Author:Dao tuo
Cancer is still the number one killer of human health. According to the National Institutes of Health (NIH), in 2012, there were 14.1 million new cases worldwide and 8.2 million cancer-related deaths. In 2012, 57% of new cancer cases occurred in less developed regions of the world, including Central America and parts of Africa and Asia, and 65% of cancer deaths also occurred in these areas. In 2018 alone, there are more than 1.7 million new cases of cancer. By 2030, the number of new cancer cases is expected to increase to 23.6 million per year.
In recent years, the benefits of anti-cancer drugs have increased. In 2017, global cancer treatment costs have exceeded $133 billion, an increase of nearly $96 billion over 2013. According to some studies, in the next five years, research and development funds in this field can reach 18-200 billion US dollars, with a compound annual growth rate of 10%-13%.
In the past 5 years, 63 anti-tumor drugs have been approved, covering 24 different tumor types. In 2017, 14 drugs were approved for marketing, 11 of which were granted FDA-approved breakthrough therapy, and the overall response rate of this group of drugs exceeded 50%, significantly improving patient survival and improving patients' quality of life. Since the introduction of PD-1 and PD-L1 inhibitors in 2014, they have already occupied a large share. The market prospects are still broad in the future. By 2017, these drugs have been used in the treatment of 23 kinds of cancers, and for the first time for lung cancer.
⧫ Clinical research pipeline
Currently, more than 700 drugs are undergoing clinical trials, an increase of 60% from a decade ago. More than 33% of the drugs are guided by the patient's biomarkers in clinical trials, which is more reasonable and accurate than previous clinical trials. In Phase I or Phase II clinical trials, nearly half of the drugs are related to immunotherapy, covering 34 tumor types. In 2016, the success rates of Phase I and Phase III clinical trials were 66% and 73%, respectively, while the success rate of Phase II trials was only 30%. From the time of clinical trials, the duration of the entire clinical trial and the number of people required are decreasing. Among the drugs approved in 2017, the time from patent application to drug approval was 14 years, slightly faster than 2013.
⧫ Immunological checkpoint inhibitor
Immune cells can effectively kill tumor cells, but some tumor cells destroy the signaling pathway of immune checkpoints involved in PD-1 (programmed death protein-1). PD-1 inhibitors can help eliminate tumor cells that overexpress PD-1 protein and escape immune surveillance. Following the launch of Ipilimumab (an anti-CTLA4 drug) in 2011, two highly anticipated anti-PD-1 drugs (Keytruda and Opdivo) were introduced at the end of 2014 for the treatment of melanoma. In 2016, the US FDA approved Genentech's Atezolizumab for the treatment of bladder cancer and non-small cell lung cancer. In 2017, Avelumab, developed by Pfizer, was approved for marketing for metastatic cell carcinoma (Merkel cell carcinoma, a rare and highly aggressive skin cancer) that was approved for metastatic bladder at the end of the year. Treatment of cancer. In the same year, AstraZeneca's Durvalumab was approved for metastatic urothelial cancer.
As a new type of therapy, immunological checkpoint inhibitors have broad room for development. In 2017, these drugs have been used in the treatment of 23 kinds of cancers, and for the first time for the treatment of lung cancer. Most of the drugs approved by the US FDA are used to treat melanoma, bladder cancer, lung cancer, etc., and more than half of these therapies are used for the treatment of lung cancer. Both Keytruda and Opdivo can be used for chemotherapy for lung cancer, and Keytruda is First-line medication. The use of immunosuppressive point combination therapy is becoming more common in the treatment of melanoma.
Next-generation immunological checkpoint inhibitors have more than 300 drugs in clinical trials at various stages, most of which are CTLA4 inhibitors, PD-1 inhibitors, PD-L1 inhibitors, CD19/CD3 antibodies, IDO (Indoleamine- Pyrrole-2,3-dioxygenase) inhibitor. Among them, PD-1/PD-L1 accounted for the most, reaching 58%, and about 8% of CD19/CD3 antibodies were in Phase I or Phase II clinical trials. 17% of IDO inhibitors are in clinical phase III trials, and 2% are in phase I or phase II clinical trials.
