In the fierce competition of new drug market, how to stand out? |Nature review: drug discovery

Source: during the past decade, the number and type of drugs on the market in the United States have changed substantially Cancer drugs are one of the drivers of these changes, accounting for 30% of the 46 drugs approved in the United States in 2015 Specialty drugs are also becoming more common on the market, replacing the most important basic drugs before We examined the situation of new drugs on the market in the United States to find out whether new drugs are more difficult to achieve commercial success in the current situation of increased competition, increased maturity of payers, and intensified price review The study used three indicators to evaluate the success of new drugs on the market, i.e the highest sales volume, sales volume curve and the ratio of actual sales volume to expected sales volume five years later The study used multiple regression analysis to evaluate the data of three and five years after the drug was listed in the United States in 2006-2013 (excluding the drugs in 2012 and 2013), and the relevant sales data came from the evaluate Pharma database The main findings of this study are discussed below The difficulty of commercial success of new drugs increases, and the average performance of drugs on the market in the research stage decreases in three evaluation indexes First of all, the proportion of drugs whose annual sales volume fails to reach US $200 million increased from 29% in 2006 to 47% in 2011, while the proportion of those drugs whose sales volume exceeds 1 billion fell from 39% to 21% (Figure 1a) Figure 1 Performance trend of new drugs on the market a | the research summarizes the new drugs with sales within a specific range five years after they were launched on the market from 2006 to 2015 The figure shows the relevant data of 2006 (28 new drugs in total) and 2011 (34 new drugs) It can be seen that the number of drugs with great success is getting fewer and fewer, and the same trend appears in other years B| analyze the new drugs that can be sold in the United States in the past 25 years and divide them into four categories according to their sales growth trajectory: zero growth, slow growth (rapid growth in the late stage), linear growth and rapid growth (rapid growth in the early stage) The figure shows the data of new drugs in two different periods, indicating that the number of slowly growing drugs is increasing C | using the relevant model of evaluatepharma, the ratio of the highest sales volume to the expected maximum sales volume of the drugs (28, 28 and 25, respectively) listed in 2006, 2008 and 2010 after five years' listing was calculated The results showed that fewer and fewer new drugs could meet the analysts' expectations Data source: evaluatepharma; IMS; pharmaprojects; McKinsey analysis Second, sales growth slowed down after the IPO According to the sales growth track in five years after listing, the drugs from 1990 to 2015 are divided into four categories: rapid growth, linear growth, slow growth and zero growth From 1990 to 1994, linear growth and rapid growth drugs were the most common, accounting for 73% of the drugs on the market However, after several years of steady decline, the proportion of drugs on the market in 2013 to 2015 decreased to half, only 36% At the same time, the proportion of slowly growing drugs doubled, from 23% in 1990-1994 to 58% in 2013-2015 (Figure 1b) Third, fewer drugs can achieve the average or similar optimal performance expected by analysts In fact, about half of the drugs on the market in 2010 failed to achieve 25% of the expected maximum sales (Figure 1c) Pharmaceutical industry is not the only industry in which analysts can not accurately predict the revenue of product listing, but it seems to be becoming increasingly difficult to accurately predict All in all, the above three findings show that in today's environment, the difficulty of commercial success of new drugs on the market has increased significantly The reason why the new drugs are difficult to succeed in the market is that the competition situation has changed Between 2006 and 2015, the number of competing drugs for the same indication increased by 37%, with an average of nine competing drugs for each indication With more and more drugs on the market to share the benefits, "winner takes all" is still common On average, the leading drugs in the competition account for about half of the sales, while the remaining competitors can only share a small part Take cancer drugs as an example In 2006-2007, the sales of the first quarter of drugs were twice the average sales of all drugs, while in 2010-2011, the sales increased by more than three times Similar patterns also exist in other drugs, with sales of the first quarter of drugs growing from about twice the average maximum sales to three times Significant clinical benefits are more difficult to achieve In the study, the ASMR grade of haute autorit é de Sant é (has) was used to evaluate the clinical benefits of new drugs, and the clinical effects of new drugs were compared with the treatment standards In recent years, the average incremental revenue of new drugs in various fields has declined due to the higher treatment standards promoted by the new drugs on the market For example, in the field of tumor and immunity, where new drugs are most active in the market during the research stage, even the drugs that have achieved great success in the 1990s and the beginning of this century, such as monoclonal antibody therapy, have seen a significant reduction in their revenue in the past five to ten years (Figure 2a) Figure 2: factors influencing the success of new drugs on the market a| the average clinical effect of new drugs on the market after 2000 was evaluated according to the ASMR rating of the French higher health administration, and the lower the ASMR ranking, the better the clinical benefit The samples included 69 tumor drugs, 44 CNS drugs and 22 immune drugs The thick line represents the median clinical benefit B | using the managed markets insight & technology database, we compared the Medicare prescription coverage drugs in 2013 and 2016 in the United States Including 143 tumor drugs, 72 central nervous system drugs and 35 immune drugs From 2013 to 2016, the proportion of people who can freely use the evaluated drugs within the scope of medical insurance prescription dropped significantly Data source: evaluatepharma; McKinsey analysis Drug payers should strengthen market access restrictions With the combination and maturity of payers and drug welfare managers (PBMs), the control of drug cost is also strengthened Even for cancer drugs, although 90% of drugs are still within the scope of Medicare prescription, the number of drugs requiring pre authorization has more than doubled Drug welfare regulators said they would exclude drugs with sharply increased prices and had already implemented the measure on a variety of drugs The willingness of drug payers and welfare managers to exclude a drug in a certain period of time before the review of the medical insurance prescription list, to a certain extent, slows down the sales growth rate after the new drug is put on the market The pressure of public opinion on drug prices is rising For example, the media's attention to high-priced drugs such as pyrimethamine daraprim and epinephrine Epipen has attracted extensive attention from the government and the public The factors influencing the success of new drug business were analyzed by regression analysis and other methods to improve the performance of drug market The results showed that pre-sale was closely related to incremental clinical benefits In the first two years of the market, the sales of FDA certified breakthrough drugs or top has drugs are on average $1 billion more than that of other general drugs In addition, competitors who gain more profits often terminate some projects more frequently and earlier in the clinical development process In this way, they may be able to release relevant resources and invest them in the truly innovative drug development At the same time, the specific treatment areas were analyzed In the field of tumor drugs, the incremental revenue of FDA certified breakthrough drugs is related to the sales growth track in the first two years of marketing In addition, the top 1 / 4 of cancer drugs sold between 2006 and 2015 were targeted at three times the indications of other cancer drugs, and the number of cancer drugs put on the market by manufacturers of these drugs was twice that of other manufacturers For central nervous system drugs, in a certain treatment area, especially for a certain indication, the priority sales are related to the early marketing revenue It may be that there are few breakthrough drugs in this field, so its incremental benefits have no significant impact Our analysis shows that the new drug market environment will continue to be grim At present, the new drugs on the market can be divided into three categories: • breakthrough drugs that can change the treatment mode These drugs are currently scarce and will be commercially successful on the market There are significant benefits but defects in safety, convenience, etc The success of these drugs depends on how manufacturers prove their value, and they are the most numerous and require the greatest effort in exchange for commercial success • drugs with poor efficacy and no commercial value at present Such projects should be identified as early as possible in the development process and stop loss in time However, many companies are still conducting phase III clinical trials on such drugs with little chance of success Therefore, the classification of a new drug should be expected and targeted, which should be conducive to the success of new drug commercialization.