Erythromycin is one of the bulk products exported from China's pharmaceutical raw materials, with a long-term export volume of thousands of tons and hundreds of millions of dollars. Recently, China's erythromycin exports showed an increase in the price of the trend, and how will the future trend?
Production capacity continues to improve
Entering the 21st century, with the rising demand for erythromycin in the international market, China's erythromycin production began to grow significantly, and grow rapidly. So far, the annual production capacity of erythromycin in China has reached more than 10,000 tons, with an annual output of more than 6,000 tons.
According to CFDA data, as of May 17, 2022, the country has a total of 17 erythromycin API production approval numbers (including erythromycin lactate 3 approvals).
The main manufacturers are JINDUN MEDICAL, Hubei Yidu East Sunshine Biochemical Pharmaceutical Company, Sichuan Neijiang Shanshan Pharmaceutical Company, Henan Xinxiang Huaxing Pharmaceutical Company, Xi'an Lijun Pharmaceutical Group, etc.
The combined output of these enterprises accounts for about 85% of the total domestic production, the output of other companies only accounts for about 15%.
At present, the largest erythromycin API manufacturer in China is JINDUN MEDICAL, with an annual production capacity of more than 5000 tons. The company's erythromycin, tetracycline hydrochloride and other APIs have passed the European COS and U.S. FDA certification, and the products have stable customers in dozens of countries and regions in Europe, South America, Africa, Southeast Asia, etc. The export is relatively smooth, and has a high market share and product reputation in the international market.
Export embarrassment, quantity increase and price decrease
Since the 21st century, erythromycin export growth rate is faster, has developed into China's macrolide antibiotics in the bulk of exports, exports account for about 60% of the total domestic macrolide drugs.
At the beginning of the 21st century, China's erythromycin exports reached more than 500 tons, accounting for about 60% of that year's production. 2006, China's erythromycin exports exceeded 1,000 tons for the first time, accounting for nearly 30% of the total exports of macrolide antibiotics.
In 2010, erythromycin production capacity has exceeded 9,000 tons, production reached more than 2,500 tons, exports of more than 1,500 tons. 2014, erythromycin exports reached 2,390 tons, the export amount of $ 167.03 million.
Our exports of erythromycin are mainly for feed additive use, and the main export markets have been Asia, Africa, Latin America, etc., accounting for about 80% of the total erythromycin exports. But the export volume to the EU countries and other developed countries accounted for only about 20%.
India is the first largest export market of erythromycin in China, generally accounting for about 50% of our total exports.
Indian enterprises import our erythromycin API, mostly reprocessed into the market selling semi-synthetic erythromycin, made into preparations to obtain higher profits.
In addition, Malaysia, Puerto Rico, Spain and other countries also account for a larger share.
In recent years, Puerto Rico, Brazil and other South American countries have developed into another major export market for erythromycin in China.
In China's exports of erythromycin pharmaceutical enterprises, JINDUN MEDICAL in recent years, the export share has been steady first, accounting for about 50% of the country, Yidu East Sunshine biochemical pharmaceuticals, Henan Huaxing Pharmaceuticals, etc. is also a major exporter.
However, in recent years, the global market environment is still sluggish, the world trade is in a slow recovery period.
China's exports of pharmaceutical materials also encountered many difficulties, the export of many products are presented in the volume of price or the volume of flat price down the embarrassing situation, the overall export of red mold is also in the volume of price reduction trend.
Erythromycin mainly as a veterinary antibiotic, for many years, in foreign countries are widely used as feed additives and animal growth promoters.
In recent years, both China and India, Brazil, Russia and other emerging countries have maintained a relatively fast economic growth situation, the people's living standards continue to improve, the total population of these countries and nearly 3 billion, the demand for poultry, meat, eggs, etc. is strong and rigid.
The huge market keeps pushing the farming industry to maintain high speed development, and the demand for antibiotics and additives for feed is very huge.
In addition, erythromycin is also a key intermediate raw material for synthesizing the three major semi-synthetic erythromycin azithromycin, roxithromycin and clarithromycin that sell well in the international pharmaceutical market.
