China's generic drug market in 2017 may be close to 500 billion

[market analysis of chinapharma.com] China has become the second largest pharmaceutical market country in the world, and the scale of domestic generic pharmaceutical market is about 500 billion yuan this year According to the statistics provided by the State Food and drug administration, the total number of drug approval numbers in China has reached 189000, and more than 95% of them are generic drugs However, the world's big generic battlefield is still in the United States According to IMS statistics, the United States accounted for 50 billion of the 160 billion US dollars of global generic market in 2013 (2017 China's generic pharmaceutical market scale or close to 500 billion picture source: Baidu picture) among China's nearly 5000 pharmaceutical enterprises, there are 25 enterprises with a market value of more than 20 billion, 49 enterprises with a market value of 10-20 billion, and 68 enterprises with a market value of 5-10 billion In the past few years, China's R & D investment in the pharmaceutical industry has increased from $162 million in 2001 to $3.25 billion in 2011 The market concentration of the top ten enterprises in the United States has reached more than 50%, and most of the approval documents for generic drugs are in the hands of these large generic companies In China, drugs can be divided into new drugs and generic drugs The so-called generic drugs, in a simple sense, are the drugs that have been imitated according to the national standards After the State Council's "opinions on reforming the review and approval system for medical devices" was officially issued on August 18, this standard has been adjusted to "imitate the drugs with the same quality and efficacy as the original drugs" The proportion of generic drugs is high in China, which is inseparable from the high cost of innovative drug research and development The average cost of developing a new drug is about $2.6 billion, according to data from the center for drug development and research at Tufts University In 2013, the R & D investment of the top ten pharmaceutical companies in China was only 1% of the sales, which was not optimistic compared with the R & D ratio of the top ten pharmaceutical companies in the world of 17.8% "R & D of new drugs takes a long time, costs up to, and the success rate of promotion and listing is low, which is not as low as the cost of generic drugs, small risk, and quick return of funds This is the fundamental reason why Chinese pharmaceutical companies are piling up generic drugs " A person in the pharmaceutical industry described the times weekly as such China's big health industry should set sail, the health industry should go out in the future, and the reform of medical system is imperative In order to solve the problem of "difficult and expensive medical treatment", we need to "use knife" and "exchange blood" on drugs and medical services The "moving knife" here is to raise the threshold of drug approval and regulate the price of drugs The pattern of Chinese pharmaceutical enterprises is seriously out of balance, and the homogeneity of production is serious, which is doomed to be transformed More than 90% of the generic pharmaceutical enterprises are in fierce competition, the sales volume of drugs is becoming less and less ideal, and the profit is getting lower and lower It is not realistic to improve the competitiveness by improving the equipment and providing the technology in a short time, and the research and development of innovative drugs are lingering in the cradle Companies need to find a way out There are two ways out for small and medium-sized generic pharmaceutical enterprises: one is to "hold the thigh", that is, to "attach" to large pharmaceutical enterprises through various ways for cooperation and development; the other is to "seek transformation", to achieve the purpose of transformation by improving research and development ability and using capital to "exchange blood" Chen Zhisheng, technical officer of Wuxi apptec new drug development Co., Ltd., said that China's pharmaceutical market is currently in a state of chaos, but in the future it is bound to move towards the "Three Kingdoms" I hope that China's future pattern is that there are 3-5 large generic pharmaceutical enterprises, as well as 2300 innovative pharmaceutical enterprises To achieve such a pattern, the pharmaceutical industry is bound to face a bloody reshuffle, which will be accelerated and intensified by national policies Since China embarked on the economic road of "with Chinese characteristics", all walks of life are exploring the reform road that can adapt to China's unique national conditions China's drug approval reform has been brewing for more than ten years At this critical time node in 2015, it finally launched In the past few decades of China's economic reform, our government has become more and more adept at using the leverage of macro-control, and has become more and more adept at making policies In 2015, the first two are licensing and drug approval The lifeblood of enterprises cannot be separated from the price, and the price regulation is the policy that the government has been using since the economic reform However, the "double-edged sword" of price, which leaves the market regulation, often produces linkage effect Before the government plays this card, it tends to lay out first The regulation of drug pricing tests not only the government's economic skills, but also the international pharmaceutical giants In terms of drug pricing, the government first took the step of "licensing" Bidding is the government's strict examination of the application of imported innovative drugs through the State Intellectual Property Office The effect of strict examination is to promote domestic and foreign pharmaceutical companies to reach an agreement by declaring the application invalid, so as to realize the domestic imitation of the original research drug The second is to issue "compulsory license" to realize the legal imitation of domestic pharmaceutical enterprises Both of them can reduce the price of medicine and partly alleviate the problem of "expensive medicine" On June 26, 2015, the State Intellectual Property Office confirmed to Caijing that a few months ago, the State Intellectual Property Office rejected the news that Gilead science of the United States rejected its key application for sofibwe Gilead company immediately submitted a review after receiving the rejection information, and the office will give a review opinion within three months What kind of medicine is Sofitel? And what's the hallowed of Gilead? Sofafbuvir is a new drug developed by Gilead