The hottest pharmaceutical production capacity in

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45% of China's pharmaceutical production capacity is idle, and the pharmaceutical market outsourcing is heating up.

"in addition to the large-scale API outsourcing, the current demand for foreign pharmaceutical enterprises' pharmaceutical preparations and R & D outsourcing business has soared. The existence of three major factors, namely, the expiration of multinational pharmaceutical enterprises' patented drugs, low costs in China, and overcapacity in pharmaceutical enterprises, will make China a hot spot in the world pharmaceutical outsourcing market." A few days ago, at the "Boao Forum for Asia International Pharmaceutical Industry Conference" held in Taizhou, Jiangsu Province, Zhou Xiaoming, President of the China Chamber of Commerce for pharmaceutical and health products, made a speech about undertaking outsourcing business opportunities for foreign pharmaceutical enterprises, which greatly inspired the representatives of domestic pharmaceutical enterprises attending the meeting

China's labor cost is about 1/10 of that of the United States

"China has a cost advantage unmatched by developed countries, and more and more multinational pharmaceutical companies have invested outsourcing contracts in China." According to Zhou Xiaoming's analysis, on the one hand, China's labor cost is about 1/10 of that of the United States, and raw materials, energy and other supporting facilities are also highly competitive; On the other hand, in recent years, more than 4000 pharmaceutical enterprises in China have invested about US $40billion in GMP certification technology transformation, which has greatly improved their production capacity

it is reported that at present, Chinese pharmaceutical enterprises have a first mover advantage in API outsourcing business. China can produce more than 1500 kinds of chemical raw materials, more than 60 of which are highly competitive in the international market, and the advantages of penicillin, streptomycin, tetracycline, chloramphenicol and other anti infective drugs are more obvious. In recent years, BASF with Chinese characteristics has cooperated with Jilin Province, Changchun City and the economic development zone in two aspects. The API industry has risen rapidly, such as anti-tumor (special interview and consultation) drugs produced in Taizhou, Zhejiang Province, hypolipidemic drugs, anti-tumor drugs that promote the new production mode and the rapid growth of emerging industries. Nine categories of APIs have entered the international market, including 614. Report generation: a variety is generated by connecting a USB flash disk to a computer to obtain cos FDA and TGA registration certification

According to the latest data, China's annual production of APIs reached 1.23 million tons, nearly half of which were exported. In 2005, the export volume reached US $7.9 billion, accounting for about 1/4 of the total global trade Most of the export of this kind of API is for multinational pharmaceutical enterprises - Zhejiang Haizheng pharmaceutical company and Suzhou Lida pharmaceutical company process and produce for Merck and Wyeth respectively, and dozens of enterprises such as Sinochem Ningbo Group, Shandong Meiji Lukang Pharmaceutical, Xinhua Pharmaceutical Company also undertake API outsourcing business

China's pharmaceutical production capacity is idle by 45%

in addition to bulk drugs, the global pharmaceutical outsourcing market has also begun to open to Chinese pharmaceutical enterprises

Guo Xia, President of Wanquan Pharmaceutical Group (China) Co., Ltd., believes that China's pharmaceutical industry is divided into four stages: generic drugs, generic drugs, outsourced drugs, innovative drugs and so on. At present, China is in the third stage of "product driven" and is moving towards the fourth generation of "R & D driven"

relevant experts emphasized that the production technology of pharmaceutical preparations in China has matured, and can produce more than 4000 varieties of preparations, involving advanced technologies such as controlled-release technology, targeted preparations, transdermal absorption and so on

however, at present, the production lines of more than 4000 domestic pharmaceutical enterprises that have passed GMP certification are generally under operated, and there is still a large amount of idle capacity. According to the statistics of China Pharmaceutical Enterprise Management Association in July 2005, the utilization rate of the overall equipment of Chinese pharmaceutical enterprises is only 55.3%, of which the injection equipment with the highest utilization rate is only 71.51%, while the utilization rate of oral liquid equipment is only 38.3%

at the same time, around 2008, there will be 30 blockbuster drug patents with annual sales of US $1billion expiring around the world. After the expiration of these drug patents, the market value left to the generic drug business will be as high as US $100million every year, which will provide huge business opportunities for Chinese pharmaceutical manufacturers

in response to this business opportunity, some pharmaceutical companies have carried out pharmaceutical OEM business. At the beginning of 2005, Shanghai Fosun Zhaohui pharmaceutical company signed an agreement with Leo pharmaceutical company, a Danish drug research and development company, to undertake the production of an anti skin infection drug. In addition, Xi'an Qianhe pharmaceutical also signed a processing agreement with a British company for 1billion blood pressure lowering tablets every year last year

the "cake" of global R & D outsourcing currently has $14billion

different from manufacturing outsourcing, multinational pharmaceutical enterprises also have a trend of R & D outsourcing. This kind of outsourcing is undoubtedly more technical and valuable

