Life Sciences Report

分子診断市場は2030年までに200億ドルの規模に達します

分子診断 2020-2030年

技術、市場および見通し


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分子診断は、技術の進歩(第3世代 DNA シークエンシング、デジタル PCR およびマイクロ流体デバイスなど)、医療現場の分子診断市場の拡大、ならびに実証済みの臨床的有用性を持つ遺伝子バイオマーカーの発見が相次いでいることに刺激され、医療業界においてもっとも急速な成長を遂げている市場の一つです。分子診断市場は2030年までに200億ドルに達すると予想されています。
Molecular diagnostics (MDx) is used to assess an individual's health at the molecular level, analyzing specific genetic sequences encoded in deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or the proteins that are expressed from these genetic sequences. All disease is a result of genes interacting with the environment. MDx provide a golden path toward personalized health care, precision medicine and predictive health care.
 
 
Molecular diagnostics is the fastest growing segment of the broader diagnostics market. The market for MDx is expected to grow from $8.5 billion at present to around $20 billion by 2030. The growth of MDx is driven by the technology developments, the growth of the point-of-care MDx market, and the continued discovery of genetic biomarkers with proven clinical utility.
There are multiple techniques for testing genetic materials, some of which lend themselves more readily to miniaturization. Initially, molecular diagnostics were carried out using hybridization methods, such as fluorescence in situ hybridization. Later, polymerase chain reaction (PCR) and microarrays offered high throughput and more accurate tests. More recently DNA sequencing is an alternative for MDx as an unbiased and direct method. This report gives a comprehensive study and complete analysis of the important trends in the field of molecular diagnostics and particularly focuses on three categories of technologies and equipment:
 
• Microarrays:
• Polymerase chain reaction (PCR)
• DNA sequencing
 
For each technology category, this report summarises the technology advancements and innovations, lists the dominant companies and their key technologies, and provides ten-year forecasts on the market growth from 2020-2030. The forecasts are mainly built on information derived from historic data of key players, intensive company interviews, and the assumptions of the adoption rate of new technologies such as digital polymerase chain reaction and third generation sequencing.
Traditionally, molecular diagnostics has been used in life science research, infectious disease testing and cancer diagnostics, but the market of MDx is expanding into new areas, such as companion diagnostics, liquid biopsy, direct-to-consumer and more. The report gives a 10-year market forecast segmented by the following applications:
 
• Infectious disease
• Cancer and liquid biopsy
• Genetic testing
• Life science research
• Companion diagnostic
• Direct-to-consumer
 
