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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 and Companion Diagnostic Market to 2021- 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 397 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 and Companion Diagnostic Market to 2021- Strategic Analysis of Industry Trends, Technologies, Participants, and Environment
出版日: 2017年05月01日 ページ情報: 英文 397 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および背景

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
  • Abbott Laboratories
  • Admera Health (GENEWIZ)
  • Agena Biosciences (Sequenom)
  • Affymetrix
  • Agendia
  • Astex Pharmaceuticals
  • AstraZeneca
  • Atossa Genetics
  • Becton Dickinson
  • BioMerieux
  • BioRad
  • Bristol-Myers Squibb Company
  • Cancer Genetics
  • Celera Corporation (Quest Diagnostics)
  • Celldex Therapeutics
  • Cephid
  • Claritas Genomics
  • CuraGen
  • deCode Genetics (Amgen)
  • EDP Biotech
  • ELDA BioTech
  • エーザイ
  • Foundation Medicine
  • HalioDx
  • Human Longevity Inc (Cypher Genomics)
  • Ikonisys
  • Illumina
  • Intergenetics
  • Genelex
  • Johnson & Johnson (Janssen) 、他

第9章 オーダーメイド医療市場の分析

  • コンパニオン診断と標的治療法
  • 心臓血管の標的治療法市場
  • 感染症の標的治療法市場
  • 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
  • 薬理ゲノム学・薬理遺伝学市場の分析
  • 分子診断学市場
  • コンシューマーゲノミクス市場
  • リキッド・バイオプシー(液体生検)市場
  • 主要企業の利益幅分析
  • 市場参入企業分析

第10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11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12章 オーダーメイド医療と規制政策

第13章 最終サマリーと将来の展望

第14章 主要なオピニオンリーダーとのインタビュー

図表リスト

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目次
Product Code: 2017PMCDx

Kelly Scientific forecasts that the companion diagnostic and targeted therapeutic submarkets of the personalized medicine industry were worth $113 billion in 2016, and will hit over $162 billion by 2021 with a CAGR of 8.74%. The total personalised therapeutic market, for all indications, will be worth $x billion by 2021, with a CAGR of x%. Currently it is estimated that the companion diagnostic segment is worth $x billion globally, mainly coming from oncology, cardiovascular and infectious disease (HIV/HCV) tests. This is set to rise vertically over the next five years and by 2021 will be worth over $x billion, with a CAGR of x%.

This study details a comprehensive financial and strategic review of key players in the personalized medicine industry. Significant drivers and restraints of this market are revealed and market opportunities and challenges are identified. Disruptive technologies that are propelling the personalized medicine and companion diagnostic market are scrutinized. 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 with respect to companion diagnostics, targeted cancer therapeutics, medical technologies, pharmacogenomics, consumer genomics, molecular diagnostics and liquid biopsies. Specific indication markets are also included such as cancer, cardiovascular and infectious disease.

The report provides value and growth of the global personal therapeutics market from 2017-2021. Also historic figures back to 2014 are given to illustrate growth. As the personal targeted therapeutics market is part of the overall personalized medicine market, the companion diagnostics market is also included in the report

The report goes into detail regarding different indications, mainly oncology drugs as these hold most market share, and also cardiovascular and infectious disease markets.

It contains specific data for both the targeted therapeutic and companion diagnostic sections of the personalized medicine market.

These sections are then further divided into indications - Oncology, Cardiovascular and Infectious Disease.

The report also analyses the market with regards to major players such as GSK, Amgen, Sanofi, Novartis, Janssen, BMS, Pfizer, AstraZeneca, Roche.

To give an comprehensive view of how the PM market relates to associated markets, a number of these are analysed and forecast to 2021 (medical technology, pharmacogenomics, consumer genomics, molecular diagnostics, liquid biopsy).

