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Diagnostic Cardiac Biomarkers for Acute Coronary Syndromes EU Analysis and Market Forecasts
GDME1026CFR / Published April 2013
Executive Summary
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 2 GDME1026CFR / Published APR 2013
Diagnostic Cardiac Biomarkers for Acute Coronary Syndromes: Key Metrics in EU Device Markets
Number of suspected acute coronary syndromes cases (2012) 1.48 million
Number of acute coronary syndromes cases (2012) 0.49 million
2012 Reagents Market Sales
EU $23.9m
Pipeline Assessment
Acute coronary syndromes risk prediction tests 40%
Acute coronary syndromes diagnostic tests 60%
Key events (2012–2018) Level of Impact
2015: Major European uptake of Thermo Scientific’s copeptin biomarker tests ↑↑
2015: Major European uptake of heart-type fatty acid binding protein biomarker tests ↑↑
2018 Reagents Market Sales
EU $32.8m
Source: GlobalData. Note: EU = France, Germany, Italy, Spain, and the UK
Sales for Acute Coronary Syndromes In Vitro Diagnostic Testing Reagents
GlobalData estimates the 2012 sales of ACS in vitro
diagnostic testing reagents to be just under $24m across
the five regions covered in this study, which are France,
Germany, Italy, Spain, and the UK.
By 2018, the end of the forecast period, the ACS in vitro
diagnostic testing reagents market will grow to $33m,
corresponding to a Compound Annual Growth Rate
(CAGR) of 5.4%.
The key drivers for the market in the forecast are:
Uptake of pipeline biomarker tests such as copeptin
and heart-type fatty acid binding protein (H-FABP)
Increasing adoption of premium-priced point-of-care
testing (POC) as POC troponin tests become more
sensitive
The key barriers for the market in the forecast are as
follows.
The decreasing number of cases of ACS in the UK,
and steady rates in the other countries covered in the
report is an overall constrainer to the market.
Cardiac troponin testing, the major in vitro test
carried out for the diagnosis of ACS, has reached
saturation and therefore further growth is constrained
in Europe.
Creatine kinase-MB isoenzyme (CK-MB) and
myoglobin in vitro diagnostic testing volumes are on
the decline across the European markets and this will
have a negative impact on the market for the first half
of the study period as clinicians are not replacing
these tests.
Executive Summary
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ACS In Vitro Diagnostic Testing Reagents Revenue by European Market, 2012 and 2018
France14%
Germany21%
Italy21%
Spain27%
UK17%
2012Total: $23.9m
France14%
Germany22%
Italy20%
Spain28%
UK16%
2018Total: $32.8m
Source: GlobalData.
A Market Dominated by Cardiac Troponin Testing
Cardiac troponins, namely troponin I and T, are the gold-
standard biomarkers for the diagnosis of ACS and
myocardial infarction (MI). Interviewed key opinion
leaders in Europe all report that the vast majority of their
suspected ACS patients will receive a troponin biomarker
test. The only situation when a patient might not get a
test immediately is that if they are having an obvious and
severe MI, and even in these cases a test will often be
ordered as a matter of course. Interviewed experts also
note that the tests are relatively inexpensive and the
results are available in a short time frame.
The advent of high-sensitivity troponin testing will provide
emergency physicians with a diagnostic tool that can
potentially shorten the time to diagnosis of ACS;
however, interviewed cardiologists are concerned about
the potential increase in false positives, and how that will
impact the management of their patients.
GlobalData expects the troponins to maintain a dominant
position across the European markets, and based on key
opinion leader insight, expects pipeline tests such as
copeptin and H-FABP to be supplementary to the
troponins rather than replacements.
Unmet Need Remains a Challenge
While the cardiac troponins have transformed the
landscape for ACS in vitro diagnostic testing, there still
remain several areas of unmet need. Some of the major
unmet needs reported by key opinion leaders interviewed
by GlobalData are listed below.
Tests that can rule in or rule out ACS earlier in
suspected ACS patients are a major need.
