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Cardiac Biomarkers: Technologies and Global Markets

  • June 2016
  • -
  • BCC Research
  • -
  • 191 pages

This BCC Research report provides a comprehensive analysis of the cardiac biomarker market and its trends from 2014 through 2020. It details the history and current state of cardiovascular diseases (CVDs), background on cardiac biomarkers and the current industrial technologies for their diagnosis.

Use this report to:

Analyze the cardiac biomarkers market by cerebrovascular, congestive, coronary, hypertensive, and peripheral arterial disease and the current industrial technologies for their diagnosis.
Identify overall market trends, product opportunities, emerging regional markets, merger and acquisition opportunities and insights.
Address critically important topics for analyzing and accessing a changing market dynamic, emerging players and technologies, strategies and specific disease segments.
Investigate one of the most important drivers in the in vitro diagnostics market: additional biomarkers for heart failure, including ST2, galectin-3 and others, and biomarkers for stroke such as glial fibrillary acidic protein and S100-beta.

Highlights

The global cardiac biomarkers market grew to $4.9 billion in 2015 from $4.4 billion in 2014.
The market is expected to grow at a five-year compound annual growth rate (CAGR) of 12.4% from 2015 to 2020, increasing to over $8.8 billion in 2020.
North American biomarkers is the largest sector of the market.
The market is expected to grow from $2.5 billion in 2015 to $3.9 billion in 2020 at a CAGR of 9.5% for the period 2015-2020.
The APAC biomarkers market is expected to grow from $1.1 billion in 2015 to $2.5 billion in 2020 at a CAGR of 17.6% for the period 2015-2020.

STUDY GOALS AND OBJECTIVES

This report provides a comprehensive analysis of the cardiac biomarker market and its trends from 2014 through 2020. It details the history and current state of cardiovascular diseases (CVDs), background on cardiac biomarkers and the current industrial technologies for their diagnosis.

An in-depth analysis is provided of the predominant biomarkers in the market:

- Cardiac troponin (cTn) proteins (complex I and T).
- Natriuretic peptide (BNP [brain natriuretic peptide] and NT-proBNP [N-terminal pro-hormone of brain natriuretic peptide]).
- D-dimer.
- C-reactive protein (CRP).
- Creatine kinase-MB (CK-MB).

Other related topics including intellectual property, regulatory requirement, leading diagnostics companies and the competitive landscape are also discussed. The market analysis is based on biomarker, region, demographics and instrumentation platform.

REASONS FOR DOING THE STUDY

This study was conducted to offer support to companies by providing analytical information and to help them generate business strategies. Often, the ability to successfully execute business strategies hinges on how to effectively develop an effective plan with the relevant information and data.

This report investigates one of the most important drivers in the in vitro diagnostics market: the introduction of additional biomarkers for heart failure (HF), including ST2, galectin-3 and others, as well as ongoing research of biomarkers for stroke such as GFAP (glial fibrillary acidic protein) and S100-beta.

Together, they are expected to substantially contribute to the growth of the market for cardiac biomarkers over the forecast period of 2015 through 2020. This report analyzes the emerging markets by assay type, instrumentation and region. Continued growth is expected in emerging countries, driven by the growth in the practice of preventive medicine in developing regions such as China, South America and the rest of the world.

