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

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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)

Product Name

Total Studies

Vistusertib (AZD2014)


Dactolisib (RTB101)


Gedatolisib (PF-05212384)


Samotolisib (LY3023414)


Paxalisib (GDC-0084)


Voxtalisib (SAR245409)


Bimiralisib (PQR309)


Niclosamide topical (ATx 201)


















Niclosamide (FW-1022)


Omipalisib (GSK2126458)






Target Indication Analysis of mTOR

mTOR inhibitors are a class of drugs that target the mechanistic target of the rapamycin (mTOR) pathway, which plays a crucial role in regulating cell growth, metabolism, and survival. These drugs have shown promise in various indications, including cancer, autoimmune diseases, and neurological disorders. By inhibiting mTOR signaling, these drugs can impede the abnormal proliferation and survival of cancer cells, suppress immune responses in autoimmune diseases, and modulate neuronal activity in neurological disorders. Additionally, mTOR inhibitors have been investigated for their potential anti-aging effects and as therapeutic options for metabolic disorders. Their ability to target the mTOR pathway makes them an attractive treatment option for a wide range of diseases.

Frequently Asked Questions

mTOR drugs are used in the management of cancer, autoimmune diseases, and neurological disorders.

The market is primarily driven by factors such as the rising incidence of cancer and the increasing prevalence of autoimmune diseases and neurological disorders. Additionally, the growing aging population, advancements in precision medicine, and the availability of favorable reimbursement policies further contribute to market growth.

The major players in this space are First Wave Bio, Bayer, GSK, Avalo Therap, Novartis, BMS, Diffusion Pharma, Zhejiang DTRM Biopharma, HEC Pharm, Kazia, Santen, Sanofi, PIQUR, UNION Therap, Palvella Therapeutics, Ability Pharma, CNIO, REVA Medical, Nobelpharma, Selecta, Daewoong Pharma, MEI, SignalRx, Navitor Pharma, and Emtora Biosci.

Despite favorable market conditions, the mTOR drug market faces certain restraints. One major challenge is the high cost of mTOR inhibitors, which can limit access for patients and strain healthcare budgets. Additionally, the potential side effects and toxicity associated with mTOR inhibitors pose concerns for both patients and healthcare providers, requiring careful monitoring and management during treatment.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
  • Kazia
  • Abbott
  • Pfizer
  • Medtronic
  • Santen
  • Sanofi
  • UNION Therap
  • Palvella Therapeutics
  • Ability Pharma
  • CNIO
  • REVA Medical
  • Nobelpharma
  • Selecta
  • Daewoong Pharma
  • MEI
  • SignalRx
  • Navitor Pharma
  • Emtora Biosci
  • First Wave Bio
  • Bayer
  • GSK
  • Avalo Therap
  • Novartis
  • BMS
  • Diffusion Pharma
  • Zhejiang DTRM Biopharma
  • HEC Pharm
  • Verastem
  • UNION Therap
  • Incuron
  • CSPC Pharma
  • Daiichi Sankyo
  • Imuneks
  • Microbio
  • VetDC
  • Jiatan
  • SoVarGen
  • Piramal Phytocare
  • Memorial Sloan-Kettering Cancer Center
  • Sanofi
  • Santen
  • Tavanta Therap
  • HebaBiz Biotech

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