Avutometinib and Defactinib API Market

period 2025-2035. The market growth is driven by increasing investment in targeted cancer therapies and the rising prevalence of solid tumors, particularly low-grade serous ovarian cancer and non-small cell lung cancer (NSCLC).

By route of administration, the oral segment dominates due to the convenience, patient compliance, and ongoing clinical trials for both Avutometinib and Defactinib being administered primarily in oral forms. However, intravenous (IV) formulations are being explored in combination therapies and may see increased interest in future research settings.

Innovator companies, particularly those spearheading clinical development, hold a major share of the manufacturer type segment, given the proprietary nature of these compounds. However, Contract Development and Manufacturing Organizations (CDMOs) are emerging as critical partners for scaling up clinical-grade production and enabling broader distribution, especially in regions like Asia-Pacific and Europe.

Among end-users, pharmaceutical and biotechnology companies lead the market owing to their R&D intensity and involvement in clinical trials. Academic & research institutes and Contract Research Organizations (CROs) also play crucial roles in early-phase studies and biomarker-driven research. Hospitals and cancer research centers are pivotal in trial recruitment and translational studies.

The US is the key country in this market, hosting leading clinical trials and being home to regulatory and commercial frontrunners. Notable players include Verastem Oncology (developer of both APIs), BioReliance (Merck KGaA), Lonza, WuXi STA, and Catalent. The market outlook remains promising with opportunities for CDMOs and CROs to support expanding oncology pipelines targeting RAS/RAF-mutated cancers.

Recent Development

• In May 2025, the FDA granted accelerated approval to the combination of avutometinib and defactinib for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy. The combination was evaluated in an open-label, multicenter trial, which included 57 adult patients with measurable KRAS-mutated recurrent LGSOC. The confirmed overall response rate was 44%, with the duration of response ranging from 3.3 months to 31.1 months. Common adverse reactions included increased creatine phosphokinase, nausea, fatigue, and other symptoms.