Generic Drugs: The Global Market: Focus on the Americas

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

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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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