Emergency room overcrowding is a significant
problem in Europe, and this invokes both a health
and economic cost to already overburdened
healthcare systems.
Due to the issue of false-positive results, particularly
with the high-sensitivity troponin assays, cardiologists
interviewed by GlobalData report a need for more
specific diagnostic tests that can identify ACS
patients with accuracy.
Some interviewed experts call for markers that can
detect myocardial ischemia, a major event in the
pathway towards MI and ACS. A reliable biochemical
marker for myocardial ischemia could have a major
impact, especially as it would negate the need to
utilize relatively expensive imaging tests.
Executive Summary
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Remaining Opportunities for New and Existing Manufacturers
Significant market opportunities still exist for developers
of high-sensitivity troponin assays. Interviewed experts
report the screening assessment of the normal, healthy
population with high-sensitivity troponin could be the
future model for these tests. In this situation patients
would be monitored much like the current situation with
cholesterol tests, with the aim of limiting cardiac injury.
Furthermore, there remains market potential for
developers of new tests for the early rule-in and rule-out
of ACS, especially as this will reduce the requirement for
serial troponin testing. Copeptin and H-FABP have the
potential to address this opportunity to some degree;
however, experts report that the utility of these tests is in
early rule-out of ACS and neither of these tests provides
any advantages over troponin for early rule-in of the
disease. Also, GlobalData anticipates that developers of
POC tests with enhanced troponin sensitivity will have an
opportunity for market penetration as hospitals continue
to covet time-saving measures in their emergency rooms.
What do Physicians Think?
Physicians support cardiac troponin as the gold standard
for the diagnosis of ACS and MI, and do not differentiate
between the two subtypes, I and T:
“Troponin is the preferred biomarker for the investigation
of MI, as the diagnosis is defined now on the basis of
troponin elevation in the new universal definition.
Troponin I or T doesn’t matter; the choice of this is
hospital-dependent. In the global market place troponin I
tests have the lion’s share and they are more useful in
patients with renal impairment. So, troponin I is a good
test.”
European Key Opinion Leader, January, 2013
Physicians expect laboratories to move to high-sensitivity
troponin assays when they become available:
“There are still some hospitals using the previous-
generation tests, but the high-sensitivity tests will become
a majority, particularly as the vendors will phase out the
previous-generation assays and move entirely over to
high-sensitivity. The biochemists have defined what they
want in terms [of] sensitivity, and only the high-sensitivity
assays meet those criteria. So, the old ones will have to
be phased out, and I think in the next year or so, in the
UK there will be nobody on the previous generation of
troponin assays.”
European Key Opinion Leader, January, 2013
Physicians report that hospitals are removing CK-MB and
myoglobin from their ACS in vitro diagnostic testing
panels:
“The argument for measurement of CK-MB and
myoglobin was on the basis that these would show an
earlier rise than cardiac troponin. But the sensitivity of
troponin assays has proved this not to be the case in a
series of studies now. It has been shown quite clearly
that the diagnostic performance of CK-MB and myoglobin
is inferior to that of a troponin assay. They only remain in
place in some of the POC testing panels and that’s
because the troponin assay being used there is not up to
scratch.”
European Key Opinion Leader, February, 2013
Executive Summary
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Physicians believe that hospitals will switch to POC if
these troponin assays have sufficient sensitivity:
“As the POC assays get better there will be less of any
issue [of repeating tests in the laboratory]. You know,
POC lives and dies, and grows and shrinks… and even
though we were not true believers in POC, the crowding
problems that US hospitals are having in the ER is a real
public health problem. So, accepting a less-than-perfect
assay and dispositioning patients faster has been a
necessary move on our part, and [while] there is no
solution in sight for ER overcrowding, this is where POC
can really help, by moving patients expeditiously.”
US Key Opinion Leader, January, 2013
Physicians call for new tests that can diagnose ACS
earlier:
“From the clinical point of view the greatest unmet need
is for more rapid diagnosis, both for the rule-out and the
rule-in of MI… We are wasting time in providing this
diagnosis, and the more rapid diagnosis the more benefit
from the therapy. So this is our challenge. There are
some recommendations saying that if you are unable to
produce a result within 60 minutes of arrival, you should
consider point-of-care systems. The World Health
Organization guidelines say that we need to get an
answer before 60 minutes to get the best outcome, so
the laboratories have to reduce the turnaround time, and
[this should] obviously reduce the time from onset to
clinical diagnosis of the patient.”
