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COVID-19時代における分子診断の世界市場

The World Market for Molecular Diagnostics in the COVID-19 Era

出版日: | 発行: Kalorama Information | ページ情報: 英文 140 Pages | 納期: 即日から翌営業日

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COVID-19時代における分子診断の世界市場
出版日: 2020年07月10日
発行: Kalorama Information
ページ情報: 英文 140 Pages
納期: 即日から翌営業日
担当者のコメント
COVID-19の感染の長期化が懸念される中、診断検査の世界のトレンドについてもこの影響下の中、市場動向や新たな参入企業の動向など、引き続きニーズを収集していく必要がございます。Kalorama Information(米国)は、過去15年以上にわたり、Molecular Diagnostics分野における市場、各社の動向の調査を継続している調査会社になり、当最新調査レポートは、診断検査分野における製品の海外展開を今後も加速する企業様必見の調査レポートです。
  • 全表示
  • 概要
  • 目次
概要

これまで以上に、分子診断は体外診断の最も重要な部分となっています。2020年は、あらゆる状況下での分子診断における成長と革新の年となる見込みです。新製品、他の体外診断カテゴリーよりも高い成長、次世代シーケンシング手法の継続的な受け入れが推進されました。リキッドバイオプシー技術と予見的な遺伝学的検査の使用の増加は、引き続き収益成長が見込まれる分野です。 SARS-CoV-2およびその結果としてのCOVID-19の突然の発生により、世界は分子診断に予期せぬ方法で焦点を当てました。

当レポートでは、世界の分子診断市場について調査し、各セグメント・地域別による市場規模と成長予測、各種技術、および主要企業のプロファイルなどを提供しています。

第1章 エグゼクティブサマリー

  • 注目の分子診断
  • COVID-19市場
  • 新たな動向
    • オートメーション
    • 分子ポイントオブケア
    • 次世代シーケンシングの台頭
    • LDT規制とCOVID-19
    • 医療費償還環境
    • Thermo と Qiagen の合併
    • CRISPR、シーケンスおよびCOVID-19
  • COVID-19時代における世界の分子診断市場

第2章 COVID-19分子診断市場の分析

  • 主要IVD企業は活発にCOVID-19テストを販売
  • 南北アメリカ、欧州、APAC、ROW、LATAM、世界
  • 北米
  • 欧州
  • アジア太平洋
  • ラテンアメリカ
  • その他の地域
  • COVID テスト市場の計算方法
  • テストベンダー
  • テスト動向、推奨事項、コンセンサス作成

第3章 その他の分子診断テスト市場

  • 感染症
    • 呼吸器疾患:COVID-19の影響
    • 抗酸菌/結核:市場とCOVID-19の影響
    • 医療関連感染(HAI):市場とCOVID-19の影響
    • 性感染症:市場とCOVID-19の影響
    • 肝炎:COVID-19の影響
    • HIV:市場とCOVID-19の影響
  • NAT血液スクリーニング
    • COVID-19の影響
  • 分子組織学および細胞学診断
    • COVID-19の影響
    • HPV
    • COVID-19の影響
    • 製品開発
  • 分子癌診断の市場
    • がん分子血液マーカー:COVID-19の影響
  • 分子移植の診断
    • COVID-19(新型コロナウイルス感染症)(#文字数制限がない場合、初出時にかっこ書きを追加
  • 分子遺伝性疾患の診断
    • 遺伝性疾患:COVID-19の影響
    • 血栓症と凝固マーカー
    • 非侵襲的出生前検査(NIPT)
    • 遺伝性疾患検査

第4章 動向:シーケンシング、CRISPR、自動化

  • シーケンス
    • COVIDおよびNGS
    • NGSと遺伝性疾患
    • NGSとコンパニオン診断
    • 分子診断におけるNGSの展望
    • 臨床シーケンスにおける進化する情報学ソリューション
    • サンプル調製と品質管理
  • ラボの自動化と分子診断
  • CRISPRおよび分子診断
    • CRISPRおよびCOVID-19

