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市場調查報告書

個體化治療、標靶治療、伴隨式診斷的全球市場:至2025年的業界趨勢、技術、參與企業、事業環境的戰略分析

Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market to 2025- Strategic Analysis of Industry Trends, Technologies, Participants, and Environment

出版商 Kelly Scientific Publications 商品編碼 940593
出版日期 內容資訊 英文 464 Pages
訂單完成後即時交付
價格
個體化治療、標靶治療、伴隨式診斷的全球市場:至2025年的業界趨勢、技術、參與企業、事業環境的戰略分析 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market to 2025- Strategic Analysis of Industry Trends, Technologies, Participants, and Environment
出版日期: 2020年06月01日內容資訊: 英文 464 Pages
簡介

本報告中,調查了全球個體化治療、標靶治療、伴隨式診斷的市場,提供了市場的狀況、醫療制度的整合、政府資金與民間資金、償還、歐洲市場的投資、商業模型分析、主要企業、市場分析、個體化治療的利多、法規政策、將來展望、主要意見領袖訪問等等的情報。

目次

第1章 執行摘要

第2章 導論

第3章 個體化治療、標靶治療、伴隨式診斷

  • CYP2C9及VKORC1基因變異與對華法林的反應
  • HLA-B * 5701與對阿巴卡韋的反應
  • KRAS變異個體化治療、標靶治療、伴隨式診斷市場
  • 曲妥珠單抗與乳癌
  • BRACAnalysis
  • Oncotype Dx實驗
  • TherascreenEGFR RGQ PCR組
  • Therascreen KRAS RGQ PCR系統
  • TherascreenIDH1 / 2測試
  • THxID-BRAF組
  • CobasEGFR變異實驗(Roche)
  • Prolaris前列腺癌檢查
  • ALK及非小細胞肺癌

第4章 個體化治療與醫療制度的整合

  • The Personalized Medicine Coalition
  • 個體化治療與醫療制度
  • 個體化治療的臨床應用
  • 臨床檢查室的改善-基因組病理學的認定檢查室

第5章 民間資金與政府資金、個體化治療的償還

  • 國際間的研究開發活動
  • 藥理遺傳學/藥理基因組學研究的領域中備受注目的生物學標靶/路徑
  • 公平的保險者償還
  • 生物材料儲存庫與生物庫
  • 知識財產與個體化治療

第6章 歐洲的個體化治療市場:支付與投資

  • 個體化醫療與歐洲市場
  • 歐洲對個體化醫療的投資
  • 歐洲償還政策的概要
  • 實現EU個體化治療、標靶治療、伴隨式診斷市場的市場浸透
  • 英國的個體化(層別)醫藥品法規與償還
  • 英國的CE標誌的個體化治療/診斷檢查
  • 德國的個體化醫療法規
  • 法國的個體化醫療法規
  • 西班牙的個體化醫療法規
  • 義大利的個體化醫療法規
  • 歐洲個體化治療的開發與今後課題

第7章 個體化治療:商業模型分析

  • 個體化治療所必需的新型商業模型
  • 診斷、製藥、生物技術企業的商業模型戰略
  • 供應商、供應商系統、學術醫療中心的商業模型戰略
  • 針對保險者的商業模型戰略
  • 針對政府的商業模型戰略
  • 醫療分野以外的企業對個體化治療市場的參與
  • 大型製藥公司商業模型之變更
  • 個體化治療費用及效果與商業價值
  • 個體化治療的比較有效性調查
  • 關於償還、補償、支付的指針

第8章 個體化治療相關的主要企業

  • 23andMe
  • Abbott Laboratories
  • Admera Health(GENEWIZ)
  • Agena Biosciences(Sequenom)
  • Affymetrix
  • Agendia
  • Alere
  • Amgen Inc.
  • Astex Pharmaceuticals
  • AstraZeneca
  • Atossa Genetics
  • Becton Dickinson
  • BioMerieux
  • BioRad
  • Bristol-Myers Squibb
  • Cancer Genetics
  • Celera Corporation(Quest Diagnostics)
  • Celldex Therapeutics
  • Cephid
  • Claritas Genomics
  • CuraGen
  • deCode Genetics(Amgen)
  • EDP Biotech
  • ELDA BioTech
  • Eisai
  • Foundation Medicine
  • HalioDx
  • Human Longevity Inc(Cypher Genomics)
  • Ikonisys
  • Illumina
  • Intergenetics
  • Genelex
  • Johnson & Johnson (Janssen)
  • LabCorp(Covance)
  • Integrated Oncology
  • Merck & Co
  • MDx Health
  • MolecularMD Corporation
  • Monogram Biosciences
  • Myriad
  • Nanostring Technologies
  • Nodality
  • Novartis
  • Orion Genomics
  • Oxford BioTherapeutics
  • Pfizer
  • Qiagen
  • Roche
  • Roche Diagnostics
  • Sanofi
  • Siemens Healthcare
  • Takeda
  • Thermo Fisher Scientific
  • Transgenomic
  • Vertex Pharmaceuticals