Table Of Contents

Cardiac Biomarkers: Technologies and Global Markets
CARDIAC BIOMARKERS: TECHNOLOGIES AND GLOBAL MARKETS
TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
SCOPE OF REPORT 2
INTENDED AUDIENCE 3
METHODOLOGY AND INFORMATION SOURCES 4
ANALYST'S CREDENTIALS 4
RELATED BCC RESEARCH REPORTS 5
BCC RESEARCH WEBSITE 5
DISCLAIMER 5
CHAPTER 2 SUMMARY 7
SUMMARY TABLE GLOBAL CARDIAC BIOMARKER MARKET BY REGION, THROUGH
2020 ($ MILLIONS) 8
SUMMARY FIGURE GLOBAL CARDIAC BIOMARKER MARKET BY REGION, 2014-2020
($ MILLIONS) 8
CHAPTER 3 OVERVIEW 11
MAJOR TRENDS IN THE CARDIAC BIOMARKERS MARKET 11
DEVELOPMENT OF POINT-OF-CARE BIOMARKERS MARKET 11
IMPROVED CLINICAL AND ANALYTICAL SENSITIVITY 11
CHINA TO BE THE LEADING FORCE IN THE ASIAN MARKET 11
FIGURE 1 NUMBER OF PATENTS BY COUNTRY, IT* AND HEALTHCARE, 2013 (NO. OF
PATENTS) 11
GLOBAL INCREASE IN LIFESTYLE-ORIENTED DISEASES AND FATALITIES 12
PATENT TRENDS 13
Cardiac Biomarkers Patent by Region 13
FIGURE 2 NUMBER OF CARDIAC BIOMARKER PATENTS BY REGION*, 2011-2015 (NO.
OF PATENTS) 13
Cardiac Biomarkers by Stakeholders 14
FIGURE 3 SHARES OF STAKEHOLDERS IN CARDIAC BIOMARKERS PATENTS,
2011-2015 (NO./%) 14
Patents by Assignee 15
FIGURE 4 NUMBER OF CARDIAC BIOMARKER PATENTS BY ASSIGNEE, 2011-2015
(NO. OF PATENTS) 15
STRATEGIC TRENDS 16
FIGURE 5 TOP STRATEGIES, 2011-2015 (NUMBER) 17
TYPE OF BIOMARKERS 18
PREDICTIVE 18
DIAGNOSTIC 19
GOLD STANDARD OF CARDIAC BIOMARKERS 19
BIOMARKER DISCOVERY AND VALIDATION 19
BIOMARKER CANDIDATE SCREENING 19
BIOMARKER CANDIDATE VALIDATION 20
ALTERNATIVE MARKETS 20
DIAGNOSTIC DEVICES 20
CORONARY ANGIOGRAPHY 20
TABLE 1 PRICE RANGE OF CORONARY ANGIOGRAPHY/CT ANGIOGRAPHY ($) 21
MAGNETIC RESONANCE ANGIOGRAM 21
X-RAY IMAGING 22
ECHOCARDIOGRAPHY 22
TABLE 2 DIFFERENT BRANDS AND COST OF ECG MACHINES ($) 23
RELATED MARKETS 23
PROTEOMICS 23
END USERS AND STAKEHOLDERS IN THE BIOMARKER INDUSTRY 24
HOSPITALS AND ACADEMIA 24
TABLE 3 LEADING HOSPITALS AND INSTITUTES INVOLVED IN BIOMARKER STUDY 25
CONTRACT RESEARCH ORGANIZATIONS 25
BIOTECHNOLOGY COMPANIES 26
TABLE 4 COMPANIES INVOLVED IN BIOMARKER STUDIES 26
EPIDEMIC OF CARDIOVASCULAR DISEASE 27
TABLE 5 EPIDEMIC OF CARDIOVASCULAR DISEASES, 2015 28
RISK FACTORS AND PREVENTION OF CARDIOVASCULAR DISEASE 30
FIGURE 6 GLOBAL DISTRIBUTION OF CARDIOVASCULAR DISEASE: DALY, 2004 (PER
100,000 PEOPLE) 31
FIGURE 7 GLOBAL CARDIOVASCULAR DISEASE TRENDS, 2011-2018 (MILLION
CASES) 32
CLASSIFICATION OF CARDIOVASCULAR DISEASE 32
CORONARY HEART DISEASE 33
TABLE 6 DISEASE PROFILE: CORONARY HEART DISEASE 34
TABLE 7 HEART DISEASE PERCENTAGE IN DIFFERENT RACES AND ETHNICITIES,
2013 (%) 36
ACUTE MYOCARDIAL INFARCTION 36
TABLE 8 DISEASE PROFILE: ACUTE MYOCARDIAL INFARCTION 37
HYPERTENSIVE HEART DISEASE 39
TABLE 9 DISEASE PROFILE OF HYPERTENSIVE HEART DISEASE 40
CEREBROVASCULAR DISEASE 42
TABLE 10 DISEASE PROFILE: CEREBROVASCULAR DISEASE 43
CONGESTIVE HEART FAILURE 45
TABLE 11 DISEASE PROFILE: CONGESTIVE HEART FAILURE 46
PERIPHERAL ARTERIAL DISEASE 48
OTHER DISEASES 48
TABLE 12 DISEASE PROFILE: HEMORRHAGIC STROKE 48
HISTORY AND CURRENT STATE OF HEART DISEASE 52
FUTURE DIRECTION OF CARDIAC BIOMARKERS DIAGNOSIS 58
BACKGROUND AND CLINICAL VALUE OF CARDIAC BIOMARKERS 59
BNP AND NT-PROBNP 59
C-REACTIVE PROTEIN 60
COPEPTIN 61
CREATINE KINASE MB 62
D-DIMER 63
GALECTIN-3 64
HEART FATTY ACID BINDING PROTEIN 65
MYOGLOBIN 66
TABLE 13 PRODUCT PROFILE: MYOGLOBIN 67
