long time.
    2 Global Vaccine Market Competition Data Source: New vaccines and multi-linked multi-priced vaccines occupy the vast majority of the market share based on publicly available data.
    vaccine industry is a variety-driven industry, the world's top 10 sales of heavy vaccine products are new vaccines and multi-linked multi-priced vaccines.
    , HPV vaccine series, DTaP and its seedling series, pneumonia vaccine series, etc. are often the cradle of heavy varieties.
    2019, Pfizer's 13-price pneumonia vaccine and Mercedon's HPV vaccine were ranked first and second on the 2019 top-10 list of global vaccine sales with sales of $5.847 billion and $3.737 billion, respectively.
    Table 2 Global Sales TOP10 Vaccine Variety Data Source: According to public information, China's vaccine industry development status quo China's vaccine market as a whole has grown steadily.
    vaccines are suitable for healthy people, so the size of the vaccine market is directly related to the size of the population.
    China has a large population base of about 1.4 billion in 2018 and is expected to reach 1.46 billion by 2030, with a large vaccine market.
    2018, the domestic vaccine market will be about Rmb33.6bn, just 16.39 per cent of the global vaccine market.
    With the opening of China's second-born policy, the future of about 18 million newborns per year, and the domestic aging trend is increasingly obvious, the elderly population is more vulnerable to some infectious diseases, so China's growing population of newborn infants and young children and a large group of elderly people will provide new market space for the vaccine industry, is expected to reach 116.1 billion yuan in 2030, a compound annual growth rate of 10.9%.
    3 China's vaccine industry market size data source: according to public information collated the domestic vaccine market pattern is relatively dispersed.
    from the high concentration of the global vaccine market, because China's vaccine industry into the market only less than 20 years, so China's vaccine market pattern is relatively dispersed.
    As of the end of September 2020, There are currently 334 domestic vaccine batches in China, scattered in the hands of 53 vaccine enterprises (regardless of the situation of parent subsidiaries and affiliated enterprises), of which China Biotechnology Co., Ltd. (China Health Group) under the Beijing, Shanghai, Wuhan, Chengdu, Changchun, Lanzhou Institute of Biological Products received 186 batches, accounting for 55.69% of all vaccine approvals in China.
    70 approved vaccines, distributed in GSK, Sanofi, Pfizer, Mercadon and other 8 multinational pharmaceutical companies.
    4 Vaccine Approved Enterprise Distribution Data Source: Firestone Creation Database The total number of vaccine approvals nationwide remained stable.
    2019, there were 52 vaccines issued in China, with a total of about 575.4 million vaccines issued, an increase of 6.36 percent year-on-year.
    2020, the new crown pneumonia swept the world, has had a greater impact on all walks of life, but China's vaccine batch issuance has not stalled, the first half of the cumulative approval of 281.62 million vaccines, an increase of 22.03 percent year-on-year.
    Figure 5 China's vaccine batch issuance in the first half of 2016-2020 (units: 10,000 units / 10,000 bottles) Data source: China Central Inspection Institute, Firestone Creation Database, a class of vaccines is still the mainstream of China's consumption.
    from the top ten vaccine varieties approved in China in 2019, the first is the adsorption of cell-free white-break vaccine, the number of approved issued 79.5598 million, followed by the meningococcal vaccine (meningococcal vaccine) The vaccines, including the flow-brain A and flow-brain A-C vaccines, and hepatitis B vaccines, were approved and issued in 63.7292 million and 63.2311 million, respectively, with the highest number of vaccines in the first category.
    and overseas mainstream vaccine varieties, such as 13-price pneumonia vaccine, HPV vaccine, shingles vaccine, etc. in China is relatively small, but with the continuous development and accumulation of domestic enterprises, domestic large-variety vaccine gradually listed, in January 2020 Xiamen Wantay Bohai double-priced human papillomavirus vaccine (commodity name Xin Corning) and Watson bio-13-price pneumococcal polysaccharide combination vaccine (commodity named Waughin) has been listed, the opening of the domestic vaccine era.
    6 The number of batch issues of China's top ten vaccine products in 2019 (in 10,000 bottles/10,000 units) Data source: Firestone Creation Database Heavy products will see an explosion in recent years.