Zhou Xiaoming said at the "Boao Forum for Asia International Pharmaceutical Industry Conference" that in recent years, the global average R & D cost of a new drug has increased from $500million in the past to $1.2 billion. In order to reduce costs, many European and American pharmaceutical enterprises have separated the non core part of new drug development and outsourced it to developing countries. China has undoubtedly become one of the preferred places for foreign enterprises because of its dense talent and low cost

it is reported that China has a large number of high-quality and low-cost scientific researchers in terms of 20.0~30.0 modified wood flour. A domestic life science researcher who has obtained a doctorate in the United States earns about US dollars a year, less than 1/4 of that in the United States On the other hand, the cost of drug research and development in China is only about half that of the United States, and China has rich clinical trial patient samples and disease resources, so it can invest less money to complete clinical trials in a short time

at present, 15 GLP laboratories in China have passed the inspection, and 8 have passed the inspection for approval. It is expected that the total number will reach 30 by the end of this year. Beijing, Shanghai and other high-tech development zones have begun to set up biomedical service outsourcing alliances, such as Shanghai Zhangjiang pharmaceutical valley. At the beginning of 2005, Shanghai biomedical outsourcing service base and Shanghai Pudong biomedical R & D outsourcing service center were established, which is expected to form a branch field of biomedical industry with an annual output value of more than 2billion yuan within five years

Guo Xia, President of Wanquan Pharmaceutical Group (China) Co., Ltd., said that according to the latest statistics of IMS, the global drug commissioned research and development market will rise from the current US $14billion to US $28billion by 2008. Among them, each drug R & D investment is US $1billion, and a considerable part will be taken out for outsourcing R & D, which is a good business opportunity for China

Guo Xia said that now, many Chinese enterprises have entered the research and development of commissioned new drugs. Due to the rapid development of international generic drugs, China, like India, also faces a very favorable opportunity for generic drug research and development. It is understood that Wanquan Pharmaceutical (China) Co., Ltd. is the largest contract pharmaceutical organization in Asia. So far, the company has applied for more than 400 new drugs and applied for more than 60 drug patents every year

background data

nearly half of the global pharmaceutical enterprises will implement business outsourcing in 2008

with the acceleration of international economic integration, the world's pharmaceutical outsourcing business (including R & D and manufacturing) is showing a rapid growth trend

according to the statistics of American antisoma company, at present, more than one-third of the companies in the world implement business outsourcing, which will rise to 47% by 2008

the overseas drug OEM policy was relaxed

at the end of November 2005, the State Food and Drug Administration issued the provisions on the administration of the filing of drugs commissioned by overseas pharmaceutical manufacturers, which further refined the current relevant provisions on the commissioned processing of overseas drugs, which came into force on January 1, 2006. According to the regulation, raw materials, naked packaging preparations, excipients, packaging materials and other materials required for processing drugs from abroad are not required to go through import registration and import filing procedures

Chinese pharmaceutical enterprises are keen on international certification

according to incomplete statistics, at present, more than 50 Chinese enterprises that have passed cos certification have obtained more than 90 cos certificates, and 259 products that have passed the cGMP specification of FDA have reached more than 130 enterprises

at present, more than 10 preparation enterprises have passed the GMP certification of TGA and FDA. Wuxi Kaifu pharmaceutical and Zhejiang Haizheng pharmaceutical have successively obtained the European cGMP certificate. In addition, a number of domestic pharmaceutical enterprises are still applying for certification. For example, stone Pharmaceutical Group plans to achieve FDA certification for two preparation varieties in the next five years, and Shanghai Xinyi Pharmaceutical Co., Ltd. also plans to invest US $30million to build a solid preparation production base that meets FDA and EU cGMP standards, with a design capacity of 5billion tablets

source: Beijing News

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