Global Markets for Enzyme Inhibitors -- Focus on the US

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Global Markets for Enzyme Inhibitors -- Focus on the US

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INTRODUCTION

STUDY GOALS AND OBJECTIVES

The overall goal of this study is to provide a comprehensive understanding of the current and future characteristics of the global market for enzyme inhibitors.

This report explores present and future strategies within the market for enzyme inhibitors, which includes proton pump inhibitors (PPIs), protease inhibitors, reverse transcriptase inhibitors, kinase inhibitors, statins, aromatase inhibitors, phosphodiesterase type 5 (PDE5) inhibitors, neuraminidase inhibitors, and angiotensin-converting enzyme (ACE) inhibitors. The improvements in the market and the setbacks and needs of the market are discussed in this report. The comparisons, usage, and advantages and disadvantages of different types of enzyme inhibitors are also discussed in this report.

A detailed analysis of the enzyme inhibitors industry structure has been conducted. Revenues are broken down by region. Sales figures are estimated for the five-year forecast period of this report, from 2011 to 2016.

Applications for enzyme inhibitors are also discussed in the report, with emphasis on the usage of the inhibitors in therapeutic categories and various disease sectors. The report also covers significant patents and their allotments in each category.

REASONS FOR DOING THE STUDY

Extensive research in the field of enzyme inhibitors has revealed their target-specific functionality in being able to provide therapeutic treatments for various chronic diseases. Modern industries have now begun to explore the advantages of enzyme inhibitors in their productions and processes. This has led to steady market growth for enzyme inhibitors.

Research and development (R&D) spending, along with increasing competition, patent expirations and new technologies, is directing this to a new level. Although, due to patent expirations, the overall revenue for the market has decreased slightly from 2009 to 2011, new advancements, new product launches and the changing lifestyle will cause the market to grow in the foreseeable future. This study looks at almost all the systems affected by these factors.

Acquisition strategies and collaborations by companies are also covered in this report. This study also discusses the strengths and weaknesses of each type/technology in light of the new technologies, growing competition and changing customer needs.

CONTRIBUTIONS OF THE STUDY AND INTENDED AUDIENCE

This report provides invaluable information to manufacturers and users of PPIs, protease inhibitors, reverse transcriptase inhibitors, kinase inhibitors, statins, aromatase inhibitors, PDE5 inhibitors, neuraminidase inhibitors, and ACE inhibitors. Pharmaceutical and biotechnology companies, research institutes, and physicians will find this study to be of interest.

SCOPE OF REPORT

The scope of this study encompasses enzyme inhibitors in the pharmaceutical and biotechnology industry. BCC Research analyzes each market and its applications, regulatory environment, technology involved, market projections and market share. Technological issues include the latest trends and developments. Emerging markets for enzyme inhibitors include countries such as India, China, Japan, Korea, Taiwan, Canada, Africa, Australia and New Zealand.

METHODOLOGY AND INFORMATION SOURCES

BCC conducted a comprehensive literature search, which included technical newsletters and journals. The data were collected through interviews and correspondence with technical experts manufacturing enzyme inhibitors. Projections were based on estimates such as the current number of end users, potential end users, mergers and acquisitions, and market trends.

Many companies within the industry were surveyed to obtain data for this study. Included were manufacturers and end users of enzyme inhibitors in therapeutic categories and various disease sectors industries. The data were carefully collected from various industry sources. BCC spoke with officials within the industry and consulted newsletters; company and product literature; and a host of technical articles, journals, indexes and abstracts. Exhaustive investigations of databases by key terminology were completed. In addition, the data were compiled from current financial, trade and government sources.

ANALYST CREDENTIALS

The study has been carried out by a team of professionals in the biotechnology industry. The project manager for this project is Shalini S. Dewan, who holds a master's degree in pharmaceutical chemistry and has more than 14 years of industry experience. Among the research topics she has covered are studies on compounds of potential pharmaceutical interest from ibuprofen and 2-naphthyl acetic acid. Dewan was awarded a Gold Medal by the prime minister of India for her work and has worked with top companies in India and in the U.S. Some of her other reports with BCC are Reagents for Chromatography; Spectroscopy, An Enduring Market; Advanced Drug Delivery Systems: Technologies and Global Markets; Orthopedic Drugs, Implants and Devices; Medical Imaging Reagents and Analysis Equipment; Pharmaceutical Regulatory Industry; The Dynamic Media, Sera and Reagent Market in Biotechnology; Contract Pharmaceutical Manufacturing, Research and Packaging: Global Markets; Chiral Technology: Global Markets; Autacoids and Related Drugs: Technologies and Global Markets; Contraceptives: Technologies and Global Markets; Liver Disease Treatments: The Global Market; Hormone Replacement Therapies and Other Hormone Therapies: Global Markets; Cardiovascular Medicine: Diagnostics, Drugs and Devices; and Cancer Therapies: Technologies and Global Markets.