European Key Opinion Leader, January, 2013
Physicians are cautiously optimistic about the impact the
pipeline biomarkers copeptin and H-FABP will have on
the diagnosis of ACS:
“The biomarker of interest for me in the area of ACS is
copeptin, [which is] a very early marker of myocardial
disease. Most importantly it is a marker that can
potentially rule-out earlier than troponin. Troponin
requires three to six hours of negative results before you
can confidently say that a person is not suffering a heart
attack; on the other hand, with copeptin, in theory, the
decision could be made in one to two hours. If true, and if
adopted, this will accelerate the rule-out process. The
majority of patients that present to the hospital with chest
pain, 85%–90% do not have MI and do not need to be
there for the six hours that are necessary with troponin.
So copeptin may be able to accelerate that decision.”
US Key Opinion Leader, January, 2013
“I would say H-FABP is interesting, again, it was a
formerly an assay that was not appropriate for the STAT
department. [However,] we need to check whether it has
any complementary role with troponin.”
European Key Opinion Leader, January, 2013
Table of Contents
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1 Table of Contents
1 Table of Contents ............................................................................................................... 6
1.1 List of Tables ............................................................................................................. 12
1.2 List of Figures ........................................................................................................... 15
2 Introduction ....................................................................................................................... 16
2.1 Catalyst ..................................................................................................................... 16
2.2 Related Reports ........................................................................................................ 16
2.3 Upcoming Related Reports ........................................................................................ 16
3 Disease Overview ............................................................................................................. 17
3.1 Acute Coronary Syndromes ....................................................................................... 17
3.2 Anatomy and Physiology ........................................................................................... 18
3.3 Pathophysiology ........................................................................................................ 19
3.4 Clinical Presentation .................................................................................................. 20
3.4.1 Symptoms ........................................................................................................... 20
3.4.2 Diagnosis ............................................................................................................ 20
3.5 Clinical Outcomes ..................................................................................................... 25
3.5.1 Treatment Options .............................................................................................. 25
3.5.2 Treatment Paradigm ........................................................................................... 28
3.6 Epidemiology ............................................................................................................ 29
3.7 Economic Impact ....................................................................................................... 30
4 Competitive Assessment ................................................................................................... 32
4.1 Overview ................................................................................................................... 32
4.2 Cardiac Troponins ..................................................................................................... 33
4.2.1 Overview............................................................................................................. 33
4.2.2 Clinical Application and Utility .............................................................................. 34
4.2.3 Market Penetration .............................................................................................. 38
4.2.4 SWOT Analysis ................................................................................................... 39
4.3 Creatine Kinase-MB .................................................................................................. 39
Table of Contents
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4.3.1 Overview............................................................................................................. 39
4.3.2 Clinical Application and Utility .............................................................................. 40
4.3.3 Market Penetration .............................................................................................. 42
4.3.4 SWOT Analysis ................................................................................................... 42
4.4 Myoglobin ................................................................................................................. 42
4.4.1 Overview............................................................................................................. 42
4.4.2 Clinical Application and Utility .............................................................................. 43
4.4.3 Market Penetration .............................................................................................. 45
4.4.4 SWOT Analysis ................................................................................................... 45
4.5 Point-of-Care ............................................................................................................. 45
4.5.1 Overview............................................................................................................. 45
4.5.2 Clinical Application and Utility .............................................................................. 47
4.5.3 Market Penetration .............................................................................................. 50
4.5.4 SWOT Analysis ................................................................................................... 51
5 Unmet Needs.................................................................................................................... 52
5.1 Overview ................................................................................................................... 52
5.2 Earlier Diagnosis ....................................................................................................... 53
5.3 Specificity and False Positives ................................................................................... 55