This report provides 30 company profiles of the main players across different segments. It also gives a comprehensive study on both currently available and incoming devices. This report will be useful to any company wishing to know the molecular diagnostics market, advanced techniques and devices, current market size and future tendency.
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アイディーテックエックス株式会社 (IDTechEx日本法人)
担当: 村越美和子 m.murakoshi@idtechex.com
Table of Contents
1.EXECUTIVE SUMMARY
1.1.Molecular diagnostics (MDx)
1.2.Drivers for the MDx markets
1.3.What are the benefits and limitations of MDx?
1.4.Working flow of MDx devices
1.5.Key technologies for MDx: overview
1.6.Market forecast for MDx technologies from 2020-2030
1.7.DNA microarray: high-throughput analysis of target regions in the genome
1.8.Synthesis of DNA microarrays
1.9.Key players for DNA microarrays
1.10.Market share of DNA microarrays in 2019
1.11.Market forecast for microarrays devices from 2020-2030
1.12.Polymerase chain reaction (PCR): Process
1.13.Real-Time PCR/ Quantitative PCR (qPCR)
1.14.Digital PCR (dPCR)
1.15.Key players for PCR devices
1.16.Key players for PCR reagents/consumables
1.17.Market share for PCR equipment in 2019
1.18.Market forecast for PCR devices from 2020-2030
1.19.DNA sequencing technology: first generation
1.20.Next generation sequencing (NGS)
1.21.3rd generation sequencing
1.22.Future trends and opportunities
1.23.Market share for DNA sequencers in 2019
1.24.Market forecast for DNA sequencers from 2020-2030
1.25.Miniaturized devices enable molecular diagnostics at point-of-care
1.26.Market drivers for pushing MDx to the point-of-care
1.27.Examples of POC MDx devices
1.28.Cost of cartridges for POC MDx devices
1.29.Key applications for molecular diagnostics
1.30.MDx applications are divided into two categories
1.31.Key players for Human Genetic Tests
1.32.Key players for Microbial Tests
1.33.Market forecast for MDx market segments from 2020-2030
1.34.Market forecast for molecular diagnostics for infectious diseases
1.35.Market forecast for molecular diagnostics for direct-to-consumer
1.36.Market forecast for molecular diagnostics for cancer diagnostics and liquid biopsy
1.37.Market forecast for molecular diagnostics for companion diagnostics
2.INTRODUCTION TO MOLECULAR DIAGNOSTICS
2.1.1.Global healthcare trend
2.1.2.US, Europe and Asia are the key markets
2.1.3.Why the healthcare market is growing
2.1.4.Molecular diagnostics (MDx)
2.1.5.The central dogma: DNA, RNA and Proteins
2.1.6.Key technologies for MDx: overview
2.1.7.Drivers for the MDx markets
2.1.8.Key applications for molecular diagnostics
2.1.9.Clinical market for genomic testing is expanding
2.1.10.All disease is a result of genes interacting with the environment
2.1.11.Testing genetic mutations
2.1.12.Biomarker development in the precision medicine era
2.1.13.What are the benefits and limitations of MDx?
2.1.14.2018: Turning point for MDx
2.2.Genetic Data
2.2.1.Applications of genetic data
2.2.2.Race to build up genetic database and the dilemma for privacy
2.2.3.Global Genetics projects
2.2.4.Population sequencing: backing by governments
2.2.5.Moral and ethical concerns
2.3.Regulations
2.3.1.Regulatory routes to market depend on the target market
2.3.2.EU regulations for medical devices are changing
2.3.3.Changing regulations: Advice to manufacturers
2.3.4.A regulatory road map for diagnostic products in the US
2.3.5.US regulations for diagnostics: CLIA categorizations
3.TECHNOLOGIES OF MOLECULAR DIAGNOSTICS
3.1.1.Introduction to Genome
3.1.2.Genotyping
3.1.3.Gene expression
3.1.4.Genotyping and SNP Analysis
3.1.5.Working flow of MDx devices
3.1.6.Extraction and purification
3.1.7.Amplification: PCR or isothermal amplification
3.1.8.Detection: DNA sequencing vs. DNA probe
3.1.9.Detection methods are being used commercially
3.1.10.Optical detection: fluorescence
3.1.11.Optical detection: colorimetric
3.1.12.Electrochemical detection: with label
3.1.13.Electrochemical detection: label free
