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體外診斷生技設備

市場調查報告書

商品編碼

1069934

分子診斷劑：技術和全球市場

Molecular Diagnostics: Technologies and Global Markets

出版日期: 2022年04月14日 | 出版商:

BCC Research | 英文 204 Pages | 訂單完成後即時交付

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簡介
目錄

簡介

2021年全球分子診斷市場規模達到176億美元。

預計從 2021 年到 2026 年，該市場將以 19.3% 的複合年增長率增長，到 2026 年將達到 426 億美元。

本報告調查了全球分子診斷市場，並提供了市場概況，以及技術、應用、地區和進入市場的公司概況的趨勢。

傳染病
腫瘤學
白血病
慢性粒細胞白血病
慢性粒細胞白血病的遺傳標誌物
產前產後篩查
職業篩選
產前診斷測試
羊膜穿刺術
絨毛取樣
遺傳諮詢
胚胎植入前基因診斷
新生兒篩查
市場規模和預測
身份證/親子關係確認檢查
親子鑑定
技術
認證
法律問題
獸醫鑑定測試
其他

第 8 章市場細分，按地區

按地區分列的全球分子診斷藥物市場
北美
歐洲
亞太地區
其他領域

第9章監管和財政

概覽
歐洲
美國
日本
保險
食品藥品監督管理局指南
DNA診斷內標
關於微陣列的最少信息
實驗：MIAME 2.0
芯片質量控制項目
實驗室改進的修正
個性化醫療和伴隨診斷
FDA 體外伴隨診斷指南
體外診斷伴隨診斷設備的定義和使用
體外診斷配套診斷裝置及治療藥物審評審批
新型治療劑
一般政策
已獲批准的 IVD 配套診斷設備批准，無需診斷設備
FDA 批准的伴隨診斷
核酸檢測
藥理基因組學研究網

第10章專利

第11章競爭態勢

概覽

第 12 章公司簡介

ABBOTT
AGILENT TECHNOLOGIES INC.
ALMAC GROUP
BECTON, DICKINSON AND CO.
BIOMERIEUX SA
BIO-RAD LABORATORIES INC.
CARDINAL HEALTH
DANAHER CORP.
ELITECH GROUP
GENERAL ELECTRIC
HOLOGIC INC.
ILLUMINA INC.
MYRIAD GENETICS
GRIFOLS(NOVARTIS MOLECULAR DIAGNOSTICS)
PHILIPS HEALTHCARE
QIAGEN N.V.
QUEST DIAGNOSTICS
ROCHE HOLDING AG(F. HOFFMANN-LA ROCHE LTD.)
SIEMENS HEALTHCARE
THERMO FISHER SCIENTIFIC INC.

Product Code: BIO063E

Highlights:

The global molecular diagnostics market should reach $42.6 billion by 2026 from $17.6 billion in 2021 at a compound annual growth rate (CAGR) of 19.3% for the forecast period of 2021 to 2026.

The North American molecular diagnostics market is expected to grow from $7.6 billion in 2021 to $17.1 billion in 2026 at a CAGR of 17.5% for the forecast period of 2021 to 2026.

The European molecular diagnostics market is expected to grow from $4.7 billion in 2021 to $11.9 billion in 2026 at a CAGR of 20.1% for the forecast period of 2021 to 2026.

Report Scope:

This study examines the global market for assays used to detect specific nucleic acid sequences in medical and life science applications. The goal of all DNA-based diagnostic assays is similar, but 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. Government regulations, major collaborations, recent patents and factors affecting the industry from a global perspective are examined. New directions for DNA diagnostic technologies and emerging applications in clinical diagnostics are also examined.

Key molecular diagnostic technologies and products are analyzed to determine present and future market status, and growth is forecast from 2021 to 2026. In-depth discussion of strategic alliances, industry structures, competitive dynamics, patents and market driving forces are also provided.

Report Includes:

60 tables
An overview of the global market and technologies for molecular diagnostics
Estimation of the market size and analyses of global market trends, with data from 2019 to 2021 and projections of compound annual growth rates (CAGRs) through 2026
Characterization and quantification of market potential for molecular diagnostic technologies by technology, application and region
Information about food and drug administration guidelines and internal standards for DNA diagnostics, and coverage of novel therapeutic products and their approvals
Discussion on related issues, government regulations, and reimbursement through insurance, patient confidentiality and other legal ramifications
Identification of market drivers, restraints and other forces impacting the global market and evaluation of current market trends, market size and forecast
Market share analysis of the key companies of the industry and coverage of events like mergers & acquisitions, joint ventures, collaborations or partnerships, and other key market strategies
Company profiles of major players, including Abbott, Becton, Dickinson and Company, General Electric, Siemens Healthcare GmbH and Thermo Fisher Scientific Inc.

