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Vaccine industry has broad market prospects, industry concentration will be further improved under supervision

Vaccine industry has broad market prospects, industry concentration will be further improved under supervision

Release time:
2018/11/30
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  On the evening of November 11, 2018, the State Administration of Market Supervision and Administration announced the "Vaccine Management Law (Draft for Comment)" (hereinafter referred to as the "Draft for Comment") on the official website. It consists of 11 chapters, covering the development and marketing authorization of vaccines, Production and batch issuance, post-marketing research and management, vaccine circulation, vaccination, abnormal reaction monitoring and compensation, safeguards, supervision and management, legal responsibility, etc., make specific provisions for the special requirements of vaccine supervision.

 
The "Draft for Comment" was formed on the basis of the "Pharmaceutical Administration Law", and strengthened the punishment. However, it is not of much practical significance to impose fines based on multiples of the value of the goods. More importantly, the punishment Be deepened. With the tightening of supervision, under the new regulations, existing enterprises will inevitably further improve their product quality and production specification processes in order to survive, and some small, scattered, and chaotic enterprises will be eliminated, and the market concentration will be further improved. However, in order to truly achieve substantial reshuffle integration, the degree of intervention by the State Food and Drug Administration is the key.
 
Analysis and forecast of global vaccine sales in 2018
 
The large-scale foreign vaccines sold are mainly new vaccines and multivalent multi-linked vaccines, including pneumonia vaccine series, HPV vaccine series, DTaP and its combined vaccine series, measles-varicella zoster vaccine series, oral rotavirus vaccine series Etc. are often the cradle of abundance of heavyweight varieties. According to the statistical data of the "In-depth Investigation and Investment Strategic Planning Analysis Report of the Vaccine Industry" released by the Prospective Industry Research Institute, the global vaccine sales in 2013 were only 25.8 billion US dollars. It has exceeded US $ 30 billion, and it is expected that the total global vaccine sales in 2018 will further increase to US $ 32.3 billion.
 
2017 global vaccine industry market pattern analysis
 
Vaccines have extremely high safety requirements and high research and development difficulties. Only a few companies have the strength, and the global vaccine market is highly concentrated. In recent years, the total sales of the top four vaccine giants (GlaxoSmithKline, Sanofi, Merck, Pfizer) accounted for more than 80% of the total global market. In 2017, the vaccine business of the above four giants achieved 66.5 sales A total of US $ 24 billion, US $ 5.76 billion, US $ 6.16 billion, and US $ 5.6 billion, with a total sales of US $ 24.17 billion.
 
China's vaccine market has broad prospects
 
As a country with a large population, the strong demand for disease prevention caused by the improvement of living standards stimulates the vigorous development of China's vaccine industry. From 2005 to 2015, the scale of China's vaccine market increased from 6.5 billion yuan to 24.5 billion yuan, with an average annual compound growth rate of 14%. In the future, with the further expansion of the demand for disease prevention, as well as the supplement and improvement of China's immunization planning system, the expansion of vaccine varieties will further develop market potential. It is expected that China's vaccine market will exceed 50 billion yuan in 2020, with a five-year compound growth rate of about 15% .
 
2017 China vaccine batch was issued to pick up
 
Issues of vaccine batches are the only way for vaccines to enter the Chinese market. The volume of first-class seedlings issued is large, the unit price is low, and the profit is relatively small; the second-class seedlings have high barriers and high profits, and are mainly domestically produced (about 90% of the second-class seedlings). Due to the impact of the Shandong vaccine incident in 2016, the volume of second-class vaccines issued was significantly reduced. The batch of vaccines issued in 2017 recovered, and the HPV vaccine began to be issued in batches and entered the Chinese market.
 
China is the world's largest producer of vaccines for human use. China has issued 500 million to 1 billion bottles of vaccine each year, ranking first in the world. In 2015, there were a total of 43 domestic enterprises that had the license to issue vaccines. Among them, there are 38 local enterprises, distributed in 14 provinces / municipalities according to the site.
 
Industry concentration may be further improved
 
Compared with the highly concentrated market competition pattern of the four major giants in the foreign vaccine market, China's vaccine industry has a low concentration and the industry is relatively large but not strong.
 
Under the influence of the previous vaccine circulation regulations and the one-vote system, the advantages of large-scale vaccine manufacturers have been highlighted, which has promoted the integration of industry resources, increased industry concentration and market competitiveness, and helped the healthy development of the vaccine industry. With the tightening of supervision, under the new regulations of the upcoming "Vaccine Management Law", existing enterprises will inevitably further improve their product quality and production standardization processes in order to survive, and some small, scattered and chaotic enterprises will be eliminated , The market concentration will be further improved.
 
Vaccines have very unique attributes, and the regulatory approach plays a decisive role in the development of the entire industry. To truly achieve substantial reshuffle integration, the degree of involvement of the State Food and Drug Administration in supervision is the key.
 
The most critical issue is that the sales and use of vaccines and adverse reactions are in the CPC ’s CPC system (Commercial Products Business System). The State Food and Drug Administration must intervene in this system for effective supervision and punishment, but there is currently no department Or the agency may coordinate the overall involvement of the Food and Drug Administration in this system, resulting in disputes with related companies and relevant departments of other countries when dealing with various vaccines and drugs, and this system includes hospitals, doctors, pharmacies and other medical care. The information of the organization is very complicated. Even if the FDA successfully intervenes, it will face great management difficulties.