Medical Device Leader Series: Top Companion Diagnostics (CDx) Developers, Manufacturers and Marketers in 2016


◆タイトル:Medical Device Leader Series: Top Companion Diagnostics (CDx) Developers, Manufacturers and Marketers in 2016
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1. レポート概要

2. コンパニオン診断薬の概要

3. コンパニオン診断薬の世界市場2016-2026

4. 米国に拠点を置くコンパニオン診断薬の主要企業2016

5. 欧州におけるコンパニオン診断薬の主要企業2016

6. その他地域におけるコンパニオン診断薬の主要企業2016

7. 調査インタビュー

8. コンパニオン診断薬市場の定性分析2016-2026

9. 調査・分析の結論

Companion Diagnostics – Discover Leading Companies’ Activities and Outlooks
How are companies in the companion diagnostics (CDx) industry performing? Visiongain’s new report gives you data, analysis and discussions for producers of those medical devices.

Our study lets you assess top companies in that industry and market, showing you their activities and outlooks. There you see financial results, opinion, trends, opportunities and revenue prediction for those developments in biomarkers, genomics, targeted therapies, theranostics and personalised medicine.

That way you explore the potentials of established and rising companies. Please read on to scan those 17 leading competitors and see what their future market could be worth.

Forecasts and discussions to help you stay ahead in knowledge and authority
Our new study assesses 17 leading companies and analyses that overall market. There you find sales results, revenue forecasting and growth rates. In our 166 page report you get 34 tables, 23 charts and an interview with MedGenome.

You also gain qualitative analyses, including discussion of research and development. Our work lets you assess the most beneficial and lucrative applications of those diagnostic tests for advancing human medicine, making it more personalised. Discover what is happening.

Company profiles – see why firms succeed, also exploring their potentials
Our report profiles 17 leading companies worldwide. Our investigation discusses prominent companies, exploring their activities by:
• Analysing companion diagnostic product portfolios and technologies
• Investigating the status of commercial developments
• Assessing R&D and applications for those medical devices
• Uncovering organisations’ strengths, weaknesses, activities, strategies and prospects
• Giving qualitative analyses and revenue forecasting of the overall world companion diagnostics market from 2016 to 2026.

Our survey shows you how technology changes, as well as explaining how diagnostic needs develop from 2016. Assess the rising demand for companion diagnostic products.

Prospects for US-based developers, manufacturers and marketers
Chapter 4 profiles companion diagnostic manufacturers based in the United States. Leading companies profiled there are these seven organisations:
• Abbott Laboratories
• Myriad Genetics
• Genomic Health
• Thermo Fisher Scientific
• Johnson & Johnson
• LabCorp
• Illumina.

There you discover what the future holds, seeing how companies compare and compete. Suppliers and users of companion diagnostic systems will benefit from 2016.

Outlooks for European manufacturers of those diagnostic medical devices
Chapter 5 profiles companion diagnostic manufacturers based in Europe. Leading companies profiled there are these six firms:
• Roche
• Qiagen
• Agilent Technologies
• bioMérieux
• Siemens
• MDxHealth.

Many opportunities remain, with expanding revenues likely from 2016 to 2026. Discover what is possible, seeing how you could gain.

Potentials of developers and producers in the rest of the world
Chapter 6 profiles companion diagnostic manufacturers based in the rest of the world. Leading companies profiled there are these four organisations:
• MedGenome
• Diagnocure
• Seegene
• Savyon Diagnostics.

Our work shows you possibilities for improving those technologies and raising sales, harnessing biopharmaceuticals, gene technologies and targeted therapies, including personalised medicine. See what the present and future hold, finding how you could gain.

Forces affecting the companion diagnostics industry – what shapes its present and future?
Our report discusses pressures, opportunities and other events affecting that industry and market from 2016, including these influences:
• Biomarker discovery and technologies including genomics, pharmacogenomics, proteomics and metabolomics
• Laboratory developed tests (LDT)
• Theranostics – the fastest growing segment of the CDx market
• Partnerships and other deals, including M&A and collaborations with pharma companies including Eli Lilly, AstraZeneca, Merck, GSK, Pfizer and Novartis
• Applications in cancer therapy and other therapeutic fields
• Regulations for companion diagnostic tests – opportunities and challenges.

