The report provides a detailed analysis essential for establishing a pazopanib production plant. It encompasses all critical aspects necessary for pazopanib production, including the cost of pazopanib production, pazopanib plant cost, pazopanib production costs, and the overall pazopanib production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a pazopanib 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.
Pazopanib is an oral multitargeted tyrosine kinase inhibitor (TKI). It selectively stops vascular endothelial growth factor receptors, platelet-derived growth factor receptors (PDGFR-α and -β), and c-Kit. This disrupts tumour angiogenesis, cell proliferation, and metastasis signalling pathways in cancer cells. It is FDA-approved for advanced renal cell carcinoma (RCC) in treatment-naïve adults or those previously treated with cytokines. It is administered continuously at 800 mg once daily without food, with dose reductions for toxicity. Its applications target hypervascular tumours where angiogenesis inhibition provides clinical benefit. It is also used for ovarian cancer, thyroid cancer, and desmoid tumours.
The market for pazopanib is driven by increasing global cases of renal cell carcinoma and soft tissue sarcoma. The rise in the ageing population and improved diagnostics in emerging regions like the Asia-Pacific contribute to its market growth. The demand for affordable TKI options in second and later line therapies boosts accessible volumes. The industrial pazopanib procurement is affected by generic price drops post-patent expiry, favouring low-bid tenders and divergent reimbursement in the North American and European regions. The strict production rules for the key ingredient and health agencies' studies, compared to newer immune drugs, impact its market dynamics. Other factors, like hospital decisions for their approved lists and steady supply chains, further impact its sourcing strategies.
Raw Material for Pazopanib Production
According to the pazopanib production plant project report, the key raw materials used in the production of pazopanib include 2,4-dichloropyrimidine | 2,3-dimethyl-2H-indazol-6-amine | 5-amino-2-methyl-N-(methylsulfonyl)benzenesulfonamide.
Production Process of Pazopanib
The extensive pazopanib production cost report consists of the following major industrial production process:
- By nucleophilic aromatic substitution: The production process of pazopanib starts with 2,4-dichloropyrimidine. This goes through nucleophilic aromatic substitution with 2,3-dimethyl-2H-indazol-6-amine to form N-(2-chloropyrimidin-4-yl)-2,3-dimethyl-2H-indazol-6-amine. This is followed by selective displacement of the 2-chloro group with 5-(3-(methyl(methylsulfonamido)phenyl)ureido)aniline or direct coupling with the sulfonamide aniline derivative. The reaction mixture is quenched with water, extracted with dichloromethane and isopropyl alcohol, purified, filtered, and dried to get pazopanib as a free base.
Pazopanib is a small-molecule tyrosine kinase inhibitor with the molecular formula C21H23N7O2S and a molecular weight of around 437.5 g/mol. It appears as a solid with a high melting point above 255 degree Celsius (decomposition). It shows solubility in methanol and aqueous acid solutions, which supports its formulation into 200 mg, 400 mg, or 800 mg oral tablets for cancer treatments. It features an indazolylpyrimidine core with sulfonamide and dimethylamide groups, contributing to its multitargeted inhibition profile. Its hydrochloride salt form is commonly used clinically, with low aqueous solubility at neutral pH but good bioavailability after oral dosing.
