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2013 Pharmaceuticals Research Review

  • December 2013
  • -
  • BCC Research
  • -
  • 96 pages

FOREWORD

Research Reviews from BCC Research provide market professionals with concise market coverage within a specific research category. These Research Reviews include portions of several market research reports that were published in 2013, and are an efficient way for market professionals to keep up with the general market developments of 2013.
Please note that page references in the text are to pages in the original, complete report, and do not reflect the actual page numbers in this Research Review.

This 2013 Pharmaceuticals Research Review includes excerpts from the following reports:
• PHM119A Antithrombotic/Anticoagulant Drugs: Technologies and Global Markets.
• PHM045C Global Markets for Drug-Device Combinations.
• PHM005C Global Markets for Treatment and Diagnosis of Sexually Transmitted Diseases.
• PHM128A Histone Methyltransferases: Global Markets for Research Tools, Diagnostics and Drug Discovery.
• PHM066B Ubiquitin Proteasome: Global Markets for Research Tools, Diagnostics and Drug Discovery.

REPORT HIGHLIGHTS

• The global anticoagulant drug market was valued at nearly $5.8 billion in 2011 and should reach nearly $5.7 billion in 2012. Total market value is expected to reach nearly $5.4 billion in 2017 after decreasing at a five-year compound annual growth rate (CAGR) of -1.1%.
• The market for global drug device combination products was valued at $18.5 billion in 2011 and should reach $19 billion in 2012. Total market value is expected to reach $30.5 billion in 2017 after increasing at a five-year compound annual growth rate (CAGR) of 9.9%.
• The global market for treatment and diagnosis of sexually transmitted diseases was valued at $28.2 billion in 2011 and $33.2 billion in 2012. Total market value is expected to reach nearly $52 billion in 2017 after increasing at a five-year compound annual growth rate of 9.3%.

Table Of Contents

2013 Pharmaceuticals Research Review
TABLE OF CONTENTS

CHAPTER 1 ABOUT BCC RESEARCH REVIEWS 2

FOREWORD 2

CHAPTER 2 ANTITHROMBOTIC/ANTICOAGULANT DRUGS: TECHNOLOGIES AND

GLOBAL MARKETS (REPORT PHM119A) 4
INTRODUCTION 4
STUDY GOALS AND OBJECTIVES 4
REASONS FOR STUDY 4
SCOPE OF STUDY 4
METHODOLOGY AND INFORMATION SOURCES 5
ANALYST CREDENTIALS 5
RELATED BCC RESEARCH REPORTS 5
SUMMARY 5
TABLE 1 TOTAL GLOBAL MARKET SIZE AND GROWTH BY REGION FOR
ANTICOAGULANT DRUGS, THROUGH 2017 ($ MILLIONS) 6
FIGURE 1 TOTAL GLOBAL MARKET SIZE AND GROWTH BY REGION FOR
ANTICOAGULANT DRUGS, 2011-2017 ($ MILLIONS) 7
INDUSTRY OVERVIEW 8
THE CIRCULATORY SYSTEM 8
BLOOD VESSEL STRUCTURE 8
BLOOD FLOW 9
CONDITIONS 10
THROMBUS 10
EMBOLUS 11
ALTERATIONS IN VENOUS FLOW 12
DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM 12
TABLE 2 FACTORS PREDISPOSING TO PULMONARY EMBOLISM OF VIRCHOW'S
TRIAD 13
HEMOSTASIS (THE CLOTTING PROCESS) 14
DISEASES ASSOCIATED WITH THROMBOEMBOLISM 15
ACUTE CORONARY SYNDROME 15
Ischemic Heart Disease 16
Etiology 16
Mechanisms of Coronary Atherosclerosis 16
Pathophysiology of Ischemia 17
ANGINA PECTORIS 18
ACUTE ISCHEMIA AND MYOCARDIAL INFARCTION 19
CHRONIC ISCHEMIC CARDIOMYOPATHY 19
SUDDEN CARDIAC DEATH 19
ATRIAL FIBRILLATION 20
Causes 20
CEREBROVASCULAR DISEASE 21
Peripheral Artery Disease (PAD) 22
Prevalence and Incidence 22
Symptoms 22
Causes 23
STENTS AND THROMBOSIS 23
DEMOGRAPHICS 24
TABLE 3 TOTAL GLOBAL POPULATION BY SELECTED GEOGRAPHICAL REGION, 2000
TO 2050 25
FIGURE 2 TOTAL GLOBAL POPULATION BY SELECTED GEOGRAPHICAL REGION,
2000 TO 2050 (MILLIONS) 25
CARDIOVASCULAR, VTE, ATRIAL FIBRILLATION AND STROKE
DEMOGRAPHICS 26
Venous Thromboembolism 26
Cardiovascular Disease 27
TABLE 4 HEART DISEASE DEATHS BY COUNTRY 28
Stroke 28
TABLE 5 U.S. STROKE DEMOGRAPHICS BY SELECTED CHARACTERISTICS, 2010
(THOUSANDS) 29
Atrial Fibrillation 30
VENOUS THROMBOEMBOLISM AND LIFESTYLE 30
VENOUS THROMBOEMBOLISM AND AIR TRAVEL 31

