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オーダーメイド医療・コンパニオン診断市場:産業動向、技術、市場参入企業および環境の戦略的分析

Personalized Medicine, Targeted Therapeutics & Companion Diagnostic Market to 2019 -Strategic Analysis of Industry Trends, Technologies, Participants, and Environment

発行 Kelly Scientific Publications 商品コード 278604
出版日 ページ情報 英文 393 Pages
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オーダーメイド医療・コンパニオン診断市場:産業動向、技術、市場参入企業および環境の戦略的分析 Personalized Medicine, Targeted Therapeutics & Companion Diagnostic Market to 2019 -Strategic Analysis of Industry Trends, Technologies, Participants, and Environment
出版日: 2016年02月08日 ページ情報: 英文 393 Pages
概要

当レポートでは、オーダーメイド医療・コンパニオン診断市場における市場規模、セグメント、主要企業、SWOT分析、影響力の大きい技術、およびビジネス・経済環境について詳細に分析しており、企業、地域、セグメント、および2次市場別の分析、財務データ・ビジネス戦略情報、SWOT分析、経済、および規制環境などをまとめてお届けいたします。

第1章 エグゼクティブサマリー

第2章 イントロダクション

第3章 オーダーメイド医療による治療・コンパニオン診断

第4章 オーダーメイド医療および医療制度への統合

第5章 民間・公共資金およびオーダーメイド医療の医療費償還

  • 国際的なオーダーメイド医療活動の研究・開発
  • 薬理遺伝学/薬理ゲノム学研究における人気の生物学的標的/経路
  • 衡平支払者の医療費償還
  • バイオレポジトリーおよびバイオバンク
  • 知的財産およびオーダーメイド医療

第6章 欧州のオーダーメイド医療市場‐支払い・投資

  • オーダーメイド医療と欧州市場
  • 欧州のオーダーメイド医療投資
  • 欧州における医療費償還政策の概要
  • EUにおける市場普及率の獲得
  • 英国におけるオーダーメイド医療規制と医療費償還
  • 英国におけるCEマーク付きオーダーメイド医療/診断検査
  • ドイツにおけるオーダーメイド医療規制
  • フランスにおけるオーダーメイド医療規制
  • スペインにおけるオーダーメイド医療規制
  • イタリアにおけるオーダーメイド医療規制
  • 将来におけるオーダーメイド医療開発の課題

第7章 オーダーメイド医療‐ビジネスモデル分析

  • オーダーメイド医療は新しいビジネスモデルを必要とする
  • 診断、医薬品およびバイオテクノロジー企業のためのビジネスモデル戦略
  • プロバイダー、プロバイダーシステム、大学の医療センターのためのビジネスモデル戦略
  • 医療費支払者のためのビジネスモデル戦略
  • 政府のためのビジネスモデル戦略
  • オーダーメイド医療市場への非医療企業の採用
  • 大手製薬企業のビジネスモデルへの変化
  • オーダーメイド医療のコスト効率とビジネス価値
  • オーダーメイド医療の比較効果研究
  • 償還、保障および支払い政策

第8章 オーダーメイド医療の主要企業

  • 23andMe
  • Affymetrix
  • Astex Pharmaceuticals
  • Atossa Genetics
  • CuraGen
  • Celera Corporation (Quest Diagnostics)
  • Celldex Therapeutics
  • deCode Genetics (Amgen)
  • Illumina
  • Genelex
  • Myriad
  • Nodality
  • Qiagen
  • Admera Health (GeneWiz)
  • Claritas Genomics

第9章 オーダーメイド医療産業の製品・キット

  • 23andMe
  • Affymetrix
  • Astex Pharmaceuticals
  • Atossa Genetics
  • Celera (Quest Diagnostics)
  • deCode Genetics
  • Illumina
  • Genelex
  • Myriad Genetics
  • Nodality
  • Qiagen
  • Admera Health (GENEWIZ)
  • Claritas Genomics

第10章 オーダーメイド医療市場の分析

  • 概要
  • オーダーメイド医療市場
  • オーダーメイド医療ケア市場
  • オーダーメイド医療-栄養・ウェルネス2次市場
  • オーダーメイド医療-診断・治療2次市場
  • 世界のオーダーメイド医療技術市場
  • 世界のオーダーメイド医療2次市場の成長率
  • 分子診断市場
  • コンシューマーゲノミクス市場
  • 主要企業の利益幅分析
  • 市場参入企業分析

第11章 オーダーメイド医療の強みとメリット

  • ヒトゲノムのシーケンシング
  • 患者ケアの改善と副作用の軽減
  • 医療費を減らすオーダーメイド医療
  • オーダーメイド医療規制におけるFDAの前進
  • 先進技術
  • 薬理ゲノム学における産業投資
  • コンシューマーゲノミクスとPOC市場
  • 癌はオーダーメイド医療の促進因子

第12章 オーダーメイド医療市場の抑制因子

  • 十分な規制の欠如
  • 疾病表現型の十分な遺伝子型連鎖研究の不足
  • 医療費償還問題

第13章 オーダーメイド医療と規制政策

第14章 最終サマリーと将来の展望

図表リスト

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目次
Product Code: 2016PMCDx

This is a comprehensive account of the market size, segmentation, key players, SWOT analysis, influential technologies, and business and economic environments. The report is supported by over 360 tables & figures over 393 pages. The personalized medicine (global & USA) market is presented as follows:

  • By Company (e.g., Qiagen, AFFYMETRIX, ATOSSA GENETICS, NODALITY, deCode /Amgen, CELERA, MYRIAD)
  • By Segment (Targeted therapeutics, Companion Diagnostics, Liquid Biopsies)
  • By Sub-market (Companion diagnostic, targeted cancer therapeutic, medical technology, pharmacogenomics, consumer genomics, molecular diagnostics, liquid biopsy)
  • By Therapy (Cancer, Cardiovascular, Infectious Disease)

Key Opinion Leaders that contributed to interview questions within the report include:

  • Iain D. Miller, PhD, MBA, Founder & CEO, Healthcare Strategies Group
  • Stephen Finn, MBBS, PhD, Associate Professor, Cancer Molecular Diagnostic Laboratory, Consultant Histopathologist and Head of Histopathology, St James's Hospital and Trinity College Dublin, Ireland
  • Ronald Przygodzki, MD, Director, Genomic Medicine Implementation at U.S. Department of Veterans Affairs, Washington DC
  • Elaine Kenny, PhD, Founder, Elda Biotech, Dublin 2, Ireland
  • Chad Clark, Co-President and Chief Operating Officer, Precision for Medicine
  • Tobias Guennel, PhD, Principal, Biomarker and IVD Analytics, Precision for Medicine
  • David Parker, PhD, Vice President, Integrated Market Access, Precision for Medicine
  • Deborah Phippard, PhD, Vice President, Research, Precision for Medicine
  • Judi Smith, MS, Vice President, In Vitro Diagnostics Regulatory and Quality, Precision for Medicine

A wealth of financial data & business strategy information is provided including:

  • Company financials, sales & revenue figures
  • Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies
  • Business Model Strategies for Providers. Provider Systems and Academic Medical Centres
  • Business Model Strategies for Payers & Governments
  • Private and Public Funding and Personalized Medicine Reimbursement
  • Revisions to Current Payment Systems and intellectual property
  • How to Gain Market Penetration in the EU
  • Cost-effectiveness and Business Value of Personalized Medicine
  • Therapeutics and Companion Diagnostics (e.g., BRAC Analysis, Oncotype Dx , KRAS Mutations)
  • Comprehensive account of company product portfolios & kits

SWOT, Economic & Regulatory Environment specifics include:

  • Key strengths, weaknesses and threats influencing leading player position within the market
  • Technologies driving the market (e.g., New-Generation Sequencing Technologies, Ultra-High Throughput Sequencing)
  • Top fastest growing market segments and emerging opportunities
  • Top pharmaceutical companies within the IPM by market share and revenue
  • Comprehensive product portfolios, R&D activity and pipeline therapeutics
  • M&A activity and future strategies of top personalized medicine pharmacos
  • Personalized Medicine Regulation (USA, UK, Germany, France, Spain, Italy)
  • CE-marked Personalized Medicine/Diagnostic Tests
  • FDA Advances in Personalized Medicine Regulation

This report highlights a number of significant pharmacos and gives details of their operations, products, financials and business strategy.

