The global generic drugs market was worth around US$ 315 Billion in 2017, exhibiting a CAGR of 6.7% during 2010-2017. The market is further projected to reach a value of US$ 474 Billion by 2023, at a CAGR of 6.8% during 2018-2023. Generic drugs are bioequivalents of brand-name drugs in terms of strength, quality, dosage, form, effect, side effect, intended use and route of administration. Generally, pharmaceutical companies spend a huge amount of money on the marketing of innovator drugs as they have to educate both the physicians and authorities on the efficacy and safety profile of the new drug. As generics do not require such extensive marketing to establish their safety and efficacy, they offer higher profit margins to the manufacturers.
Global Generic Drugs Market Drivers:
- Generic drugs are less expensive, require low capital investment and take less approval time than their branded counterparts as they do not require extensive research and clinical trials which save both money and time, thereby lowering the cost.
- Generic drugs, being economical counterparts of branded drugs, play a major role in reducing overall healthcare cost. Owing to this, the governments of various countries are regulating and introducing policies for boosting their sales.
- An increase in the prevalence of chronic diseases such as cardiovascular diseases, diabetes, Alzheimer’s disease and Parkinson’s disease, in both the developing and developed regions, is creating a positive outlook for the generic drug manufacturers.
- Branded drugs worth several billion dollars are expected to lose patent protection in the coming years. This is expected to create huge opportunities for the generic drugs manufacturers.
Breakup by Therapy Area:
On the basis of therapy area, the market has been divided into CNS, cardiovascular, dermatology, genitourinary/hormonal, respiratory, rheumatology, diabetes and oncology. Amongst these, cardiovascular diseases hold the largest share, accounting for the majority of total market. This can be accredited to the increasing cases of cardiovascular diseases as a result of sedentary lifestyles and unhealthy eating habits.
Breakup by Drug Delivery:
Based on drug delivery, oral generic drugs represent the most popular segment, holding the largest market share. Oral generic drugs are generally preferred owing to the convenience attached with their administration which requires minimal or no medical assistance. Other major segments include injectables, dermal/topical and inhalers.
Breakup by Distribution Channel:
On the basis of distribution channel, retail pharmacy stores dominate the market, representing the largest segment. Customer-service plays a significant role for a retail pharmacist as patients tend to interact directly with them while purchasing medication. Retail pharmacy stores are followed by hospitals.
Regional Insights:
On a geographical front, the United States enjoys the leading position in the global generic drugs market on account of favorable regulations by the Government. It is followed by China, Brazil, Germany, France, India, United Kingdom, Japan, Canada and Italy.
Competitive Landscape:
On analyzing the competitive landscape, it has been found that the market is highly fragmented with the presence of numerous manufacturers. Some of the largest players operative in the market are:
- Teva Pharmaceuticals
- Mylan NV
- Sandoz (Novartis)
- Hospira (Pfizer Inc.)
- Sun Pharmaceutical Industries Ltd.
- Fresenius Kabi Ag
- Lupin
- Endo Pharma
- Aurbindo Pharma
- Aspen Pharmacare
This report provides a deep insight into the global generic drugs industry covering all its essential aspects. This ranges from macro overview of the market to micro details of the industry performance, recent trends, key market drivers and challenges, SWOT analysis, Porter’s five forces analysis, value chain analysis, etc. The report also provides a comprehensive analysis for setting up a generic drug manufacturing plant. The study analyses the processing and 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 have any kind of stake or are planning to foray into the generic drugs industry in any manner.
Key Questions Answered in This Report:
- How has the global generic drugs market performed so far and how will it perform in the coming years?
- What are the key regional markets in the global generic drugs industry?
- What are the major drug delivery segments in the global generic drugs industry?
- What are the key therapy areas in the global generic drugs industry?
- What are the major distribution channels in the global generic drugs industry?
- What are the various stages in the value chain of the global generic drugs industry?
- What are the key driving factors and challenges in the global generic drugs industry?
- What is the structure of the global generic drugs industry and who are the key players?
- What is the degree of competition in the global generic drugs industry?
- What are the profit margins in the global generic drugs industry?
- What are the key requirements for setting up a generic drug manufacturing plant?
- How are generic drugs manufactured?
- 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 packaging requirements for generic drugs?
- What are the transportation requirements for generic drugs?
- 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 will be the income and expenditures for a generic drug manufacturing plant?
- What is the time required to break-even?
