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市場調查報告書

COVID-19 (新冠狀病毒)的診斷,技術,參與企業,趨勢

COVID-19 Diagnostics, Technologies, Players and Trends

出版商 IDTechEx Ltd. 商品編碼 932907
出版日期 內容資訊 英文 182 Slides
商品交期: 最快1-2個工作天內
價格
COVID-19 (新冠狀病毒)的診斷,技術,參與企業,趨勢 COVID-19 Diagnostics, Technologies, Players and Trends
出版日期: 2020年05月14日內容資訊: 英文 182 Slides
簡介

COVID-19是SARS-CoV-2造成的感染疾病,在中國報告第一例病例後於2019年12月開始爆發。世衛組織承認2020年3月11日爆發COVID-19疫情。到2020年4月,確診病例已超過200萬,影響了許多國家的經濟。

本報告提供全球COVID-19診斷相關技術,提供COVID-19最新趨勢,同時依基準測試驗證各種技術上超過100種設備,並介紹部分企業再詳細檢驗其技術趨勢。

第1章 摘要整理

第2章 簡介

  • 什麼是傳染病?
  • 歷史上,傳染病一直是死亡的主要原因
  • 傳染病可能導致大流行
  • COVID-19是由新型冠狀病毒SARS-CoV-2引起的傳染病
  • 診斷感染疾病的主要技術
  • 顯微鏡和培養物生長方法不適用於快速病毒檢測
  • COVID-19診斷技術概要
  • 生物標記 其他

第3章 分子診斷COVID-19診斷的黃金標準

  • 分子診斷COVID-19診斷的中心
  • 技術:定量的逆轉錄聚合酵素鏈鎖反應(qRT-PCR)
  • 技術:等溫放大
  • 技術:DNA定序

第4章 在照護現場的新興分子診斷

  • 小型設備可在現場即時進行分子診斷
  • 現場護理分子診斷可加快COVID-19診斷的從樣品到答案的時間
  • 照護現場分子診斷檢驗結構
  • 對診斷市場的影響 其他

第5章 側流化驗迅速檢驗

  • 橫向流動分析(LFA)是檢測傳染病的主要商業化方法之一
  • 廣泛用於各種應用
  • 生物標記和生物受體
  • 免疫測量
  • 側流免疫測量的機制
  • ELISA
  • 側流化驗帶的材料和生產 其他

第6章 混合診斷

  • 混合診斷化驗:性能,速度,價格的權衡
  • Luminex
  • Mesa Biotech
  • CRISPR-Cas
  • Octant
  • BillionToOne

第7章 其他技術創新

  • 氣味診斷
  • 呼氣診斷
  • 生物學模式的診斷和監測
  • 診斷用AI
  • 主要加入企業
  • Infervision
  • 其他的企業
  • COVID-19檢測AI:演算法比較
目錄

"Demand for testing is over 600 million including 100m genetic tests and over 500m rapid tests."

COVID-19 is an infectious disease caused by SARS-CoV-2. The outbreak of COVID-19 started in Dec. 2019 with the first case reported in China. The World Health Organization (WHO) recognised the outbreak of COVID-19 as a pandemic on 11 March 2020. By April 2020, there are over 2 million confirmed cases and have brought the economies of many countries to a halt.

Diagnostic testing is possibly the only efficient way to know the spread of the SARS-CoV-2 in time and space, enabling policymakers and healthcare workers to track and mitigate the outbreak of COVID-19. The WHO has appealed for global mass testing. The demand for COVID-19 testing is estimated to be over 600 million tests including 120 million genetic tests and over 500 million rapid tests.

The need for universal and massive testing across the population has led to a race for technology innovations for COVID-19 diagnostics. This report surveys the technology landscape, with an in-depth analysis of the technology innovations that are enabling a quick access to COVID-19 diagnosis in response to the global pandemic.

Molecules derived from the virus-nucleic acids like RNA or DNA, or proteins-form the basis of diagnostics as well as being essential for developing new therapies and vaccines. Depending on the target biomarkers, the diagnostic methods can be separated into two categories: genetic testing (detecting the viral genome) and serological & antigenic testing (detecting antibodies and viral antigens, respectively). From the technological perspective, molecular diagnostics (MDx) and lateral flow assays (LAFs) dominate COVID-19 diagnostics. The gold standard used across clinical laboratories is quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR, MDx), which requires a central lab setting. Such qRT-PCR testing lasts for more than 2 hour and the sample shipment cost up to several days. With the demand for quicker tests at community settings, the market is moving into point-of-care (POC) devices, including POC MDx and POC LFAs.

