The report provides a detailed analysis essential for establishing a ticagrelor production plant. It encompasses all critical aspects necessary for ticagrelor production, including the cost of ticagrelor production, ticagrelor plant cost, ticagrelor production costs, and the overall ticagrelor production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a ticagrelor 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.
Ticagrelor is an oral antiplatelet medication that reversibly blocks the P2Y12 receptor on platelets. It prevents ADP-induced aggregation to reduce harmful blood clot formation. It is utilised to lower the risk of cardiovascular death, heart attack (myocardial infarction), and stroke in adults with acute coronary syndrome (ACS).
It is combined with low-dose aspirin and approved for high-risk coronary artery disease (CAD). It is used without prior events of CAD and for acute ischemic stroke or high-risk transient ischemic attack (TIA). Its dosing starts with a 180 mg loading dose followed by 90 mg twice daily for ACS, or 60 mg twice daily for CAD and stroke prevention. Its common side effects include dyspnea, bleeding risks, and bradycardia, requiring caution in patients prone to haemorrhage.
The market for ticagrelor is fuelled by growing cardiovascular disease rates around the globe. The ageing populations, lifestyle risks like obesity and smoking, and survival post-heart events contribute to its demand. Its strong demand in North America and Europe, and fastest expansion in Asia-Pacific, because of better healthcare spending, fuels its market.
Its preference over clopidogrel in cutting heart attacks and strokes, along with new uses in stroke prevention, telemedicine access, and advanced diagnostics, expands its applications. The industrial ticagrelor procurement is affected by high branded pricing pressures, leading to payer negotiations, generic competition post-patent expiry, and bulk hospital and retail tenders. Also, regional reimbursement variations, balanced by reliable supply chains and government CVD initiatives in developing markets impacts its sourcing.
Raw Material for Ticagrelor Production
According to the ticagrelor production plant project report, the key raw materials used in the production of ticagrelor include 4,6-dichloro-5-nitroso-pyrimidine-2-yl propyl sulfide | protected cyclopentyl glycidyl ether | (1R,2S)-2-(3,4-difluorophenyl)cyclopropanamine.
Production Process of Ticagrelor
The extensive ticagrelor production cost report consists of the following major industrial production process:
- From 4,6-dichloro-5-nitroso-pyrimidine-2-yl propyl sulfide: The production process for ticagrelor involves a multi-step method. It starts with protected pyrimidine and cyclopentane intermediates. First, the coupling of the chloropyrimidine precursor to a protected cyclopentyl amino alcohol takes place. This is followed by nitrous acid cyclisation to the triazolopyrimidine core, deprotection and amination to the diol intermediate. The final thioether oxidation to sulfinyl with coupling to difluorophenylcyclopropylamine to give Ticagrelor as the final product.
Ticagrelor is a cyclopentyl triazolopyrimidine antiplatelet with a molecular formula of C23H28F2N6O4S with a molecular weight of 522.57 g/mol. It appears as a white to off-white solid powder, hygroscopic, with specific rotation [α]/D -55 to -65 degree. It has a pKa value of 13.3 with moderate solubility in methanol but low solubility in water. It features a complex structure with a triazolopyrimidine core, difluorophenylcyclopropylamino substituent, propylsulfanyl group, and cyclopentanediol-hydroxyethoxy side chain. It has high plasma protein binding, CYP3A4 metabolism, and oral bioavailability. All these physical and chemical properties make it useful as an oral antiplatelet medication.