表紙
市場調査レポート

遺伝子検査における分子診断

Molecular Diagnostics in Genetic Testing

発行 TriMark Publications 商品コード 278635
出版日 ページ情報 英文 185 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=104.18円で換算しております。
Back to Top
遺伝子検査における分子診断 Molecular Diagnostics in Genetic Testing
出版日: 2013年11月01日 ページ情報: 英文 185 Pages
概要

遺伝子検査における分子診断は、遺伝子疾患の診断や治療に最先端の分析技術を提供します。ゲノミクスとプロテオミクスにおける飛躍的な進歩と血液および様々な生体組織において検体を測定するマイクロアレイ機器の発展が、この分野の急成長を促進しました。

当レポートでは、世界の遺伝子検査における分子診断市場について調査し、市場規模と成長率、さまざまな市場セグメントにおける成長影響因子と世界・米国における売上高、および主要企業のプロファイルなどをまとめ、概略下記の内容でお届けいたします。

第1章 概要

第2章 遺伝子検査部門における分子診断の役割と機会

  • 遺伝子検査向け分子診断のイントロダクション
  • 遺伝子疾患の診断検査
  • 遺伝子疾患の保因者検査
  • 着床前遺伝子診断・着床前遺伝子スクリーニング
  • 出生前/子宮内遺伝子検査
  • 新生児遺伝子スクリーニング検査
  • 成人発症疾患の兆候前・予測検査
  • 薬理遺伝学・薬理ゲノム学
  • 組織・血液型判定
  • 親子/リレーションシップ鑑定(実父確定検査)
  • 系統DNA検査
  • 犯人・フォレンジック検査

第3章 遺伝子検査向け分子診断技術のイントロダクション

  • ゲノミクスとその機会のイントロダクション
  • 遺伝的変異性と疾患
  • 分子診断におけるヒトゲノムプロジェクトの影響
  • 分子診断の主な検討事項
  • ポストゲノム時代における分子診断
  • 分子診断技術における進歩
  • 分子診断検査技術・プラットフォーム

第4章 遺伝子検査における分子診断のビジネス情勢

  • 市場分析:規模、成長率、シェアおよび競合企業
  • 成長している遺伝子検査市場セグメント
  • 市場成長促進因子・阻害因子
  • 市場・技術動向
  • 業界の課題・戦略的提言
  • 近年の産業活動
  • 遺伝子検査産業において製品が成功するためのビジネスモデル・要件

第5章 市販の遺伝子検査の分子診断アッセイ・主なラボ

  • 遺伝子疾患向けの主な診断検査
  • 遺伝子疾患の保因者検査
  • 着床前遺伝子検査
  • 出生前/子宮内遺伝子検査
  • 新生児遺伝子スクリーニング検査
  • 成人発症疾患の兆候前・予測検査
  • 薬理遺伝学・薬理ゲノム学
  • 組織・血液型判定
  • 実父確定検査
  • 犯人・フォレンジック検査
  • 直販遺伝子検査
  • 遺伝子検査サービスを提供している主なラボ
  • 市販遺伝子検査向けの主な技術プラットフォーム
  • 製品発売・投入

第6章 分子診断遺伝子検査の医療費償還・課金情勢

  • 概要
  • 医療費償還業務の動向
  • メディケア医療費償還プログラム
  • メディケア課金手続き
  • 分子診断向けCPTコーディング規則
  • 収益の脅威
  • Bundled Payments for Care Improvement (BPCI) イニシアチブ

第7章 遺伝子検査の規制問題

  • 米国のFDA(食品医薬品局)
  • 臨床検査改善修正案(CLIA)
  • CLIA規制
  • 州によるサービスラボ向けのライセンシング
  • 体外診断多変数指標測定(IVDMIA)、ほか

第8章 遺伝子検査における分子診断検査利用のビジネス決定、戦略的展望および提言

  • 遺伝子検査の発展・商業化における主な機会
  • 分子診断遺伝子検査の実行における現在の障害は?
  • 遺伝子検査製品はビジネス戦略によってどのように促進されているか?
  • 新しい遺伝子検査開発はどのように買収戦略を導くか?
  • 関連医薬品のマーケティング計画において遺伝子検査はどのように価値を増しているか?、ほか

第9章 企業プロファイル

  • Abbott Laboratories
  • Beckman Coulter
  • CombiMatrix
  • EntroGen, Inc.
  • Genmark Diagnostics, Inc.
  • Genomic Health
  • Hologic, Inc.
  • Illumina, Inc.
  • IntegenX
  • Laboratory Corporation of America Holdings
  • Life Technologies Corporation
  • Luminex Corporation
  • Myriad Genetics, Inc.
  • Natera
  • NetBio
  • PerkinElmer Genetics
  • Progenika, Inc.
  • Roche Diagnostics
  • Sequenom, Inc.
  • Signature Genomics
  • Spartan Bioscience, Inc.
  • Transgenomic, Inc.