第5章 企業プロファイル

  • Abbott Diagnostics
  • Agena Bioscience
  • Agendia BV
  • ARUP Laboratories
  • Asuragen
  • Advanced Cell Diagnostics
  • Agilent
  • Amoy Diagnostics
  • Applied Spectral Imaging
  • Becton, Dickinson & Co.
  • Biocartis
  • BGI
  • Berry Genomics
  • BioMerieux
  • Bio-Rad
  • Care DX
  • Danaher
  • Cepheid
  • Beckman Coulter
  • Leica Biosystems
  • Eiken Chemical
  • Fluidigm
  • GenMark
  • Genotypic Technology PVT
  • Greiner Bio-One GMBH
  • Grifols
  • Hologic
  • Illumina
  • Immucor
  • Meridian
  • Molbio
  • Myriad Genetics
  • Nanostring
  • Neogenomics
  • NeuromoDX
  • Perkin Elmer
  • Oxford Nanopore
  • Promega
  • Prescient Medicine
  • Qiagen
  • Quidel
  • Roche
  • Thermo
  • Vela
  • Veracyte
目次
Product Code: 20-033

Now more than ever, molecular diagnostics are the most important part of in vitro diagnostics. Kalorama Information has, for many years, estimated the size of and forecasted the growth of the worldwide market for molecular diagnostics in all major segments, and does so in this edition as a pandemic has reached developed markets including the United States.

2020 was set to be a year of growth and innovations in molecular diagnostics under any circumstances. New products, higher growth than other in vitro diagnostic categories, continued acceptance of next-generation sequencing methods were driving. Liquid biopsy technologies and the increased use of predictive genetic tests were and still are areas of anticipated revenue growth. The sudden onsent of SARS-CoV-2 and the resulting disease COVID-19 put the world's focus on molecular diagnostics in an unexpected way.

This will not be universally the case. In non-COVID-19 testing areas, such as cancer and inherited diseases, molecular diagnostics vendors need to continue to persuade. Here volumes may be reduced by social distancing measures. But they are expected to continue to make progress converting laboratory customers. New technologies such as molecular near-patient and next-generation sequencing are increasingly part of the mix. The report details these trends.

This report provides 2020 market sizing and expected growth to 2025 for the following segments:

  • COVID-19 Molecular IVD Test Market (Full Year 2020 Projected and Market 2H 2020)
  • COVID-19 Molecular IVD Test Market North America
  • COVID-19 Molecular IVD Test Market Europe
  • COVID-19 Molecular IVD Test Market Asia Pacific
  • COVID-19 Molecular IVD Test Market Rest of World
  • Infectious Disease Markets, including:
  • Hepatitis
  • HIV
  • Respiratory
  • HAIs and Sepsis Tests
  • TB
  • Sexually Transmitted Diseases
  • NAT Blood Testing
  • Molecular Histology
  • Molecular Cancer Testing
  • Molecular Transplantation Testing
  • Inherited Disease Testing
  • NIPT
  • Inherited
  • Thrombophilia
  • Pharmacogenomics

There has also been a huge influx of product introductions from small, obscure companies. These have mostly targeted the low end of the price range and often had poor performance, while a small number of high-end automated systems are mostly limited to certain segments of the market, such as independent reference laboratories and centralized hospital laboratories. Low-quality products from fly-by-night companies are the predictable result of the shortages and the relatively basic resources needed to produce mediocre antibody test kits with a low level of quality control. A few major companies are seeing the most test runs, particularly in the United States.

COVID-19 testing has also been a bit of a double-edged sword for labs generally, for in vitro diagnostics and for molecular tests. Boosting volumes in infectious disease have been notably paired with drops due to social distancing measures and hospital surgical postponements. What is the result? Kalorama Information's report helps to sort out the array of news and reports about the current state of molecular diagnostics, reasonable global estimates for COVID, and the impact of COVID-19 on the rest of molecular testing.