The lead consultant for this project is Dr. Kapil A. Setia, who has a doctorate in life sciences. She has a number of research publications in her credit, including her thesis on "Studies on Phenotypic Variation, Clonal Propagation and Phyto-chemistry of Tinospora cordifolia (Willd.)," which was given an award of excellence.

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 1

STUDY GOALS AND OBJECTIVES 1

REASONS FOR DOING THE STUDY 1

CONTRIBUTIONS OF THE STUDY AND INTENDED AUDIENCE 1

SCOPE OF REPORT 2

METHODOLOGY AND INFORMATION SOURCES 2

ANALYST CREDENTIALS 2

RELATED REPORTS 3

BCC ON-LINE SERVICES 3

DISCLAIMER 3

CHAPTER 2 SUMMARY 5

SUMMARY TABLE GLOBAL REVENUE OF ENZYME INHIBITORS MARKET, THROUGH 2016 ($

MILLIONS) 5

SUMMARY FIGURE GLOBAL REVENUE OF ENZYME INHIBITORS MARKET, 2009-2016 ($

MILLIONS) 6

CHAPTER 3 OVERVIEW 8

DEFINITIONS 8

STRUCTURE OF ENZYMES 8

ACTIVATION ENERGY 8

SPECIFICITY 8

ENZYME SUBSTRATE INTERACTION 9

CONDITIONS OF ENZYME ACTION 9

CLASSIFICATION OF ENZYMES 9

OXIDOREDUCTASES 10

TRANSFERASES 10

HYDROLASES 10

NUCLEASES 11

PHOSPHATASES 11

LYASES 11

ISOMERASES 11

LIGASES 11

REAL-LIFE APPLICATIONS OF ENZYMES 11

METABOLIC ENZYMES 12

DIGESTIVE ENZYMES 13

FOOD ENZYMES 14

NEED FOR ENZYMES IN HUMAN BODY 14

PROTEOLYTIC ENZYMES 14

LIPOLYTIC ENZYMES 15

AMYLOLYTIC ENZYMES 15

RENNIN ENZYMES 15

WHAT ARE ENZYME INHIBITORS 15

WHY ENZYME INHIBITION 15

USE OF ENZYME INHIBITORS 16

MECHANISM OF ENZYME INHIBITION 16

TYPES OF ENZYME INHIBITORS 16

MIXED INHIBITION 17

COMPETITIVE INHIBITION 17

CLASSIFICATION OF ENZYME INHIBITORS 17

TABLE 1 CLASSIFICATION OF ENZYME INHIBITORS 17

OXIDOREDUCTASE INHIBITORS 18

ALDOSE REDUCTASE INHIBITORS 18

STATINS 19

HISTORY OF DEVELOPMENT OF STATINS 19

TABLE 2 HISTORY OF DEVELOPMENT OF STATINS 19

5-ALPHA-REDUCTASE INHIBITORS 19

AROMATASE INHIBITORS 20

COX-2 INHIBITORS 20

HYDROLASE INHIBITORS 20

NEURAMINIDASE INHIBITORS 20

PROTEASE INHIBITORS 21

TABLE 3 HISTORY OF DISCOVERY OF PROTEASE INHIBITORS 21

PHOSPHODIESTERASE TYPE 5 (PDE5) INHIBITORS 22

PHOSPHODIESTERASE TYPE 4 (PDE4) INHIBITORS 22

ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS 22

TABLE 4 DEVELOPMENT OF ACE INHIBITORS 23

PROTON PUMP INHIBITORS 23

TRANSFERASE INHIBITORS 23

PROTEIN KINASE INHIBITORS 23

REVERSE TRANSCRIPTASE INHIBITORS 24

CHAPTER 4 REGULATORY ASPECTS 26

TABLE 5 NEW DRUG APPROVALS FOR ENZYME INHIBITORS, 2008-2011 26

TABLE 6 NEW DRUG APPLICATIONS FOR ENZYME INHIBITORS 29

TABLE 7 SAFETY ALERTS FOR ENZYME INHIBITORS, 2008-2011 30

CHAPTER 5 MARKET LEADERS AND THEIR PRODUCTS FOR ENZYME INHIBITORS 34

TABLE 8 LEADING MANUFACTURERS/SUPPLIERS OF PROTON PUMP INHIBITORS 34

TABLE 9 LEADING MANUFACTURERS/SUPPLIERS OF PROTEASE INHIBITORS 34

TABLE 10 LEADING MANUFACTURERS/SUPPLIERS OF KINASE INHIBITORS 35