All molecular diagnostics tests detecting viral genomes share three common steps: sample collection from Nasopharyngeal swab and extraction of viral RNA, amplification of the analyte and read-out. The amplification step is performed reliably by RT-PCR, however alternatives that do not require expensive and bulky equipment exist, i.e. isothermal amplification. This approach, although less sensitive than PCR, allows for a quicker amplification step at a constant temperature.

The read-out of the amplified signal is normally achieved through fluorescence probes in the sample and detectors in qRT-PCR devices. Many companies have resorted to lateral flow assays and alternative read-out methods that require proprietary detection equipment. These "hybrid systems" benefit from the high specificity and sensitivity of MDx and the speed and low cost of LFAs.

This report identifies key innovations and technology trends currently being developed in the diagnostics ecosystem that will enable quick and sensitive diagnosis of COVID-19 at point-of-care settings:

Apart from genetic testing, antigenic tests and serological tests, so-called "rapid tests", are also becoming central tools in the fight against the pandemic. Both types of immunoassays rely on antibody-antigen recognition. Antigen tests are able to detect the presence of viral proteins in the blood All molecular diagnostics tests detecting viral genomes share three common steps: sample collection from Nasopharyngeal swab and extraction of viral RNA, amplification of the analyte and read-out. The amplification step is performed reliably by RT-PCR, however alternatives that do not require expensive and bulky equipment exist, i.e. isothermal amplification. This approach, although less sensitive than PCR, allows for a quicker amplification step at a constant temperature.

The read-out of the amplified signal is normally achieved through fluorescence probes in the sample and detectors in qRT-PCR devices. Many companies have resorted to lateral flow assays and alternative read-out methods that require proprietary detection equipment. These "hybrid systems" benefit from the high specificity and sensitivity of MDx and the speed and low cost of LFAs.

This report identifies key innovations and technology trends currently being developed in the diagnostics ecosystem that will enable quick and sensitive diagnosis of COVID-19 at point-of-care settings:

Apart from the effort from biotech, multiple software companies have developed algorithms to identify signs of COVID-19-related pneumonia in patient scans. CT imaging is an effective way of detecting abnormalities indicative of COVID-19, and image recognition AI algorithms have the potential to detect these abnormalities faster and more efficiently than radiologists.

In this report, we benchmarked more than 100 commercial devices across various technologies, providing a deep insight into the technology trends and biotech innovations surrounding the COVID-19 global response. Some of the companies mentioned in the report:

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TABLE OF CONTENTS

1. EXECUTIVE SUMMARY

  • 1.1. COVID-19 is an infectious disease caused by the novel coronavirus SARS-CoV-2
  • 1.2. Overview of the technologies for COVID-19 diagnostics
  • 1.3. Performance comparison of different technologies for COVID-19 diagnostics
  • 1.4. Molecular diagnostics sits at the heart of COVID-19 diagnostics
  • 1.5. US companies lead the COVID-19 molecular diagnostics test
  • 1.6. Real-Time PCR/ Quantitative PCR (qPCR)
  • 1.7. Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
  • 1.8. Genetic testing for COVID-19
  • 1.9. Amplification: isothermal amplification as alternative
  • 1.10. Digital PCR (dPCR) for COVID-19 diagnostics are being developed
  • 1.11. Antibody and antigen test
  • 1.12. Lateral flow assays enable rapid tests of COVID-19
  • 1.13. Antibody and antigen test: enzyme-linked immunosorbent assay (ELISA)
  • 1.14. Highly sensitive and specific immunoassays: big equipment and longer testing time
  • 1.15. Countries are struggling to find good quality rapid test kits
  • 1.16. Chinese companies dominate the LFAs market for COVID-19 test
  • 1.17. Key trends in COVID-19 diagnostics innovations
  • 1.18. Point-of-Care Molecular Diagnostics accelerate the sample-to-answer time for COVID-19 diagnostics
  • 1.19. Isothermal amplification will replace PCR?
  • 1.20. Hybrid diagnostics assays: trade-off between performance, speed and price
  • 1.21. Omit RNA extraction?
  • 1.22. CRISPR-Cas based diagnostics
  • 1.23. The role of DNA sequencing in COVID-19 detection
  • 1.24. Combine of PCR and DNA sequencing for high through-put COVID-19 diagnostics
  • 1.25. Market landscape for post COVID-19

2. INTRODUCTION

  • 2.1. What are infectious diseases?
  • 2.2. Historically infectious diseases have been the leading cause of death
  • 2.3. Infectious diseases may lead to a pandemic
  • 2.4. COVID-19 is an infectious disease caused by the novel coronavirus SARS-CoV-2
  • 2.5. COVID-19 as a pandemic
  • 2.6. Epidemiology of Covid-19
  • 2.7. Main techniques to diagnose infectious diseases
  • 2.8. Microscopy and culture growth methods are not suitable for fast virus detection
  • 2.9. Overview of the technologies for COVID-19 diagnostics
  • 2.10. Biomarkers for COVID-19
  • 2.11. RNA genome as biomarker
  • 2.12. Mass testing for COVID-19
  • 2.13. Sample-to-answer time for different diagnostic technologies
  • 2.14. Sensitivity and specificity
  • 2.15. Sensitivity and specificity for different diagnostic technologies
  • 2.16. Performance comparison of different technologies for COVID-19 diagnostics
  • 2.17. Key trends in COVID-19 diagnostics innovations