  • 23andMe
  • Abbott Laboratories
  • Abbott Molecular Inc.
  • Admera Health (GENEWIZ)
  • Affymetrix
  • Agendia
  • Alere
  • Amgen
  • Astex Pharmaceuticals
  • AstraZeneca
  • Atossa Genetics
  • Becton Dickenson
  • bioMerieux
  • BristolMyersSquibb
  • Cancer Genetics
  • Celera (Quest Diagnostics)
  • Celldex Therapeutics
  • Claritas Genomics
  • CuraGen
  • Danaher (Leica Biosystems)
  • deCode Genetics (Amgen)
  • Foundation Medicine
  • EDP Biotech
  • Eli Lilly
  • ELDA BioTech
  • Eisai
  • Genelex
  • GlaxoSmithKline
  • Human Longevity Inc (Cypher Genomics)
  • HalioDx
  • Ikonisys
  • Illumina
  • InterGenetics
  • Johnson & Johnson
  • LabCorp
  • Life Technologies
  • Merck
  • MDxHealth
  • MolecularMD Corporation
  • Monogram Biosciences
  • Myriad
  • Nodality
  • Novartis MDx
  • Orion Genomics
  • Oxford BioTherapeutics
  • NanoString Technologies
  • Pfizer
  • Qiagen
  • Roche Molecular Diagnostics
  • Sanofi
  • SensiGen
  • Siemens Healthcare Diagnostics
  • Takeda
  • Thermo Fisher Scientific
  • Transgenomic
  • Ventana (Roche)
  • Vermillion (Ciphergen)
  • Vertex Pharmaceuticals

What you will gain:

  • An in-depth understanding of the global personalized medicine market and it's environment
  • Current market facts, figures and product lines of key players in the industry
  • Emerging trends in key markets such as the US, UK, Germany and France
  • Knowledge of how the personalized medicine market will integrate into the global healthcare market
  • Technical insights into new generation sequencing technologies and ultra-high throughput sequencing
  • Updates on bioinformatics, high throughput systems, genetic analysis kits, companion diagnostics and future technologies
  • FDA approved pharmacogenetic tests and recognized biomarkers
  • Information on key government and regulatory policies
  • Strategies on how to adapt and restructure current business models to this industry

This report tackles key concerns to the personalized medicine market such as:

  • Lack of regulatory policy and legislation in the US and Europe
  • Reimbursement schemes and payers concerns
  • Transition of investigational diagnostic assays and therapeutics to clinical practice
  • Direct to consumer (DTC) test kits and implications for the public

Who should read this report?

  • Pharmaceutical, biotechnology and diagnostic companies (CEOs, VPs, Business Development, C-Suite)with an interest in personalized medicine
  • Industry professionals and business strategists will discover key information to propel their policies
  • Investors will gain inside information to dominant players in the industry and future forecasts
  • Scientists will get a business perspective and industry insight into how scientific breakthroughs influence the market environment

This report will tell you if the companies mentioned are:

  • Strong, competitive players
  • Pooling their resources for specific growth and therapeutic areas
  • Investing strategically in R&D
  • Have a history of strategic M&A activity

This detailed report is supported with 360 figures and tables over 393 pages and profiles the main pharmacos in personalized medicine.

Table of Contents

1.0. Executive Summary

  • 1.1. Objectives of Report
  • 1.2. Scope of Study
  • 1.3. Data Sources and Methodology
  • 1.4. Key Findings and Observations
    • 1.4.1. CYP2C9 and VKORC1 mutations and Warfarin Response
    • 1.4.2. KRAS Mutations
    • 1.4.3. HerceptinR and Breast Cancer
    • 1.4.4. BRACAnalysisR
    • 1.4.5. Oncotype Dx Test
    • 1.4.6. Public and Private Funding for Personalized Medical Research
    • 1.4.7. New Business Model Required for Personalized Medicine
    • 1.4.8. Cost-effectiveness and Business Value of Personalized Medicine
    • 1.4.9. Personalized Medicine Market
    • 1.4.10. Personalized Medicine Oncology Therapeutics & Diagnostics Market
    • 1.4.11. Personalized Medicine Cardiovascular Therapeutics Market
    • 1.4.12. PharmacoGenomics/PharmacoGenetics Market Analysis
    • 1.4.13. Liquid Biopsy Market Analysis

2.0. Introduction and Background

  • 2.1. Genetics Explained in Five Minutes
    • 2.1.1. Why is the Central Dogma of Molecular Biology Important in Personalized Medicine?
    • 2.1.2. Genetic Mutations Explained
    • 2.1.3. What is the Difference between Genotype and Phenotype?
    • 2.1.4. Why do we Need to Look at Genetic Diversity with Respect to Personalized Medicine?
  • 2.2. Introduction to Personalized Medicine
  • 2.3. Pharmacogenetics
  • 2.4. How Personalized Medicine Monitoring can Reduce Adverse Drug Reactions
  • 2.5. Pharmacogenetic Study Challenges
  • 2.6. Pharmacogenomics
  • 2.7. Applications of Pharmacogenomics
    • 2.7.1. Pharmacogenomics: Improving the Safety of Medications
      • 2.7.1.1. Adverse Drug Reactions
      • 2.7.1.2. Pharmacogenomics: Improving the Efficacy of Therapeutics
    • 2.7.2. Vioxx Disaster Could have been Prevented with Personalized Medicine
  • 2.8. Pharmacogenetic Analysis
    • 2.8.1. Single Base Primer Extension
    • 2.8.2. Primer Based Base Extension
    • 2.8.3. Hybridization Based SNP Analysis
    • 2.8.4. Ligation Based Approach
    • 2.8.5. New-Generation Sequencing Technologies
    • 2.8.6. Ultra-High Throughput Sequencing
  • 2.9. Companion Diagnostics
    • 2.9.1. Companion Diagnostic Deals
  • 2.10. Selected Personalized Medicine Drugs by Biomarker and Indication
  • 2.11. Selected Personalized Medicine Test/Kit According to Therapeutic and Indication
  • 2.12. Targeted Cancer Therapy
  • 2.13. What Percentage of Cancer Patients Could be Treated by Targeted Therapy?
  • 2.14. Liquid Biopsies
    • 2.14.1. CANCER-ID Project
    • 2.14.2. Challenges for Liquid Biopsies
  • 2.15. Tumor Genetic Heterogeneity
    • 2.15.1. Introduction
    • 2.15.2. Clonal Evolution. How Phylogenetic Analysis is Aiding Personalized Medicine
    • 2.15.3. Therapeutic Resistance
    • 2.15.4. Tumor Immunogenicity
    • 2.15.5. Tumor Neo-Antigen Production
    • 2.15.6. Sampling Tumor Heterogeneity with Liquid Biopsies
    • 2.15.7. How Does Tumor Heterogeneity Impact Personalized Medicine?
    • 2.15.8. Summary
  • 2.16. How Next Generation Functional Diagnostics is Helping Personalized Medicine

3.0. Personalized Medicine Targeted Therapeutics and Associated Companion Diagnostics

  • 3.1. CYP2C9. and VKORC1 mutations and Warfarin Response
  • 3.2. HLA-B*5701 and Abacavir Response
  • 3.3. KRAS Mutations
    • 3.3.1. Erbitux
    • 3.3.2. Vectibix
  • 3.4. HerceptinR and Breast Cancer
  • 3.5. BRACAnalysisR
    • 3.5.1. Comprehensive BRACAnalysisR
    • 3.5.2. BRACAnalysisR Rearrangement Test (BART)
    • 3.5.3. Single Site BRACAnalysisR
    • 3.5.4. Multisite 3 BRACAnalysisR
  • 3.6. Oncotype Dx Test
  • 3.7. TherascreenR EGFR RGQ PCR Kit
  • 3.8. Therascreen KRAS RGQ PCR System
  • 3.9. TherascreenR IDH1/2 test
  • 3.10. THxID. -BRAF Kit
  • 3.11. CobasR EGFR Mutation Test (Roche)
  • 3.12. Prolaris Prostate Cancer Test
  • 3.13. ALK and Non-Small Cell Lung Cancer
    • 3.13.1. ALK-Fusion Testing
    • 3.13.2. VYSIS ALK Break Apart FISH Probe Kit
    • 3.13.3. VENTANA ALK (D5F3) CDx Assay
    • 3.13.4. ResponseDx: Lung.