In recent years, the sales of macrolide antibiotics led by third-generation erythromycin, such as azithromycin, clarithromycin, and roxithromycin, have been steadily increasing in the international market, and the market share has been expanding, having risen from 5% in 2000 to about 12% in 2014.
Since the introduction of the "Management of Clinical Application of Antibacterial Drugs" in 2012, many cephalosporin antibiotics, quinolones and aminoglycoside antibiotics have been included in the scope of "restricted drugs" and "special drugs", and their market expansion has been greatly restricted and their sales have shrunk. The antibiotics market has been reshuffled.
Although erythromycin and other antibiotics have been included in the scope of "restricted drugs" in some provinces and cities, erythromycin, azithromycin, roxithromycin, clarithromycin, erythromycin and erythromycin have been included in the national medical insurance drug list and the national essential drug list.
"During the 12th Five-Year Plan period, the anti-infective drug market has experienced a rise, a rapid decline, a rebound and a normal development due to the influence of various factors such as "antibacterial restrictions".
In recent years, in the domestic hospital drug market, several semi-synthetic erythromycin products, such as azithromycin, roxithromycin, clarithromycin and erythromycin, have been clinically favored, and the dosage in domestic hospitals has been increasing, and now occupies more than 90% of the market share of macrolides.
As the basic raw material for the synthesis of these erythromycin products, the market demand for erythromycin API is very strong. Although the export volume of erythromycin in China is still growing in recent years, but due to the increase in domestic market usage, the proportion of export volume to total production has decreased. In other words, the two major demand increases for veterinary and human drugs, will become the main driving force for the continued robustness of the erythromycin market.
Supply is slightly inadequate
Erythromycin for fermentation products, the production process will produce a large number of "three waste" substances, as countries to improve environmental protection requirements, fermentation products in foreign countries have been gradually eliminated, by the high cost of environmental protection, API profits are relatively thin and other factors, many foreign erythromycin production enterprises have stopped production.
The United States Abbott and Russia, Poland and other countries erythromycin are no longer produced, the required products turned to China and other purchases, the international market erythromycin supply tightening, the market demand for Chinese goods greatly increased.
After years of efforts, China's production capacity of erythromycin has reached more than 10,000 tons, if the production at full capacity, basically to meet the market supply. But the production capacity of our enterprises can not be fully released, now the national annual production of erythromycin is about 6000 tons, about half of the production capacity, erythromycin API supply is slightly inadequate.
The relevant industry analysis that the main reasons are two.
First, environmental factors. Erythromycin production process produces toxic substances is difficult to pass the environmental protection treatment, a large amount of water is needed to dilute. China issued a few years ago, "pharmaceutical industry sewage treatment methods", the environmental indicators have been improved.
In recent years, the country is paying more and more attention to environmental issues, the cost of environmental management of enterprises is getting higher and higher. Environmental problems are not well solved, enterprises can not and dare not open full production.
Second, the production technology factor. Fermented products are different from synthetic compounds, strains of bacteria is the key factor in the production of erythromycin. The strains will directly lead to the quality and yield of the product and production costs and a series of problems, which is also some enterprises can not be large-scale expansion and the threshold of the horse.
Some industry insiders said that at present, in addition to a small number of domestic enterprises to produce better product quality, the quality of the product of some enterprises and the standard of human medicine is still a gap, can only be used as veterinary medicine, and the market price of human medicine and veterinary medicine is quite different.
Product quality is not up to standard, but also lead to rising production costs and business economic benefits decline, which is also unacceptable to enterprises.
Due to the erythromycin market long-term bullish, some places in China have invested in new erythromycin API production lines, there are also some old plants to expand the original production scale.
Once these new projects are completed and put into operation, China's erythromycin API production capacity and production will take a new step forward, exports will also further improve. Previously, China's peak exports of erythromycin had reached the level of more than 4,000 tons of annual exports, more than 3,000 tons of annual exports than the current amount of more than 1,000 tons.
2022-10-08
Shanghai, China