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分子診断:技術および世界市場

Molecular Diagnostics: Technologies and Global Markets

発行 BCC Research 商品コード 63238
出版日 ページ情報 英文 172 pages
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分子診断:技術および世界市場 Molecular Diagnostics: Technologies and Global Markets
出版日: 2017年09月19日 ページ情報: 英文 172 pages
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概要

世界の分子診断市場規模は、2016年に約106億米ドルとなりました。同市場は2017年から2022年にかけて14.3%のCAGR (年間複合成長率) で成長し、2017年までに122億米ドル、2022年までに238億米ドルへ達すると予測されています。

当レポートでは、世界の分子診断市場について調査分析し、世界市場の概要、実績データ・推計・CAGR予測を含めた市場動向の分析、政府規制・保険金給付・患者の秘密保持などの問題についての議論、関連特許の分析、および主要企業のプロファイルなどを提供しています。

第1章 イントロダクション

第2章 サマリー・ハイライト

第3章 概要

  • ゲノム診断のイントロダクション
  • 発現プロファイルと疾病
  • 発現プロファイルと感染症
  • ジェノタイピング・診断のためのDNAシーケンス
  • 臨床薬理
  • 変異検出・特定遺伝子のジェノタイピング
  • 新疾患遺伝子の特定

第4章 規制・財源

  • 概要
  • 保険
  • 食品と薬剤投与のガイドライン
  • DNA診断のための内部標準
  • マイクロアレイについての最低限の情報
  • 体外コンパニオン診断のFDAガイドライン

第5章 商用市場の動向

  • 市況
    • 医療、病院、医師、規制強化および保険金給付のニーズ
  • 成功のための新しい要件
    • 販売・マーケティング
    • メディカルアフェアーズ
    • 規制コンプライアンス
    • 医療費償還
    • アライアンス・合併

第6章 分子診断市場:技術別

  • 概要
  • マイクロアレイ、ラボオンチップ/バイオチップ
  • PCR
  • In situ ハイブリダイゼーション(ISH)
  • 新興・その他の診断技術

第7章 分子診断市場:アプリケーション・製品別

  • 概要
  • 出生前・新生児遺伝子スクリーニング
  • 感染症診断
  • 癌診断
  • 身元鑑定、法医学および親子鑑定
  • 薬理ゲノミクス/その他のアプリケーション

第8章 地域予測

  • PCR
  • アレイ
  • ISH
  • バイオチップ
  • 新興技術 他

第9章 特許分析

  • PCR
  • ISH
  • マイクロアレイ
  • マイクロ流体・バイオチップ

第10章 企業プロファイル

BCC Researchについて

図表リスト

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目次
Product Code: BIO063D

Report Highlights

The global molecular diagnostics market was valued at nearly $10.6 billion in 2016. The market is projected to grow at a compound annual growth rate (CAGR) of 14.3% from 2017 through 2022 to reach $12.2 billion by 2017 and $23.8 billion by 2022.

Report Includes:

  • An overview of the global market for molecular diagnostics
  • Analyses of global market trends, with data from 2016, estimates for 2017, and projections of compound annual growth rates (CAGRs) through 2022
  • Discussion of related issues, such as government regulations, reimbursement through insurance, patient confidentiality, and other legal ramifications
  • Identification of scientific challenges and advances, including the latest trends in the market
  • A relevant patent analysis
  • Comprehensive company profiles of major players in the field

Report Scope

This study examines the global market for assays used to detect specific nucleic acid sequences in medical and life sciences applications. While the goal of all DNA-based diagnostic assays is similar, several different technologies can be employed. BCC Research analyzes each technology in detail, determines major players and current market status and presents forecasts of growth over the next five years. Scientific challenges and advances including the latest trends are emphasized. We examine government regulations, major collaborations, recent patents and factors affecting the industry globally. In addition, we examine new directions for DNA diagnostic technologies and emerging applications in clinical diagnostics.

Analyst Credentials

JON EVANS has been involved in business development and research for the biotechnology industry since 1984. He has been involved in sales, market research and strategy analysis with Fortune 500 clients - with a particular focus on business development challenges and strategies to optimize market performance. He holds a B.S. degree in biology from Rutgers University and MBA in business analysis from San Francisco State University.

