Generic Drugs: The Global Market Focus on the Americas

REPORT HIGHLIGHTS

THIS REPORT CONTAINS:

• An examination of the strategies employed by companies specializing in generics to meet the challenges of this highly competitive market as well as those utilized by “originator” companies to forestall generic competition; this report will focus on the markets in the Americas
• Analyses of market trends, with data from 2010, estimates for 2011, and projections of compound annual growth rates (CAGRs) through 2016
• Discussion of how fierce price competition has put some companies in difficulties because of slashed profit margins, and of the resulting wave of merger-and-acquisition activity, and the rise of “supergenerics” that offer added value as well as low prices
• A breakdown of the nature and structure of the generics industry, with profiles of the leading 10 to 20 generics companies in the region, and an update of M&A activity

INTRODUCTION

STUDY GOALS AND OBJECTIVES
The aim of this report is to provide detailed market, technology, and industry analyses to help readers quantify and qualify the market for prescription generic drugs.  Important trends are identified and sales forecasts by product categories and major country markets are provided through 2016; these are based on industry sources and considered assessment of the regulatory environment, healthcare policies, demographics, and other factors that directly affect the generic drug market.  The wider economic environment is also taken into account.

The report examines strategies employed by companies specializing in generics to meet the challenges of this highly competitive market, while also summarizing strategies employed by “originator” companies to forestall generic competition.

REASONS FOR DOING THE STUDY
This is a time of growth and change for the generic pharmaceuticals sector.  Major aspects that combine to create an opportunity for an up-to-date market analysis include the following:

• The demand for generics is increasing steadily because of pressure to control healthcare costs.  At the same time, fierce price competition in this area has created difficulties for some companies because of slashed profit margins.  The main result has been a wave of merger and acquisition (M&A) activity, and the rise of “supergenerics,” offering added value as well as low prices.  Not all traditional companies are positioned to exploit this trend.
• A major growth driver for the generics sector is the fact that several blockbuster pharmaceutical brands are coming off-patent and are therefore open to generic competition—the phenomenon widely known as the “patent cliff.”  But the originator companies are deploying formidable strategies to protect their franchises, including marketing their own branded generics.
• With first-generation biopharmaceutical products reaching the end of their patent lives, a whole new market field—biogenerics or biosimilars—is opening up for those generics companies capable of (or prepared to buy-into) the technological expertise required.
• The international landscape is changing for generics as for all pharmaceuticals.  China, India, Russia, Mexico, and Brazil are among the rising markets for generic activity.

SCOPE OF REPORT
This report discusses the implications of all the above-mentioned trends, in the context of the current size and growth of the generics market, both in global terms and analyzed by the most important national markets.  The nature and structure of the generics industry is discussed, with profiles of the leading 20+ generics companies, and an update on M&A activity.  Five-year sales forecasts are provided for the national markets and the major therapeutic categories of products involved.

The report presents overall market size estimates and analysis for the overall global market, as well as more detailed market coverage of the three major segments of the global market: the American market, the European market, and the Asian market.  The American market coverage focuses on the largest markets of North and Latin America (the U.S., Canada, Brazil, and Mexico); European market coverage focuses on the markets in France, Germany, Italy, Spain, and the United Kingdom, as well as an analysis of the Russian market; and Asia market coverage focuses on the three major markets of Japan, China, and India.

MARKET ANALYSES AND FORECASTS
Market figures are based on revenues at the manufacturer level and are projected based on 2011 dollar value without attempting to predict the effect of inflation/deflation.
Therapeutic categories quantified and forecast include antibacterials, antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs (e.g., hypolipidaemics and antihypertensives), and drugs for respiratory conditions, including asthma and COPD.

METHODOLOGY
Both primary and secondary research methodologies were used in preparing this study.  Primary research includes interviews with leading individuals in generics companies, industry associations, and regulatory bodies.   Sources of published data include company annual reports, SEC filings, government and industry publications, literature searches, industry journals, and other commercial publications.  Data for market estimates and forecasts are pooled from a range of sources, and are critically assessed by BCC Research.

INTENDED AUDIENCE
This report is designed to satisfy the information needs of a wide variety of individuals involved in the generics marketplace, including company senior management executives seeking to base their strategic decisions on the best available information on market forces and trends.  However, it is also aimed at managers and executives in marketing, research, planning, and sales departments who need readable, comprehensive, and up-to-date background on the marketplace in which they are operating.

