Mirabegron (Myrbetriq) Manufacturing Plant Project Report 2024

The report is the result of extensive primary and secondary research, offering a detailed analysis of current market trends, including the effects of COVID-19 on both global and regional scales. It profiles key industry players, giving insights into their market strategies, production capacities, and financial performance, which are crucial for benchmarking and competitive analysis.

It delves into historical, current, and forecasted price trends, helping stakeholders understand market dynamics and price volatility. The report provides a thorough analysis of the mass balance and raw materials requirements, ensuring a clear understanding of the input-output ratios essential for efficient production. Detailed examinations of the various unit operations integral to the mirabegron (myrbetriq) manufacturing process are included, highlighting process optimisation techniques and technological advancements.

The report presents a comprehensive capital cost analysis, detailing the financial investment required for setting up a mirabegron (myrbetriq) plant. This includes an exhaustive breakdown of costs associated with raw materials, catchem, utilities, labour, packaging, transportation, land acquisition, construction, and machinery. Additionally, it offers an in-depth look at the operating costs, providing clarity on the recurring expenses involved in running the plant.

Projected profit margins and optimal product pricing strategies are outlined, offering guidance on maximising profitability. The report also addresses regulatory frameworks, environmental impacts, and sustainability measures pertinent to the mirabegron (myrbetriq) industry.

About Mirabegron (Myrbetriq)

Mirabegron (myrbetriq) is a monocarboxylic acid amide which is used to provide relief from the overactive bladder condition. It belongs to the family of 1,3-thiazoles, an aromatic amide, and can reduce the tension in the smooth muscles of the bladder to provide better control over urinary incontinence. This medication was approved by the FDA in 2012 under the brand name Myrbetriq, and in March 2021, an extended-release granule formulation was approved for the treatment of paediatric patients who suffer from neurogenic detrusor overactivity.

Properties of Mirabegron (Myrbetriq)

Mirabegron (myrbetriq) possesses a molar mass of 396.51 g/mol and a melting point of 138-140°C. Its colour ranges from white to off-white form and it is also insoluble in water. This medication is generally available in the dosage forms of 25 mg and 80 mg extended-release oral tablets and 8 mg/mL extended-release oral suspension. It is also recommended to be stored at a temperature between 68 F to 77 F to maintain its integral properties.

Manufacturing Process of Mirabegron (Myrbetriq)

The production process of mirabegron (myrbetriq) comprises four primary steps. Firstly, an amino protective agent is used to treat 2-aminothiazole-5-acetic acid, for the formation of intermediate product A. Secondly, intermediate product A is combined with 4-amino phenethyl alcohol in the condensation reaction to produce intermediate product B. This is followed by the oxidation reaction in which intermediate product B undergoes oxidation for the formation of intermediate product C. Lastly, this intermediate product C is made to react with (R)-2-amino-1-phenethyl alcohol, followed by the removal of the protecting group, to obtain mirabegron.

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Synthesis of Mirabegron (Myrbetriq)

The chemical synthesis of Mirabegron is described in steps below:

Step 1: Starting Material Preparation

The synthesis of Mirabegron starts with the preparation of the starting compound, 2-(2-aminothiazol-4-yl) acetic acid.

Step 2: Formation of Acyl Chloride

This compound is first converted into its acyl chloride form using thionyl chloride.

Reaction: C4H6N2O2S + SOCl2 -> C4H5N2O2S-Cl + SO2 + HCl

Step 3: Coupling with Amine

The acyl chloride is then reacted with a tertiary amine to form mirabegron.

Reaction: C4H5N2O2S-Cl + C19H32N2O3 -> C23H29N3O4S + HCl

Step 4: Purification

The product is purified using techniques such as recrystallisation or chromatography to achieve the desired purity.

Step 5: Final Product

The final product, Mirabegron, is obtained as a solid which can be formulated into tablets or other dosage forms suitable for clinical use.

Each step involves careful control of reaction conditions like temperature, pH, and the use of catalysts to optimise yield and purity.

