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Global Markets for Generic Drugs

  • February 2017
  • -
  • BCC Research
  • -
  • 155 pages

Use this report to:
- Analyze the challenges and opportunities of developing generic drugs and compare difference fast track drug development approaches.
- Provide detailed market, technology and industry analyses to help readers quantify and qualify the market for prescription generic drugs.
- Examine strategies employed by companies specializing in generics to meet the challenges of this highly competitive market.
- Discuss the current size and growth of the generics industry, both in global terms and analyzed by the most important national markets.

Highlights
- The global market for generic drugs should reach $533 billion by 2021 from $352 billion in 2016 at a compound annual growth rate (CAGR) of 8.7%, from 2016 to 2021.
- The BRIC markets region of the generic drugs industry is the largest market. The market is expected to grow from $132 billion in 2016 to $219 billion in 2021 at a CAGR of 10.7% for the period 2016-2021.
- The North America region of the generic drugs industry is expected to grow from $112 billion in 2016 to $180 billion in 2021 at a CAGR of 10.0% for the period 2016-2021.

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 2018; 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.

REASONS FOR DOING THE STUDY
This is a time of growth and change for the generic pharmaceutical sector. Major aspects that have combined 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 put some companies in difficulties because of slashed profit margins. The main result has been a wave of 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 franchise, 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 in) the technological expertise required.
- The international landscape is changing for generics as for all pharmaceuticals. The BRIC nations (Brazil, Russia, India and China) are among rising centers of 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.

MARKET ANALYSES AND FORECASTS
Market figures are based on revenues at the manufacturer level and are projected on the basis of 2016 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. hypolipidemics and antihypertensive) and drugs for respiratory conditions, including asthma and COPD.

METHODOLOGY
Primary research includes interviews with leading individuals in generics companies, industry associations and regulatory bodies. Primary sources of published data include company annual reports, SEC filings, and government and industry publications. Secondary sources consist of literature searches, industry journals and other commercial publications. Data for market estimates and forecasts are pooled from a range of sources, 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 corporate senior management executives seeking to base their strategic decisions on the best available information on market forces and trends. 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 trade associations such as the Generic Pharmaceutical Association (GPhA) and the European Generic Medicines Association (EGA).

ANALYST'S CREDENTIALS
Paul Evers has been involved in analyzing pharmaceutical and medical markets for 20 years. He is the author of three previous reports on the generics marketplace as well as analyses of major therapeutic categories and the pharmaceutical regulatory environment.