4.0. Personalized Medicine and Integration into the Healthcare System

  • 4.1. The Personalized Medicine Coalition
  • 4.2. Personalized Medicine and the Healthcare System
  • 4.3. Clinical Application of Personalized Medicine
  • 4.4. Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology

5.0. Private and Public Funding and Personalized Medicine Reimbursement

  • 5.1. International Research and Development Personalized Medicine Activity
    • 5.1.1. Publically Funded Personalized Medicine Research
    • 5.1.2. Privately Funded Personalized Medicine Research
  • 5.2. Popular Biological Targets/Pathways in Pharmacogenetic/Pharmacogenomic Research
  • 5.3. Equitable Payer Reimbursement
    • 5.3.1. Molecular Diagnostic Payments in Personalized Medicine
      • 5.3.1.1. RVU-CPT-ICD Coding System
    • 5.3.2. Laboratory Service Payments in Personalized Medicine
    • 5.3.3. Revisions to Current Payment System
  • 5.4. Biorepositories and Biobanks
  • 5.5. Intellectual Property and Personalized Medicine

6.0. European Personalized Medicine Market. Payments and Investment

  • 6.1. Personalized Medicine and The European Market
  • 6.2. European Investment in Personalized Medicine
  • 6.3. Overview of Reimbursement Policies in Europe
  • 6.4. Gaining Market Penetration in the EU
  • 6.5. Personalized (Stratified) Medicine Regulation and Reimbursement in the UK
    • 6.5.1. Precision Medicine Catapult
  • 6.6. CE-marked Personalized Medicine/Diagnostic Tests in the UK
  • 6.7. Personalized Medicine Regulation in Germany
  • 6.8. Personalized Medicine Regulation in France
    • 6.8.1. R&D UNICANCER France
  • 6.9. Personalized Medicine Regulation in Spain
  • 6.10. The Personalized Medicine Regulation in Italy
  • 6.11. Challenges of Future Personalized Medicine Development in Europe

7.0. Personalized Medicine .Business Model Analysis

  • 7.1. New Business Model Required for Personalized Medicine
  • 7.2. Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies
  • 7.3. Business Model Strategies for Providers. Provider Systems and Academic Medical Centres
  • 7.4. Business Model Strategies for Payers
  • 7.5. Business Model Strategies for Governments
  • 7.6. Introduction of Non-Health Companies to the Personalized Medicine Market
  • 7.7. Change to the Big Pharma Business Model
  • 7.8. Cost-effectiveness and Business Value of Personalized Medicine
  • 7.9. Comparative Effectiveness Research in Personalized Medicine
  • 7.10. Reimbursement, Coverage and Payment Policy

8.0. Personalized Medicine Main Industry Players

  • 8.1. 23andMe
    • 8.1.1. Key Products
  • 8.2. Abbott Laboratories
    • 8.2.1. Abbott Molecular Inc.
  • 8.3. Admera Health (GENEWIZ)
    • 8.3.1. Products and Kits
    • 8.3.2. PGxOne
    • 8.3.3. OncoGxOne
    • 8.3.4. OncoGxOne Plus
    • 8.3.5. FloraCheck
    • 8.3.6. EGFR & KRAS Clinical Sequencing
  • 8.4. Agena Biosciences (Sequenom)
    • 8.4.1. MassARRAY System
    • 8.4.2. Acquisition of Sequenom-*スfs Bioscience Business by Agena Biosciences
  • 8.5. Affymetrix
    • 8.5.1. Products and Kits
  • 8.6. Agendia
  • 8.7. Alere
  • 8.8. Amgen Inc.
    • 8.8.1. Vectibix (panitumumab)
    • 8.8.2. Blinatumomab (Blincyto)
    • 8.8.3. Rilotumumab
  • 8.9. Astex Pharmaceuticals
    • 8.9.1. Products and Kits
  • 8.10. AstraZeneca
    • 8.10.1. Iressa
    • 8.10.2. Tagrisso AZD9291 (Osimertinib)
  • 8.11. Atossa Genetics
    • 8.11.1. Mammary Aspirate Specimen Cytology Test (MASCT.)
    • 8.11.2. ForeCYTE Breast Health Test (SM)
    • 8.11.3. ArgusCYTE Breast Health Test(SM)
    • 8.11.4. FullCYTE Breast Health Test
  • 8.12. Becton Dickinson
    • 8.12.1. Key Products
  • 8.13. BioMerieux
    • 8.13.1. Key Products
  • 8.14. BioRad
  • 8.15. Bristol-Myers Squibb Company
    • 8.15.1. Erbitux (cetuximab)
    • 8.15.2. OPDIVO (nivolumab)
    • 8.15.3. Yervoy (ipilimumab)
  • 8.16. Cancer Genetics
    • 8.16.1. Key Products
  • 8.17. Celera Corporation (Quest Diagnostics)
  • 8.17. Key Products
    • 8.17.1. ViroSeqR HIV-1 Genotyping System
    • 8.17.2. ViroSeqR HIV-1 Integrase Assay
    • 8.17.3. ViroSeqR HCV Assay
    • 8.17.4. ViroSeqR HBV Assay
    • 8.17.5. Cystic Fibrosis Genotyping Assay
    • 8.17.6. LDL-S3GGER Test
    • 8.17.7. HDL-S10GGER Test
    • 8.17.8. KIF6-StatinCheckTM Genotype Test
    • 8.17.9. LPA-AspirinCheckTM Genotype Test
    • 8.17.10. 9p21-EarlyMICheckTM Genotype Test
    • 8.17.11. AlleleSEQRR HLA PCR/Sequencing Kits
    • 8.17.12. m2000R RealTime PCR System
    • 8.17.13. CEGA -16. Instrument
  • 8.18. Celldex Therapeutics
  • 8.19. Cephid
  • 8.20. Claritas Genomics
    • 8.20.1. Products and Kits
    • 8.20.2. ClariFocus Exome for Pediatric Neurology
  • 8.21. CuraGen
  • 8.22. deCode Genetics (Amgen)
    • 8.22.1. deCodeT2 Genetic Test
    • 8.22.2. deCODE Breast Cancer.
    • 8.22.3. deCODE Prostate Cancer.
    • 8.22.4. deCODE AF.
    • 8.22.5. deCODE Glaucoma.
    • 8.22.6. deCODE MI.
    • 8.22.7. deCODE Complete.
    • 8.22.8. deCODE Cancer.
    • 8.22.9. deCODE Cardio.
    • 8.22.10. deCODE Services
  • 8.23. EDP Biotech
  • 8.24. ELDA BioTech
  • 8.25. Eisai
  • 8.26. Foundation Medicine
    • 8.26.1. FoundationOne
    • 8.26.2. FoundationOne Heme
  • 8.27. HalioDx
  • 8.28. Human Longevity Inc (Cypher Genomics)
  • 8.29. Ikonisys
  • 8.30. Illumina
    • 8.30.1. Illumina HiSeq 2000/1000
    • 8.30.2. Genome Analyzer IIx
    • 8.30.3. Illumina MiSeq
    • 8.30.4. Illumina HiScanHQ
    • 8.30.5. Illumina HiScan and iScan Array
  • 8.31. Intergenetics
  • 8.32. Genelex
    • 8.32.1. You Script.
  • 8.33. Johnson & Johnson (Janssen)
  • 8.34. LabCorp (Covance)
    • 8.34.1. Covance and M2Gen Partnership
  • 8.35. Integrated Oncology
    • 8.35.1. Main Products
  • 8.36. Merck & Co., Inc.
    • 8.36.1. Main Products
  • 8.37. MDx Health
  • 8.38. MolecularMD Corporation
  • 8.39. Monogram Biosciences
  • 8.40. Myriad
    • 8.40.1. Key Products
    • 8.40.2. COLARISR/COLARIS APR
    • 8.40.3. MELARISR
    • 8.40.4. PANEXIAR
    • 8.40.5. OnDoseR
    • 8.40.6. PREZEON.
    • 8.40.7. THERAGUIDER 5FU
    • 8.40.8. ProlarisR
  • 8.41. Nanostring Technologies
  • 8.42. Nodality
    • 8.42.1. Products and Kits
  • 8.43. Novartis
    • 8.43.1. Novartis Molecular Diagnostics
    • 8.43.2. Novartis Oncology
  • 8.44. Orion Genomics
  • 8.45. Oxford BioTherapeutics
  • 8.46. Pfizer
    • 8.46.1. Pfizer Merger with Allergan
    • 8.46.2. Pfizers Oncology Strategy
    • 8.46.3. Pfizer-*スfs Personalized Healthcare Strategy
  • 8.47. Qiagen
    • 8.47.1. Key Products
    • 8.47.2. Genotyping Products
    • 8.47.3. QIAsymphony Platform
  • 8.48. Roche
  • 8.49. Roche Diagnostics
    • 8.49.1. Roche Acquisition of Ventana Medical Systems
    • 8.49.2. Roche-*スfs Personalized Medicine Strategy
    • 8.49.3. Avastin (Bevacizumab)
    • 8.49.4. Herceptin (Trastuzumab)
    • 8.49.5. Kadcyla (Trastuzumabum emtansinum)
    • 8.49.6. Perjeta (Pertuzumab)
    • 8.49.7. MabThera/Rituximab
    • 8.49.8. Tarceva
  • 8.50. Sanofi
    • 8.50.1. Sanofi-*スfs Personalized Medicine Strategy
  • 8.51. Siemens Healthcare
    • 8.51.1. Companion Diagnostic Development at the Siemens Clinical Laboratory (SCL)
  • 8.52. Takeda
    • 8.52.1. Takeda-*スfs to Discover Therapeutic Targets in the Microbiome
    • 8.52.2. Millennium: The Takeda Oncology Company
  • 8.53. Thermo Fisher Scientific
    • 8.53.1. ThermoFisher-*スfs Personalized Healthcare Strategy
    • 8.53.2. ThermoFisher-*スfs Involvement in the NCI-MATCH Trial
  • 8.54. Transgenomic
  • 8.55. Vertex Pharmaceuticals
    • 8.55.1. Orkambi (lumacaftor/ivacaftor)
    • 8.55.2. Kalydeco (ivacaftor)