Applications and Drivers of Mirabegron (Myrbetriq)

Mirabegron (Myrbetriq) is primarily used for the treatment of overactive bladder, in which a person gets an urge to urinate frequently, causing discomfort in day-to-day life. This medication relaxes the bladder muscles to increase the capacity of the bladder as well as avoid frequent urination episodes. Moreover, its rising demand is due to its growing preference over antimuscarinic agents that often come with side effects  such as constipation and palpitations, among others. The rising awareness regarding the overactive bladder condition and people’s willingness to seek medical advice further contribute to its growth.

Key Features of the Mirabegron (Myrbetriq) Production Cost Report:

This production cost analysis report by Expert Market Research scrutinises the mirabegron (myrbetriq) manufacturing process, offering a comprehensive overview necessary for stakeholders considering venturing into this sector. Based on the latest economic data, the report encompasses detailed insights into the primary process flow, raw material requirements, reactions involved, utility costs, operating costs, capital investments, pricing strategies, and profit margins. This report is an indispensable resource for entrepreneurs, investors, researchers, consultants, business strategists, and all those who have any kind of stake in the mirabegron (myrbetriq) industry. It equips them with essential information and strategic insights to effectively navigate the complexities of the market.

The following sections detail the comprehensive scope of the prefeasibility report for a mirabegron (myrbetriq) production plant:

• Market Dynamics and Trends: This section analyses the prevailing market conditions, growth drivers, and trends impacting the mirabegron (myrbetriq) industry. It offers a thorough examination of demand fluctuations and projections.

• Impact of COVID-19: An assessment of how the pandemic has affected industry operations, supply chains, and overall market dynamics.

• Geographic Analysis: Detailed insights into the major regions active in mirabegron (myrbetriq)production and consumption, highlighting regional market specifics and growth potential.

• Key Industry Players: Profiles of leading manufacturers in the mirabegron (myrbetriq) sector, outlining their market share, strategic positions, and operational strengths.

• Price Fluctuations: Analysis of historical, current, and projected price trends, providing stakeholders with essential pricing intelligence.

• Technical Specifications and Process Description: A detailed overview of the mirabegron (myrbetriq) production process including the technology used and innovations within the industry.

• Raw Material Requirements and Sourcing: Evaluation of necessary raw materials, their sourcing strategies, and cost implications.

• Utility Requirements and Costs: Detailed analysis of utilities needed to produce mirabegron (myrbetriq), such as electricity, steam, and process water along with their cost assessments. 

• Labour Force Dynamics: Insights into manpower requirements, including skill specifications and labour cost projections.

• Packaging Needs: Overview of packaging requirements for mirabegron (myrbetriq) to ensure product integrity and cost efficiency.

• Logistics and Transportation: Examination of transportation needs and logistics planning for distribution and supply chain efficiency.

• Capital and Operating Costs: An in-depth look at investment requirements, including land and its development costs, civil work costs, construction, machinery procurement, and ongoing operational expenses, such as salaries and wages, plant overheads, tax and insurance as well as packaging, transportation, and administration costs.

• Financial Performance and Profitability Analysis: Projected profit margins and return on investment based on current market and operational parameters.

• Product Pricing Strategy: Recommendations on pricing mechanisms based on industry benchmarks and production costs.

• Environmental Impact and Regulatory Compliance: Analysis of environmental considerations and compliance with local and international regulations.

• Risk Assessment and Mitigation Strategies: Identification of potential risks associated with mirabegron (myrbetriq) production and strategies to mitigate them.

Key Questions Addressed:

• What are the detailed unit operations for mirabegron (myrbetriq) production?

• Who are major technology licensors with their process evaluation?

• How are raw materials or catchem procured and what are their cost implications?

• What utilities are essential for production and what will they cost?

• What are the labour requirements and how does this affect operational costs?

• What packaging solutions are optimal for cost and efficiency?

• What logistical arrangements are necessary for efficient product distribution?

• What are the estimated land and construction costs for a new mirabegron (myrbetriq) plant?

• How can profitability be maximised in the mirabegron (myrbetriq) market?

• What pricing strategy should be adopted for mirabegron (myrbetriq) to remain competitive?