Table Of Contents

Global Markets for Generic Drugs
TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
SCOPE OF REPORT 3
MARKET ANALYSES AND FORECASTS 3
METHODOLOGY 3
INTENDED AUDIENCE 3
INFORMATION SOURCES 3
ANALYST'S CREDENTIALS 4
RELATED BCC RESEARCH REPORTS 4
BCC RESEARCH WEBSITE 4
DISCLAIMER 5
CHAPTER 2 SUMMARY 7
MARKET SIZE AND EVOLUTION 8
SUMMARY TABLE GLOBAL MARKET FOR GENERIC DRUGS, BY REGION, THROUGH 2021 ($ BILLIONS) 9
SUMMARY FIGURE GLOBAL MARKET FOR GENERIC DRUGS, BY REGION, 2014-2021 ($ BILLIONS) 9
CHAPTER 3 OVERVIEW 11
TABLE 1 GLOBAL PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS) 12
RECENT HISTORY OF THE GENERICS SECTOR 13
ROCHE-BOLAR 13
GENERICS LOBBY 14
ICH 15
CHAPTER 4 THE NEW GENERICS ERA 17
THE PATENT CLIFF 18
TABLE 2 MAJOR RECENT AND UPCOMING PATENT EXPIRIES, 2014-2020 18
TABLE 3 BRAND SALES BEFORE AND AFTER PATENT EXPIRY ($ MILLIONS) 19
TYPES OF GENERICS 19
SIMPLE GENERICS 20
Adequate Market Size 20
Patent-expired Therapies 20
Older Products Still Used 21
Long-term Use 21
Straightforward Production Technology 21
Drugs Used in Primary Care 22
SUPERGENERICS 22
BIOSIMILARS 23
TABLE 4 BIOTHERAPEUTICS AMONG TOP 40 PRESCRIPTION PHARMACEUTICALS, 2015 ($ BILLIONS) 24
TABLE 5 BIOLOGICS WITH RECENT OR UPCOMING LOSS OF PATENT PROTECTION 24
SPECIAL CHALLENGES 26
THE BIOSIMILARS MARKET 28
Biosimilar Developments and Introductions 28
EPO 28
G-CSF 29
Interferons 29
hGH 29
Monoclonal Antibodies 29
CHAPTER 5 MAJOR GENERIC ISSUES 32
REGULATORY ENVIRONMENT 32
UNITED STATES 32
TABLE 6 REQUIREMENTS FOR NDA AND ANDA APPLICATIONS 33
EUROPEAN UNION 34
EU Marketing Authorization Systems 35
The Centralized Procedure 35
Decentralized and Mutual Recognition Procedures 36
Mutual Recognition Procedure 37
Types of Applications 37
Applications Under Article 10 (Generic Products) 38
JAPAN 38
Approval of Pharmaceuticals 39
REGULATION OF BIOSIMILARS 39
EU Provisions 40
Evolving Situation in the U.S. 40
User Fees 42
Hatch-Waxman and Bolar 42
DEFENSIVE STRATEGIES BY "BIG PHARMA" 43
"AUTHORIZED GENERICS" 44
User Fees 45
Changing Climate for Generics 45
Situation in Europe 46
PATENTS AND IP 47
SUPPLEMENTARY PROTECTION CERTIFICATES 48
CHAPTER 6 THE GENERICS MARKET 51
GLOBAL PHARMACEUTICAL AND GENERICS MARKET 51
GLOBAL GENERICS MARKET 51
MAIN NATIONAL GENERICS MARKETS 51
TABLE 7 GLOBAL MARKET FOR PHARMA AND GENERIC DRUGS, THROUGH 2021 ($ BILLIONS) 52
TABLE 8 GLOBAL MARKET FOR GENERIC DRUGS, BY COUNTRY, THROUGH 2021 ($ BILLIONS) 52
MARKET OPPORTUNITIES BY PRODUCT CLASS 52
LEADING GENERIC MOLECULES 52
TABLE 9 TOP 20 GENERIC MOLECULES, BY PRESCRIPTION SALES, 2015 ($ BILLIONS) 53
TABLE 10 GLOBAL TOP-SELLING PRESCRIPTION PHARMACEUTICALS 54
Anti-infectives 55
TABLE 11 LEADING ANTI-INFECTIVE PRODUCT SALES, 2015 ($ MILLIONS) 56
CNS Therapies 56
Antidepressants 57
Antipsychotics 58
TABLE 12 LEADING CNS PRODUCT SALES, 2015 ($ MILLIONS) 58
Anxiolytics 59
Sleep Disorders 59
Epilepsy 60
Parkinson's Disease 61
Migraine 61
Cardiovascular Products 61
TABLE 13 LEADING CARDIOVASCULAR PRODUCT SALES, 2015 ($ MILLIONS) 62
Anti-arthritis Products 63
Steroids 63
NSAIDs 63
COX-II Inhibitors 64
DMARDs 65
TABLE 14 LEADING ANTI-ARTHRITIS PRODUCT SALES, 2015 ($ MILLIONS) 65
Respiratory Products 66
Asthma 66
COPD 66
Allergic Rhinitis 67
Bronchodilators 67
Inhaled bronchodilators 67
Anticholinergics 68
Oral bronchodilators 68
Leukotriene antagonists 68
Steroids 69
FIGURE 1 GLOBAL MARKET SHARE OF ASTHMA PRODUCT CATEGORIES (%) 69
TABLE 15 LEADING RESPIRATORY PRODUCT SALES, 2015 ($ MILLIONS) 70
Anticancer Products 70
Cytotoxic Drugs 70
Hormonal Therapy 71
Biologic Response Modifiers 71
Anti-angiogenesis Drugs 71
Monoclonal Antibodies 71
TABLE 16 LEADING ANTICANCER PRODUCT SALES, 2015 ($ MILLIONS) 72
CHAPTER 7 GENERICS MARKETS AND FORECASTS BY COUNTRY 75
AMERICAS 75
UNITED STATES 75
Vital Statistics 75
Health and Healthcare 75
Pharmaceutical Market 76
TABLE 17 U.S. PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 77
Generics Market 77
Biosimilars 77