TABLE 11 LEADING MANUFACTURERS/SUPPLIERS OF STATINS 35

TABLE 12 LEADING MANUFACTURERS/SUPPLIERS OF AROMATASE INHIBITORS 36

TABLE 13 LEADING MANUFACTURERS/SUPPLIERS OF REVERSE TRANSCRIPTASE

INHIBITORS 36

TABLE 14 LEADING MANUFACTURERS/SUPPLIERS OF PED5 INHIBITORS 37

TABLE 15 LEADING MANUFACTURERS/SUPPLIERS OF NEURAMINIDASE INHIBITORS 38

TABLE 16 LEADING MANUFACTURERS/SUPPLIERS OF ACE INHIBITORS 38

CHAPTER 6 NEW DEVELOPMENTS 41

TABLE 17 CLINICAL TRIALS ENZYME INHIBITORS 41

TABLE 18 CLINICAL TRIALS OF STATINS 42

TABLE 19 CLINICAL TRIALS FOR AROMATASE INHIBITORS 44

TABLE 20 CLINICAL TRIALS FOR REVERSE TRANSCRIPTASE INHIBITORS 44

TABLE 21 CLINICAL TRIALS FOR PROTEIN KINASE INHIBITORS 47

TABLE 22 CLINICAL TRIALS FOR PDE5 INHIBITORS 51

TABLE 23 CLINICAL TRIALS FOR PDE4 INHIBITORS 52

TABLE 24 CLINICAL TRIALS FOR PROTEASE INHIBITORS 53

TABLE 25 CLINICAL TRIALS FOR ACE INHIBITORS 53

TABLE 26 CLINICAL TRIALS FOR PROTON PUMP INHIBITORS 55

NEW DRUGS IN CLINICAL TRIALS 56

TABLE 27 NEW ENZYME INHIBITORS IN CLINICAL TRIALS 56

CHAPTER 7 GLOBAL MARKETS 58

MARKET ANALYSIS 58

TABLE 28 GLOBAL MARKET FOR ENZYME INHIBITORS, THROUGH 2016 ($ MILLIONS) 59

FIGURE 1 GLOBAL MARKET FOR ENZYME INHIBITORS, 2009-2016 ($ MILLIONS) 59

PROTON PUMP INHIBITORS 60

MARKET OVERVIEW 60

MARKET REVENUE 61

TABLE 29 GLOBAL MARKET FOR PROTON PUMP INHIBITORS, THROUGH 2016 ($ MILLIONS) 61

FIGURE 2 GLOBAL MARKET FOR PROTON PUMP INHIBITORS, 2009-2016 ($ MILLIONS) 62

PROTEASE INHIBITORS 62

MARKET OVERVIEW 62

MARKET REVENUE 63

TABLE 30 GLOBAL MARKET FOR PROTEASE INHIBITORS, THROUGH 2016 ($ MILLIONS) 64

FIGURE 3 GLOBAL MARKET FOR PROTEASE INHIBITORS, 2009-2016 ($ MILLIONS) 64

REVERSE TRANSCRIPTASE INHIBITORS 64

MARKET OVERVIEW 65

MARKET REVENUE 66

TABLE 31 GLOBAL MARKET FOR REVERSE TRANSCRIPTASE INHIBITORS, THROUGH 2016 ($

MILLIONS) 66

FIGURE 4 GLOBAL MARKET FOR REVERSE TRANSCRIPTASE INHIBITORS, 2009-2016 ($

MILLIONS) 66

KINASE INHIBITORS 67

MARKET OVERVIEW 67

MARKET REVENUE 69

TABLE 32 GLOBAL MARKET FOR KINASE INHIBITORS, THROUGH 2016 ($ MILLIONS) 69

FIGURE 5 GLOBAL MARKET FOR KINASE INHIBITORS, 2009-2016 ($ MILLIONS) 69

STATINS 70

MARKET OVERVIEW 71

MARKET REVENUE 72

TABLE 33 GLOBAL MARKET FOR STATINS, THROUGH 2016 ($ MILLIONS) 72

FIGURE 6 GLOBAL MARKET FOR STATINS, 2009-2016 ($ MILLIONS) 72

AROMATASE INHIBITORS 73

MARKET OVERVIEW 73

MARKET REVENUE 74

TABLE 34 GLOBAL MARKET FOR AROMATASE INHIBITORS, THROUGH 2016 ($ MILLIONS) 74

FIGURE 7 GLOBAL MARKET FOR AROMATASE INHIBITORS, 2009-2016 ($ MILLIONS) 74

PHOSPHODIESTERASE TYPE 5 (PDE5) INHIBITORS 75

MARKET OVERVIEW 75

MARKET REVENUE 76

TABLE 35 GLOBAL MARKET FOR PDE5 INHIBITORS, THROUGH 2016 ($ MILLIONS) 77

FIGURE 8 GLOBAL MARKET FOR PDE5 INHIBITORS, 2009-2016 ($ MILLIONS) 77

NEURAMINIDASE INHIBITORS 77

MARKET OVERVIEW 78

MARKET REVENUE 78