For example, data from the targeted therapeutics section includes the following specifics:

  • Targeted Therapeutic Sales Revenue, All Indications (by Company, GSK, Amgen, Sanofi, Novartis, Janssen, BMS, Pfizer, AstraZeneca, Roche).
  • Global Targeted Therapeutic Market, All Indications, Forecast 2014-2021
  • Global Oncology Targeted Therapeutics Forecast 2014-2021
  • HER-2 Positive Breast Cancer Targeted Therapeutic Market Forecast 2014-2021
  • Oncology Targeted Therapeutic Market Forecast By Drug 2014-2021 (Herceptin Erbitux Gilotrif Gleevec Mekinist Tafinlar Zelboraf Tarceva Xalkori Zelboraf Kadcyla Perjeta Adcetris Xeloda Afinitor, Faslodex Iressa, Revlimid Avastin Alimta)
  • Branded Oncology Therapeutics Market Share 2014-2021 (Herceptin Erbitux Gleevec Tarceva Kadcyla Perjeta Xeloda Afinitor Revlimid Avastin Alimta)
  • Top Pharma Companies Revenue from Targeted Therapeutics in Oncology (Roche, Novartis, Janssen, BMS, AstraZeneca, Sanofi, GSK, Pfizer, Amgen, Eli Lilly)
  • Branded Cardiovascular Targeted Therapeutic Total Market 2014-2021
  • Branded Cardiovascular Targeted Therapeutics Market Forecast by Drug 2014-2021 (Metoprolol, Bidil, Plavix, Carvedilol)
  • Infectious Disease Targeted Therapeutics Market to 2014 - 2021
  • Branded Infectious Disease Targeted Therapeutics Market by Drug 2014-2021 (Incivek, Pegasys, Selzentry, Ziagen, Sovaldi, Harvoni)

Similarly, data for the companion diagnostic section is given.

Personalized Medicine Targeted Therapeutics - Oncology

In order to get an in depth understanding of the oncology therapeutics section within the personalized medicine market it is important to initially review the global oncology therapeutics market. Oncology continues to be an area of high unmet need and product revenue potential. Oncology is the largest global therapeutic area, with global sales of $x billion in 2016; that is anticipated to reach $x billion by 2021. Increasing cancer prevalence globally is a major driver of the market, and this is further underlined by more sensitive diagnostics and screening methods. The predicted revenue growth in the oncology space is reinforced by increasing cancer prevalence, as well as advances in diagnosis methods and screening programs. The current trend is that patients are advancing to 2nd, 3rd and 4th line therapy regimes, and so this progression further expands the market.

A significant driver of revenue growth is the cost of oncology therapeutics and biologics. For example, Yervoy (BMS) annual costs are $x for four doses. Another example is Dendreon's Provenge which has an annual cost of $x for three doses. This significant increase in the price of oncology therapeutics has expanded the market, even though price reductions have been fought for by payers.

Targeted Cancer Therapeutics

Targeted cancer therapeutic sales have significantly risen in the recent past with a x% increase from 2013 to 2014 alone. The global oncology market is currently booming and one of the main reasons for this increase is the dramatic rise in the number of prescribed targeted therapies. The market is also growing in size as the cost of targeted therapeutics is high. This is due to longer treatment times, increased investment and development costs. Targeted therapeutics also are, by definition, designed to treat smaller cohorts of patients, albeit more effectively. Therefore, pharmaco's need to recoup costs via pricing.

Two major targeted therapeutics on the market are Roche's melanoma agent Zelboraf and Pfizer's lung cancer agent Xalkori. Zelboraf (vemurafenib) is a MEK inhibitor indicated for skin cancer and in FY2013 reached $x million. Xalkori (crizotinib) is indicated in patients positive for an ALK mutation and has an annual sale figure of €x million.

Top Ten Companies in Oncology Drug Sales

Roche Holdings continues to occupy its first position in oncology market. The company's sales performance was driven by HER 2-positive breast cancer therapies. Globally, it is the largest maker of cancer treatments and mainly focuses on biologic drugs. Most of its cancer drugs are developed by California-based Genentech, a pioneer in biologic therapies that Roche acquired in 2009. Worldwide sales of Herceptin, that is about to lose patent protection year, rose 9%. But sales of Perjeta and Kadcyla, two follow-on therapies, increased by triple-digit percentages, drawing attention to the company's success in developing successor products. Roche is pinning its hopes on follow-on products to preserve its place in the market once generic competition, known as biosimilars, begin to appear. These biologic therapies usually have higher margins than conventional drugs and are more difficult to copy.