With our analysis you assess that industry’s strengths, weaknesses, opportunities and threats. See what is happening and how to gain. That way you explore what restricts and stimulates companies developing, producing, marketing and selling those diagnostic tools.

Value of that market in 2020 – what sales growth is possible?
Our investigation predicts overall world revenues for companion diagnostic tests will reach $10.52bn in 2020. Those sales will rise further to 2026, showing strong revenue growth. Many opportunities exist for companies large and small as personalised medicine expands.

Ways Medical Device Leader Series: Top Companion Diagnostics (CDx) Developers, Manufacturers and Marketers in 2016 helps your work
In particular our new study gives you this knowledge to benefit your research, analyses, plans and presentations:
• Profiles of 17 leading companion diagnostic companies – assess their products, technologies, partnerships, R&D and results
• Forecasted revenue to 2026 for that overall market at world level – discover expected sales rises for companion diagnostic products, finding the gains possible
• Competition and opportunities – explore what affects that industry, assessing forces influencing its sales and determining its future
• Opinion from an interview with a leading company – gain information to help you stay ahead in knowledge, benefiting your reputation for commercial insight.

That new study, by our in-house analysts in the UK, has the purpose of helping your work. There you gain data and discussions you find nowhere else, helping you succeed.

Independent analysis to benefit your authority on companion diagnostics
Our work gives independent analysis. There you receive competitive intelligence found only in that report, seeing where technological and financial prospects are most promising.

With our study you are less likely to fall behind in knowledge or miss opportunity. See how you could help your research, analyses and decisions, also saving time and benefiting your authority. Explore that industry’s future, seeing what is possible and how you could gain.

Our new investigation is for everyone analysing companion diagnostic tests and associated medical products. There you find data, trends, opportunities and forecasts. Avoid missing out. Instead benefit in knowledge and influence by getting our report here now.


1. Report Overview
1.1 Overview of the Top Companion Diagnostic Companies
1.2 Why You Should Read This Report
1.3 How This Report Delivers
1.4 Main Questions Answered by This Industry Survey
1.5 Who is This Study For?
1.6 Methods of Research and Analysis
1.7 Frequently Asked Questions (FAQ)
1.8 Associated Visiongain Reports
1.9 About Visiongain

2. Introduction to Companion Diagnostics
2.1 Changing Paradigms of Treatment
2.2 What is Personalised Medicine?
2.3 In Vitro Diagnostics (IVD) and Targeted Therapies: The Core of Personalised Medicine
2.3.1 What are In Vitro Diagnostic (IVD) Tests?
2.3.2 How IVDs Help Provide Personalised Treatment
2.4 Companion Diagnostics: Tools for Personalised Medicine
2.4.1 Theranostics: A Subset of Companion Diagnostics
2.5 Biomarkers to Companion Diagnostics
2.5.1 Advancements in Biomarker Discovery
2.5.2 Genomics
2.5.3 Pharmacogenomics
2.5.4 Genomic Biomarkers in Oncology
2.5.5 Proteomics
2.5.6 Metabolomics
2.6 Development of Companion Diagnostics
2.7 Regulations in the Companion Diagnostics Market
2.7.1 FDA’s Draft Guidance on Companion Diagnostics Laboratory Developed Tests (LDT) – A New Direction

3. The World Companion Diagnostics Market, 2016-2026
3.1 The Global Companion Diagnostics Market, 2015
3.2 The Global Companion Diagnostics Market Sales Forecast, 2016-2026
3.3 Companion Diagnostics: Increasing Market Share of the IVD Market
3.4 The Companion Diagnostics Market by Submarket, 2015
3.5 Theranostics: Fastest Growing Segment of the CDx Market
3.6 Changing Market Shares of the Leading Companion Diagnostics Submarkets, 2016-2026
3.7 Drivers
3.7.1 Stakeholders in the Companion Diagnostics Market
3.7.2 Regulatory Authorities
3.7.3 Payers
3.7.4 Partnerships
3.8 Restraints
3.8.1 Competitive Landscape
3.8.2 Testing Laboratories
3.8.3 Physicians and Patients

