Generic Drugs: The Global Market

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

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REPORT HIGHLIGHTS

* 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.

* 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

U.S. ... 29

TABLE 4 REQUIREMENTS FOR NDA AND ANDA APPLICATIONS . 30

U.S. (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 U.S. 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 U.S.

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 U.S. MARKET .. 76

VITAL STATISTICS .. 76

HEALTH AND HEALTHCARE 76

Health and Healthcare (Continued) ... 77

THE U.S. PHARMACEUTICAL MARKET .. 78

THE GENERICS MARKET: SIZE AND GROWTH . 78

Biosimilars ... 79

Generic Prices .. 79

"Carve-Outs" 80

Generics Industry 80

FIGURE 3 U.S. 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 U.S. 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

PróGenéricos . 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: THE EUROPEAN MARKET .. 102

TABLE 19 PHARMACEUTICAL PRICES IN EUROPE AND U.S., 2000-

2008 ($) . 102

FRANCE .. 103

VITAL STATISTICS 103

HEALTH AND HEALTHCARE .. 104

Healthcare Provision . 104

FIGURE 4 TOTAL EXPENDITURES ON HEALTH IN MAJOR

EUROPEAN MARKETS AND THE U.S. AS A PERCENTAGE OF

GDP, 2007 (%) .. 105

PHARMACEUTICAL MARKET . 106

GENERIC SECTOR . 106

TABLE 20 PHARMACEUTICAL AND GENERICS MARKET IN

FRANCE, THROUGH 2016 ($ BILLIONS) 107

GERMANY .. 108

VITAL STATISTICS 108

HEALTH AND HEALTHCARE .. 108

Provision of Healthcare . 108

PHARMACEUTICAL MARKET . 109

Price Controls 109

GENERICS SECTOR ... 110

TABLE 21 PHARMACEUTICAL AND GENERICS MARKET IN

GERMANY, THROUGH 2016 ($ BILLIONS) 111

ITALY .. 111

VITAL STATISTICS 111

HEALTH AND HEALTHCARE .. 112

Healthcare System 112

PHARMACEUTICAL MARKET . 113

Implications for Research .. 114

TABLE 22 SELECTED PRIORITY AREAS IN ITALY'S NATIONAL

HEALTH PLAN ... 115

GENERICS SECTOR ... 115

Generics Sector (Continued) . 116

TABLE 23 PHARMACEUTICAL AND GENERICS MARKET IN ITALY,

THROUGH 2016 ($ BILLIONS) . 117

SPAIN .. 117

VITAL STATISTICS 117

HEALTH AND HEALTHCARE .. 117

Healthcare Provision . 118

Pharmaceutical Services ... 119

PHARMACEUTICAL MARKET . 119

GENERICS SECTOR ... 120

Generics Industry .. 121

TABLE 24 LEADING GENERICS COMPANIES IN SPAIN, 2010 ($

MILLIONS) .. 121

TABLE 25 PHARMACEUTICAL AND GENERICS MARKET IN SPAIN,

THROUGH 2016 ($ BILLIONS) . 122

UNITED KINGDOM... 122

VITAL STATISTICS 122

HEALTH AND HEALTHCARE .. 122

Healthcare Provision . 123

Private Sector Involvement 123

Pharmaceuticals.. 124

THE PHARMACEUTICAL MARKET . 124

GENERICS SECTOR ... 125

TABLE 26 PHARMACEUTICAL AND GENERICS MARKET IN THE

UNITED KINGDOM, THROUGH 2016 ($ BILLIONS) . 126

RUSSIA ... 126

VITAL STATISTICS 126

HEALTH AND HEALTHCARE .. 127

Healthcare Delivery ... 127

PHARMACEUTICAL MARKET . 127

"Pharma 2020" ... 128

GENERICS SECTOR ... 128

TABLE 27 PHARMACEUTICAL AND GENERICS MARKET IN RUSSIA,

THROUGH 2016 ($ BILLIONS) . 129

CHAPTER EIGHT: THE ASIAN REGION . 130

JAPAN . 130

VITAL STATISTICS 130

HEALTH AND HEALTHCARE .. 130

PHARMACEUTICAL MARKET . 131

TABLE 28 TOP 5 JAPANESE PHARMA COMPANIES, 2008 (%) ... 132

GENERICS SECTOR ... 133

Foreign Presence ... 134

Market Resistance . 135

Generics Industry .. 136

TABLE 29 JAPANESE PHARMACEUTICAL AND GENERICS

MARKET, 2011–2016 ($ BILLIONS) .. 137

INDIA .. 137

VITAL STATISTICS 137

HEALTH AND HEALTHCARE .. 137

Growing Affluence—Changing Medical Needs 138

Regulatory Changes .. 138

PHARMACEUTICAL MARKET . 138

Demographic Factors . 139

Pharma Industry ... 139

