PI3Kδ inhibitors are a class of drugs that target the delta isoform of phosphoinositide 3-kinase (PI3Kδ). These inhibitors work by blocking the activity of PI3Kδ, which is involved in signaling pathways that regulate cell growth, survival, and immune responses. By inhibiting PI3Kδ, these drugs help to suppress the proliferation of certain cells, including B cells and T cells. PI3Kδ inhibitors have shown promise in the treatment of diseases such as chronic lymphocytic leukemia (CLL), follicular lymphoma, and certain autoimmune disorders like rheumatoid arthritis. The market for PI3Kδ inhibitors is driven by several factors. Firstly, there is a growing prevalence of diseases such as chronic lymphocytic leukemia (CLL), follicular lymphoma, and autoimmune disorders, which are potential indications for PI3Kδ inhibitors. Secondly, advancements in research and development efforts led to the discovery and development of more selective and potent PI3Kδ inhibitors. According to the PubMed publication of Jan 2022, CLL accounts for 25–30% of all leukemia in Western Countries, with over 100,000 incidence cases and over 40,000 death cases globally reported in 2019. Companies such as Gilead, AstraZeneca, GSK, Incyte, Bayer, BeiGene, J&J, Novartis, Pharming Group, Sanofi, TG Therapeutics, and UCB currently cater to chronic lymphocytic leukemia (CLL), follicular lymphoma, and autoimmune disorders. Aliqopa (copanlisib) is one of the prominent drugs by Bayer, which is being used to treat follicular lymphoma and leukemia. Moreover, Zydelig (idelalisib) by Gilead and Ukoniq (Umbralisib) by TG Therapeutics are other prominent drugs that are used extensively in cases of mantle cell lymphoma and Hodgkin cell lymphoma respectively, apart from getting used in before mentioned indications. Moreover, many companies are coming up with new molecules in this space. For instance, Pharming Group is one such company that got the drug Joenja (Leniolisib) approved for the treatment of endocrine gland neoplasm and breast cancer.
Key Developments
- In February 2023, Pharming Technologies B.V. in collaboration with Cmed, LabCorp Corporation of America Holdings, inc, CMIC co, ltd. (Japan), LabCorp central laboratory has started an open-label, single-arm study of the safety, pharmacokinetics, pharmacodynamics, and efficacy of Leniolisib in pediatric patients aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome followed by an open-label long-term extension.
- In April 2023, The FDA approved Pharming’s Leniolisib for activated phosphoinositide 3-kinase (PI3K) δ syndrome (APDS), a rare genetic disorder that weakens the immune system.
Approved PI3Kδ Inhibitors
- Aliqopa (Copanlisib) (Bayer)
- Zydelig (Idelalisib) (Gilead)
- Copiktra (Duvelisib) (Secure Bio, Yakult Honsha)
- Joenja (leniolisib) (Pharming Group)
Drugs under the Pipeline - PI3Kδ Inhibitors
- Aliqopa (Copanlisib)/ Bayer
- Zydelig (Idelalisib)/ Gilead
- Copiktra (Duvelisib)/ Secura Bio, Yakult Honsha
- Parsaclisib (Incb50465)/ Incyte
- Ukoniq (Umbralisib)/ Tg Therap
- Itari (Linperlisib)/ Shanghai Yingli Pharma
- Nemiralisib (GSK2269557)/ GSK
- TQ-B3525 / Sino Biopharm
- Tenalisib (Rp6530)/ Rhizen
- Zandelisib (ME-401)/ MEI
- Amdizalisib (HMPL-689)/ Hutchmed
- Joenja (leniolisib)/ Pharming Group
- Seletalisib (UCB5857)/ UCB
- ACP-319 / AstraZeneca
- Cybolise (SHC014748M)/ Nanjing Sanhome Pharma
- AZD8154 / AstraZeneca
- RV1729 / J&J
- ZX-101A / Zenshine Pharma
- Acalisib (GS-9820)/ Gilead
- Dezapelisib (INCB040093)/ Incyte
- AZD8835 / AstraZeneca
- BGB-10188 / BeiGene
- BR101801 / Boryung Group
- CAL-263 / Gilead
- GS-9901 / Gilead
- GSK2292767 / GSK
- KA2237 / Karus Therap
- roginolisib (IOA-244)/ iOnctura
Clinical Activity and Development of PI3Kδ Inhibitor
In the PI3Kδ inhibitor space, approximately 29 companies are focusing on 64 disease indications, and more than 140 clinical trials are being conducted in this category of drugs. For instance,
- In January 2023, Innovent announces the national medical products administration in China has accepted and granted priority review designation to the new drug application for Parsaclisib (pi3kδ inhibitor) for the treatment of relapsed or refractory follicular lymphoma.
