The report provides a detailed analysis essential for establishing an axitinib production plant. It encompasses all critical aspects necessary for axitinib production, including the cost of axitinib production, axitinib plant cost, axitinib production costs, and the overall axitinib production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating an axitinib production plant. These encompass production processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.
Axitinib is an anticancer medicine that is mainly used in the treatment of advanced kidney cancer. It is primarily utilised in the treatment of advanced renal cell carcinoma, which is a type of kidney cancer. It works by blocking certain proteins called tyrosine kinases that help tumours form new blood vessels, thereby slowing down cancer growth. It finds its main application in patients whose cancer has progressed after prior treatment. In addition to kidney cancer, it may also be studied or used in combination with other therapies for the treatment of different types of solid tumours, under medical guidance. Moreover, it is often prescribed either alone or in combination with other immunotherapy medicines to improve treatment response after one prior treatment fails. Additionally, it is used in oncology research and clinical practice to support personalised cancer treatment plans, especially in cases where controlling tumour progression is the primary goal.
The demand for axitinib is primarily driven by its application as a targeted anticancer medicine for the treatment of advanced kidney cancer (renal cell carcinoma), which fuels its market expansion. Its application as an oral anticancer drug in the treatment of advanced renal cell carcinoma after one prior treatment fails significantly boosts its demand in the pharmaceutical industry. Its application for first-line therapy in advanced cases and its potential in clinical studies for pancreatic and thyroid cancers also drives its demand in the medical research and healthcare industries. In addition, expanding research activities and clinical trials exploring its role in the treatment of other solid tumours also boost its market demand. Moreover, industrial axitinib procurement is influenced by factors such as the cost and availability of active pharmaceutical ingredients, strict regulatory approvals, patent considerations, quality standards, and supply chain stability. Technological progress in drug production, partnerships between pharmaceutical companies, and reliable distribution networks also play an important role in shaping the global market for axitinib.
Raw Material for Axitinib Production
According to the axitinib production plant project report, the major raw materials for axitinib production include an aryl iodide and thiophenol.
Production Process of Axitinib
The extensive axitinib production cost report consists of the following industrial production process:
- Production via Migita Coupling: The production process of axitinib begins with a Migita coupling reaction between a commercially available iodide and thiophenol to form a major thioether linkage. The resulting indazole intermediate is then directly iodinated, without isolation, to produce a diarylthioether compound. Then, the indazole group is temporarily protected as an acetamide to enable a Heck coupling reaction with 2-vinylpyridine to form the core carbon–carbon bond required in the final structure. After the coupling step, the protecting group is removed, and the product is purified through repeated recrystallisation to obtain axitinib as the active final product.
Axitinib is a small-molecule tyrosine kinase inhibitor that selectively targets vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, and VEGFR-3). It appears as a white to light yellow, non-hygroscopic powder. The molecular formula of the compound is C22H18N4OS, and its molar mass is 386.47 g/mol. Its density is approximately 1.35 g/cm³, and it is very poorly soluble in water but soluble in DMSO. Additionally, the boiling point of the compound is approximately 668.9 degrees Celsius at 760 mmHg and its flash point is around 358.3 degrees Celsius. The compound has a pKa value of 4.8, which classifies it as a weak base, and its aqueous solubility decreases across the pH range of 1.1 to 7.8. It has a melting point in the range of 213-215 degrees Celsius. The compound is classified as hazardous and should be handled with appropriate protective equipment in a well-ventilated area. Improper handling of this substance may pose serious health risks, and its known adverse effects in therapeutic use include hypertension, fatigue, diarrhoea, and potential cardiac complications.