Patent Reform 140

GENERICS INDUSTRY .. 141

TABLE 30 LEADING PHARMA COMPANIES IN INDIA, 2010 ($

MILLIONS) .. 141

TABLE 31 PHARMACEUTICAL AND GENERICS MARKET IN INDIA,

THROUGH 2016 ($ BILLIONS) . 142

CHINA . 142

VITAL STATISTICS 142

HEALTH AND HEALTHCARE .. 142

Health and Healthcare (Continued) . 143

PHARMACEUTICAL MARKET . 144

Domestic Industry . 145

Foreign Company Involvement . 146

Importance of R&D 147

Challenges .. 148

Market Trends ... 148

Regulatory Changes .. 149

Generic Exports . 149

Domestic Generics Market 150

Local Dominance 151

FIGURE 5 GENERICS MARKET THERAPEUTIC CATEGORIES 2008

(%) . 152

TABLE 32 PHARMACEUTICAL AND GENERICS MARKET, CHINA,

THROUGH 2016 ($ BILLIONS) . 153

CHAPTER NINE: PROFILES OF THE TOP TEN GENERICS COMPANIES 154

TABLE 33 LEADING GENERICS MANUFACTURERS, 2010 ($

BILLIONS/%) .. 154

TRENDS .. 154

STRUCTURE OF THE GENERICS INDUSTRY .. 155

PROFILES OF TOP 10 GENERICS COMPANIES .. 156

ACTAVIS .. 156

Actavis (Continued) ... 157

APOTEX INC 158

DR. REDDY'S LABORATORIES, LTD. .. 159

Acquisitions 160

Financials ... 161

HOSPIRA, INC. 161

Biogenerics . 162

Financials ... 163

MYLAN INC. 163

Mylan Inc. (Continued) .. 164

Financials ... 165

Looking Ahead ... 165

PAR PHARMACEUTICAL, INC. 165

Generics . 166

Financials ... 166

RANBAXY LABORATORIES, LTD. ... 167

History 167

Acquisition by Daiichi Sankyo .. 168

Financials ... 169

Looking Ahead ... 169

SANDOZ INTERNATIONAL GMBH .. 170

Products . 170

TEVA PHARMACEUTICAL INDUSTRIES, LTD. . 171

Teva Pharmaceutical Industries, Ltd. (Continued) . 172

Financials ... 173

WATSON PHARMACEUTICALS, INC. . 174

Products . 174

Financials ... 174

Looking Ahead ... 175

CHAPTER TEN: PROFILES OF OTHER INTERNATIONAL GENERICS

COMPANIES 176

PROFILES ... 176

ALAPIS GROUP ... 176

AMNEAL PHARMACEUTICALS, LLC .. 177

Amneal Pharmaceuticals Co. India Pvt., Ltd. .. 177

ASPEN PHARMACARE HOLDINGS, LTD. .. 178

Financial Results ... 179

AUROBINDO PHARMA, LTD. ... 180

Products . 180

Financials ... 181

Looking Ahead ... 181

BERLIN-CHEMIE AG . 181

BIOCON 182

Biocon U.S. . 182

Biocon U.S. (Continued) 183

Biocon U.S. (Continued) 184

BIOGARAN FRANCE .. 185

CIPLA, LTD. . 186

COBALT ... 187

EGIS PHARMACEUTICALS, PLC . 188

APIs 189

Pharmaceutical R&D . 189

GEDEON RICHTER, PLC ... 190

GENEPHARM GROUP 191

KRKA, D.D., NOVO MESTO ... 192

Products . 193

Financials ... 194

Looking Ahead ... 194

KV PHARMACEUTICAL CO. . 194

LUPIN, LTD. 194

Lupin, Ltd. (Continued) . 195

MITSUBISHI TANABE PHARMA CORP. . 196

Tanabe Seiyaku Hanbai Co., Ltd. . 196

NICHI-IKO PHARMACEUTICAL CO., LTD. 197

Products . 197

Financials ... 198

Looking Ahead ... 198

NIPPON CHEMIPHAR CO., LTD... 198

Financials ... 199

Looking Ahead ... 199

NOVARTIS INTERNATIONAL AG 199

Looking Ahead ... 200

ORION CORP. .. 200

Products . 200

Generics . 201

Financials ... 201

Looking Ahead ... 201

PFIZER INC. 201

U.S. Basic Patent Expiry ... 202

TABLE 34 PFIZER'S U.S. PATENT EXPIRIES, THROUGH 2021 . 202

Financials ... 203

PLIVA D.D. ... 203

ROXANE LABORATORIES, INC. .. 204

SANOFI-AVENTIS .. 205

Looking Ahead ... 206

SAWAI PHARMACEUTICAL . 206

Products . 207

Financials ... 207

Looking Ahead ... 207

STADA ARZNEIMITTEL 208

Generics . 208

Biosimilars . 209

Financials ... 209

Looking Ahead ... 209

STRIDES ARCOLAB, LTD. . 210

Product Range 211

Looking Ahead ... 211

WOCKHARDT, LTD. ... 212

Financials ... 213

Looking Ahead ... 213

ZYDUS CADILA ... 214

Zydus U.S. Corporate Office .. 214

Zydus U.S. … (Continued) .. 215

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