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ST2 69
TABLE 14 BIOMARKER PROFILE: ST2 70
CARDIAC TROPONIN I/TROPONIN T 71
TABLE 15 PRODUCT PROFILE: TROPONIN 72
Description of Troponin Biomarkers 75
Troponin as the Preferred Biomarker 82
FIGURE 8 INTERPRETING ELEVATED LEVELS OF CARDIAC TROPONIN 82
CARDIAC BIOMARKERS UNDER DEVELOPMENT 84
Choline 84
Glial Fibrillary Acidic Protein 84
Ischemia-Modified Albumin 84
Myeloperoxidase 85
S100-Beta 85
CLINICAL GUIDELINES OF BIOMARKERS 86
TROPONIN/CK-MB/MYOGLOBLIN 86
BNP/NT-PROBNP 87
COPEPTIN 87
GALECTIN-3 88
C-REACTIVE PROTEIN 89
ST2 89
CHAPTER 4 INDUSTRY STRUCTURE AND COMPETITIVE ANALYSIS 92
INDUSTRY STRUCTURE 92
DIAGNOSTIC METHODS 92
IMMUNOASSAY 92
Radioimmunoassay 93
Enzyme-Linked Immunosorbent Assay 93
Chemiluminescent Enzyme Immunoassay 94
LIGHT SCATTERING 95
Turbidimetry 95
Nephelometry 95
Particle Counting 95
New Developments 95
LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY 96
PATENT ANALYSIS 96
NEWLY ISSUED PATENTS 96
TABLE 16 PATENT TRENDS ON CARDIAC BIOMARKER ASSAYS USED FOR
DIAGNOSTIC TESTING, 2009-2015 (NO. OF PATENTS) 97
Patents on Assays 97
TABLE 17 PATENTS BY BIOMARKER CATEGORY, 2009-2015 (NO./%) 97
Patents by Manufacturer/Research Institute 97
TABLE 18 PATENTS BY COMPANY, 2009-2015 (NO./%) 98
TABLE 19 PATENTS ON CARDIAC BIOMARKER BY ASSIGNEE TYPE (NO./%) 98
TABLE 20 PATENT ANALYSIS BY REGION, 2009-2015 (NO./%) 99
TABLE 21 U.S. PATENT ANALYSIS, 2009-2015 (NO./%) 99
TABLE 22 EUROPEAN PATENT ANALYSIS, 2009-2015 (NO./%) 100
TABLE 23 PATENTS ON CARDIAC BIOMARKER ASSAYS USED FOR DIAGNOSTIC
TESTING, 2015 100
NEW PATENT APPLICATIONS 102
Patents by Focus 102
TABLE 24 PATENT APPLICATION TRENDS ON CARDIAC BIOMARKER ASSAYS USED
FOR DIAGNOSTIC TESTING, APRIL-JUNE 2015 (NO.) 103
TABLE 25 EXAMPLES OF PATENT APPLICATIONS BY COMPANY, APRIL-JUNE 2015 103
Patents by Manufacturer/Research Institute 105
TABLE 26 PATENT APPLICATIONS BY COMPANY, APRIL-JUNE 2015 (NO./%) 105
COMPETITIVE LANDSCAPE 106
FIGURE 9 RECENT KEY STRATEGIES OF CARDIAC BIOMARKER MARKET, 2011-2015
(NO./%) 106
TABLE 27 PARTNERSHIP AND COLLABORATION, 2011-2015 107
FIGURE 10 PARTNERSHIP AND COLLABORATION BY COMPANY,* 2011-2015 (NO./%) 110
PRODUCT APPROVALS AND PRODUCT CLEARANCES 111
TABLE 28 PRODUCT APPROVALS AND PRODUCT CLEARANCES, 2011-2015 111
FIGURE 11 PRODUCT APPROVALS AND PRODUCT CLEARANCES BY COMPANIES,
2011-2015 (NO./%) 112
NEW PRODUCT DEVELOPMENTS AND PRODUCT LAUNCHES 113
TABLE 29 NEW PRODUCT DEVELOPMENTS AND PRODUCT LAUNCHES, 2011-2015 114
FIGURE 12 NEW PRODUCT DEVELOPMENTS AND PRODUCT LAUNCHES BY
COMPANY, 2011-2015 (NO./%) 115
MERGERS AND ACQUISITIONS 116
TABLE 30 MERGERS AND ACQUISITIONS, 2011-2015 116
FIGURE 13 MERGERS AND ACQUISITIONS BY COMPANY, 2011-2015 (NO./%) 117
OTHER STRATEGIES 118
TABLE 31 OTHER STRATEGIES, 2011-2015 118
GOVERNMENT REGULATION 120
U.S. FDA 501K APPROVAL 120
Division Acceptance and Review 120
Examples of U.S. FDA 501(k) Approval 121
CE MARKING IN EUROPE 122
Examples of CE Marking in Europe 123
OTHER INTERNATIONAL REGULATORY AGENCIES 123
TRENDS IN PRICE AND PRICE/PERFORMANCE 123
GENERAL TECHNOLOGY ISSUES 124
SENSITIVITY AND SPECIFICITY 124
POSITIVE AND NEGATIVE PREDICTIVE VALUES 125
RECEIVER OPERATOR CHARACTERISTIC CURVES 125
FIGURE 14 RECEIVER OPERATOR CHARACTERISTIC CURVES 126
CHAPTER 5 SUMMARY OF MARKET BY ASSAYS 128
TABLE 32 GLOBAL CARDIAC BIOMARKERS MARKET BY ASSAY CATEGORY,
THROUGH 2020 ($ MILLIONS) 128
