コンパニオン診断(CDx)の世界市場...市場調査レポートについてご紹介

【英文タイトル】The Companion Diagnostics (CDx) Market Forecast 2015-2025

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【レポートの概要(一部)】

1. Report Overview
1. Executive Summary
1.1 The Companion Diagnostics Market Overview
1.2 Companion Diagnostics Market Segmentation
1.3 Why You Should Read This Report
1.4 How This Report Delivers
1.5 Key Questions Answered by This Analytical Report
1.6 Who is This Report For?
1.7 Methodology
1.8 Frequently Asked Questions (FAQ)
1.9 Associated Reports
1.10 About Visiongain

2. Introduction to Companion Diagnostics
2.1 The Foundation of Personalised Medicine
2.2 Personalised Medicine: Changing the Patient Treatment Paradigm
2.3 In Vitro Diagnostic (IVD) Tests
2.3.1 Companion Diagnostics: A Type of IVD
2.3.2 Differences between Companion Diagnostics and Theranostics
2.3.4 Biomarkers to Companion Diagnostics
2.3.5 Genomic Biomarkers
2.3.6 Genomic Oncology Biomarkers
2.4 Regulations in the Companion Diagnostics Market
2.4.1 FDA’s Final Guidance on Companion Diagnostics
2.4.2 LDTs: A Changing Landscape
2.5 Encouraging the Contemporaneous Development of Companion Diagnostics

3. The World Companion Diagnostics Market, 2015-2025
3.1 Scope and Limitations
3.2 The Global Companion Diagnostics Market, 2014
3.3 The Global Companion Diagnostics Market Sales Forecast, 2015-2025
3.4 Companion Diagnostics: Outpacing the Rest of the IVD Market
3.5 Companion Diagnostics: Increasing Market Share of the IVD Market
3.6 The Companion Diagnostics Market by Submarket, 2014
3.7 Theranostics: Will Outpace the Rest of the CDx Market
3.8 Changing Market Shares of the Leading Companion Diagnostics Submarkets, 2015-2025

4. Leading National Markets for Companion Diagnostics, 2015-2025
4.1 The Leading National Markets for Companion Diagnostics: Led by 3 Dominant Markets in 2014
4.2 The Leading National Markets for Companion Diagnostics Sales Forecast, 2015-2025
4.2.1 Changing Market Shares of Leading National Markets, 2015-2025
4.3 The US Companion Diagnostics Market Sales Forecast, 2015-2025
4.3.1 The U.S Will Continue to Dominate the Market
4.3.2 Leading Companion Diagnostics U.S Companies
4.4 The EU5 Companion Diagnostics Sales Market, 2014
4.4.1 The EU5 Companion Diagnostics Market Sales Forecast, 2015-2025
4.4.2 Changing Market Shares of the EU5 Companion Diagnostics Market
4.4.3 The German Companion Diagnostics Market Sales Forecast, 2015-2025
4.4.4 The French Companion Diagnostics Market Sales Forecast, 2015-2025
4.4.5 The Italian Companion Diagnostics Market Sales Forecast, 2015-2025
4.4.6 The Spanish Companion Diagnostics Market Sales Forecast, 2015-2025
4.4.7 The UK Companion Diagnostics Market Sales Forecast, 2015-2025
4.5 The Japanese Companion Diagnostics Market Sales Forecast, 2015-2025
4.5.1 Japan’s Slow Medical Technology Regulatory Process
4.6 The Chinese Companion Diagnostics Market Sales Forecast, 2015-2025
4.6.1 Cancer Rates will Drive Adoption of Companion Diagnostic tests
4.6.2 Ventana: A Major Player Moving into China’s Companion Diagnostics Space
4.7 The Indian Companion Diagnostics Market Sales Forecast, 2015-2025
4.8 The Brazilian Companion Diagnostics Market Sales Forecast, 2015-2025
4.9 The Russian Companion Diagnostics Market Sales Forecast, 2015-2025
4.10 The South Korean Companion Diagnostics Market Sales Forecast, 2015-2025
4.11 The Mexican Companion Diagnostics Market Sales Forecast, 2015-2025
4.12 The Rest of the World Companion Diagnostics Market Sales Forecast, 2015-2025

5. The Companion Diagnostics Market: Marketed Products and Pipeline Partnerships Market
5.1 Biomarkers: At the Forefront of Companion Diagnostics Development
5.2 U.S FDA Approved Companion Diagnostic Tests, 2015
5.3 Oncology Continues to Dominate the R&D Pipeline of Companion Diagnostics
5.4 Expensive Cancer Therapies Encourages the Development of CDx
5.5 Other Disease Indication Opportunities in the Companion Diagnostics Market
5.6 Companion Diagnostic/Pharma Partnerships, 2013-2014

