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市場調查報告書

分子診斷:技術及全球市場

Molecular Diagnostics: Technologies and Global Markets

出版商 BCC Research 商品編碼 63238
出版日期 內容資訊 英文 172 pages
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分子診斷:技術及全球市場 Molecular Diagnostics: Technologies and Global Markets
出版日期: 2017年09月19日 內容資訊: 英文 172 pages
簡介

全球分子診斷市場規模,是2016年約106億美金。該市場預計從2017年到2022年以14.3%的年複合成長率成長,2017年達122億美元,2022年達238億美元。

本報告提供全球分子診斷市場相關調查分析,全球市場概要,包含成果資料、估計、年複合成長率預測的市場趨勢分析,政府法規、保險金供給、患者保密等問題相關的議論,相關專利分析,及主要企業簡介等資訊。

第1章 簡介

第2章 摘要、亮點

第3章 概要

  • 基因診斷的簡介
  • 表現圖譜和疾病
  • 表現圖譜和感染疾病
  • 基因型鑑定、診斷的DNA序列
  • 臨床藥理
  • 變異檢測、特定遺傳基因的基因型鑑定
  • 新疾病遺傳基因的特定

第4章 法規、財源

  • 概要
  • 保險
  • 食品和藥物給藥的指南
  • DNA診斷的內部標準
  • 微陣列相關的最低限度的資訊
  • 體外搭配診斷的FDA指南

第5章 商用市場趨勢

  • 市場情況
    • 醫療,醫院,醫生,法規強化及保險金供給的需求
  • 成功的新的必要條件
    • 銷售、行銷
    • 醫療事務
    • 法規遵守
    • 醫療費償付
    • 聯盟、合併

第6章 分子診斷市場:各技術

  • 概要
  • 微陣列,實驗室晶片/生物晶片
  • PCR
  • In situ 雜合反應(ISH)
  • 新興、其他診斷技術

第7章 分子診斷市場:各應用、產品

  • 概要
  • 產前、新生兒遺傳基因篩檢
  • 感染疾病診斷
  • 癌症診斷
  • 身分鑑別,司法鑑定及親子鑑定
  • 藥理基因學/其他應用

第8章 地區預測

  • PCR
  • 陣列
  • ISH
  • 生物晶片
  • 新興技術 其他

第9章 專利分析

  • PCR
  • ISH
  • 微陣列
  • 微流體、生物晶片

第10章 企業簡介

關於BCC Research

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目錄
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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