The global sales volume of new drugs exceeded trillion dollars for the first time, and new drug research and development should have a global perspective

Source: new Kangjie 2015-9-28 "global sales of new drugs in 2014 exceeded US $1 trillion for the first time, reaching US $1043 billion In 2014, the ratio of new drug R & D expenditure to global new drug sales was 18% " Li Yin, science and Solution Consultant of Thomson Reuters, quoted the data of 2014 CMR global R & D annual report of the company (hereinafter referred to as "the report") at the Thomson Reuters national tour seminar held in Guangzhou In recent years, domestic enterprises pay more and more attention to the research and development of new drugs From the perspective of national policy orientation, in the future, Chinese pharmaceutical enterprises will become stronger and larger and move towards internationalization, and new drug research and development will become a barrier that many enterprises have to face Over the years, domestic enterprises have been competing fiercely in the field of generic drugs and made some progress But new drug development needs a global perspective In 2014, the global sales revenue of new drugs was almost twice of that in 2004, while the expenditure of new drug research and development in 2014 was only 1.4 times of that in 2004 According to the Thomson Reuters report, the proportion of drug R & D investment in sales of small and medium-sized enterprises is actually higher than that of large enterprises In 2014, the sales of new drugs was almost double that of 2004, and the expenditure of new drug research and development in 2014 was about 1.4 times that of 2004 However, from the perspective of China's actual situation, small and medium-sized enterprises are not easy to develop new drugs, especially the source of funds However, it can be predicted that with the country's multi-level layout of the capital market, more and more enterprises will join in the new drug research and development in the future According to the cortellis database of Thomson Reuters, in 2014, the global tumor sector was the largest R & D investment, accounting for nearly 3% of the R & D investment Tumor, metabolism and anti infection are the three most popular fields of new molecular entity NME in 2014, accounting for 2 / 3 of all drugs on the market In addition, there are digestive system, skeletal muscle and nervous system, which are also active in research and development In addition, orphan drugs have played a significant role in promoting the growth of new drug sales in recent years At present, many enterprises do not have a very clear concept of new drug investment In fact, the R & D cost of each field is quite different In addition, the R & D stage of each treatment field is also very different For example, the cost of cardiovascular disease in phase III clinical trials is very high, "mainly because in this field of treatment, it may be necessary to group 10000-20000 patients to get clinical statistical difference data, even at the most cursory average cost (5000-6000 USD per patient), this cost is very large." In terms of R & D investment, Li Yin said that the full time emploee (full time emploee) of discovery, CMC and clinical stage accounted for 70% of the total FTE in the whole R & D process According to the R & D investment, the clinical stage accounts for 36% of the whole R & D process Whether it is R & D investment or FTE investment, the clinical stage is the first in all stages When you get the clinical approval, your R & D journey is only half, especially in terms of cost The input-output ratio is the most important indicator to measure the new drug project From the perspective of the success rate of new drugs, each treatment field is different If we subdivide each stage of R & D, we can draw a conclusion that with the passage of each stage, the probability of successful marketing of new drugs increases constantly According to Li Yin, there are 5 out of every 100 new drugs entering the toxicology test stage Seven out of every 100 new drugs have been successfully listed in the first phase of clinical practice In the first pivotal dose to market stage, 2 / 3 of the drugs can be successfully marketed This requires our enterprises to pay more attention to the clinical investment in all stages, tailor to fit, and make better choices There are two main modes of new drug research and development: independent research and development and cooperative licensing Li Yin pointed out that there is a difference in the probability of successful marketing of new drugs with independent research and cooperation license, especially in the early stage of research and development, the success rate of drugs with cooperation license process is 14% (the success rate from phase I clinical stage to Marketing), while the success rate of independent research and development is only 4% The difference of success rate between NBE (new biological entity) and nce (small molecular entity) is also obvious The success rate of NBE is much higher than that of nce, especially in the early stage, the success rate of NBE is 20%, while that of nce is only 4% From the perspective of global new drugs in 2004-2014, NBE's first listed drugs accounted for 35% of all first listed drugs in 2014 For the generic industry, 199 of these new drugs are expected to lose patent rights in the next seven years (in the United States), 8% of which are blockbuster drugs And 2017 will be a peak of patent expiration of blockbuster drugs in the future There will be four blockbuster drugs.