TABLE 36 GLOBAL MARKET FOR NEURAMINIDASE INHIBITORS, THROUGH 2016 ($

MILLIONS) 78

FIGURE 9 GLOBAL MARKET FOR NEURAMINIDASE INHIBITORS, 2009-2016 ($ MILLIONS) 78

ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS 79

MARKET OVERVIEW 80

MARKET REVENUE 80

TABLE 37 GLOBAL MARKET FOR ACE INHIBITORS, THROUGH 2016 ($ MILLIONS) 81

FIGURE 10 GLOBAL MARKET FOR ACE INHIBITORS, 2009-2016 ($ MILLIONS) 81

MARKET SHARES 81

TABLE 38 PROTON PUMP INHIBITOR MARKET SHARES BY REGION, 2010 (%) 82

FIGURE 11 PROTON PUMP INHIBITOR MARKET SHARES BY REGION, 2010 (%) 82

TABLE 39 PROTEASE INHIBITOR MARKET SHARES BY REGION, 2010 ($ MILLIONS) 82

FIGURE 12 PROTEASE INHIBITOR MARKET SHARES BY REGION, 2010 (%) 82

TABLE 40 REVERSE TRANSCRIPTASE INHIBITOR MARKET SHARES BY REGION, 2010 (%) 83

FIGURE 13 REVERSE TRANSCRIPTASE INHIBITOR MARKET SHARES BY REGION, 2010 (%) 83

TABLE 41 KINASE INHIBITOR MARKET SHARES BY REGION, 2010 (%) 84

FIGURE 14 KINASE INHIBITOR MARKET SHARES BY REGION, 2010 (%) 84

TABLE 42 STATINS INHIBITOR MARKET SHARES BY REGION, 2010 (%) 85

FIGURE 15 STATINS INHIBITOR MARKET SHARES BY REGION, 2010 (%) 85

TABLE 43 AROMATASE INHIBITOR MARKET SHARES BY REGION, 2010 (%) 85

FIGURE 16 AROMATASE INHIBITOR MARKET SHARES BY REGION, 2010 (%) 85

TABLE 44 PDE5 INHIBITOR MARKET SHARES BY REGION, 2010 (%) 86

FIGURE 17 PDE5 INHIBITOR MARKET SHARES BY REGION, 2010 (%) 86

TABLE 45 NEURAMINIDASE INHIBITOR MARKET SHARES BY REGION, 2010 (%) 87

FIGURE 18 NEURAMINIDASE INHIBITOR MARKET SHARES BY REGION, 2010 (%) 87

TABLE 46 ACE INHIBITOR MARKET SHARES BY REGION, 2010 (%) 88

FIGURE 19 ACE INHIBITOR MARKET SHARES BY REGION, 2010 (%) 88

MARKET BY APPLICATIONS 88

TABLE 47 GLOBAL ENZYME INHIBITORS MARKET BY THERAPEUTIC CATEGORIES/ DISEASE

SECTORS, THROUGH 2016 ($ MILLIONS) 89

FIGURE 20 GLOBAL ENZYME INHIBITORS MARKET BY THERAPEUTIC CATEGORIES/

DISEASE SECTORS, 2009-2016 ($ MILLIONS) 89

CARDIOVASCULAR (CV) DISEASE 90

TABLE 48 GLOBAL MARKET FOR ENZYME INHIBITORS IN CARDIOVASCULAR DISEASE,

THROUGH 2016 ($ MILLIONS) 91

FIGURE 21 GLOBAL MARKET OF ENZYME INHIBITORS IN CARDIOVASCULAR DISEASE,

2009-2016 ($ MILLIONS) 91

GASTROINTESTINAL DISORDERS 91

TABLE 49 GLOBAL MARKET OF ENZYME INHIBITORS IN GASTROINTESTINAL DISEASE,

THROUGH 2016 ($ MILLIONS) 92

FIGURE 22 GLOBAL MARKET OF ENZYME INHIBITORS IN GASTROINTESTINAL DISEASE,

2009-2016 ($ MILLIONS) 92

ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) 93

TABLE 50 GLOBAL MARKET OF ENZYME INHIBITORS IN HIV/AIDS, THROUGH 2016 ($

MILLIONS) 94

FIGURE 23 GLOBAL MARKET OF ENZYME INHIBITORS IN HIV/AIDS, 2009-2016 ($ MILLIONS) 94

HEPATITIS 95

TABLE 51 GLOBAL MARKET OF ENZYME INHIBITORS IN HEPATITIS, THROUGH 2016 ($

MILLIONS) 96

FIGURE 24 GLOBAL MARKET OF ENZYME INHIBITORS IN HEPATITIS, 2009-2016 ($

MILLIONS) 96

CANCER 97

TABLE 52 GLOBAL MARKET OF ENZYME INHIBITORS IN VARIOUS CANCERS, THROUGH