第9章 個體化醫療市場之分析

  • 伴隨式診斷與標靶治療的市場
  • 心血管標靶治療市場
  • 感染症標靶治療市場
  • 各地域市場的分析
  • 主要企業的收益幅度分析
  • 主要企業的個案研究分析

第10章 個體化治療的長處與優點

  • 人類基因組的排列決定
  • 患者照顧的改善與副作用減少
  • 減少醫療費
  • FDA與世界法規的進步
  • 技術的進步

第12章 個體化治療與法規政策

第13章 調查結果與今後的展望

第14章 對主要意見領袖的訪問

目錄
Product Code: 2020PMCDx

"Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market: Strategic Analysis of Industry Trends, Technologies, Participants, and Environment " by Kelly Scientific Publications is a comprehensive report and financial forecast to 2025 on the precision medicine industry and its impact on the health system. This report tackles the growing market interest in pharmacogenomics, targeted therapeutics, companion diagnostics and the associated market environment.

In 2019, 11 personalized therapeutics gained approval from the the FDA's Center for Drug Evaluation and Research (CDER) including a gene therapy and a small interfering ribonucleic acid (siRNA) based therapy. Over 20% of all new approvals in 2019 were personalized therapeutics and in 2018 alone, 42% were personalized medicines (25 agents). This was an increase from 34% in 2017 and 27% in 2016. Individualized, targeted or personalized medicine aims to increase the efficacy of therapeutics via genetic testing and companion diagnostics. Personalized therapeutics and associated companion diagnostics will be more specific and effective thereby giving pharma/biotech companies a significant advantage to recuperate R&D costs. Personalized medicine will reduce the frequency of adverse drug reactions and therefore have a dramatic impact on health economics. Developmental and diagnostic companies will benefit from lower discovery and commercialization costs and more specific market subtypes.

This report describes the current technologies that are propelling the personalized medicine and companion diagnostic market. It examines the current genetic diagnostic tests and companion diagnostic assays that are in use by the medical and pharmaceutical industry today. Current developments in personalized medicine and the pharmacogenomics revolution are discussed. The emerging trends that appear in key markets such as the US, UK, Germany and France are elucidated and analysed. This study reveals market figures of the overall personalized medicine market and also sub-market figures.

The study also provides a comprehensive financial and product review of key players in the personalized medicine industry. Strategic drivers and restraints of this market are revealed and market opportunities and challenges are identified.

In summary, the personalized therapeutic and associated companion diagnostic market have huge opportunities for growth. This industry is revolutionizing the healthcare system and will improve therapeutic effectiveness and reduce the severity of adverse effects. It has enormous potential for investment and the emergence of genetic-based in vitro diagnostics. 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 470 pages. The personalized medicine market is presented as follows:

  • By Company (e.g., QIAGEN, AFFYMETRIX, ATOSSA GENETICS, NODALITY, deCode /Amgen, CELERA, MYRIAD)
  • By Segment (Targeted therapeutics, Companion Diagnostics)
  • By Sub-market (Cancer, Cardiovascular, Infectious Disease)
  • By Geography (North America, Europe, RoW)

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
  • Cost-effectiveness and Business Value of Personalized Medicine
  • Consumer genomics and POC market
  • 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 (US, UK, Germany, France, Spain, Italy)
  • CE-Marked Personalized Medicine/Diagnostic Tests
  • FDA Advances in Personalized Medicine Regulation

This report highlights a number of significant players and influential company's and gives details of their operations, products, financials and business strategy.

  • 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 Pharmaceutical

Updates on the Personalized medicine, targeted therapeutic and companion diagnostic space have been included in this latest edition to include cutting edge material from international conferences, workshops and symposia.