6. Business Models and Stakeholders in the Companion Diagnostics
6.1 Business Models for the Development of Companion Diagnostics
6.1.1 The Partnership Model is the Most Practiced Method
6.1.2 The Stand-alone Model: Licensing an IP
6.1.3 The One Stop Shop Model: An Approach by Large Pharma
6.1.4 Using Contract Diagnostics Organisations (CDO): An Emerging Trend
6.2 Factors Driving Companies to Enter the Companion Diagnostics Market
6.3 Stakeholders influencing the Companion Diagnostics Market
6.3.1 Pharmaceutical Companies and Diagnostic Manufacturers
6.3.2 Regulatory Authorities
6.3.3 Testing Laboratories
6.3.4 Physicians and Patients
6.3.5 Payers
6.4 Companion Diagnostics Competitive Landscape, 2015

7. Leading Companies in the Companion Diagnostics Market
7.1 Roche: Global Diagnostics Leader
7.1.1 Ventana Medical Systems (Roche)
7.1.2 Sales and Recent Performance Analysis, 2014
7.1.3 Roche Diagnostics by Region, 2014
7.1.4 Roche: Internal Growth
7.1.5 Approval of Tarceva and Cobas EGFR Mutation Test
7.1.6 Companion Diagnostic Project Pipeline
7.1.7 Roche’s Portfolio of Marketed Companion Diagnostics, 2015
7.1.8 Ventana Companion Diagnostics: New Robust Prototype Assays
7.1.9 Recent Companion Diagnostic External Collaborations, 2014-2015
7.1.9.1 Ventana/Genmab
7.1.9.2 Ferring/ Roche: CDx Development for Infertility Treatment
7.1.9.3 MedImmune (AstraZeneca)/Ventana: Assay for NSCLC Targeted Clinical Trials
7.1.9.4 Merck/Ventana: CDx for an Undisclosed Target
7.1.9.5 AstraZeneca/Roche: CDx to Support Target Drug AZD9291
7.1.9.6 Boehringer Ingelheim/Roche
7.1.9.7 ImmunoGene/ Ventana
7.1.9.8 Foundation Medicine/Roche
7.1.9.9 Acquisitions: Bolstering their Genomic-based Diagnostic Technologies
7.2 Qiagen: Leading CDx Collaborator with Pharmaceutical Companies
7.2.1 Sales and Recent Performance Analysis, 2013-2014
7.2.1.1 Sales and Recent Performance Analysis, Q1-Q3 2014
7.2.2 Companion Diagnostics Collaboration Agreements with Pharma, 2014
7.2.2.1 Collaboration with Eli Lilly
7.2.2.2 Collaboration with AstraZeneca
7.2.2.3 Collaboration with Astellas Pharma
7.2.2.4 Collaboration with Novartis
7.2.2.5 Collaborative Agreements with Technology Companies, 2014
7.2.2.5.1 Collaboration with Protagen
7.2.3 Qiagen: CDx Portfolio and Pipeline
7.3 Abbott Molecular: An Established Competitor
7.3.1 Sales and Recent Performance Analysis, 2013-2014
7.3.1.1 Sales and Recent Performance Analysis, Q1-Q3 2014
7.3.2 Abbott Molecular: Expansive Oncology Biomarker Pipeline
7.3.3 Recent Activity
7.3.3.1 Collaboration with Merck
7.3.3.2 Collaborative Efforts with Idera
7.4 Dako (Agilent)
7.4.1 Life Sciences and Diagnostics Business
7.4.2 Agilent Life Sciences and Diagnostics, Sales and recent Performance Analysis, 2014
7.4.3 Agilent: Next Generation Sequencing Platforms
7.4.4 Recent Companion Diagnostic Collaborations
7.4.4.1 Agilent/ Merck: Several Cancer Collaborations
7.4.4.2 Agilent/Pfizer: An Ongoing Collaboration
7.5 Myriad Genetics
7.5.1 Acquisition of Myriad RBM: Increases the Company’s Market Share of Companion Diagnostics
7.5.2 Companion Diagnostic Service Offerings
7.5.3 Sales and Recent Performance Analysis, 2013-2014
7.5.3.1 BART Test: A High Revenue Generating Product
7.5.3.2 Sales and Recent Performance, Q1-Q3 2014
7.5.4 Myriad Genetics Recent Collaborations
7.5.4.1 Myriad/AstraZeneca: Premarket Approval Application
7.5.4.2 Acquisition of Crescendo Bioscience: Entry into the Autoimmune Market
7.5.4.3 Myriad/ TESARO Companion Collaboration
7.6 BioMérieux
7.6.1 Sales and Recent Performance Analysis, 2013-2014
7.6.2 Sales by Region, 2013
7.6.3 Sales and Recent Performance Analysis, Q1-Q3, 2014
7.6.4 FDA Approval for Metastatic Melanoma Companion Diagnostic Test
7.6.5 Companion Diagnostics: Recent M&A Activity & Collaboration
7.6.5.1 Collaboration Gilead Sciences
7.6.5.2 Collaboration with Ipsen
7.6.5.3 Collaboration with Merck
7.7 Siemens Diagnostics
7.7.1 Siemens Diagnostics: Sales and Recent Performance Analysis, 2013-2014
7.7.2 Siemens Healthcare Research and Development for Diagnostics
7.7.3 Recent Companion Diagnostics Partnerships
7.7.3.1 Agreement with Pfizer
7.7.3.2 Collaboration with Janssen Pharmaceutical
7.7.3.3 Partnership with ViiV Healthcare
7.7.3.4 Partnership with Tocagen
7.7.3.5 Siemens Healthcare: An Uncertain Future
7.8 Thermo Fisher Scientific
7.8.1 Sales and Recent Performance Analysis, 2013-2014
7.8.1.1 Sales Performance by Region, 2013
7.8.1.2 Thermo Fisher Scientific Financial Performance, Q1-3Q 2014
7.8.2 Recent Collaborations and Acquisitions
7.8.2.1 Acquisition of Life Technologies
7.8.2.2 Acquisition of Prionics
7.8.2.3 Thermo Fisher: Developing a ‘Universal’ Companion Diagnostics Using Next Generation Sequencing
7.8.2.4 Thermo Fisher Life Technologies Collaborates with Merck Serono
7.9 Lab 21: Fast Grower in Companion Diagnostics
7.9.1 Partnership with IntegraGen
7.9.2 Partnership with an Undisclosed Major Pharmaceutical Company
7.9.3 Lab 21: A Forerunner in Offering FDA approved Companion Diagnostics
7.9.4 New Lung Cancer Companion Diagnostic Service

