According to the latest data, as of January 2019, the number of new drugs under research worldwide was 16,181, compared with 15,267 in 2018, a year-on-year increase of 5.99%.
The author further analyzed the therapeutic field and indications of the Pharmaprojects database and found that more than one-third of the drug indications under study were anticancer drugs.
In the context of limited resources, the excessive tilt of such resources may have adverse effects on other equally important clinical treatment needs and require vigilance.
16 major therapeutic areas: TOP 2 anticancer drugs, biopharmaceuticals
When the new drug project was classified according to the main therapeutic field, it was found that the growth rate of new drugs in various therapeutic fields in 2019 varied. The Pharmaprojects database was used to analyze the status of the drug under investigation in 16 major therapeutic areas and biotechnology categories.
On the whole, anticancer drugs, biotechnology drugs, nervous system drugs, anti-infective drugs and digestive/metabolizing drugs are the top TOP5 therapeutic areas, which are basically consistent with the rankings in 2018.
Among them, cancer is an important indication field for drug research and development. The number of anti-cancer/anti-tumor drugs continues to grow steadily. The number has increased from 5,212 in 2018 to 5,697, and the number of drug candidates has increased by 485, an increase of 9.3%. The average growth rate of the pharmaceutical R&D industry is higher than 6%.
The number of biotech drugs has also maintained a substantial increase, and the number has increased from 4,751 in 2018 to 5,422, an increase of 14.1%. It is important to note that as cancer treatments are gradually tilted toward more targeted biotech therapies, more drugs will be counted in these two sub-areas.
In addition, the treatment areas with growth rates exceeding the industry's average growth rate include neurological medications (up 6.6%), digestion/metabolism (7.6% increase), immunological drugs (up 6.7%), and sensory medications (increases) 7.7%).
Compared with the continuous increase in the investment of anti-tumor drugs by global pharmaceutical companies , the number of drugs under investigation in some therapeutic areas has dropped significantly. For example, in 2019, the number of antiparasitic drugs and hormonal drugs decreased by 8.9% and 4.1%, respectively.
In addition, the number of drugs under study in some therapeutic areas has only changed slightly. For example, in 2019, the number of anti-infective drugs increased by only 1.4%, and the growth rate of musculoskeletal drugs was only 0.9%, which is far lower than the average growth rate of the industry. Compared with the increase in previous years, the increase in the number of drugs in these categories is relatively limited.
Judging from the existing statistics, anti-cancer/anti-tumor drugs have basically occupied the absolute dominant position in the research and development of new drugs, and their number is increasing year by year. Judging from the changes in the proportion of global anticancer drug product lines in 2010-2019, the number of anti-tumor drugs in research continued to grow steadily, and its proportion has increased from 26.8% in 2010 to 35.2% in 2019. This means that more than a third of research in drug development targets for tumor diseases. Not difficult to see the entire industry resources to tilt the field of anti-tumor drugs. In the context of limited resources, the excessive tilt of this resource may have an impact on other equally important clinical treatment needs.
236 subdivided treatment categories: immune anticancer drugs topped the list, gene therapy increased the most
Drugs in 16 therapeutic areas were subdivided into 236 treatment categories and compared with 2018 data to reflect changes in the number of drugs being studied in different treatment categories.
From the TOP25 ranking of treatment categories, immune anticancer drugs (2731 drugs in research), general anticancer drugs (2450), gene therapy (864), other monoclonal antibody drugs (818), anti-infection prevention Sex vaccines (702) were among the top five treatment categories.
Overall, the two main types of anti-cancer/anti-tumor drugs have been at the forefront of the list for many years, but this year's situation is different. Immune anticancer drugs are growing rapidly, ranking first, which is the first time since 2003 that the drug has topped the list, with an increase of 16.5% in 2019. The ranking of general anticancer drugs has dropped to the second place, and the number of drugs under study in 2019 has increased by only 3.2%. It is not difficult to see from this information that immunological therapies including monoclonal antibodies, CAR-T cell therapies, and tumor immunology technologies are playing an increasingly important role in cancer treatment.