CHAPTER 3 GLOBAL MARKETS FOR DRUG-DEVICE COMBINATIONS (REPORT PHM045C) 34

INTRODUCTION 34
STUDY GOALS AND OBJECTIVES 34
THE IMPORTANCE OF THIS STUDY 34
INTENDED AUDIENCE 35
SCOPE AND FORMAT 35
METHODOLOGY AND INFORMATION SOURCES 36
ANALYST CREDENTIALS 36
RELATED BCC RESEARCH REPORTS 36
SUMMARY 37
SCOPE OF THE INDUSTRY 37
DRUG-DEVICE COMBINATIONS: THE GLOBAL MARKET 37
TABLE 6 SALES OF DRUG DEVICE COMBINATION PRODUCTS, THROUGH 2017 ($
BILLIONS) 38
FIGURE 3 SALES OF DRUG DEVICE COMBINATION PRODUCTS, 2011-2017 ($
BILLIONS) 38
TECHNOLOGY AND PATENT ACTIVITY 39
THE CENTRAL ROLE OF THE FDA 39
CURRENT STATUS OF THE DRUG DEVICE COMBINATION INDUSTRY 40
ROLE OF THE FDA 40
TABLE 7 EXAMPLES OF FDA APPROVED COMBINATION PRODUCTS 42
OFFICE OF COMBINATION PRODUCTS ORGANIZATIONAL STRUCTURE 42
HIGHLY ADVANCED TECHNOLOGIES ARE A MARKET CORE 43
EXAMPLES OF THE MOST PATH-BREAKING PRODUCTS 43
FDA CLASSIFICATION SCHEME FOR INDIVIDUAL SEGMENTS 44
TABLE 8 FDA CLASSIFICATION SCHEME FOR COMBINATION PRODUCTS 45
THE RELATION BETWEEN NANOTECHNOLOGY AND COMBINATION PRODUCTS 45
TABLE 9 COMPANIES INVOLVED IN DRUG RELATED NANOTECHNOLOGY RandD OR
MANUFACTURING 46
FDA TRENDS IN REVIEWING COMBINATION PRODUCTS 48
TABLE 10 FDA TRENDS IN COMBINATION PRODUCT APPLICATIONS, 2003-2010 (NO.
OF PRODUCT SUBMISSIONS) 48
TABLE 11 FDA COMBINATION PRODUCT CATEGORIES IN FY2010 49