3. MOLECULAR DIAGNOSTICS IS THE GOLD STANDARD FOR COVID-19 DIAGNOSTICS

  • 3.1.1. Molecular diagnostics sits at the heart of COVID-19 diagnostics
  • 3.1.2. US companies lead the COVID-19 molecular diagnostics test
  • 3.1.3. Working flow of MDx devices
  • 3.1.4. Detection methods are being used commercially
  • 3.1.5. Fluorescence detection is the top option
  • 3.1.6. Electrochemical detection: label free
  • 3.2. Technology: Quantitative reverse transcription-polymerase chain reaction (qRT-PCR)
    • 3.2.1. Polymerase chain reaction (PCR): Introduction
    • 3.2.2. Polymerase chain reaction (PCR): Process
    • 3.2.3. Real-time reverse transcription-polymerase chain reaction is the most popular choice
    • 3.2.4. Real-Time PCR/ Quantitative PCR (qPCR)
    • 3.2.5. Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
    • 3.2.6. qRT-PCR is the gold standard to diagnose COVID-19
    • 3.2.7. RNA extraction is a bottleneck for many laboratories
    • 3.2.8. Droplet Digital PCR (ddPCR, Bio-Rad)
    • 3.2.9. Digital PCR (dPCR) for COVID-19 diagnostics are being developed
    • 3.2.10. Key players for PCR devices
    • 3.2.11. Key players for PCR reagents/consumables
    • 3.2.12. Market share for PCR equipment For COVID-19 diagnostics
  • 3.3. Technology: Isothermal amplification
    • 3.3.1. Isothermal amplification of nucleic acids
    • 3.3.2. Overview of Isothermal Amplification Technologies I
    • 3.3.3. Overview of Isothermal Amplification Technologies II
    • 3.3.4. Which is the future: isothermal amplification or PCR?
    • 3.3.5. Isothermal amplification based COVID-19 diagnostics
  • 3.4. Technology: DNA sequencing
    • 3.4.1. The role of DNA sequencing in COVID-19 detection
    • 3.4.2. DNA sequencing
    • 3.4.3. DNA sequencing technology: first generation
    • 3.4.4. Capillary Electrophoresis DNA sequencers
    • 3.4.5. Next generation sequencing (NGS)
    • 3.4.6. Second generation sequencing workflows (Illumina)
    • 3.4.7. Key players for second generation sequencing
    • 3.4.8. 3rd generation sequencing
    • 3.4.9. Key players for third generation sequencing
    • 3.4.10. Cost of DNA sequencing is dropping
    • 3.4.11. Future trends and opportunities
    • 3.4.12. Lists of qRT-PCR test kits with approval for COVID-19 diagnostics (excl. POC MDx) (1)
    • 3.4.13. Lists of qRT-PCT test kits with approval for COVID-19 diagnostics (excl. POC MDx) (2)
    • 3.4.14. Lists of qRT-PCT test kits with approval for COVID-19 diagnostics (excl. POC MDx) (3)
    • 3.4.15. Lists of qRT-PCT test kits with approval for COVID-19 diagnostics (excl. POC MDx) (4)
    • 3.4.16. Lists of qRT-PCT test kits with approval for COVID-19 diagnostics (excl. POC MDx) (5)
    • 3.4.17. Lists of qRT-PCT test kits with approval for COVID-19 diagnostics (excl. POC MDx) (6)
    • 3.4.18. Roche molecular systems: Cobas SARS-CoV-2
    • 3.4.19. BGI Genomics: Real-Time SARS-CoV-2 Test
    • 3.4.20. PerkinElmer: New Coronavirus Nucleic Acid Detection Kit
    • 3.4.21. Quest Diagnostic: SARS-CoV-2 RNA, qRT-PCR
    • 3.4.22. Quidel: Lyra SARS-CoV-2 Assay
    • 3.4.23. Primerdesign COVID-19 genesig Real-Time PCR assay
    • 3.4.24. Gnomegen: COVID-19 RT-Digital PCR Detection Kit
    • 3.4.25. Vision Medicals: SARS-CoV-2 Clinical Sequencing assay