Generic Prices 77
"Carve-outs" 78
Generics Industry 78
The Future 79
CANADA 79
Vital Statistics 79
Pharmaceutical Market 80
TABLE 18 CANADA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 80
Generics Market 80
Prices of Generics 81
How Generics Are Supplied 82
BRAZIL 82
Vital Statistics 82
Pharmaceutical Market 83
TABLE 19 BRAZIL'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 83
Generics Market 84
MandA Activity 86
Future Prospects 86
ProGenericos 87
ASIA 87
JAPAN 87
Vital Statistics 87
Health and Healthcare 87
Pharmaceutical Market 88
TABLE 20 JAPAN'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 88
TABLE 21 TOP 25 JAPANESE PHARMA COMPANIES ($ MILLIONS/%) 89
Generics Market 90
Generics Industry 92
INDIA 93
Vital Statistics 93
Health and Healthcare 93
Growing Affluence - Changing Medical Needs 93
Pharmaceutical Market 93
TABLE 22 INDIA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 94
Pharma Industry 95
Patent Reform 95
Generics Industry 96
TABLE 23 LEADING PHARMA COMPANIES IN INDIA, 2012 ($ MILLIONS) 96
CHINA 97
Vital Statistics 97
Health and Healthcare 97
Pharmaceutical Market 98
TABLE 24 CHINA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 99
Domestic Industry 99
Foreign Company Involvement 100
Importance of RandD 102
Challenges 102
Market Trends 102
Regulatory Changes 103
Generics Exports 103
Domestic Generics Market 104
Local Dominance 104
EUROPE 105
FRANCE 106
Vital Statistics 106
Health and Healthcare 106
Healthcare Provision 106
FIGURE 2 HEALTH EXPENDITURE IN MAJOR EUROPEAN MARKETS AND THE U.S., 2014 (PERCENTAGE OF GDP) 106
Pharmaceutical Market 108
TABLE 25 FRANCE'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 108
Generics Market 108
GERMANY 110
Vital Statistics 110
Health and Healthcare 110
Provision of Healthcare 110
Pharmaceutical Market 111
Price Controls 111
TABLE 26 GERMANY'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 112
Generics Market 113
ITALY 113
Vital Statistics 113
Health and Healthcare 114
Healthcare System 114
Pharmaceutical Market 114
TABLE 27 ITALY'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 116
Pharmaceutical Industry 116
Generics Market 117
SPAIN 118
Vital Statistics 118
Health and Healthcare 118
Healthcare Provision 118
Pharmaceutical Services 119
Pharmaceutical Market 119
TABLE 28 SPAIN'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 120
Generics Market 120
Generics Industry 121
TABLE 29 LEADING GENERICS COMPANIES IN SPAIN, 2015 ($ MILLIONS) 121
UNITED KINGDOM 121
Vital Statistics 122
Health and Healthcare 122
Healthcare Provision 122
Private Sector Involvement 122
Pharmaceuticals 123
Pharmaceutical Market 123
TABLE 30 LEADING PHARMA COMPANIES IN THE U.K., BY MARKET SHARE, 2013 (%) 124
Generics Market 124
TABLE 31 U.K.'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 125
RUSSIA 126
Vital Statistics 127
Health and Healthcare 127
Healthcare Delivery 127
Pharmaceutical Market 127
Pharma 2020 128
TABLE 32 RUSSIA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 129
TABLE 33 LEADING PHARMA COMPANIES IN RUSSIA, BY MARKET SHARE, 2012 (%) 129
Generics Market 130
CHAPTER 8 THE GLOBAL GENERICS INDUSTRY 132
TABLE 34 LEADING GENERICS COMPANIES, BY SALES, 2015 ($ BILLIONS) 132
TRENDS 132
STRUCTURE OF THE GENERICS INDUSTRY 133
RECENT MandA ACTIVITY 134
BRAND COMPANY INVOLVEMENT 135
PROFILES OF THE LEADING GENERICS COMPANIES 136
ACTAVIS (TEVA) 136
ASPEN PHARMACARE HOLDINGS LTD. 137
CIPLA LTD. 139
FRESENIUS KABI 140
HOSPIRA INC. 141
Biogenerics 141
Financials 142
LUPIN, LTD. 142
MYLAN INC. 143
SANDOZ INTERNATIONAL GMBH 145
Products 145
SANOFI 147
SUN PHARMACEUTICAL INDUSTRIES LTD. 148
TEVA PHARMACEUTICAL INDUSTRIES LTD. 148
Financials 150
OTHER INTERNATIONAL GENERICS COMPANIES 150
AUROBINDO PHARMA LTD. 150
DR. REDDY'S LABORATORIES LTD. 152
EGIS PHARMACEUTICALS PLC 153
APIs 154
KRKA 154
Products 155
PAR PHARMACEUTICAL, INC. 156
Generics 156
STADA ARZNEIMITTEL 157
Generics 157
Biosimilars 158
STRIDES SHASUN LTD. 159
WOCKHARDT LTD. 160
ZYDUS CADILA 161