CHAPTER 4 GLOBAL MARKETS FOR TREATMENT AND DIAGNOSIS OF SEXUALLY TRANSMITTED DISEASES (REPORT PHM005C) 52

INTRODUCTION 52
REASONS FOR DOING THE STUDY 52
SCOPE OF REPORT 52
METHODOLOGY/INFORMATION SOURCES 52
INTENDED AUDIENCE 53
ANALYST CREDENTIALS 53
RELATED BCC RESEARCH REPORTS 53
SUMMARY 53
TABLE 12 GLOBAL MARKET FOR TREATMENT AND DIAGNOSIS OF SEXUALLY
TRANSMITTED DISEASES, THROUGH 2017 ($ MILLIONS) 54
FIGURE 4 GLOBAL MARKET FOR TREATMENT AND DIAGNOSIS OF SEXUALLY
TRANSMITTED DISEASES, 2011 AND 2017 (%) 54
INDUSTRY OVERVIEW 56
EPIDEMIOLOGY AND ETIOLOGY OF SEXUALLY TRANSMITTED DISEASES 56
TRENDS IN GLOBAL TRANSMISSION OF STDS 56
DIAGNOSIS OF STD 56
VISUAL OBSERVATION 56
BLOOD/TISSUE STAINING 57
AUTOMATED TESTING 57
TABLE 13 MAJOR MANUFACTURERS OF AUTOMATED STD TESTS, 2012 57
NONAUTOMATED STD DIAGNOSTIC TESTING 57
TABLE 14 MAJOR MANUFACTURERS OF RAPID AND LABORATORY DIAGNOSTIC STD
KITS, 2012 58
VACCINES 58
TABLE 15 MAJOR MANUFACTURERS OF VACCINES FOR STDS 59
MARKET ANALYSIS BY DISEASE 59
HPV/GENITAL WARTS 59
Diagnostic Product Market 59
TABLE 16 HPV DIAGNOSTIC PRODUCTS, MANUFACTURER AND MARKET SHARE,
2011 (%) 59
GONORRHEA 60
Diagnostic Product Market 60
TABLE 17 GONORRHEA DIAGNOSTIC PRODUCT MANUFACTURERS AND PRODUCT
NAMES 60
Treatment Market 60
TABLE 18 MAJOR GONORRHEA TREATMENT MANUFACTURERS AND PRODUCTS 61
HEPATITIS A, B AND C 61
Diagnostic Product Market 61
TABLE 19 HEPATITIS A, B AND C DIAGNOSTIC PRODUCT MARKET SHARE AND
REVENUES BY TYPE OF TEST, 2011 ($ MILLIONS/%) 61
Treatment Market 61
TABLE 20 MARKET STANDING OF MAJOR HEPATITIS B AND C TREATMENT
MANUFACTURERS BY REVENUES, 2011 ($ MILLIONS) 62
FIGURE 5 TOP PHARMACEUTICAL MANUFACTURERS IN THE HEPATITIS MARKET
AND THEIR MARKET SHARE, 2011 (%) 62
HIV/AIDS 63
Diagnostic Market 63
TABLE 21 HIV DIAGNOSTIC PRODUCT MARKET SHARE AND REVENUES BY TYPE,
2011 ($ MILLIONS/%) 63
Treatment Market 63
TABLE 22 HIV/AIDS TREATMENT MANUFACTURER MARKET STANDING BY
REVENUES, 2011 ($ MILLIONS/%) 64
FIGURE 6 MARKET SHARE OF LEADING COMPANIES IN THE HIV/AIDS TREATMENT
MARKET, 2011 (%) 64
MARKET SHARE, BY DISEASE 65
TABLE 23 NUMBER OF DIAGNOSTIC AND PHARMACEUTICAL MANUFACTURERS, BY
DISEASE TREATED, WITH REVENUES AND MARKET SHARE, 2011 ($ MILLIONS/%) 65
MERGERS AND ACQUISITIONS 65
TABLE 24 SELECTED MERGERS AND ACQUISITIONS, 2008-2012 ($ MILLIONS) 66

