The global generic drugs market reached a value of US$ 340 Billion in 2018, registering a CAGR of 6.6% during 2011-2018. 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. Owing to the aforementioned factors, IMARC Group expects the market to reach US$ 475 Billion by 2024, growing at a CAGR of 5.3% during 2019-2024.
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:
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 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 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 Overview
5.8.2 Strengths
5.8.3 Weaknesses
5.8.4 Opportunities
5.8.5 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
6.1.1 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 CNS
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
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 Figure
Figure 1: Global: Generic Drug Market: Major Drivers and Challenges
Figure 2: Global: Generic Drug Market: Sales Value Trends (in Billion US$), 2011 - 2018
Figure 3: Global: Generic Drug Market Forecast: Sales Value Trends (in Billion US$), 2019 - 2024
Figure 4: Global: Generic Drug Market: Breakup by Country (in %), 2018
Figure 5: Global: Generic Drug Market: Breakup by Therapy Area (in %), 2018
Figure 6: Global: Generic Drug Market: Breakup by Drug Delivery (in %), 2018
Figure 7: Global: Generic Drug Market: Breakup by Distribution Channel (in %), 2018
Figure 8: Global: Generic Drug Industry: SWOT Analysis
Figure 9: Global: Generic Drug Industry: Value Chain Analysis
Figure 10: Global: Generic Drug Industry: Porter’s Five Forces Analysis
Figure 11: USA: Generic Drug Market (in Million US$), 2011 & 2018
Figure 12: USA: Generic Drug Market Forecast (in Million US$), 2019-2024
Figure 13: China: Generic Drug Market (in Million US$), 2011 & 2018
Figure 14: China: Generic Drug Market Forecast (in Million US$), 2019-2024
Figure 15: Brazil: Generic Drug Market (in Million US$), 2011 & 2018
Figure 16: Brazil: Generic Drug Market Forecast (in Million US$), 2019-2024
Figure 17: Germany: Generic Drug Market (in Million US$), 2011 & 2018
Figure 18: Germany: Generic Drug Market Forecast (in Million US$), 2019-2024
Figure 19: France: Generic Drug Market (in Million US$), 2011 & 2018
Figure 20: France: Generic Drug Market Forecast (in Million US$), 2019-2024
Figure 21: India: Generic Drug Market (in Million US$), 2011 & 2018
Figure 22: India: Generic Drug Market Forecast (in Million US$), 2019-2024
Figure 23: United Kingdom: Generic Drug Market (in Million US$), 2011 & 2018
Figure 24: United Kingdom: Generic Drug Market Forecast (in Million US$), 2019-2024
Figure 25: Japan: Generic Drug Market (in Million US$), 2011 & 2018
Figure 26: Japan: Generic Drug Market Forecast (in Million US$), 2019-2024
Figure 27: Canada: Generic Drug Market (in Million US$), 2011 & 2018
Figure 28: Canada: Generic Drug Market Forecast (in Million US$), 2019-2024
Figure 29: Italy: Generic Drug Market (in Million US$), 2011 & 2018
Figure 30: Italy: Generic Drug Market Forecast (in Million US$), 2019-2024
Figure 31: Global: Generic Drug Market: Orals (in Million US$), 2011 & 2018
Figure 32: Global: Generic Drug Market Forecast: Orals (in Million US$), 2019-2024
Figure 33: Global: Generic Drug Market: Injectables (in Million US$), 2011 & 2018
Figure 34: Global: Generic Drug Market Forecast: Injectables (in Million US$), 2019-2024
Figure 35: Global: Generic Drug Market: Dermal/Topical (in Million US$), 2011 & 2018
Figure 36: Global: Generic Drug Market Forecast: Dermal/Topical (in Million US$), 2019-2024
Figure 37: Global: Generic Drug Market: Inhalers (in Million US$), 2011 & 2018
Figure 38: Global: Generic Drug Market Forecast: Inhalers (in Million US$), 2019-2024
Figure 39: Global: Generic Drug Market: CNS (in Million US$), 2011 & 2018
Figure 40: Global: Generic Drug Market Forecast: CNS (in Million US$), 2019-2024
Figure 41: Global: Generic Drug Market: Cardiovascular (in Million US$), 2011 & 2018