1 Preface
2 Research Methodology
3 Executive Summary
4 Introduction
4.1 Overview
4.2 Key Industry Trends
5 Global Generic Drug Industry
5.1 Market Overview
5.2 Market Performance
5.3 Market Breakup by Country
5.4 Market Breakup by Therapy Area
5.5 Market Breakup by Drug Delivery
5.6 Market Breakup by Distribution Channel
5.7 Market Forecast
5.8 SWOT Analysis
5.8.1 Strengths
5.8.2 Weaknesses
5.8.3 Opportunities
5.8.4 Threats
5.9 Value Chain Analysis
5.9.1 Research and Development
5.9.2 Manufacturing
5.9.3 Marketing and Distribution
5.10 Porter’s Five Forces Analysis
5.10.1 Overview
5.10.2 Bargaining Power of Buyers
5.10.3 Bargaining Power of Suppliers
5.10.4 Degree of Competition
5.10.5 Threat of New Entrants
5.10.6 Threat of Substitutes
5.11 Regulations in the Generic Industry
5.12 Key Market Drivers and Success Factors
6 Performance of Key Countries
6.1 United States
6.2 China
6.3 Brazil
6.4 Germany
6.5 France
6.6 India
6.7 United Kingdom
6.8 Japan
6.9 Canada
6.10 Italy
6.11 Others
7 Market Breakup by Therapy Area
7.1 CNS
7.2 Cardiovascular
7.3 Dermatology
7.4 Genitourinary/Hormonal
7.5 Respiratory
7.6 Rheumatology
7.7 Diabetes
7.8 Oncology
7.9 Others
8 Market Breakup By Drug Delivery
8.1 Oral
8.2 Injectables
8.3 Dermal/Topical
8.4 Inhalers
9 Market Breakup By Distribution Channel
9.1 Retail Pharmacies
9.2 Hospital Pharmacies
10 Competitive Landscape
10.1 Competitive Structure
10.2 Market Breakup by Key Players
10.3 Key Player Profiles
10.3.1 Teva Pharmaceuticals
10.3.2 Mylan
10.3.3 Novartis
10.3.4 Pfizer
10.3.5 Sun Pharma
10.3.6 Fresenius
10.3.8 Lupin
10.3.8 Endo Pharma
10.3.9 Aurbindo Pharma
10.3.10 Aspen Pharmacare
11 Generic Drug 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
12.12 Manpower Requirements and Expenditures
12.12 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
List of Figures
Figure 1: Global: Generic Drug Industry Overview
Figure 2: Global: Generic Drug Market: Sales Value Trends (in Billion US$), 2010 - 2017
Figure 3: Global: Generic Drug Market Forecast: Sales Value Trends (in Billion US$), 2018 - 2023
Figure 4: Global: Generic Drug Market: Breakup by Country (in %), 2017
Figure 5: Global: Generic Drug Industry: SWOT Analysis
Figure 6: Global: Generic Drug Industry: Value Chain Analysis
Figure 7: Global: Generic Drug Industry: Porter’s Five Forces Analysis
Figure 8: USA: Generic Drug Market (in Million US$), 2010, 2017 & 2023
Figure 9: China: Generic Drug Market (in Million US$), 2010, 2017 & 2023
Figure 10: Brazil: Generic Drug Market (in Million US$), 2010, 2017 & 2023
Figure 11: Germany: Generic Drug Market (in Million US$), 2010, 2017 & 2023
Figure 12: France: Generic Drug Market (in Million US$), 2010, 2017 & 2023
Figure 13: India: Generic Drug Market (in Million US$), 2010, 2017 & 2023
Figure 14: United Kingdom: Generic Drug Market (in Million US$), 2010, 2017 & 2023
Figure 15: Japan: Generic Drug Market (in Million US$), 2010, 2017 & 2023
Figure 16: Canada: Generic Drug Market (in Million US$), 2010, 2017 & 2023
Figure 17: Italy: Generic Drug Market (in Million US$), 2010, 2017 & 2023
Figure 18: Global: Generic Drug Market: Orals (in Million US$), 2010, 2017 & 2023
Figure 19: Global: Generic Drug Market: Injectables (in Million US$), 2010, 2017 & 2023
Figure 20: Global: Generic Drug Market: Dermal/Topical (in Million US$), 2010, 2017 & 2023
Figure 21: Global: Generic Drug Market: Inhalers (in Million US$), 2010, 2017 & 2023
Figure 22: Global: Generic Drug Market: Retail Pharmacies (in Million US$), 2010, 2017 & 2023
Figure 23: Global: Generic Drug Market: Hospital Pharmacies (in Million US$), 2010, 2017 & 2023
Figure 24: Generic Drug Industry: Profit Margins at Various Levels of the Supply Chain
Figure 25: Generic Drug Manufacturing: Production Cost Breakup (in %)
Figure 26: Generic Drug Manufacturing Plant: Detailed Process Flow
Figure 27: Generic Drug Manufacturing Process: Conversion Rate of Feedstocks
Figure 28: Generic Drug Manufacturing Plant: Proposed Plant Layout
Figure 29: Generic Drug Manufacturing Plant: Breakup of Capital Costs (in %)
List of Tables
Table 1: Global: Generic Drug Market: Key Industry Highlights, 2017 and 2023
Table 2: Global: Generic Drug Market Forecast: Breakup by Country (in Million US$), 2018 – 2023
Table 3: Global: Generic Drug Market Forecast: Breakup by Therapy Area (in Million US$), 2018 – 2023
Table 4: Global: Generic Drug Market Forecast: Breakup by Drug Delivery (in Million US$), 2018 – 2023
Table 5: Global: Generic Drug Market Forecast: Breakup by Distribution Channel (in Million US$), 2018 - 2023
Table 6: Generic Drug Manufacturing Plant: Costs Related to Land and Site Development (in US$)
Table 7: Generic Drug Manufacturing Plant: Costs Related to Civil Works (in US$)
Table 8: Generic Drug Manufacturing Plant: Costs Related to Machinery Unit (in US$)
Table 9: Generic Drug Manufacturing Plant: Raw Material Requirements
Table 10: Generic Drug Manufacturing Plant: Costs Related to Salaries and Wages (in US$)
Table 11: Generic Drug Manufacturing Plant: Costs Related to Other Capital Investments (in US$)
Table 12: Details of Financial Assistance Offered by Financial Institutions
Table 13: Generic Drug Manufacturing Plant: Capital Costs (in US$)
Table 14: Generic Drug Manufacturing Plant: Techno-Economic Parameters
Table 15: Generic Drug Manufacturing Plant: Taxation and Depreciation (in US$)
Table 16: Generic Drug Manufacturing Plant: Income Projections (in US$)
Table 17: Generic Drug Manufacturing Plant: Expenditure Projections (in US$)
Table 18: Generic Drug Manufacturing Plant: Cash Flow Analysis Without Considering the Income Tax Liability
Table 19: Generic Drug Manufacturing Plant: Cash Flow Analysis on Considering the Income Tax Liability
Table 20: Generic Drug Manufacturing Plant: Profit and Loss Account