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 Summary
    • 1.4.2 New Therapies and Companion Diagnostics Launched
    • 1.4.3 Public and Private Funding for Personalized Medical Research
    • 1.4.4 Personalized Medicine Market Forecast
    • 1.4.5 Personalized Medicine Oncology Therapeutics & Diagnostics Market
    • 1.4.6 Personalized Medicine Cardiovascular Therapeutics Market
    • 1.4.7 Personalized Medicine Infection Disease Market
    • 1.4.8 Personalized Medicine Geographical Market Share Analysis
    • 1.4.9 Profit Margin Analysis on Major Players
    • 1.4.10 Future of Personalized Medicine

2.0 Introduction to Precision/Personalized Medicine

  • 2.1 Genetics Basis of Personalized Medicine
    • 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 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • 2.16 How Next Generation Functional Diagnostics is Helping Personalized Medicine
  • 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 Introduction
    • 2.9.1 Introduction
    • 2.9.2 Companion Diagnostics in Clinical Trials
    • 2.9.3 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

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 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
    • 3.3.1 Erbitux
    • 3.3.2 Vectibix
  • 3.4 Herceptin® and Breast Cancer
  • 3.5 BRACAnalysis®
    • 3.5.1 Comprehensive BRACAnalysis®
    • 3.5.2 BRACAnalysis® Rearrangement Test (BART)
    • 3.5.3 Single Site BRACAnalysis®
    • 3.5.4 Multisite 3 BRACAnalysis®
  • 3.6 Oncotype Dx Test
  • 3.7 Therascreen® EGFR RGQ PCR Kit
  • 3.8 Therascreen KRAS RGQ PCR System
  • 3.9 Therascreen® IDH1/2 test
  • 3.10 THxID™ -BRAF Kit
  • 3.11 Cobas® 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™
    • 3.13.5 FoundationOne CDx
    • 3.13.6 Oncomine DX Target Test

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 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • 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
    • 8.3.7 LiquidGx
    • 8.3.8 AtheroGxOne
    • 8.3.9 CardioGxOne
  • 8.4 Agena Biosciences (Sequenom)
    • 8.4.1 MassARRAY System
    • 8.4.2 Acquisition of Sequenom's Bioscience Business by Agena Biosciences
  • 8.5 Affymetrix
    • 8.5.1 Products and Kits
  • 8.6 Agendia
  • 8.7 Alere Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • 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)
    • 8.10.3 Lynparza (Olaparib)
    • 8.10.4 Infinzi (Durvalumab)
  • 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
    • 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)
    • 8.17.1 ViroSeq® HIV-1 Genotyping System
    • 8.17.2 ViroSeq® HIV-1 Integrase Assay
    • 8.17.3 ViroSeq® HCV Assay
    • 8.17.4 ViroSeq® HBV Assay
    • 8.17.5 Cystic Fibrosis Genotyping Assay
    • 8.17.6 LDL-S3GGE® Test
    • 8.17.7 HDL-S10GGE® 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 AlleleSEQR® HLA PCR/Sequencing Kits
    • 8.17.12 m2000® 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™ Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
    • 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
    • 8.26.3 FoundationOne Liquid
  • 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
    • 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 COLARIS®/COLARIS AP®
    • 8.40.3 MELARIS®
    • 8.40.4 PANEXIA®
    • 8.40.5 OnDose®
    • 8.40.6 PREZEON™
    • 8.40.7 THERAGUIDE® 5FU
    • 8.40.8 Prolaris®
  • 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 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • 8.46 Pfizer
    • 8.46.1 Pfizer Merger with Allergan
    • 8.46.2 Pfizers Oncology Strategy
    • 8.46.3 Pfizer's 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's 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's 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's to Discover Therapeutic Targets in the Microbiome
    • 8.52.2 Millennium: The Takeda Oncology Company
  • 8.53 Thermo Fisher Scientific
    • 8.53.1 ThermoFisher's Personalized Healthcare Strategy
    • 8.53.2 ThermoFisher's Involvement in the NCI-MATCH Trial
  • 8.54 Transgenomic
  • 8.55 Vertex Pharmaceuticals
    • 8.55.1 Orkambi (lumacaftor/ivacaftor)
    • 8.55.2 Kalydeco (ivacaftor)
    • 8.55.3 Symdeko/Symkevi