CHAPTER 6 MARKET BY INSTRUMENT 130
CLINICAL CHEMISTRY ANALYZERS 130
FUTURE OF CLINICAL CHEMISTRY ANALYZERS 130
POINT-OF-CARE DEVICES 131
FUTURE OF POINT-OF-CARE TESTING 131
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MARKET BY INSTRUMENT CATEGORY 132
TABLE 33 GLOBAL CARDIAC BIOMARKER MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 133
TABLE 34 GLOBAL CTNI BIOMARKERS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 133
TABLE 35 GLOBAL BNP AND NT-PROBNP BIOMARKERS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 133
TABLE 36 GLOBAL CK-MB BIOMARKERS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 134
TABLE 37 GLOBAL NEW CHF BIOMARKERS* MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 134
TABLE 38 GLOBAL OTHER BIOMARKERS* MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 134
CHAPTER 7 MARKET BY REGION 136
SUMMARY OF MARKET BY REGION 136
NORTH AMERICA 136
UNITED STATES 137
CANADA 137
TABLE 39 NORTH AMERICA CARDIAC BIOMARKERS MARKET BY ASSAY, THROUGH
2020 ($ MILLIONS) 138
TABLE 40 NORTH AMERICA CARDIAC BIOMARKERS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 138
TABLE 41 NORTH AMERICA CTNI BIOMARKERS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 139
TABLE 42 NORTH AMERICA BNP AND NT-PROBNP BIOMARKERS MARKET BY
INSTRUMENT CATEGORY, THROUGH 2020 ($ MILLIONS) 139
TABLE 43 NORTH AMERICA CK-MB BIOMARKERS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 139
TABLE 44 NORTH AMERICA NEW CHF BIOMARKERS* MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 140
TABLE 45 NORTH AMERICA OTHER BIOMARKERS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 140
EUROPEAN MARKET 140
UNITED KINGDOM 141
FRANCE 142
GERMANY 142
TABLE 46 EUROPEAN CARDIAC BIOMARKERS MARKET BY ASSAY, THROUGH 2020
($ MILLIONS) 143
TABLE 47 EUROPEAN CARDIAC BIOMARKERS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 143
TABLE 48 EUROPEAN CTNI ASSAYS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 143
TABLE 49 EUROPEAN BNP AND NT-PROBNP ASSAYS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 144
TABLE 50 EUROPEAN CK-MB ASSAYS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 144
TABLE 51 EUROPEAN NEW CHF BIOMARKERS* MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 144
TABLE 52 EUROPEAN OTHER BIOMARKERS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 145
ASIA-PACIFIC MARKET 145
INDIA 145
CHINA 146
Regulations in China 146
JAPAN 147
Regulations in Japan 147
TABLE 53 ASIA-PACIFIC CARDIAC BIOMARKER MARKET BY ASSAY, THROUGH 2020
($ MILLIONS) 148
TABLE 54 ASIA-PACIFIC CARDIAC BIOMARKER MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 148
TABLE 55 ASIA-PACIFIC CTNI ASSAYS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 149
TABLE 56 ASIA-PACIFIC BNP AND NT-PROBNP ASSAYS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 149
TABLE 57 ASIA-PACIFIC CK-MB ASSAYS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 149
TABLE 58 ASI-PACIFIC NEW CHF BIOMARKERS* MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 150
TABLE 59 ASIA-PACIFIC MARKET FOR OTHER BIOMARKERS BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 150
MARKET IN THE REST OF THE WORLD 150
TABLE 60 REST OF WORLD CARDIAC BIOMARKERS MARKET BY ASSAY, THROUGH
2020 ($ MILLIONS) 151
TABLE 61 REST OF WORLD CARDIAC BIOMARKERS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 151
TABLE 62 REST OF WORLD CTNI ASSAYS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 152