4. Leading US-Based Companion Diagnostic Companies, 2016
4.1 Abbott Laboratories, Inc.
4.1.1 Abbott Laboratories: Financial Overview
4.1.2 Companion Diagnostics Product Portfolio Vysis ALK Break Apart FISH Probe Kit PathVysion HER-2 DNA Probe Kit
4.1.3 Companion Diagnostics in Pipeline
4.1.4 Recent Activity and Collaborations Collaboration with Merck Collaborative Efforts with Idera Collaboration with AstraZeneca
4.2 Myriad Genetics
4.2.1 Myriad Genetics: Financial Overview
4.2.2 Myriad Genetics: Companion Diagnostics Product Portfolio myRisk Hereditary Cancer Test BRACAnalysis® CCP Assay PREZEON™
4.2.3 Myriad Genetics: Companion Diagnostics Pipeline HRD Assay
4.2.4 Myriad Genetics: Companion Diagnostics Collaborations: Myriad/AstraZeneca: Premarket Approval Application Acquisition of Crescendo Bioscience: Entry into the Autoimmune Market Myriad/ TESARO Companion Collaboration Collaboration with AbbVie Agilent/Bristol-Myers Squibb
4.3 Genomic Health
4.3.1 Genomic Health: Financial Overview
4.3.2 Genomic Health: Companion Diagnostics Product Portfolio Oncotype Dx Portfolio Oncotype SEQ
4.3.3 Genomic Health: Companion Diagnostics in Pipeline RxPonder Trial
4.3.4 Genomic Health: Collaborations & Partnerships Partnership with OncoMed Genomic Health Partners with Epic Sciences
4.4 Thermo Fisher Scientific – Life Technologies
4.4.1 Thermo Fisher: Financial Overview
4.4.2 Thermo Fisher: Geographic Segmentation
4.4.3 Recent Collaborations and Acquisitions Acquisition of Life Technologies Acquisition of Prionics Acquisition of Advanced Scientifics, Inc. Acquisition of Alfa Aesar Affymetrix: Thermo Fisher’s Next Target Thermo Fisher: Developing a ‘Universal’ Companion Diagnostics Using Next Generation Sequencing Thermo Fisher: Life Technologies Collaborates with Merck Serono Thermo Fisher Scientific Collaboration with Pfizer and Novartis to Offer NGS-Based Companion Test for NSCLC
4.5 Johnson & Johnson
4.5.1 Johnson & Johnson: Financial Overview
4.5.2 Johnson & Johnson Division by Region
4.5.3 Johnson & Johnson: Companion Diagnostics Portfolio Companion Diagnostics Center of Excellence
4.5.4 Johnson & Johnson: Companion Diagnostics Partnerships Collaboration with Tianjin Medical University Cancer Institute and Hospital Partnership with Massachusetts General Hospital Partnership with Biocartis
4.6 Laboratory Corporation of America (LabCorp)
4.6.1 LabCorp: Financial Overview
4.6.2 LabCorp Companion Diagnostics Portfolio
4.6.3 Recent M&A Activity and Other Key Developments Agreement with Medco Health Sciences Non-Exclusive License Agreement with Merck Acquisition of Monogram Biosciences Acquisition of Genzyme Genetics Partnership with ARCA Biopharma
4.7 Illumina
4.7.1 Illumina: Financial Overview
4.7.2 Illumina: Companion Diagnostics Product Portfolio MiSeqDx™ System
4.7.3 Illumina: Recent Activity & Collaborations AstraZeneca Partners with Illumina bioMérieux Collaborates with Illumina