Chapter 1 Introduction

Study Goals and Objectives
Reasons for Doing the Study
Intended Audience
What's New in This Update?
Scope of Report
Methodology
Information Sources
Geographical Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports

Chapter 2 Summary and Highlights

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 Impact of the COVID-19 Pandemic

Introduction
Impact of COVID-19 on Market
Changes in Consumption Trends for Health-Related Products

Chapter 5 Market Dynamics

Market Drivers
High Incidences of Infectious Diseases
Increasing Incidences of Chronic Disease
Increasing Research and Development Budget
Increasing Healthcare Expenditures
Restraints and Challenges
Stringent Regulatory Framework
High R&D and Marketing Costs
Opportunities
Point-of Care Tests that Minimize Dependency on Lab Testing
Discovery of New Biomarkers and Advances in Molecular Techniques

Chapter 6 Market Breakdown by Technology

Microarrays
Description
Microfluidic Devices
Market Size and Forecast
PCR
Market Size and Forecast
In Situ Hybridization
Labeling Techniques
In Situ Hybridization Applications
Fiber Fish
Her2 Fish Testing
Market Size and Forecast
Others
Trend Toward Single-Cell Measurements
Market Size and Forecast

Chapter 7 Molecular Diagnostics by Application

Infectious Diseases
Market Size and Forecast
Oncology
Leukemias
Chronic Myeloid Leukemia
Genetic Marker of Chronic Myeloid Leukemia
Market Size and Forecast
Pre- and Post-Natal Screening
Carrier Screening
Prenatal Diagnostic Testing
Amniocentesis
Chorionic Villus Sampling
Genetic Counseling
Preimplantation Diagnosis
Newborn Screening
Market Size and Forecast
Identity and Paternity
Paternity Testing
Technology
Accreditation
Legal Issues
Veterinary Identity Testing
Market Size and Forecast
Others
Market Size and Forecast

Chapter 8 Market Breakdown by Region

Global Molecular Diagnostic Market by Region
North America
U.S.
Canada
Europe
Germany
U.K.
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Rest of Asia-Pacific
Rest of the World

Chapter 9 Regulations and Finance

Overview
Europe
U.S.
Japan
Insurance
Food and Drug Administration Guidelines
Internal Standards for DNA Diagnostics
Minimum Information about a Microarray
Experiment: MIAME 2.0
Microarray Quality Control Project
Clinical Laboratory Improvement Amendments
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 10 Patents

Chapter 11 Competitive Landscape

Overview

Chapter 12 Company Profiles

ABBOTT
AGILENT TECHNOLOGIES INC.
ALMAC GROUP
BECTON, DICKINSON AND CO.
BIOMERIEUX SA
BIO-RAD LABORATORIES INC.
CARDINAL HEALTH
DANAHER CORP.
ELITECH GROUP
GENERAL ELECTRIC
HOLOGIC INC.
ILLUMINA INC.
MYRIAD GENETICS
GRIFOLS (NOVARTIS MOLECULAR DIAGNOSTICS)
PHILIPS HEALTHCARE
QIAGEN N.V.
QUEST DIAGNOSTICS
ROCHE HOLDING AG (F. HOFFMANN-LA ROCHE LTD.)
SIEMENS HEALTHCARE
THERMO FISHER SCIENTIFIC INC.