TABLE 63 REST OF WORLD BNP AND NT-PROBNP ASSAYS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 152
TABLE 64 REST OF WORLD CK-MB ASSAYS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 152
TABLE 65 REST OF WORLD NEW BIOMARKERS* MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 153
CHAPTER 8 COMPANY PROFILES 155
ABBOTT DIAGNOSTICS 155
TABLE 66 ABBOTT DIAGNOSTICS: KEY PRODUCTS 155
TABLE 67 ABBOTT DIAGNOSTICS: RECENT DEVELOPMENTS 155
ALERE INC. 156
TABLE 68 ALERE INC.: KEY PRODUCTS 157
COMPANY STRATEGY 157
TABLE 69 ALERE INC.: RECENT DEVELOPMENTS 157
BECKMAN COULTER 158
TABLE 70 BECKMAN COULTER: KEY PRODUCTS 158
COMPANY STRATEGY 159
TABLE 71 BECKMAN COULTER: RECENT DEVELOPMENTS 159
BECTON, DICKINSON AND CO. 159
TABLE 72 BECTON, DICKINSON AND CO.: KEY PRODUCTS 160
COMPANY STRATEGY 160
TABLE 73 BECTON, DICKINSON AND CO.: RECENT DEVELOPMENTS 160
BG MEDICINE INC. 161
TABLE 74 BG MEDICINE INC: KEY PRODUCTS 161
TABLE 75 BG MEDICINE INC: RECENT DEVELOPMENTS 161
BIOMERIEUX 162
TABLE 76 BIOMERIEUX: KEY PRODUCTS 162
COMPANY STRATEGY 163
TABLE 77 BIOMERIEUX: RECENT DEVELOPMENTS 163
BIO-RAD LABORATORIES 163
TABLE 78 BIO-RAD LABORATORIES: KEY PRODUCTS 164
TABLE 79 BIO-RAD LABORATORIES: RECENT DEVELOPMENTS 164
CISBIO BIOASSAYS 164
TABLE 80 CISBIO BIOASSAYS: KEY PRODUCTS 165
COVANCE 166
TABLE 81 COVANCE: KEY PRODUCTS 166
EKF DIAGNOSTICS 167
TABLE 82 EKF DIAGNOSTICS: KEY PRODUCTS 167
TABLE 83 EKF DIAGNOSTICS: RECENT DEVELOPMENTS 168
ENZO BIOCHEM INC. 168
TABLE 84 ENZO BIOCHEM INC.: KEY PRODUCTS 168
HOLOGIC INC. 169
TABLE 85 HOLOGIC INC.: KEY PRODUCTS 169
MESO SCALE DIAGNOSTICS 169
TABLE 86 MESO SCALE DIAGNOSTICS: KEY PRODUCTS 170
ORTHO CLINICAL DIAGNOSTICS 171
TABLE 87 ORTHO CLINICAL DIAGNOSTICS: KEY PRODUCTS 171
TABLE 88 ORTHO CLINICAL DIAGNOSTICS: RECENT DEVELOPMENTS 171
PACIFIC BIOMARKERS INC. 171
TABLE 89 PACIFIC BIOMARKERS INC.: KEY PRODUCTS (CARDIOVASCULAR) 172
TABLE 90 PACIFIC BIOMARKERS INC.: RECENT DEVELOPMENTS 173
PERKIN ELMER INC. 173
TABLE 91 PERKIN ELMER INC.: KEY PRODUCTS 173
QIAGEN NV 174
TABLE 92 QIAGEN NV: KEY PRODUCTS 174
TABLE 93 QIAGEN NV: RECENT DEVELOPMENTS 175
RADIOMETER MEDICAL 175
TABLE 94 RADIOMETER MEDICAL: KEY PRODUCTS 176
TABLE 95 RADIOMETER MEDICAL: RECENT DEVELOPMENTS 176
RANDOX LABORATORIES LTD. 176
TABLE 96 RANDOX LABORATORIES LTD.: KEY PRODUCTS 177
TABLE 97 RANDOX LABORATORIES LTD.: RECENT DEVELOPMENTS 178
RESPONSE BIOMEDICAL CORP. 178
TABLE 98 RESPONSE BIOMEDICAL CORP.: KEY PRODUCTS 179
TABLE 99 RESPONSE BIOMEDICAL CORP.: RECENT DEVELOPMENTS 179
ROCHE HOLDING AG 180
TABLE 100 ROCHE HOLDING AG: KEY PRODUCTS 180
TABLE 101 ROCHE HOLDING AG: RECENT DEVELOPMENTS 181
SIGNOSIS INC. 182
TABLE 102 SIGNOSIS INC.: KEY PRODUCTS 182
SIEMENS HEALTHCARE DIAGNOSTICS 182
TABLE 103 SIEMENS HEALTHCARE DIAGNOSTICS: KEY PRODUCTS 183
TABLE 104 SIEMENS HEALTHCARE DIAGNOSTICS: RECENT DEVELOPMENTS 183
SINGULEX, INC. 184
TABLE 105 SINGULEX, INC.: KEY PRODUCTS 184
TABLE 106 SINGULEX, INC.: RECENT DEVELOPMENTS 185
THERMO FISHER SCIENTIFIC INC. 186
TABLE 107 THERMO FISHER SCIENTIFIC INC: KEY PRODUCTS 187
TABLE 108 THERMO FISHER SCIENTIFIC INC: RECENT DEVELOPMENTS 187
WUXI APPTEC 188
TABLE 109 WUXI APPTEC'S SERVICES 189
TABLE 110 WUXI APPTEC: RECENT DEVELOPMENTS 189
POTENTIAL ENTRANTS 190
EVOTEC 190
JOHNSON and JOHNSON 190
MERCK AND CO. INC. 191
QUINTILES 191
CHAPTER 9 APPENDIX 193
TABLE 111 LIST OF PATENTS, 2006-2015 193