9.0. Personalized Medicine Market Analysis

  • 9.1. Companion Diagnostic and Targeted Therapeutic Market
    • 9.1.1. Global OncologyTherapeutic Market
    • 9.1.2. Targeted Therapeutics. Oncology
    • 9.1.3. Top Ten Companies in Oncology Drug Sales to 2020
    • 9.1.4. Top Five Oncology Drugs to 2020
    • 9.1.5. Global Oncology Market by Cancer Type
    • 9.1.6. Oncology Targeted Therapeutics Market Analysis to 2020
    • 9.1.7. Companion Diagnostic Assays. Oncology
  • 9.2. Cardiovascular Targeted Therapeutics Market to 2019
    • 9.2.1. Cardiovascular Companion Diagnostics Market to 2020
  • 9.3. Infectious Disease Targeted Therapeutics Market to 2019
    • 9.3.1. Infectious Disease Diagnostic Assay Market to2019
  • 9.4. Global Personalized Medical Technology Market
  • 9.5. Global Personalized Medicine Sub-Market Growth
  • 9.6. PharmacoGenomics/PharmacoGenetics Market Analysis to 2019
  • 9.7. Molecular Diagnostics Market to 2020
  • 9.8. Consumer Genomics Market
  • 9.9. Liquid Biopsy Market to 2021
  • 9.10. Major Player Profit Margin Analysis
  • 9.11. Select Market Participant Case Study Analysis
    • 9.11.1. 23andme
    • 9.11.2. Affymetrix
    • 9.11.3. Astex Pharmaceuticals
    • 9.11.4. Atossa Genetics
    • 9.11.5. Celera (Quest Diagnostics)
    • 9.11.6. Celldex Therapeutics
    • 9.11.7. deCode Genetics (Amgen)
    • 9.11.8. Illumina
    • 9.11.9. Genelex
    • 9.11.10. Myriad
    • 9.11.11. Nodality
    • 9.11.12. Qiagen
    • 9.11.13. bioMerieux

10.0. Strengths and Advantages of Personalized Medicine

  • 10.1. Sequencing of the Human Genome in 2000
  • 10.2. Improving Patient Care and Reducing Side Effects
  • 10.3. Personalized Medicine will Reduce Healthcare Costs
  • 10.4. FDA Advances in Personalized Medicine Regulation
  • 10.5. Advancing Technologies
    • 10.5.1. Next Generation Sequencing
  • 10.6. Industry Investing in Pharmacogenomics
  • 10.7. Consumer Genomics and POC Market
  • 10.8. Oncology a Driving Force of Personalized Medicine

11.0. Restraints of the Personalized Medicine Market

  • 11.1. Lack of Sufficient Regulation
  • 11.2. Lack of Sufficient Genotypic Linkage Studies to Disease Phenotype
  • 11.3. Reimbursement Issues

12.0. Personalized Medicine and Regulatory Policies

  • 12.1. Regulation by the Centres for Medicare and Medicaid Services (CMS) and US Food and Drug Administration (FDA)
  • 12.2. Genetic Information Non-discrimination Act (GINA)
  • 12.3. FDA Advancements on Genetic Testing Approval
  • 12.4. FDA- New Models to Assess Gene Therapy Safety
  • 12.5. FDA- Companion Diagnostics
  • 12.6. FDA - Partnership in Applied Comparative Effectiveness Science (PACES) Initiative
  • 12.7. National Institutes of Health Genetic Testing Registry

13.0. Final Summary and Future Perspectives

  • 13.1. Re-cap of Personalized Medicine in 2015

14.0. Interviews with Key Opinion Leaders

  • Iain D. Miller, PhD, MBA, Founder & CEO, Healthcare Strategies Group
  • Stephen Finn, MBBS, PhD, Associate Professor, Cancer Molecular Diagnostic Laboratory, Consultant Histopathologist and Head of Histopathology, St James-*スfs Hospital and Trinity College Dublin, Ireland Ronald Przygodzki, MD, Director, Genomic Medicine Implementation at U.S. Dept Veterans Affairs, Washington DC
  • Elaine Kenny, PhD, Founder, Elda Biotech, Dublin, Ireland
  • Chad Clark, Co-President and Chief Operating Officer, Precision for Medicine
  • Tobias Guennel, PhD, Principal, Biomarker and IVD Analytics, Precision for Medicine
  • David Parker, PhD, Vice President, Integrated Market Access, Precision for Medicine
  • Deborah Phippard, PhD, Vice President, Research, Precision for Medicine
  • Judi Smith, MS, Vice President, In Vitro Diagnostics Regulatory and Quality, Precision for Medicine