Kalorama covers the global markets. For All Markets, Kalorama Information provides the following:

  • Impacts of COVID-19 on Market Segments
  • Regional Market Distribution
  • Profiles of Top Companies
  • Major Companies with COVID-19 Tests
  • Other Companies with COVID-19 Tests
  • HIV Products on the Market
  • Transplantation Products on the Market
  • The Increasing Role of Next-Generation Sequencing
  • Trends - Lab Automation and Molecular Diagnostics
  • Trends - CRISPR
  • Trends - Artificial Intelligence
  • Company Profiles

Kalorama Information has monitored 2020 secondary sources, trade publications, medical journals, government websites and policy documents, as well as financial statements from vendors to assess the market impact of COVID-19. In addition, Kalorama has been tracking lab volumes with a survey since mid-April, and Kalorama's U.S. MasterFile product was used to keep track of instrument trends.

Companies Profiled in the Report Include:

  • Abbott Diagnostics
  • Agena Bioscience
  • Agendia BV
  • ARUP Laboratories
  • Asuragen
  • Advanced Cell Diagnostics
  • Agilent
  • Amoy Diagnostics
  • Applied Spectral Imaging
  • Becton, Dickinson & Co.
  • Biocartis
  • BGI
  • Berry Genomics
  • BioMerieux
  • Bio-Rad
  • Care DX
  • Danaher
  • Cepheid
  • Beckman Coulter
  • Leica Biosystems
  • Eiken Chemical
  • Fluidigm
  • GenMark
  • Genotypic Technology PVT
  • Greiner Bio-One GMBH
  • Grifols
  • Hologic
  • Illumina
  • Immucor
  • Meridian
  • Molbio
  • Myriad Genetics
  • Nanostring
  • Neogenomics
  • NeuromoDX
  • Perkin Elmer
  • Oxford Nanopore
  • Promega
  • Prescient Medicine
  • Qiagen
  • Quidel
  • Roche
  • Thermo
  • Vela
  • Veracyte

TABLE OF CONTENTS

CHAPTER ONE: EXECUTIVE SUMMARY

  • MOLECULAR DIAGNOSTICS IN THE SPOTLIGHT
    • Figure 1-1: Molecular Diagnostics Market (w COVID-19 and without COVID-19, 2020) $BN
    • Hundreds of PCR Tests on the Market, U.S. Labs Settle on a Few
    • COVID-19 Market
      • Table 1-1: COVID-19 Molecular Testing Market, First Half-Year 2020 and Full Year 2020 ($M)
  • EMERGING TRENDS
    • Automation
    • Molecular Point of Care
      • Table 1-2: Market-Available Molecular POC Diagnostic Platforms
    • Next-Generation Sequencing on the Rise
    • LDT Regulation and COVID-19
    • Reimbursement Environment
    • Thermo and Qiagen Merger
      • Table 1-3: Complementary diagnostic products offered by Thermo Fisher, Qiagen
    • CRISPR, Sequencing and COVID-19
  • THE GLOBAL MOLECULAR DIAGNOSTICS MARKET IN THE ERA OF COVID-19
    • Table 1-4: Non-COVID-19 Molecular Diagnostics Market ($M)

CHAPTER TWO: COVID-19 MOLECULAR DIAGNOSTIC MARKET ANALYSIS

  • Major IVD Players See Brisk COVID-19 Test Sales
    • Table 2-1: COVD-19 Molecular Detection Tests from Major Suppliers
    • Table 2-2: COVID-19 test market by Region Second Half of 2020 and Full Year 2020 Estimated: North
  • America, Europe, APAC, ROW, LATAM, World
  • NORTH AMERICA
    • Table 2-3: COVID-19 Tests, North America
  • EUROPE
    • Table 2-4: COVID Tests, Europe
  • APAC
    • Table 2-6: COVID Tests APAC Region
  • LATIN AMERICA
    • Table 2-7: Latin America COVID Testing
  • REST-OF-WORLD
    • Table 2-8: Rest of World Testing
  • COVID TESTING MARKET COMPUTATION METHODOLOGY
  • TEST VENDORS
    • Table 2-9: Other PCR Tests Products on the Market
  • TESTING TRENDS, RECOMMENDATIONS, CONSENSUS TAKING SHAPE