CHAPTER 5 HISTONE METHYLTRANSFERASES: GLOBAL MARKETS FOR RESEARCH TOOLS, DIAGNOSTICS AND DRUG DISCOVERY (REPORT PHM128A) 68

INTRODUCTION 68
STUDY GOALS AND OBJECTIVES 68
REASONS FOR DOING THIS STUDY 68
SCOPE AND FORMAT 69
METHODOLOGY AND INFORMATION SOURCES 69
INTENDED AUDIENCE 69
ANALYST CREDENTIALS 70
RELATED BCC RESEARCH REPORTS 70
SUMMARY 70
TABLE 25 GLOBAL MARKET FOR HISTONE METHYLTRANSFERASES RESEARCH AND
DEVELOPMENT, THROUGH 2018 ($ MILLIONS) 72
FIGURE 7 GLOBAL MARKET FOR HISTONE METHYLTRANSFERASES RESEARCH AND
DEVELOPMENT, 2011-2018 ($ MILLIONS) 72
INTRODUCTION TO HISTONE METHYLTRANSFERASES RESEARCH AND PRODUCT
DEVELOPMENT 73
DNA METHYLATION 75
DNA METHYLTRANSFERASES 76
DNA METHYLATION DETECTION TECHNIQUES 77
HISTONE MODIFICATIONS 78
TABLE 26 DIFFERENT CLASSES OF MODIFICATIONS IDENTIFIED ON HISTONES 78
TABLE 27 MAIN CATEGORIES IN HISTONE-MODIFICATION ENZYMES 79
CHROMATIN METHYLATION REACTION 80
FIGURE 8 SCHEMATIC PRESENTATION OF METHYLATION REACTION 80
HISTONE METHYLTRANSFERASES: LYSINE METHYLATION 81
TABLE 28 EXAMPLES OF HISTONE LYSINE METHYLATION AND ITS FUNCTIONAL
OUTCOMES 82
Role of Lysine Methylation in Chromatin Transcription 83
HISTONE METHYLTRANSFERASES: ARGININE METHYLATION 83
TABLE 29 EXAMPLES OF HISTONE ARGININE METHYLATION AND ITS FUNCTIONAL
OUTCOMES 85
Role of Arginine Methylation in Chromatin Transcription 85
PRDM FAMILY AND HISTONE METHYLTRANSFERASE ACTIVITY 86
TABLE 30 PRDM FAMILY MEMBERS, THEIR RELATED ENZYMATIC ACTIVITY AND
BINDING PARTNERS 87
TABLE 31 EXAMPLES OF EPIGENETIC ALTERATIONS IN DIFFERENT PATHOLOGIES 88

CHAPTER 6 UBIQUITIN PROTEASOME: GLOBAL MARKETS FOR RESEARCH TOOLS, DIAGNOSTICS AND DRUG DISCOVERY (REPORT PHM066B) 90

INTRODUCTION 90
STUDY GOALS AND OBJECTIVES 90
REASONS FOR DOING THIS STUDY 90
SCOPE AND FORMAT 91
METHODOLOGY AND INFORMATION SOURCES 91
INTENDED AUDIENCE 91
ANALYST CREDENTIALS 91
RELATED BCC RESEARCH REPORTS 92
SUMMARY 92
TABLE 32 GLOBAL MARKET FOR UBIQUITIN PROTEASOME RESEARCH AND
DEVELOPMENT, THROUGH 2018 ($ MILLIONS) 93
FIGURE 9 GLOBAL MARKET FOR UBIQUITIN PROTEASOME RESEARCH AND
DEVELOPMENT, 2010-2018 ($ MILLIONS) 93
OVERVIEW OF SCIENTIFIC BACKGROUND AND SIGNIFICANCE OF UBIQUITIN
PROTEASOME RESEARCH 94
UBIQUITIN PROTEASOME SYSTEM: ITS MAJOR COMPONENTS AND
ENZYMATIC PROCESS 94
FIGURE 10 SCHEMATIC REPRESENTATION OF ENZYMATIC STEPS IN
UBIQUITINATION REACTION 95
FIGURE 11 HIERARCHICAL STRUCTURE OF UBIQUITIN PROTEASOME SYSTEM 95
TABLE 33 ENZYMATIC COMPONENTS OF UBIQTUINATION/ DEUBIQUITINATION
REACTION 96
Chain Topology and its Significance in Cellular Function 96
PROTEASOME MACHINERY 97
20S Core Particle 97
19S Core Particle 98
Protein Degradation Process 98
Proteasome as a Target for Drug Discovery 99
UBIQUITIN DOMAIN PROTEINS AND UBIQUITIN-LIKE MODIFIERS 101
TABLE 34 UBIQUITIN LIKE MODIFIERS (UBLS), THEIR FUNCTION AND ASSOCIATED
SUBSTRATES 101