5. Leading European Companion Diagnostic Companies, 2016
5.1 Roche: Global Diagnostics Leader
5.1.1 Ventana Medical Systems (Roche)
5.1.2 Roche: Financial Overview
5.1.3 Roche Diagnostics Geographic Segmentation
5.1.4 Roche’s Collaborations and Recent Activity
5.1.5 Roche Diagnostics: Companion Diagnostics Product Portfolio & Pipeline
5.1.6 Ventana Companion Diagnostics: Robust New Prototype Assays
5.1.7 Recent Companion Diagnostic External Collaborations Foundation Medicine and Roche Collaborate Ventana Partners with Genmab Ferring Collaborates with Roche for CDx Development for Infertility Treatment MedImmune Partners with Ventana Merck Enters Agreement with Ventana AstraZeneca and Roche Partnership Boehringer Ingelheim Collaborate with Roche ImmunoGen Enter Agreement with Ventana
5.1.8 Roche Diagnostics: Major M&A Activity and Strategic Partnerships Genia Acquisition to Strengthen DNA Sequencing Capabilities IQuum Acquisition Allows Movement into POC MDx Market Seragon Acquisition Strengthens Leading Position in Oncology Santaris Acquisition Enhances Roche’s Position in RNA-Targeted Drugs Market Bina Acquisition Brings Big Data Solution to Support NGS Development Dutalys Acquisition Enhances Roche’s mAB Portfolio Ariosa Acquisition Adds NIPT to Diagnostic Portfolio Foundation Medicine Deal Enhances Personalised Medicine Capabilities for Oncology Signature and CAPP Acquisitions Strengthen Circulating DNA Testing Abilities GENEWEAVE and Kapa Acquisitions Help Cement Roche’s Position as the Market Leader
5.2 Qiagen
5.2.1 Qiagen: Financial Overview
5.2.2 Qiagen: Geographic Segmentation Qiagen: Companion Diagnostics Collaborations Collaboration with Eli Lilly Collaboration with AstraZeneca Collaboration with Astellas Pharma Collaboration with Novartis Collaboration with Array BioPharma Collaboration with Protagen
5.3 Agilent Technologies (Dako)
5.3.1 Life Sciences and Diagnostics Business
5.3.2 Agilent Life Sciences and Diagnostics: Financial Overview
5.3.3 Agilent: Next Generation Sequencing Platforms
5.3.4 Recent Companion Diagnostic Collaborations Merck and Aglient Cancer Collaborations Pfizer and Aglient an Ongoing Collaboration Bristol-Myers Squibb and Aglient Partnership
5.4 bioMérieux
5.4.1 bioMérieux: Financial Overview
5.4.2 Sales by Region, 2014
5.4.3 Sales by Technology, 2015
5.4.4 Companion Diagnostics: Recent M&A Activity & Collaboration Collaboration with Gilead Sciences Collaboration with Ipsen Collaboration with Merck Collaborations with GSK and Novartis Mergers, Acquisitions and Collaborations
5.4.5 bioTheranostics: Subsidiary for Oncology Diagnostics
5.5 Siemens Healthcare
5.5.1 Siemens: Financial Overview
5.5.2 Siemens Healthcare
5.5.3 Siemens Diagnostics
5.5.4 Outperforming the Market
5.5.5 Companion Diagnostics Partnership with Pfizer Partnership with ViiV Healthcare Partnership with Tocagen
5.6 MDxHealth
5.6.1 MDxHealth: Financial Overview
5.6.2 Companion Diagnostics PharmacoMDx PredictMDx for Brain Cancer PredictMDx for Colon Cancer
5.6.3 R&D Capabilities
5.6.4 Recent Collaborations and Partnerships Cerba HealthCare Belgium Collaboration SouthGenetics Partnership Sumitomo Sign Pharmaco Partnership for Japan Partnership with GSK