図表

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次
Product Code: TMRMDGT13-1101

Molecular diagnostics in genetic testing brings advanced analytical techniques to the diagnosis and treatment of genetic disorders. The confluence of breakthroughs in genomics and proteomics and the development of microarray devices to measure analytes in the blood and various body tissues are driving significant growth in the segment. Major developments include the integration of specialty labs and gene expression profiling into clinical practice, the introduction and rapid growth of cell-free fetal DNA prenatal testing, the advancement of companion diagnostics for drug development, the widespread installed base of automated instruments for molecular testing and the development of personalized medicine. The genetic testing space is one of the most profitable sectors of molecular diagnostics and is expected to be an area of high growth and corporate change throughout the forecast period. This TriMark Publications report describes the emerging field of molecular diagnostics in genetic testing. This review analyzes the size and growth of the molecular diagnostics in genetic testing market, including the factors that influence the various market segments within it and the dollar volume of sales, both in the United States and worldwide. Moreover, this analysis profiles the leading companies focused on the molecular diagnostics for genetic testing sector.

Table of Contents

1. Overview

  • 1.1. Statement of Report
  • 1.2. About this Report
  • 1.3. Scope of the Report
  • 1.4. Objectives
  • 1.5. Methodology
  • 1.6. Executive Summary

2. Role of Molecular Diagnostics and Opportunities in the Genetic Testing Sector

  • 2.1. Introduction to Molecular Diagnostics for Genetic Testing
    • 2.1.1. Definition and Scope of Molecular Genetic Testing within this Report
    • 2.1.2. Key Functions of Molecular Genetic Testing
    • 2.1.3. Overview of Molecular Genetic Testing Laboratories
  • 2.2. Diagnostic Testing of Genetic Disorders
    • 2.2.1. Review of Genetic Disorders: Characterizations of Abnormalities and Patterns of Inheritance
    • 2.2.2. Common Genetic Disorders
  • 2.3. Carrier Testing for Genetic Disorders
  • 2.4. Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening
  • 2.5. Prenatal/In utero Genetic Testing
  • 2.6. Newborn Genetic Screening Tests
    • 2.6.1. Molecular Diagnostics for Newborn Genetic Testing
  • 2.7. Pre-Symptomatic and Predictive Testing for Adult Onset Disorders
  • 2.8. Pharmacogenetics and Pharmacogenomics
    • 2.8.1. Current Applications for Pharmacogenetics and Pharmacogenomics
      • 2.8.1.1. Warfarin and VKORC1 and CYP2C9 Testing
      • 2.8.1.2. Trastuzumab and Lapatinib and HER2 Overexpression Testing
      • 2.8.1.3. Clopidogrel and CYP2C19 Testing
      • 2.8.1.4. Thiopurines and TPMT Testing
      • 2.8.1.5. Cetuximab and EGFR Expression and KRAS Mutation Testing
      • 2.8.1.6. Irinotecan and UGT1A1*28 Testing
      • 2.8.1.7. Abacavir and HLA-B*5701 Testing
      • 2.8.1.8. Carbamazepine and HLA-B*1502 Testing
  • 2.9. Tissue and Blood Typing
    • 2.9.1. HLA Determination
    • 2.9.2. Rhesus D Factor Determination
  • 2.10. Parentage/Relationship Testing (Paternity Testing)
  • 2.11. Genealogical DNA Testing
  • 2.12. Criminal and Forensics Testing

