Analysis of new drugs under research in 2016

Source: pharmaceutical economic news 2016-07-14 with the global pharmaceutical enterprises' attention to the research and development of new drugs and the further clarification of drug action target research, more and more new active compounds have been found, more and more new drug targets have been confirmed, which makes the global new drug research and development show many new characteristics By analyzing the data of the pharmaprojects / pipeline database of citeline, an international well-known consulting agency, we can help us fully understand some new changes in the global new drug market under research in 2016 and discover some new trends in new drug research and development in time Overview of the total number of drugs under research and phased situation the difficulty of developing small molecule drugs for chemical synthesis is increasing year by year, so what is the sustainability of the growth of the number of drugs under research in the world? Is the high rate of variety loss alleviated in the later stage of research and development? The overall scale is growing steadily The information of drugs under research included in the database refers to those projects still under research, including pre clinical research projects, projects in clinical research and registration stage, and projects of drugs on the market with new indications As of January 2016, the number of new drugs under research in the world was 13718, with a year-on-year growth of 11.5% compared with 12300 in 2015 According to the data from 2001 to 2016, the number of new drugs under research in the world continues to maintain a stable growth trend In 2016, the number of new drugs under research in the world increased by 11.5%, far exceeding the 8.8% year-on-year growth in 2015 The number of drugs under study increased by 1418 in 2016, compared with 993 in 2015 Based on the in-depth analysis of the drug data in research, it is found that the number of new drug varieties in research for the first time in 2016 was 3442, compared with 3138 in 2015 This also shows from the side that in the past 12 months, compared with the previous years, the number of drugs in research terminated for various reasons has been relatively reduced Although the number of new drugs under research in the world continues to grow, there is some uncertainty about the sustainability of the growth of the global drug market due to the increasing difficulty in the development of small molecule drugs for chemical synthesis year by year In 2015, for example, the number of new active substances (NAS) on the market has decreased from 63 (including 57 new molecular entities, 6 vaccines) in 2014 to 48 (including 43 NMES, 3 vaccines), which is the first time that NAS has declined since 2011 From the perspective of pharmaceutical R & D process, new drug R & D can be divided into three stages: first, to identify and confirm candidate drugs through pre clinical research; second, to verify the effectiveness and safety of candidate drugs through clinical research; finally, to achieve the clinical value of candidate drugs through registration and marketing By comparing the number and scale of drugs in research in different stages in 2016 and 2015, it is not difficult to find that the number of drugs in research in almost all stages has increased steadily Among them, the number of drugs in preclinical research stage has changed significantly In 2016, the number of drugs in this stage was 6861, with a year-on-year increase of 13.2% The number of drugs in research at this stage, to a certain extent, reflects the scale of potential candidate drugs in the field of pharmaceutical research and development, but there is a certain uncertainty whether they can finally become real candidate drugs From the existing data, the number of drugs in research at the early stage shows a more obvious growth momentum In addition, the number of drugs under study in clinical research stage (including stage I, stage II and stage III clinical stage), pre registration stage, registration stage and marketing stage was 5071, 197, 102 and 1273 respectively, with year-on-year growth of 9.6%, 16.6%, - 4.7% and 11.7% respectively After further analysis of the data of drugs in research in clinical research stage, it is found that in 2016, the number of drugs in phase I, phase II and phase III clinical stage has increased to 1856, 2261 and 954 respectively, with an increase of 11.4%, 5.1% and 18.1% respectively The increase of the number of drugs in clinical stage Ⅲ is significantly higher than that in clinical stage Ⅱ, which also shows that the high rate of loss of varieties in the later stage of research and development has been improved to some extent Because clinical trials of drugs need to be registered with regulatory agencies in different countries, the data in clinical stage often changes greatly, so it is necessary to review and analyze the data changes in a long time From the clinical data of 2007-2016, the number of drugs in phase I and phase III clinical stage increased significantly, while the number of drugs in phase II clinical stage changed relatively little On the whole, the drug data in phase III clinical stage is particularly encouraging In the past few years, the index has shown a more obvious growth trend, and some drugs in this stage are more likely to enter the list of drugs on the market in 2017 and 2018 What is the reason for the change of top 25 enterprises ranking in the number of new drug R & D secrets in enterprise data? The number of R & D enterprises is increasing year by year, among which small-scale R & D enterprises account for 56.5%, which means what? Top 25 analysis: the ranking of large-scale pharmaceutical enterprises is stable The analysis at the enterprise level is mainly to rank the enterprises in the