The success rate of new drug research and development began to rise
The success rate of new drug research and development began to rise May 26, 2016 Source: US and Chinese medicine source Today, Nat. Rev. Drug Discov. publishes an article by McKinsey analysts, reviewing the changes in the success rate of new drug development in the past 20 years from 1996 to 2014. From 1996 to 2011, the success rate of new drug research and development declined steadily year by year. The average success rate of three years from 2008 to 2011 was less than half of the average success rate of 1996-1999 (7.5% vs. 16.4%), but since 2011 The rebound is now higher than the success rate in 2000. The main driver is the small decline in small-molecule drugs over the years (from 16% to 5%), while biomacromolecules have a relatively stable success rate. Another trend that remains constant is that the success rate of cooperative development projects is higher than that of individual development projects. In the past five years, the phase III clinical phase of the cooperative project is twice the success rate of individual development projects. It is true that the quality of the projects that can be seen by the two companies is slightly higher. The decline in new drug output over the past 15 years is the most concerned issue in the pharmaceutical industry. Numerous experts have analyzed the causes and proposed improvements, and now it seems that there is always a sign of spring blossoms. Not only has the success rate started to rebound, but the number of projects that have entered the clinic in the past 10 years is growing at a rate of 6% per year, so it is expected that the number of new drugs on the market will continue to increase. Since 2000, the traditional business model, the so-called heavy drug model that targets the common diseases of the public but has no obvious value, has begun to be challenged. The drug regulatory and payment departments began to demand that drugs not only improve the number of test orders, but also improve the quality of life and longevity of patients; not only better than placebo but better than standard therapy. But the new drug is a long-term activity, and the pharmaceutical company can't immediately turn the products in the pipeline into the products needed by the drug regulatory department. This conflict leads to a decade-long recession. Now the pharmaceutical industry has basically found a new model that meets the tastes of the drug regulatory and payment departments. Unlike traditional heavy drug models, current research and development is more focused on specialist diseases that lack standard therapies. There are two main factors that influence output. First, the payment department allows the price of the specialist medicine to be high, even if the patient has less total sales. This greatly expands the types of diseases that pharmaceutical companies can profit from, and pharmaceutical companies do not have to struggle with diseases that are more difficult than current technology licenses. Second, specialist diseases are not limited to oral administration once a day, providing the necessary conditions for the growth of biological macromolecules. Biomacromolecules now account for 39% of the entire pipeline. The selectivity of biological macromolecules is better than that of small molecules, so the possibility of failure due to off-target toxicity 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 rates. Of course, pharmaceutical companies are more mature in terms of project selection. The success rate of Phase I and Phase II clinical trials is lower than that of Phase III clinical trials, indicating that capital use efficiency is improving. The FDA's approval innovation also helped the success rate to some extent. The FDA's breakthrough drug policy has accelerated the approval of some new drugs, which may have a higher success rate than average for various reasons. Many new drugs are conditionally listed. In principle, some drugs will be withdrawn from the market because they will not reach the contract. Therefore, even if the R&D technology does not improve these approval policies, the success rate will be improved on the surface. The payment department’s tolerance for high drug prices has given the pharmaceutical industry a chance to retreat to specialist diseases. If the drug price is restricted, the drug factory will have to return to the public. The rebound in R&D efficiency over the past three years has been exciting, but the crisis still exists. Erythritol For Preserved Fruit Ningxia Eppen Biotec CO.,LTD , https://www.nxeppen.com