Specialty Active Pharmaceutical Ingredients Industry – Overview, Price Trends, COVID-19 Effect, Manufacturers & Distributors and Regional Analysis, Future Development.
API is a key link in pharmaceutical production and closely related to public health and the Special API is different from the bulk API, has the characteristics of strong growth attribute, high customer stickiness, non-standard and so on, usually the gross profit rate and the net profit rate are high. Once the enterprise occupies a higher share in the dominant variety market, it can enjoy long-term stable profits.
Special APIs are components of chemical APIs. Chemical API companies generally produce and sell products independently or according to the needs of downstream customers. Its market is large, and its customers are usually pharmaceutical preparation manufacturers, health products manufacturers, feed manufacturers and food manufacturers.
Featured API usually refers to the drug under patent protection or the drug under patent protection. If the enterprise can in the innovative drug development stage and the original drug firms through customization methods such as establish relations of cooperation, to provide the clinical trials needed for active pharmaceutical ingredients, then after the product, the enterprise can to provide the original manufacturer pharmaceutical intermediates or APIs, usually can get stable orders, lasting profits for the enterprise.
For drugs that have passed the patent period, take the export to the us market as an example, the API manufacturers usually pass the FDA certification before the patent drug expires, apply for the DMF filing, and carry out production capacity reserve. The customers also inform the API manufacturers to prepare the products in time. Generally, after the expiration of patented drugs, many generic drugs will come to market, and drug prices will fall, which will increase the sales volume of generic drugs, and thus drive the demand for API drugs.
The main levels of Statins API are divided into Statins API, Heparin API and others such as Sartans API according to different fields.
Statins, with their high efficiency, safety, and tolerability in lowering LDL and cholesterol, are in an unassailable position compared with other lipid-lowering drugs such as niacin and betts, with a market share of up to 90%.
Heparin API is in the middle of the heparin industry chain. First, the crude heparin sodium was extracted from the small intestinal mucosa of healthy pigs and made into heparin. Due to the impurities such as miscellaneous proteins, it was further purified and turned into a heparin API. Heparin APIs are commonly found in the form of Sodium or Calcium salts, known as Heparin Sodium or Heparin Calcium, and are used in excess of standard Heparin Sodium.
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The major Statins APIs player in the market
- Livzon Pharmaceutical Group
- Zhejiang Medicine
- Zhejiang Hisun Pharmaceutical
- Chongqing Daxin Pharmaceutical
- Jiangsu Guotai International Group
In addition to the mainstream Statins APIs of various manufacturers, each manufacturer also has different models and functions of Heparin API
The major Heparin API player in the market
- Changzhou Qianhong Biopharma
- Shenzhen Hepalink Pharmaceutical Group
- CSBIO
- Nanjing King-friend Biochemical Pharmaceutical
Heparin API belongs to Special API (different from bulk API). Heparin APIs are mainly used in the production of standard heparin preparations or low molecular weight heparin APIs, which can be further used in the production of low molecular weight heparin preparations.
In addition to the companies listed in the above table, Huahai Pharmaceutical, Apeloa Pharmaceutical, Borui Medicine, Jiuzhou Pharmaceutical, Zhejiang Tianyu Pharmaceutical, Zhejiang Xianju Pharmaceutical, Zhejiang Starry Pharmaceutical, Ningbo Menovo Pharmaceutical, Zhejiang Ausun Pharmaceutical, Jiangxi Synergy Pharmaceutical, Jiangxi Fushine Pharmaceutical, developed and manufacture Statins API.
According to the statistics of the medical insurance chamber of commerce, in 2018, China exported 929.72 tons of western medicine API (synthesis + fermentation), with a total export value of us $30.048 billion, accounting for about 19% of the global API market. outlines the location of manufacturing facilities used to make APIs for US-marketed drugs. For all regulated drugs (prescription [branded and generics], OTC products, and compounded drugs, the US has 510 manufacturing facilities or 28%, the rest of the world (non-China) 1,048 facilities, or 59%, and China 230 facilities or 13%.
With the optimization of statin API production process and the formation of industrial scale in China, the capacity and output of statin API have been objectively promoted. With COVID-19 spreading globally, Europe and the United States have suffered a major impact. Meanwhile, COVID-19 affect major API suppliers such as India, China and Japan.
On March 24, India announced the start of a nationwide lockdown for 21 days as a precaution against COVID 19. But when India announced its decision, the global drug industry was not calm – after all, India is the world’s largest producer of generic drugs, the 13th largest exporter by value and the third largest exporter by volume, which is crucial to the world’s drug supply.
Under the influence of the global COVID 19 epidemic, China’s API products ushered in a wave of price rise tide.
Vitamin, March 25, VD3 quoted US$ 35.25 /kg, compared to the beginning of the year (January 20, 2020) increase 170%;VB1 quoted US$42 yuan/kg, up 90% from the beginning of the year; Biotin quoted US$43 /kg, up 74% from the beginning of the year; The quotation of VA is US$71.2 /kg, which is 64% higher than that of the beginning of the year. Vitamin K3 quoted US$13 /kg, 59% higher than the beginning of the year; VE quoted US$10.22/kg, up 49% from the beginning of the year.
In terms of antibiotics, under the influence of the epidemic, the supply side is gradually tight, and the price of major varieties has also shown a trend of increasing, especially the intermediate varieties with oligopoly pattern, such as 6-apa, whose market price recently increased from 20.0 US$ to 28.7 US$ per kg.
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