LIST OF TABLES

TABLE 1 TOTAL GLOBAL MARKET SIZE AND GROWTH BY REGION FOR
ANTICOAGULANT DRUGS, THROUGH 2017 ($ MILLIONS) 6
TABLE 2 FACTORS PREDISPOSING TO PULMONARY EMBOLISM OF VIRCHOW'S TRIAD 13
TABLE 3 TOTAL GLOBAL POPULATION BY SELECTED GEOGRAPHICAL REGION, 2000
TO 2050 25
TABLE 4 HEART DISEASE DEATHS BY COUNTRY 28
TABLE 5 U.S. STROKE DEMOGRAPHICS BY SELECTED CHARACTERISTICS, 2010
(THOUSANDS) 29
TABLE 6 SALES OF DRUG DEVICE COMBINATION PRODUCTS, THROUGH 2017 ($
BILLIONS) 38
TABLE 7 EXAMPLES OF FDA APPROVED COMBINATION PRODUCTS 42
TABLE 8 FDA CLASSIFICATION SCHEME FOR COMBINATION PRODUCTS 45
TABLE 9 COMPANIES INVOLVED IN DRUG RELATED NANOTECHNOLOGY RandD OR
MANUFACTURING 46
TABLE 10 FDA TRENDS IN COMBINATION PRODUCT APPLICATIONS, 2003-2010 (NO.
OF PRODUCT SUBMISSIONS) 48
TABLE 11 FDA COMBINATION PRODUCT CATEGORIES IN FY2010 49
TABLE 12 GLOBAL MARKET FOR TREATMENT AND DIAGNOSIS OF SEXUALLY
TRANSMITTED DISEASES, THROUGH 2017 ($ MILLIONS) 54
TABLE 13 MAJOR MANUFACTURERS OF AUTOMATED STD TESTS, 2012 57
TABLE 14 MAJOR MANUFACTURERS OF RAPID AND LABORATORY DIAGNOSTIC STD
KITS, 2012 58
TABLE 15 MAJOR MANUFACTURERS OF VACCINES FOR STDS 59
TABLE 16 HPV DIAGNOSTIC PRODUCTS, MANUFACTURER AND MARKET SHARE, 2011
(%) 59
TABLE 17 GONORRHEA DIAGNOSTIC PRODUCT MANUFACTURERS AND PRODUCT
NAMES 60
TABLE 18 MAJOR GONORRHEA TREATMENT MANUFACTURERS AND PRODUCTS 61
TABLE 19 HEPATITIS A, B AND C DIAGNOSTIC PRODUCT MARKET SHARE AND
REVENUES BY TYPE OF TEST, 2011 ($ MILLIONS/%) 61
TABLE 20 MARKET STANDING OF MAJOR HEPATITIS B AND C TREATMENT
MANUFACTURERS BY REVENUES, 2011 ($ MILLIONS) 62
TABLE 21 HIV DIAGNOSTIC PRODUCT MARKET SHARE AND REVENUES BY TYPE,
2011 ($ MILLIONS/%) 63
TABLE 22 HIV/AIDS TREATMENT MANUFACTURER MARKET STANDING BY REVENUES,
2011 ($ MILLIONS/%) 64
TABLE 23 NUMBER OF DIAGNOSTIC AND PHARMACEUTICAL MANUFACTURERS, BY
DISEASE TREATED, WITH REVENUES AND MARKET SHARE, 2011 ($ MILLIONS/%) 65
TABLE 24 SELECTED MERGERS AND ACQUISITIONS, 2008-2012 ($ MILLIONS) 66
TABLE 25 GLOBAL MARKET FOR HISTONE METHYLTRANSFERASES RESEARCH AND
DEVELOPMENT, THROUGH 2018 ($ MILLIONS) 72
TABLE 26 DIFFERENT CLASSES OF MODIFICATIONS IDENTIFIED ON HISTONES 78
TABLE 27 MAIN CATEGORIES IN HISTONE-MODIFICATION ENZYMES 79
TABLE 28 EXAMPLES OF HISTONE LYSINE METHYLATION AND ITS FUNCTIONAL
OUTCOMES 82
TABLE 29 EXAMPLES OF HISTONE ARGININE METHYLATION AND ITS FUNCTIONAL
OUTCOMES 85
TABLE 30 PRDM FAMILY MEMBERS, THEIR RELATED ENZYMATIC ACTIVITY AND
BINDING PARTNERS 87
TABLE 31 EXAMPLES OF EPIGENETIC ALTERATIONS IN DIFFERENT PATHOLOGIES 88
TABLE 32 GLOBAL MARKET FOR UBIQUITIN PROTEASOME RESEARCH AND
DEVELOPMENT, THROUGH 2018 ($ MILLIONS) 93
TABLE 33 ENZYMATIC COMPONENTS OF UBIQTUINATION/ DEUBIQUITINATION
REACTION 96
TABLE 34 UBIQUITIN LIKE MODIFIERS (UBLS), THEIR FUNCTION AND ASSOCIATED
SUBSTRATES 101