LIST OF TABLES

SUMMARY TABLE GLOBAL CARDIAC BIOMARKER MARKET BY REGION, THROUGH
2020 ($ MILLIONS) 8
TABLE 1 PRICE RANGE OF CORONARY ANGIOGRAPHY/CT ANGIOGRAPHY ($) 21
TABLE 2 DIFFERENT BRANDS AND COST OF ECG MACHINES ($) 23
TABLE 3 LEADING HOSPITALS AND INSTITUTES INVOLVED IN BIOMARKER STUDY 25
TABLE 4 COMPANIES INVOLVED IN BIOMARKER STUDIES 26
TABLE 5 EPIDEMIC OF CARDIOVASCULAR DISEASES, 2015 28
TABLE 6 DISEASE PROFILE: CORONARY HEART DISEASE 34
TABLE 7 HEART DISEASE PERCENTAGE IN DIFFERENT RACES AND ETHNICITIES,
2013 (%) 36
TABLE 8 DISEASE PROFILE: ACUTE MYOCARDIAL INFARCTION 37
TABLE 9 DISEASE PROFILE OF HYPERTENSIVE HEART DISEASE 40
TABLE 10 DISEASE PROFILE: CEREBROVASCULAR DISEASE 43
TABLE 11 DISEASE PROFILE: CONGESTIVE HEART FAILURE 46
TABLE 12 DISEASE PROFILE: HEMORRHAGIC STROKE 48
TABLE 13 PRODUCT PROFILE: MYOGLOBIN 67
TABLE 14 BIOMARKER PROFILE: ST2 70
TABLE 15 PRODUCT PROFILE: TROPONIN 72
TABLE 16 PATENT TRENDS ON CARDIAC BIOMARKER ASSAYS USED FOR
DIAGNOSTIC TESTING, 2009-2015 (NO. OF PATENTS) 97
TABLE 17 PATENTS BY BIOMARKER CATEGORY, 2009-2015 (NO./%) 97
TABLE 18 PATENTS BY COMPANY, 2009-2015 (NO./%) 98
TABLE 19 PATENTS ON CARDIAC BIOMARKER BY ASSIGNEE TYPE (NO./%) 98
TABLE 20 PATENT ANALYSIS BY REGION, 2009-2015 (NO./%) 99
TABLE 21 U.S. PATENT ANALYSIS, 2009-2015 (NO./%) 99
TABLE 22 EUROPEAN PATENT ANALYSIS, 2009-2015 (NO./%) 100
TABLE 23 PATENTS ON CARDIAC BIOMARKER ASSAYS USED FOR DIAGNOSTIC
TESTING, 2015 100
TABLE 24 PATENT APPLICATION TRENDS ON CARDIAC BIOMARKER ASSAYS USED
FOR DIAGNOSTIC TESTING, APRIL-JUNE 2015 (NO.) 103
TABLE 25 EXAMPLES OF PATENT APPLICATIONS BY COMPANY, APRIL-JUNE 2015 103
TABLE 26 PATENT APPLICATIONS BY COMPANY, APRIL-JUNE 2015 (NO./%) 105
TABLE 27 PARTNERSHIP AND COLLABORATION, 2011-2015 107
TABLE 28 PRODUCT APPROVALS AND PRODUCT CLEARANCES, 2011-2015 111
TABLE 29 NEW PRODUCT DEVELOPMENTS AND PRODUCT LAUNCHES, 2011-2015 114
TABLE 30 MERGERS AND ACQUISITIONS, 2011-2015 116
TABLE 31 OTHER STRATEGIES, 2011-2015 118
TABLE 32 GLOBAL CARDIAC BIOMARKERS MARKET BY ASSAY CATEGORY, THROUGH
2020 ($ MILLIONS) 128
TABLE 33 GLOBAL CARDIAC BIOMARKER MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 133
TABLE 34 GLOBAL CTNI BIOMARKERS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 133
TABLE 35 GLOBAL BNP AND NT-PROBNP BIOMARKERS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 133
TABLE 36 GLOBAL CK-MB BIOMARKERS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 134
TABLE 37 GLOBAL NEW CHF BIOMARKERS* MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 134
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TABLE 38 GLOBAL OTHER BIOMARKERS* MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 134
TABLE 39 NORTH AMERICA CARDIAC BIOMARKERS MARKET BY ASSAY, THROUGH
2020 ($ MILLIONS) 138
TABLE 40 NORTH AMERICA CARDIAC BIOMARKERS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 138
TABLE 41 NORTH AMERICA CTNI BIOMARKERS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 139
TABLE 42 NORTH AMERICA BNP AND NT-PROBNP BIOMARKERS MARKET BY
INSTRUMENT CATEGORY, THROUGH 2020 ($ MILLIONS) 139
TABLE 43 NORTH AMERICA CK-MB BIOMARKERS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 139
TABLE 44 NORTH AMERICA NEW CHF BIOMARKERS* MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 140
TABLE 45 NORTH AMERICA OTHER BIOMARKERS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 140
TABLE 46 EUROPEAN CARDIAC BIOMARKERS MARKET BY ASSAY, THROUGH 2020 ($
MILLIONS) 143
TABLE 47 EUROPEAN CARDIAC BIOMARKERS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 143
TABLE 48 EUROPEAN CTNI ASSAYS MARKET BY INSTRUMENT CATEGORY, THROUGH
2020 ($ MILLIONS) 143
TABLE 49 EUROPEAN BNP AND NT-PROBNP ASSAYS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 144
