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.
Market Trends:
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, IMARC Group expects the global generic drugs market to exhibit moderate growth during the next five years.
Breakup by Therapy Area:
- Central Nervous System
- Cardiovascular
- Dermatology
- Genitourinary/Hormonal
- Respiratory
- Rheumatology
- Diabetes
- Oncology
- Others
Cardiovascular diseases (CVDs) are the leading therapy area, accounting for the majority of the total market, on account of the increasing cases of CVDs as a result of unhealthy eating habits and sedentary lifestyles.
Breakup by Drug Delivery:
- Oral
- Injectables
- Dermal/Topical
- Inhalers
Currently, oral medicines are the most preferred product, owing to the convenience attached to their administration, which requires minimal to no medical assistance.
Breakup by Distribution Channel:
- Retail Pharmacies
- Hospital Pharmacies
At present, the majority of the generics are distributed through retail pharmacy stores as most generic drugs are over the counter (OTC) medicines that can be bought without a prescription.
Regional Insights:
- United States
- China
- Brazil
- Germany
- France
- India
- United Kingdom
- Japan
- Canada
- Italy
- Others
On a regional basis, the United States represents the biggest market, accounting for the largest market share. This growth is led by numerous initiatives by the US Government to improve generic drug manufacturing and access in the country.
Competitive Landscape:
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?
1 Preface
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
7 Market Breakup by Therapy Area
7.1 Central Nervous System
7.1.1 Market Trends
7.1.2 Market Forecast
7.2 Cardiovascular
7.2.1 Market Trends
7.2.2 Market Forecast
7.3 Dermatology
7.3.1 Market Trends
7.3.2 Market Forecast
7.4 Genitourinary/Hormonal
7.4.1 Market Trends
7.4.2 Market Forecast
7.5 Respiratory
7.5.1 Market Trends
7.5.2 Market Forecast
7.6 Rheumatology
7.6.1 Market Trends
7.6.2 Market Forecast
7.7 Diabetes
7.7.1 Market Trends
7.7.2 Market Forecast
7.8 Oncology
7.8.1 Market Trends
7.8.2 Market Forecast
7.9 Others
7.9.1 Market Trends
7.9.2 Market Forecast
8 Market Breakup by Drug Delivery
8.1 Oral
8.1.1 Market Trends
8.1.2 Market Forecast
8.2 Injectables
8.2.1 Market Trends
8.2.2 Market Forecast
8.3 Dermal/Topical
8.3.1 Market Trends
8.3.2 Market Forecast
8.4 Inhalers
8.4.1 Market Trends
8.4.2 Market Forecast
9 Market Breakup by Distribution Channel
9.1 Retail Pharmacies
9.1.1 Market Trends
9.1.2 Market Forecast
9.2 Hospital Pharmacies
9.2.1 Market Trends
9.2.2 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
List of Figure
Figure 1: Global: Generic Drugs Market: Major Drivers and Challenges
Figure 2: Global: Generic Drugs Market: Sales Value Trends (in Billion US$), 2015-2020
Figure 3: Global: Generic Drugs Market Forecast: Sales Value Trends (in Billion US$), 2021-2026
Figure 4: Global: Generic Drugs Market: Breakup by Country (in %), 2020
Figure 5: Global: Generic Drugs Market: Breakup by Therapy Area (in %), 2020
Figure 6: Global: Generic Drugs Market: Breakup by Drug Delivery (in %), 2020
Figure 7: Global: Generic Drugs Market: Breakup by Distribution Channel (in %), 2020
Figure 8: Global: Generic Drugs Industry: SWOT Analysis
Figure 9: Global: Generic Drugs Industry: Value Chain Analysis
Figure 10: Global: Generic Drugs Industry: Porter’s Five Forces Analysis
Figure 11: USA: Generic Drugs Market (in Million US$), 2015 & 2020
Figure 12: USA: Generic Drugs Market Forecast (in Million US$), 2021-2026
Figure 13: China: Generic Drugs Market (in Million US$), 2015 & 2020
Figure 14: China: Generic Drugs Market Forecast (in Million US$), 2021-2026
Figure 15: Brazil: Generic Drugs Market (in Million US$), 2015 & 2020
Figure 16: Brazil: Generic Drugs Market Forecast (in Million US$), 2021-2026
Figure 17: Germany: Generic Drugs Market (in Million US$), 2015 & 2020
Figure 18: Germany: Generic Drugs Market Forecast (in Million US$), 2021-2026
Figure 19: France: Generic Drugs Market (in Million US$), 2015 & 2020
Figure 20: France: Generic Drugs Market Forecast (in Million US$), 2021-2026
Figure 21: India: Generic Drugs Market (in Million US$), 2015 & 2020
Figure 22: India: Generic Drugs Market Forecast (in Million US$), 2021-2026
Figure 23: United Kingdom: Generic Drugs Market (in Million US$), 2015 & 2020
Figure 24: United Kingdom: Generic Drugs Market Forecast (in Million US$), 2021-2026
Figure 25: Japan: Generic Drugs Market (in Million US$), 2015 & 2020
Figure 26: Japan: Generic Drugs Market Forecast (in Million US$), 2021-2026
Figure 27: Canada: Generic Drugs Market (in Million US$), 2015 & 2020
Figure 28: Canada: Generic Drugs Market Forecast (in Million US$), 2021-2026
Figure 29: Italy: Generic Drugs Market (in Million US$), 2015 & 2020
Figure 30: Italy: Generic Drugs Market Forecast (in Million US$), 2021-2026