2016 ($ MILLIONS) 99

FIGURE 25 GLOBAL MARKET OF ENZYME INHIBITORS IN VARIOUS CANCERS, 2009-2016 ($

MILLIONS) 99

ERECTILE DYSFUNCTION (ED) 99

TABLE 53 GLOBAL MARKET OF ENZYME INHIBITORS IN ERECTILE DYSFUNCTION,

THROUGH 2016 ($ MILLIONS) 100

FIGURE 26 GLOBAL MARKET OF ENZYME INHIBITORS IN ERECTILE DYSFUNCTION,

2009-2016 ($ MILLIONS) 100

OTHERS 101

TABLE 54 GLOBAL MARKET OF ENZYME INHIBITORS IN OTHER SECTORS, THROUGH 2016

($ MILLIONS) 102

FIGURE 27 GLOBAL MARKET OF ENZYME INHIBITORS IN OTHER SECTORS, 2009-2016 ($

MILLIONS) 102

GLOBAL MARKET SHARE OF ENZYME INHIBITORS BY APPLICATION 102

TABLE 55 GLOBAL MARKET SHARE OF ENZYME INHIBITORS BY APPLICATION, 2010 (%) 102

FIGURE 28 GLOBAL MARKET SHARE OF TECHNICAL ENZYMES, 2010 (%) 103

CHAPTER 8 MARKETS IN THE UNITED STATES 105

MARKET ANALYSIS 105

TABLE 56 U.S. MARKET FOR ENZYME INHIBITORS, THROUGH 2016 ($ MILLIONS) 105

FIGURE 29 U.S. MARKET FOR ENZYME INHIBITORS, 2009-2016 ($ MILLIONS) 106

PROTON PUMP INHIBITORS (PPI) 107

MARKET OVERVIEW 107

MARKET REVENUE 108

TABLE 57 U.S. MARKET FOR PROTON PUMP INHIBITORS, THROUGH 2016 ($ MILLIONS) 108

FIGURE 30 U.S. MARKET FOR PROTON PUMP INHIBITORS, 2009-2016 ($ MILLIONS) 108

PROTEASE INHIBITORS 109

MARKET OVERVIEW 109

MARKET REVENUE 110

TABLE 58 U.S. MARKET FOR PROTEASE INHIBITORS, THROUGH 2016 ($ MILLIONS) 111

FIGURE 31 U.S. MARKET FOR PROTEASE INHIBITORS, 2009-2016 ($ MILLIONS) 111

REVERSE TRANSCRIPTASE INHIBITORS 111

MARKET OVERVIEW 111

MARKET REVENUE 112

TABLE 59 U.S. MARKET FOR REVERSE TRANSCRIPTASE INHIBITORS, THROUGH 2016 ($

MILLIONS) 112

FIGURE 32 U.S. MARKET FOR REVERSE TRANSCRIPTASE INHIBITORS, 2009-2016 ($

MILLIONS) 113

KINASE INHIBITORS 113

MARKET OVERVIEW 113

MARKET REVENUE 115

TABLE 60 U.S. MARKET FOR KINASE INHIBITORS, THROUGH 2016 ($ MILLIONS) 115

FIGURE 33 U.S. MARKET FOR KINASE INHIBITORS, 2009-2016 ($ MILLIONS) 115

STATINS 115

MARKET OVERVIEW 116

MARKET REVENUE 117

TABLE 61 U.S. MARKET FOR STATINS, THROUGH 2016 ($ MILLIONS) 117

FIGURE 34 U.S. MARKET FOR STATINS, 2009-2016 ($ MILLIONS) 117

AROMATASE INHIBITORS 118

MARKET OVERVIEW 118

MARKET REVENUE 119

TABLE 62 U.S. MARKET FOR AROMATASE INHIBITORS, THROUGH 2016 ($ MILLIONS) 119

FIGURE 35 U.S. MARKET FOR AROMATASE INHIBITORS, 2009-2016 ($ MILLIONS) 119

PHOSPHODIESTERASE TYPE 5 (PDE5) INHIBITORS 120

MARKET OVERVIEW 120

MARKET REVENUE 120

TABLE 63 U.S. MARKET FOR PDE5 INHIBITORS, THROUGH 2016 ($ MILLIONS) 121

FIGURE 36 U.S. MARKET FOR PDE5 INHIBITORS, 2009-2016 ($ MILLIONS) 121

NEURAMINIDASE INHIBITORS 121

MARKET OVERVIEW 122

MARKET REVENUE 122

TABLE 64 U.S. MARKET FOR NEURAMINIDASE INHIBITORS, THROUGH 2016 ($ MILLIONS) 122

FIGURE 37 U.S. MARKET FOR NEURAMINIDASE INHIBITORS, 2009-2016 ($ MILLIONS) 122

ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS 123

MARKET OVERVIEW 123

