- The drug substance industry eliminates hidden dangers
- The transformation of APIs depends on many factors. Innovation is the key.
- Improving the domestic pharmaceutical innovation market system is the prerequisite for the transform
- China's hormonal API exports stepped into the normal trade track
- Innovation in the API industry requires both corporate and government
According to a recent report issued by the International Association of Pharmaceutical Raw Materials Industry (CPA), based in Milan, Italy, the international API market has shown a “rising-slipping-re-rising” wave pattern over the past 10 years.
According to the report, the average annual growth rate of the international API market was 7.2% between 2004 and 2008. After 2008, European and American countries entered the economic recession. Therefore, from 2008 to 2012, they were affected by the economic recession of developed countries in Europe and America. As a result, the average annual growth rate of the international API market is only 5.6%. As Europe gradually emerged from the shadow of recession and the slow recovery of the US economy, the international API market has regained an annual growth rate of more than 7% in the past three years. In 2014, the total sales volume of the international API market reached US$134 billion, compared with 2012. The annual increase of more than 20 billion US dollars.
China and India win low prices
According to the “market active participation” standard adopted by the international market, China, India, the United States and Europe are regarded as the four active participating countries (regions) of the international API market. Although Japan is the third largest pharmaceutical market in the world, Japanese pharmaceutical companies have not been selected as “active participants” because their raw materials are mainly used for domestic consumption and are rarely exported as much as China, India and Europe.
Why China and India can rapidly grow into the world's leading producers and exporters of chemical raw materials in just 30 years, which is related to the low labor costs of these two countries. According to the CPA report, among the four major exporters in the international API market, the average annual salary of employees in the US pharmaceutical industry is about 60,000 US dollars, and the higher in Europe is more than 70,000 US dollars. The average annual salary of employees in Chinese pharmaceutical companies is generally 5000. ～8,000 US dollars, the annual salary of Indian pharmaceutical companies is lower, only 3,000 to 4,000 US dollars, so if the same raw material medicine products are produced, China and India have low labor cost advantages unmatched by developed countries in Europe and America. This is also the main factor driving China and India to become the world's largest producers of APIs.
As early as six years ago, the Chinese Ministry of Commerce announced that China has become the world's largest producer and exporter of APIs. At present, China has been able to produce more than 1360 APIs, of which 60 to 70 APIs have advantages in the international market (pricing power), but the CPA report also pointed out: in the profit margin of export APIs, the United States and India is higher than China.
In the past three years, the total profit margin of the US API industry is generally around 15%, India is 17%, and the total profit margin of China's export bulk drugs is only about 10%, which indicates that China is the world's largest raw material drug production. Countries and exporting countries, but still can only win by quantity rather than by profit. Due to the high labor costs in the country, developed countries in Europe and the United States have gradually abandoned the production of large-tonnage, low-margin chemical raw materials (including large-scale products such as fermented drugs such as antibiotics, vitamins and organic acids) and imported them from China and India.
At the same time, in the past few years, European and American countries have gradually turned to the R&D and production of “small-dose, high-priced” APIs, while pushing high-dose, low-efficiency varieties to other countries for production, such as the list of the top 100 best-selling drugs in the world. There are basically no varieties developed by Chinese or Indian companies, and they are all products of European and American pharmaceutical companies. It can be seen that in the international pharmaceutical market, high-end products are occupied by developed countries in Europe and the United States, while Chinese and Indian pharmaceutical companies can only occupy the low-end raw material drug market, and from the development trend of the international raw material drug market in the past three years, the future The year will continue to be the world of macromolecular drugs (protein drugs), and the situation of small-molecular-weight chemical drugs dominated the world in the 1980s is long gone.
Macromolecular drugs lead the market
According to the "Global Raw Material Medicine White Paper" published by the German Pharmaceutical Industry Federation in 2014, the synthesis of biopharmaceuticals represented by monoclonal antibodies, EPO (erythropoietin) and insulin in the international API market over the past three years. The growth rate is as high as 9.4%, and its growth rate will definitely exceed 10% in the next five years. Therefore, biopharmaceuticals will become the main products in the international API market.
