New drug R & D has passed a decade of decline

Today, NAT Rev Drug discov Publishes an article written by McKinsey analysts to review the changes in the success rate of new drug research and development in the past 20 years (1996-2014) From 1996 to 2011, the success rate of new drug research and development has steadily declined year by year The average success rate in 2008-2011 is less than half of that in 1996-1999 (7.5% vs 16.4%), but it has rebounded since 2011 and is now higher than that in 2000 The main driving factor is that small molecule drugs have declined significantly (from 16% to 5%) in recent years, while the success rate of biomacromolecules is relatively stable Another constant trend is that the success rate of cooperative development projects is higher than that of individual development projects In the past five years, the success rate of three phases of cooperative projects is twice that of individual development projects It shows that the quality of the projects that can be looked upon by both sides is indeed slightly higher In the past 15 years, the decline of new drug output has been the most concerned problem in the pharmaceutical industry Numerous experts have analyzed the reasons and put forward improvement plans, and now it seems that there is finally a sign of spring Not only is the success rate starting to rebound, but the number of projects entering the clinic in the past 10 years is growing at a rate of 6% per year, so it can be predicted that the number of new drugs on the market will continue to increase Since 2000, the traditional business model, i.e the so-called heavy drug model aiming at common diseases but without obvious value differentiation, has been challenged Drug supervision and payment departments began to demand that drugs not only improve the number of test sheets, but also the quality of life and life span of patients; not only better than placebo, but also better than standard therapy But new drugs are a long-term activity Pharmaceutical companies can't turn the products in the pipeline into the products needed by the pharmaceutical supervision department at once This conflict leads to a recession period of up to 10 years Now, the pharmaceutical industry has basically found a new model that conforms to the taste of drug supervision and payment departments Different from the traditional heavy drug model, the current research and development is more inclined to the specialized disease without standard therapy There are two main factors that affect output First, the payment department allows the high price of specialty drugs, even if the patients are less, the total sales will be considerable This greatly expands the types of diseases that pharmaceutical companies can benefit from, and they don't have to struggle with diseases that are more difficult than the current technology permits Second, specialized diseases are not limited to once a day oral, which provides necessary conditions for the growth of biological macromolecules Now biomacromolecules account for 39% of the total pipeline The selectivity of biomacromolecule is better than that of small molecule, so the possibility of Miss target toxicity failure is greatly reduced In addition, the high selectivity of biomacromolecules is more suitable for the modern development model centered on biomarkers, with more accurate indications and higher success rate Of course, pharmaceutical companies are more mature in project choice The success rate of phase I and phase II clinical is lower than that of phase III clinical, indicating that the efficiency of capital use is improving FDA's approval innovation also helped the success rate to some extent FDA's breakthrough drug policy has accelerated the approval of some new drugs, and the success rate of these drugs may be higher than the average due to various reasons Many new drugs are conditionally listed In principle, some drugs will be withdrawn from the market because they fail to meet the contract, so even if the R & D technology fails to improve these approval policies, the success rate will be improved on the surface The tolerance of the payment department for high drug prices gives the pharmaceutical industry a breathing space to retreat from specialty diseases If the drug prices are limited, the pharmaceutical companies will have to return to common diseases The rebound in R & D efficiency over the past three years has been encouraging, but the crisis remains.