diagnostic cardiac biomarkers for acute coronary ...pipeline assessment acute coronary syndromes...

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. 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


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


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.”


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


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.”


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.”


Table of Contents


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


4.3.1 Overview............................................................................................................. 39



4.3.4 SWOT Analysis ................................................................................................... 42

4.4 Myoglobin ................................................................................................................. 42

4.4.1 Overview............................................................................................................. 42



4.4.4 SWOT Analysis ................................................................................................... 45

4.5 Point-of-Care ............................................................................................................. 45

4.5.1 Overview............................................................................................................. 45



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


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


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


8.5 Beckman Coulter ....................................................................................................... 86

8.5.1 Overview............................................................................................................. 86


8.6 bioMérieux ................................................................................................................ 88

8.6.1 Overview............................................................................................................. 88


8.7 Mitsubishi Chemical Medience Corporation ............................................................... 90

8.7.1 Overview............................................................................................................. 90


8.8 Ortho-Clinical Diagnostics ......................................................................................... 92

8.8.1 Overview............................................................................................................. 92


8.9 Radiometer Medical .................................................................................................. 94

8.9.1 Overview............................................................................................................. 94


8.10 Randox Laboratories ................................................................................................. 96

8.10.1 Overview............................................................................................................. 96


8.11 Response Biomedical ................................................................................................ 98

8.11.1 Overview............................................................................................................. 98


Table of Contents


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


8.14 Thermo Scientific .................................................................................................... 104

8.14.1 Overview........................................................................................................... 104


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


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


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


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


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


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


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

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 146 GDME1026CFR / Published APR 2013

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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