Among the treatment categories, the most noticeable category is gene therapy, which has risen from sixth place in 2018 to third place, and the number of drugs under study has increased from 633 in 2018 to 864. The increase was as high as 36.5%. Gene therapy has emerged since the 1990s, and data records can be traced back to 1995. In 1996, the number of drugs under research exceeded 100, and then experienced a rapid increase in the number of drugs under study, and reached 275 in 2003. The peak value of the year ranked third in the TOP25. After the death of the subjects in the clinical trial, the development of the drug was affected. The number of drugs under study remained at around 200, and the ranking continued to decline. Significant signs of recovery, both in 2012 and 2014 fell out of the TOP25 ranks.
With the first global gene therapy drug, Glybera (alipogene tiparvovec), the Dutch research and development drug UniQure, approved by the European Commission for the first time, the development of this drug has only recovered, and returned to the TOP25 list in 2015. Since then, we have seen traditional gene therapy products such as Spark Therapeutics' Luxturna (voretigene neparvovec), as well as new therapeutic technologies such as CAR-T and CRISPR technology associated with ex vivo gene therapy.
From the statistical data, most treatment categories have shown a trend of product line expansion. Among them, the number of monoclonal antibody drugs continued to grow steadily, and all three sub-categories have entered the TOP25, and each sub-category has an increase in the number of drugs under study.
However, there are also some treatment categories that do not perform as well. In 2019, the number of anti-infective preventive vaccines declined slightly, and its ranking has dropped from the third to the fifth. The most obvious treatment category is diabetes treatment, although its ranking remains at 7th. However, the number of drugs under research has dropped from 605 in 2018 to 571, a decrease of 5.6%.
More than 1,400 indications: TOP 5 all, TOP 10 has 8 kinds, TOP 20 has 14 kinds of anticancer drugs
Further statistics according to the indications of the drug under study can be classified into more than 1400 diseases or indications, of which more than 470 diseases are rare diseases recognized by official or authoritative organizations.
Compared with the ranking in 2018, there was no significant change in the ranking order of each indication. The global TOP5 indications for research drugs include breast cancer (774 in the study), non-small cell lung cancer (586), colorectal cancer (535), ovarian cancer (442), and pancreatic cancer (438). . Among them, breast cancer continued to rank first, with the number of drugs under research increasing by 6.5% year-on-year; non-small cell lung cancer ranked second with an increase of 7.7%, and the growth rate was more obvious; colorectal cancer increased by 6.4%. Ranked third; ovarian cancer and pancreatic cancer, both increased by 1.8%. The TOP5 indications are all cancer, which has been the second consecutive occurrence.
In the TOP15 disease category, in addition to prostate cancer and brain cancer, most of the indications associated with cancer are on the rise. In addition to the top five cancer categories, there are prostate cancer (366), brain cancer (360), malignant melanoma (357), myeloma (283), head and neck cancer (283), gastrointestinal Cancer (276) increased by -3.9%, -0.3%, 3.2%, 11.4%, 9.7%, and 14.0%, respectively. The cancer categories included in TOP25 also included liver cancer (273), non-Hodgkin's lymphoma (231), kidney cancer (221), and bladder cancer (179). Compared with other types of drugs, anti-tumor drugs are often used in the treatment of a variety of diseases, so from the statistical data, anti-cancer / anti-tumor drugs will rank higher. In TOP10, there are 8 drugs that are anticancer drugs, while in TOP20, 14 drugs are anticancer drugs.
From the increase in the number of drugs under investigation, gastrointestinal cancer (14.0% increase), myeloma (11.4%), head and neck cancer (9.7%), non-small cell lung cancer (7.7%) and Parkinson's disease (7.5) %) are all categories of indications with a large increase.
The number of drugs in the list of indications for asthma (12.5% ​​reduction), type 2 diabetes (down 6.1%), rheumatoid arthritis (down 4.8%), and prostate cancer (3.9%) appeared to varying degrees. The decline.
In addition, the new indication for entering the TOP25 ranking is nonalcoholic steatohepatitis. The number of drugs under study is 222, ranking 21st.
NINGBO MEDICAL EQUIPMENT CO.,LTD , https://www.techartmeds.com