INFORMATION SOURCES
Sources of information included marketing strategists, industry executives, government agencies and regulatory bodies, and surveys of physicians and pharmacists.  Company annual reports and SEC filings, journal articles, and data from healthcare institutions were also mined, as well as publications of relevant trade associations such as the Generic Pharmaceutical Association (GPhA) and the European Generic Medicines Association (EGA).

Table of Contents :

Chapter- 1: INTRODUCTION - Complimentary 4 $0
STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THE STUDY
SCOPE OF REPORT
MARKET ANALYSES AND FORECASTS
METHODOLOGY
INTENDED AUDIENCE
INFORMATION SOURCES

Chapter- 2: SUMMARY 3 $150
MARKET SIZE AND EVOLUTION
Table 0 : MAJOR GENERICS MARKETS, THROUGH 2016
Figure 0 : MAJOR GENERICS MARKETS, THROUGH 2016

Chapter- 3: OVERVIEW 7 $251
RECENT HISTORY OF THE GENERICS SECTOR

Chapter- 4: THE NEW GENERICS ERA 33 $1184
THE PATENT CLIFF
TYPES OF GENERICS
MAJOR GENERIC ISSUES
PATENTS AND IP

Chapter- 5: THE GLOBAL PHARMACEUTICAL AND GENERICS MARKET 28 $1005
GLOBAL GENERICS MARKET
MAIN NATIONAL GENERICS MARKETS
MARKET OPPORTUNITIES BY PRODUCT CLASS

Chapter- 6: THE AMERICAN MARKET 26 $933
THE U.S. MARKET
CANADA
LATIN AMERICA

Chapter- 7: PROFILES OF THE TOP TEN GENERICS COMPANIES 22 $790
TRENDS
STRUCTURE OF THE GENERICS INDUSTRY
PROFILES OF TOP 10 GENERICS COMPANIES

Chapter- 8: PROFILES OF OTHER INTERNATIONAL GENERICS COMPANIES 40 $1436
PROFILES

List of Tables
Summary Table : MAJOR GENERICS MARKETS, THROUGH 2016
Table 1 : GLOBAL PHARMACEUTICAL AND GENERICS MARKETS, THROUGH 2016
Table 2 : FIRST PATENT EXPIRIES, 2012–2023
Table 3 : BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS, 2001–2006
Table 4 : REQUIREMENTS FOR NDA AND ANDA APPLICATIONS
Table 5 : WORLD PHARMA AND GENERICS MARKETS, THROUGH 2016
Table 6 : CURRENT AND FORECAST NATIONAL GENERICS MARKETS, THROUGH 2016
Table 7 : WIDELY PRESCRIBED GENERIC MOLECULES IN THE U.S. AND EUROPE
Table 8 : LEADING ANTI-INFECTIVE PRODUCTS SALES ESTIMATES WITH YEAR OF PATENT EXPIRY, 2010
Table 9 : CNS MARKET BY MAJOR INDICATIONS, 2010
Table 10 : LEADING CNS PRODUCT SALES ESTIMATES, 2010
Table 11 : LEADING CARDIOVASCULAR PRODUCT SALES, 2009
Table 12 : LEADING ANTI-ARTHRITIS PRODUCT SALES ESTIMATES, 2009
Table 13 : LEADING RESPIRATORY PRODUCT SALES ESTIMATES, 2009
Table 14 : LEADING ANTICANCER PRODUCT SALES ESTIMATES, 2009
Table 15 : U.S. PHARMACEUTICAL AND GENERICS MARKETS, THROUGH 2016
Table 16 : GENERICS MARKET IN CANADA, THROUGH 2016
Table 17 : PHARMACEUTICAL AND GENERICS MARKET IN BRAZIL, THROUGH 2016
Table 18 : PHARMACEUTICAL AND GENERICS MARKET IN MEXICO, THROUGH 2016
Table 19 : LEADING GENERICS MANUFACTURERS, 2010
Table 20 : PFIZER’S U.S. PATENT EXPIRIES, THROUGH 2021

List of Figures
Summary Figure : MAJOR GENERICS MARKETS, THROUGH 2016
Figure 1 : CNS MARKET SHARES BY MAJOR INDICATIONS, 2010
Figure 2 : USAGE OF MAIN PRODUCT CATEGORIES BASED REVENUES
Figure 3 : U.S. PHARMACEUTICAL MARKET SHARES BASED ON DOLLAR SALES AND PERCENTAGE SHARE OF PRESCRIPTIONS BY TYPE, 2010