mTOR Market: Competitive Landscape, Pipeline, and Market Analysis 2022

mTOR, or mammalian target of rapamycin, is a protein kinase that plays a crucial role in regulating cellular processes such as growth, metabolism, and survival. It acts as a central hub in signaling pathways, integrating various signals from growth factors, nutrients, and energy levels. The mechanism of action of mTOR involves the activation of downstream targets involved in protein synthesis, cell cycle progression, and autophagy. Dysregulation of mTOR signaling has been implicated in numerous diseases, leading to the development of mTOR inhibitors for therapeutic purposes. These inhibitors are utilized in the treatment of various indications, including cancer, neurodegenerative disorders, metabolic diseases, and certain renal and pulmonary conditions. According to the World Health Organization (WHO), cancer is a significant health concern in both Europe and the USA, in Europe, there are an estimated 3.9 million new cases of cancer annually, leading to 1.9 million deaths. The USA also experiences a high burden of cancer, with approximately 1.8 million new cases and 600,000 deaths each year, according to the Centers for Disease Control and Prevention (CDC). Furthermore, neurodegenerative disorders such as Alzheimer's and Parkinson's disease affect a substantial portion of the population in both regions. In Europe, over 10 million people suffer from Alzheimer's disease, while in the USA, Parkinson's disease affects approximately one million individuals, as reported by Alzheimer Europe and the Parkinson's Foundation, respectively.

The growth drivers of the mTOR market can be attributed to several factors. Firstly, the increasing prevalence of cancer and neurodegenerative disorders worldwide creates a significant demand for effective treatments, driving the adoption of mTOR inhibitors. Secondly, advancements in precision medicine and personalized therapies have led to the development of targeted approaches, where mTOR inhibitors play a vital role. Companies such as Abbott, Pfizer, Medtronic Bayer, GSK, Avalo Therap, Novartis, BMS, Kazia, Santen, Sanofi, and PIQUR cater to this category. Moreover, many companies are coming up with new molecules in this space. For instance, GSK is one such company that is currently conducting a clinical trial of the drug Omipalisib (GSK2126458) for the treatment of idiopathic pulmonary fibrosis.

Key Developments:
In May 2022, Medinol completed a phase III trial OF Ridaforolimus in Coronary artery restenosis in Japan.

In April 2023, Celcuity presented pharmacodynamics data of Gedatolisib from a preclinical study in Cancer at the 114th Annual Meeting of the American Association for Cancer Research (AACR-2023)

Approved mTOR molecules

• Everolimus
• Sirolimus
• Xience (everolimus-eluting stent)
• Torisel (temsirolimus)
• Resolute ZES (zotarolimus-eluting stent)
• Taltorvic (ridaforolimus)
• Absorb (everolimus-eluting bioresorbable vascular scaffold)
• Niclosamide
• Opsiria (sirolimus)
• QTORIN 3.9% (rapamycin topical)
• Fantom (sirolimus-eluting bioresorbable scaffold)

mTOR Pipeline Molecules

• Vistusertib (AZD2014)
• Dactolisib (RTB101)
• Gedatolisib (PF-05212384)
• Samotolisib (LY3023414)
• Paxalisib (GDC-0084)
• Voxtalisib (SAR245409)
• Bimiralisib (PQR309)
• Niclosamide topical (ATx 201)
• ABTL0812
• AZD8055
• ETP-47187
• PF-04691502
• SEL-110
• ME-344
• SF1126
• SPN-820
• Niclosamide (FW-1022)
• Omipalisib (GSK2126458)
• AVTX-006
• BGT226
• CC-115
• DFN-529
• DTRM-555
• HEC68498
• VS-5584
• Niclosamide nasal spray (UNI91103)
• Quinacrine (CBL0102)
• CLL442
• DS-3078
• DS-7423
• OB318
• VCD-597
• WXFL10030390
• Everolimus (SVG101)
• Niclosamide inhalation (UNI91104)
• Panulisib (P7170)
• Salirasib (KD 032)
• Sirolimus (STN1010904)
• Sirolimus (TAVT-18)
• Siroquine (JP001)

Clinical Activity and Development of mTOR

In the mTOR space, more than 30 companies are conducting more than 800 clinical trials in this category of drugs. For instance,

• In April 2021, Medtronic completed the Onyx ONE Clear clinical trial of Zotarolimus for Coronary artery restenosis in the USA and Japan
• In March 2023, AstraZeneca presented efficacy and adverse events data from a phase II/III trial of Vistusertib in meningioma at the 57th annual meeting of the American Society of Clinical Oncology (ASCO-2021)