Figure 42: Global: Generic Drug Market Forecast: Cardiovascular (in Million US$), 2019-2024
Figure 43: Global: Generic Drug Market: Dermatology (in Million US$), 2011 & 2018
Figure 44: Global: Generic Drug Market Forecast: Dermatology (in Million US$), 2019-2024
Figure 45: Global: Generic Drug Market: Genitourinary/Hormonal (in Million US$), 2011 & 2018
Figure 46: Global: Generic Drug Market Forecast: Genitourinary/Hormonal (in Million US$), 2019-2024
Figure 47: Global: Generic Drug Market: Respiratory (in Million US$), 2011 & 2018
Figure 48: Global: Generic Drug Market Forecast: Respiratory (in Million US$), 2019-2024
Figure 49: Global: Generic Drug Market: Rheumatology (in Million US$), 2011 & 2018
Figure 50: Global: Generic Drug Market Forecast: Rheumatology (in Million US$), 2019-2024
Figure 51: Global: Generic Drug Market: Diabetes (in Million US$), 2011 & 2018
Figure 52: Global: Generic Drug Market Forecast: Diabetes (in Million US$), 2019-2024
Figure 53: Global: Generic Drug Market: Oncology (in Million US$), 2011 & 2018
Figure 54: Global: Generic Drug Market Forecast: Oncology (in Million US$), 2019-2024
Figure 55: Global: Generic Drug Market: Other Therapy Areas (in Million US$), 2011 & 2018
Figure 56: Global: Generic Drug Market Forecast: Other Therapy Areas (in Million US$), 2019-2024
Figure 57: Global: Generic Drug Market: Retail Pharmacies (in Million US$), 2011 & 2018
Figure 58: Global: Generic Drug Market Forecast: Retail Pharmacies (in Million US$), 2019-2024
Figure 59: Global: Generic Drug Market: Hospital Pharmacies (in Million US$), 2011 & 2018
Figure 60: Global: Generic Drug Market Forecast: Hospital Pharmacies (in Million US$), 2019-2024
Figure 61: Generic Drug Industry: Profit Margins at Various Levels of the Supply Chain
Figure 62: Generic Drug Manufacturing: Production Cost Breakup (in %)
Figure 63: Generic Drug Manufacturing: Detailed Process Flow
Figure 64: Generic Drug Manufacturing Process: Conversion Rate of Feedstocks
Figure 65: Generic Drug Manufacturing: Proposed Plant Layout
Figure 66: Generic Drug Manufacturing Plant: Breakup of Capital Costs (in %)
List of Table
Table 1: Global: Generic Drug Market: Key Industry Highlights, 2018 and 2024
Table 2: Global: Generic Drug Market Forecast: Breakup by Country (in Million US$), 2019-2024
Table 3: Global: Generic Drug Market Forecast: Breakup by Therapy Area (in Million US$), 2019- 2024
Table 4: Global: Generic Drug Market Forecast: Breakup by Drug Delivery (in Million US$), 2019- 2024
Table 5: Global: Generic Drug Market Forecast: Breakup by Distribution Channel (in Million US$), 2019-2024
Table 6: Generic Drug Market: Competitive Structure
Table 7: Generic Drug Market: Key Players
Table 8: Generic Drug Manufacturing Plant: Costs Related to Land and Site Development (in US$)
Table 9: Generic Drug Manufacturing Plant: Costs Related to Civil Works (in US$)
Table 10: Generic Drug Manufacturing Plant: Costs Related to Machinery Unit (in US$)
Table 11: Generic Drug Manufacturing Plant: Raw Material Requirements
Table 12: Generic Drug Manufacturing Plant: Costs Related to Salaries and Wages (in US$)
Table 13: Generic Drug Manufacturing Plant: Costs Related to Other Capital Investments (in US$)
Table 14: Details of Financial Assistance Offered by Financial Institutions
Table 15: Generic Drug Manufacturing Plant: Capital Costs (in US$)
Table 16: Generic Drug Manufacturing Plant: Techno-Economic Parameters
Table 17: Generic Drug Manufacturing Plant: Taxation and Depreciation (in US$)
Table 18: Generic Drug Manufacturing Plant: Income Projections (in US$)
Table 19: Generic Drug Manufacturing Plant: Expenditure Projections (in US$)
Table 20: Generic Drug Manufacturing Plant: Cash Flow Analysis Without Considering the Income Tax Liability (in US$)
Table 21: Generic Drug Manufacturing Plant: Cash Flow Analysis on Considering the Income Tax Liability (in US$)
Table 22: Generic Drug Manufacturing Plant: Profit and Loss Account (in US$)