3.1.14.The industry moves toward CMOS chips
3.2.Technology: DNA microarrays
3.2.1.DNA microarray: high-throughput analysis of target regions in the genome
3.2.2.Key players for DNA microarrays
3.2.3.Substrate for DNA microarray
3.2.4.Synthesis of DNA microarrays
3.2.5.Synthesis of DNA microarrays: printed methods
3.2.6.Synthesis of DNA microarrays: In-situ synthesis
3.2.7.Synthesis of DNA microarrays: microbeads/ self assembled arrays
3.2.8.Research trend in DNA microarrays: Microfluidic DNA Microarrays
3.2.9.GeneChip® microarrays (Affymetrix, Thermal Fishers)
3.2.10.NimbleGen (Roche): Maskless Array Synthesis
3.2.11.SurePrint technology (Agilent Technologies)
3.2.12.BeadArray Microarray Technology (Illumina)
3.2.13.DualChip (Eppendorf)
3.2.14.NanoChip electronic microarray (Savyon Diagnostics )
3.2.15.DNA microarrays for DNA sequence (exome sequencing)
3.2.16.Limitation of DNA microarray
3.2.17.Revenue of DNA microarrays from 2010 to 2018
3.2.18.Market share of DNA microarrays in 2019
3.2.19.Market forecast for microarrays devices from 2020-2030
3.3.Technology: Polymerase chain reaction (PCR)
3.3.1.Polymerase chain reaction (PCR): Introduction
3.3.2.Polymerase chain reaction (PCR): Process
3.3.3.Trend for PCR technology
3.3.4.Various PCR technologies
3.3.5.Multiplex polymerase chain reaction (mPCR)
3.3.6.Real-Time PCR/ Quantitative PCR (qPCR)
3.3.7.Labelling for qPCR
3.3.8.QuantStudio (Thermal Fisher Scientific): smart PCR
3.3.9.Digital PCR (dPCR)
3.3.10.Digital PCR devices
3.3.11.Droplet Digital PCR (ddPCR, Bio-Rad)
3.3.12.Key players for PCR devices
3.3.13.Key players for PCR reagents/consumables
3.3.14.Isothermal amplification of nucleic acids techniques
3.3.15.Which is the future: isothermal amplification or PCR?
3.3.16.Revenue of PCR devices from 2010 to 2018
3.3.17.Market share for PCR equipment in 2019
3.3.18.Market forecast for PCR devices from 2020-2030
3.4.Technology: DNA sequencing
3.4.1.What's DNA sequencing
3.4.2.DNA sequencing
3.4.3.Applications of DNA sequencing in research and clinical use
3.4.4.DNA sequencing provides insight
3.4.5.DNA sequencing technology: first generation
3.4.6.Capillary Electrophoresis DNA sequencers
3.4.7.Next generation sequencing (NGS)
3.4.8.Second generation sequencing workflows (Illumina)
3.4.9.Key players for second generation sequencing
3.4.10.3rd generation sequencing
3.4.11.Key players for third generation sequencing
3.4.12.DNA sequencers by Thermo Fisher Scientific
3.4.13.DNA sequencers by Oxford nanopore
3.4.14.DNA sequencing supply-chain
3.4.15.Business model: research, clinical genetic tests, direct-to-consumer
3.4.16.Cost for DNA sequencing test
3.4.17.Cost to sequence whole human genome
3.4.18.Future trends and opportunities
3.4.19.Revenue of DNA sequencers from 2010 to 2018
3.4.20.Market share for DNA sequencers in 2019
3.4.21.Market forecast for DNA sequencers from 2020-2030
3.5.Lab-on-a-chip to support molecular diagnostics technologies
3.5.1.What is Lab-on-a-chip (LOC)?
3.5.2.Ideal LOC devices for POC
3.5.3.Lab-on-a-chip applications
3.5.4.Example: the simple chip for low-cost, quantitative, and portable nucleic acid testing
3.5.5.Lab-on-a-chip for digital polymerase chain reaction (dPCR)
3.5.6.Lab-on-a-chip for DNA sequencing
3.5.7.Sample preparation
3.5.8.Biocompatible photoresists
3.5.9.Bio-patterning
3.5.10.Photolithography bio-patterning
3.5.11.Microstamping bio-patterning
3.5.12.Microfluidic patterning
3.5.13.Self-assembly bio-patterning
3.5.14.Active flow control and digital microfluidics
3.5.15.Droplet microfluidics (digital microfluidics)
4.MOLECULAR DIAGNOSTICS AT POINT-OF-CARE
4.1.Miniaturised devices enable molecular diagnostics at point-of-care
4.2.Molecular diagnostics is moving to point-of-care
4.3.Varying importance of molecular diagnostics and point-of-care
4.4.Market drivers for pushing MDx to the point-of-care
4.5.Barriers to success for POC MDx
4.6.The impact of POC MDx on the diagnostics market
4.7.What it takes to win in point-of-care molecular diagnostics
