The mitogen activated protein kinase (MAPK) pathway has a vital role in the regulation of diverse cellular activities including cell proliferation, survival, differentiation, and motility. Studies have revealed that aberrant signaling of MAPK pathway is common in cancer, leading to dysregulation of cell proliferation and signaling. Further analyses have revealed that several differentiation mutations involving BRAF or NRAS exert a oncogenic effect by activating the MAPK pathway, resulting in an increase in cellular proliferation. Therefore, researchers have put in continuous efforts for the development of MEK inhibitors which have the ability to inhibit growth and induce cell death in these cells.
Mekinist (Trametinib) developed by GlaxoSmithKline was the first MEK inhibitor approved by regulatory bodies in 2014. The drug in combination with Tafinlar (dabrafenib) is indicated for the treatment of patients with unresectable/metastatic melanoma with BRAF V600E or V600K mutations. Apart fom this, the drug is also used in treatment of anaplastic thyroid cancer and non-small cell lung cancer. The rapid approval of the first MEK inhibitor and its robust response in the market has further led to entry of three MEK inhibitors in the market.
Recently in 2020, US FDA has approved novel MEK 1/2 inhibitor Koselugo indicated solely for the treatment of Neurofibromatosis type 1 (NF-1) in a limited age group. However, several clinical trials are evaluating the role of the drug in the management of various cancers including thyroid, breast, pancreatic, colorectal, or non-small cell lung cancer. It is expected that the drug will gain extended approval in other therapeutic conditions in coming years, which will further propel the growth of market. In addition to this, researchers are also evaluating combinational therapies involving MEK inhibitors along with other cancer targeting regimens, to enhance their efficacy and specificity towards targeted cell.
However, high cost of development coupled with threat of drug resistance is expected to somewhat effect the growth of market. Conversely, high potential of emerging economies and higher number of potential drugs in pipeline is expected to provide new opportunities to market players in future. The increased research activities by pharmaceutical companies have led to the development of robust pipeline of MEK inhibitor drugs which is expected to enter the market during the forecast period. The potential candidates in the developmental pipeline are NFX-179, CS3006, HL085, Pimacertib and Mirdametinib. These drugs have shown encouraging response in clinical trials as monotherapy as well as combinational therapy and are mostly present in phase-I/II clinical trials.
The global MEK inhibitor market was valued to be around US$ XX Million in 2020 which is growing at high CAGR rates. In coming years, the global market will witness increase in prevalence of cancer attributing to several factors including rising geriatric population, smoking, drinking, physical inactivity and poor diet. This will increase the demand of targeted therapies, thus increasing the demand of MEK inhibitors in the market. In addition, rising initiatives by government and pharmaceutical companies will also boost the growth of market for forthcoming years.