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

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


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Companion Diagnostics Overview
2.2 Catalyst
2.3 Related Reports
3 Market Opportunities
3.1 Market Drivers
3.1.1 Increased Emphasis on Cost-Effective Healthcare
3.1.2 Availability of New Technologies
3.1.3 FDA Regulations
3.1.4 Economic Benefits in Drug Development
3.1.5 Rising Prevalence of Cancer
3.1.6 Demand for Targeted Therapies
3.2 Market Barriers
3.2.1 Reimbursement Landscape
3.2.2 Limited Clinical Use
3.2.3 Competitors Using the Same Biomarkers
3.2.4 Competition with Laboratory-Developed Tests
3.2.5 Emergence of Next Generation Sequencing
3.2.6 Linking Tests to Specific Instruments Limits Laboratories
3.2.7 Physician Resistance
3.3 Unmet Needs
3.3.1 Improving Selection for Existing Cancer Treatments
3.3.2 Need for Objective Tests
3.3.3 Need for High-Throughput Tests
3.3.4 Certainty of Reimbursement
3.3.5 Quantity of Tissue Required
3.3.6 Clarification on When to Test Patients
3.3.7 Accuracy of Techniques
3.3.8 Test Complexity Leading to Increased Process Failure
4 Market Access
4.1 Overview
4.2 Regulatory Issues and Recalls
4.2.1 FDA Regulation
4.2.2 Recalls
4.3 Reimbursement Trends
4.3.1 US
4.3.2 France
4.3.3 Germany
4.3.4 Italy
4.3.5 Spain
4.3.6 UK
4.3.7 China
4.3.8 India
4.3.9 Japan
4.3.10 Brazil
4.4 Mergers, Acquisitions, and Key Partnerships
5 Product Assessment
5.1 Technology Overview
5.1.1 Immunohistochemistry
5.1.2 In Situ Hybridization
5.1.3 Polymerase Chain Reaction
5.1.4 Next Generation Sequencing
5.2 Marketed Products
5.2.1 Breast Cancer Companion Diagnostic Tests
5.2.2 Colorectal Cancer Companion Diagnostic Tests
5.2.3 Melanoma Companion Diagnostic Tests
5.2.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests
5.3 Pipeline Products
5.4 Clinical Trials
6 Competitive Assessment
6.1 Company Share Analysis
6.1.1 Global Analysis
6.1.2 US Company Share Analysis
6.2 Trends in Corporate Strategy
6.3 Company Profiles
6.3.1 Abbott Laboratories
6.3.2 Agilent Technologies (Dako)
6.3.3 bioMérieux
6.3.4 Illumina
6.3.5 Leica Microsystems
6.3.6 Life Technologies (Thermo Fisher Scientific)
6.3.7 Qiagen
6.3.8 Roche
7 Testing Trends
7.1 Breast Cancer Companion Diagnostic Tests
7.2 Colorectal Cancer Companion Diagnostic Tests
7.3 Melanoma Companion Diagnostic Tests
7.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests
8 Market Outlook
8.1 Global Overview
8.2 US
8.3 France
8.4 Germany
8.5 Italy
8.6 Spain
8.7 UK
8.8 Japan
8.9 China
8.10 India
8.11 Brazil
9 Appendix
9.1 Bibliography
9.2 Abbreviations
9.3 Report Methodology
9.3.1 Overview
9.3.2 Coverage
9.3.3 Secondary Research
9.3.4 Forecasting Methodology
9.3.5 Primary Research - Key Opinion Leader Interviews
9.4 About the Authors
9.4.1 Analysts
9.4.2 Tyler Fletcher, Global Head of Medical Devices
9.5 About MediPoint
9.6 About GlobalData
9.7 Disclaimer
1.1 List of Tables
Table 1: Possible Companion Diagnostic Test Platform Technologies
Table 2: Regulatory Issues and Recalls, 2014-2016
Table 3: Mergers and Acquisitions, 2016
Table 4: Key Partnerships in 2016
Table 5: Breast Cancer Companion Diagnostic Tests, 2016
Table 6: CRC Companion Diagnostic Tests, 2016
Table 7: Melanoma Companion Diagnostic Tests, 2016
Table 8: NSCLC Companion Diagnostic Tests, 2016
Table 9: Companion Diagnostic Tests Pipeline, 2014
Table 10: Key Clinical Trials Utilizing Companion Diagnostic Tests Linked to Specific Drug Therapies
Table 11: Company Profile - Abbott Laboratories
Table 12: Abbott Laboratories Portfolio Assessment, 2016
Table 13: SWOT Analysis - Abbott Laboratories
Table 14: Company Profile - Agilent Technologies
Table 15: Agilent Technologies Portfolio Assessment, 2016
Table 16: SWOT Analysis - Agilent Technologies
Table 17: Company Profile - bioMérieux
Table 18: bioMérieux Portfolio Assessment, 2016
Table 19: SWOT Analysis - bioMérieux
Table 20: Company Profile - Illumina
Table 21: SWOT Analysis - Illumina
Table 22: Company Profile - Leica
Table 23: Leica Portfolio Assessment, 2016
Table 24: SWOT Analysis - Leica
Table 25: Company Profile - Life Technologies (Thermo Fisher Scientific)
Table 26: Life Technologies Portfolio Assessment, 2016
Table 27: SWOT Analysis - Life Technologies
Table 28: Company Profile - Qiagen
Table 29: Qiagen Portfolio Assessment, 2016
Table 30: SWOT Analysis - Qiagen
Table 31: Company Profile - Roche
Table 32: Roche Portfolio Assessment, 2016
Table 33: SWOT Analysis - Roche
Table 34: Breast Cancer Companion Diagnostic Testing Volume (thousands), 2014-2023
Table 35: CRC Companion Diagnostic Testing Volume (thousands), 2014-2023
Table 36: Melanoma Companion Diagnostic Testing Volume (thousands), 2014-2023
Table 37: NSCLC Companion Diagnostic Testing Volume (thousands), 2014-2023
Table 38: Global Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Table 39: US Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Table 40: France Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Table 41: Germany Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Table 42: Italy Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Table 43: Spain Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Table 44: UK Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Table 45: Japan Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Table 46: China Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Table 47: India Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Table 48: Brazil Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
1.2 List of Figures
Figure 1: Reasons for Companion Diagnostic Test Failure in the SATURN trial
Figure 2: Female Breast Cancer Treatment Patterns by Stage, 2008
Figure 3: Colon Cancer Treatment Patterns by Stage, 2008
Figure 4: Lung Cancer Treatment Patterns by Stage, 2008
Figure 5: Global Company Share Analysis, 2016
Figure 6: US Company Share Analysis, 2016
Figure 7: Breast Cancer Companion Diagnostic Testing Volume, 2014-2023
Figure 8: CRC Companion Diagnostic Testing Volume, 2014-2023
Figure 9: Melanoma Companion Diagnostic Testing Volume, 2014-2023
Figure 10: NSCLC Companion Diagnostic Testing Volume, 2014-2023
Figure 11: Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Figure 12: US Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Figure 13: France Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Figure 14: Germany Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Figure 15: Italy Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Figure 16: Spain Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Figure 17: UK Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Figure 18: Japan Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Figure 19: China Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Figure 20: India Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
Figure 21: Brazil Cancer Companion Diagnostic Test Market Value ($m), 2014-2023

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