industry according to the number of drugs under research, and list the top 25 companies in the number of products under research, namely top 25 According to 2016 data, the top five pharmaceutical companies are GSK, Novartis, AstraZeneca, Johnson & Johnson and Merck & Co Among them, GSK has surpassed Pfizer in ranking first since 2012, and has been ranked first in the past six years Although GSK China was involved in bribery scandals at the end of 2014 and 2015, and GSK terminated two clinical phase III drug research projects (i.e anti atherosclerotic darapladib and tumor vaccine astuprotimut-r), GSK still ranks first after a series of shocks In terms of the number of research and development, in 2016, the number of GSK drug projects under research was 242, a significant decline compared with the data in 2015, and the gap between GSK and Novartis (240 drug projects under research) ranked second was further narrowed For AstraZeneca, ranked third, the failure of Pfizer's plan to acquire AstraZeneca in 2014 gave it some breathing opportunities Although the scale of AstraZeneca's drugs under research has hardly changed from 2015, the overall ranking of AstraZeneca has risen to the third place from the fourth place last year due to the sharp decline of Roche's ranking The decline of Roche's ranking is related to the number of research projects terminated in 2015 With the increase of the scale of drugs under research, Johnson & Johnson and MSD ranked fourth and fifth respectively Among them, the merger and acquisition of Cubist by MSD in early 2015 further promoted the steady rise of their ranking Pfizer, ranked sixth, originally planned to merge with Allergan, an Irish pharmaceutical company, to form a super company with 336 drugs under research Unfortunately, for various reasons, Pfizer has given up the acquisition of Allergan In addition, shire and baxalta have recently completed the merger, and are expected to enter the top 25 list next year According to the current data, shire is ranked 28th, baxalta is ranked 78th, and after the merger, the company's research drug scale will reach 83 In the top 25 ranking, compared with the ranking in 2015, the new shortlisted enterprises are Searle gene (22nd) and gillid (23rd) Among them, Searle gene ranking has been basically stable at 20-25 over the years, and only dropped out of the top 25 in 2015 Gilead was absent from the top 25 list for two consecutive years in 2014 and 2015 In this return, the number of drugs under research has increased from 47 in 2013 to 60 In the past year, Gilead's market value and profits have soared rapidly with its advantages in the hepatitis C treatment drug product line After sovaldi and harvoni, the FDA approved the new hepatitis C drug epclusa developed by Gilead on June 28, which is used to treat all six genotypes of hepatitis C At the same time, Gilead's over pricing of hepatitis C drugs has been criticized, which has also raised concerns among some governments, including California At present, Gilead has put forward a "global tiered pricing" system, that is, pricing based on a country's per capita gross national income, which may cause a series of problems in the next few years In any case, Gilead is very lucky At a time when the public's doubts about high drug prices are growing, the pricing scandals of generic companies Turing and Valeant have eased the public's hostility to the pricing of innovative drugs to some extent Both companies have made huge profits from generic drug sales by adjusting pricing policies, especially Turing, which overnight increased the price of pyrimethamine, a 60 year old drug that can be used to treat toxoplasmosis, which is more common in AIDS patients, from $13.5 to $750, or more than 5000% It should be noted that Valeant, another company, ranked 26th in the number of research drugs in 2016 Although some companies have been punished for drug pricing, there is no doubt that drug pricing will be the most controversial topic in the industry in the next few years Compared with 2015, only Germany Merck and Japan union fermentation Kirin are absent from this year's top 25 ranking But fortunately, these companies have not been merged or acquired From the current situation, in the ranking in 2017, there should not be a situation where enterprises disappear due to M & A, but from the development trend of the whole industry, M & A among large enterprises will be inevitable in the future Small R & D enterprises account for more than half of the total: while large pharmaceutical R & D companies have attracted a lot of attention, there are also thousands of small pharmaceutical R & D companies in the pharmaceutical industry, with a large number of drug projects under research According to the existing statistics, the number of these pharmaceutical R & D companies has not only increased to a new historical level, but also exceeded the overall growth rate (11.5%) of the global drugs under research (12.2%) It is not hard to see from 2016 data that a large number of new pharmaceutical R & D companies are emerging At present, the number of pharmaceutical companies with research projects in the world has reached 3687, an increase of 401 compared with the data in 2015, a year-on-year increase of 12.2% In terms of the number of enterprises, this year's number of enterprises has changed to the largest ever, and the proportion of this part of enterprises is also the second largest ever According to statistics, in the past year, the number of newly established pharmaceutical R & D companies is 618, basically consistent with the data in 2014; at the same time, there are fewer and fewer enterprises in the inactive state of R & D projects, which is also a reason for the significant growth of data in 2016 In 2016, more and more small-scale drugs appeared in the field of pharmaceutical research and development