NEW YORK, Sept. 21, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Generic Drugs: The Global Market: Focus on the Americas
http://www.reportlinker.com/p0619264/Generic-Drugs-The-Global-Market-Focus-on-the-Americas.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Machine_Tool_and_Equipment
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
* 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
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).
CHAPTER ONE: INTRODUCTION 1
STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 1
SCOPE OF REPORT 2
MARKET ANALYSES AND FORECASTS 2
METHODOLOGY 2
INTENDED AUDIENCE 3
INFORMATION SOURCES 3
ANALYST CREDENTIALS 3
RELATED REPORTS 3
BCC ONLINE SERVICES 4
DISCLAIMER 4
CHAPTER TWO: SUMMARY 5
SUMMARY 5
MARKET SIZE AND EVOLUTION 6
SUMMARY TABLE MAJOR GENERICS MARKETS, THROUGH 2016 ($
BILLIONS) 7
SUMMARY FIGURE MAJOR GENERICS MARKETS, THROUGH 2016
($ BILLIONS) 7
CHAPTER THREE: OVERVIEW 8
OVERVIEW 8
OVERVIEW (CONTINUED) 9
TABLE 1 GLOBAL PHARMACEUTICAL AND GENERICS MARKETS,
THROUGH 2016 ($ BILLIONS) 10
RECENT HISTORY OF THE GENERICS SECTOR 11
ROCHE-BOLAR 11
Roche-Bolar (Continued) 12
GENERICS LOBBY 13
ICH 14
CHAPTER FOUR: THE NEW GENERICS ERA 15
THE PATENT CLIFF 16
TABLE 2 FIRST PATENT EXPIRIES, 2012–2023 17
TYPES OF GENERICS 17
"SIMPLE" GENERICS 17
Factors Influencing the Success or Failure of Generics 18
Adequate Market Size 18
Patent-Expired Therapies 18
Older Products Still Used 19
Long-Term Use 19
Straightforward Production Technology 19
Drugs Used in Primary Care 20
SUPERGENERICS 20
BIOSIMILARS 21
Biosimilars (Continued) 22
TABLE 3 BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS,
2001–2006 23
Special Challenges 24
Special Challenges (Continued) 25
The Biosimilar Market 26
Some Biosimilar Developments and Introductions 26
EPO 26
G-CSF 26
Interferons 26
HGH 27
Monoclonal Antibodies 27
Monoclonal … (Continued) 28
MAJOR GENERIC ISSUES 29
REGULATORY ENVIRONMENT 29
US 29
TABLE 4 REQUIREMENTS FOR NDA AND ANDA APPLICATIONS 30
US (Continued) 31
European Union 32
EU Marketing Authorization Systems 32
The Centralized Procedure 33
Decentralized and Mutual Recognition
Procedures 34
Mutual-Recognition Procedure 34
Types of Applications 35
Applications Under Article 10 (Generic
Products) 35
Japan 36
Approval (Shonin) of Pharmaceuticals 37
REGULATION OF BIOSIMILARS 37
EU Provisions 38
Evolving Situation in the US 39
Hatch-Waxman and Bolar 39
Defensive Strategies by "Big Pharma" 40
"AUTHORIZED GENERICS" 41
User Fees 42
A "Mood Swing" Toward Generics 43
The Situation in Europe 44
PATENTS AND IP 45
SUPPLEMENTARY PROTECTION CERTIFICATES 46
Supplementary Protection Certificates (Continued) 47
CHAPTER FIVE: THE GLOBAL PHARMACEUTICAL AND GENERICS
MARKET 48
GLOBAL GENERICS MARKET 48