company for the treatment of chronic hepatitis C, which was approved by the US Food and Drug Administration (FDA) on December 6, 2013 and European Drug Administration (EMEA) on January 16, 2014 The new drug developed by Gilead company is a safe and effective drug for the treatment of certain types of hepatitis C without interferon In the treatment of type 1, type 2 and type 4 hepatitis C, the clinical cure rate of sofibovir combined with other drugs is higher than 90%, and there are no influenza like symptoms, hemocytopenia, mental disorders, autoimmune diseases, kidney damage produced by traditional treatment schemes Harmful side effects In addition, the clinical trial of suofebuvir also included some patients with hepatitis C transformed into cirrhosis, and the curative effect was also significant At present, sofibway has not been listed in China In the United States, hepatitis C is often missed Hepatitis C virus affects about 3.2 million Americans Every year, about 15000 people die, mainly from liver cirrhosis and liver cancer According to Cara Miller, a spokesman for Gilead, most patients need to use the drug, which costs $1000 a day, for 12 weeks, with a total cost of about $84000 According to the report released by independent analysis company Datamonitor healthcare, the hepatitis C market is expected to grow by 230% in the next nine years and reach US $15.5 billion in 2022 A course of treatment in the United States is about $84000 and a pill is about $1000 It will cost nearly 1 million yuan to cure the patients who purchase drugs in the United States This is undoubtedly a sky high price for the families of patients in China A study by a research group at the University of Liverpool in the UK shows that the cost of producing each pill is only US $1, and the cost of producing the whole course is about US $101 In our neighboring India, how does the government deal with such high price imported drugs? The Indian Department directly rejected the key applications of sofibwe, including the former drugs and basic compounds In September 2014, Gilead signed a non exclusive franchise agreement with seven Indian generic giants According to the agreement, seven Indian manufacturers can obtain the complete technology transfer of Gilead, produce sofibwe independently and set their own price Indian pharmaceutical companies with independent pricing power set the price of generic drugs at about $900 for a course of treatment The efficacy of sofibwex is similar to that of the original drug Indian pharmaceutical companies have the right to distribute the generic drugs to 91 countries, excluding China The Chinese government tries to follow an "Indian" road, but can such "good things" be replicated in China? Even if Gilead's pre drug application fails in the end, it is difficult for Chinese pharmaceutical companies to achieve the same legal imitation as Indian pharmaceutical companies According to the website of the State Intellectual Property Office, Gilead has mastered the basic compound of sofibwex, which is in the status of "right maintenance" and expires on April 21, 2024 In view of China's special drug audit system, the original research drug of sofibovir and Indian generic drugs are bound to be unable to "land" in China Can the government's "application review" promote the legal imitation of 5000 domestic pharmaceutical enterprises? According to the website of the State Intellectual Property Office, no less than nine domestic pharmaceutical enterprises have submitted applications for sofibuproir preparation However, the research and development of generic drugs is not easy to complete Because Gilead company has mastered the key, the legal production of generic drugs by domestic pharmaceutical companies is basically not feasible, so they can only retreat to produce "me too" drugs "Me too" drug is a kind of drug with its own intellectual property rights, which is developed by pharmaceutical enterprises in order to avoid the protection of drug property rights However, this kind of generic drugs will have a great difference in efficacy from the original drugs Due to the uneven production process of pharmaceutical enterprises with different strengths, the final generic drugs produced will also be greatly reduced in efficacy Once such a situation occurs, the government has to use the second method of "permission": compulsory permission Drug compulsory licensing is regarded as a good way to solve the contradiction between public health crisis and drug cost The WTO's agreement on trade related aspects of intellectual property rights (TRIPS) stipulates that in the event of public health crisis in member countries, such as HIV / AIDS, malaria, tuberculosis and other epidemic diseases, compulsory licensing of drugs can be considered to solve the public crisis by copying the drugs that are still in the period of production Once this move is used, it will be released under the administrative intervention, although it can solve the public health crisis, it will certainly affect the enthusiasm of enterprises with innovative drug development ability, and encourage the opportunism of generic pharmaceutical enterprises, which is unfavorable for the development of the medical industry in the long run After the "9 / 11" incident, the U.S Department of health once panicked because of anthrax, using compulsory licensing as a negotiating weight, forcing Bayer to substantially reduce the price of CIPROFLOX, a drug for the treatment of anthrax Brazil, South Africa, Thailand and other countries have implemented compulsory licensing of second-line drugs for the treatment of AIDS and other infectious diseases In March 2012, the Indian government approved the compulsory license of anti-cancer drugs in history, allowing local pharmaceutical manufacturers to produce the imitated version of Nexavar, a German pharmaceutical manufacturer Bayer company's anti-cancer drug, which eventually brought the price reduction of imitated drugs to 97% compared with the original drugs Since the promulgation of the law for more than 30 years, China has never implemented a compulsory license The government has no experience in using this method Although domestic pharmaceutical companies welcome the government to start compulsory application, the law of "bottom decides head" can only make enterprises retreat to seek the research and development of "me too" drugs in the process of being unable to wait No pharmaceutical company dares to be a "crab eater" to put pressure on the government to start compulsory licensing At the end of the day, this is due to the lack of support from domestic pharmaceutical companies Less than 10% of innovative pharmaceutical enterprises, no more than 1%