MARKET REVENUE 124

TABLE 65 U.S. MARKET FOR ACE INHIBITORS, THROUGH 2016 ($ MILLIONS) 124

FIGURE 38 U.S. MARKET FOR ACE INHIBITORS, 2009-2016 ($ MILLIONS) 125

MARKET SHARES OF INDUSTRY LEADERS IN THE UNITED STATES 125

PROTON PUMP INHIBITORS 125

TABLE 66 U.S. MARKET SHARES OF PROTON PUMP INHIBITOR MANUFACTURERS, 2010 (%) 126

FIGURE 39 U.S. MARKET SHARES OF PROTON PUMP INHIBITOR MANUFACTURERS, 2010 (%) 126

PROTEASE INHIBITORS 126

TABLE 67 U.S. MARKET SHARES OF PROTEASE INHIBITOR MANUFACTURERS, 2010 (%) 127

FIGURE 40 U.S. MARKET SHARES OF PROTEASE INHIBITORS MANUFACTURERS, 2010 (%) 127

KINASE INHIBITORS 127

TABLE 68 U.S. MARKET SHARES OF KINASE INHIBITOR MANUFACTURERS, 2010 (%) 128

FIGURE 41 U.S. MARKET SHARES OF KINASE INHIBITORS MANUFACTURERS, 2010 (%) 128

STATINS 128

TABLE 69 U.S. MARKET SHARES OF STATINS MANUFACTURERS, 2010 (%) 128

FIGURE 42 U.S. MARKET SHARES OF STATINS MANUFACTURERS, 2010 (%) 129

AROMATASE INHIBITORS 129

TABLE 70 U.S. MARKET SHARES OF AROMATASE INHIBITOR MANUFACTURERS, 2010 (%) 130

FIGURE 43 U.S. MARKET SHARES OF AROMATASE INHIBITOR MANUFACTURERS, 2010 (%) 130

REVERSE TRANSCRIPTASE INHIBITORS 130

TABLE 71 U.S. MARKET SHARES OF REVERSE TRANSCRIPTASE INHIBITOR

MANUFACTURERS, 2010 (%) 130

FIGURE 44 U.S. MARKET SHARES OF REVERSE TRANSCRIPTASE INHIBITOR

MANUFACTURERS, 2010 (%) 131

PDE5 INHIBITORS 131

TABLE 72 U.S. MARKET SHARES OF PDE5 INHIBITOR MANUFACTURERS, 2010 (%) 131

FIGURE 45 U.S. MARKET SHARES OF PDE5 MANUFACTURERS, 2010 (%) 132

NEURAMINIDASE INHIBITORS 132

TABLE 73 U.S. MARKET SHARES OF NEURAMINIDASE INHIBITOR MANUFACTURERS, 2010

(%) 132

FIGURE 46 U.S. MARKET SHARES OF NEURAMINIDASE MANUFACTURERS, 2010 (%) 132

ACE INHIBITORS 133

TABLE 74 U.S. MARKET SHARES OF ACE INHIBITOR MANUFACTURERS, 2010 (%) 133

FIGURE 47 U.S. MARKET SHARES OF ACE MANUFACTURERS, 2010 (%) 133

MARKET BY APPLICATIONS 134

TABLE 75 U.S. ENZYME INHIBITORS MARKET BY THERAPEUTIC CATEGORIES/DISEASE

SECTORS, THROUGH 2016 ($ MILLIONS) 135

FIGURE 48 U.S. MARKET INHIBITORS MARKET BY THERAPEUTIC CATEGORIES/DISEASE

SECTORS, 2009-2016 ($ MILLIONS) 135

CARDIOVASCULAR (CV) DISEASES 136

TABLE 76 U.S. MARKET OF ENZYME INHIBITORS IN CARDIOVASCULAR DISEASE, THROUGH

2016 ($ MILLIONS) 137

FIGURE 49 U.S. MARKET OF ENZYME INHIBITORS IN CARDIOVASCULAR DISEASE,

2009-2016 ($ MILLIONS) 137

GASTROINTESTINAL DISORDERS 138

TABLE 77 U.S. MARKET OF ENZYME INHIBITORS IN GASTROINTESTINAL DISEASE,

THROUGH 2016 ($ MILLIONS) 138

FIGURE 50 U.S. MARKET OF ENZYME INHIBITORS IN GASTROINTESTINAL DISEASE,

2009-2016 ($ MILLIONS) 138

ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) 139

TABLE 78 U.S. MARKET OF ENZYME INHIBITORS IN HIV/AIDS, THROUGH 2016 ($ MILLIONS) 140

FIGURE 51 U.S. MARKET OF ENZYME INHIBITORS IN HIV/AIDS, 2009-2016 ($ MILLIONS) 140

HEPATITIS 140

