Phosphatidylinositol-3-kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR) signaling is one of the most important intracellular pathways, which regulates cell growth, motility, survival, metabolism, and angiogenesis. Activation of the PI3K pathway contributes to the development of tumor PI3K/AKT/(mTOR). PI3K inhibitors are subdivided into dual PI3K/mTOR inhibitors, pan-PI3K inhibitors, and isoform-specific inhibitors. They inhibit the (PI3K)/AKT signaling pathway, thereby resulting in decreased cellular proliferation and increased cellular death. PI3K inhibitors are indicated for HER2-negative breast cancer, chronic lymphocytic leukemia, follicular lymphoma, marginal zone B-cell lymphoma, angiomyolipoma, and astrocytoma. Novartis, AbbVie, Bayer, Gilead Sciences, Roche, Genentech, Abbott, GSK, and Eli Lilly & Company are some of the major players in the PI3K inhibitors market.
Key Market Developments:
- In Jan 2022, Gilead Sciences launched Idelalisib for chronic lymphocytic leukemia as first-line therapy in the UK, and as second-line therapy in New Zealand and Australia.
- In Jan 2023, Secura Bio’s Duvelisib received Orphan Drug status for peripheral T-cell lymphoma in the European Union.
Approved Drug Molecules and Brand Names for PI3K Inhibitors:
- Piqray (Alpelisib)
- Aliqopa (Copanlisib)
- Copiktra (Duvelisib)
- Zydelig (Idelalisib)
- Vijoice (Alpelisib)
- Fyarro (Sirolimus protein-bound particles for injectable suspension)
- Perjeta (Pertuzumab)
- Intarel (Linperlisib)
- Kisqali (Ribociclib)
- Ibrance (Palbociclib)
- Verzenio (Abemaciclib)
- Afinitor (Everolimus)
Drugs under the Pipeline for PI3K Inhibitors:
- Ganetespib (ADX-1612)
- GSK2636771
- Paxalisib
- MEN1611
- Gedatolisib
- TL117
- IBI376
- IPI-549 (Enganelisib)
- Ribociclib
- HMPL-689
- BYL719
Clinical Activity and Developments of PI3K Inhibitors:
Currently, there are more than 20 drug products in the PI3K inhibitors, including 12 approved drug products and the rest of them are in the clinical development phases.
- In June 2023, Medica Scientia Innovation Research and Roche released updated efficacy data from a phase-II clinical trials in breast cancer for Pertuzumab.
- In March 2023, Novartis completed a phase-III clinical trials in breast cancer for Ribociclib in the USA, Argentina, Australia, Belgium, Brazil, France, Canada, Russia, Spain, Switzerland, and others.
Target Indication Analysis of PI3K Inhibitors
PI3K inhibitors such as Alpelisib, Copanlisib, Duvelisib, Idelalisib, Linperlisib, and others are primarily indicated for the treatment of breast cancer. These drugs are also in clinical trial phases for conditions like non-hodgkin’s lymphoma, hematological malignancies, peripheral T-cell lymphoma, squamous cell cancer, multiple myeloma, cholangiocarcinoma, diffuse large B cell lymphoma, endometrial cancer, mantle-cell lymphoma, solid tumors, and others.
Regional Analysis of PI3K Inhibitors
PI3K Inhibitors Market
Novartis’s Piqray (Alpelisib) had a total sale of US$ 373 million in 2022, which was an increase from the sales of US$ 329 in 2021, and will witness all of its patent expiration by 2029. According to the World Health Organization, breast cancer is the most common cancer occurring in women (22,61,419 patients globally), with the highest number of cancer rates in the USA (253,465 patients), followed by France (58,083), and Australia (19,617 patients). China had the highest number of new cases of leukemia (85,404), followed by the USA (61,252), and India (48,419) in 2020. In the case of multiple myeloma USA (32,119 new cases) was at the top. With the growing burden of cancer cases, the PI3K inhibitors market is also expected to grow.
Latin America
Europe
Asia Pacific
Middle East
North America
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Frequently Asked Questions
Piqray (Alpelisib), Aliqopa (Copanlisib), Copiktra (Duvelisib), Zydelig (Idelalisib), and Vijoice (Alpelisib) are some of the approved PI3K inhibitors.
Novartis, AbbVie, Bayer, Gilead Sciences, Roche, Genentech, Abbott, GSK, and Eli Lilly & Company are some of the major players in the PI3K inhibitors market.
Major indications for PI3K inhibitors are HER2-negative breast cancer, chronic lymphocytic leukemia, follicular lymphoma, marginal zone B-cell lymphoma, angiomyolipoma, and astrocytoma.
There are a total of 11 molecules in the clinical development phases for PI3K inhibitors.
- Novartis AG
- AbbVie
- Bayer
- Gilead Sciences
- Roche
- Genentech
- Abbott
- GSK
- Eli Lilly & Company