Bristol-Myers Squibb's overall sales rose by about x% only, but its cancer immunotherapy drugs witnessed huge sales gains. Its Yervoy, a skin-cancer immunotherapy, leaped x% to $x million in the fourth quarter, while Opdivo, another skin-cancer drug approved in late December 2014, contributed sales of $x million. The company's sales of leukemia drug Sprycel rose x% to $x million in 2016.

Celgene Corporation has reported that its revenue rose in the most recent period, driven by sales growth of its key cancer treatment, particularly in the U.S. The company expects 2015 to be an important year for Revlimid, a blockbuster blood-cancer drug, which will be tested in trials for treatment of a kind of lymphoma. The FDA is expected to decide whether the drug can be used to treat newly diagnosed multiple myeloma. Regulatory bodies in the U.S. and the E.U. are making key decisions on the drug. Revlimid sales increased x% to $x billion in the most recent quarter, as market share expanded along with the duration of therapy. U.S. sales of the drug grew by x% while international sales increased x%.

The personalized medicine, targeted therapeutic and associated companion diagnostic market have huge opportunities for growth. This industry will revolutionize 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.

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. Herceptin® and Breast Cancer
    • 1.4.4. BRACAnalysis®
    • 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. 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™

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's 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. 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™
    • 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. 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
  • 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)

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 2021
    • 9.1.4. Top Five Oncology Drugs to 2021
    • 9.1.5. Global Oncology Market by Cancer Type
    • 9.1.6. Oncology Targeted Therapeutics Market Analysis to 2021
    • 9.1.7. Companion Diagnostic Assays - Oncology
  • 9.2. Cardiovascular Targeted Therapeutics Market to 2021
    • 9.2.1. Cardiovascular Companion Diagnostics Market to 2021
  • 9.3. Infectious Disease Targeted Therapeutics Market to 2021
    • 9.3.1. Infectious Disease Diagnostic Assay Market to 2021
  • 9.4. Global Personalized Medical Technology Market
  • 9.5. Global Personalized Medicine Sub-Market Growth
  • 9.6. PharmacoGenomics/PharmacoGenetics Market Analysis to 2021
  • 9.7. Molecular Diagnostics Market to 2021
  • 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 2016

