医療機器リーダーシリーズ:コンパニオン診断薬(CDx)開発、製造および販売のトップ企業2016...市場調査レポートについてご紹介

【英文タイトル】Medical Device Leader Series: Top Companion Diagnostics (CDx) Developers, Manufacturers and Marketers in 2016

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【レポートの概要(一部)】

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2.7.1 FDA’s Draft Guidance on Companion Diagnostics
2.7.1.1 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
4.1.2.1 Vysis ALK Break Apart FISH Probe Kit
4.1.2.2 PathVysion HER-2 DNA Probe Kit
4.1.3 Companion Diagnostics in Pipeline
4.1.4 Recent Activity and Collaborations
4.1.4.1 Collaboration with Merck
4.1.4.2 Collaborative Efforts with Idera
4.1.4.3 Collaboration with AstraZeneca
4.2 Myriad Genetics
4.2.1 Myriad Genetics: Financial Overview
4.2.2 Myriad Genetics: Companion Diagnostics Product Portfolio
4.2.2.1 myRisk Hereditary Cancer Test
4.2.2.2 BRACAnalysis®
4.2.2.3 CCP Assay
4.2.2.4 PREZEON™
4.2.3 Myriad Genetics: Companion Diagnostics Pipeline
4.2.3.1 HRD Assay
4.2.4 Myriad Genetics: Companion Diagnostics Collaborations:
4.2.4.1 Myriad/AstraZeneca: Premarket Approval Application
4.2.4.2 Acquisition of Crescendo Bioscience: Entry into the Autoimmune Market
4.2.4.3 Myriad/ TESARO Companion Collaboration
4.2.4.4 Collaboration with AbbVie
4.2.4.5 Agilent/Bristol-Myers Squibb
4.3 Genomic Health
4.3.1 Genomic Health: Financial Overview
4.3.2 Genomic Health: Companion Diagnostics Product Portfolio
4.3.2.1 Oncotype Dx Portfolio
4.3.2.2 Oncotype SEQ
4.3.3 Genomic Health: Companion Diagnostics in Pipeline
4.3.3.1 RxPonder Trial
4.3.4 Genomic Health: Collaborations & Partnerships
4.3.4.1 Partnership with OncoMed
4.3.4.2 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
4.4.3.1 Acquisition of Life Technologies
4.4.3.2 Acquisition of Prionics
4.4.3.3 Acquisition of Advanced Scientifics, Inc.
4.4.3.4 Acquisition of Alfa Aesar
4.4.3.5 Affymetrix: Thermo Fisher’s Next Target
4.4.3.6 Thermo Fisher: Developing a ‘Universal’ Companion Diagnostics Using Next Generation Sequencing
4.4.3.7 Thermo Fisher: Life Technologies Collaborates with Merck Serono
4.4.3.8 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
4.5.3.1 Companion Diagnostics Center of Excellence
4.5.4 Johnson & Johnson: Companion Diagnostics Partnerships
4.5.4.1 Collaboration with Tianjin Medical University Cancer Institute and Hospital
4.5.4.2 Partnership with Massachusetts General Hospital
4.5.4.3 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
4.6.3.1 Agreement with Medco Health Sciences
4.6.3.2 Non-Exclusive License Agreement with Merck
4.6.3.3 Acquisition of Monogram Biosciences
4.6.3.4 Acquisition of Genzyme Genetics
4.6.3.5 Partnership with ARCA Biopharma
4.7 Illumina
4.7.1 Illumina: Financial Overview
4.7.2 Illumina: Companion Diagnostics Product Portfolio
4.7.2.1 MiSeqDx™ System
4.7.3 Illumina: Recent Activity & Collaborations
4.7.3.1 AstraZeneca Partners with Illumina
4.7.3.2 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
5.1.7.1 Foundation Medicine and Roche Collaborate
5.1.7.2 Ventana Partners with Genmab
5.1.7.3 Ferring Collaborates with Roche for CDx Development for Infertility Treatment
5.1.7.4 MedImmune Partners with Ventana
5.1.7.5 Merck Enters Agreement with Ventana
5.1.7.6 AstraZeneca and Roche Partnership
5.1.7.7 Boehringer Ingelheim Collaborate with Roche
5.1.7.8 ImmunoGen Enter Agreement with Ventana
5.1.8 Roche Diagnostics: Major M&A Activity and Strategic Partnerships
5.1.8.1 Genia Acquisition to Strengthen DNA Sequencing Capabilities
5.1.8.2 IQuum Acquisition Allows Movement into POC MDx Market
5.1.8.3 Seragon Acquisition Strengthens Leading Position in Oncology
5.1.8.4 Santaris Acquisition Enhances Roche’s Position in RNA-Targeted Drugs Market
5.1.8.5 Bina Acquisition Brings Big Data Solution to Support NGS Development
5.1.8.6 Dutalys Acquisition Enhances Roche’s mAB Portfolio
5.1.8.7 Ariosa Acquisition Adds NIPT to Diagnostic Portfolio
5.1.8.8 Foundation Medicine Deal Enhances Personalised Medicine Capabilities for Oncology
5.1.8.9 Signature and CAPP Acquisitions Strengthen Circulating DNA Testing Abilities
5.1.8.10 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
5.2.2.1 Qiagen: Companion Diagnostics Collaborations
5.2.2.2 Collaboration with Eli Lilly
5.2.2.3 Collaboration with AstraZeneca
5.2.2.4 Collaboration with Astellas Pharma
5.2.2.5 Collaboration with Novartis
5.2.2.6 Collaboration with Array BioPharma
5.2.2.7 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
5.3.4.1 Merck and Aglient Cancer Collaborations
5.3.4.2 Pfizer and Aglient an Ongoing Collaboration
5.3.4.3 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
5.4.4.1 Collaboration with Gilead Sciences
5.4.4.2 Collaboration with Ipsen
5.4.4.3 Collaboration with Merck
5.4.4.4 Collaborations with GSK and Novartis
5.4.4.5 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
5.5.5.1 Partnership with Pfizer
5.5.5.2 Partnership with ViiV Healthcare
5.5.5.3 Partnership with Tocagen
5.6 MDxHealth
5.6.1 MDxHealth: Financial Overview
5.6.2 Companion Diagnostics
5.6.2.1 PharmacoMDx
5.6.2.2 PredictMDx for Brain Cancer
5.6.2.3 PredictMDx for Colon Cancer
5.6.3 R&D Capabilities
5.6.4 Recent Collaborations and Partnerships
5.6.4.1 Cerba HealthCare Belgium Collaboration
5.6.4.2 SouthGenetics Partnership
5.6.4.3 Sumitomo Sign Pharmaco Partnership for Japan
5.6.4.4 Partnership with GSK

