The global market for generic drugs should grow from $411.6 billion in 2020 to $650.3 billion by 2025, at a compound annual growth rate (CAGR) of 9.6% for the period of 2020-2025.
Report Scope
This report discusses the implications of all the above-mentioned trends in the context of the current size and growth of the market for generic drugs, both in global terms and broken down by the most important national markets. The nature and structure of the generic drug industry is discussed, with profiles of the leading 20+ generic drug companies and an update on M&A activity. Five-year sales forecasts are provided for the national markets and the major therapeutic categories of the products involved.
Based on geography, the market has been segmented into North America, Europe, Asia-Pacific and Rest of the World. Detailed analyses of major countries such as the U.S., Canada, Germany, the U.K., France, Spain, Italy, Japan, China and India are covered in regional segments. For market estimates, data has been provided for the year 2019 as the base year, with forecasts for 2020 through 2025. The estimated values used are based on drug manufacturers’ total revenues. Projected and forecasted revenue values are in constant U.S. dollars that have not been adjusted for inflation.
The Report Includes
- 38 tables
- An updated review of the global market for generic drugs
- Analyses of the global market trends, with data from 2018-2020, and projections of compound annual growth rates (CAGRs) through 2025
- Highlights of current and future market potential of generic drugs along with an emphasis on the major generics issue, regulatory landscape and patent cliff within the generic drugs industry
- COVID-19 impact (both short term vs. long term) on the global generic drugs market compared to the overall pharmaceutical industry
- Estimation of the market size and market forecast for pharmaceuticals and generic drugs by the most important geographies and major therapeutic categories of products
- Key M&A deals, collaborations and partnerships, licensing and manufacturing agreements, and other investment strategies within this market
- Competitive landscape of the key players in the global generic drugs market, analysis of company sales data, and structure of the generics industry
- Insight into the pipeline analysis of new and generic drugs and their impact on the growth of the market
- Company profiles of the leading players operating in the global generic drugs market including Aspen, Cipla, Lupin, Pfizer, Sanofi, Sun Pharmaceuticals and Teva Pharmaceuticals
Table of Contents
Chapter 1 Introduction
- Study Goals and Objectives
- Reasons for Doing This Study
- Scope of Report
- Information Sources
- Methodology
- Intended Audience
- Geographic Breakdown
- Analyst's Credentials
- Custom Research
- Related Reports
Chapter 2 Summary and Highlights
- Market Size and Evolution
Chapter 3 Market Overview
- Introduction
- Recent History of the Generic Drug Industry
- Roche-Bolar
- Generics Lobby
- ICH
Chapter 4 Impact of COVID-19
- Overview
- Short-Term Impact on the Pharma Industry
- Long-Term Impact on the Pharma Industry
- Impact of COVID-19 on the Market for Generic Drugs
- Impact on the Supply Chain
Chapter 5 The New Generics Era
- Overview
- The Patent Cliff
- Types of Generic Drugs
- Simple Generics
- Super Generics
- Biosimilars
- ANDA (Abbreviated New Drug Application) Approvals
Chapter 6 Major Issues Within the Market for Generic Drugs
- Regulatory Environment
- U.S.
- European Union
- Japan
- Regulation of Biosimilars
- EU Provisions
- Evolving Situation in the U.S.
- User Fees
- Defensive Strategies Used by Big Pharma
- Authorized Generic Drugs
- User Fees
- Changing Climate for Generics
- Situation in Europe
- Patents and IP
- Supplementary Protection Certificates
Chapter 7 Global Market for Generic Drugs
- Global Pharmaceutical Market: Brand Name and Generic Drugs
- Global Market for Generic Drugs
- Market Opportunities by Product Class
- Market Shares of Pharmaceutical Drugs by Therapeutic Area
Chapter 8 Market Breakdown by Region
- Introduction
- North America
- U.S.
- Canada
- Asia-Pacific
- China
- Japan
- India
- Rest of Asia-Pacific
- Europe
- France
- Germany
- Italy
- U.K.
- Spain
- Rest of Europe
- Rest of the World
Chapter 9 Industry Trends
- Competitive Landscape
- Market Trends
- Structure of the Generic Drug Industry
- Recent Mergers and Acquisitions
- Brand Name Company Involvement
Chapter 10 Company Profiles
- Aspen Holdings
- Cipla Inc.
- Fresenius Kabi
- Lupin Ltd.
- Mylan Inc.
- Pfizer Inc.
- Sandoz International Gmbh
- Sanofi
- Sun Pharmaceutical Industries Ltd.
- Teva Pharmaceutical Industries Ltd.
Chapter 11 Other International Companies
- Aurobindo Pharma Ltd.
- Dr. Reddy's Laboratories Ltd.
- Egis Pharmaceuticals Plc
- Krka
- Par Pharmaceutical Inc.
- Stada Arzneimittel
- Strides Shasun Ltd.
- Wockhardt Ltd.