LIST OF FIGURES

FIGURE 1 TOTAL GLOBAL MARKET SIZE AND GROWTH BY REGION FOR
ANTICOAGULANT DRUGS, 2011-2017 ($ MILLIONS) 7
FIGURE 2 TOTAL GLOBAL POPULATION BY SELECTED GEOGRAPHICAL REGION, 2000
TO 2050 (MILLIONS) 25
FIGURE 3 SALES OF DRUG DEVICE COMBINATION PRODUCTS, 2011-2017 ($
BILLIONS) 38
FIGURE 4 GLOBAL MARKET FOR TREATMENT AND DIAGNOSIS OF SEXUALLY
TRANSMITTED DISEASES, 2011 AND 2017 (%) 54
FIGURE 5 TOP PHARMACEUTICAL MANUFACTURERS IN THE HEPATITIS MARKET AND
THEIR MARKET SHARE, 2011 (%) 62
FIGURE 6 MARKET SHARE OF LEADING COMPANIES IN THE HIV/AIDS TREATMENT
MARKET, 2011 (%) 64
FIGURE 7 GLOBAL MARKET FOR HISTONE METHYLTRANSFERASES RESEARCH AND
DEVELOPMENT, 2011-2018 ($ MILLIONS) 72
FIGURE 8 SCHEMATIC PRESENTATION OF METHYLATION REACTION 80
FIGURE 9 GLOBAL MARKET FOR UBIQUITIN PROTEASOME RESEARCH AND
DEVELOPMENT, 2010-2018 ($ MILLIONS) 93
FIGURE 10 SCHEMATIC REPRESENTATION OF ENZYMATIC STEPS IN UBIQUITINATION
REACTION 95
FIGURE 11 HIERARCHICAL STRUCTURE OF UBIQUITIN PROTEASOME SYSTEM 95

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