The global generic drugs market reached a value of US$ 386 Billion in 2020. A generic drug is a medicine that contains the same active ingredient and has an equivalent therapeutic effect as the branded drug. It is also identical in terms of safety, quality, dosage, strength, route of administration, intended use, effect, form, quality and side effects. These medications can be produced only after the patent expiration of the brand-name drug. As compared to branded drugs, the production of generics costs much less as it does not require the repetition of clinical (human) and animal studies to demonstrate the effectiveness and safety of the medicine. Due to a reduction in the upfront cost of research, generics are typically sold at a substantially lower price in the market.
Due to an aging population and increasing incidences of chronic diseases, governments of developed countries have been making efforts to reduce healthcare costs by promoting the production of generics. Whereas, in developing countries, affordability and accessibility are some of the primary issues faced by the healthcare industry. To address these problems, governments and other regulatory bodies have been encouraging manufacturers to introduce effective generic drugs. However, despite the rapid patent expiry of branded drugs, there has been a shortage of generics. This situation is currently being rectified by various initiatives taken by hospitals, institutions and other organizations across the globe.
For instance, in 2018, a coalition of seven hospitals and three philanthropies in the US announced that they would be addressing drug shortages and the high cost of essential medications by launching a generic drug company, named Civica Rx. The company is producing 14 short-supply, FDA-approved drugs that have been available in the market since the beginning of 2019. Other than this, in 2018, the United States Food and Drug Administration (USFDA) created policies to make the process of market entry and generic approval more efficient. It issued guidance documents for the development of both hard-to-copy drug categories and specific complex drugs. Looking forward, the publisher expects the global generic drugs market to exhibit moderate growth during the next five years.
The market is fragmented in nature with the presence of various small and large manufacturers. Some of the leading players operating in the market include Teva Pharmaceuticals Industries Ltd., Mylan N.V., Novartis AG, Pfizer Inc., Sun Pharmaceutical Industries Ltd., Fresenius SE & Co., Lupin Limited, Endo Pharmaceuticals Inc., Aurobindo Pharma Limited, and Aspen Pharmacare Holdings Limited.
Key Questions Answered in This Report:
How has the market performed so far and how will it perform in the coming years?
What are the key regional markets?
What has been the impact of COVID-19 on the global generic drugs market?
What are the major drug delivery segments?
What are the key therapy areas?
What are the major distribution channels?
What are the various stages in the value chain of the industry?
What are the key driving factors and challenges in the industry?
What is the structure of the industry and who are the key players?
What is the degree of competition in the industry?
What are the profit margins in the industry?
What are the key requirements for setting up a manufacturing plant?
How are generic drugs manufactured?
What are the various unit operations involved in a manufacturing plant?
What is the total size of land required for setting up a manufacturing plant?
What are the machinery requirements for setting up a manufacturing plant?
What are the raw material requirements for setting up a manufacturing plant?
What are the packaging requirements for generic drugs?
What are the transportation requirements for generic drugs?
What are the utility requirements for setting up a manufacturing plant?
What are the manpower requirements for setting up a manufacturing plant?
What are the infrastructure costs for setting up a manufacturing plant?
What are the capital costs for setting up a manufacturing plant?
What are the operating costs for setting up a manufacturing plant?
What will be the income and expenditures for a manufacturing plant?
What is the time required to break-even?
Key Topics Covered:
2 Scope and Methodology 2.1 Objectives of the Study 2.2 Stakeholders 2.3 Data Sources 2.3.1 Primary Sources 2.3.2 Secondary Sources 2.4 Market Estimation 2.4.1 Bottom-Up Approach 2.4.2 Top-Down Approach 2.5 Forecasting Methodology
3 Executive Summary
4 Introduction 4.1 Overview 4.2 Key Industry Trends
5 Global Generic Drugs Industry 5.1 Market Overview 5.2 Market Performance 5.3 Impact of COVID-19 5.4 Market Breakup by Country 5.5 Market Breakup by Therapy Area 5.6 Market Breakup by Drug Delivery 5.7 Market Breakup by Distribution Channel 5.8 Market Forecast 5.9 SWOT Analysis 5.9.1 Overview 5.9.2 Strengths 5.9.3 Weaknesses 5.9.4 Opportunities 5.9.5 Threats 5.10 Value Chain Analysis 5.10.1 Research and Development 5.10.2 Manufacturing 5.10.3 Marketing and Distribution 5.11 Porter's Five Forces Analysis 5.11.1 Overview 5.11.2 Bargaining Power of Buyers 5.11.3 Bargaining Power of Suppliers 5.11.4 Degree of Competition 5.11.5 Threat of New Entrants 5.11.6 Threat of Substitutes 5.12 Regulations in the Generic Industry 5.13 Key Market Drivers and Success Factors
6 Performance of Key Countries 6.1 United States 6.1.1 Market Trends 6.1.2 Market Forecast 6.2 China 6.2.1 Market Trends 6.2.2 Market Forecast 6.3 Brazil 6.3.1 Market Trends 6.3.2 Market Forecast 6.4 Germany 6.4.1 Market Trends 6.4.2 Market Forecast 6.5 France 6.5.1 Market Trends 6.5.2 Market Forecast 6.6 India 6.6.1 Market Trends 6.6.2 Market Forecast 6.7 United Kingdom 6.7.1 Market Trends 6.7.2 Market Forecast 6.8 Japan 6.8.1 Market Trends 6.8.2 Market Forecast 6.9 Canada 6.9.1 Market Trends 6.9.2 Market Forecast 6.10 Italy 6.10.1 Market Trends 6.10.2 Market Forecast 6.11 Others 6.11.1 Market Trends 6.11.2 Market Forecast
10 Competitive Landscape 10.1 Competitive Structure 10.2 Market Breakup by Key Players 10.3 Key Player Profiles 10.3.1 Teva Pharmaceuticals Industries Ltd. 10.3.2 Mylan N.V. 10.3.3 Novartis AG 10.3.4 Pfizer Inc. 10.3.5 Sun Pharmaceutical Industries Ltd. 10.3.6 Fresenius SE & Co. 10.3.7 Lupin Limited 10.3.8 Endo Pharmaceuticals Inc. 10.3.9 Aurobindo Pharma Limited 10.3.10 Aspen Pharmacare Holdings Limited
11 Generic Drugs Manufacturing Process 11.1 Product Overview 11.2 Detailed Process Flow (Tablets) 11.3 Detailed Process Flow (Injectable) 11.4 Various Types of Unit Operations Involved 11.5 Mass Balance and Raw Material Requirements
12 Project Details, Requirements and Costs Involved 12.1 Land Requirements and Expenditures 12.2 Construction Requirements and Expenditures 12.3 Plant Machinery 12.4 Machinery Pictures 12.5 Raw Material Requirements and Expenditures 12.6 Packaging Requirements and Expenditures 12.7 Transportation Requirements and Expenditures 12.8 Utility Requirements and Expenditures 12.9 Manpower Requirements and Expenditures 12.10 Other Capital Investments
13 Loans and Financial Assistance
14 Project Economics 14.1 Capital Cost of the Project 14.2 Techno-Economic Parameters 14.3 Product Pricing and Margins Across Various Levels of the Supply Chain 14.4 Taxation and Depreciation 14.5 Income Projections 14.6 Expenditure Projections 14.7 Financial Analysis 14.8 Profit Analysis