In addition to immunological checkpoint inhibitors, other therapies such as vaccines, carT cell therapy, oncolytic viruses, and the like. At present, carT cell therapy such as Tisagenlecleucel and Axicabtagene ciloleucel specifically target B lymphocyte CD19 for the treatment of refractory B cell acute lymphocytic leukemia and diffuse large B cell lymphoma. Second-generation carT cell therapy is still under investigation, with approximately 90% of patients having symptoms resolved.
⧫ Top 5 best-selling drugs in the next 6 years
In the next six years, Keytruda's sales will exceed Revlimid, more than $12 billion, with a compound annual growth rate of 19%, ranking first among the best-selling anti-cancer drugs. Revlimid's patents will expire in 2019, when generics will compete with them, and Revlimid's sales pressure will increase, but the drug has a wide range of indications that will continue to maintain its dominance for some time to come. It is estimated that sales in 2024 will reach 11.9 billion US dollars, with a compound annual growth rate of 6%, ranking second. In the third place, Opdivo, which has the same target as Keytruda, is a PD-1 inhibitor with sales of $5.7 billion in 2017. It is expected to generate $11.4 billion in sales in 2024. The rate is 10%. In the fourth place is Imbruvica, the first listed Bruton's tyrosine kinase (BTK) inhibitor. With sales of $3.1 billion in 2017, it is expected to have annual sales of $9.6 billion in 2024, a compound annual growth rate of 17%. In fifth place, Ibrance, a CDK 4&6 (Cyclin-dependent kinases 4&6) inhibitor, was approved by the US FDA in May 2017. Its 2017 sales were $3.1 billion, and its sales are expected in 2024. It is $8.3 billion.
⧫ Summarize
Anti-tumor drug development is a hot area for drug development, not only because of its large audience, but also because of its high investment efficiency. In 2017, there were more than 700 clinical trials of anti-tumor drugs, and half of them were immunotherapy. It can be seen that immunotherapy has broad application prospects. At present, the PD-1 inhibitors Keytruda and Opdivo have great growth potential and will be among the forefront of anti-tumor drugs in the next few years. The research on CD19 inhibitor drug JCAR017 is currently in the phase II clinical stage, and it is likely to be successful in the next few years, and it has a broad space for development.
Cancer is still the number one killer of human health. According to the National Institutes of Health (NIH), in 2012, there were 14.1 million new cases worldwide and 8.2 million cancer-related deaths. In 2012, 57% of new cancer cases occurred in less developed regions of the world, including Central America and parts of Africa and Asia, and 65% of cancer deaths also occurred in these areas. In 2018 alone, there are more than 1.7 million new cases of cancer. By 2030, the number of new cancer cases is expected to increase to 23.6 million per year.
In recent years, the benefits of anti-cancer drugs have increased. In 2017, global cancer treatment costs have exceeded $133 billion, an increase of nearly $96 billion over 2013. According to some studies, in the next five years, research and development funds in this field can reach 18-200 billion US dollars, with a compound annual growth rate of 10%-13%.
In the past 5 years, 63 anti-tumor drugs have been approved, covering 24 different tumor types. In 2017, 14 drugs were approved for marketing, 11 of which were granted FDA-approved breakthrough therapy, and the overall response rate of this group of drugs exceeded 50%, significantly improving patient survival and improving patients' quality of life. Since the introduction of PD-1 and PD-L1 inhibitors in 2014, they have already occupied a large share. The market prospects are still broad in the future. By 2017, these drugs have been used in the treatment of 23 kinds of cancers, and for the first time for lung cancer.
⧫ Clinical research pipeline
Currently, more than 700 drugs are undergoing clinical trials, an increase of 60% from a decade ago. More than 33% of the drugs are guided by the patient's biomarkers in clinical trials, which is more reasonable and accurate than previous clinical trials. In Phase I or Phase II clinical trials, nearly half of the drugs are related to immunotherapy, covering 34 tumor types. In 2016, the success rates of Phase I and Phase III clinical trials were 66% and 73%, respectively, while the success rate of Phase II trials was only 30%. From the time of clinical trials, the duration of the entire clinical trial and the number of people required are decreasing. Among the drugs approved in 2017, the time from patent application to drug approval was 14 years, slightly faster than 2013.