Table of Contents

Chapter 1: Introduction

  • Study Goals and Objectives
  • Reasons for Doing the Study
  • Scope of Report
  • Intended Audience
  • Methodology and Information Sources
  • Geographic Breakdown
  • Analyst's Credentials
  • Related BCC Research Reports

Chapter 2: Summary and Highlights

  • Forecasts

Chapter 3: Overview

  • Introduction to Genomic Diagnostics
  • Expression Profiling and Disease
  • Expression Profiling and Infectious Disease
  • DNA Sequencing for Genotyping and Diagnosis
  • Clinical Pharmacology
  • Mutation Detection and Genotyping for Specific Genes
  • Identification of New Disease Genes

Chapter 4: Regulations and Finance

  • Overview
  • Insurance
  • Food and Drug Administration Guidelines
  • Internal Standards for DNA Diagnostics
  • Minimum Information about a Microarray
    • Experiment - Miame 2.0
    • Microarray Quality Control (MAQC) Project
    • Clinical Laboratory Improvement Amendments (CLIA)
    • Personalized Medicines and Companion Diagnostics
  • FDA Guidelines for In Vitro Companion Diagnostics
    • Definition and Use of an IVD Companion Diagnostic Device
    • Review and Approval of IVD Companion Diagnostic Devices and Therapeutic Products
    • Novel Therapeutic Products
    • Approval of a Therapeutic Product without an Approved IVD Companion Diagnostic Device
    • General Policies
    • FDA Approved Companion Diagnostics
    • Nucleic Acid Based Tests
    • Pharmacogenomics Research Network

Chapter 5: Commercial Market Trends

  • Market Conditions
    • Healthcare, Hospitals, Doctors, Greater Regulation and Need for Insurance Reimbursement
  • New Requirements for Success
    • Sales and Marketing
    • Medical Affairs
    • Regulatory Compliance
    • Reimbursement
    • Alliances and Mergers

Chapter 6: Market for Molecular Diagnostics by Technology

  • Overview
    • Description
    • Revenues and Forecasts
    • Manufacturers
  • Microarray, Lab-on-a-Chip/Biochips
    • Description
    • Microfluidic Devices
    • Revenues and Forecasts
    • Manufacturers and Products
  • PCR
    • Description
    • Revenues and Forecasts
    • Manufacturers and Products
  • In Situ Hybridization (ISH)
    • Description
    • Labeling Techniques
    • Applications of In Situ Hybridization
    • Fiber Fish
    • Her2 Fish Testing
    • Revenues and Forecasts
  • Emerging and Other Diagnostic Technologies
    • Description
    • The Trend toward Single-Cell Measurements
    • Revenues and Forecasts

Chapter 7: Market for Molecular Diagnostics by Application and Products

  • Overview
    • Description
    • Revenues and Forecasts
  • Pre-/Postnatal Genetic Screening
    • Description
    • Carrier Screening
    • Prenatal Diagnostic Testing
    • Amniocentesis
    • Chorionic Villus Sampling
    • Genetic Counseling
    • Preimplantation Diagnosis
    • Newborn Screening
    • Revenues and Forecasts
  • Infectious Disease Diagnostics
    • Description
    • Revenues and Forecasts
  • Oncology Diagnostics
    • Description
    • Leukemias
    • Chronic Myeloid Leukemia
    • Genetic Marker of Chronic Myeloid Leukemia
    • Revenues and Forecasts
  • Identity Diagnostics, Forensics and Paternity
    • Description
    • Paternity Testing
    • Technology
    • Accreditation
    • Legal Issues
    • Veterinary Identity Testing
    • Revenues and Forecasts
  • Pharmacogenomics/Other Applications
    • Description
    • Revenues and Forecasts