List of Tables

  • Table 2.1: Glossary: Common Terms Used in Genetics and Personalized Medicine
  • Table 2.2: Types of Genetic Markers used as Biomarkers in Personalized Medicine
  • Table 2.3: Genetic Disease Associated with the Ashkenazi Jew Population
  • Table 2.4: Disease Types Associated with Specific Populations
  • Table 2.5: Personalized Medicine
  • Table 2.6: Genetic Mutations that Predispose Individuals to Disease
  • Table 2.7: Potential Applications of Pharmacogenetics/genomics in Personalized Medicine
  • Table 2.8: Main Cytochrome P450 Enzymes Involved in Drug Metabolism
  • Table 2.9: Rapid & Slow Metabolizer Phenotypes
  • Table 2.10: Population Frequency of Cytochrome P450(CYP) 2C19 Metabolizer Types
  • Table 2.11: Population Frequency of Cytochrome P450 (CYP) Metabolizer Types
  • Table 2.12: Depression Medications Affected by Genetic Mutations
  • Table 2.13: Cardiovascular Medications Affected by Genetic Mutations
  • Table 2.14: Cancer Medications that may be Affected by Genetic Mutations
  • Table 2.15: Diabetes Medications Affected by Genetic Mutations
  • Table 2.16: Anti-Epileptic Drugs Affected by Genetic Mutations
  • Table 2.17: Anti-Retroviral Drugs Affected by Genetic Mutations
  • Table 2.18: Anti-Reflux/Ulcer Drugs Affected by Genetic Mutations
  • Table 2.19: List of Therapeutics According to Cytochrome P450 Subtype Metabolism
  • Table 2.20: Cytochrome (CYP) P450 Drug-Interactions Inhibitor List
  • Table 2.21: Cytochrome (CYP) P450 Drug-Interactions Inducer List
  • Table 2.22: Main Aims of Pharmacogenomics
  • Table 2.23: How Pharmacogenomics has Influenced the Top Ten Selling Drugs Globally
  • Table 2.24: Advantages, Disadvantages and Cost of Popular Genotyping Methods
  • Table 2.25: Top Ten Pharmacogenomics Tests
  • Table 2.26: FDA Accepted Pharmacogenomic Biomarkers
  • Table 2.27: Benefits of Single Base Primer Extension in Pharmacogenetics
  • Table 2.28: Future Applications of Ultra-High Throughput Sequencing
  • Table 2.29: Comparison of Genotyping Techniques
  • Table 2.30: Problems associated with Microarray Sequencing
  • Table 2.31: Top Ten Genetic Findings by 23andMe
  • Table 2.32: EMA Approved Drugs that Require Companion Diagnostics
  • Table 2.33: FDA Approved Drugs that Require Companion Diagnostics
  • Table 2.34: FDA Companion Diagnostics Device List: In Vitro and Imaging Tools
  • Table 2.35: Important Strategies for a Successful Companion Diagnostic Launch
  • Table 2.36: Selected Personalized Medicine Drugs by Biomarker and Indication
  • Table 2.37: Selected Personalized Medicine Test/Kit According to Therapeutic and Indication
  • Table 2.38: Targeted Cancer Therapeutics by Tumor Type, Target & Detection Method Available
  • Table 2.39: FDA Approved Targeted Therapies and Approved Indications for Solid Tumors
  • Table 2.40: List of all Academic and Industry Partners of CANCER-ID Consortium
  • Table 2.41: Scientific Advisory Board Members of CANCER-ID
  • Table 2.42: Details of Tumor Heterogeneity- Intratumor, Interpatient, Inter/intrametastatic
  • Table 2.43: Polyclonal Genetic Mechanisms of Therapy Resistance by Tumor Type and Study
  • Table 3.1: Predicted Warfarin Concentrations depending on CYP2C9 and VKORC1 Genotype
  • Table 3.2: Top Five Most Frequent Cancers in Men and Women, Globally
  • Table 3.3: Estimated Age-Standardised Incidence Rate of Breast Cancer per Country, Worldwide
  • Table 3.4: Diagnostic Tests Available to Determine HER2 Status in Breast Cancer Patients
  • Table 3.5: Validated HER2 Tests for Cancer
  • Table 3.6: Advantages and limitations of IHC HER2 testing applied to breast cancer
  • Table 3.7: In-SituHybridization Determination HER2 Expression: PathVysionR and HER2 FISH pharmDx
  • Table 3.8: HER2 CISH Determination
  • Table 3.9: Validated FISH Kits for HER2 Testing in Breast Cancer
  • Table 3.10: Validated SISH Kits for HER2 Testing in Breast Cancer
  • Table 3.11: Validated CISH Kits for HER2 Testing in Breast Cancer
  • Table 3.12: Advantages and limitations of ISH techniques applied to HER2 testing in breast cancer
  • Table 3.13: Prevalence of Deleterious Mutations in BRCA1 and BRCA2 Genes
  • Table 3.14: Prevalence of Deleterious Mutations in BRCA1 and BRCA2 in Individuals of Ashkenazi Ancestry
  • Table 3.15: Risk Factors for Hereditary Breast and Ovarian Cancer (HBOC)
  • Table 3.17: BRACAnalysisR Panel of Assays
  • Table 3.18: The Prolaris Score for Prostate Cancer
  • Table 4.1: Objectives of the Personalized Medicine Coalition
  • Table 4.2: Current Personalized Medicine Coalition Members
  • Table 4.3: Genetic Variants used in care of melanoma, gastrointestinal stromal tumors, non-small-cell lung cancer, thymic cancer and breast and ovarian cancers.
  • Table 4.4: Minimum Definition of a clinically Actionable Variant
  • Table 4.5: Minimum Criteria for Whole Genome Analysis in Clinical Laboratory Improvement Amendments Laboratory of Genomic Pathology, Clinical Whole Genome Analysis
  • Table 5.1: Public Funding Bodies for Pharmacogenetic/Pharmacogenomic Research
  • Table 5.2: American Companies Involved in Pharmacogenomics/genetics Drug Development & Diagnostics
  • Table 5.3: European Companies Involved in Pharmacogenomics/genetics Drug Development & Diagnostics
  • Table 5.4: North American Companies Involved in Pharmacogenomics/genetics Services
  • Table 5.5: European/Other Companies Involved in Pharmacogenomics/genetics Services
  • Table 5.6: American Companies Involved in Pharmacogenomics/genetics Tools Kits & Software
  • Table 5.7: European Companies Involved in Pharmacogenomics/genetics Tools Kits & Software
  • Table 5.8: North American Companies with Minor interest in Pharmacogenomics/genetics
  • Table 5.9: European/Other Companies with Minor interest in Pharmacogenomics/genetics
  • Table 5.10: North American Companies with Minor interest in Pharmacogenomics/genetics
  • Table 5.11: European/Other Companies with Minor interest in Pharmacogenomics/genetics
  • Table 5.12: Large US Companies with Investment into Pharmacogenomics/genetics
  • Table 5.13: Large European Companies with Investment into Pharmacogenomics/genetics
  • Table 5.14: Large Japanese Companies with Investment into Pharmacogenomics/genetics
  • Table 5.15: Top Ten Biological Areas of Interest in Pharmacogenetics/genomics
  • Table 5.16: Top International Pharmacogenetic/Pharmacogenomic Research Institutions
  • Table 5.17: Top European Pharmacogenetic/Pharmacogenomic Research Institutions
  • Table 6.1: Variation of Reimbursement Policies for HER2 & KRAS Testing in Europe
  • Table 6.2: Pharma Providing Subsidization of Personalized Medicine Tests in Europe
  • Table 6.3: Challenges Within Personalized Medicine Market in Europe
  • Table 6.4: Function of the European network for Health Technology Assessment Organisation
  • Table 6.5: European network for Health Technology Assessment (EUnetHTA) Partners
  • Table 6.6: European network for Health Technology Assessment (EUnetHTA) Associates
  • Table 6.7: Diagnostics Guidance Assessment by the National Institute Health Clinical Excellence
  • Table 6.8: Current Diagnostics Guidance in Development by the Diagnostics Access Program, UK
  • Table 6.9: Published Diagnostics Guidance by the Diagnostics Access Program, UK
  • Table 6.10: Medical Technologies Guidance Assessment by NICE
  • Table 6.11: Published Medical Technologies Guidance by NICE
  • Table 6.12: Published Medical Technologies Guidance in Development NICE
  • Table 6.13: Precision Medicine Catapult Tools to Aid Market Entry
  • Table 6.14: Key Challenges to Personalized Medicine
  • Table 6.15: Strategic Objectives of French Comprehensive Cancer Centers within UNICANCER
  • Table 6.16: Key Challenges to Personalized Medicine
  • Table 6.17: Personalized Medicine - Translation into Medical Applications
  • Table 7.1: Major Market Trends in Personalized Medicine
  • Table 7.2: Collaboration Strategies Required between Industry, Payers & Governments
  • Table 7.3: Business Model Recommendations: Diagnostic, Pharma& Biotech Companies
  • Table 7.4: Business Model Recommendations: Providers. Provider Systems & Medical Centres
  • Table 7.5: Business Model Recommendations for Payers
  • Table 7.6: Business Model Recommendations for Governments
  • Table 7.7: Non-Healthcare Companies with Potential to enter the Personalized Medicine Market
  • Table 7.8: Hurdles of Personalised Medicine with Respect to Cost-Effectiveness
  • Table 8.1: 23andMe Disease Risk Genetic Test Panel
  • Table 8.2: 23andMe Carrier Status Genetic Test Panel
  • Table 8.3: 23andMe Drug Response Genetic Marker Test Panel
  • Table 8.4: 23andMe Genetic Traits Test Panel
  • Table 8.5: Admera Health Commercial Drug List that are Covered by the PGxOne Assay
  • Table 8.6: Admera Health PGxOne Gene & Variant List, Therapeutic Area & Endorsing Agency
  • Table 8.7: Patent Listing of Affymetrix Array technology
  • Table 8.8: Patent Listing of Affymetrix Genotyping Technology
  • Table 8.9: Patent Listing of Affymetrix Expression and Profiling Technology
  • Table 8.10: Product Overview of Affymetrix
  • Table 8.11: Microarray Products by Affymetrix
