MEK Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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Mitogen-activated protein kinases are a family of enzymes that has an important role in regulating the physiological processes in mammalian cells and tissues. These play a significant role in signal transduction by modulating gene transcription in the nucleus in response to the changes in the cellular environment. Mitogen is a substance- protein or peptide or anything else that induces mitosis in a cell or enhances the rate of mitosis like Glucose, Glycerol, Cytokinins etc. There are 11 members of the MEK superfamily. Various MEK isoforms are present that are specific to their substrates. These link extracellular signals to the intracellular signals that regulate growth, apoptosis, migration and proliferation, cell cycle progression, metabolism, cell adhesion, motility and more. MEKs have been seen to be associated with the pathogenesis of various types of cancers i.e. Prostate cancer, Colon cancer, Lung cancer and more. These have also been associated with the pathogenesis of various neurodegenerative disorders like Alzheimer’s disease, Parkinson’s disease, Amyotrophic lateral sclerosis (ALS) and others. Therefore, inhibiting it might be an approach to slowing down the progression of these diseases. Research is being conducted globally to discover new and novel molecules to be used as anti-IL-23 agents. The development and launch of new products will thus increase the revenue of the market in the forecasted years. For instance, according to the American Cancer Society, there are on average 2000 – 4500 newly diagnosed lung carcinoid tumors in the USA wherein lung carcinoid cancers account for about 1% to 2% of all carcinoid cancers.

A number of these inhibitors are in the market while many are in ongoing clinical trials. 51 companies have various products in their pipelines with 322 products in various stages of clinical trials. 3 products are in Phase 4, 3 in Phase 3, 16 in Phase 2 and 11 in Phase 1 of the clinical trials.

Key Developments of MEK Inhibitors

In March 2023, the FDA approved Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatrics 1 year or older to treat Low-grade glioma with a BRAF V6OOE mutation.
In September 2018, the EU approved Tafinlar (dabrafenib) with Mekinist (trametinib) as an adjuvant treatment for various melanoma patients.
In September 2018, the EU approved Braftovi (encorafenib) and Mektovi (binimetinib) in combination for patients with Advanced BRAF-mutated melanoma.
In June 2018, the FDA approved Braftovi (encorafenib) and Mektovi (binimetinib) in combination for patients with unresectable or metastatic melanoma with a BRAF-V6OOE or V6OOK mutation.

Approved molecules of MEK Inhibitors

Mekinist (Trametinib)
Mektovi (Binimetinib)
Zepsun (Donafenib)

Drugs In The Pipeline Of MEK Inhibitors

Koselugo (Selumetinib)
Cotellic (Cobimetinib)
Avutometinib (VS-6766)
Pimasertib (AS703026)
Mirdametinib (PD-0325901)
Refametinib (BAY86-9766)
Hocena (Antroquinonol)
Tunlametinib (HL-085)
E6201
SHR7390
FCN-159
LNP3794
NFX-179
REC-4881
Zapnometinib (ATR-002)
CI-1040
CS3006
GDC-0623
TQ-B3234
WX-554
ABM-168
ARRY-300
AZD8330
BI 847325
CH4987655
IMM-1-104
MG-D-1509
MSC2015103B
PF-07799544
Trametinib Repurposed (SNR1611)

Clinical Activity and Developments of MEK Inhibitors

As of June 2023, various companies have approximately 51 MEK for 322 diseases. For these diseases, many trials are being conducted by players globally. For instance,

AstraZeneca is conducting a Phase 3 clinical trial to assess the safety and efficacy of Selumetinib in combination with Docetaxel in patients receiving 2^nd line treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) positive non-small cell lung cancer that is expected to complete by December 2023.
AstraZeneca is conducting a Phase 3 clinical trial to assess the efficacy and safety of Selumetinib in adult patients with NF1 who have symptomatic, inoperable, Plexiform Neurofibromas that is expected to complete by May 2025.
In March 2022, Assistance Publique completed a Phase 3 trial to assess the treatment of Cobimetinib for BRAF-wild-type or Mutated Histocytoses.

Molecule name	Number of studies
Mekinist (trametinib)	282
Mektovi (binimetinib)	131
Zepsun (donafenib)	48
Koselugo (selumetinib)	137
Cotellic (cobimetinib)	116

Target Indication Analysis of MEK Inhibitors

MEK inhibitors are advanced anti-cancer medications that selectively target the MAPK pathway. These drugs, such as Mekinist (trametinib), Mektovi (binimetinib), and Zepsun (donafenib), have been approved for the treatment of BRAS and NRAS-Mutant melanoma cell lines. However, their potential extends far beyond that. They are currently undergoing pre-clinical and clinical trials for a wide range of indications, including various types of carcinoid tumors like lung carcinoid tumors, sarcomas, respiratory tract diseases and neoplasms, lung neoplasms, nevus pigmented, adenocarcinoma and more. The clinical trials have shown promising results, and many regulatory agencies have granted approval for various indications globally.

MEK Inhibitors Regional Analysis

MEK Inhibitors Market

Novartis’s Tafinlar (dabrafenib) with Mekinist (trametinib) combination had net sales of $1770 million in the financial year 2022 which was 5% higher than the net sales in the financial year 2021. It has net sales of $465 million in the 4^th quarter of 2022 which was 2% higher than the net sales in the 4^th quarter of 2021. Pfizer’s Mektovi (binimetinib) had net sales of $176 million in the financial year 2022 which was 14% higher than the last year’s net sales globally. Out of $176 million in sales in 2022, $175 million in sales was from the USA itself. The drugs are prescribed in combination regimens driving the sales of all the drugs given together to the patient. According to the Alzheimer’s Association, in 2023 more than 6 million Americans are living with Alzheimer’s disease and about 1 in 9 people age 65 and above have Alzheimer’s. It is projected that by 2050, the number would grow to 12.7 million patients. Therefore, there is an opportunity for the market players to generate revenues by launching new treatment drugs and regimens.

Latin America

Europe

Asia Pacific

Middle East

North America

Frequently Asked Questions

Mekinist (trametinib), Mektovi (binimetinib) and Zepsun (donafenib) are approved by various regulatory agencies.

These are being used in the treatment of BRAS and NRAS-Mutant melanoma cell lines. These are in the clinical trials for various other indications like Carcinoid tumors, Nevus pigmented, Adenocarcinoma and others

Novartis (Switzerland), Merck (MSD) (USA), AstraZeneca Inc. (USA), Ono Pharmaceutical Co., Ltd (Japan) and Pierre Fabre (France) are some of the major market players for MEK Inhibitors.

Rising incidence of diseases improvement in technologies, development of new treatment lines in the market and changing lifestyles leading to various kinds of cancers and neurodegenerative disorders are the key opportunities for MEK Inhibitors in the market.

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