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

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


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Executive Summary

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

Summary

Companion diagnostics is synonymous with personalized, stratified, and precision medicine, and heralds a new era of treatment in which a patients' treatment will become increasingly individualized. A companion diagnostic test is defined as an in vitro diagnostic device or imaging tool whose use allows the safe application of a therapy. In practice, this involves measuring the expression or presence of a specific biomarker that is linked to a disease condition or therapy in order to ascertain how a patient will respond to a particular treatment. A relatively narrow range of core technologies is used for companion diagnostic tests, based around the detection of nucleic acids (such as DNA) or proteins (such as cell surface receptors).

This report focuses on the companion diagnostic testing markets in the US, five major European markets (5EU: France, Germany, Italy, Spain, and the UK), Japan, and the future markets in China, India, and Brazil, to identify unmet needs in the global market, physician attitudes toward current companion diagnostic testing, and the future of companion diagnostic testing in the face of rapid technological advancement. The four major cancers covered in this report are breast cancer, colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and melanoma.

Highlights

Key Questions Answered

What is the current and future companion diagnostics market outlook in the developed and emerging markets? What trends are affecting the global market?

What is the competitive landscape of major players in the companion diagnostics space across different regions?

What are the key, high growth markets that manufacturers should expand into? Which market segments are growing the fastest?

What are the unmet needs with the companion diagnostic tests currently on the market?

What are the key factors influencing a physician to use companion diagnostic tests? What is physician perception and market outlook of these devices?

What are the challenges and barriers that have hindered widespread adoption of companion diagnostic testing?

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



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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

1.2 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

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

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