1. Generic Drugs: The Global Market-Focus on the Americas
Published:September 2011
No.Of pages:175
Price:US $ 3900
Report Summary
* 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
* Patent analyses.
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

2. 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.
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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 Generic Drugs: The Global Market-Focus on the Americas 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.

3. 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).
ANALYST CREDENTIALS
Paul Evers has been involved in analyzing pharmaceutical and medical markets for
20 years. He is the author of two previous reports on the generics marketplace as
well as analyses of major therapeutic categories and the pharmaceutical regulatory
environment.

4. Table Of Contents
CHAPTER ONE: INTRODUCTION
STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THE STUDY
SCOPE OF REPORT
MARKET ANALYSES AND FORECASTS
METHODOLOGY
INTENDED AUDIENCE
INFORMATION SOURCES
ANALYST CREDENTIALS
RELATED REPORTS
BCC ONLINE SERVICES
DISCLAIMER
CHAPTER TWO: SUMMARY
SUMMARY
MARKET SIZE AND EVOLUTION
SUMMARY TABLE MAJOR GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)
SUMMARY FIGURE MAJOR GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)
CHAPTER THREE: OVERVIEW
OVERVIEW
TABLE 1 GLOBAL PHARMACEUTICAL AND GENERICS MARKETS, THROUGH 2016 ($
BILLIONS)
RECENT HISTORY OF THE GENERICS SECTOR
ROCHE-BOLAR
GENERICS LOBBY
ICH
CHAPTER FOUR: THE NEW GENERICS ERA
THE PATENT CLIFF
TABLE 2 FIRST PATENT EXPIRIES, 2012-2023
TYPES OF GENERICS
“SIMPLE” GENERICS
Factors Influencing the Success or Failure of Generics
Adequate Market Size
Patent-Expired Therapies
Older Products Still Used
Long-Term Use
Straightforward Production Technology
Drugs Used in Primary Care
SUPERGENERICS
BIOSIMILARS
TABLE 3 BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS, 2001-2006

5. Special Challenges
The Biosimilar Market
Some Biosimilar Developments and Introductions
EPO
G-CSF
Interferons
HGH
Monoclonal Antibodies
MAJOR GENERIC ISSUES
REGULATORY ENVIRONMENT
U.S.
TABLE 4 REQUIREMENTS FOR NDA AND ANDA APPLICATIONS
European Union
EU Marketing Authorization Systems
The Centralized Procedure
Decentralized and Mutual Recognition Procedures
Mutual-Recognition Procedure
Types of Applications
Applications Under Article 10 (Generic Products)
Japan
Approval (Shonin) of Pharmaceuticals
REGULATION OF BIOSIMILARS
EU Provisions
Evolving Situation in the U.S.
Hatch-Waxman and Bolar
Defensive Strategies by “Big Pharma”
“AUTHORIZED GENERICS”
User Fees
A “Mood Swing” Toward Generics
The Situation in Europe
PATENTS AND IP
SUPPLEMENTARY PROTECTION CERTIFICATES
CHAPTER FIVE: THE GLOBAL PHARMACEUTICAL AND GENERICS MARKET
GLOBAL GENERICS MARKET
MAIN NATIONAL GENERICS MARKETS
TABLE 5 WORLD PHARMA AND GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)
TABLE 6 CURRENT AND FORECAST NATIONAL GENERICS MARKETS, THROUGH
2016 ($ BILLIONS)
MARKET OPPORTUNITIES BY PRODUCT CLASS
LEADING GENERIC MOLECULES
TABLE 7 WIDELY PRESCRIBED GENERIC MOLECULES IN THE U.S. AND EUROPE
Anti-infectives
TABLE 8 LEADING ANTI-INFECTIVE PRODUCTS SALES
ESTIMATES WITH YEAR OF PATENT EXPIRY, 2010 ($ BILLIONS)
CNS Therapies
TABLE 9 CNS MARKET BY MAJOR INDICATIONS, 2010 ($ BILLIONS)

6. FIGURE 1 CNS MARKET SHARES BY MAJOR INDICATIONS, 2010 (%)
Antidepressants
Antipsychotics
TABLE 10 LEADING CNS PRODUCT SALES ESTIMATES, 2010 ($ BILLIONS)
Anxiolytics
Sleep Disorders
Epilepsy
Parkinson’s Disease
Migraine
Cardiovascular Products
TABL 11 LEADING CARDIOVASCULAR PRODUCT SALES, 2009 ($ BILLIONS)
Anti-arthritis Products
Steroids
NSAIDs
COX- II Inhibitors
DMARDs
TABLE 12 LEADING ANTI-ARTHRITIS PRODUCT SALES ESTIMATES, 2009 ($
BILLIONS)
Respiratory Products
Asthma
COPD
Allergic Rhinitis
TABLE 13 LEADING RESPIRATORY PRODUCT SALES ESTIMATES, 2009 ($
BILLIONS)
Drugs Used to Treat Asthma and COPD
Bronchodilators
Inhaled Bronchodilators
Anticholinergics
Oral Bronchodilators
Leukotriene Antagonists
Steroids
FIGURE 2 USAGE OF MAIN PRODUCT CATEGORIES BASED REVENUES (%)
Anticancer Products
Cytotoxic Drugs
Hormonal Therapy
Biologic Response Modifiers
Antiangiogenesis Drugs
Monoclonal Antibodies
TABLE 14 LEADING ANTICANCER PRODUCT SALES ESTIMATES, 2009 ($ BILLIONS)
CHAPTER SIX: THE AMERICAN MARKET
THE U.S. MARKET
VITAL STATISTICS
HEALTH AND HEALTHCARE
THE U.S. PHARMACEUTICAL MARKET
THE GENERICS MARKET: SIZE AND GROWTH
Biosimilars