  • Table 8.12: Affymetrix Research Services Laboratory (ARSL) Premier Services
  • Table 8.13: Genetic Applications of AxiomR Technology by Affymetrix
  • Table 8.14: Amgen?fs Product Pipeline
  • Table 8.15: Selected Programs in Pivotal Trial (Phase III) or Development, Amgen
  • Table 8.16: Advantages of Astex Pharmaceuticals
  • Table 8.17: Astex Pharmaceuticals Pipeline Portfolio
  • Table 8.18: Astex Pharmaceuticals Pipeline Portfolio Funded Completely by Partner Companies
  • Table 8.19: Range of Small Molecule Therapeutics Available from Astex Pharmaceuticals
  • Table 8.20: Biomarkers by Cancer Type Offered by bioMerieux
  • Table 8.21: Cancer Genetics Product Portfolio Flow Cytometry Based Assays
  • Table 8.22: Cancer Genetics Product Portfolio FISH Based Assays
  • Table 8.23: Cancer Genetics Product Portfolio Molecular Diagnostics Based Assays
  • Table 8.24: Cancer Genetics Product Portfolio Complete. Test Program
  • Table 8.25: Select One Clinical Trial Services
  • Table 8.26: Panel of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutations Screened for in Celera Cystic Fibrosis Genotyping Assay
  • Table 8.27: Genetic Tests Available from BHL/Celera
  • Table 8.28: Panel of BHL Clinical Diagnostic Tests
  • Table 8.29: Features of the m2000R RealTime PCR System by Celera
  • Table 8.30: Potential Business Partnerships of Celldex Therapeutics
  • Table 8.31: Cephid Product Portfolio to 2019 in the US
  • Table 8.32: Cephid Product Portfolio to 2019 Internationally
  • Table 8.33: Claritas Genomics Genetic Test Portfolio, by Gene
  • Table 8.34: Genetic Diagnostic Tests Available from deCode Genetics
  • Table 8.35: Type 2 Diabetes risk range and distribution according to continental ancestry as Determined by deCodeT2 Genetic Test
  • Table 8.36: Genetic Mutations Identified by the deCODE MI. Test in a European Population
  • Table 8.37: Genetic Mutations Identified by the deCODE MI. Test in an East Asian Population
  • Table 8.38: Disease States that are Included in the deCODE Complete. Genetic Screen
  • Table 8.39: Panel of Diseases Screened for in the deCODE Cancer. Test
  • Table 8.40: Panel of Cardiovascular Diseases in the deCODE Cardio. Test
  • Table 8.41: deCODE Genetics Genotyping and Sequencing Service
  • Table 8.42: deCODE Genetics Data Management, Protection and Storage Service
  • Table 8.43: deCODE Genetics Sequence Inputation and Data Analysis Service
  • Table 8.44: FoundationOne Current Gene List
  • Table 8.45: FoundationOne Heme Gene List
  • Table 8.46: Foundation Medicine Company-Sponsored Clinical Trials
  • Table 8.47: Illumina Core Technologies
  • Table 8.48: Illumina Core Technology Applications
  • Table 8.49: Illumina Instrument Product Portfolio
  • Table 8.50: Illumina Assay Product Portfolio
  • Table 8.51: Illumina HiSeq 2500/1500 Performance Parameters
  • Table 8.52: Illumina HiSeq 2000/1000 Performance Parameters
  • Table 8.53: Genome Analyzer IIx Performance Parameters
  • Table 8.54: Illumina MiSeq Product Specifications
  • Table 8.55: Illumina HiScanHQ Product Specifications
  • Table 8.56: Illumina HiScan and iScan Array Product Applications
  • Table 8.57: Illumina HiScan and iScan Array Kits
  • Table 8.58: Clinical Applications of Diagnostic Tests Offered by Intergenetics
  • Table 8.59: Genetic Test Panel Available from Genelex for Research Institutions and Clinical Trials
  • Table 8.60: Panel of Genetic Screens Available from Genelex
  • Table 8.61: Drug Sensitivity Screens Available from Genelex
  • Table 8.62: Integrated Oncology Cancer Test Portfolio
  • Table 8.63: Biopharma Merck?fs Key Product Range
  • Table 8.64: Molecular MD Biomarker Assays by Platform and Method Used
  • Table 8.65: MolecularMD Test Panels by Next Generation Sequencing, Molecular Targeted Therapy Management and Pathway Analysis
  • Table 8.66: MolecularMD Companion Diagnostic Development Capabilities
  • Table 8.67: Monogram Biosciences HIV Genotypic and Phenotypic Test Portfolio
  • Table 8.68: Predictive Genetic Tests Available from Myriad
  • Table 8.69: Services offered with BRACAnalysisR Testing from Myriad
  • Table 8.70: Advantages of BRACAnalysisR Testing
  • Table 8.71: COLARISR Test Range by Myriad
  • Table 8.72: COLARIS APR Test Range by Myriad
  • Table 8.73: MELARISR Test Range from Myriad
  • Table 8.74: Personalized Medicine Tests from Myriad
  • Table 8.75: OnDoseR Testing Procedure from Myriad
  • Table 8.76: Nanostring Technologies nCounter Workflow Platform Product Portfolio
  • Table 8.77: Pre-Clinical, Clinical and Commercial Applications of SCNP by Nodality
  • Table 8.78: Novartis Oncology Key Personalized Medicine Drug Targets
  • Table 8.79: Orion Genomics Collaboration and Commercial Agreements
  • Table 8.80: Oxford BioTherapeutics Main Technologies in Cancer Targeting
  • Table 8.81: Oxford BioTherapeutics Product Pipeline Portfolio by Development Stage
  • Table 8.82: Pfizer Key Branded Products
  • Table 8.83: Pfizer Oncology Targets and Technologies
  • Table 8.84: Pfizer Early Stage Pipeline Oncology Portfolio
  • Table 8.85: Qiagen Timeline of Events, 1994-2012
  • Table 8.86: Range of Product Groups from Qiagen
  • Table 8.87: Qiagen Genotyping Products for Sample Collection, stabilization and Storage
  • Table 8.88: Qiagen Genotyping Products for Genomic DNA Isolation and Purification
  • Table 8.89: Qiagen Genotyping Products for PCR Based Genotyping Analysis
  • Table 8.90: Qiagen Products for Genotyping Analysis
  • Table 8.91: Qiagen Genotyping Products for PCR Detection
  • Table 8.92: Qiagen Assays for Genetic Analysis
  • Table 8.93: Qiagen Pyrosequencing-Based Genetic Analysis Products
  • Table 8.94: Specifications and Features of Qiagen?fs QIAsymphony and QIAsymphony RGQ
  • Table 8.95: Roches Personalized Medicine Products by Patient Stage
  • Table 8.96: ThermoFisher Scientific Clinical Assays and Technologies for Personalized Healthcare
  • Table 8.97: Transgenomic Technology Platforms
  • Table 8.98: Transgenomic Partnerships and Collaborations
  • Table 9.1: Global Market for Oncology Drugs by Geography/Country, Through 2020
  • Table 9.2: Top Ten Companies in Oncology Sales Forecast 2013 . 2020
  • Table 9.3: Top Five Oncology Drugs, Through 2020
  • Table 9.4: Submarkets within the Personalized Medicine Technology Market
  • Table 9.5: Global Market for Liquid Biopsy by Region (North America, Europe, RoW), to 2021
  • Table 9.6: Operating Profit Margin Analysis for Selected Players in the PM Industry
  • Table 9.7: Personalized Medicine Industry Segments and Companies Analysed
  • Table 9.8: Drug Classes Investigated by 23andMe Using Genome Wide Association Studies
  • Table 9.9: Acquisition Profile of Affymetrix
  • Table 9.10: Genetic Applications of AxiomR Technology by Affymetrix
  • Table 9.11: Diversified Business Units of Affymetrix
  • Table 9.12: Affymetrix AgBio Microarray Portfolio
  • Table 9.13: Celera (Quest Diagnostics) Historic Operating (Loss) Laboratory Services & Products
  • Table 9.14: Diagnostic Test Product Manufactured by BHL/Celera & Distributed by Abbott
  • Table 9.15: Celldex Therapeutics R&D Expenses ($ Thousands) 2010-2012
  • Table 9.16: Price Listing of Genelex Familial Genetic Tests
  • Table 9.17: Myriad - Core Business Decisions and Impact on Industry
  • Table 9.18: Future Test Portfolio of Myriad
  • Table 9.19: Nodality?fs Single Cell Network Profiling (SCNP) for Drug Discovery & Validation
  • Table 9.20: BioMerieux Immunodiagnostic Product Portfolio
  • Table 9.21: BioMerieux Microbiology Product Portfolio
  • Table 9.22: BioMerieux Molecular Diagnostic Product Portfolio
  • Table 10.1: Strengths and Advantages of Genotyping Techniques
  • Table 10.2: Strengths, Drivers and Advantages of Personalized Medicine Market
  • Table 11.1: Restraints of Personalized Medicine Market
  • Table 12.1: Summary of Clinical Laboratory Improvement Amendments (CLIA)
  • Table 12.2: Clinical Laboratory Improvement Amendments (CLIA) Testing Categories
  • Table 12.3: Test Features required prior to FDA Approval and Clearance
  • Table 12.4: Impact of Genetic Information Non-discrimination Act (GINA) on Healthcare Companies & Health Plans
  • Table 12.5: Impact of Genetic Information Non-discrimination Act (GINA) on US Employers, employment agencies, labor organizations and training programs
  • Table 12.6: FDA Commitment to the Personalized Medicine Industry
  • Table 12.7: Objectives of the ?eAdvancing Regulatory Science at FDA: A Strategic Plan?f
  • Table 12.8: FDA Policy & Guidance Recommendations
  • Table 12.9: Implementation Strategy of the FDA to Advance Regulatory Science - Develop better Models of Human Adverse response
  • Table 12.10: Implementation Strategy of the FDA to Advance Regulatory Science - Identify and evaluate biomarkers and endpoints that can be used in non-clinical & clinical evaluations
  • Table 12.11: Implementation Strategy of the FDA to Advance Regulatory Science - Use and develop computational methods and in silico modelling
  • Table 12.12: National Institutes of Health Genetic Testing Registry Test Information
  • Table 13.1 2015 Targeted Therapeutic and Companion Diagnostic FDA Drug Approvals