TABLE 79 U.S. MARKET OF ENZYME INHIBITORS IN HEPATITIS, THROUGH 2016 ($

MILLIONS) 142

FIGURE 52 U.S. MARKET OF ENZYME INHIBITORS IN HEPATITIS, 2009-2016 ($ MILLIONS) 142

CANCER 142

TABLE 80 U.S. MARKET OF ENZYME INHIBITORS IN VARIOUS CANCER, THROUGH 2016 ($

MILLIONS) 144

FIGURE 53 U.S. MARKET OF ENZYME INHIBITORS IN VARIOUS CANCER, 2009-2016 ($

MILLIONS) 144

ERECTILE DYSFUNCTION 144

TABLE 81 U.S. MARKET OF ENZYME INHIBITORS IN ERECTILE DYSFUNCTION, THROUGH

2016 ($ MILLIONS) 145

FIGURE 54 U.S. MARKET OF ENZYME INHIBITORS IN ERECTILE DYSFUNCTION, 2009-2016

($ MILLIONS) 145

OTHERS 146

TABLE 82 U.S. MARKET OF ENZYME INHIBITORS IN OTHER SECTORS, THROUGH 2016 ($

MILLIONS) 147

FIGURE 55 U.S. MARKET OF ENZYME INHIBITORS IN OTHER SECTORS, 2009-2016 ($

MILLIONS) 147

CHAPTER 9 PATENT ANALYSIS 149

PATENTS BY YEAR 149

TABLE 83 NUMBER OF SIGNIFICANT PATENTS BY YEAR, 2008-2012 149

FIGURE 56 NUMBER OF PATENTS BY YEAR, 2008–2012 149

FIGURE 57 NUMBER OF PATENTS BY YEAR, 2008-2012 (%) 150

PATENTS BY TYPE 150

TABLE 84 PATENTS BY TYPE FOR ENZYME INHIBITORS, 2008-2012 151

FIGURE 58 PATENTS BY TYPE FOR ENZYME INHIBITORS, 2008–2012 151

PATENTS BY COMPANY 151

TABLE 85 NUMBER OF U.S. PATENTS BY COMPANY FOR ENZYME INHIBITORS, 2008-2012 152

PATENTS BY COUNTRY 153

TABLE 86 TOTAL NUMBER OF U.S. PATENTS BY COUNTRY FOR ENZYME INHIBITORS,

2008-2012 153

FIGURE 59 TOTAL NUMBER OF U.S. PATENTS BY COUNTRY FOR ENZYME INHIBITORS,

2008–2012 154

TABLE 87 PATENT SHARES BY COUNTRY FOR INDUSTRIAL ENZYMES, 2008-2012 (%) 155

FIGURE 60 PATENT SHARES BY COUNTRY FOR ENZYME INHIBITORS, 2008-2012 (%) 155

PATENTS BY ASSIGNEE 155

TABLE 88 PATENTS BY TYPE FOR INDUSTRIAL ENZYMES, 2008-2012 156

FIGURE 61 PATENTS BY ASSIGNEE FOR INDUSTRIAL ENZYMES, 2008–2012 (%) 156

CHAPTER 10 CURRENT SITUATION 158

MARKET CONDITIONS 158

UNITED STATES 158

EUROPE 158

EMERGING MARKETS 158

TRENDS AND ISSUES IN ENZYME INHIBITORS MARKET 159

COMPETITION 159

PATENT EXPIRATIONS 159

UPCOMING PATENT EXPIRATIONS/UPCOMING PATENT CLIFF 159

PATENT CHALLENGES / LEGAL PROCEEDINGS 159

NEW INDICATIONS APPROVED 160

NEW DRUG APPROVALS 160

RX- TO- OTC SWITCH 161

INCREASING NUMBER OF BABY BOOMERS 161

MERGERS AND ACQUISITIONS AND ALLIANCES 161

DIRECT-TO-CONSUMER ADVERTISING 162

CHAPTER 11 COMPANY PROFILES 164

ABBOTT LABORATORIES 164

AMGEN INC. 164

ASTRAZENECA PLC 165

AUROBINDO PHARMA 165

BAYER HEALTHCARE PHARMACEUTICALS 165

BOEHRINGER INGELHEIM GMBH 166

BRISTOL-MYERS SQUIBB 166

CIPLA LTD. 167

DR. REDDY'S LABORATORIES LTD. 167

EISAI INC. 168

ELI LILLY & CO. 168

ENDO PHARMACEUTICALS 169

GILEAD SCIENCES INC. 169

GLAXOSMITHKLINE PLC 169

GLENMARK GENERICS LTD. 170

HETERO DRUGS LTD. 171

HOFFMAN-LA ROCHE LTD. 171

INCYTE CORP. 171

JOHNSON & JOHNSON 172

LUPIN PHARMACEUTICALS INC. 172

MERCK & CO. INC. 173

MERCK SERONO SA 174

MYLAN LABORATORIES INC. 174

