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MediPoint: Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts

Summary

Companion diagnostic test is defined as an in vitro diagnostic device or an imaging tool whose use allows the safe application of a therapy.

Companion diagnostic test market is growing, particularly in the emerging markets of Japan and China. The US currently has the largest share of the companion diagnostic market, with 27.9% of total market revenue, as is expected to remain the largest market throughout the forecast period of 2016-2023. The companion diagnostics market in China and Japan is expected to increase at compound annual growth rates (CAGRs) of 9.4% and 7.9%, respectively, driving growth in the Asia-Pacific (APAC: Japan, China, and India) region.

Overall, 2.5 Million companion diagnostic tests were performed in 2016. Breast cancer diagnostic tests accounted for the majority of tests conducted globally, followed by non-small cell lung cancer (NSCLC). Melanoma companion diagnostic testing remains low, due to the lower incidence rate, accounting for 5.5% of the market volume. Moreover, the majority of companion diagnostic tests performed are for human epidermal growth factor receptor 2 (HER2), because the tests performed are typically the cheaper immunohistochemistry (IHC) test, they only account for 26.3% of market value.

Reimbursement remains a significant challenge in the companion diagnostics market. Adoption is highly dependent upon reimbursement policies, so approval of new tests does not necessarily signify immediate adoption. If the molecular test cannot be reimbursed, adoption will be low. If the new therapy cannot be reimbursed, there will be no need for uptake of the companion diagnostic test, unless a secondary use can be found that is of utility to the physician in managing the patient’s condition.

The report “MediPoint: Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts” provides an analysis of the companion diagnostic market for four major cancers in the US, the 5EU (France, Germany, Italy, Spain, and UK), Asia-Pacific (APAC) regions (Japan, China, and India) and South America. Additionally, it identifies the unmet needs in this companion diagnostics market and analyses companion diagnostic tests used in breast, colorectal, melanoma and non-small cell lung cancer. This report also discusses physician attitudes towards current companion diagnostic tests, and the future of companion diagnostic tests.

Scope
- Competitive assessment: Currently marketed companion diagnostic products and evolving competitive landscape
- In-depth analysis of unmet needs and adoption trends of different companion diagnostic tests
- Insightful review of the key industry drivers, opportunities, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications
- Pipeline analysis: Emerging products and technologies.
- Annualized total companion diagnostic market volume and revenue by segment, and market outlooks by country from 2014-2023.
- Other key topics covered include strategic competitive assessment, market characterization, identification of unmet needs, market dynamics, and implications of the emerging technologies on the market.

Reasons to buy
The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline
- Develop business strategies by understanding the trends shaping and driving the global market
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global market in the future
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage
- Track device sales in the global market from 2014-2023
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships

Table Of Contents

MediPoint: Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts
1 Table of Contents
1 Table of Contents 6
1.1 List of Tables 10
1.2 List of Figures 12
2 Introduction 14
2.1 Companion Diagnostics Overview 14
2.2 Catalyst 15
2.3 Related Reports 15
3 Market Opportunities 16
3.1 Market Drivers 16
3.1.1 Increased Emphasis on Cost-Effective Healthcare 16
3.1.2 Availability of New Technologies 16
3.1.3 FDA Regulations 17
3.1.4 Economic Benefits in Drug Development 18
3.1.5 Rising Prevalence of Cancer 18
3.1.6 Demand for Targeted Therapies 18
3.2 Market Barriers 19
3.2.1 Reimbursement Landscape 19
3.2.2 Limited Clinical Use 19
3.2.3 Competitors Using the Same Biomarkers 20
3.2.4 Competition with Laboratory-Developed Tests 21
3.2.5 Emergence of Next Generation Sequencing 21
3.2.6 Linking Tests to Specific Instruments Limits Laboratories 22
3.2.7 Physician Resistance 23
3.3 Unmet Needs 24
3.3.1 Improving Selection for Existing Cancer Treatments 24
3.3.2 Need for Objective Tests 25
3.3.3 Need for High-Throughput Tests 26
3.3.4 Certainty of Reimbursement 28
3.3.5 Quantity of Tissue Required 29
3.3.6 Clarification on When to Test Patients 31
3.3.7 Accuracy of Techniques 35
3.3.8 Test Complexity Leading to Increased Process Failure 38
4 Market Access 39
4.1 Overview 39
4.2 Regulatory Issues and Recalls 39
4.2.1 FDA Regulation 39
4.2.2 Recalls 40
4.3 Reimbursement Trends 41
4.3.1 US 41
4.3.2 France 41
4.3.3 Germany 42
4.3.4 Italy 42
4.3.5 Spain 43
4.3.6 UK 44
4.3.7 China 45
4.3.8 India 45
4.3.9 Japan 46
4.3.10 Brazil 46
4.4 Mergers, Acquisitions, and Key Partnerships 48
5 Product Assessment 52
5.1 Technology Overview 52
5.1.1 Immunohistochemistry 52
5.1.2 In Situ Hybridization 53
5.1.3 Polymerase Chain Reaction 54
5.1.4 Next Generation Sequencing 55
5.2 Marketed Products 56
5.2.1 Breast Cancer Companion Diagnostic Tests 56
5.2.2 Colorectal Cancer Companion Diagnostic Tests 57
5.2.3 Melanoma Companion Diagnostic Tests 58
5.2.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 58
5.3 Pipeline Products 59
5.4 Clinical Trials 61
6 Competitive Assessment 62
6.1 Company Share Analysis 62
6.1.1 Global Analysis 62
6.1.2 US Company Share Analysis 62
6.2 Trends in Corporate Strategy 63
6.3 Company Profiles 64
6.3.1 Abbott Laboratories 64
6.3.2 Agilent Technologies (Dako) 66
6.3.3 bioMerieux 69
6.3.4 Illumina 71
6.3.5 Leica Microsystems 72
6.3.6 Life Technologies (Thermo Fisher Scientific) 74
6.3.7 Qiagen 76
6.3.8 Roche 78
7 Testing Trends 82
7.1 Breast Cancer Companion Diagnostic Tests 82
7.2 Colorectal Cancer Companion Diagnostic Tests 84
7.3 Melanoma Companion Diagnostic Tests 85
7.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 87
8 Market Outlook 89
8.1 Global Overview 89
8.2 US 91
8.3 France 93
8.4 Germany 95
8.5 Italy 97
8.6 Spain 99
8.7 UK 101
8.8 Japan 103
8.9 China 105
8.10 India 108
8.11 Brazil 110
9 Appendix 113
9.1 Bibliography 113
9.2 Abbreviations 117
9.3 Report Methodology 121
9.3.1 Overview 121
9.3.2 Coverage 121
9.3.3 Secondary Research 121
9.3.4 Forecasting Methodology 122
9.3.5 Primary Research - Key Opinion Leader Interviews 123
9.4 About the Authors 124
9.4.1 Analysts 124
9.4.2 Tyler Fletcher, Global Head of Medical Devices 125
9.5 About MediPoint 126
9.6 About GlobalData 126
9.7 Disclaimer 127