8. Quantitative Analysis of the Companion Diagnostics Market, 2015-2025
8.1 SWOT Analysis of the Companion Diagnostics Market
8.2 Strengths
8.2.1 A CDx Strategy Decreases the Length of Approval Process
8.2.2 Premium Prices for Companion Diagnostics
8.2.3 A CDx Development Strategy can Generate more Effective Drugs
8.2.4 Therapeutics Tied with CDx can have Safer Profiles
8.2.5 Reducing the Cost of Healthcare
8.2.6 Increased Regulatory Scrutiny on Marketed Drugs
8.2.7 Target Therapies Will Drive the CDx Market
8.3 Weaknesses
8.3.1 Reimbursement Challenges and Undervalue
8.3.2 Lack of Clear Regulatory Guidelines
8.3.3 Capital Intensity is High
8.4 Opportunities
8.4.1 Fast-growing Emerging Markets
8.4.2 Next Generation Sequencing
8.4.3 Full Oncology Pipeline and Other Drug Categories will Benefit from CDx
8.4.4 Many New CDx/ Pharma Company Partnerships
8.5 Threats
8.5.1 Complex Business Models and Business Partnerships
8.5.2 Medical Device Excise Tax
8.6 Porter’s 5 Analysis of the Companion Diagnostics Market
8.6.1 Rivalry Among Competitors [High]
8.6.2 Power of Suppliers [High]
8.6.3 Power of Buyers [Medium]
8.6.4 Threat of New Entrants [Medium]
8.6.5 Threat of Substitutes [High]

9. Expert Opinions
9.1 Interview with Dr Philip D. Cotter, Principal and Co-Founder of ResearchDx, and Laboratory Director of Pacific Diagnostics Clinical Laboratory, a subsidiary of ResearchDx
9.1.1 Contract Diagnostics: A Growing Industry
9.1.2 Identifying Companion Diagnostic Partners During the Drug Development Phase
9.1.3 Oncology is Still the Largest Category for Companion Diagnostics
9.1.4 Timing the CDx/Drug Development Phase is Key to Success
9.1.5 Companion Diagnostics: A Faster Route to Therapy Approval
9.1.6 Next Generation Sequencing: A Necessary Technology?
9.2 Professor Herbie Newell, Professor of Cancer Therapeutics, Northern Institute for Cancer Research
9.2.1 Companion Diagnostics: Also Known as Predictive Biomarkers
9.2.2 Oncology: A Promising Pipeline of Targeted Therapies
9.2.3 Technological Platforms for Biomarker Discovery
9.2.4 Cancer Targets: Some are More Challenging than Others
9.2.5 Beyond Oncology: Biomarkers could Aid Infectives
9.2.6 The Challenges of Heterogeneous Cancers
9.2.7 Cancer Research UK Drug Discovery Programme

10. Conclusion
10.1 Overview
10.2 Theranostics: A Fast Growing Market
10.3 Leading Companion Diagnostic Companies
10.4 Pharmaceutical/Diagnostic Partnership Model
10.5 Oncology is the Leading Therapy Area Driving Companion Diagnostics
10.6 Commercial Drivers of the Companion Diagnostics Market
10.7 Commercial Restraints of the Companion Diagnostics Market
10.8 Concluding Remarks


【レポート販売概要】

■ タイトル:コンパニオン診断(CDx)の世界市場
■ 英文:The Companion Diagnostics (CDx) Market Forecast 2015-2025
■ 発行日:2015年2月
■ 調査会社:visiongain
■ 商品コード:VGAIN502206
■ 調査対象地域:グローバル
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