5.4 Interpretation of Biochemical Assay Results .............................................................. 56
5.5 Markers for Myocardial Ischemia ............................................................................... 58
6 Pipeline Products .............................................................................................................. 59
6.1 Overview ................................................................................................................... 59
6.2 BAG3 (Biouniversia) .................................................................................................. 60
6.2.1 Overview............................................................................................................. 60
6.2.2 SWOT Analysis ................................................................................................... 60
6.3 CAVARISK (Cavadis) ................................................................................................ 60
6.3.1 Overview............................................................................................................. 60
6.3.2 SWOT Analysis ................................................................................................... 60
Table of Contents
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6.4 CardioScore (BG Medicine) ....................................................................................... 61
6.4.1 Overview............................................................................................................. 61
6.4.2 SWOT Analysis ................................................................................................... 61
6.5 Circulating Endothelial Cells ...................................................................................... 62
6.5.1 Overview............................................................................................................. 62
6.5.2 SWOT Analysis ................................................................................................... 63
6.6 Copeptin (Thermo Scientific) ..................................................................................... 63
6.6.1 Overview............................................................................................................. 63
6.6.2 SWOT Analysis ................................................................................................... 66
6.7 Heart-Type Fatty Acid Binding Protein ....................................................................... 66
6.7.1 Overview............................................................................................................. 66
6.7.2 SWOT Analysis ................................................................................................... 68
6.8 MIRISK VP Assessment (Aviir) .................................................................................. 69
6.8.1 Overview............................................................................................................. 69
6.8.2 SWOT Analysis ................................................................................................... 69
6.9 Early Emerging Tests ................................................................................................ 70
6.9.1 Heart Diagnostic Assay (Prevencio/University of Pittsburgh) ................................ 70
6.9.2 Sentinel CVD (GeneNews) .................................................................................. 70
6.9.3 SomaScan Cardiovascular Assay (SomaLogic) ................................................... 70
7 Industry Overview ............................................................................................................. 71
7.1 ACS Diagnostic Biomarker Testing Trends ................................................................ 71
7.2 Market Access........................................................................................................... 73
7.3 Reimbursement Trends ............................................................................................. 75
7.4 Regulatory Environment ............................................................................................ 78
7.4.1 Approval of New Tests ........................................................................................ 78
7.4.2 Product Recalls ................................................................................................... 79
8 Current and Future Players ............................................................................................... 81
8.1 Overview ................................................................................................................... 81
Table of Contents
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8.2 Trends in Corporate Strategy..................................................................................... 81
8.3 Abbott Diagnostics .................................................................................................... 82
8.3.1 Overview............................................................................................................. 82
8.3.2 Portfolio Assessment .......................................................................................... 82
8.4 Alere ......................................................................................................................... 84
8.4.1 Overview............................................................................................................. 84
8.4.2 Portfolio Assessment .......................................................................................... 85
8.5 Beckman Coulter ....................................................................................................... 86
8.5.1 Overview............................................................................................................. 86
8.5.2 Portfolio Assessment .......................................................................................... 87
8.6 bioMérieux ................................................................................................................ 88
8.6.1 Overview............................................................................................................. 88
8.6.2 Portfolio Assessment .......................................................................................... 89
8.7 Mitsubishi Chemical Medience Corporation ............................................................... 90
8.7.1 Overview............................................................................................................. 90
8.7.2 Portfolio Assessment .......................................................................................... 91
8.8 Ortho-Clinical Diagnostics ......................................................................................... 92