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: 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: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
  • 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 Axiom® Technology by Affymetrix
  • Table 8.14: Amgen's 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 m2000® 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'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, 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'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 2021
  • Table 9.2: Top Ten Companies in Oncology Sales Forecast 2013 - 2021
  • Table 9.3: Top Five Oncology Drugs, Through 2021
  • 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 Axiom® 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's 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 ‘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: 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
  • Figure 9.2: Personalized Targeted Therapeutic Market, All Indications, 2014-2021
  • Figure 9.3: Companion Diagnostic and Targeted Therapeutic Personalized Medicine Market Growth
  • Figure 9.4: Companion Diagnostic Market 2014-2021
  • Figure 9.5: Combined Targeted Therapeutic and Companion Diagnostic Market, 2014-2021
  • Figure 9.6: Global Market for Oncology Drugs by Geography/Country, Through 2021
  • Figure 9.7: Global Oncology Drug Sales by Top Five Companies, Through 2021
  • Figure 9.8: Top Five Oncology Drugs, Through 2021
  • Figure 9.9: Global Oncology Market by Cancer Type
  • Figure 9.10: Global Personalized Medicine Oncology Therapeutics Forecast 2014-2021
  • Figure 9.11: HER-2 Positive Breast Cancer Therapeutic Market Forecast 2014-2021
  • Figure 9.12: Personalized Medicine Oncology Therapeutic Market Forecast 2014-2021
  • Figure 9.13: Personalized Medicine Branded Oncology Therapeutics Market Share 2016
  • Figure 9.14: Personalized Medicine Branded Oncology Therapeutics Market Share 2021
  • Figure 9.15: Top Pharma Companies Revenue from Targeted Therapeutics in Oncology
  • Figure 9.16: Global Cancer Companion Diagnostics Market 2014-2021
  • 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 2014-2021
  • Figure 9.21: Personalized Medicine Branded Cardiovascular Therapeutics Market Forecast 2014-2021
  • Figure 9.22: Cardiovascular Companion Diagnostics Market Forecast 2014-2021
  • Figure 9.23: Personalized Medicine Branded Infectious Disease Therapeutics Market 2014-2021
  • Figure 9.24: Gilead Sciences Sovaldi and Harvoni Sales Revenue 2014-2021
  • Figure 9.25: HIV and Hepatitis Diagnostic Assay Market Growth 2014 to 2021
  • 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 2014-2021
  • Figure 9.31: Pharmacogenetics Market Forecast 2014-2021
  • Figure 9.32: Global Molecular Diagnostics Predicted Market Share (%) 2015
  • Figure 9.33: Global Molecular Diagnostics Market (US$) 2015
  • Figure 9.34: Global Market for Molecular Diagnostics through 2021
  • Figure 9.35: Global Market for Liquid Biopsy by Geography (North America, Europe, RoW), Through 2021
  • Figure 9.36: Average Operating Profit Margin Analysis for Selected Players in the Personalized Medicine Industry
  • Figure 9.37: Oncology, Infectious Disease, Cardiovascular and Genomic Submarket Operating Profit Margins
  • Figure 9.38: Personalized Medicine Oncology Submarket Operating Profit Margin Analysis
  • Figure 9.39: Personalized Medicine Infectious Disease Submarket Operating Profit Margin Analysis
  • Figure 9.40: Personalized Medicine Cardiovascular Submarket Operating Profit Margin Analysis
  • Figure 9.41: Personalized Medicine Genomics Submarket Operating Profit Margin Analysis
  • Figure 9.42: Private Funding Gained by 23andMe
  • Figure 9.43: Affymetrix Revenue by Business Segment (Percentage)
  • Figure 9.44: Affymetrix Revenue From Affymetrix Core and eBioscience (Percentage)
  • Figure 9.45: Affymetrix Total Revenue
  • Figure 9.46: Affymetrix Revenue by Product Division - Consumables, Instruments
  • Figure 9.47: Affymetrix Core Product Sales - Gene Expression, Genetic Analysis & Clinical Applications and Life Science Reagents
  • Figure 9.48: Affymetrix Revenue Derived from Outside the US
  • Figure 9.49: Affymetrix Revenue Derived from the US
  • Figure 9.50: Affymetrix Net Loss
  • Figure 9.51: Affymetrix Research and Development Funding
  • Figure 9.52: Affymetrix Revenue Generated within USA (Percentage)
  • Figure 9.53: Astex Pharmaceuticals Priority Pipeline Products SGI-110 and AT13387 by Indication, Clinical Phase and Timeline
  • Figure 9.54: Astex Pharmaceuticals Revenue Generated
  • Figure 9.55: Astex Pharmaceuticals Net Income
  • Figure 9.56: Atossa Genetics Total Revenue (US$)
  • 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)
  • Figure 9.60: Quest Diagnostics Operating Revenue ($ Billions)
  • Figure 9.61: Quest Diagnostics Net Income ($ Billions)
  • Figure 9.62: Celera (Quest Diagnostics) Historic Revenue Generated
  • Figure 9.63: Celera (Quest Diagnostics) Historic Gross Margin Generated
  • Figure 9.64: Celera (Quest Diagnostics) Historic Revenue Generated- Laboratory Services and Products
  • Figure 9.65: Celera (Quest Diagnostics) Historic Revenue (%) Generated by Distribution Agreement with Abbott
  • Figure 9.66: Celera (Quest Diagnostics) Historic Research and Development Spending
  • Figure 9.67: deCode Genetics Historic Net Loss Incurred
  • Figure 9.68: Illumina Revenue Generated ($ Billions)
  • Figure 9.69: Illumina Net Income Generated ($ Billions)
  • Figure 9.70: Myriad Revenue Generated
  • Figure 9.71: Operating Income Generated by Myriad
  • Figure 9.72: Myriad Revenue Generated by Molecular Diagnostic Testing and Pharmaceutical and Clinical (Companion Diagnostic) Services
  • Figure 9.73: Future Molecular Diagnostic Pipeline of Myriad
  • Figure 9.74: Customer Profile of Qiagen - Percentage of Net Sales
  • Figure 9.75: Qiagen Global Net Sales
  • Figure 9.76: Qiagen Operating Income
  • Figure 9.77: Qiagen Global Net Income
  • 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
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