A generic drug is a pharmaceutical product that can be interchanged with the innovator product and is comparable with it in terms of dosage, intended use and efficacy. Generic drugs are manufactured without a licence from the innovator company and are usually marketed after the patent expiry of the innovator drug. The approval process of a generic drug is less time consuming and involves significantly lower costs compared to their branded counterparts. Manufacturers of generic drugs do not require to spend significantly in research and development enabling them to price their products significantly lower than their branded counterparts.
Generics today represent a multibillion dollar industry. One of their biggest drivers is an increasing global pharmaceutical spending trend towards generics. Continuously increasing healthcare expenditures have pushed governments and third-party payers to seek ways to control their healthcare expenditures. This is catalyzing an increasing demand for generics versus their branded counterparts. Another major driver of this industry is the continued patent cliff that is providing growing pipelines opportunities for generic firms. Similarly, a growth in the overall global population and aging demographics is also proving to be beneficial for the overall healthcare sector including generic drug manufacturers. Healthcare reforms in the US and other developed markets coupled with strong growth in emerging market are some other important drivers for the industry.
IMARC’s latest study “Generic Drug Manufacturing Plant Project Report: Industry Trends, Manufacturing Process, Machinery, Raw Materials, Cost and Revenue” provides a techno-commercial roadmap for setting up a generic drug manufacturing plant. The study, which has been done by one of the world’s leading research and advisory firms, covers all the requisite aspects of the generic drug manufacturing plant. This ranges from macro overview of the market to micro details of the industry performance, manufacturing requirements, project cost, project funding, project economics, expected returns on investment, profit margins, etc. This report is a must-read for entrepreneurs, investors, researchers, consultants, business strategists, and all those who are planning to foray into the generic drug industry in any manner.
Key Questions Answered in This Report?
• What are the key success and risk factors in the generic industry?
• How has the generic market performed so far and how will it perform in the coming years?
• What is the structure of the generic industry and who are the key players?
• What are the various unit operations involved in a generic drug manufacturing plant?
• What is the total size of land required for setting up a generic drug manufacturing plant?
• What are the machinery requirements for setting up a generic drug manufacturing plant?
• What are the raw material requirements for setting up a generic drug manufacturing plant?
• What are the utility requirements for setting up a generic drug manufacturing plant?
• What are the manpower requirements for setting up a generic drug manufacturing plant?
• What are the infrastructure costs for setting up a generic drug manufacturing plant?
• What are the capital costs for setting up a generic drug manufacturing plant?
• What are the operating costs for setting up a generic drug manufacturing plant?
• What should be the pricing mechanism of generic drugs?
• What will be the income and expenditures for a generic drug manufacturing plant?
• What is the time required to break-even?
Table of Contents
1 Research Methodology
2 Executive Summary
4 Global Generic Drug Industry Analysis
4.1 Classification of Generic Drugs
4.2 Market Trends
4.2.1 Current, Historical and Future Market Trends
4.2.2 Market Breakup by Region
4.2.3 Competitive Structure and Major Players in the Generic Drug Industry
4.2.4 Market Forecast
4.3 Value Chain Analysis of Generic Drugs
4.4 Key Success Factors for Generic Manufacturers
4.6 Regulations in the Generic Industry
5 Manufacturing Process of Generic Drugs
5.1 Detailed Process Flow
5.2 Generic Drugs Manufacturing Plant: Raw Material Requirements
6 Project Details, Requirements and Costs Involved
6.1 Land, Location and Site Development
6.2 Plant Layout
6.3 Plant Machinery
6.4 Machinery Pictures
6.5 Raw Materials
6.9 Other Capital Investments
7 Generic Drug Manufacturing Plant: Project Economics
7.1 Capital Cost of the Project
7.2 Loans and Financial Assistance
7.3 Techno-Economic Parameters
7.4 Product Pricing
7.5 Income Projections
7.6 Expenditure Projections
7.7 Financial Analysis
List of Figures
Figure 4 1: Global: Generic Drug Market: Sales Value (in US$ Billion), 2010-2014
Figure 4 2: Global: Generic Drug Market: Breakup by Country (in %), 2014
Figure 4 3: Global: Generic Drug Market Forecast: Sales Value (in US$ Billion), 2015-2020
Figure 4 4: Global: Generic Drug Market: Value Chain
Figure 6 1: Generic Drug Manufacturing: Detailed Process Flow and Various Types of Unit Operations Involved
Figure 6 2: Generic Drug Manufacturing Process: Conversion Rate of Feedstocks
Figure 7 1: Generic Drug Manufacturing Plant: Proposed Plant Layout
Figure 7 2: Generic Drug Manufacturing Plant: Primary Packaging
Figure 7 3: Generic Drug Manufacturing Plant: Secondary Packaging
Figure 7 4: Generic Drug Manufacturing Plant: Tertiary Packaging
Figure 8 1: Generic Drug Manufacturing Plant: Breakup of Capital Costs (in %)
Figure 8 2: Generic Drug Manufacturing Plant: Breakup of Production Costs (in %)
List of Tables
Table 4 1: Global: Generic Drug Market: Revenues of Key Players (in US$ Billion), 2014
Table 7 1: Generic Drug Manufacturing Plant: Costs Related to Land and Site Development (in US$)
Table 7 2: Generic Drug Manufacturing Plant: Costs Related to Civil Works (in US$)
Table 7 3: Generic Drug Manufacturing Plant: Machinery Costs (in US$)
Table 7 4: Generic Drug Manufacturing Plant: Raw Material Requirements (in Kg/Day)
Table 7 5: Generic Drug Manufacturing Plant: Costs Related to Salaries and Wages (in US$)
Table 7 6: Generic Drug Manufacturing Plant: Costs Related to Other Capital Investments
Table 8 1: Generic Drug Manufacturing Plant: Capital Costs (in US$)
Table 8 2: Details of Financial Assistance Offered by Financial Institutions
Table 8 3: Generic Drug Manufacturing Plant: Loan Installments
Table 8 4: Generic Drug Manufacturing Plant: Techno- Economic Parameters
Table 8 5: Generic Drug Manufacturing Plant: Income Projections (in US$)
Table 8 6: Generic Drug Manufacturing Plant: Expenditure Projections (in US$)
Table 8 7: Generic Drug Manufacturing Plant: Cash Flow Analysis Without Considering the Income Tax Liability
Table 8 8: Generic Drug Manufacturing Plant: Cash Flow Analysis on Considering the Income Tax Liability
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