MAIN NATIONAL GENERICS MARKETS 49
TABLE 5 WORLD PHARMA AND GENERICS MARKETS, THROUGH
2016 ($ BILLIONS) 49
TABLE 6 CURRENT AND FORECAST NATIONAL GENERICS
MARKETS, THROUGH 2016 ($ BILLIONS) 50
MARKET OPPORTUNITIES BY PRODUCT CLASS 50
LEADING GENERIC MOLECULES 50
TABLE 7 WIDELY PRESCRIBED GENERIC MOLECULES IN THE US
AND EUROPE 50
TABLE 7 (CONTINUED) 51
Anti-infectives 51
Anti-infectives (Continued) 52
TABLE 8 LEADING ANTI-INFECTIVE PRODUCTS SALES
ESTIMATES WITH YEAR OF PATENT EXPIRY, 2010 ($ BILLIONS) 53
CNS Therapies 54
TABLE 9 CNS MARKET BY MAJOR INDICATIONS, 2010 ($
BILLIONS) 54
FIGURE 1 CNS MARKET SHARES BY MAJOR INDICATIONS, 2010
(%) 55
Antidepressants 55
Antipsychotics 56
TABLE 10 LEADING CNS PRODUCT SALES ESTIMATES, 2010 ($
BILLIONS) 57
Anxiolytics 57
Sleep Disorders 58
Epilepsy 58
Parkinson's Disease 59
Migraine 59
Cardiovascular Products 60
TABLE 11 LEADING CARDIOVASCULAR PRODUCT SALES, 2009 ($
BILLIONS) 61
Anti-arthritis Products 62
Steroids 62
NSAIDs 63
COX- II Inhibitors 63
DMARDs 64
TABLE 12 LEADING ANTI-ARTHRITIS PRODUCT SALES
ESTIMATES, 2009 ($ BILLIONS) 65
Respiratory Products 66
Asthma 66
COPD 66
Allergic Rhinitis 67
Allergic … (Continued) 68
TABLE 13 LEADING RESPIRATORY PRODUCT SALES ESTIMATES,
2009 ($ BILLIONS) 69
Drugs Used to Treat Asthma and COPD 69
Bronchodilators 69
Inhaled Bronchodilators 69
Anticholinergics 70
Oral Bronchodilators 70
Leukotriene Antagonists 70
Steroids 71
FIGURE 2 USAGE OF MAIN PRODUCT CATEGORIES BASED
REVENUES (%) 71
FIGURE 2 (CONTINUED) 72
Anticancer Products 72
Cytotoxic Drugs 72
Hormonal Therapy 72
Biologic Response Modifiers 73
Antiangiogenesis Drugs 73
Monoclonal Antibodies 73
TABLE 14 LEADING ANTICANCER PRODUCT SALES ESTIMATES,
2009 ($ BILLIONS) 74
Monoclonal Antibodies (Continued) 75
CHAPTER SIX: THE AMERICAN MARKET 76
THE US MARKET 76
VITAL STATISTICS 76
HEALTH AND HEALTHCARE 76
Health and Healthcare (Continued) 77
THE US PHARMACEUTICAL MARKET 78
THE GENERICS MARKET: SIZE AND GROWTH 78
Biosimilars 79
Generic Prices 79
"Carve-Outs" 80
Generics Industry 80
FIGURE 3 US PHARMACEUTICAL MARKET SHARES BASED ON
DOLLAR SALES AND PERCENTAGE SHARE OF PRESCRIPTIONS
BY TYPE, 2010 (%) 81
FIGURE 3 (CONTINUED) 82
The Future 83
TABLE 15 US PHARMACEUTICAL AND GENERICS MARKETS,
THROUGH 2016 ($ BILLIONS) 84
CANADA 84
VITAL STATISTICS 84
HEALTH AND HEALTHCARE 85
THE PHARMACEUTICAL MARKET 86
GENERICS 86
Generic Prices 87
Future Market Growth 88
How Generics are Supplied 88
TABLE 16 GENERICS MARKET IN CANADA, THROUGH 2016 ($
BILLIONS) 89
LATIN AMERICA 89
BRAZIL 90
Vital Statistics 90
Health and Healthcare 90
Pharmaceutical Market 91
Generics Market 92
M&A Activity 92
Background 93
Background (Continued) 94
ProGenericos 95
TABLE 17 PHARMACEUTICAL AND GENERICS MARKET IN BRAZIL,
THROUGH 2016 ($ BILLIONS) 95
MEXICO 95