List of Tables

Summary Table : Global Molecular Diagnostic Market, by Region, Through 2026
Table 1 : Global HIV Data, 2000-2020
Table 2 : Global Leading Causes of Disease, 2004 and 2030
Table 3 : National Institutes of Health Funding Estimates for Various Conditions and Diseases, 2014-2019
Table 4 : Global Molecular Diagnostic Market, by Technology, Through 2026
Table 5 : Global Molecular Diagnostic Market, by Application, Through 2026
Table 6 : Global Molecular Diagnostic Market, by Region, Through 2026
Table 7 : North American Molecular Diagnostic Market, by Technology, Through 2026
Table 8 : North American Molecular Diagnostic Market, by Application, Through 2026
Table 9 : North American Molecular Diagnostic Market, by Country, Through 2026
Table 10 : U.S. Estimated Number of New Cancer Cases, 2021
Table 11 : European Molecular Diagnostic Market, by Technology, Through 2026
Table 12 : European Molecular Diagnostic Market, by Application, Through 2026
Table 13 : European Molecular Diagnostic Market, by Country, Through 2026
Table 14 : Asia-Pacific Molecular Diagnostic Market, by Technology, Through 2026
Table 15 : Asia-Pacific Molecular Diagnostic Market, by Application, Through 2026
Table 16 : Asia-Pacific Molecular Diagnostic Market, by Country, Through 2026
Table 17 : Rest of the World Molecular Diagnostic Market, by Technology, Through 2026
Table 18 : Rest of the World Molecular Diagnostic Market, by Application, Through 2026
Table 19 : Class I and Class II Exempt Devices
Table 20 : Minimum Information About a Microarray Experiment: MIAME 2.0
Table 21 : Microarray Quality Control Project
Table 22 : U.S. Laboratories CLIA-Certified for Molecular Diagnostics and Number of Disease Tests
Table 23 : U.S. Genetic Testing Procedures, by Type, 2015
Table 24 : FDA-Approved In Vitro Companion Diagnostic Devices, June 1, 2017
Table 25 : Nucleic Acid-Based Tests Cleared or Approved by the Center for Devices and Radiological Health, June 1, 2017
Table 26 : Nucleic Acid-Based Tests Cleared or Approved by the Center for Devices and Radiological Health, June 1, 2017
Table 27 : Selected Molecular Diagnostics, 2020-2021
Table 28 : Global Molecular Diagnostic Market Shares, by Manufacturer, 2020
Table 29 : Abbott: Financials, 2016-2020
Table 30 : Abbott: Product Portfolio, by Business Segment
Table 31 : Abbott: Point of Care Diagnostic Products
Table 32 : Abbott: Recent Developments, October 2017-September 2021
Table 33 : Agilent Technologies Inc.: Product Portfolio
Table 34 : Almac Group: Product Portfolio
Table 35 : Becton, Dickinson and Company: Product Portfolio
Table 36 : bioMerieux S.A.: Product Portfolio
Table 37 : BioRad Laboratories: Product Portfolio
Table 38 : Cardinal Health Inc.: Product Portfolio
Table 39 : Danaher Corp.: Product Portfolio
Table 40 : ELITech Group: Product Portfolio
Table 41 : General Electric: Financial Performance, 2019 and 2020
Table 42 : General Electric Healthcare: Molecular Diagnostics Products
Table 43 : Hologic Inc.: Product Portfolio
Table 44 : Illumina Inc.: Product Portfolio
Table 45 : Myriad Genetics: Product Portfolio
Table 46 : Novartis Molecular Diagnostics: Product Portfolio
Table 47 : Philips Healthcare: Product Portfolio
Table 48 : Qiagen N.V.: Product Portfolio
Table 49 : Quest Diagnostics: Product Portfolio
Table 50 : F. Hoffmann-La Roche Ltd.: Financials, 2019
Table 51 : F. Hoffmann-La Roche Ltd.: Revenue, by Diagnostic Segment, 2016-2018
Table 52 : F. Hoffmann-La Roche Ltd.: Product Portfolio
Table 53 : F. Hoffmann-La Roche Ltd.: Recent Developments, June 2017-April 2020
Table 54 : Siemens Healthcare GmbH: Product Segments
Table 55 : Siemens Healthcare GmbH: Molecular Diagnostics Products
Table 56 : Siemens Healthcare GmbH: Financials, 2019
Table 57 : Siemens Healthcare GmbH: Key Developments
Table 58 : Thermo Fisher Scientific: Product Portfolio
Table 59 : Thermo Fisher Scientific: Key Developments, 2021

