Generic Drugs: The Global Market

  • September 2011
  • -
  • BCC Research


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).

Table Of Contents

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
MandA Activity 92
Background ... 93
Background (Continued) ... 94
PróGenericos . 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 RandD 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 RandD . 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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