From February this year, China's API enterprises returned to work late, which led to the global shortage of API supply. In March, India restricted the export of a variety of APIs, which led to concerns and dissatisfaction from API importing countries. The supply of API has attracted unprecedented attention from the international community.

 

 

 

Novel coronavirus pneumonia will be remodeled in the future. The outbreak of the new crown pneumonia will further promote the reshaping process of the industrial structure. How to occupy a place in it will become an important issue for API enterprises in China.

 

 

 

 

"De China" trend of API supply

 

 

 

Novel coronavirus pneumonia, China and India, were the main export countries and regions in China.

 

 

 

Analysis of data in recent years shows that the United States does not rely on China's API very much. In October 2019, a report issued by the US FDA showed that there were 230 factories exporting API to the United States, accounting for only 13% of the total number of factories selling API to the United States. According to a list of 150 medicines at risk of shortage in the U.S. market recently compiled by the FDA, only about 14% of the key ingredients of drugs are produced in China.

 

 

 

In addition, the statistical data also shows that in 2019, the value of China's API exports to the United States was $4.215 billion, a year-on-year decrease of 1.23%, and a negative growth for the first time in three years.

 

 

 

 

In recent years, India has also increased the production of APIs to reduce its dependence on APIs in other countries. In 2015, a committee of the Indian medical board formulated and submitted a long-term plan report on revitalizing India's domestic API production capacity, which put forward a large number of policy recommendations to comprehensively encourage the production of API in India. In that year, the federal government of India studied and launched the development plan of pharmaceutical industry cluster to ensure that India's API industry is more competitive and self-sufficient. In March this year, the federal cabinet of India approved a $1.3 billion stimulus plan to reduce dependence on Chinese APIs through two specific measures: encouraging enterprises to produce 53 kinds of key APIs and key starting materials and intermediates; and funding the establishment of three API parks to facilitate the operation of domestic API manufacturers and increase their revenue.

 

 

 

In addition to encouraging domestic enterprises to produce APIs, the Indian government has adopted various means to suppress Chinese api enterprises. For example, in recent 10 years, India has launched anti-dumping investigations on various advantageous raw materials such as ibuprofen, vitamin B12, ceftriaxone, paracetamol, amoxicillin, gliclazide, ofloxacin, etc. in recent 10 years, India has launched anti-dumping investigations on China's dominant raw materials, such as ibuprofen, vitamin B12, ceftriaxone, paracetamol, amoxicillin, gliclazide, ofloxacin, etc.; in 2018, India issued a warning to 8 Chinese api enterprises and suspended the import of API; and increased the import tariff On April 17, this year, the Indian government suddenly revised its investment policy to change the automatic approval of investment paths from countries bordering India, including China, to government approval.

 

 

 

Even so, in recent years, India's demand for China's API is still growing. According to the statistical data, in 2019, India imported 807900 tons of API from China, with a year-on-year increase of 22.56%; the value of goods was US $5.653 billion, with a year-on-year growth of 25.53%, accounting for nearly 17% of China's total exports of API. According to relevant reports, 70% of India's pharmaceutical raw materials come from China, and the import proportion of key starting materials and intermediates is higher. Therefore, it is not easy for India to get rid of its dependence on Chinese APIs in the short and medium term.

 

 

 

 

In addition to the United States and India, Europe has also come to realize that it cannot rely too much on Chinese APIs. Some European pharmaceutical companies have taken action. At the end of February this year, Sanofi announced that it planned to reorganize its six existing API production bases in Europe within two years to become the world's second largest API company, striving to achieve 1 billion euro sales by 2022 and take commercial operation. The plan aims to increase its API production capacity to meet the demand in Europe and other countries and regions, and help balance Europe's "heavy dependence on APIs originating in Asia".

 

 

 

European pharmaceutical and chemical industry has a strong foundation, and the output value of patent API and characteristic API with complex structure is higher, but in the field of bulk API, it is in an obvious disadvantage compared with China. Therefore, whether to get involved in bulk API production and how to make up the gap will be the biggest problem that Sanofi new API company needs to face.

 

 

 

According to relevant data statistics, in 2019, China exported 2.0763 million tons of API to Europe, with a value of US $9.461 billion, up 14.1% year-on-year, mainly involving anti infective, amino acids, vitamins, tetracyclines and other bulk raw materials.

 

 

 

 

China pays more and more attention to the safety of API supply chain

 

 

 

China is not only a big producer and exporter of API, but also a big country of demand and import. In recent years, the import scale of API in China has been expanding year by year. In 2019, the import volume of API reached a record high, reaching US $10.75 billion, with a year-on-year increase of 24.7%. From the perspective of demand, there are four reasons for the large increase in imports: first, the in-depth promotion of the quality and efficacy consistency evaluation of generic drugs has increased the domestic demand for overseas high-quality API; second, the domestic environmental protection and safety requirements have continued to improve, and some API enterprises have stopped production or relocated due to environmental problems