9.0 Personalized Medicine Market Analysis

  • 9.1 Companion Diagnostic and Targeted Therapeutic Market
    • 9.1.1 Global Oncology Therapeutic Market
    • 9.1.2 Targeted Therapeutics - Oncology
    • 9.1.3 Top Companies in Oncology Drug Sales to 2025
    • 9.1.4 Top Oncology Drugs to 2025
    • 9.1.5 Global Oncology Market by Cancer Type
    • 9.1.6 Oncology Targeted Therapeutics Market Analysis to 2025
    • 9.1.7 Companion Diagnostic Assays - Oncology Market to 2025
  • 9.2 Cardiovascular Targeted Therapeutics Market to 2025
    • 9.2.1 Cardiovascular Companion Diagnostics Market to 2025
  • 9.3 Infectious Disease Targeted Therapeutics Market to 2025
    • 9.3.1 Infectious Disease Diagnostic Assay Market to 2025 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • 9.4 Global Personalized Medicine Market Geographical Analysis to 2025
  • 9.5 Major Player Profit Margin Analysis
  • 9.6 Select Market Participant Case Study Analysis
    • 9.6.1 Affymetrix
    • 9.6.2 Astex Pharmaceuticals
    • 9.6.3 Quest Diagnostics
    • 9.6.4 Celldex Therapeutics
    • 9.6.5 deCode Genetics (Amgen)
    • 9.6.6 Illumina
    • 9.6.7 Genelex
    • 9.6.8 Myriad
    • 9.6.9 Qiagen
    • 9.6.10 bioMerieux

10.0 Strengths and Advantages of Personalized Medicine

  • 10.1 Sequencing of the Human Genome
  • 10.2 Improving Patient Care and Reducing Side Effects
  • 10.3 Personalized Medicine will Reduce Healthcare Costs
  • 10.4 FDA and Global Regulatory Advances
  • 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 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com

