At present, China is one of the world's major API (Active Pharmaceutical Ingredient) producers and exporters, with a total of 189 countries and regions exported. The main exports are concentrated in the three major markets of Asia, Europe, and North America, which together account for 89% of China's total export of APIs. Exports of APIs to the Asian market amounted to 5,446,100 tons with a value of USD 15.917 billion. Among them, India is China's largest export market for APIs, with 70% of APIs coming from China and a higher proportion of intermediates.
Although the Indian government has vigorously supported "Made in India" in recent years, it accounts for more than one-third of China's API exports to the Asian market. Therefore, it is still difficult to reduce its dependence on China's APIs in the short term. However, India imports from China The bulk medicines of the company are mainly low value-added bulk medicines and pharmaceutical intermediates. Japan has always been among the top three in China's API export market. The main export products to Japan include traditional APIs, as well as characteristic APIs such as sartan and Puri. More than 90% of ASEAN's APIs depend on imports. It is also the main export market of China's APIs in Asia.
Mainly Export Bulk Active Pharmaceutical Ingredients
From the perspective of global API downstream formulations, the global drug market in 2018 was approximately US$1.2 trillion, with an annual growth rate of approximately 3.8%. The global pharmaceutical market is expected to grow to approximately US$1.55 trillion in 2023, with a CAGR of 5.1% from 2018 to 2023.
Among them, the market size of patented drugs in 2018 is estimated to be approximately US$766.5 billion, with an annual growth rate of approximately 5.8%; for generic drugs, the market size in 2018 is estimated to be US$320.2 billion. It can be seen that the scale of the global API market is also developing rapidly and as the focus of international chemical pharmaceuticals gradually shifts to developing countries, China's API companies have maintained a rapid growth trend in recent years. According to data from the National Bureau of Statistics, in 2019, China The output of chemical original medicines reached 2.769 million tons, an increase of 20.2% year-on-year, and the growth rate was the highest in recent years; in 2020, the output of chemical original medicines in China was 2.734 million tons, an increase of 2.7% year-on-year.
From the perspective of the breakdown of API categories, the Yaorong Cloud database shows that at this stage, most of the export types are mainly bulk APIs, and all have achieved varying degrees of growth: since 2019, the export volume of anti-infective APIs has continued Increasingly, the export of antiviral, anti-tuberculosis, penicillin and other varieties all increased; the export of hormone raw materials also increased by 78% year-on-year, and the export volume increased by 76% year-on-year. Among them, the export of estrogen and progesterone products The amount has increased by 200%; bulk drug substances such as antipyretic and analgesic, amino acids, tetracyclines, cephalosporins, lincomycins, etc. have increased by more than 8% year-on-year, paracetamol, ibuprofen, and ceftriax The export value of pine and other major varieties also increased. Chinese API manufacturers use more than 60 bulk API products such as vitamin C, penicillin potassium, paracetamol, and aspirin as their strong market competition points, and their export scale is gradually approaching 20% of the global API market.
It is undeniable that China's API industry still has problems such as overcapacity of large varieties and disorderly competition of small products monopolizing prices. Although in the long run, aging, industrial chain transfer, patent barriers, etc. will better ensure that APIs Stable growth in demand, but due to the impact of the new crown pneumonia epidemic in the past two years, China’s API foreign trade has faced more uncertainties. For example, domestic API companies, upstream chemical raw materials, and pharmaceutical intermediate companies generally started operations late, and domestic and foreign logistics are also affected. Large restrictions have caused many companies to postpone their production plans, making it difficult for export orders to be delivered on time, and multiple costs have increased. And in recent years, as environmental protection requirements have become stricter, the state has become more stringent in reviewing and approving the capacity building of new APIs, and the API industry and enterprises are facing greater pressure.
In the face of various unfavorable factors, the acceleration of high-end transformation of domestic API manufacturers will become the general trend. The country has vigorously promoted supply-side structural reforms in recent years. Policies such as concentration, mass procurement and MAH are also conducive to the transformation of specialty API companies to preparations and CMO/CDMO business. On the one hand, through reasonable improvement of environmental protection standards, leading companies are guided to improve their technological level and competitiveness, and promote high pollution and non-compliance. Of companies withdraw from the market to reduce low-price competitors in the API market; on the other hand, the "Guidelines for the Price Behavior of Short Drugs and API Operators" were issued to penalize malicious manipulation of the prices of APIs. The integration of production capacity, the improvement of technology and the maintenance of reasonable profits will lay a more solid foundation for the sustainable and healthy development of China's API industry in the future. Therefore, API manufacturers should make good use of the above superimposed factors, take the development of high-value-added specialty APIs as an important goal of the company's market development, and develop into an integrated mode of API + preparations.