- Zydus Cadila
Chapter 12 Appendix: Terminology and Acronyms
List of Tables
Summary Table: Global Market for Generic Drugs, by Region, Through 2025
Table 1: Global Market for Generic Drugs Compared with the Total Pharmaceutical Market, by Region, Through 2025
Table 2: Coronavirus Reported Cases and Deaths, by Country, as of March 8, 2021
Table 3: Major Recent and Upcoming Patent Expiries, 2016-2021
Table 4: Sales of Brand Name Drugs Before and After Patent Expiry
Table 5: Biologics with Recent or Upcoming Loss of Patent Protection
Table 6: Recent Approvals of Biosimilars, 2018-2020
Table 7: ANDA Approvals of Generic Drugs, by Company, 2019
Table 8: Requirements for NDA and ANDA Applications
Table 9: Global Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 10: Global Market for Generic Drugs, by Top 10 Countries, Through 2025
Table 11: Top 20 Generic Molecules, 2019
Table 12: Global Top Selling Pharmaceuticals, 2019
Table 13: Leading Anti-infective Products Sales, 2018
Table 14: Leading CNS Products Sales, 2018
Table 15: Leading Cardiovascular Product Sales, 2019
Table 16: Leading Anti-arthritis Product Sales, 2018
Table 17: Leading Respiratory Product Sales, 2018
Table 18: Leading Anticancer Product Sales, 2018
Table 19: U.S. Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 20: Canadian Leading Therapeutic Classes in Retail and Hospital Purchases, 2019
Table 21: Canadian Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 22: Chinese Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 23: Japanese Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 24: Japanese Pharmaceutical Sales, by Top 25 Japanese Pharma Companies, 2018 and 2019
Table 25: Indian Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 26: Leading Generic Drug Companies in India
Table 27: Rest of Asia-Pacific Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 28: French Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 29: German Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 30: Italian Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 31: U.K. Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 32: Leading Pharma Companies in the U.K., by Company, 2018
Table 33: Spanish Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 34: Penetration of Generic Drugs in the Pharmaceutical Market in the Rest of Europe, by Country, 2019
Table 35: Rest of European Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 36: Rest of World Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 37: Leading Generic Drug Companies, by Sales, 2019
Table 38: Acronyms Used in This Report
List of Figures
Summary Figure: Global Market for Generic Drugs, by Region, 2018-2025
Figure 1: Impact of COVID-19 on the Pharma Industry
Figure 2: Trends in Global Prescription Drug Sales, 2015-2019
Figure 3: Global Market Shares of Pharmaceutical Drugs, by Therapeutic Area, 2019
Figure 4: Global Market Shares of Asthma Drugs, by Product Category, 2015
Figure 5: Healthcare Expenditures in Major European Markets and the U.S., 2019
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Executive Summary
This report is being published at a time when the pharmaceutical industry faces challenges and changes more radical than any it has faced in the last half-century. The worldwide economic recession in 2008 has had a profound impact on an industry that is normally resilient to the usual ups and downs of commercial life. Apart from the sometimes painful process of cutting costs and restructuring, the industry has had to confront the fact that its trading environment has fundamentally changed because all its customers are now aware of prices.
At this critical time, the pharmaceutical world has also endured a phase for which the label “patent cliff” was coined. A stream of blockbuster drugs has begun losing their patent protection, and R&D pipelines have not been able to produce a satisfactory supply of replacements. The doors have been thrown open to generic drug producers to do what they do best: provide low-cost alternatives.
And there is an added complexity. Over the past two decades, advances in biotechnology have led to the introduction of a generation of biotherapeutic agents that are often more efficacious than traditional small-molecule drugs at treating their target diseases. The earliest of these biotherapeutics are now losing their patent protection, and this offers yet another opportunity for generic copies - although this is a technically fraught area, as will be seen. In fact, the challenges facing “originator” companies - the major purveyors of own-brand pharmaceuticals - are matched by those confronting generic drug suppliers.
Suppliers of generic drugs relied initially on low cost as their main market advantage. It became a potent argument, as the government health departments in most European countries operating national health schemes began to introduce measures designed to curb pharmaceutical expenditure. In the U.S., developments in managed care had a similar effect. Everywhere, these cost-cutting exercises favored generics.
However, the low-cost argument that had been the generic products’ main rationale acted against the commercial promise of this industry sector. This occurred partly because the attractiveness (and thus high-volume sales potential) of blockbuster drugs remained in place after these drugs lost their patent cover. Generic drug companies vied with each other to introduce low-cost copies, and they were driven to undercut each other to the point where a year after patent expiry on the original brand, the mean price of copy products was merely 20% or less of the original.
Partly, too, generic price competition was fueled by government reimbursement measures, which favored low-cost drugs and thus tended to trigger further price cutting among the generic drug contenders.
This development had two far-reaching effects. First, it began to weed out the weaker generic drug companies in favor of companies that had the means and the resolve to exist in an environment where profit margins were severely cut, sometimes to less than 10%. One of the survival strategies adopted by these manufacturers has been to widen their appeal beyond mere cost-cutting, to include, for example, “super generics” products with added value, often in the form of special delivery formulations.
Companies Mentioned
- Aspen Holdings
- Cipla Inc.
- Fresenius Kabi
- Lupin Ltd.
- Mylan Inc.
- Pfizer Inc.
- Sandoz International Gmbh
- Sanofi
- Sun Pharmaceutical Industries Ltd.
- Teva Pharmaceutical Industries Ltd.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 155 |
| Published | May 2021 |
| Forecast Period | 2020 - 2025 |
| Estimated Market Value ( USD | $ 411.6 Billion |
| Forecasted Market Value ( USD | $ 650.3 Billion |
| Compound Annual Growth Rate | 9.6% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