Secondly, with the rapid growth of tumor incidence, anti-tumor drugs have rapidly grown from a small category of one or two decades ago to a major variety in the international bulk drug market. According to the report, in 2010, the total sales of global anti-cancer drugs was only over 40 billion US dollars. By 2012, it had reached more than 60 billion US dollars. In 2014, it exceeded 80 billion US dollars. The growth momentum is surprising. As for the sales of anti-tumor bulk drugs, the white paper pointed out that the total sales of global anti-tumor bulk drugs are between 10 billion and 12 billion US dollars. Its market annual growth rate is 8.9%.
Among the more than 100 anti-tumor drugs that have been marketed, the sales of monoclonal antibodies have been the most significant. From 2013 to 2014, all of the monoclonal antibody anti-tumor drugs represented by Herceptin entered the list of 50 best-selling biopharmaceuticals in the world. In the past few years, the rapid growth of the international monoclonal antibody market has been witnessed.
According to statistics, in 2011, the total sales of monoclonal antibodies in the international market totaled 44.6 billion US dollars, and last year this figure has exceeded 80 billion US dollars, and the growth momentum is very rapid. But unfortunately, so far, China's API production still shows the phenomenon of "long legs" (chemical synthetic drugs for China's strengths, while bioengineering drugs for "short legs"), in the development and production of monoclonal antibody new drugs and the West There is still a large gap in the country, and it is also true for the production of macromolecular drugs. The macromolecular drug is precisely one of the most profitable products in the international API market. Therefore, Chinese pharmaceutical companies can only watch the Western countries make a lot of money on biopharmaceuticals. The bulk API products exported by China can only earn meager profits because the selling price is too low. This is the current reality of the international API market.
In 2015, some of the varieties produced in China that have advantages in the international API market, such as penicillin salt, tetracycline and oxytetracycline (including chlortetracycline and doxycycline), vitamin C, vitamin E, biotin , cortisone hormonal drugs, citric acid organic acids, three major antipyretic and analgesic API products (paracetamol, aspirin and ibuprofen) and the sales of heparin sodium and stevioside with absolute advantages in the international market will be Keep optimistic. However, as domestic labor costs continue to increase, the export prices of these products may be adjusted. In particular, the sales of macrolides and cephalosporin antibiotics and new antibiotic products led by meropenem are expected to increase in the international market. Such products will become the key export products of pharmaceutical companies in China.
It is precisely because the manufacturers in developed countries in Europe and the United States have turned some chemical synthetic API products with large tonnage and low selling prices to Asian countries for production. In 2015, the international API market will face another new situation: due to the large number of world-selling products in the past three years. The drug expires and has quickly become the new darling of the international bulk drug market, including atorvastatin, sildenafil, duloxetine, oxycodone, rabeprazole, capecitabine, Zoledronic acid, temozolomide, mesalazine, eszopiclone, levoprazole, celecoxib, raloxifene hydrochloride, aripiprazole, etc., the market is expected
However, some foreign professionals in the industry pointed out that although the profits of the above-mentioned international market-selling drugs that have lost patent protection are very rich, the imitation process is by no means easy, because many of them are “chiral drugs”, and currently on the market. Compared with the racemic drugs, the synthesis is extremely difficult. For example, atorvastatin, which has long occupied the top spot in the world's best-selling drugs list, has two chiral center molecules, and its synthesis difficulty is conceivable. Therefore, even if the above-mentioned former best-selling drugs have lost patent protection, the difficulty of imitation will still pose a great challenge to the copycats. However, there is still a huge demand for such drugs in the international market, so the imitation of the above-mentioned best-selling drugs will become the primary task of China's raw material drug manufacturers.
According to German CPA experts, in 2015, the total sales of APIs with only generic patents will exceed 10 billion US dollars. Therefore, the imitation of the best-selling drugs will become the key export products of this year. But the question is who can get the production and export rights of these varieties as soon as possible.
In summary, due to the serious excess capacity of common chemical synthetic drugs in China and the low export price, the development and production of the best-selling patent-expired API products will become an important issue for the domestic pharmaceutical industry in 2015. I believe that in the near future, the best-selling generic drugs The profit halo will be based on China's API industry.