3. Introduction to Molecular Diagnostics Technology for Genetic Testing

  • 3.1. Introduction to Genomics and Its Opportunity
    • 3.1.1. Science Background: Structures and Functions of Nucleic Acids and Proteins
    • 3.1.2. The Human Genome
    • 3.1.3. Genomics: Opening Opportunities in Molecular Diagnostics
  • 3.2. Genetic Variability and Disease
  • 3.3. Impact of the Human Genome Project on Molecular Diagnostics
  • 3.4. Key Considerations for Molecular Diagnostics
  • 3.5. Molecular Diagnostics in the Post-Genomic Era
  • 3.6. Advances in Molecular Diagnostics Technologies
  • 3.7. Molecular Diagnostics Testing Technologies and Platforms
    • 3.7.1. Amplification Technologies
      • 3.7.1.1. PCR and PCR Derivative Platforms
      • 3.7.1.2. Multiple Displacement Amplification
      • 3.7.1.3. Multiple Annealing and Looping-Based Amplification Cycles
      • 3.7.1.4. Whole Genome Amplification
      • 3.7.1.5. Nucleic Acid Sequence-based Amplification
    • 3.7.2. Detection of Amplified Gene Products
      • 3.7.2.1. High Resolution Melting Analysis
      • 3.7.2.2. Microparticle-based Flow Cytometry
    • 3.7.3. DNA and Oligonucleotide Microarrays and Chips
      • 3.7.3.1. Array Comparative Genomic Hybridization
    • 3.7.4. Gene Sequencing
      • 3.7.4.1. Sanger Sequencing
      • 3.7.4.2. Next Generation Sequencing
    • 3.7.5. Fluorescence In situ Hybridization

4. Business Landscape for Molecular Diagnostics in Genetic Testing

  • 4.1. Market Analysis: Size, Growth, Share and Competitors
    • 4.1.1. Worldwide Genetic Testing Markets
    • 4.1.2. Market Structure and Competitive Situation
    • 4.1.3. Primary Competitors
    • 4.1.4. Commercialization Strategies for Molecular Diagnostic Products
    • 4.1.5. Market Penetration Strategies for Genetic Testing
  • 4.2. Growing Genetic Testing Market Segments
    • 4.2.1. Personalized Medicine and Companion Diagnostics Market
    • 4.2.2. Predictive Molecular Diagnostics Market
    • 4.2.3. Parallel Genetic Tests for Drug Development
    • 4.2.4. Direct-to-Consumer Genetic Testing Market
    • 4.2.5. Detecting Genetic Disorders
    • 4.2.6. Prenatal Screening
    • 4.2.7. Neonatal Screening
    • 4.2.8. Forensic Testing
    • 4.2.9. Blood and Tissue Typing
    • 4.2.10. Parentage Testing
    • 4.2.11. DNA Sequencing
  • 4.3. Market Drivers and Restraints
    • 4.3.1. Market Drivers
    • 4.3.2. Market Restraints
  • 4.4. Market and Technology Trends
    • 4.4.1. Market Trends
    • 4.4.2. Technology Trends
  • 4.5. Industry Challenges and Strategic Recommendations
  • 4.6. Recent Industry Activity
    • 4.6.1. M&A Activity
    • 4.6.2. License Agreements and Partnerships
  • 4.7. Business Models and Requirements for Successful Products in the Genetic Testing Industry
    • 4.7.1. Commercial Manufacturing of Genetic Testing Products: Requirements
      • 4.7.1.1. Regulatory Requirements
      • 4.7.1.2. Manufacturing Process Scale
      • 4.7.1.3. In-House Manufacturing
      • 4.7.1.4. Contract Manufacturing: Commercial and Academic