List of Figures

  • Figure 2.1: DNA, Histones and Chromosomes
  • Figure 2.2: DNA is Composed of Four Nucleotide Bases
  • Figure 2.3: The Central Dogma of Molecular Biology . How DNA Encodes Protein
  • Figure 2.4: How Research, Technology, Regulation, Clinical Implementation and Legislation Integrates into Personalized Medicine
  • Figure 2.5: Identification of Good and Non-Responders in a Patient Population
  • Figure 2.6: Pharmacodynamic and Pharmacokinetic Examples of Drug Targets and Drug metabolism in Pharmacogenomics
  • Figure 2.7: Flow Diagram of Pharmacogenetic Analysis
  • Figure 2.8: Primer Based Base Extension in Pharmacogenetics
  • Figure 2.9: Genetic Mutation Detection by Hybridization
  • Figure 2.10: Ligation based SNP Detection
  • Figure 2.11: New-Generation Sequencing: Pyrosequencing
  • Figure 2.12: Number of Companion Diagnostic Deals Signed on a Yearly Basis
  • Figure 2.13: Percentage of Cancer Patients with Genetic Mutations that could be Treated by Targeted Therapy
  • Figure 2.14: Detection of Cell Free cfDNA in Cancer Patients . Timeline of Events
  • Figure 2.15: Cell Free Nucleic Acids Present in Blood from Cancer Patients
  • Figure 2.16: Detection of cfDNA and its Alterations in Different Forms of Cancer
  • Figure 2.17: CANCER-ID Consortium Global Location of Collaborators
  • Figure 2.18: CANCER-ID Consortium Work Package Outline
  • Figure 2.19: Use of Tumor Educated Blood Platelet mRNA Expression Levels in Liquid Biopsies
  • Figure 2.20: Types of Tumor Heterogeneity- Intratumor, Interpatient, Inter/intrametastatic
  • Figure 2.21: Tumor Clonal Evolution as Depicted in a Phylogenetic Tree
  • Figure 2.22: Mechanisms of Resistance to Targeted Therapies (Vemurafenib, Crizotinib, EGFR MAbs, EGFR TKIs, Imatinib)
  • Figure 2.23: Next Generation Functional Diagnostics in Cancer
  • Figure 3.1: Warfarin Metabolism and Response
  • Figure 3.2: Percentage Frequency of CYP2C9 and VKORC1 mutations in Caucasian, African-American and Asian Populations
  • Figure 3.3: Anti-EGFR Therapy and KRAS Mutations
  • Figure 3.4: KRAS and BRAF Genetic Tests Available from Asuragen
  • Figure 3.5: Global Incidence and Mortality of Cancer in Women
  • Figure 3.6: Cancer Deaths in Women, Globally according to Cancer Type
  • Figure 3.7: Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer Globally
  • Figure 3.8: HER2 Testing Algorithm for Breast Cancer
  • Figure 3.9: HER2 Cellular Signalling
  • Figure 3.10: Herceptin . Mechanism of Action
  • Figure 3.11: BRCA Mutation Increases the Risk of Breast and Ovarian Cancer
  • Figure 3.12: Proactive Cancer Management and Preventative Measures Reduces the Risks of Developing BRCA-associated Breast and Ovarian Cancer
  • Figure 3.13: ALK Cellular and Nuclear Signalling Pathway
  • Figure 3.14: ALK-Positive Cancers by Fusion Protein, ALK expression & Point Mutations
  • Figure 4.1: Integration of Multiple components for a Personalized Medicine Healthcare System
  • Figure 4.2: Workflow Diagram illustrating Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology
  • Figure 4.3: Hypothetical Flow Diagram of a Patient & the Genomic Pathology Clinical Laboratory
  • Figure 5.1: Personalized Medicine Scheme Interaction with Industry, Regulatory Bodies and Funding Agencies
  • Figure 5.2: Number of Publically Funded Pharmacogenetic and Pharmacogenomic Research Teams Internationally
  • Figure 6.1: Adverse Drug Reactions are the Fourth Leading Cause of Death
  • Figure 6.2: Efficacy Rate of Major Disease Types with Standard Treatment
  • Figure 6.3: The In Vitro Diagnostic Market in Europe
  • Figure 6.4: Organization of the European network for Health Technology Assessment (EUnetHTA)
  • Figure 6.5: Key Differences in Reimbursement Policy Approaches for Oncology Diagnostics and Therapeutics in Europe and the US
  • Figure 6.6: Flow Diagram of the German Healthcare System and Key Agencies
  • Figure 6.7: German Reimbursement Arrangement, Process and Implications
  • Figure 6.8: Key Information about UNICANCER France
  • Figure 6.9: Strategic Flow Diagram of UNICANCER France and its Operations
  • Figure 7.1: Annual Healthcare Expenditure for Major Industrial Nations
  • Figure 7.2: Estimated Life Expectancy from Birth for Major Industrialized Countries
  • Figure 8.1: Flow Diagram of Celera CEGA -16. Instrument for Cystic Fibrosis Gene Analysis
  • Figure 8.2: Celldex Therapeutics Product Pipeline
  • Figure 8.3: Percentage of Individual Populations who have an Increased Risk of Developing Type 2 Diabetes as Determined Using the deCodeT2 Genetic Test
  • Figure 8.4: FoundationOne and FoundationOne Heme Platforms
  • Figure 8.5: Tumor Microenvironment Showing Infiltrating Immune Cells
  • Figure 8.6: HalioDx ImmunoScore System
  • Figure 8.7: Human Longevity Inc (Cypher Genomics) Mantis Technology Platform
  • Figure 8.8: Illumina New Generation Sequencing Technology Workflow Station
  • Figure 8.9: Monogram Biosciences HIV Assay Porfolio Timeline
  • Figure 8.10: Single Cell Network Profiling (SCNP) Technology by Nodality
  • Figure 8.11: Developed Functional Assays that Nodality has explored using SCNP Technology
  • Figure 8.12: Sanofi Late Stage Product Pipeline
  • Figure 8.13: Sanofi Pipeline Products in Stage I
  • Figure 8.14: Sanofi Pipeline Products in Stage II
  • Figure 8.15: Takeda Pipeline Portfolio of Oncology and Gastrointestinal Therapeutics
  • Figure 8.16: Millenium Takeda Oncology Development Pipeline
  • Figure 8.17: Vertex Pharmaceuticals Cystic Fibrosis, Oncology, Pain & Influenza Pipeline Products
  • Figure 9.1: Personalized Targeted Therapeutic Sales Revenue, All Indications, 2014
  • Figure 9.2: Personalized Targeted Therapeutic Market, All Indications, 2014-2020
  • Figure 9.3: Companion Diagnostic and Targeted Therapeutic Personalized Medicine Market Growth
  • Figure 9.4: Companion Diagnostic Market 2014-2020
  • Figure 9.5: Combined Targeted Therapeutic and Companion Diagnostic Market, 2014-2020
  • Figure 9.6: Global Market for Oncology Drugs by Geography/Country, Through 2020