4.8.Examples of POC MDx devices
4.9.POC MDx available and in pipeline
4.10.Costing of cartridges for POC MDx devices
4.11.Examples of disposable cartridge technologies I
4.12.Examples of disposable cartridge technologies II
4.13.Direction for point-of-care molecular diagnostics
4.14.Key trends: multiplexing
4.15.Key trends: connectivity and data management
5.MARKETS FOR MOLECULAR DIAGNOSTICS
5.1.1.Key applications for molecular diagnostics
5.1.2.New markets for molecular diagnostics
5.1.3.MDx applications are divided into two categories
5.1.4.Key players for Human Genetic Tests
5.1.5.Numbers of products with FDA approval for Human Genetic Tests for each key players
5.1.6.Key players for Microbial Tests
5.1.7.Numbers of products with FDA approval for Microbial Tests for each key players
5.2.Infectious diseases diagnosis
5.2.1.What are infectious diseases
5.2.2.Why does it matter
5.2.3.Infectious diseases today
5.2.4.Infectious diseases will lead to pandemic disease
5.2.5.Major infectious threats in 21st Century
5.2.6.Main techniques to diagnose infectious diseases
5.2.7.Microscopy and culture growth methods
5.2.8.Immunoassays
5.2.9.Enzyme-linked immunosorbent assay (ELISA)
5.2.10.Key players in the lateral flow assay market
5.2.11.Molecular diagnostics: Polymerase Chain Reaction (PCR) for infectious disease
5.2.12.Point-of-care molecular diagnostic (POC MDx) will take over the infectious disease market from lateral flow assays (LFA)
5.2.13.Comparison of MDx and immunoassays for infectious diseases
5.2.14.Players in molecular diagnostics for infectious disease detection
5.2.15.Devices: Atlas io system
5.2.16.Devices: Cobas Liat
5.2.17.Devices: Alere i
5.2.18.Devices: Alere q Analyzer
5.2.19.Devices: Spartan Cube
5.2.20.Devices: FilmArray 2.0
5.2.21.Devices: PanNAT system
5.2.22.Devices: GeneXpert Omni
5.2.23.Devices: Spartan Cube
5.2.24.Devices: Q-POC
5.2.25.Additional molecular diagnostic systems
5.2.26.Market forecast for molecular diagnostics for infectious diseases
5.3.Direct-to-consumer (DTC)
5.3.1.23andMe starts DTC business model
5.3.2.Customer motivations for DTC
5.3.3.Considerations when customers purchase DTC
5.3.4.Why DTC diagnostics might not be correct and genetic counsellors are needed
5.3.5.Market forecast for molecular diagnostics for direct-to-consumer
5.4.Liquid Biopsy
5.4.1.Global cancer
5.4.2.Liquid biopsy for cancer: Written in blood
5.4.3.Circulating tumor DNA (ctDNA)
5.4.4.Circulating tumour cells (CTCs)
5.4.5.Liquid biopsy for cancer: Challenges
5.4.6.Project to study the landscape of genomic cancer signal in the blood
5.4.7.Liquid biopsy for lung cancer (OncoCyte)
5.4.8.Early cancer detection by DNA sequencing (GRAIL)
5.4.9.Debate on ctDNA: evolutional or fantasy
5.4.10.Market forecast for molecular diagnostics for cancer diagnostics and liquid biopsy
5.5.Companion Diagnostic
5.5.1.The future: companion diagnostic (CDx)
5.5.2.Some FDA approved CDx products in 2019
5.5.3.Number of FDA approved CDx products (by Oct. 2019)
5.5.4.Market forecast for molecular diagnostics for companion diagnostics
6.MARKET FORECASTS 2020-2030
6.1.Market forecast for MDx technologies from 2020-2030
6.2.Revenue of DNA microarrays from 2010 to 2018
6.3.Market share of DNA microarrays in 2019
6.4.Market forecast for microarrays devices from 2020-2030
6.5.Revenue of PCR devices from 2010 to 2018
6.6.Market share for PCR equipment in 2019
6.7.Market forecast for PCR devices from 2020-2030
6.8.Revenue of DNA sequencers from 2010 to 2018
6.9.Market share for DNA sequencers in 2019
6.10.Market forecast for DNA sequencers from 2020-2030
6.11.Market forecast for MDx market segments from 2020-2030
6.12.Market forecast for molecular diagnostics for infectious diseases
6.13.Market forecast for molecular diagnostics for direct-to-consumer
6.14.Market forecast for molecular diagnostics for cancer diagnostics and liquid biopsy
6.15.Market forecast for molecular diagnostics for companion diagnostics
7.COMPANY PROFILES
 

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