6. Leading Rest of the World Companion Diagnostic Companies, 2016
6.1 MedGenome
6.1.1 MedGenome: Companion Diagnostics Product Portfolio Integrated Genomics Platform OncoPept OncoMD Next-Generation Sequencing Informatics
6.2 Diagnocure
6.2.1 Diagnocure Products Gene Expression and Copy Number Variation (CNV) Analysis Mutation Detection SNP Genotyping Platform and Laboratory Environment
6.2.2 DiagnoCure Collaborations and Partnerships
6.3 Seegene Inc.
6.3.1 Seegene: Product Portfolio MuDT™(Multiple Detection Temperatures) Technology TOCE™ Technology DPO™ Technology READ Technology ACP™ Technology
6.3.2 Seegene Collaborations and Partnerships
6.4 Savyon Diagnostics
6.4.1 Savyon: Product Portfolio NanoCHIP®
6.4.2 Savyon Diagnostics Product Lines
6.4.3 Savyon Diagnostics Services
6.5 Other Leading Companion Diagnostics Partnerships

7. Research Interview
7.1 Dr Ramprasad, Chief Operating Officer, and Mr Hiranjith G H, Director, Corporate Planning, MedGenome
7.1.1 MedGenome Overview
7.1.2 CDx Portfolio at MedGenome
7.1.3 MedGenome’s Competitive Advantage
7.1.4 Future Directions For MedGenome and the Industry

8. Qualitative Analysis of the Companion Diagnostics Market, 2016-2026
8.1 SWOT Analysis of the Companion Diagnostics Market, 2016-2026
8.1.1 Strengths A CDx Strategy Decreases the Length of Approval Process Premium Prices for Companion Diagnostics A CDx Development Strategy Can Generate More Effective Drugs Therapeutics Tied with CDx can have Safer Profiles Reducing the Cost of Healthcare Increased Regulatory Scrutiny on Marketed Drugs Targeted Therapies Will Drive the CDx Market
8.1.2 Weaknesses Reimbursement Challenges Lack of Clear Regulatory Guidelines Capital Intensity is High
8.1.3 Opportunities Fast-growing Emerging Markets Next Generation Sequencing Many New CDx/ Pharma Company Partnerships
8.1.4 Threats Complex Business Models and Business Partnerships Medical Device Excise Tax
8.2 STEP Analysis of the Companion Diagnostics Market, 2016-2026
8.2.1 Social Factor: Raising Awareness will Lead to Greater Product Adoption
8.2.2 Technologically Innovation Driven – Growing Manufacturing Efficiency
8.2.3 Economic Potential: Emerging Markets Create Demand
8.2.4 Political Issues: Government Influence

9. Conclusions from Our Research and Analysis
9.1 Overview
9.2 Theranostics: A Fast Growing Market
9.3 Leading Companion Diagnostic Companies
9.4 Pharmaceutical/Diagnostic Partnership Model
9.5 Oncology is the Leading Therapy Area Driving Companion Diagnostics
9.6 Commercial Drivers of the Companion Diagnostics Market
9.7 Commercial Restraints of the Companion Diagnostics Market
9.8 Concluding Remarks