⧫ Immunological checkpoint inhibitor
Immune cells can effectively kill tumor cells, but some tumor cells destroy the signaling pathway of immune checkpoints involved in PD-1 (programmed death protein-1). PD-1 inhibitors can help eliminate tumor cells that overexpress PD-1 protein and escape immune surveillance. Following the launch of Ipilimumab (an anti-CTLA4 drug) in 2011, two highly anticipated anti-PD-1 drugs (Keytruda and Opdivo) were introduced at the end of 2014 for the treatment of melanoma. In 2016, the US FDA approved Genentech's Atezolizumab for the treatment of bladder cancer and non-small cell lung cancer. In 2017, Avelumab, developed by Pfizer, was approved for marketing for metastatic cell carcinoma (Merkel cell carcinoma, a rare and highly aggressive skin cancer) that was approved for metastatic bladder at the end of the year. Treatment of cancer. In the same year, AstraZeneca's Durvalumab was approved for metastatic urothelial cancer.
As a new type of therapy, immunological checkpoint inhibitors have broad room for development. In 2017, these drugs have been used in the treatment of 23 kinds of cancers, and for the first time for the treatment of lung cancer. Most of the drugs approved by the US FDA are used to treat melanoma, bladder cancer, lung cancer, etc., and more than half of these therapies are used for the treatment of lung cancer. Both Keytruda and Opdivo can be used for chemotherapy for lung cancer, and Keytruda is First-line medication. The use of immunosuppressive point combination therapy is becoming more common in the treatment of melanoma.
Next-generation immunological checkpoint inhibitors have more than 300 drugs in clinical trials at various stages, most of which are CTLA4 inhibitors, PD-1 inhibitors, PD-L1 inhibitors, CD19/CD3 antibodies, IDO (Indoleamine- Pyrrole-2,3-dioxygenase) inhibitor. Among them, PD-1/PD-L1 accounted for the most, reaching 58%, and about 8% of CD19/CD3 antibodies were in Phase I or Phase II clinical trials. 17% of IDO inhibitors are in clinical phase III trials, and 2% are in phase I or phase II clinical trials.
In addition to immunological checkpoint inhibitors, other therapies such as vaccines, carT cell therapy, oncolytic viruses, and the like. At present, carT cell therapy such as Tisagenlecleucel and Axicabtagene ciloleucel specifically target B lymphocyte CD19 for the treatment of refractory B cell acute lymphocytic leukemia and diffuse large B cell lymphoma. Second-generation carT cell therapy is still under investigation, with approximately 90% of patients having symptoms resolved.
⧫ Top 5 best-selling drugs in the next 6 years
In the next six years, Keytruda's sales will exceed Revlimid, more than $12 billion, with a compound annual growth rate of 19%, ranking first among the best-selling anti-cancer drugs. Revlimid's patents will expire in 2019, when generics will compete with them, and Revlimid's sales pressure will increase, but the drug has a wide range of indications that will continue to maintain its dominance for some time to come. It is estimated that sales in 2024 will reach 11.9 billion US dollars, with a compound annual growth rate of 6%, ranking second. In the third place, Opdivo, which has the same target as Keytruda, is a PD-1 inhibitor with sales of $5.7 billion in 2017. It is expected to generate $11.4 billion in sales in 2024. The rate is 10%. In the fourth place is Imbruvica, the first listed Bruton's tyrosine kinase (BTK) inhibitor. With sales of $3.1 billion in 2017, it is expected to have annual sales of $9.6 billion in 2024, a compound annual growth rate of 17%. In fifth place, Ibrance, a CDK 4&6 (Cyclin-dependent kinases 4&6) inhibitor, was approved by the US FDA in May 2017. Its 2017 sales were $3.1 billion, and its sales are expected in 2024. It is $8.3 billion.
⧫ Summarize
Anti-tumor drug development is a hot area for drug development, not only because of its large audience, but also because of its high investment efficiency. In 2017, there were more than 700 clinical trials of anti-tumor drugs, and half of them were immunotherapy. It can be seen that immunotherapy has broad application prospects. At present, the PD-1 inhibitors Keytruda and Opdivo have great growth potential and will be among the forefront of anti-tumor drugs in the next few years. The research on CD19 inhibitor drug JCAR017 is currently in the phase II clinical stage, and it is likely to be successful in the next few years, and it has a broad space for development.
Reference：
1. Global Oncology Trends 2018
2. EvaluatePharma World Preview 2018, Outlook to2024
3. https://www.nih.gov/
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