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세계의 분자진단 검사 시장 : 제11판

The World Market for Molecular Diagnostics Tests, 11th Edition

발행일: | 리서치사: Kalorama Information | 페이지 정보: 영문 296 Pages | 배송안내 : 1-2일 (영업일 기준)

※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

분자진단 검사 시장 규모는 210억 달러를 초과하고 있습니다. 비교를 위해 이것은 20년전 IVD 시장의 규모와 거의 같습니다. 시장의 대부분은 COVID-19이나, 암, 이식형, 감염증 등 기타 분자 IVD 용도로도 시장이 확대되고 있습니다.

세계의 분자진단 검사 시장에 대해 조사했으며, 시장의 개요와 지역별 동향 및 시장에 참여하는 기업의 개요 등을 정리하여 전해드립니다.

목차

제1장 주요 요약

제2장 2022년 COVID-19 분자진단 시장 분석

  • 주요 IVD 참여 기업은 COVID-19 판매에서 감소를 보이고 있다.
  • 북미
  • 유럽
  • 아시아태평양
  • 라틴아메리카
  • 기타 지역
  • COVID 검사 시장의 산정 방법
  • 테스트 벤더

제3장 분자진단 시장

제4장 주목할 만한 동향 - 시퀀싱, CRISPR, 자동화

제5장 기업 개요

  • Abbott Diagnostics
  • Alinity s System
  • Agena Bioscience
  • Agendia BV
  • Agilent Technologies(incl. Dako)
  • Aidian Oy
  • Altona Diagnostics
  • Amoy Diagnostics
  • Applied Spectral Imaging
  • ARUP Laboratories
  • Asuragen Inc.(Bio-Techne)
  • Becton, Dickinson & Co.(BD)
  • BD Medical
  • BD Life Sciences
  • BD Interventional
  • TVA Medical, Inc.
  • 1.R. Bard, Inc.
  • CareFusion Corporation
  • Advanced Bio-processing
  • Respiratory Solutions and Vyaire Medical
  • Beijing Genomics Institute(BGI)
  • Berry Genomics
  • binx health
  • Bio-Rad Laboratories, Inc.
  • Biocartis
  • Biodesix
  • Biomeme, Inc
  • bioMerieux
  • Bioneer
  • CareDx, Inc.
  • Credo Bioscience
  • CTK Biotech
  • Danaher(Cepheid and Leica Biosystems)
  • Cepheid
  • Leica Biosystems
  • DiaSorin
  • Eiken Chemical
  • Exact Sciences Corp.
  • GenMark Diagnostics(Roche)
  • Genotypic Technology Pvt. Ltd.
  • Greiner Bio-One GmbH
  • Grifols, S. A
  • NAT Blood Screening
  • Hologic, Inc.
  • Illumina, Inc.
  • Immucor, Inc.
  • Meridian Bioscience Inc
  • Molbio Diagnostics Pvt. Ltd.
  • Myriad Genetics, Inc.
  • NanoString Technologies, Inc.
  • NeuroMoDX
  • Oxford Nanopore Technologies Ltd
  • PerkinElmer Inc.
  • Promega Corporation
  • Qiagen
  • Thermo Fisher Purchase
  • QuantuMDx Group
  • QuidelOrtho
  • Rheonix, Inc.
  • Roche Diagnostics
  • Cobas Liat System - POC
  • Stratos Genomics
  • PLUS Cytoogy
  • ASPiRATION study
  • Seegene
  • Sekisui Diagnostics LLC
  • Sherlock Biosciences
  • SOLVD Health(AutoGenomics)
  • Standard BioTools
  • T2 Biosystems
  • Thermo Fisher Scientific Inc.
  • Vela Diagnostics
  • Veracyte, Inc.
KSA 22.11.17

There is a market in excess of $21 billion for molecular testing technologies. For comparison purposes, this is nearly the size of the IVD market two decades ago. The majority of the market is COVID-19, but there remains a sizable market for other molecular IVD applications, from cancer to transplant typing to infectious diseases. This Kalorama Information report assess the business opportunity in each of these areas. Molecular diagnostics proved themselves during the COVID-19 pandemic, but the market in 2022 is a different place. Kalorama Information's 11th Edition report of the clinical molecular testing industry provides marketing sizing and forecasts for IVDs over a five-year period.