List of Tables
Table 2.1 Differences Between Traditional & Personalised Medicine, 2016
Table 2.2 Technologies and Platforms for Biomarker Research, 2016
Table 2.3 Examples of Clinically Relevant Cancer Biomarkers, 2016
Table 3.1 The World IVD Market: Main Segment Revenue Shares ($bn), 2015
Table 3.2 The World CDx Market: Revenue ($bn), AGR (%) and CAGR (%), 2015-2020
Table 3.3 The World CDx Market: Revenue ($bn), AGR (%) and CAGR (%), 2020-2026
Table 3.4 CDx Market Share (%) in the IVD Market, 2014, 2020, 2026
Table 4.1 Abbott Laboratories: Company Overview, 2016
Table 4.2 Abbott Laboratories: Historical Revenue ($bn), 2012-2015
Table 4.3 Abbott Laboratories: Biomarkers Pipeline, 2016
Table 4.4 Myriad Genetics: Company Overview, 2016
Table 4.5 Genomic Health: Company Overview, 2016
Table 4.6 Thermo Fisher Scientific: Revenue Sales ($bn), by Business Sector, 2012-2015
Table 4.7 Thermo Fisher Scientific: Revenue ($bn), Revenue Share (%) by Geography, 2013-2015
Table 4.8 Johnson & Johnson: Revenues ($bn) and Shares (%) by Sector, 2015
Table 4.9 Johnson & Johnson: Revenues ($bn) by Sector, 2015
Table 4.10 Johnson & Johnson: Revenue ($bn) and Shares (%) by Region, 2015
Table 4.11 LabCorp: Revenues ($bn) and Shares (%) by Business Segment, 2015
Table 4.12 Selected List of LabCorp’s Portfolio of Companion Diagnostics, 2016
Table 4.13 Selected List of LabCorp’s Portfolio of Companion Diagnostics, 2016
Table 5.1 Roche Diagnostics: Revenue ($bn) and Revenue Share (%) by Business Area, 2014
Table 5.2 Roche Diagnostics: Major Companion Diagnostic Projects, 2015
Table 5.3 Roche Diagnostics: List of Marketed Companion Diagnostics, 2015
Table 5.4 Qiagen: Revenue ($bn), Net Income ($bn) and Profit Margin, 2010-2015
Table 5.5 Qiagen: Revenue ($m), Revenue Share (%) by Geography, 2012-2015
Table 5.6 Agilent Technologies: Revenue ($bn) by Business Segment 2013-2015
Table 5.7 bioMérieux: Revenue ($bn) and AGR (%), 2010-2015
Table 5.8 bioMérieux: Revenue ($bn) and Revenue Change (%) by Region, 2014-2015
Table 5.9 bioMérieux: Revenue ($bn) and Revenue Change (%) by Technology, 2014-2015
Table 5.10 Siemens Diagnostics: Ranking (#) by Sector, 2016
Table 5.11 MDxHealth: Companion Diagnostics Pipeline, 2016
Table 6.1 Other Leading Companion Diagnostics Partnerships, 2016
Table 6.2 List of Other Companies in the Companion Diagnostics Market, 2016
Table 6.3 List of Other Companies in the Companion Diagnostics Market, 2016

List of Figures
Figure 1.1 Companion Diagnostics Market Segmentation, 2016
Figure 2.1 The Pillars of Personalised Medicine
Figure 2.2 Type of Companion Diagnostics on the Basis of Application, 2016
Figure 3.1 The World IVD Market: Main Segment Revenue Shares (%), 2015
Figure 3.2 The World CDx Market: Revenue ($bn), AGR (%) and CAGR (%), 2015-2026
Figure 3.3 The World CDx Market Share (%) in the IVD Market, 2020
Figure 3.4 The World CDx Market Share (%) in the IVD Market, 2026
Figure 4.1 Thermo Fisher Scientific: Revenue Sales ($bn), by Business Sector, 2015
Figure 4.2 Thermo Fisher Scientific: Revenue Share (%) by Geography, 2015
Figure 4.3 Johnson & Johnson: Revenues ($bn) by Sector, 2015
Figure 4.4 Johnson & Johnson: Revenue Shares (%) by Sector, 2015
Figure 4.5 Johnson & Johnson: Revenue Shares (%) by Region, 2015
Figure 4.6 Johnson & Johnson: Revenue Share (%) for US, 2015
Figure 4.7 LabCorp: Revenues ($bn) by Business Segment, 2015
Figure 4.8 LabCorp: Revenue Shares (%) by Business Segment, 2015
Figure 5.1 Roche Diagnostics: Revenue ($bn) by Business Area, 2014
Figure 5.2 Roche Diagnostics: Revenue (%) by Business Area, 2014
Figure 5.3 Roche Diagnostics: Revenue (%) by Geography, 2014
Figure 5.4 Qiagen: Revenue ($m), Revenue Share (%) by Geography, 2015
Figure 5.5 Agilent Technologies: Revenue ($bn) by Business Segment 2013-2015
Figure 5.6 bioMérieux: Revenue ($bn) by Region, 2015
Figure 5.7 bioMérieux: Revenue Share (%) by Technology, 2015
Figure 8.1 Drivers and Restraints in the Companion Diagnostics Market, 2016-2026

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