4. EMERGING 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. The Rise of Point-of-Care Molecular Diagnostics
  • 4.4. Point-of-Care Molecular Diagnostics accelerate the sample-to-answer time for COVID-19 diagnostics
  • 4.5. What constitutes a Point-of-Care MDx test?
  • 4.6. What it takes to win in point-of-care molecular diagnostics
  • 4.7. The value of point-of-care testing
  • 4.8. The importance of POC biosensors and comparison to centralised testing
  • 4.9. Examples of POC MDx devices
  • 4.10. Costing of test kits for POC MDx devices
  • 4.11. POC MDx: Atlas io system
  • 4.12. POC MDx: Cobas Liat
  • 4.13. POC MDx: Alere i
  • 4.14. POC MDx: Alere q Analyzer
  • 4.15. POC MDx: Spartan Cube
  • 4.16. POC MDx: FilmArray 2.0
  • 4.17. POC MDx: PanNAT system
  • 4.18. POC MDx: GeneXpert Omni
  • 4.19. POC MDx: Spartan Cube
  • 4.20. POC MDx: Q-POC
  • 4.21. Additional POC MDx: systems
  • 4.22. Lists of POC MDx kits with approval for COVID-19 diagnostics
  • 4.23. Cepheid: Xpert® Xpress SARS-CoV-2
  • 4.24. Abbott: ID NOW™ COVID-19 rapid test
  • 4.25. Technology for ID NOW™ COVID-19 rapid test
  • 4.26. bioMérieux: BioFire COVID-19 Test
  • 4.27. DiaSorin Molecular: Simplexa COVID-19 Direct assay

5. IMMUNOASSAYS

  • 5.1. Immunoassays
  • 5.2. Antibody and antigen test
  • 5.3. Lateral flow assays (LFAs) is one of the main commercialised methods to detect infectious disease
  • 5.4. Lateral flow assays is widely used for various applications
  • 5.5. Biomarker and bioreceptor: antigens and antibodies
  • 5.6. Mechanisms of lateral flow immunoassays
  • 5.7. Materials and manufacturing of lateral flow assay strips
  • 5.8. Point-of-care molecular diagnostic (POC MDx) is taking over the infectious disease market from lateral flow assays
  • 5.9. MDx or LFAs
  • 5.10. Lateral flow assays enable rapid tests of COVID-19
  • 5.11. Enzyme-linked immunosorbent assay (ELISA)
  • 5.12. Antigenic tests
  • 5.13. Serological test
  • 5.14. Chinese companies dominate the LFAs market for COVID-19 test
  • 5.15. Countries are struggling to find good quality rapid test kits
  • 5.16. Rapid tests purchased by Spain
  • 5.17. Rapid tests purchased by the UK
  • 5.18. List of LAFs test kits with approval for COVID-19 diagnostics (1)
  • 5.19. List of LAFs test kits with approval for COVID-19 diagnostics (2)
  • 5.20. List of LAFs test kits with approval for COVID-19 diagnostics (3)
  • 5.21. Cellex: qSARS-CoV-2 IgG/IgM Rapid Test
  • 5.22. Roche: Elecsys Anti-SARS-CoV-2 serology test
  • 5.23. Abbott: serology test
  • 5.24. Bio-Rad: Platelia SARS-CoV-2 Total Ab assay
  • 5.25. Quidel: Sofia 2 SARS Antigen FIA Test

6. HYBRID DIAGNOSTICS SYSTEMS

  • 6.1. Hybrid diagnostics assays: trade-off between performance, speed and price
  • 6.2. Lateral flow assays to detect DNA biomarkers
  • 6.3. MDx with electrochemical detection without label
  • 6.4. Luminex Molecular Diagnostics: NxTAG CoV Extended Panel Assay
  • 6.5. Luminex: xMAP Technology
  • 6.6. Mesa Biotech: Accula SARS-Cov-2 Test
  • 6.7. CRISPR-Cas based diagnostics
  • 6.8. CRISPR-Cas based diagnostics work flow
  • 6.9. Competition of CRISPR-Cas based diagnostics
  • 6.10. Other player in CRISPR technology for COVID-19 testing
  • 6.11. Combine of PCR and DNA sequencing for high through-put COVID-19 diagnostics
  • 6.12. Octant: next generation sequencing for mass COVID-19
  • 6.13. BillionToOne: sanger sequencing for large scale COVID-19 testing

7. OTHER TECHNOLOGY INNOVATIONS

  • 7.1. COVID-19 diagnostics via smell
  • 7.2. COVID-19 diagnostics via breath
  • 7.3. COVID-19 diagnostics and monitoring via biological patterns
  • 7.4. AI for COVID-19 diagnostics
  • 7.5. AI for COVID-19: Key players
  • 7.6. AI for COVID-19: Infervision
  • 7.7. AI for COVID-19: Other companies
  • 7.8. COVID-19 detection AI: Algorithm comparison