  • Figure 9.7: Global Oncology Drug Sales by Top Five Companies, Through 2020
  • Figure 9.8: Top Five Oncology Drugs, Through 2020
  • Figure 9.9: Global Oncology Market by Cancer Type, 2014
  • Figure 9.10: Global Personalized Medicine Oncology Therapeutics Forecast 2014-2019
  • Figure 9.11: HER-2 Positive Breast Cancer Therapeutic Market Forecast 2014-2019
  • Figure 9.12: Personalized Medicine Oncology Therapeutic Market Forecast 2014-2019
  • Figure 9.13: Personalized Medicine Branded Oncology Therapeutics Market Share 2014
  • Figure 9.14: Personalized Medicine Branded Oncology Therapeutics Market Share 2019
  • Figure 9.15: Top Pharma Companies Revenue from Targeted Therapeutics in Oncology
  • Figure 9.16: Global Cancer Companion Diagnostics Market 2014-2020
  • Figure 9.17: Most Popular Proteomic and Genomic Technologies Performed by End-Users
  • Figure 9.18: Oncogenic Biomarker Share of Total Personalized Medicine Biomarker Space
  • Figure 9.19: Oncogenic Biomarker Market Distribution by Cancer Type
  • Figure 9.20: Personalized Medicine Branded Cardiovascular Therapeutic Market 2014-2019
  • Figure 9.21: Personalized Medicine Branded Cardiovascular Therapeutics Market Forecast 2014-2019
  • Figure 9.22: Cardiovascular Companion Diagnostics Market Forecast 2014-2020
  • Figure 9.23: Personalized Medicine Branded Infectious Disease Therapeutics Market 2014-2019
  • Figure 9.24: Gilead Sciences Sovaldi and Harvoni Sales Revenue 2014-2019
  • Figure 9.25: HIV and Hepatitis Diagnostic Assay Market Growth 2014 to 2019
  • Figure 9.26: Global Market Personalized Medicine Technology Growth 2009-2015
  • Figure 9.27: Global Personalized Sub-market Growth 2015
  • Figure 9.28: Personalized Medicine Sub-Market Share (Percentage) 2009
  • Figure 9.29: Personalized Medicine Sub-Market Share (Percentage) 2014
  • Figure 9.30: Global Genomic Testing Market Forecast 2014-2019
  • Figure 9.31: Pharmacogenetics Market Forecast 2014-2019
  • Figure 9.32: Global Molecular Diagnostics Predicted Market Share (%) 2015
  • Figure 9.33: Global Molecular Diagnostics Market (US$) 2015
  • Figure 9.34: Global Market for Molecular Diagnostics through 2021
  • Figure 9.35: Global Market for Liquid Biopsy by Geography (North America, Europe, RoW), Through 2021
  • Figure 9.36: Average Operating Profit Margin Analysis for Selected Players in the Personalized Medicine Industry 2012-2014
  • Figure 9.37: Oncology, Infectious Disease, Cardiovascular and Genomic Submarket Operating Profit Margins
  • Figure 9.38: Personalized Medicine Oncology Submarket Operating Profit Margin Analysis
  • Figure 9.39: Personalized Medicine Infectious Disease Submarket Operating Profit Margin Analysis
  • Figure 9.40: Personalized Medicine Cardiovascular Submarket Operating Profit Margin Analysis
  • Figure 9.41: Personalized Medicine Genomics Submarket Operating Profit Margin Analysis
  • Figure 9.42: Private Funding Gained by 23andMe 2007-2012
  • Figure 9.43: Affymetrix Revenue by Business Segment (Percentage), 2014
  • Figure 9.44: Affymetrix Revenue From Affymetrix Core and eBioscience (Percentage), 2014
  • Figure 9.45: Affymetrix Total Revenue 2007-2014
  • Figure 9.46: Affymetrix Revenue by Product Division . Consumables, Instruments 2010-2014
  • Figure 9.47: Affymetrix Core Product Sales . Gene Expression, Genetic Analysis & Clinical Applications and Life Science Reagents, 2011-2014
  • Figure 9.48: Affymetrix Revenue Derived from Outside the US, 2009-2014
  • Figure 9.49: Affymetrix Revenue Derived from the US, 2009-2014
  • Figure 9.50: Affymetrix Net Loss, 2009-2014
  • Figure 9.51: Affymetrix Research and Development Funding, 2009-2014
  • Figure 9.52: Affymetrix Revenue Generated within USA (Percentage) 2010-2014
  • Figure 9.53: Astex Pharmaceuticals Priority Pipeline Products SGI-110 and AT13387 by Indication, Clinical Phase and Timeline
  • Figure 9.54: Astex Pharmaceuticals Revenue Generated 2008-2012
  • Figure 9.55: Astex Pharmaceuticals Net Income 2009-2012
  • Figure 9.56: Atossa Genetics Total Revenue (US$) 2012-2014
  • Figure 9.57: Atossa Genetics Revenue (US$) Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing
  • Figure 9.58: Atossa Genetics Percentage Revenue Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing
  • Figure 9.59: Quest Diagnostics Revenue ($ Billions) 2008-2014
  • Figure 9.60: Quest Diagnostics Operating Revenue ($ Billions) 2008-2014
  • Figure 9.61: Quest Diagnostics Net Income ($ Billions) 2008-2014
  • Figure 9.62: Celera (Quest Diagnostics) Historic Revenue Generated 2008-2010
  • Figure 9.63: Celera (Quest Diagnostics) Historic Gross Margin Generated 2008-2010
  • Figure 9.64: Celera (Quest Diagnostics) Historic Revenue Generated. Laboratory Services and Products 2008-2010
  • Figure 9.65: Celera (Quest Diagnostics) Historic Revenue (%) Generated by Distribution Agreement with Abbott 2008-2010
  • Figure 9.66: Celera (Quest Diagnostics) Historic Research and Development Spending 2008-2010
  • Figure 9.67: deCode Genetics Historic Net Loss Incurred 2004-2008
  • Figure 9.68: Illumina Revenue Generated ($ Billions) 2010-2014
  • Figure 9.69: Illumina Net Income Generated ($ Billions) 2010-2014
  • Figure 9.70: Myriad Revenue Generated 2007-2014
  • Figure 9.71: Operating Income Generated by Myriad 2007-2014
  • Figure 9.72: Myriad Revenue Generated by Molecular Diagnostic Testing and Pharmaceutical and Clinical (Companion Diagnostic) Services, 2012-2014
  • Figure 9.73: Future Molecular Diagnostic Pipeline of Myriad
  • Figure 9.74: Customer Profile of Qiagen . Percentage of Net Sales 2014
  • Figure 9.75: Qiagen Global Net Sales 2007-2014
  • Figure 9.76: Qiagen Operating Income 2007-2014
  • Figure 9.77: Qiagen Global Net Income 2007-2014
  • Figure 10.1: Percentage Oncology (Lung, Colorectal, Breast, Prostate) Patients Undergoing Next Generation Sequencing Testing in the US, 2018
  • Figure 10.2: Pipeline and On-market Oncology (Lung, Breast, Colorectal, Prostate) Therapeutics Directed Against Specific Mutations, 2013
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