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市場調查報告書

分子診斷:2020-2030年

Molecular Diagnostics 2020-2030

出版商 IDTechEx Ltd. 商品編碼 919262
出版日期 內容資訊 英文 311 Slides
商品交期: 最快1-2個工作天內
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分子診斷:2020-2030年 Molecular Diagnostics 2020-2030
出版日期: 2020年01月08日內容資訊: 英文 311 Slides
簡介

分子診斷市場,預計從目前85億美元到2030年擴大到約200億美元。

本報告提供分子診斷 (MDx) 市場相關調查,市場概要,技術、各用途分析與預測,及主要企業的簡介等相關彙整。

第1章 摘要整理

第2章 分子診斷的簡介

  • 全球醫療保健趨勢
  • 遺傳基因資料
  • 法規

第3章 分子診斷技術

  • 基因的簡介
  • 技術:DNA微陣列
  • 技術:聚合酵素鏈鎖反應 (PCR)
  • 技術:DNA定序
  • 為了支撐分子診斷技術的晶片實驗室

第4章 照護現場 (POC) 的分子診斷 (MDx)

  • 小型化的設備使照護現場的分子診斷化為可能
  • 分子診斷轉移到照護現場
  • 分子診斷和照護現場的重要性的變化
  • 分子診斷推向照護現場的市場成長的推動要素
  • POC MDx的成功的障礙
  • POC MDx帶給診斷市場的影響
  • POC MDx的勝利所必要的要素
  • POC MDx設備的實例
  • 可利用的開發平台的POC MDx
  • POC MDx設備用濾芯的成本
  • 拋棄式濾芯技術的實例I
  • 拋棄式濾芯技術的實例II
  • POC MDx的方向性
  • 主要趨勢:多重化
  • 主要趨勢:連接性、資料管理

第5章 分子診斷市場

  • 分子診斷的主要用途
  • 感染疾病診斷
  • DTC (直銷)
  • 液態切片

第6章 市場預測

  • MDx技術市場預測
  • DNA微陣列的收益
  • DNA微陣列的市場佔有率
  • DNA微陣列設備市場預測
  • PCR設備的收益
  • PCR設備的市場佔有率
  • PCR設備市場預測
  • DNA定序器的收益
  • DNA定序器的市場佔有率
  • DNA定序器市場預測
  • MDx市場區隔的預測
  • 感染疾病MDx市場預測
  • DTCMDx市場預測
  • 癌症診斷、液態切片MDx市場預測
  • 搭配診斷MDx市場預測

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目錄

Title:
Molecular Diagnostics 2020-2030
Technologies, markets and forecast.

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.

Analyst access from IDTechEx

All report purchases include up to 30 minutes telephone time with an expert analyst who will help you link key findings in the report to the business issues you're addressing. This needs to be used within three months of purchasing the report.

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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