Overall Market

  • Infectious Disease Molecular Diagnostics (COVID-19, Hepatitis, HIV, Respiratory, STI, HAIs, Others)
  • Cancer Molecular Diagnostic Markets (Blood-based and Tissue-based)
  • Genetic Molecular Diagnostic Markets (SNPs, Inherited, NIPT, Other)
  • Blood Banking Molecular Diagnostics Markets
  • Transplantation Molecular Diagnostic Markets
  • Regional Molecular Diagnostics Markets (North America, Europe, Asia, Global)

This report is published as the industry experienced accelerated installed bases and new product introductions. Molecular diagnostics has always been a fast-evolving and dynamic field. Taken together, it is the fastest growing segment within the in vitro diagnostics (IVD) market. It has become an indispensable tool in clinical medicine that touches all aspects of healthcare including treatment decisions in terms of identifying antimicrobial resistant (AMR) infections at the earliest, companion diagnostics assisting in the evaluation of suitability of various cancer treatment options, pharmacokinetics or patient metabolism of drugs for HIV, psychiatric conditions or blood thinners; cancer prognosis and therapy, organ matching, blood safety, and the diagnosis of latent and neonatal conditions.

This market is heavily competitive. Companies considered include:

  • Roche
  • Abbott
  • Thermo Fisher
  • Meridian Bioscience
  • Myriad
  • Perkin Elmer
  • Cepheid
  • BioMérieux
  • Promega
  • QuantuMDX
  • QuidelOrtho
  • Hologic
  • Qiagen
  • ARUP
  • Asuragen
  • CareDX
  • Vela Diagnostics
  • Becton, Dickinson &Co.
  • BGI
  • Bio-Rad
  • Leica Biosystems
  • Greiner Bio-One
  • Biocartis
  • Credo
  • Eiken
  • CTK
  • Leica Biosystems
  • Grifols
  • Illumina
  • T2

These are among the competitors in this field; there are others and there are expected to be more given the growth rates in this area of testing. Indeed, detection of active and latent patient infections by targeting genetic sequences specific to pathogens is the approach used in molecular infectious disease tests. Clinical molecular tests available for infectious disease testing offer a combination of high sensitivity, specificity and low turnaround time advantages.

This has powered this segment for high market growth over other major diagnostic platforms commonly used for infectious disease testing such as immunoassay and ID/AST. Molecular detection platforms are increasingly being recognized for the improved sensitivity and specificity they can offer, even though they are more expensive. The report offers global analysis of the molecular infectious disease diagnostics segment, as well as analysis of subsegments that include CT/NG, HPV, hepatitis, HIV, HAIs, respiratory diseases, and tuberculosis.

It is notable that the first category where molecular diagnostics earned their place was infectious disease. In this category, specific results were needed for treatment decisions. The pioneers in the molecular diagnostics field include Roche Diagnostics, Gen-Probe, and Becton Dickinson. The main focus of the initial molecular diagnostics products was infectious disease including HIV, Chlamydia Trachomatis/Neisseria Gonorrhoea (CT/NG), and TB. These diseases are still critical components of the market. Recently growth in molecular diagnostics methods has also been coming from inherited diseases, cancer, coagulation, and other areas.

  • Global Molecular Infectious Disease Diagnostics Markets (2022-2027), By Infection (Hepatitis, HIV, HAIs/Sepsis, HPV, CT/NG, Respiratory diseases, Mycobacteria/TB, Other, Total) ($, Million)
  • Global Molecular Infectious Disease Diagnostics Markets, by Region (2022-2027)
  • Global Molecular HPV Testing Markets, By Region (2022-2027)
  • Global Molecular CT/NG Testing Markets, By Region (2022-2027)
  • Global Molecular Hepatitis Testing Markets, By Region (2022-2027)
  • Global Molecular HIV Testing Markets,
  • Global Molecular HAIs/Sepsis Testing Markets,
  • Global Molecular Respiratory Diseases Testing Markets
  • Global Molecular Mycobacteria/TB Testing Markets

As a result of concerted efforts to make blood product transfusions safer, there is an increase in antigen testing by nucleic acid test (NAT) screening to test for common pathogens. Developing countries are replacing immunoassays by molecular tests, especially for HIV, hepatitis, etc. World Molecular Diagnostics Market covers the markets for molecular blood screening diagnostics, outlining the blood testing market by geography:

  • Global Molecular Blood Screening Diagnostics Markets, By Region (2022-2027) ($, Million)

Molecular histology, which predominantly consists of ISH tests, captures several different areas of testing including molecular cytogenetics or study of chromosomes, related techniques for the detection of pre- and post-natal genetic disorders, cancer testing, and the detection of pathogens or pathogenic activity from tissues and blood cultures. Various sub-segments within the ISH segment of molecular histology market include FISH, CISH, Rapid ISH (RISH), etc. CISH for RNA markers is increasingly used in drug development and companion diagnostics. The report analyzes key molecular histology segments:

  • Global Molecular Histology and Cytology Diagnostics Markets by Application (2022-2027) (Cancer, Inherited diseases, Infectious/Other, Total) ($, Million)
  • Global Molecular Histology and Cytology Diagnostics Markets, by Region (2022-2027) ($, Million)
  • Global Molecular Histology Diagnostics Markets, by Region (2022-2027) l) ($, Million)

This report reviews the current makeup of the molecular diagnostics market in cancer, including its notable products and geographical segmentation. The report also reviews expected developments, such as technology and product introduction. The current market is largely composed of tissue-based tests, companion assays, and tests for the prognosis and diagnosis of specific cancer types. Some of the most significant developments in this field may have an impact in shaping cancer diagnostics and treatment management. The report examines the markets for molecular cancer diagnostics, outlining the global market by geography:

  • Global Molecular Cancer Diagnostics Markets, By Region (2022-2027) (North America, Europe, APAC, RoW, Total) ($, Million)

The molecular transplant diagnostics space is a competitive market with many companies offering PCR-based and bead-array-based test kits based on the HLA genes that have been characterized. The demand for NGS has been growing in the segment. An HLA test requires that some six genes are screened in parallel, with each displaying about 100 important (known) local variants. This requirement lends itself to technologies such as microarrays and sequencing that can screen for many targets. The report outlines the markets for molecular transplant diagnostics by geography:

  • Global Molecular Transplant Diagnostics Markets, By Region (2022-2027) ($, Million)

The detection of single nucleotide polymorphisms (SNPs) or gene variants from tissue, blood, urine and saliva samples can be used to diagnose inherited diseases and genetic disorders as well as determine the risk of disease manifestation or progression. One of the major challenges facing molecular tests for gene based inherited diseases is getting stakeholders including payers, physicians, researchers and regulators to work together to close the gap between research and clinical applicability. World Molecular Diagnostics Market analyzes the developments in most significant markets within molecular inherited disease diagnostics and provides the following market data:

  • Global Molecular Genetic Diagnostics Markets, By Disease Segments (2022-2027) (Inherited, Thrombophilia [SNP tests] & Coagulation Markers, NIPT, Others, Total) ($, Million)

Table of Contents

Chapter One: Executive Summary

  • Size of Molecular Diagnostics Market
    • Figure 1-1: Molecular Diagnostics Market (w COVID-19 and w/out COVID-19, $B)
  • Growth Areas in Molecular Diagnostics
    • Figure 1-2: Non-COVID-19 Growth Applications by Revenue Growth %
    • Figure 1-3: COVID-19 Molecular Testing Market, 2020- Q2 2022 ($M)
  • Recent Developments
  • Emerging Trends
  • Monkeypox
  • Automation
  • Molecular Point of Care
    • Table 1-1: Market-Available Molecular POC Diagnostic Platforms
  • Next-Generation Sequencing
  • CRISPR
  • Other 2022 Developments in Molecular Diagnostics