Figure 31: Global: Generic Drugs Market: Orals (in Million US$), 2015 & 2020
Figure 32: Global: Generic Drugs Market Forecast: Orals (in Million US$), 2021-2026
Figure 33: Global: Generic Drugs Market: Injectables (in Million US$), 2015 & 2020
Figure 34: Global: Generic Drugs Market Forecast: Injectables (in Million US$), 2021-2026
Figure 35: Global: Generic Drugs Market: Dermal/Topical (in Million US$), 2015 & 2020
Figure 36: Global: Generic Drugs Market Forecast: Dermal/Topical (in Million US$), 2021-2026
Figure 37: Global: Generic Drugs Market: Inhalers (in Million US$), 2015 & 2020
Figure 38: Global: Generic Drugs Market Forecast: Inhalers (in Million US$), 2021-2026
Figure 39: Global: Generic Drugs Market: Central Nervous System (in Million US$), 2015 & 2020
Figure 40: Global: Generic Drugs Market Forecast: Central Nervous System (in Million US$), 2021-2026
Figure 41: Global: Generic Drugs Market: Cardiovascular (in Million US$), 2015 & 2020
Figure 42: Global: Generic Drugs Market Forecast: Cardiovascular (in Million US$), 2021-2026
Figure 43: Global: Generic Drugs Market: Dermatology (in Million US$), 2015 & 2020
Figure 44: Global: Generic Drugs Market Forecast: Dermatology (in Million US$), 2021-2026
Figure 45: Global: Generic Drugs Market: Genitourinary/Hormonal (in Million US$), 2015 & 2020
Figure 46: Global: Generic Drugs Market Forecast: Genitourinary/Hormonal (in Million US$), 2021-2026
Figure 47: Global: Generic Drugs Market: Respiratory (in Million US$), 2015 & 2020
Figure 48: Global: Generic Drugs Market Forecast: Respiratory (in Million US$), 2021-2026
Figure 49: Global: Generic Drugs Market: Rheumatology (in Million US$), 2015 & 2020
Figure 50: Global: Generic Drugs Market Forecast: Rheumatology (in Million US$), 2021-2026
Figure 51: Global: Generic Drugs Market: Diabetes (in Million US$), 2015 & 2020
Figure 52: Global: Generic Drugs Market Forecast: Diabetes (in Million US$), 2021-2026
Figure 53: Global: Generic Drugs Market: Oncology (in Million US$), 2015 & 2020
Figure 54: Global: Generic Drugs Market Forecast: Oncology (in Million US$), 2021-2026
Figure 55: Global: Generic Drugs Market: Other Therapy Areas (in Million US$), 2015 & 2020
Figure 56: Global: Generic Drugs Market Forecast: Other Therapy Areas (in Million US$), 2021-2026
Figure 57: Global: Generic Drugs Market: Retail Pharmacies (in Million US$), 2015 & 2020
Figure 58: Global: Generic Drugs Market Forecast: Retail Pharmacies (in Million US$), 2021-2026
Figure 59: Global: Generic Drugs Market: Hospital Pharmacies (in Million US$), 2015 & 2020
Figure 60: Global: Generic Drugs Market Forecast: Hospital Pharmacies (in Million US$), 2021-2026
Figure 61: Generic Drugs Industry: Profit Margins at Various Levels of the Supply Chain
Figure 62: Generic Drugs Manufacturing: Production Cost Breakup (in %)
Figure 63: Generic Drugs Manufacturing: Detailed Process Flow
Figure 64: Generic Drugs Manufacturing Process: Conversion Rate of Feedstocks
Figure 65: Generic Drugs Manufacturing: Proposed Plant Layout
Figure 66: Generic Drugs Manufacturing Plant: Breakup of Capital Costs (in %)
List of Table
Table 1: Global: Generic Drugs Market: Key Industry Highlights, 2020 and 2026
Table 2: Global: Generic Drugs Market Forecast: Breakup by Country (in Million US$), 2021-2026
Table 3: Global: Generic Drugs Market Forecast: Breakup by Therapy Area (in Million US$), 2021-2026
Table 4: Global: Generic Drugs Market Forecast: Breakup by Drug Delivery (in Million US$), 2021-2026
Table 5: Global: Generic Drugs Market Forecast: Breakup by Distribution Channel (in Million US$), 2021-2026
Table 6: Generic Drugs Market: Competitive Structure
Table 7: Generic Drugs Market: Key Players
Table 8: Generic Drugs Manufacturing Plant: Costs Related to Land and Site Development (in US$)
Table 9: Generic Drugs Manufacturing Plant: Costs Related to Civil Works (in US$)
Table 10: Generic Drugs Manufacturing Plant: Costs Related to Machinery Unit (in US$)
Table 11: Generic Drugs Manufacturing Plant: Raw Material Requirements
Table 12: Generic Drugs Manufacturing Plant: Costs Related to Salaries and Wages (in US$)
Table 13: Generic Drugs Manufacturing Plant: Costs Related to Other Capital Investments (in US$)
Table 14: Details of Financial Assistance Offered by Financial Institutions
Table 15: Generic Drugs Manufacturing Plant: Capital Costs (in US$)
Table 16: Generic Drugs Manufacturing Plant: Techno-Economic Parameters
Table 17: Generic Drugs Manufacturing Plant: Taxation and Depreciation (in US$)
Table 18: Generic Drugs Manufacturing Plant: Income Projections (in US$)
Table 19: Generic Drugs Manufacturing Plant: Expenditure Projections (in US$)
Table 20: Generic Drugs Manufacturing Plant: Cash Flow Analysis Without Considering the Income Tax Liability (in US$)
Table 21: Generic Drugs Manufacturing Plant: Cash Flow Analysis on Considering the Income Tax Liability (in US$)
Table 22: Generic Drugs Manufacturing Plant: Profit and Loss Account (in US$)