Global Markets for Generic Drugs

Publisher Name :
Date: 19-May-2021
No. of pages: 155

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.

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 global generic drugs market including Aspen, Cipla, Lupin, Pfizer, Sanofi, Sun Pharmaceuticals and Teva Pharmaceuticals

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.

Global Markets for Generic Drugs

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
BCC Custom Research
Related BCC Research 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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