5. Molecular Diagnostic Assays and Select Laboratories for Genetic Testing on the Market

  • 5.1. Select Diagnostic Tests for Genetic Disorders
    • 5.1.1. CombiMatrix Diagnostics' DNAarray Pediatric Microarray Oligo 105K
    • 5.1.2. GeneDx's Genetic Testing for Hereditary Disorders
    • 5.1.3. Hologic's Factor V Reagents
    • 5.1.4. Progenika's FH Test
  • 5.2. Carrier Tests for Genetic Disorders
    • 5.2.1. Abbott Molecular's Cystic Fibrosis Genotyping Assay
    • 5.2.2. Counsyl's Universal Genetic Test
    • 5.2.3. GenPath's InheriGen and InheriGen Plus
    • 5.2.4. Good Start Genetics' Good Start Select
    • 5.2.5. Hologic's InPlex CF Molecular Test
    • 5.2.6. Integrated Genetic's Inheritest Carrier Screen
    • 5.2.7. Luminex's xTAG Cystic Fibrosis v2 Assays
    • 5.2.8. Natera's Natera One Multi-Disease Genetic Carrier Screening Panel
    • 5.2.9. Sequenom's Heredi-T Cystic Fibrosis Carrier Screen Test
  • 5.3. Pre-implantation Genetic Tests
    • 5.3.1. Natera's Preimplantation Genetic Diagnosis Test
  • 5.4. Prenatal/In utero Molecular Genetic Screening Tests
    • 5.4.1. Cell-free Fetal DNA Testing
      • 5.4.1.1. Ariosa Diagnostics' Harmony Prenatal Test
      • 5.4.1.2. Natera's Panorama
      • 5.4.1.3. Sequenom's MaterniT21 PLUS Test
      • 5.4.1.4. Verinata Health's verifi Prenatal Test
    • 5.4.2. Molecular Cytogenetic Tests
      • 5.4.2.1. Abbott Molecular's AneuVysion (Vysis CEP 18/X/Y-alpha satellite/LSI 13/21) Multicolor DNA Probe Panel
      • 5.4.2.2. CombiMatrix Diagnostics' DNAarray™ Prenatal Microarrays
      • 5.4.2.3. Signature Genomics' Signature Precision Panel I Prenatal
      • 5.4.2.4. Signature Genomics' Signature PrenatalChip TE (Targeted Enhanced) Microarray
      • 5.4.2.5. Signature Genomics' Signature PrenatalChip OS Microarray
  • 5.5. Newborn Genetic Screening Tests
    • 5.5.1. Screening for Cystic Fibrosis with Molecular Diagnostic Assays
    • 5.5.2. Screening for SCID with the TREC Assay
      • 5.5.2.1. PerkinElmer Genetics
  • 5.6. Predictive and Presymptomatic Tests for Adult Onset Disorders
    • 5.6.1. Sequenom's RetnaGene AMD Test for Age-Related Macular Degeneration
  • 5.7. Pharmacogenomics and Pharmacogenetics
    • 5.7.1. Warfarin Sensitivity
    • 5.7.2. EntroGen's Mutation Analysis and Genotyping Kits
    • 5.7.3. Qiagen's Therascreen KRAS RGQ PCR Kit
    • 5.7.4. Roche's COBAS AmpliPrep/COBAS TaqMan HLA-B*5701 Screening Test
    • 5.7.5. Genomic Health Oncotype Tests
    • 5.7.6. Life Technologies
      • 5.7.6.1. Life Technologies' Pervenio Lung RS Test
    • 5.7.7. Nanosphere's Verigene Human Genetic Tests
    • 5.7.8. Agendia's SYMPHONY Personalized Breast Cancer Profile
    • 5.7.9. CardioDx's Corus CAD
    • 5.7.10. Veracyte's Afirma Thyroid FNA Analysis
  • 5.8. Tissue and Blood Typing Tests
    • 5.8.1. Immunocor's LIFECODES HLA Typing Kits
      • 5.8.1.1. LIFECODES HLA SSO Typing Kits
      • 5.8.1.2. LIFECODES HLA SSP Typing
    • 5.8.2. Life Technology/Invitrogen's AllSet+ Gold HLA Typing Kits
    • 5.8.3. Life Technology/Invitrogen's SeCore HLA Sequence-Based Typing Kits
    • 5.8.4. One Lambda's LABType SSO
    • 5.8.5. Progenika's BLOODchip
    • 5.8.6. Sequenom's SensiGene Fetal RhD Genotyping Test
  • 5.9. Paternity Tests
    • 5.9.1. Natera's Non-Invasive Prenatal Paternity Test
  • 5.10. Criminal and Forensics Tests
    • 5.10.1. IntengenX's RapidHIT 200 Human DNA Identification System
    • 5.10.2. NetBio's and GE Healthcare Life Sciences' DNAscan Rapid DNA Analysis System
    • 5.10.3. Sorenson Forensics
  • 5.11. Direct-to-Consumer Genetic Tests
    • 5.11.1. 23andMe
    • 5.11.2. Lumigenix
    • 5.11.3. DNA DTC
    • 5.11.4. Family Tree DNA
    • 5.11.5. Gene by Gene
    • 5.11.6. AncestryDNA Test
  • 5.12. Select Laboratories Providing Genetic Testing Services
    • 5.12.1. Ambry Genetics
    • 5.12.2. ARUP Laboratories
    • 5.12.3. GeneDx
    • 5.12.4. LabCorp and Integrated Genetics
    • 5.12.5. Mayo Medical Laboratories
    • 5.12.6. Medical Genetics Laboratory at Baylor College of Medicine
    • 5.12.7. Pathway Genomics
    • 5.12.8. Quest Diagnostics
  • 5.13. Major Technology Platforms for Genetic Testing on the Market
  • 5.14. Product Launches and Introductions
    • 5.14.1. Ariosa Diagnostics Introduces Y-Chromosome Analysis Test Option
    • 5.14.2. Ariosa Diagnostics Expands Harmony Prenatal Test to Twin Pregnancies and Launches New X,Y Analysis Test
    • 5.14.3. Natera Launches Panorama
    • 5.14.4. Rubicon Genomics Launched Its New ThruPlex Technology and Partners with Agendia
    • 5.14.5. Sequenom Center for Molecular Medicine Launches New Cystic Fibrosis Carrier Screen Test
    • 5.14.6. Sequenom Launches the MaterniT21 PLUS
    • 5.14.7. Next Generation Sequencing with Roche's GS Junior System Approved for Tissue Typing