TABLE 50 EUROPEAN CK-MB ASSAYS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 144
TABLE 51 EUROPEAN NEW CHF BIOMARKERS* MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 144
TABLE 52 EUROPEAN OTHER BIOMARKERS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 145
TABLE 53 ASIA-PACIFIC CARDIAC BIOMARKER MARKET BY ASSAY, THROUGH 2020 ($
MILLIONS) 148
TABLE 54 ASIA-PACIFIC CARDIAC BIOMARKER MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 148
TABLE 55 ASIA-PACIFIC CTNI ASSAYS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 149
TABLE 56 ASIA-PACIFIC BNP AND NT-PROBNP ASSAYS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 149
TABLE 57 ASIA-PACIFIC CK-MB ASSAYS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 149
TABLE 58 ASI-PACIFIC NEW CHF BIOMARKERS* MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 150
TABLE 59 ASIA-PACIFIC MARKET FOR OTHER BIOMARKERS BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 150
TABLE 60 REST OF WORLD CARDIAC BIOMARKERS MARKET BY ASSAY, THROUGH
2020 ($ MILLIONS) 151
TABLE 61 REST OF WORLD CARDIAC BIOMARKERS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 151
TABLE 62 REST OF WORLD CTNI ASSAYS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 152
TABLE 63 REST OF WORLD BNP AND NT-PROBNP ASSAYS MARKET BY INSTRUMENT
CATEGORY, THROUGH 2020 ($ MILLIONS) 152
TABLE 64 REST OF WORLD CK-MB ASSAYS MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 152
TABLE 65 REST OF WORLD NEW BIOMARKERS* MARKET BY INSTRUMENT CATEGORY,
THROUGH 2020 ($ MILLIONS) 153
TABLE 66 ABBOTT DIAGNOSTICS: KEY PRODUCTS 155
TABLE 67 ABBOTT DIAGNOSTICS: RECENT DEVELOPMENTS 155
TABLE 68 ALERE INC.: KEY PRODUCTS 157
TABLE 69 ALERE INC.: RECENT DEVELOPMENTS 157
TABLE 70 BECKMAN COULTER: KEY PRODUCTS 158
TABLE 71 BECKMAN COULTER: RECENT DEVELOPMENTS 159
TABLE 72 BECTON, DICKINSON AND CO.: KEY PRODUCTS 160
TABLE 73 BECTON, DICKINSON AND CO.: RECENT DEVELOPMENTS 160
TABLE 74 BG MEDICINE INC: KEY PRODUCTS 161
TABLE 75 BG MEDICINE INC: RECENT DEVELOPMENTS 161
TABLE 76 BIOMERIEUX: KEY PRODUCTS 162
TABLE 77 BIOMERIEUX: RECENT DEVELOPMENTS 163
TABLE 78 BIO-RAD LABORATORIES: KEY PRODUCTS 164
TABLE 79 BIO-RAD LABORATORIES: RECENT DEVELOPMENTS 164
TABLE 80 CISBIO BIOASSAYS: KEY PRODUCTS 165
TABLE 81 COVANCE: KEY PRODUCTS 166
TABLE 82 EKF DIAGNOSTICS: KEY PRODUCTS 167
TABLE 83 EKF DIAGNOSTICS: RECENT DEVELOPMENTS 168
TABLE 84 ENZO BIOCHEM INC.: KEY PRODUCTS 168
TABLE 85 HOLOGIC INC.: KEY PRODUCTS 169
TABLE 86 MESO SCALE DIAGNOSTICS: KEY PRODUCTS 170
TABLE 87 ORTHO CLINICAL DIAGNOSTICS: KEY PRODUCTS 171
TABLE 88 ORTHO CLINICAL DIAGNOSTICS: RECENT DEVELOPMENTS 171
TABLE 89 PACIFIC BIOMARKERS INC.: KEY PRODUCTS (CARDIOVASCULAR) 172
TABLE 90 PACIFIC BIOMARKERS INC.: RECENT DEVELOPMENTS 173
TABLE 91 PERKIN ELMER INC.: KEY PRODUCTS 173
TABLE 92 QIAGEN NV: KEY PRODUCTS 174
TABLE 93 QIAGEN NV: RECENT DEVELOPMENTS 175
TABLE 94 RADIOMETER MEDICAL: KEY PRODUCTS 176
TABLE 95 RADIOMETER MEDICAL: RECENT DEVELOPMENTS 176
TABLE 96 RANDOX LABORATORIES LTD.: KEY PRODUCTS 177
TABLE 97 RANDOX LABORATORIES LTD.: RECENT DEVELOPMENTS 178
TABLE 98 RESPONSE BIOMEDICAL CORP.: KEY PRODUCTS 179
TABLE 99 RESPONSE BIOMEDICAL CORP.: RECENT DEVELOPMENTS 179
TABLE 100 ROCHE HOLDING AG: KEY PRODUCTS 180
TABLE 101 ROCHE HOLDING AG: RECENT DEVELOPMENTS 181
TABLE 102 SIGNOSIS INC.: KEY PRODUCTS 182
TABLE 103 SIEMENS HEALTHCARE DIAGNOSTICS: KEY PRODUCTS 183
TABLE 104 SIEMENS HEALTHCARE DIAGNOSTICS: RECENT DEVELOPMENTS 183
TABLE 105 SINGULEX, INC.: KEY PRODUCTS 184
TABLE 106 SINGULEX, INC.: RECENT DEVELOPMENTS 185
TABLE 107 THERMO FISHER SCIENTIFIC INC: KEY PRODUCTS 187
TABLE 108 THERMO FISHER SCIENTIFIC INC: RECENT DEVELOPMENTS 187
TABLE 109 WUXI APPTEC'S SERVICES 189
TABLE 110 WUXI APPTEC: RECENT DEVELOPMENTS 189
TABLE 111 LIST OF PATENTS, 2006-2015 193