8.8.1 Overview............................................................................................................. 92
8.8.2 Portfolio Assessment .......................................................................................... 93
8.9 Radiometer Medical .................................................................................................. 94
8.9.1 Overview............................................................................................................. 94
8.9.2 Portfolio Assessment .......................................................................................... 95
8.10 Randox Laboratories ................................................................................................. 96
8.10.1 Overview............................................................................................................. 96
8.10.2 Portfolio Assessment .......................................................................................... 97
8.11 Response Biomedical ................................................................................................ 98
8.11.1 Overview............................................................................................................. 98
8.11.2 Portfolio Assessment .......................................................................................... 99
Table of Contents
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8.12 Roche Diagnostics .................................................................................................. 100
8.12.1 Overview........................................................................................................... 100
8.12.2 Portfolio Assessment ........................................................................................ 101
8.13 Siemens Healthcare ................................................................................................ 102
8.13.1 Overview........................................................................................................... 102
8.13.2 Portfolio Assessment ........................................................................................ 103
8.14 Thermo Scientific .................................................................................................... 104
8.14.1 Overview........................................................................................................... 104
8.14.2 Portfolio Assessment ........................................................................................ 105
9 Market Drivers and Opportunities and Barriers ................................................................ 106
9.1 Market Drivers ......................................................................................................... 106
9.1.1 Uptake of Pipeline Biomarker Tests ................................................................... 106
9.1.2 Increasing Adoption of POC Testing .................................................................. 107
9.2 Market Opportunities ............................................................................................... 108
9.2.1 High-Sensitivity Troponin Assays ...................................................................... 108
9.2.2 Enhancement in Sensitivity of Troponin POC Assays ........................................ 110
9.2.3 New Pipeline Tests for Early Diagnosis of ACS ................................................. 110
9.3 Market Barriers........................................................................................................ 111
9.3.1 Saturation of Troponin Testing in the European Markets.................................... 111
9.3.2 Removal of CK-MB and Myoglobin from Testing Panels .................................... 111
9.3.3 Reimbursement................................................................................................. 111
10 Country Outlooks and Forecasts ..................................................................................... 112
10.1 European Markets Overview ................................................................................... 112
10.2 France .................................................................................................................... 114
10.3 Germany ................................................................................................................. 117
10.4 Italy ......................................................................................................................... 118
10.5 Spain ...................................................................................................................... 119
10.6 UK ......................................................................................................................... 122
Table of Contents
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11 Appendix ........................................................................................................................ 125
11.1 Bibliography ............................................................................................................ 125
11.2 Abbreviations .......................................................................................................... 137
11.3 Research Methodology ............................................................................................ 139
11.3.1 Overview........................................................................................................... 139
11.3.2 Coverage .......................................................................................................... 139
11.3.3 Secondary Research ......................................................................................... 139
11.3.4 Forecast Methodology ....................................................................................... 140
11.4 Primary Research.................................................................................................... 141
11.5 Physicians and Specialists Included in this Study .................................................... 142
11.6 About the Authors ................................................................................................... 144
11.6.1 Analysts ............................................................................................................ 144
11.6.2 Global Head of Healthcare ................................................................................ 145
11.7 About MediPoint................................................................................................ 146
11.8 About GlobalData .............................................................................................. 146
11.9 Contact Us ........................................................................................................ 146
11.10 Disclaimer ......................................................................................................... 147
