As new medicines on the market have gradually decreased, and the world raw material medicine industry has shifted to developing countries, in this situation, China's chemical raw material medicine industry has found a pedal that will make a new leap forward in the next few years—imitation of chemical raw materials. This is the latest judgment made by the participating experts on the role of generic drugs under the new situation at the high-end forum for the construction of the national chemical raw material drug base held in Jiangsu Rudong Coastal Economic Development Zone last weekend.
New drug market is decreasing
According to data released by the China National Pharmaceutical Industry Information Center, since 2000, the growth rate of the global generic pharmaceutical market is about twice that of the pharmaceutical market. Taking the United States, a major pharmaceutical country, as an example, in 2009, the amount of prescriptions for generic drugs in the United States accounted for 75% of the total prescriptions, and this number was only 57% in 2004. It can be said that generic drugs have become the main force of the pharmaceutical market. This trend will continue. The data show that from 2012 to 2015, the number of drugs whose annual patents expired was 111, 120, 132, and 122, respectively, which was higher than the number of previous years.
Gu Wen, director of the China Pharmaceutical Industry Information Center, believes that the reason for this situation is that R & D is increasingly difficult, R & D costs are increasing, it can be said that the original "bomb bomb" drug to promote the rapid development of the pharmaceutical industry is gradually being broken. Large-scale mergers and acquisitions by international companies can show that the growth model for companies to use new drug development as a profit-driven force is changing: Pfizer has merged Wyeth (involving a value of US$68 billion) and Roche has acquired Genentech (involving US$46.8 billion). , Mercy East purchases Schering-Plough (involving a total of USD 41.1 billion).
Generic drugs were pushed to the front desk. According to reports, since 1996, the US FDA has accepted the trend of changes in the number of new drug applications, and it has shown a decreasing trend overall. It is predicted that by 2015, a large number of best-selling drugs with total sales of more than US$142 billion will face competition from generic drugs in major markets. It can be said that generic drugs have become the main force of the market.
The center of gravity of generic drugs moved eastward
Zhang Welfare, vice president of the Shanghai Pharmaceutical Industry Research Institute, believes that the next few years will be the peak period for the expiration of international pharmaceutical patents. Developing countries such as China will become the focus of the development of the generic pharmaceutical industry.
According to data released by the China National Pharmaceutical Information Center, overall, the global pharmaceutical market will continue to grow in the next few years, with an average annual growth rate of 3% to 6%. Emerging markets represented by countries such as China, India, Brazil, South Korea, Mexico, and Turkey will become the fastest growing regions with an annual growth rate of more than 10%. The growth rate of the generic drug market in China is more than 20%, far higher than the global growth rate of about 10%, which has become a new frontier for multinational companies to compete for the market.
It is understood that China will become the second largest pharmaceutical market in the world in 2015. This is the latest forecast of an international consulting company. Previously, the company’s time to achieve this assessment was also predicted to be 2020. It can be said that the strong growth of China's pharmaceutical market has attracted much attention.
Zhang Weilian pointed out that the intermediate links for the development of new drugs are very complex, and there is a problem of poor convergence between the discovery and development of new drugs. This brings opportunities for the development of generic drugs because the approved drugs have been planned for production. It can completely "improve the system" and has a lot to do in process innovation.
Characteristic imitation is the right way
Gu Wen analyzed that from 2009 to 2010, China's pharmaceutical industry entered a platform period, mainly due to China's pharmaceutical industry in the global pharmaceutical industry chain in the low-end API market, especially the bulk API market. In 2010, a total of 8,563 enterprises in China exported API products. The top 10 export volume has increased by a large margin, and 80% of the enterprises have increased by more than 20%, which reflects the good operating conditions of leading enterprises. However, the average export price of 40% of the company's products has fallen, indicating that leading companies are also facing greater competitive pressure.
In fact, China's advantageous chemical raw material medicines are mainly concentrated in large traditional fields such as antibiotics and vitamins. According to Wu Haidong, deputy director of the Consumer Products Division of the Ministry of Industry and Information Technology, at present, China can already produce more than 1,600 kinds of medicines, and large traditional products have a higher market share in the international market. However, there is a problem that penicillins and other products have production capacity. In excess, exports rely on low-price competition to keep prices low. There is a low level of repeated production of bulk APIs. Many API manufacturers compete in the homogenous market of low-end APIs, often triggering cyclical price fluctuations or even low-cost competitive marketing, which seriously affects the healthy development of the industry. In addition, the biggest problems brought about by the production of APIs are high resource consumption, heavy environmental pollution, low added value, difficulty in wastewater treatment due to API production, and high cost.
Gu Wen believes that only in the past will be the production of extensive pharmaceutical intermediates or raw material drugs to the transformation of the fine characteristics of raw materials, as well as the extension of the downstream industrial chain, the extensive use of green medicine technology, it is possible to obtain a breakthrough in the highly competitive API industry . It is understood that at present, some raw material medicine companies have begun to implement new process transformation to replace the old high energy consumption, high pollution production methods.