LIST OF FIGURES

FIGURE TITLE PAGE NO.
SUMMARY FIGURE GLOBAL CARDIAC BIOMARKER MARKET BY REGION, 2014-2020 ($
MILLIONS) 8
FIGURE 1 NUMBER OF PATENTS BY COUNTRY, IT* AND HEALTHCARE, 2013 (NO. OF
PATENTS) 11
FIGURE 2 NUMBER OF CARDIAC BIOMARKER PATENTS BY REGION*, 2011-2015 (NO.
OF PATENTS) 13
FIGURE 3 SHARES OF STAKEHOLDERS IN CARDIAC BIOMARKERS PATENTS,
2011-2015 (NO./%) 14
FIGURE 4 NUMBER OF CARDIAC BIOMARKER PATENTS BY ASSIGNEE, 2011-2015 (NO.
OF PATENTS) 15
FIGURE 5 TOP STRATEGIES, 2011-2015 (NUMBER) 17
FIGURE 6 GLOBAL DISTRIBUTION OF CARDIOVASCULAR DISEASE: DALY, 2004 (PER
100,000 PEOPLE) 31
FIGURE 7 GLOBAL CARDIOVASCULAR DISEASE TRENDS, 2011-2018 (MILLION CASES) 32
FIGURE 8 INTERPRETING ELEVATED LEVELS OF CARDIAC TROPONIN 82
FIGURE 9 RECENT KEY STRATEGIES OF CARDIAC BIOMARKER MARKET, 2011-2015
(NO./%) 106
FIGURE 10 PARTNERSHIP AND COLLABORATION BY COMPANY,* 2011-2015 (NO./%) 110
FIGURE 11 PRODUCT APPROVALS AND PRODUCT CLEARANCES BY COMPANIES,
2011-2015 (NO./%) 112
FIGURE 12 NEW PRODUCT DEVELOPMENTS AND PRODUCT LAUNCHES BY COMPANY,
2011-2015 (NO./%) 115
FIGURE 13 MERGERS AND ACQUISITIONS BY COMPANY, 2011-2015 (NO./%) 117
FIGURE 14 RECEIVER OPERATOR CHARACTERISTIC CURVES 126

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