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's 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: Selected EMA Approved Drugs that Require Companion Diagnostics
  • Table 2.33: Selected FDA Approved Drugs that Require Companion Diagnostics Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • 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 Types of 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: PathVysion® 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: BRACAnalysis® 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 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • 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 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • 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 Axiom® Technology by Affymetrix
  • Table 8.14: Amgen's Oncology Phase III Product Pipeline
  • Table 8.15: Selected Programs in Pivotal Trial (Phase III) or Development, Amgen
  • Table 8.16 Advantages of Astex Pharmaceuticals Pyramid™ Fragment-Drug-Discovery System
  • 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 m2000® RealTime PCR System by Celera
  • Table 8.30: Potential Business Partnerships of Celldex Therapeutics
  • Table 8.31: Cephid Product Portfolio in the US
  • Table 8.32: Cephid Product Portfolio 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 State 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 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • 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's 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 BRACAnalysis® Testing from Myriad
  • Table 8.70 Advantages of BRACAnalysis® Testing
  • Table 8.71 COLARIS® Test Range by Myriad
  • Table 8.72 COLARIS AP® Test Range by Myriad
  • Table 8.73 MELARIS® Test Range from Myriad
  • Table 8.74 Personalized Medicine Tests from Myriad
  • Table 8.75 OnDose® 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 - Oncology and Precision Medicine
  • 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's 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 2025 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • Table 9.2 Top Ten Companies in Oncology Sales Forecast 2017 - 2025
  • Table 9.3 Top Oncology Drugs, Through 2025
  • Table 9.4 Submarkets within the Personalized Medicine Technology Market
  • Table 9.5 Global Market for Liquid Biopsy by Region (North America, Europe, RoW)
  • 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: Acquisition Profile of Affymetrix
  • Table 9.9: Genetic Applications of Axiom® Technology by Affymetrix
  • Table 9.10: Diversified Business Units of Affymetrix
  • Table 9.11: Affymetrix AgBio Microarray Portfolio
  • Table 9.12: Genelex Individual Gene Panel
  • Table 9.13: Myriad - Core Business Decisions and Impact on Industry
  • Table 9.14: Current Test Portfolio of Myriad
  • Table 9.15: BioMerieux Immunodiagnostic Product Portfolio
  • Table 9.16: BioMerieux Microbiology Product Portfolio
  • Table 9.17: 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 'Advancing Regulatory Science at FDA: A Strategic Plan'
  • 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 Select 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 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • Figure 2.10: Ligation based SNP Detection
  • Figure 2.11 New-Generation Sequencing: Pyrosequencing
  • Figure 2.12: Selected Diagnostics by Drug, Cancer Type and Technology
  • 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 5.3: Collaborative Institutions of Pharmacogenetics
  • 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 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • 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
  • 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 by Select Companies, All Indications
  • Figure 9.2 Personalized Targeted Therapeutic Market, All Indications, 2019-2025
  • Figure 9.3 Companion Diagnostic and Targeted Therapeutic Personalized Medicine Market Growth 2019-2025
  • Figure 9.4 Personalized Companion Diagnostic Market 2019-2025
  • Figure 9.5 Combined Targeted Therapeutic and Companion Diagnostic Market, 2019-2025
  • Figure 9.6 Global Market for Oncology Drugs by Geography/Country, Through 2025
  • Figure 9.7 Global Oncology Companies Revenue, Through 2025
  • Figure 9.8 Top Oncology Drugs, Through 2025
  • Figure 9.9 Global Oncology Market by Cancer Type 2019-2025
  • Figure 9.10 Global Personalized Medicine Oncology Therapeutics Forecast 2019-2025
  • Figure 9.11 HER-2 Positive Breast Cancer Therapeutic Market Forecast to 2025
  • Figure 9.12 Personalized Medicine Oncology Therapeutic Market Forecast 2019-2025
  • Figure 9.13 Personalized Medicine Branded Oncology Therapeutics Market Share 2019
  • Figure 9.14 Personalized Medicine Branded Oncology Therapeutics Market Share 2025
  • Figure 9.15 Top Pharma Companies Revenue from Targeted Therapeutics in Oncology
  • Figure 9.16 Global Cancer Companion Diagnostics Market 2019-2025
  • 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 2019-2025
  • Figure 9.21 Personalized Medicine Branded Cardiovascular Therapeutics Market Forecast 2019-2025 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com
  • Figure 9.22 Cardiovascular Companion Diagnostics Market Forecast 2019-2025
  • Figure 9.23 Personalized Medicine Branded Infectious Disease Therapeutics Market 2019-2025
  • Figure 9.24 Select Personalized Medicine Infectious Disease Therapeutics Sales Revenue Forecast 2019-2025
  • Figure 9.25 HIV and Hepatitis Diagnostic Assay Market Growth 2019 to 2025
  • Figure 9.26 Market Share by Geographic Region ($ Billions) 2019-2025
  • Figure 9.27 Percentage Geographical Breakdown of Total Personalized Medicine Market 2019 and 2025
  • Figure 9.28 Average Operating Profit Margin Analysis for Selected Players in the Personalized Medicine Industry
  • Figure 9.29 Affymetrix Revenue by Business Segment (Percentage)
  • Figure 9.30 Affymetrix Revenue From Affymetrix Core and eBioscience (Percentage)
  • Figure 9.31 Astex Pharmaceuticals Priority Pipeline Products
  • Figure 9.32 Quest Diagnostics Revenue ($ Billions)
  • Figure 9.33 Quest Diagnostics Routine Clinical Test Revenue 2017-2019
  • Figure 9.34 Quest Diagnostics Gene-Based and Esoteric Test Revenue 2017-2019
  • Figure 9.35 Quest Diagnostics Anatomic Pathology Test Revenue 2017-2019
  • Figure 9.36 Illumina Revenue Generated ($ Billions)
  • Figure 9.37 Illumina Sequencing Consumables Income Generated ($ Billions)
  • Figure 9.37: Illumina Microarray Consumables Income Generated ($ Billions)
  • Figure 9.38 Myriad Revenue Generated
  • Figure 9.39 Operating Income Generated by Myriad
  • Figure 9.40 Myriad Revenue Generated by Molecular Diagnostic Testing and Pharmaceutical and Clinical (Companion Diagnostic) Services
  • Figure 9.41 Myriad Hereditary Cancer Test Revenue
  • Figure 9.42 Myriad EndoPredict, Polaris, Vectra, Prenatal and GeneSight Revenue
  • Figure 9.43 Customer Profile of Qiagen - Percentage of Net Sales
  • Figure 9.44 Qiagen Global Net Sales
  • Figure 9.45 Qiagen Operating Income
  • Figure 9.46 Qiagen Global Net Income/Loss
  • Figure 10.1 The Future of Personalized Medicine
  • Figure 10.2: Percentage Oncology (Lung, Colorectal, Breast, Prostate) Patients Undergoing Next Generation Sequencing Testing in the US
  • Figure 10.3: Pipeline and On-market Oncology (Lung, Breast, Colorectal, Prostate) Therapeutics Directed Against Specific Mutations
  • Figure 13.1 Personalized Medicine Percentage of FDA Approvals 2014-2019 Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market www.kellysci.com