TIM3 Inhibitors Drug Clinical Trials & Market Opportunity Insight 2028 Report Highlights:

  • Insight on Emerging TIM3 Inhibitors in Development As Monotherapy & combination Therapy
  • Future Market Opportunity Insight From First Drug Approval: 2024 - 2028
  • Insight On TIM3 Inhibitors Drug In clinical Trials: > 15 Drugs
  • TIM3 Inhibitors Drug In Clinical Trials Insight By Country, Company, Indication
  • Comprehensive Clinical Insight On Biomarker Identified During Clinical Trials
  • TIM3 Targeted Therapy Application By Various Cancers


Cancer immunotherapy is novel approach which harnesses the potential of immune system to target tumor cells. Subsequently, the entrance of immune checkpoint including cytotoxic T-lymphocyte antigen 4 (CTLA-4) and programmed cell death-1 (PD-1) and its ligand (PD-L1) have shown huge potential in the treatment of cancer. However, despite these promising long-term responses, the majority of patients failed to respond to immune checkpoint blockade, demonstrating primary resistance. Additionally, many of these patients who initially respond to treatment eventually experience relapse secondary to acquired resistance. Recent studies have identified several new immune checkpoint targets, like lymphocyte activation gene-3 (LAG-3), T cell immunoglobulin and mucin-domain containing-3 (TIM-3), T cell immunoglobulin and ITIM domain (TIGIT), V-domain Ig suppressor of T cell activation (VISTA), and so on.

More recently TIM3 has emerged as potential immune checkpoint inhibitor in the management of cancer. TIM-3 is regulatory of both innate and adaptive immune response and is expressed on multiple tumor types including effector T cells, monocytes, natural killer cells, and dendritic cells. Apart from this, TIM-3 has been shown to promote immune tolerance, and overexpression of TIM-3 is associated with more advanced stage and poor prognosis of disease. Owing to this, pharmaceutical companies have designed novel TIM-3 inhibitors across wide range of cancers.

The promising preclinical data has encouraged pharmaceutical companies to develop clinical pipeline of monoclonal antibodies targeting TIM-3 as an alternate to target cancers. Currently, several anti-TIM-3 monoclonal antibodies have been developed which have shown encouraging response in clinical trials. However, studies have supported the fact that combined blockade of PD-1 and TIM-3 pathways synergistically improved the CD8 T cell response and viral control. The advancement in the field of biotechnology and their encouraging response in combination therapy have led to development of bispecific antibodies. Currently, only a few bispecific antibodies have been developed, however with the advancement in the field of genetic engineering, it is expected that bispecific antibodies will emerge as shining star in TIM-3 therapy owing to several benefits associated with them.

The pipeline for novel TIM-3 inhibitors is highly concentrated and is expected to flourish in market during the forthcoming years. Cobolimab developed by Tesaro Therapeutics is one of the advanced stage TIM-3 inhibitors which are currently being evaluated in phase-II clinical trial. Recent data has shown that anti–TIM-3 antibody cobolimab is well-tolerated as monotherapy and in combination with the PD-1 inhibitor dostarlimab. Based on this encouraging data, company is translating the drug into late stage clinical trials for the management of solid tumors. Apart from this, several others drugs are under development including MBG453, Sym-023, BMS-986258, AZD7789, INCAGN02390, and others which are also present in initial stages of clinical development.

US is currently dominating the global market development for TIM3 Drugs driven by large number of ongoing clinical trials and presence of pharmaceutical companies which actively invest in this segment. Apart from this, US FDA also grants several special designations to expedite the drug development and approval process. For instance in 2021, US FDA granted fast track designation for sabatolimab (MBG453) for the treatment of adult patients with myelodysplastic syndromes (MDS) in combination with hypomethylating agents.

The global TIM-3 inhibitor market is expected to surpass US$ 1 Billion by 2028 driven by first drug approval expected to be launch by 2024. Surge in prevalence of cancer across geographies, high demand for targeted therapeutics for cancer management, development of favorable reimbursement policies, and rise in awareness of TIM-3 immune checkpoint inhibitors for the management of cancer due to positive results in combination therapy are the major factors boosting the growth of market. In addition, surge in geriatric population and increase in technological advancements in screening and diagnosing cancer will supplement the market growth during the forecast period.