CHAPTER THREE: MARKETS FOR OTHER MOLECULAR DIAGNOSTIC TESTS

  • Table 3-1: Molecular Diagnostic Market, 2020 and 2025 by Category $M
  • Figure 3-1: Market by Regions: US, Europe, Asia, ROW
  • INFECTIOUS DISEASES
    • Repiratory Diseases: COVID-19 Impact
    • Mycobacteria/Tuberculosis: Market and COVID-19 Impact
    • Hospital-Acquired Infections (HAIs) : Market and COVID-19 Impact
    • Sexually Transmitted Infections: Market and COVID-19 Impact
    • Hepatitis: COVID-19 Impact
      • Table 3-2: Selected Molecular Hepatitis Tests
    • HIV Market and COVID-19 Impact
      • Table 3-3: Selected Molecular Test Products for HIV
  • NAT BLOOD SCREENING
    • COVID-19 Impact
  • MOLECULAR HISTOLOGY AND CYTOLOGY DIAGNOSTICS
    • COVID-19 Impact
    • HPV
    • COVID-19 Impact
    • Product Developments
  • MARKETS FOR MOLECULAR CANCER DIAGNOSTICS
    • Cancer Molecular Blood Markers - COVID-19 Impact
  • MOLECULAR TRANSPLANT DIAGNOSTICS
    • COVID-19
      • Table 3-4: Selected Innovations in the Field of Molecular Transplant Diagnostics
  • MOLECULAR INHERITED DISEASES DIAGNOSTICS
    • Inherited Diseases - COVID-19 Impact
    • Thrombophilia and Coagulation Markers
    • Non-Invasive Prenatal Testing (NIPT)
    • Inherited Disease Tests

CHAPTER FOUR: TRENDS TO WATCH - SEQUENCING, CRISPR, AUTOMATION

  • SEQUENCING
    • COVID and NGS
    • NGS and Inherited Disease
    • NGS and Companion Diagnostics
      • Table 4-1: Selected Clinical NGS Platforms in the Market
    • Outlook For NGS in Molecular Diagnostics
      • Figure 4-1: Percent of the MDX Market Revenues for Tests Using NGS 2020 and 2025
    • Evolving Informatics Solutions in Clinical Sequencing
    • Sample Preparation and Quality Control
  • LAB AUTOMATION AND MOLECULAR DIAGNOSTICS
    • Table 4-2: Selected Automated Molecular Test Instrument Platforms
    • Table 4-3: Selected FDA Declared EUA Tests
  • CRISPR AND MOLECULAR DIAGNOSTICS
    • CRISPR and COVID-19
      • Table 4-4: CRISPR Innovations