6. Leading Rest of the World Companion Diagnostic Companies, 2016
6.1 MedGenome
6.1.1 MedGenome: Companion Diagnostics Product Portfolio
6.1.1.1 Integrated Genomics Platform
6.1.1.2 OncoPept
6.1.1.3 OncoMD
6.1.1.4 Next-Generation Sequencing Informatics
6.2 Diagnocure
6.2.1 Diagnocure Products
6.2.1.1 Gene Expression and Copy Number Variation (CNV) Analysis
6.2.1.2 Mutation Detection
6.2.1.3 SNP Genotyping
6.2.1.4 Platform and Laboratory Environment
6.2.2 DiagnoCure Collaborations and Partnerships
6.3 Seegene Inc.
6.3.1 Seegene: Product Portfolio
6.3.1.1 MuDT™(Multiple Detection Temperatures) Technology
6.3.1.2 TOCE™ Technology
6.3.1.3 DPO™ Technology
6.3.1.4 READ Technology
6.3.1.5 ACP™ Technology
6.3.2 Seegene Collaborations and Partnerships
6.4 Savyon Diagnostics
6.4.1 Savyon: Product Portfolio
6.4.1.1 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
8.1.1.1 A CDx Strategy Decreases the Length of Approval Process
8.1.1.2 Premium Prices for Companion Diagnostics
8.1.1.3 A CDx Development Strategy Can Generate More Effective Drugs
8.1.1.4 Therapeutics Tied with CDx can have Safer Profiles
8.1.1.5 Reducing the Cost of Healthcare
8.1.1.6 Increased Regulatory Scrutiny on Marketed Drugs
8.1.1.7 Targeted Therapies Will Drive the CDx Market
8.1.2 Weaknesses
8.1.2.1 Reimbursement Challenges
8.1.2.2 Lack of Clear Regulatory Guidelines
8.1.2.3 Capital Intensity is High
8.1.3 Opportunities
8.1.3.1 Fast-growing Emerging Markets
8.1.3.2 Next Generation Sequencing
8.1.3.3 Many New CDx/ Pharma Company Partnerships
8.1.4 Threats
8.1.4.1 Complex Business Models and Business Partnerships
8.1.4.2 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


【レポート販売概要】

■ タイトル:医療機器リーダーシリーズ:コンパニオン診断薬(CDx)開発、製造および販売のトップ企業2016
■ 英文:Medical Device Leader Series: Top Companion Diagnostics (CDx) Developers, Manufacturers and Marketers in 2016
■ 発行日:2016年8月
■ 調査会社:visiongain
■ 商品コード:VGAIN60907
■ 調査対象地域:グローバル
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