Chapter 8: Geographic Forecasts

  • PCR
  • Microarray
  • ISH
  • Emerging and Other Markets

Chapter 9: Patent Analysis

  • PCR
  • ISH
  • Microarrays
  • Microfluidics and Biochips

Chapter 10: Company Profiles

About BCC Research

  • About BCC Research
  • BCC Library Access
  • BCC Custom Research

List of Tables

  • Summary Table: Global Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions)
    • Table 1: Minimum Information About a Microarray Experiment - MIAME 2.0
    • Table 2: Microarray Quality Control (MAQC) Project
    • Table 3: U.S. Laboratories CLIA-Certified for Molecular Diagnostics and Number of Disease Tests
    • Table 4: Genetic Testing Procedures Performed in U.S. by Type, 2015
    • Table 5: FDA-approved In Vitro Companion Diagnostic Devices as of June 1, 2017
    • Table 6: Nucleic Acid-based Tests Cleared or Approved by the Center for Devices and Radiological Health, as of June 1, 2017
    • Table 7: Nucleic Acid-based Tests Cleared or Approved by the Center for Devices and Radiological Health as of June 1, 2017
    • Table 8: Diagnostics Manufacturer Mergers and Acquisitions, 2004-2017
    • Table 9: Global Market for Molecular Diagnostics by Technology, Through 2022 ($ Millions)
    • Table 10: Global Market Share for Molecular Diagnostics by Technology, 2017 (%)
    • Table 11: Global Market Share for Molecular Diagnostics by Manufacturer, 2017 (%)
    • Table 12: Global Microarray Market for Molecular Diagnostics, by Application, through 2022 ($ Millions)
    • Table 13: Global Microarray Market Share for Molecular Diagnostics, by Application, 2017 (%)
    • Table 14: Major Suppliers of Planar DNA Microarrays
    • Table 15: Major Suppliers of Bead Microarrays
    • Table 16: Global PCR Market for Molecular Diagnostics, by Application, Through 2022 ($ Millions)
    • Table 17: Global PCR Market Share for Molecular Diagnostics, by Application, 2017 (%)
    • Table 18: Global PCR Market Share, by Manufacturer, 2017 (%)
    • Table 19: Global ISH Market for Molecular Diagnostics by Application, Through 2022 ($ Millions)
    • Table 20: Global ISH Market Share for Molecular Diagnostics, by Application, 2017 (%)
    • Table 21: Global Emerging/Other Molecular Diagnostics Market, by Application, Through 2022 ($ Millions)
    • Table 22: Global Emerging/Other Molecular Diagnostics Market Share, by Application, 2017 (%)
    • Table 23: Global Market for Molecular Diagnostics, by Application, Through 2022 ($ Millions)
    • Table 24: Global Market Share for Molecular Diagnostics, by Application, 2017 (%)
    • Table 25: Global Pre/Postnatal Screening Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions)
    • Table 26: Global Pre/Postnatal Screening Market Share for Molecular Diagnostics, by Technology, 2017 .................................................................................................................................................................... (%)
    • Table 27: Global Infectious Diseases Market for Molecular Diagnostics, by Technology, Through 2022 Millions)
    • Table 28: Global Infectious Disease Screening Market Share for Molecular Diagnostics, by Technology, 2017 (%)
    • Table 29: Global Oncology Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions)
    • Table 30: Global Oncology Market Share for Molecular Diagnostics, by Technology, 2017 (%)
    • Table 31: Global Identity Testing Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions)
    • Table 32: Global Identity Testing Market Share for Molecular Diagnostics, by Technology, 2017 (%)
    • Table 33: Global Pharmacogenomics and Other Market Share for Molecular Diagnostics by Technology, Through 2022 ($ Millions)
    • Table 34: Global Pharmacogenomics and Other Market Share for Molecular Diagnostics by Technology, 2017 (%)
    • Table 35: Global PCR Molecular Diagnostics Market, by Region, Through 2022 ($ Millions)
    • Table 36: Global Microarray Molecular Diagnostics Market, by Region, Through 2022 ($ Millions)
    • Table 37: Global ISH Molecular Diagnostics Market, by Region, Through 2022 ($ Millions)
    • Table 38: Global Emerging and Other Molecular Diagnostics Markets, by Region, Through 2022 ($ Millions)
    • Table 39: Selected PCR Patents Granted from January 2015 to June 2017
    • Table 40: Selected ISH Patents Granted from January 2015 to June 2017
    • Table 41: Selected Microarray Patents Granted from January 2015 to June 2017
    • Table 42: Selected Biochip Patents Granted from January 2015 To June 2017
    • Table 43: Selected Microfluidics Patents Granted from January 2015 to June 2017
    • Table 44: List of Companies Acquired, 2014-2017

List of Figures

  • Summary Figure: Global Market for Molecular Diagnostics, 2016-2022 ($ Millions)
    • Figure 1: Growth in Clinical Laboratory Sites and Disease Testing, 2012-2015 (Number)
    • Figure 2: Global Market Share for Molecular Diagnostics by Technology, 2017 (%)
    • Figure 3: Global Market Share for Molecular Diagnostics by Manufacturer, 2017 (%)
    • Figure 4: Global Microarray Market Share for Molecular Diagnostics, by Application, 2017 (%)
    • Figure 5: Global PCR Market Share for Molecular Diagnostics, by Application, 2017 (%)
    • Figure 6: Global ISH Market Share for Molecular Diagnostics, by Application, 2017 (%)
    • Figure 7: Global Market Share for Molecular Diagnostics, by Application, 2017 (%)
    • Figure 8: Global Pre/Postnatal Screening Market Share or Molecular Diagnostics, by Technology, 2017 (%)
    • Figure 9: Global Infectious Disease Screening Market Share for Molecular Diagnostics, by Technology, 2017 (%)
    • Figure 10: Global Oncology Market Share for Molecular Diagnostics, by Technology, 2017 (%)
    • Figure 11: Global Identity Testing Market Share for Molecular Diagnostics, by Technology, 2017 (%)
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