6. Reimbursement and Billing Landscape for Molecular Diagnostic Genetic Testing

  • 6.1. Overview
  • 6.2. Trends in Healthcare Reimbursement Practices
    • 6.2.1. Molecular Genetics Testing Reimbursement
  • 6.3. Medicare Reimbursement Program
  • 6.4. Medicare Billing Procedure
  • 6.5. CPT Coding Rules for Molecular Diagnostics
    • 6.5.1. Former Coding Rules for Molecular Diagnostics
    • 6.5.2. Current Coding Rules for Molecular Diagnostics
      • 6.5.2.1. Gapfilling
      • 6.5.2.2. Reimbursement Delays for Molecular Diagnostics
  • 6.6. Revenue Threats
    • 6.6.1. Medicare Payment Exceptions
    • 6.6.2. Three Areas for Denial of Claims
  • 6.7. Bundled Payments for Care Improvement Initiative

7. Regulatory Issues for Genetic Testing

  • 7.1. U.S. Food and Drug Administration
    • 7.1.1. FDA Labeling Requirements
    • 7.1.2. U.S. Government Regulation of Medical Devices
    • 7.1.3. FDA's Qualification of Biomarkers
    • 7.1.4. FDA's Voluntary Genomic Data Submission
  • 7.2. Clinical Laboratory Improvement Act
  • 7.3. CLIA Regulations
  • 7.4. State Licensing for Service Laboratories
  • 7.5. Multivariate Index Assays
  • 7.6. FDA Draft Guidance on In Vitro Companion Diagnostic Devices
  • 7.7. Pre-Market Approval
    • 7.7.1. 510(k) Clearance
  • 7.8. De Novo Classification
  • 7.9. Laboratory Developed Tests
    • 7.9.1. Analyte Specific Reagents
  • 7.10. U.S. Patent and Trademark Office
  • 7.11. IRB Approval in Clinical Trials
  • 7.12. CE marking and European In Vitro Diagnostic Device Directive
  • 7.13. Research Use Only Reagents
  • 7.14. Regulatory Issues for Direct-to-Consumer Genetic Tests
  • 7.15. The Genetic Information Nondiscrimination Act of 2008
  • 7.16. Genetic Tests and Medical Records
  • 7.17. Recommendations by the American College of Medical Genetics and Genomics

8. Business Decisions, Strategic Outlook and Recommendations Using Molecular Diagnostic Tests in Genetic Testing

  • 8.1. Key Opportunities in Genetic Testing Development and Commercialization
  • 8.2. What are the Current Obstacles in Molecular Diagnostic Genetic Testing Implementation?
  • 8.3. How are Genetic Testing Products Driven by Business Strategies?
  • 8.4. How might Novel Genetic Test Development Lead to Acquisition Strategies?
  • 8.5. How can Genetic Tests Increase Value in Associated Drug Marketing Plans?
  • 8.6. What Steps can be Taken in the Clinical Phases to Improve the Success Rate of Genetic Tests in Development?
  • 8.7. How can Regulatory Oversight Drive Approval and Adoption of New Technologies?
  • 8.8. What are the Noteworthy Deals?
  • 8.9. How will Platform Technology Companies Enter the Space and Position Themselves for Diagnostic Development?
  • 8.10. Will Pharma Integrate with Diagnostics?
  • 8.11. How will Partnering and M&As Alter the Competitive Landscape?
  • 8.12. How will FDA Regulations Impact New Diagnostic Tests?
  • 8.13. What is Necessary for Incorporating Promising Molecular Tests into Clinical Practice
  • 8.14. What is the Best Type of Business Model for Developing Genetic Testing Biomarkers?
  • 8.15. How have Genetic Biomarkers Provided the Most Benefit in Genetic Testing?
  • 8.16. What are the Most Innovative Methods in Development of Molecular Diagnostic Biomarkers?