CHAPTER FIVE: COMPANY PROFILES

  • ABBOTT DIAGNOSTICS
    • Company Overview
    • Financial Review
      • Table 5-1: Abbott Diagnostics' Recent Revenue History ($ millions)
    • COVID-19
    • FDA approval of ALK Break Apart FISH Probe Kit
    • Alinity s System
    • WHO prequalification (PQ) approval of viral load test
  • AGENA BIOSCIENCE
  • AGENDIA BV
  • ARUP LABORATORIES
    • Table 5-2: ARUP Labs' Recent Revenue History ($ millions)
  • ASURAGEN INC.
  • ADVANCED CELL DIAGNOSTICS (BIOTECHNE)
  • AGILENT TECHNOLOGIES INC./DAKO
    • Company Overview
    • Financial Review
      • Table 5-3: Agilent Technologies' Recent Revenue History ($ millions)
  • AIDIAN OY
  • ALTONA DIAGNOSTICS
  • AMOY DIAGNOSTICS
  • APPLIED SPECTRAL IMAGING
  • BECTON, DICKINSON & CO. (BD)
    • Business Segments
    • Recent Acquisitions
    • Recent Divestitures
    • Leading Position in the Flow Cytometry Market
    • Revenue and Growth
    • Molecular Diagnostics Focus
  • BEIJING GENOMICS INSTITUTE (BGI)
    • Complete Genomics
    • Sanger Sequencing
  • BERRY GENOMICS
  • BIOCARTIS
    • Company Overview
    • Financial Review
      • Table 5-4: Biocartis' Recent Revenue History ($ millions)
      • Table 5-5: Biocartis' Recent Revenue History ($ millions)
  • BIODESIX
  • BIONEER
    • AccuPower COVID-19 Real-Time RT-PCR Kit
  • BIOMEME, INC
  • BIOM
    • Table 5-6 BioMerieux Revenue History
    • Molecular
  • BIO-RAD LABORATORIES, INC
    • Key Comment
    • Recent Revenue History
      • Table 5-7: Bio-Rad Revenue History
  • INX HEALTH
  • CAREDX, INC.
    • Products Offered by CareDx
  • CTK BIOTECH
  • CREDO BIOSCIENCE
  • DANAHER (CEPHEID AND LEICA BIOSYSTEMS)
    • Life Sciences Business
    • Diagnostics Business
    • Cepheid
    • Leica Biosystems
    • Danaher's 2019 Performance and 2020 Expectations
  • DIASORIN
  • EIKEN CHEMICAL
  • EXACT SCIENCES CORP.
  • FLUIDIGM CORPORATION
  • GENMARK DIAGNOSTICS
  • GENOTYPIC TECHNOLOGY PVT. LTD.
  • GREINER BIO-ONE GMBH
  • GRIFOLS, S. A
    • Molecular Immunohematology and Specialty Testing Products
    • NAT Blood Screening
  • HOLOGIC, INC.
    • Table 5-8: Hologic's Recent Revenue History ($ millions)
  • ILLUMINA, INC.
    • Company Overview
      • Table 5-9: Illumina's Recent Revenue History ($ millions)
      • Table 5-10: llumina's Technology Platforms and Targeted Applications
  • IMMUCOR, INC.
    • Transfusion Diagnostics
  • MERIDIAN BIOSCIENCE INC
  • MESA BIOTECH, INC.
  • MOLBIO DIAGNOSTICS PVT. LTD.
  • MYRIAD GENETICS, INC.
    • Company Overview
    • Financial Review
      • Table 5-11: Myriad Genetics' Recent Revenue History ($ millions)
  • NANOSTRING TECHNOLOGIES, INC.
  • NEUROMODX
  • PERKINELMER INC.
  • OXFORD NANOPORE TECHNOLOGIES LTD
  • PROMEGA COPRORATION
  • PRESCIENT MEDICINE HOLDINGS (AUTOGENOMICS)
  • QIAGEN
    • Company Overview
    • Thermo Fisher Purchase
      • Table 5-12: Complementary diagnostic products offered by Thermo Fisher, Qiagen
      • Table 5-13: QIAGEN's Recent Revenue History ($ millions)
  • QUANTUMDX GROUP
  • UIDEL CORPORATION
  • ROCHE DIAGNOSTICS
    • Company Overview
    • COVID-19
    • Financial Review
      • Table 5-14: Roche Diagnostics' Recent Revenue History ($ millions)
    • Cobas Liat System - POC
    • Approval for cobas EZH2 Mutation Test
    • June 2020 - partnership with SpeeDX
    • Stratos Genomics
    • HPV
    • PLUS Cytoogy
    • ASPiRATION study
    • Cobas Zika test for blood screening
    • FDA approval of Babesia test
    • FDA 510(k) clearance for cobas TV/MG test
    • Release of NAVIFY Guidelines app
    • EBV and BKV Tests on the cobas 6800/8800 Systems
    • Expanded use of VENTANA PD-L1 (SP142) Assay in triple-negative breast cancer (TNBC)
  • RHEONIX, INC.
    • Products
  • SHERLOCK BIOSCIENCES
  • EEGENE
  • SEKISUI DIAGNOSTICS LLC
  • T2 BIOSYSTEMS
  • THERMO FISHER SCIENTIFIC INC.
    • Company Overview
      • Table 5-15: Thermo Fisher's Recent Revenue History ($ millions)
    • Transplant Diagnostics
    • qPCR
    • Sequencing
    • Qiagen
  • VELA DIAGNOSTICS
  • VERACYTE, INC.
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