Vital Statistics 95
Health and Healthcare 96
Pharmaceutical Market 96
Market Resistors 97
Generic Sector 97
Generic Industry 98
Regulatory Issues 99
AMEGI 100
Forecasts 100
TABLE 18 PHARMACEUTICAL AND GENERICS MARKET IN
MEXICO, THROUGH 2016 ($ BILLIONS) 101
CHAPTER SEVEN: PROFILES OF THE TOP TEN GENERICS
COMPANIES 102
TABLE 19 LEADING GENERICS MANUFACTURERS, 2010 ($
BILLIONS/%) 102
TRENDS 102
STRUCTURE OF THE GENERICS INDUSTRY 103
PROFILES OF TOP 10 GENERICS COMPANIES 104
ACTAVIS 104
Actavis (Continued) 105
APOTEX INC 106
DR REDDY'S LABORATORIES, LTD 107
Acquisitions 108
Financials 109
HOSPIRA, INC 109
Biogenerics 110
Financials 111
MYLAN INC 111
Mylan Inc (Continued) 112
Financials 113
Looking Ahead 113
PAR PHARMACEUTICAL, INC 113
Generics 114
Financials 114
RANBAXY LABORATORIES, LTD 115
History 115
Acquisition by Daiichi Sankyo 116
Financials 117
Looking Ahead 117
SANDOZ INTERNATIONAL GMBH 118
Products 118
TEVA PHARMACEUTICAL INDUSTRIES, LTD 119
Teva Pharmaceutical Industries, Ltd (Continued) 120
Financials 121
WATSON PHARMACEUTICALS, INC 122
Products 122
Financials 122
Looking Ahead 123
CHAPTER EIGHT PROFILES OF OTHER INTERNATIONAL GENERICS
COMPANIES 124
PROFILES 124
ALAPIS GROUP 124
AMNEAL PHARMACEUTICALS, LLC 125
Amneal Pharmaceuticals Co India Pvt, Ltd 125
ASPEN PHARMACARE HOLDINGS, LTD 126
Financial Results 127
AUROBINDO PHARMA, LTD 128
Products 128
Financials 129
Looking Ahead 129
BERLIN-CHEMIE AG 129
BIOCON 130
Biocon US 130
Biocon US (Continued) 131
Biocon US (Continued) 132
BIOGARAN FRANCE 133
CIPLA, LTD 134
COBALT 135
EGIS PHARMACEUTICALS, PLC 136
APIs 137
Pharmaceutical R&D 137
GEDEON RICHTER, PLC 138
GENEPHARM GROUP 139
KRKA, DD, NOVO MESTO 140
Products 141
Financials 142
Looking Ahead 142
KV PHARMACEUTICAL CO 142
LUPIN, LTD 142
Lupin, Ltd (Continued) 143
MITSUBISHI TANABE PHARMA CORP 144
Tanabe Seiyaku Hanbai Co, Ltd 144
NICHI-IKO PHARMACEUTICAL CO, LTD 145
Products 145
Financials 146
Looking Ahead 146
NIPPON CHEMIPHAR CO, LTD 146
Financials 147
Looking Ahead 147
NOVARTIS INTERNATIONAL AG 147
Looking Ahead 148
ORION CORP 148
Products 148
Generics 149
Financials 149
Looking Ahead 149
PFIZER INC 149
US Basic Patent Expiry 150
TABLE 20 PFIZER'S US PATENT EXPIRIES, THROUGH 2021 150
Financials 151
PLIVA DD 151
ROXANE LABORATORIES, INC 152
SANOFI-AVENTIS 153
Looking Ahead 154
SAWAI PHARMACEUTICAL 154
Products 155
Financials 155
Looking Ahead 155
STADA ARZNEIMITTEL 156
Generics 156
Biosimilars 157
Financials 157
Looking Ahead 157
STRIDES ARCOLAB, LTD 158
Product Range 159
Looking Ahead 159
WOCKHARDT, LTD 160
Financials 161
Looking Ahead 161
ZYDUS CADILA 162
Zydus US Corporate Office 162
Zydus US … (Continued) 163
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Nicolas Bombourg
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