1. Generic Drugs: The Global Market
Published:September 2011
No.Of Pages:231
Price:US $ 4850
Report Summary
* The global generics market is estimated at about $225 billion in 2011. By 2016, it is expected
that the value of the total global generics sector will have risen to $358 billion, representing more
than 18% of all pharmaceuticals, a projected compound annual growth rate (CAGR) of 9.7%
between 2011 and 2016.
* The North American market is estimated to reach nearly $73 billion in 2011 and is expected to
increase at a 7.9% compound annual growth rate to reach nearly $107 billion in 2016.
* Emerging market represents the second largest market category for generic drugs with the
expected sale of $57 billion in 2011. This should reach nearly $115 billion in 2016, for a CAGR
of 15.1%.
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.

2. * 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.
Browse All Pharmaceuticals Market Research Reports
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

3. other commercial publications. Data for market estimates and forecasts are pooled from a range
of sources, and are critically assessed by BCC Research.
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

4. BIOSIMILARS
TABLE 3 BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS, 2001-2006
Special Challenges
The Biosimilar Market
Some Biosimilar Developments and Introductions
EPO
G-CSF
Interferons
HGH
Monoclonal Antibodies
Monoclonal … (Continued)
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

5. 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)
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
TABLE 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)

6. 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
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

7. Forecasts
TABLE 18 PHARMACEUTICAL AND GENERICS MARKET IN MEXICO, THROUGH
2016 ($ BILLIONS)
CHAPTER SEVEN: THE EUROPEAN MARKET
TABLE 19 PHARMACEUTICAL PRICES IN EUROPE AND U.S., 2000-2008 ($)
FRANCE
VITAL STATISTICS
HEALTH AND HEALTHCARE
Healthcare Provision
FIGURE 4 TOTAL EXPENDITURES ON HEALTH IN MAJOR EUROPEAN MARKETS
AND THE U.S. AS A PERCENTAGE OF GDP, 2007 (%)
PHARMACEUTICAL MARKET
GENERIC SECTOR
TABLE 20 PHARMACEUTICAL AND GENERICS MARKET IN FRANCE, THROUGH
2016 ($ BILLIONS)
GERMANY
VITAL STATISTICS
HEALTH AND HEALTHCARE
Provision of Healthcare
PHARMACEUTICAL MARKET
Price Controls
GENERICS SECTOR
TABLE 21 PHARMACEUTICAL AND GENERICS MARKET IN GERMANY, THROUGH
2016 ($ BILLIONS)
ITALY
VITAL STATISTICS
HEALTH AND HEALTHCARE
Healthcare System
PHARMACEUTICAL MARKET
Implications for Research
TABLE 22 SELECTED PRIORITY AREAS IN ITALY’S NATIONAL HEALTH PLAN
GENERICS SECTOR
TABLE 23 PHARMACEUTICAL AND GENERICS MARKET IN ITALY, THROUGH 2016
($ BILLIONS)
SPAIN
VITAL STATISTICS
HEALTH AND HEALTHCARE
Healthcare Provision
Pharmaceutical Services
PHARMACEUTICAL MARKET
GENERICS SECTOR
Generics Industry
TABLE 24 LEADING GENERICS COMPANIES IN SPAIN, 2010 ($ MILLIONS)
TABLE 25 PHARMACEUTICAL AND GENERICS MARKET IN SPAIN, THROUGH 2016

8. ($ BILLIONS)
UNITED KINGDOM
VITAL STATISTICS
HEALTH AND HEALTHCARE
Healthcare Provision
Private Sector Involvement
Pharmaceuticals
THE PHARMACEUTICAL MARKET
GENERICS SECTOR
TABLE 26 PHARMACEUTICAL AND GENERICS MARKET IN THE UNITED KINGDOM,
THROUGH 2016 ($ BILLIONS)
RUSSIA
VITAL STATISTICS
HEALTH AND HEALTHCARE
Healthcare Delivery
PHARMACEUTICAL MARKET
“Pharma 2020”
GENERICS SECTOR
TABLE 27 PHARMACEUTICAL AND GENERICS MARKET IN RUSSIA, THROUGH 2016
($ BILLIONS)
CHAPTER EIGHT: THE ASIAN REGION
JAPAN
VITAL STATISTICS
HEALTH AND HEALTHCARE
PHARMACEUTICAL MARKET
TABLE 28 TOP 5 JAPANESE PHARMA COMPANIES, 2008 (%)
GENERICS SECTOR
Foreign Presence
Market Resistance
Generics Industry
TABLE 29 JAPANESE PHARMACEUTICAL AND GENERICS MARKET, 2011-2016 ($
BILLIONS)
INDIA
VITAL STATISTICS
HEALTH AND HEALTHCARE
Growing Affluence—Changing Medical Needs
Regulatory Changes
PHARMACEUTICAL MARKET
Demographic Factors
Pharma Industry
Patent Reform
GENERICS INDUSTRY
TABLE 30 LEADING PHARMA COMPANIES IN INDIA, 2010 ($ MILLIONS)
TABLE 31 PHARMACEUTICAL AND GENERICS MARKET IN INDIA, THROUGH 2016

9. ($ BILLIONS)
CHINA
VITAL STATISTICS
HEALTH AND HEALTHCARE
PHARMACEUTICAL MARKET
Domestic Industry
Foreign Company Involvement
Importance of R&D
Challenges
Market Trends
Regulatory Changes
Generic Exports
Domestic Generics Market
Local Dominance
FIGURE 5 GENERICS MARKET THERAPEUTIC CATEGORIES 2008 (%)
TABLE 32 PHARMACEUTICAL AND GENERICS MARKET, CHINA, THROUGH 2016 ($
BILLIONS)
CHAPTER NINE: PROFILES OF THE TOP TEN GENERICS COMPANIES
TABLE 33 LEADING GENERICS MANUFACTURERS, 2010 ($ BILLIONS/%)
TRENDS
STRUCTURE OF THE GENERICS INDUSTRY
PROFILES OF TOP 10 GENERICS COMPANIES
ACTAVIS
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.

10. Financials
WATSON PHARMACEUTICALS, INC.
Products
Financials
Looking Ahead
CHAPTER TEN: 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
Pharmaceutical R&D
GEDEON RICHTER, PLC
GENEPHARM GROUP
KRKA, D.D., NOVO MESTO
Products
Financials
Looking Ahead
KV PHARMACEUTICAL CO.
LUPIN, LTD.
Lupin, Ltd. (Continued)
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

11. Looking Ahead
ORION CORP.
Products
Generics
Financials
Looking Ahead
PFIZER INC.
U.S. Basic Patent Expiry
TABLE 34 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
Looking Ahead
ZYDUS CADILA
Zydus U.S. Corporate Office
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