Table of Contents
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1.1 List of Tables
Table 1: Risk Factors Associated with ACS....................................................................... 21
Table 2: Properties of Common ACS and MI Diagnostic Biomarkers ................................. 24
Table 3: Diagnosis and Risk Stratification of ACS ............................................................. 24
Table 4: Common PCI Periprocedural Antithrombotic Drugs ............................................. 25
Table 5: Common Drugs for Fibrinolysis ........................................................................... 26
Table 6: Common Drugs for the Treatment of NSTEMI and UA ......................................... 27
Table 7: Description of Direct and Indirect Economic Costs ............................................... 30
Table 8: Economic Impact ($bn) of CAD in Europe, 2009 to 2018 ..................................... 30
Table 9: Product Profile – Cardiac Troponins .................................................................... 34
Table 10: Cardiac Troponin Concentrations of Selected Current Troponin Assays .............. 35
Table 11: Cardiac Troponin Concentrations of Selected High-Sensitivity Troponin Assays .. 36
Table 12: Cardiac Troponins SWOT Analysis ..................................................................... 39
Table 13: Product Profile – Creatine Kinase-MB ................................................................. 40
Table 14: Creatine Kinase-MB SWOT Analysis ................................................................... 42
Table 15: Product Profile – Myoglobin ................................................................................. 43
Table 16: Myoglobin SWOT Analysis .................................................................................. 45
Table 17: Product Profile – Point-of-Care Testing ............................................................... 46
Table 18: Cardiac Troponin Concentrations of POC Troponin Assays ................................. 48
Table 19: Point-of-Care Cardiac Panel SWOT Analysis ...................................................... 51
Table 20: ACS Cardiac Biomarker Product Pipeline ............................................................ 59
Table 21: BAG3 SWOT Analysis......................................................................................... 60
Table 22: CAVARISK SWOT Analysis ................................................................................ 60
Table 23: CardioScore SWOT Analysis .............................................................................. 61
Table 24: Circulating Endothelial Cells SWOT Analysis....................................................... 63
Table 25: Copeptin SWOT Analysis .................................................................................... 66
Table 26: Heart-Type Fatty Acid Binding Protein SWOT Analysis ....................................... 68
Table 27: MIRISK VP SWOT Analysis ................................................................................ 69
Table of Contents
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Table 28: Company Profile – Abbott Diagnostics................................................................. 82
Table 29: Abbott Diagnostics SWOT Analysis, 2013 ........................................................... 83
Table 30: Company Profile – Alere ..................................................................................... 84
Table 31: Alere SWOT Analysis, 2013 ................................................................................ 85
Table 32: Company Profile – Beckman Coulter ................................................................... 86
Table 33: Beckman Coulter SWOT Analysis, 2013 ............................................................. 87
Table 34: Company Profile – bioMérieux............................................................................. 88
Table 35: bioMérieux SWOT Analysis, 2013 ....................................................................... 89
Table 36: Company Profile – Mitsubishi Chemical Medience Corporation............................ 90
Table 37: Mitsubishi Chemical Medience Corporation SWOT Analysis, 2013 ...................... 91
Table 38: Company Profile – Ortho-Clinical Diagnostics...................................................... 92
Table 39: Ortho-Clinical Diagnostics SWOT Analysis, 2013 ................................................ 93
Table 40: Company Profile – Radiometer Medical ............................................................... 94
Table 41: Radiometer Medical SWOT Analysis, 2013 ......................................................... 95
Table 42: Company Profile – Randox Laboratories ............................................................. 96
Table 43: Randox Laboratories SWOT Analysis, 2013 ........................................................ 97
Table 44: Company Profile – Response Biomedical ............................................................ 98
Table 45: Response Biomedical SWOT Analysis, 2013....................................................... 99
Table 46: Company Profile – Roche Diagnostics............................................................... 100
Table 47: Roche Diagnostics SWOT Analysis, 2013 ......................................................... 102
Table 48: Company Profile – Siemens Healthcare ............................................................ 103
Table 49: Siemens Healthcare SWOT Analysis, 2013 ....................................................... 103
Table 50: Company Profile – Thermo Scientific ................................................................. 104
Table 51: Thermo Scientific SWOT Analysis, 2013 ........................................................... 105
Table 52: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in the European
Markets, ($m), 2009–2018 ................................................................................ 112
Table 53: Major Events Affecting the European ACS In Vitro Diagnostics Market .............. 113
Table 54: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in France, ($m),
2009–2018 ........................................................................................................ 114
Table of Contents
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Table 55: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in Germany, ($m),
2009–2018 ........................................................................................................ 117
Table 56: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in Italy, ($m),
2009–2018 ........................................................................................................ 118
Table 57: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in Spain, ($m),
2009–2018 ........................................................................................................ 119