9. Company Profiles

  • 9.1. Abbott Laboratories
  • 9.2. Beckman Coulter
  • 9.3. CombiMatrix
  • 9.4. EntroGen, Inc.
  • 9.5. Genmark Diagnostics, Inc.
  • 9.6. Genomic Health
  • 9.7. Hologic, Inc.
  • 9.8. Illumina, Inc.
  • 9.9. IntegenX
  • 9.10. Laboratory Corporation of America Holdings
  • 9.11. Life Technologies Corporation
  • 9.12. Luminex Corporation
  • 9.13. Myriad Genetics, Inc.
  • 9.14. Natera
  • 9.15. NetBio
  • 9.16. PerkinElmer Genetics
  • 9.17. Progenika, Inc.
  • 9.18. Roche Diagnostics
  • 9.19. Sequenom, Inc.
  • 9.20. Signature Genomics
  • 9.21. Spartan Bioscience, Inc.
  • 9.22. Transgenomic, Inc.

INDEX OF FIGURES

  • Figure 3.1: Segment of Double-Stranded DNA Showing the Base-Pair Relationship
  • Figure 3.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients
  • Figure 3.3: The PCR Cycle
  • Figure 3.4: Multiple Displacement Amplification
  • Figure 3.5: Using DNA Microassays to Measure Gene Expression
  • Figure 4.1: Overall Structure of Nucleic Acid Testing Market
  • Figure 4.2: Segmentation of the Biomarker Development Market
  • Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making
  • Figure 6.2: MAC Jurisdiction Map, 2012
  • Figure 7.1: Current Regulations for Laboratory Testing
  • Figure 7.2: Existing Regulatory Framework for LDTs

INDEX OF TABLES

  • Table 2.1: Common Genetic Disorders
  • Table 2.2: Recommended Uniform Screening Panel by SACHDNC
  • Table 2.3: Potential Benefits of Pharmacogenetics
  • Table 2.4: Select Drugs with Commercially Available Pharmacogenetic Tests
  • Table 2.5: HLA Allele Nomenclature
  • Table 2.6: Comparison of HLA Typing Methods
  • Table 3.1: Key Assay Technologies for Molecular Diagnostics
  • Table 3.2: Emerging Molecular Diagnostic Technologies
  • Table 3.3: DNA Microarray Applications
  • Table 3.4: Companies Involved in Next Generation Sequencing Platforms
  • Table 3.5: Desired Characteristics for Clinical Versus Discovery Next Generation Sequencing
  • Table 4.1: Summary of Molecular Diagnostics Testing Sectors
  • Table 4.2: Global Market for Molecular Diagnostics - Infectious Disease Testing, Cancer Testing and Genetic Testing, 2008-2018
  • Table 4.3: Global Market for Molecular Diagnostics for Genetic Testing, 2008-2018
  • Table 4.4: U.S. Market for Molecular Diagnostics - Infectious Disease Testing, Cancer Testing, and Genetic Testing, 2008-2018
  • Table 4.5: U.S. Market for Molecular Genetic Testing, 2008-2018
  • Table 4.6: Diagnostic Companies with Existing Pharma Relationships
  • Table 4.7: Use of Cancer Biomarkers in Drug Development
  • Table 4.8: Utility of Biomarkers as Companion Diagnostics to Drug Development
  • Table 4.9: Competitors in the Field of Forensic Testing
  • Table 4.10: Competitors in the Field of Identity, Family and Paternity Testing
  • Table 4.11: Comparison of Current Genetic Testing Protocols and Potential Use of Whole Genome Sequencing
  • Table 4.12: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
  • Table 4.13: Drivers of the Genetic Analysis Market
  • Table 4.14: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
  • Table 4.15: Total Molecular Genetic Testing Market: Impact of Top Industry Challenges (U.S.)
  • Table 4.16: The Required Elements of a Manufacturing Facility
  • Table 4.17: CMO Qualification Audit: Points to Investigate
  • Table 6.1: Factors Determining Third-Party Payment for Molecular Diagnostic Tests
  • Table 7.1: Regulatory Rules that Affect the Ability of a Diagnostic Testing Reagent Company to Conduct Business
  • Table 7.2: Strengths of the 510k Process
  • Table 7.3: Drawbacks of the 510k Process
  • Table 8.1: Effect of Regulation on MDx Infectious Disease Market Technology Platforms, 2007 and 2015
  • Table 8.2: Impediments to Incorporating Promising Molecular Tests into Clinical Practice
Back to Top