1.1 List of Tables
Table 1: Possible Companion Diagnostic Test Platform Technologies 14
Table 2: Regulatory Issues and Recalls, 2014-2016 40
Table 3: Mergers and Acquisitions, 2016 48
Table 4: Key Partnerships in 2016 49
Table 5: Breast Cancer Companion Diagnostic Tests, 2016 56
Table 6: CRC Companion Diagnostic Tests, 2016 57
Table 7: Melanoma Companion Diagnostic Tests, 2016 58
Table 8: NSCLC Companion Diagnostic Tests, 2016 59
Table 9: Companion Diagnostic Tests Pipeline, 2014 60
Table 10: Key Clinical Trials Utilizing Companion Diagnostic Tests Linked to Specific Drug Therapies 61
Table 11: Company Profile - Abbott Laboratories 65
Table 12: Abbott Laboratories Portfolio Assessment, 2016 66
Table 13: SWOT Analysis - Abbott Laboratories 66
Table 14: Company Profile - Agilent Technologies 67
Table 15: Agilent Technologies Portfolio Assessment, 2016 68
Table 16: SWOT Analysis - Agilent Technologies 69
Table 17: Company Profile - bioMerieux 70
Table 18: bioMerieux Portfolio Assessment, 2016 70
Table 19: SWOT Analysis - bioMerieux 71
Table 20: Company Profile - Illumina 71
Table 21: SWOT Analysis - Illumina 72
Table 22: Company Profile - Leica 73
Table 23: Leica Portfolio Assessment, 2016 73
Table 24: SWOT Analysis - Leica 74
Table 25: Company Profile - Life Technologies (Thermo Fisher Scientific) 75
Table 26: Life Technologies Portfolio Assessment, 2016 75
Table 27: SWOT Analysis - Life Technologies 76
Table 28: Company Profile - Qiagen 77
Table 29: Qiagen Portfolio Assessment, 2016 77
Table 30: SWOT Analysis - Qiagen 78
Table 31: Company Profile - Roche 79
Table 32: Roche Portfolio Assessment, 2016 80
Table 33: SWOT Analysis - Roche 81
Table 34: Breast Cancer Companion Diagnostic Testing Volume (thousands), 2014-2023 82
Table 35: CRC Companion Diagnostic Testing Volume (thousands), 2014-2023 84
Table 36: Melanoma Companion Diagnostic Testing Volume (thousands), 2014-2023 86
Table 37: NSCLC Companion Diagnostic Testing Volume (thousands), 2014-2023 88
Table 38: Global Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 90
Table 39: US Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 91
Table 40: France Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 94
Table 41: Germany Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 96
Table 42: Italy Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 98
Table 43: Spain Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 100
Table 44: UK Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 102
Table 45: Japan Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 104
Table 46: China Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 106
Table 47: India Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 108
Table 48: Brazil Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 111

1.2 List of Figures
Figure 1: Reasons for Companion Diagnostic Test Failure in the SATURN trial 29
Figure 2: Female Breast Cancer Treatment Patterns by Stage, 2008 32
Figure 3: Colon Cancer Treatment Patterns by Stage, 2008 33
Figure 4: Lung Cancer Treatment Patterns by Stage, 2008 34
Figure 5: Global Company Share Analysis, 2016 62
Figure 6: US Company Share Analysis, 2016 63
Figure 7: Breast Cancer Companion Diagnostic Testing Volume, 2014-2023 83
Figure 8: CRC Companion Diagnostic Testing Volume, 2014-2023 85
Figure 9: Melanoma Companion Diagnostic Testing Volume, 2014-2023 86
Figure 10: NSCLC Companion Diagnostic Testing Volume, 2014-2023 88
Figure 11: Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 90
Figure 12: US Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 92
Figure 13: France Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 94
Figure 14: Germany Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 96
Figure 15: Italy Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 98
Figure 16: Spain Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 100
Figure 17: UK Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 102
Figure 18: Japan Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 104
Figure 19: China Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 106
Figure 20: India Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 109
Figure 21: Brazil Cancer Companion Diagnostic Test Market Value ($m), 2014-2023 111

Companies Mentioned
Abbott Laboratories
Agilent Technologies (Dako)
bioMerieux
Illumina
Leica Microsystems
Life Technologies (Thermo Fisher Scientific)
Qiagen
Roche

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