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Generic Drugs: The Global Market--Focus on Europe
Date:9/22/2011

NEW YORK, Sept. 22, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Generic Drugs: The Global Market--Focus on Europe

http://www.reportlinker.com/p0619265/Generic-Drugs-The-Global-Market--Focus-on-Europe.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 Europe

* 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 several leading generics companies, 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 FORCASTS

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 EUROPEAN MARKET 76

TABLE 15 PHARMACEUTICAL PRICES IN EUROPE AND US, 2000-

2008 ($) 76

FRANCE 77

VITAL STATISTICS 77

HEALTH AND HEALTHCARE 78

Healthcare Provision 78

FIGURE 3 TOTAL EXPENDITURES ON HEALTH IN MAJOR

EUROPEAN MARKETS AND THE US AS A PERCENTAGE OF

GDP, 2007 (%) 79

PHARMACEUTICAL MARKET 80

GENERIC SECTOR 80

TABLE 16 PHARMACEUTICAL AND GENERICS MARKET IN

FRANCE, THROUGH 2016 ($ BILLIONS) 81

GERMANY 82

VITAL STATISTICS 82

HEALTH AND HEALTHCARE 82

Provision of Healthcare 82

PHARMACEUTICAL MARKET 83

Price Controls 83

GENERICS SECTOR 84

TABLE 17 PHARMACEUTICAL AND GENERICS MARKET IN

GERMANY, THROUGH 2016 ($ BILLIONS) 85

ITALY 85

VITAL STATISTICS 85

HEALTH AND HEALTHCARE 86

Healthcare System 86

PHARMACEUTICAL MARKET 87

Implications for Research 88

TABLE 18 SELECTED PRIORITY AREAS IN ITALY'S NATIONAL

HEALTH PLAN 89

GENERICS SECTOR 89

Generics Sector (Continued) 90

TABLE 19 PHARMACEUTICAL AND GENERICS MARKET IN ITALY,

THROUGH 2016 ($ BILLIONS) 91

SPAIN 91

VITAL STATISTICS 91

HEALTH AND HEALTHCARE 91

Healthcare Provision 92

Pharmaceutical Services 93

PHARMACEUTICAL MARKET 93

GENERICS SECTOR 94

Generics Industry 95

TABLE 20 LEADING GENERICS COMPANIES IN SPAIN, 2010 ($

MILLIONS) 95

TABLE 21 PHARMACEUTICAL AND GENERICS MARKET IN SPAIN,

THROUGH 2016 ($ BILLIONS) 96

UNITED KINGDOM 96

VITAL STATISTICS 96

HEALTH AND HEALTHCARE 96

Healthcare Provision 97

Private Sector Involvement 97

Pharmaceuticals 98

THE PHARMACEUTICAL MARKET 98

GENERICS SECTOR 99

TABLE 22 PHARMACEUTICAL AND GENERICS MARKET IN THE

UNITED KINGDOM, THROUGH 2016 ($ BILLIONS) 100

RUSSIA 100

VITAL STATISTICS 100

HEALTH AND HEALTHCARE 101

Healthcare Delivery 101

PHARMACEUTICAL MARKET 101

"Pharma 2020" 102

GENERICS SECTOR 102

TABLE 23 PHARMACEUTICAL AND GENERICS MARKET IN RUSSIA,

THROUGH 2016 ($ BILLIONS) 103

CHAPTER SEVEN: PROFILES OF THE TOP TEN GENERICS

COMPANIES 104

TABLE 24 LEADING GENERICS MANUFACTURERS, 2010 ($

BILLIONS/%) 104

TRENDS 104

STRUCTURE OF THE GENERICS INDUSTRY 105

PROFILES OF TOP 10 GENERICS COMPANIES 106

ACTAVIS 106

Actavis (Continued) 107

APOTEX INC 108

DR REDDY'S LABORATORIES, LTD 109

Acquisitions 110

Financials 111

HOSPIRA, INC 111

Biogenerics 112

Financials 113

MYLAN INC 113

Mylan Inc (Continued) 114

Financials 115

Looking Ahead 115

PAR PHARMACEUTICAL, INC 115

Generics 116

Financials 116

RANBAXY LABORATORIES, LTD 117

History 117

Acquisition by Daiichi Sankyo 118

Financials 119

Looking Ahead 119

SANDOZ INTERNATIONAL GMBH 120

Products 120

TEVA PHARMACEUTICAL INDUSTRIES, LTD 121

Teva Pharmaceutical Industries, Ltd (Continued) 122

Financials 123

WATSON PHARMACEUTICALS, INC 124

Products 124

Financials 124

Looking Ahead 125

CHAPTER EIGHT: PROFILES OF OTHER INTERNATIONAL GENERICS

COMPANIES 126

PROFILES 126

ALAPIS GROUP 126

AMNEAL PHARMACEUTICALS, LLC 127

Amneal Pharmaceuticals Co India Pvt, Ltd 127

ASPEN PHARMACARE HOLDINGS, LTD 128

Financial Results 129

AUROBINDO PHARMA, LTD 130

Products 130

Financials 131

Looking Ahead 131

BERLIN-CHEMIE AG 131

BIOCON 132

Biocon US 132

Biocon US (Continued) 133

Biocon US (Continued) 134

BIOGARAN FRANCE 135

CIPLA, LTD 136

COBALT 137

EGIS PHARMACEUTICALS, PLC 138

APIs 139

Pharmaceutical R&D 139

GEDEON RICHTER, PLC 140

GENEPHARM GROUP 141

KRKA, DD, NOVO MESTO 142

Products 143

Financials 144

Looking Ahead 144

KV PHARMACEUTICAL CO 144

LUPIN, LTD 144

Lupin, Ltd (Continued) 145

MITSUBISHI TANABE PHARMA CORP 146

Tanabe Seiyaku Hanbai Co, Ltd 146

NICHI-IKO PHARMACEUTICAL CO, LTD 147

Products 147

Financials 148

Looking Ahead 148

NIPPON CHEMIPHAR CO, LTD 148

Financials 149

Looking Ahead 149

NOVARTIS INTERNATIONAL AG 149

Looking Ahead 150

ORION CORP 150

Products 150

Generics 151

Financials 151

Looking Ahead 151

PFIZER INC 151

US Basic Patent Expiry 152

TABLE 25 PFIZER'S US PATENT EXPIRIES, THROUGH 2021 152

Financials 153

PLIVA DD 153

ROXANE LABORATORIES, INC 154

SANOFI-AVENTIS 155

Looking Ahead 156

SAWAI PHARMACEUTICAL 156

Products 157

Financials 157

Looking Ahead 157

STADA ARZNEIMITTEL 158

Generics 158

Biosimilars 159

Financials 159

Looking Ahead 159

STRIDES ARCOLAB, LTD 160

Product Range 161

Looking Ahead 161

WOCKHARDT, LTD 162

Financials 163

Looking Ahead 163

ZYDUS CADILA 164

Zydus US Corporate Office 164

Zydus US … (Continued) 165

To order this report:

Machine Tool and Equipment Industry: Generic Drugs: The Global Market--Focus on Europe

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