List of Figures

Summary Figure A : Global Molecular Diagnostic Market, by Region, 2019-2026
Summary Figure B : Global Molecular Diagnostic Market Shares, by Region, 2020
Figure 1 : Incidences of Diagnosed Infectious Disease, by Country, 2019
Figure 2 : Distribution of Malaria Cases, by Country, 2018
Figure 3 : Global Projections for Deaths from the Top Three Chronic Diseases, 2005-2030
Figure 4 : Increased Incidence of Cancer, 2012 and 2030
Figure 5 : Global Distribution of Deaths from Chronic Diseases, 2018
Figure 6 : Flow of Funding for Disease Research, 2014-2018
Figure 7 : Global Funding in Tuberculosis Research and Development, by Institutions, 2019
Figure 8 : Rising Trends in Healthcare Spending, by Institution, 2015-2040
Figure 9 : Global Molecular Diagnostic Market Shares, by Technology, 2020
Figure 10 : Global Molecular Diagnostic Market, by Technology, 2019-2026
Figure 11 : Global Microarray Market, 2019-2026
Figure 12 : Global PCR Market, 2019-2026
Figure 13 : Global ISH Market, 2019-2026
Figure 14 : Global Others Market, 2019-2026
Figure 15 : Global Molecular Diagnostic Market Shares, by Application, 2020
Figure 16 : Global Molecular Diagnostic Market, by Application, 2019-2026
Figure 17 : Global Infectious Disease Market, 2019-2026
Figure 18 : Global Oncology Market, 2019-2026
Figure 19 : Global Pre- and Post-Natal Screening Market, 2019-2026
Figure 20 : Global Identity and Paternity Market, 2019-2026
Figure 21 : Global Others Market, 2019-2026
Figure 22 : Global Molecular Diagnostic Market Shares, by Region, 2020
Figure 23 : North American Molecular Diagnostic Market Shares, by Technology, 2020
Figure 24 : North American Molecular Diagnostic Market Shares, by Application, 2020
Figure 25 : North American Molecular Diagnostic Market Shares, by Country, 2020
Figure 26 : U.S. Molecular Diagnostic Market, 2019-2026
Figure 27 : Canadian Molecular Diagnostic Market, 2019-2026
Figure 28 : European Molecular Diagnostic Market Shares, by Technology, 2020
Figure 29 : European Molecular Diagnostic Market Shares, by Application, 2020
Figure 30 : European Molecular Diagnostic Market Shares, by Country, 2020
Figure 31 : German Molecular Diagnostic Market, 2019-2026
Figure 32 : U.K. Molecular Diagnostic Market, 2019-2026
Figure 33 : French Molecular Diagnostic Market, 2019-2026
Figure 34 : Italy New Disease Cases, 2020
Figure 35 : Italian Molecular Diagnostic Market, 2019-2026
Figure 36 : Spain Share of New Cases, 2020
Figure 37 : Spanish Molecular Diagnostic Market, 2019-2026
Figure 38 : Rest of European Molecular Diagnostic Market, 2019-2026
Figure 39 : Asia-Pacific Molecular Diagnostic Market Shares, by Technology, 2020
Figure 40 : Asia-Pacific Molecular Diagnostic Market Shares, by Application, 2020
Figure 41 : Asia-Pacific Molecular Diagnostic Market Shares, by Country, 2020
Figure 42 : China New Cancer Cases, 2020
Figure 43 : China New Cancer Cases Share, 2020
Figure 44 : Chinese Molecular Diagnostic Market, 2019-2026
Figure 45 : Japanese Molecular Diagnostic Market, 2019-2026
Figure 46 : Indian Molecular Diagnostic Market, 2019-2026
Figure 47 : Rest of Asia-Pacific Molecular Diagnostic Market, 2019-2026
Figure 48 : Africa New Cancer Cases, 2020
Figure 49 : Rest of the World Molecular Diagnostic Market Shares, by Technology, 2020
Figure 50 : Rest of the World Molecular Diagnostic Market Shares, by Application, 2020
Figure 51 : U.S. Process for Marketing a Medical Device
Figure 52 : Growth in Clinical Laboratory Sites and Disease Testing, 2012-2015
Figure 53 : Global Molecular Diagnostic Market Shares, by Manufacturer, 2020
Figure 54 : Abbott: Revenue Share, by Region or Country,
Figure 55 : Abbott: Revenue Share, by Business Segment
Figure 56 : Becton, Dickinson and Company: Annual Revenue, 2018-2020
Figure 57 : Becton, Dickinson and Company: Revenue Share, by Region, 2020
Figure 58 : Becton, Dickinson and Company: Revenue Share, by Business Segment, 2020
Figure 59 : Danaher Corp.: Annual Revenue, 2018-2020
Figure 60 : Danaher Corp.: Revenue Share, by Geography, 2020
Figure 61 : Danaher Corp.: Revenue Share, by Segment, 2020
Figure 62 : General Electric: Revenue Share, by Business Segment, 2020
Figure 63 : General Electric Healthcare: Revenue Share, by Region, 2020
Figure 64 : F. Hoffmann-La Roche Ltd.: Revenue Share, by Segment, 2019
Figure 65 : F. Hoffmann-La Roche Ltd.: Revenue Share, by Region or Country, 2019
Figure 66 : Siemens Healthcare GmbH: Revenue Share, by Business Segment, 2019
Figure 67 : Siemens Healthcare GmbH: Revenue Share, by Region, 2019
Figure 68 : Thermo Fisher Scientific: Annual Revenue, 2019 and 2020
Figure 69 : Thermo Fisher Scientific: Revenue Share, by Region, 2020
Figure 70 : Thermo Fisher Scientific: Revenue Share, by Segment, 2020