7. Generic Prices
“Carve-Outs”
Generics Industry
FIGURE 3 U.S. PHARMACEUTICAL MARKET SHARES BASED ON DOLLAR SALES AND
PERCENTAGE SHARE OF PRESCRIPTIONS BY TYPE, 2010 (%)
The Future
TABLE 15 U.S. PHARMACEUTICAL AND GENERICS MARKETS, THROUGH 2016 ($
BILLIONS)
CANADA
VITAL STATISTICS
HEALTH AND HEALTHCARE
THE PHARMACEUTICAL MARKET
GENERICS
Generic Prices
Future Market Growth
How Generics are Supplied
TABLE 16 GENERICS MARKET IN CANADA, THROUGH 2016 ($ BILLIONS)
LATIN AMERICA
BRAZIL
Vital Statistics
Health and Healthcare
Pharmaceutical Market
Generics Market
M&A Activity
Background
PróGenéricos
TABLE 17 PHARMACEUTICAL AND GENERICS MARKET IN BRAZIL, THROUGH 2016
($ BILLIONS)
MEXICO
Vital Statistics
Health and Healthcare
Pharmaceutical Market
Market Resistors
Generic Sector
Generic Industry
Regulatory Issues
AMEGI
Forecasts
TABLE 18 PHARMACEUTICAL AND GENERICS MARKET IN MEXICO, THROUGH 2016
($ BILLIONS)
CHAPTER SEVEN: PROFILES OF THE TOP TEN GENERICS COMPANIES
TABLE 19 LEADING GENERICS MANUFACTURERS, 2010 ($ BILLIONS/%)
TRENDS
STRUCTURE OF THE GENERICS INDUSTRY
PROFILES OF TOP 10 GENERICS COMPANIES
ACTAVIS

8. APOTEX INC
DR. REDDY’S LABORATORIES, LTD.
Acquisitions
Financials
HOSPIRA, INC.
Biogenerics
Financials
MYLAN INC.
Financials
Looking Ahead
PAR PHARMACEUTICAL, INC.
Generics
Financials
RANBAXY LABORATORIES, LTD.
History
Acquisition by Daiichi Sankyo
Financials
Looking Ahead
SANDOZ INTERNATIONAL GMBH
Products
TEVA PHARMACEUTICAL INDUSTRIES, LTD.
Financials
WATSON PHARMACEUTICALS, INC.
Products
Financials
Looking Ahead
CHAPTER EIGHT PROFILES OF OTHER INTERNATIONAL GENERICS
COMPANIES
PROFILES
ALAPIS GROUP
AMNEAL PHARMACEUTICALS, LLC
Amneal Pharmaceuticals Co. India Pvt., Ltd.
ASPEN PHARMACARE HOLDINGS, LTD.
Financial Results
AUROBINDO PHARMA, LTD.
Products
Financials
Looking Ahead
BERLIN-CHEMIE AG
BIOCON
Biocon U.S.
BIOGARAN FRANCE
CIPLA, LTD.
COBALT
EGIS PHARMACEUTICALS, PLC
APIs

9. Pharmaceutical R&D
GEDEON RICHTER, PLC
GENEPHARM GROUP
KRKA, D.D., NOVO MESTO
Products
Financials
Looking Ahead
KV PHARMACEUTICAL CO.
LUPIN, LTD.
MITSUBISHI TANABE PHARMA CORP.
Tanabe Seiyaku Hanbai Co., Ltd.
NICHI-IKO PHARMACEUTICAL CO., LTD.
Products
Financials
Looking Ahead
NIPPON CHEMIPHAR CO., LTD
Financials
Looking Ahead
NOVARTIS INTERNATIONAL AG
Looking Ahead
ORION CORP.
Products
Generics
Financials
Looking Ahead
PFIZER INC.
U.S. Basic Patent Expiry
TABLE 20 PFIZER’S U.S. PATENT EXPIRIES, THROUGH 2021
Financials
PLIVA D.D.
ROXANE LABORATORIES, INC.
SANOFI-AVENTIS
Looking Ahead
SAWAI PHARMACEUTICAL
Products
Financials
Looking Ahead
STADA ARZNEIMITTEL
Generics
Biosimilars
Financials
Looking Ahead
STRIDES ARCOLAB, LTD.
Product Range
Looking Ahead
WOCKHARDT, LTD.
Financials

10. Looking Ahead
ZYDUS CADILA
Zydus U.S. Corporate Office
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