    So far in 2018, there have been 228 clinical trials of vaccines in China, 99 of which are clinical trials III.III and IV. phases, including oral six-price rematched rotavirus live vaccine, poliovirus inactivated vaccine, triethic influenza virus sub-unit vaccine, recombinant tri-priced human papillomavirus vaccine, flow-brain A-C vaccine, etc., accounting for 43.42%.
    2020, Xiamen Wantay Bohai double-priced human papillomavirus vaccine, Watson bio-13-price pneumococcal polysaccharide combination vaccine, Changchun 100 grams nasal spray influenza vaccine has been approved for the market, in addition, Watson bio-double-priced human papillomavirus vaccine A number of heavyweight varieties, such as the Zhifei Bio-Cow Disagreement Bacillus Vaccine (Tuberculosis Vaccine), the Kantai Bio13-price pneumococcal polysaccharide combination vaccine, and the Koxing Bio EV71 vaccine, are under review and approval and are expected to be approved for market by the end of 2020.
    breakthrough in china's domestic new crown vaccine.
    According to WHO statistics, so far there are more than 190 candidate new crown vaccines in the world are being developed, of which China has 22, ranked second, second only to the United States 36, and China's multi-vaccine research and development in the international first square, its Chinese medicine inactivated vaccine (Wuhan Institute and Beijing Institute of two The Consino/Military Academy Adenovirus Vector Vaccine, the Kosing ZTE Inactivated Vaccine has entered Phase III. Clinical, and the adenovirus vector vaccine (Contai/AstraZeneum/Oxford University), mRNA Vaccine (Fosun/Pfizer/BioNTech) has entered Phase III.
    financing, since 2015, China's vaccine industry has experienced a total of 40 financing incidents, 11 provinces 22 vaccine enterprises have received financing, of which Hualan Bio and Kantai Bio in the first half of 2020 received 2.07 billion yuan and 3 billion yuan of super financing.
    the amount of financing, according to the disclosed data, there were nine financing incidents with a financing amount of more than 100 million yuan between 2015 and September 2020.
    Table 3 China's vaccine industry financing more than 100 million yuan in September 2015-September 2020 List of events Data sources: Firestone Creation Database IV, vaccine industry development constraints First, the research and development cycle of vaccine products is long, investment costs are large.
    Vaccine clinical studies are similar to innovative drugs, but unlike new drug development, because vaccines are generally suitable for healthy people, especially children and infants, vaccine development is more safety and ethical than therapeutic drugs, and clinical trials of new vaccines often require larger and longer-lasting trials.
    an innovative vaccine typically takes 8 to 12 years from concept to market (14 years for influenza vaccine, 23 years for HPV vaccine, 38 years for hepatitis B vaccine).
    long research and development cycle and high cost investment make it possible for only large pharmaceutical companies to afford the development of new vaccines.
    is that large-scale industrialization has some difficulty.
    In most cases, advanced technologies such as proprietary cell line, strains and internally improved production processes are more valuable than patent protection, and raw liquid production is not only a guarantee of product quality for vaccine companies, but also a core trade secret.
    At the same time, vaccine starting material strains/strains are derived from living organisms, have complex molecular structures, and the vaccine industry has low capacity utilization rates, and a production line can usually produce only one formulated product, which can make it difficult to industrialization on a large scale.
    addition, the vaccine industry quality control requirements are high, we must control the whole process of production, effectively ensure product quality.
    third is strict policy supervision.
    The introduction of the New Vaccine Act and the Draft Amendments to the Drug Administration Act provide that vaccine manufacturers are not allowed to outsource commissioned production/CMO and accept the international inertia of the "no fault principle", which provides for compensation to vaccine manufacturers or insurance systems as long as "cannot be ruled out" as an abnormal reaction.
    October 17, 2020, the 23rd Session of the Standing Committee of the 13th National People's Congress voted to adopt the Biosecurity Law of the People's Republic of China, which clarifies the important status and principles of biosecurity and will place higher demands on the vaccine industry.
    with the aging of the population, the opening of the second child policy and other factors, China's vaccine industry market space is huge.
    with the tightening of industry regulation and the listing of many domestic heavy-weight varieties, some small vaccine manufacturers will gradually shrink, industry concentration gradually increased, the future leading enterprises will benefit significantly.
    author of the book, Jieyang
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Related Articles

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.