Table 58: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in the UK, ($m)
2009–2018 ........................................................................................................ 122
Table of Contents
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1.2 List of Figures
Figure 1: Anatomy of the Human Heart ............................................................................ 18
Figure 2: Heart Muscle Damage, Atherosclerosis and Thrombosis ................................... 19
Figure 3: Strategy for Evaluating ACS .............................................................................. 21
Figure 4: Treatment and Management of ACS .................................................................. 28
Figure 5: Annual Number of ACS Cases Across Europe, 2009‒2018................................ 29
Figure 6: Direct and Indirect Costs ($bn) of CAD in Europe, 2011 to 2018 ........................ 31
Figure 7: Europe Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents,
2012 .................................................................................................................. 32
Figure 8: Estimated European ACS Diagnostic Biomarker Testing Volumes, 2009 to 2018
......................................................................................................................... 72
Figure 9: European Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m),
2009–2018 ...................................................................................................... 112
Figure 10: European Market Share for ACS In Vitro Diagnostic Testing Reagents,
2012 and 2018 ................................................................................................ 113
Figure 11: France Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m),
2009–2018 ...................................................................................................... 114
Figure 12: France Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents,
2012 and 2018 ................................................................................................ 116
Figure 13: Germany Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m),
2009–2018 ...................................................................................................... 117
Figure 14: Italy Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m),
2009–2018 ...................................................................................................... 118
Figure 15: Spain Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m),
2009–2018 ...................................................................................................... 119
Figure 16: Spain Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents,
2012 and 2018 ................................................................................................ 121
Figure 17: UK Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m)
2009–2018 ...................................................................................................... 122
Figure 18: UK Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents,
2012 and 2018 ................................................................................................ 124
Introduction
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2 Introduction
Acute Coronary Syndromes (ACS) encompasses an array of clinical symptoms (most commonly
chest discomfort) manifesting from acute myocardial ischemia, and consists of two major diseases:
myocardial infarction and unstable angina, with the former being one of the major killers in Europe.
Though the incidence of ACS is either in decline or constant across the European countries,
hundreds of thousands of ACS and suspected ACS patients still visit emergency rooms every year
with symptoms such as chest pain. These patients are typically assessed with in vitro diagnostic
biomarker tests, and in particular these tests are essential in accurately diagnosing patients with
non-ST-segment elevation myocardial infarction. Early diagnosis of ACS can result in prompt
treatment and management of symptoms and improve outcomes substantially.
This report focuses on the ACS in vitro diagnostic testing reagents markets in Europe (France,
Germany, Italy, Spain, and the UK), and identifies unmet needs in the market, physician attitudes
towards current ACS diagnostic biomarker testing, and whether pipeline biomarkers have the
potential to meet these unmet needs.
2.1 Catalyst
In Europe, the ACS in vitro diagnostics market is dominated by a single biomarker test, cardiac
troponins. However, this market remains of high interest due to advancements in assay sensitivity
both on laboratory and point-of-care platforms. GlobalData expects these advancements to have
an impact on other diagnostic tests such as creatine kinase-MB isoenzyme and myoglobin.
Furthermore, the emergence of pipeline biomarker tests will change the landscape of ACS in vitro
diagnostic testing and is expected to provide enhancements in the early diagnosis of the disease.
This report will provide in-depth coverage of these dynamics with underpinning insight from key
opinion leaders of varying disciplines, including laboratory managers, biochemists, emergency
physicians, and cardiologists. The report also incorporates recommendations on how companies in
the market or companies interested in entering can best navigate it. Furthermore, in-depth analysis
of current products and upcoming pipeline tests is offered, as well as country-specific forecasting of
the ACS in vitro diagnostic testing reagents market.
Appendix
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11.7 About MediPoint
MediPoint is the flagship product for GlobalData’s Medical team. Each MediPoint report is built
from the ground-up by our team of healthcare analysts in the US and UK. Each report includes
input from experienced physicians and leading Key Opinion Leaders (KOL). Running throughout
each report in the series, “What Physicians Think” quotes provide a unique insight into how
healthcare professionals are reacting to events within the industry, and what their responses could
mean for industry strategists.
11.8 About GlobalData
GlobalData is a leading global provider of business intelligence in the Healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in drug research, disease analysis, and clinical research and development. Our integrated business
intelligence solutions include a range of interactive online databases, analytical tools, reports and
forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has
offices in New York, Boston, London, India and Singapore.
Appendix
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 147 GDME1026CFR / Published APR 2013
11.10 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any
form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior
permission of the publisher, GlobalData.
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