MYLAN LABORATORIES LTD. 175

NOVARTIS AG 175

NOVARTIS NORTH AMERICA 175

OSI PHARMACEUTICALS LLC 176

PAR PHARMACEUTICAL COMPANIES INC. 176

PFIZER INC. 177

RANBAXY LABORATORIES LTD. 177

ROXANE LABORATORIES LTD. 178

SANDOZ 178

SANOFI-AVENTIS 179

SANTARUS INC. 179

SUN PHARMACEUTICALS 180

TAKEDA PHARMACEUTICAL CO. LTD. 180

TEVA PHARMACEUTICAL INDUSTRIES LTD. 180

VERTEX PHARMACEUTICALS 181

VIIV HEALTHCARE 181

WATSON PHARMACEUTICALS INC. 182

CHAPTER 12 APPENDIX—ABBREVIATIONS 184

LIST OF TABLES

SUMMARY TABLE GLOBAL REVENUE OF ENZYME INHIBITORS MARKET, THROUGH 2016 ($

MILLIONS) 5

TABLE 1 CLASSIFICATION OF ENZYME INHIBITORS 17

TABLE 2 HISTORY OF DEVELOPMENT OF STATINS 19

TABLE 3 HISTORY OF DISCOVERY OF PROTEASE INHIBITORS 21

TABLE 4 DEVELOPMENT OF ACE INHIBITORS 23

TABLE 5 NEW DRUG APPROVALS FOR ENZYME INHIBITORS, 2008-2011 26

TABLE 6 NEW DRUG APPLICATIONS FOR ENZYME INHIBITORS 29

TABLE 7 SAFETY ALERTS FOR ENZYME INHIBITORS, 2008-2011 30

TABLE 8 LEADING MANUFACTURERS/SUPPLIERS OF PROTON PUMP INHIBITORS 34

TABLE 9 LEADING MANUFACTURERS/SUPPLIERS OF PROTEASE INHIBITORS 34

TABLE 10 LEADING MANUFACTURERS/SUPPLIERS OF KINASE INHIBITORS 35

TABLE 11 LEADING MANUFACTURERS/SUPPLIERS OF STATINS 35

TABLE 12 LEADING MANUFACTURERS/SUPPLIERS OF AROMATASE INHIBITORS 36

TABLE 13 LEADING MANUFACTURERS/SUPPLIERS OF REVERSE TRANSCRIPTASE

INHIBITORS 36

TABLE 14 LEADING MANUFACTURERS/SUPPLIERS OF PED5 INHIBITORS 37

TABLE 15 LEADING MANUFACTURERS/SUPPLIERS OF NEURAMINIDASE INHIBITORS 38

TABLE 16 LEADING MANUFACTURERS/SUPPLIERS OF ACE INHIBITORS 38

TABLE 17 CLINICAL TRIALS ENZYME INHIBITORS 41

TABLE 18 CLINICAL TRIALS OF STATINS 42

TABLE 19 CLINICAL TRIALS FOR AROMATASE INHIBITORS 44

TABLE 20 CLINICAL TRIALS FOR REVERSE TRANSCRIPTASE INHIBITORS 44

TABLE 21 CLINICAL TRIALS FOR PROTEIN KINASE INHIBITORS 47

TABLE 22 CLINICAL TRIALS FOR PDE5 INHIBITORS 51

TABLE 23 CLINICAL TRIALS FOR PDE4 INHIBITORS 52

TABLE 24 CLINICAL TRIALS FOR PROTEASE INHIBITORS 53

TABLE 25 CLINICAL TRIALS FOR ACE INHIBITORS 53

TABLE 26 CLINICAL TRIALS FOR PROTON PUMP INHIBITORS 55

TABLE 27 NEW ENZYME INHIBITORS IN CLINICAL TRIALS 56

TABLE 28 GLOBAL MARKET FOR ENZYME INHIBITORS, THROUGH 2016 ($ MILLIONS) 59

TABLE 29 GLOBAL MARKET FOR PROTON PUMP INHIBITORS, THROUGH 2016 ($ MILLIONS) 61

TABLE 30 GLOBAL MARKET FOR PROTEASE INHIBITORS, THROUGH 2016 ($ MILLIONS) 64

TABLE 31 GLOBAL MARKET FOR REVERSE TRANSCRIPTASE INHIBITORS, THROUGH 2016 ($

MILLIONS) 66

TABLE 32 GLOBAL MARKET FOR KINASE INHIBITORS, THROUGH 2016 ($ MILLIONS) 69

TABLE 33 GLOBAL MARKET FOR STATINS, THROUGH 2016 ($ MILLIONS) 72

TABLE 34 GLOBAL MARKET FOR AROMATASE INHIBITORS, THROUGH 2016 ($ MILLIONS) 74

TABLE 35 GLOBAL MARKET FOR PDE5 INHIBITORS, THROUGH 2016 ($ MILLIONS) 77

TABLE 36 GLOBAL MARKET FOR NEURAMINIDASE INHIBITORS, THROUGH 2016 ($ MILLIONS) 78