- In April 2023, Bayer Pharmaceuticals updated efficacy data from a phase III CHRONOS-3 trial of Copanlisib in non-Hodgkin’s lymphoma presented at the 114th Annual Meeting of the American Association for Cancer Research (AACR-2023)
Target Indication Analysis of PI3K-Delta Inhibitors
The PI3Kδ inhibitors are primarily used to treat chronic lymphocytic leukemia (CLL), follicular lymphoma, and autoimmune disorders. PI3Kδ inhibitors also help to prevent Hodgkin lymphoma. For instance, Ukoniq (Umbralisib) is a drug by TG Therapeutics which is under trial for the treatment of ovarian epithelial cancer. In the treatment of leukemia, PI3Kδ inhibitor Copiktra (Duvelisib) is used widely. Through research and development, the indications in which PI3Kδ inhibitors can be used are getting expanded. For instance, PI3Kδ inhibitors are now under clinical trial for the treatment of rhabdoid tumors.
Regional Analysis of PI3K-Delta Inhibitors
PI3K Inhibitors Insights
The global PI3Kδ inhibitor market is segmented into five major regions that are North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa region. In North America, the market for PI3Kδ inhibitors is significant and has witnessed substantial growth. The region has a well-established healthcare infrastructure, advanced research facilities, and a high prevalence of diseases like chronic lymphocytic leukemia (CLL) and autoimmune disorders. North America has been at the forefront of clinical trials and drug development, with pharmaceutical companies actively conducting research and investing in the development of PI3Kδ inhibitors. Moreover, strong regulatory frameworks and favorable reimbursement policies in countries like the United States and Canada further support the market growth of PI3Kδ inhibitors in North America. According to the Leukemia and Lymphoma Society, FL has an annual incidence of about 15,000 cases/year in the United States with patients having an average age of approximately 60. The country boasts a robust pharmaceutical sector, extensive clinical trial networks, and a large patient population. Canada, on the other hand, is known for its well-established healthcare system and supportive regulatory framework, making it an attractive market for PI3Kδ inhibitors. These countries are increasingly adopting PI3Kδ inhibitors due to their efficacy and potential to improve patient outcomes. On the other hand, the PI3Kδ inhibitor market in Europe has witnessed significant growth in recent years. Major countries driving this market include Germany, France, United Kingdom, Italy, and Spain. These countries have a robust pharmaceutical industry and a high prevalence of CLL, which is a key indication for PI3Kδ inhibitors. The market is characterized by a well-established healthcare infrastructure, strategic collaborations between pharmaceutical companies, and growing awareness about targeted therapies. With the ongoing advancements in drug development and personalized medicine approaches, the Europe regional market for PI3Kδ inhibitors is expected to continue its upward trajectory.
Latin America
Europe
Asia Pacific
Middle East
North America
Frequently Asked Questions
The approved molecules of PI3K-Delta inhibitors are Aliqopa, Zydelig, Copiktra, and Joenja
The increasing prevalence of chronic lymphocytic leukemia (CLL), advanced healthcare infrastructure, and a strong emphasis on research and development are the primary drivers for market growth.
The major players in this space are Gilead, AstraZeneca, GSK, Incyte, Bayer, BeiGene, J&J, Novartis, Pharming Group, Sanofi, and TG Therapeutics.
The emergence of alternative treatment options, such as other targeted therapies or combination therapies, and stringent reimbursement policies in some regions as well as the high cost of drugs can limit their use and impact market growth.
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- Gilead
- AstraZeneca
- GSK
- Incyte
- Rhizen
- Bayer
- BeiGene
- Boryung Group
- CSPC Pharma
- Curon Biopharma
- Hutchmed
- Innovent Biologics
- J&J
- Jiangsu Hengrui Pharma
- Karus Therap
- MEI
- Nanjing Sanhome Pharma
- Novartis
- Pharming Group
- Sanofi
- Secura Bio
- Shanghai YingLi Pharma
- Sino Biopharm
- TG Therap
- UCB
- Verastem
- Yakult Honsha
- Zenshine Pharma
- iOnctura