LIST OF TABLES
SUMMARY TABLE GLOBAL MARKET FOR GENERIC DRUGS, BY REGION, THROUGH 2021 ($ BILLIONS) 9
TABLE 1 GLOBAL PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS) 12
TABLE 2 MAJOR RECENT AND UPCOMING PATENT EXPIRIES, 2014-2020 18
TABLE 3 BRAND SALES BEFORE AND AFTER PATENT EXPIRY ($ MILLIONS) 19
TABLE 4 BIOTHERAPEUTICS AMONG TOP 40 PRESCRIPTION PHARMACEUTICALS, 2015 ($ BILLIONS) 24
TABLE 5 BIOLOGICS WITH RECENT OR UPCOMING LOSS OF PATENT PROTECTION 24
TABLE 6 REQUIREMENTS FOR NDA AND ANDA APPLICATIONS 33
TABLE 7 GLOBAL MARKET FOR PHARMA AND GENERIC DRUGS, THROUGH 2021 ($ BILLIONS) 52
TABLE 8 GLOBAL MARKET FOR GENERIC DRUGS, BY COUNTRY, THROUGH 2021 ($ BILLIONS) 52
TABLE 9 TOP 20 GENERIC MOLECULES, BY PRESCRIPTION SALES, 2015 ($ BILLIONS) 53
TABLE 10 GLOBAL TOP-SELLING PRESCRIPTION PHARMACEUTICALS 54
TABLE 11 LEADING ANTI-INFECTIVE PRODUCT SALES, 2015 ($ MILLIONS) 56
TABLE 12 LEADING CNS PRODUCT SALES, 2015 ($ MILLIONS) 58
TABLE 13 LEADING CARDIOVASCULAR PRODUCT SALES, 2015 ($ MILLIONS) 62
TABLE 14 LEADING ANTI-ARTHRITIS PRODUCT SALES, 2015 ($ MILLIONS) 65
TABLE 15 LEADING RESPIRATORY PRODUCT SALES, 2015 ($ MILLIONS) 70
TABLE 16 LEADING ANTICANCER PRODUCT SALES, 2015 ($ MILLIONS) 72
TABLE 17 U.S. PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 77
TABLE 18 CANADA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 80
TABLE 19 BRAZIL'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 83
TABLE 20 JAPAN'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 88
TABLE 21 TOP 25 JAPANESE PHARMA COMPANIES ($ MILLIONS/%) 89
TABLE 22 INDIA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 94
TABLE 23 LEADING PHARMA COMPANIES IN INDIA, 2012 ($ MILLIONS) 96
TABLE 24 CHINA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 99
TABLE 25 FRANCE'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 108
TABLE 26 GERMANY'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 112
TABLE 27 ITALY'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 116
TABLE 28 SPAIN'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 120
TABLE 29 LEADING GENERICS COMPANIES IN SPAIN, 2015 ($ MILLIONS) 121
TABLE 30 LEADING PHARMA COMPANIES IN THE U.K., BY MARKET SHARE, 2013 (%) 124
TABLE 31 U.K.'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 125
TABLE 32 RUSSIA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%) 129
TABLE 33 LEADING PHARMA COMPANIES IN RUSSIA, BY MARKET SHARE, 2012 (%) 129
TABLE 34 LEADING GENERICS COMPANIES, BY SALES, 2015 ($ BILLIONS) 132

LIST OF FIGURES
SUMMARY FIGURE GLOBAL MARKET FOR GENERIC DRUGS, BY REGION, 2014-2021 ($ BILLIONS) 9
FIGURE 1 GLOBAL MARKET SHARE OF ASTHMA PRODUCT CATEGORIES (%) 69
FIGURE 2 HEALTH EXPENDITURE IN MAJOR EUROPEAN MARKETS AND THE U.S., 2014 (PERCENTAGE OF GDP) 106

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