Chapter Two: 2022 COVID-19 Molecular Diagnostic Market Analysis

  • Major IVD Players See Decline in COVID-19 Sales
    • Table 2-1: Selected COVID-19 Molecular Tests from Major Suppliers
    • Figure 2-1: Estimated COVID-19 Molecular Diagnostics Global Monthly Volume (# tests)
    • Figure 2-2: Estimated Monthly COVID-19 Molecular Diagnostic Test Volume, 2020- Q2 '22 by Region ($M)
    • Table 2-2: COVID-19 Molecular Diagnostic Revenues by Region Estimated: North America, Europe, APAC, ROW, LATAM (#M)
    • Figure 2-3: COVID-19 Molecular Diagnostic Estimated Quarterly Rev. 2020- Q2'22 by Region
    • Figure 2-4: Estimated Molecular Diagnostic COVID-19 Revenue Shares, 2020-Q2'22 by Region
  • North America
    • Figure 2-5: USA - New Cases per Day
    • Figure 2-6: USA - Testing Volume per Day
    • Figure 2-7: Canada - New Cases per Day
    • Figure 2-8: Canada - Testing Volume per Day
  • Europe
    • Figure 2-9: Italy - New Cases per Day
    • Figure 2-10: Italy - Daily Testing Volume
    • Figure 2-11: Russia - New Cases per Day
    • Figure 2-12: Russia - Testing Volume per Day
  • APAC
    • Figure 2-13: India - New Cases per Day
    • Figure 2-14: India - Daily Testing Volume
    • Figure 2-15: Australia - New Cases per Day
    • Figure 2-16: Australia - Daily Testing Volume
  • Latin America
    • Figure 2-17: Colombia - New Cases per day
    • Figure 2-18: Colombia - Daily Testing Volume
    • Figure 2-19: Chile - New Cases per Day
    • Figure 2-20: Chile - Daily Testing Volume
  • Rest-of-World
    • Figure 2-21: Turkey - New Cases per Day
    • Figure 2-22: Turkey - Daily Testing Volume
    • Figure 2-23: South Africa - New Cases per Day
    • Figure 2-24: South Africa - Daily Testing Volume
  • COVID Testing Market Computation Methodology
  • Test Vendors
    • Table 2-3: Other PCR Tests Products on the Market

Chapter Three: Molecular Diagnostics Market

  • Brisk Recent Activity
  • Recent Product Introductions and Regulatory Approvals
    • Table 3-1: Recent Product Introductions
    • Table 3-2: Regulatory Approvals and Announcements
  • Market Size and Forecast by Segments
    • Table 3-3: Molecular Diagnostic Market, 2022 and 2027 by Segment, $M (HAI/Sepsis, Hepatitis, HIV, STIs, Respiratory, TB, Cancer Assays, Histology (ISH, FISH) Molecular HPV, NAT Blood Screening, NIPT, Thrombophilia/SNPs, Pharmacogenomics, Inherited/ genetic, Transplantation, COVID-19)
    • Table 3-4: Molecular Diagnostics Market w/ and w/o COVID
    • Table 3-5: Molecular Diagnostic (non-COVID) Market, 2022 by Region ($M)
    • Figure 3-1: Molecular Diagnostics (non-COVID) Market by Region 2022 ($M)
  • Infectious Diseases
    • Table 3-6: Selected Molecular Hepatitis Tests
  • HIV Market and COVID-19 Impact
    • Table 3-7: Selected Molecular Test Products for HIV
  • NAT Blood Screening
  • COVID-19 Impact
  • Other Trends
  • Declining Blood Transfusions in Developed Markets
  • Molecular Histology and Cytology Diagnostics
  • HPV
  • Product Developments
  • Markets for Molecular Cancer Diagnostics
  • Liquid Biopsy
  • Molecular Transplant Diagnostics
    • Table 3-8: Selected Innovations in the Field of Molecular Transplant Diagnostics
  • Molecular Inherited Diseases Diagnostics
  • Thrombophilia and Coagulation Markers
  • Non-Invasive Prenatal Testing (NIPT)
  • Promising NIPT Studies
  • Inherited Disease Tests
  • Molecular Diagnostics Market Deals, Collaborations, Acquisitions
    • Table 3-9: Molecular Diagnostics Market Deals, Collaborations, Acquisitions

Chapter Four: Trends to Watch - Sequencing, CRISPR, Automation

  • Sequencing
  • 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 by Test Technique 2022
  • 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
  • CRISPR and Molecular Diagnostics
  • CRISPR and COVID-19
    • Table 4-3: CRISPR Innovations

Chapter Five: Company Profiles

  • Abbott Diagnostics
  • Company Overview
  • Financial Review
    • Table 5-1: Abbott Diagnostics' Recent Revenue History ($M), 2015-2021
    • Figure 5-1: Abbott Diagnostics' Molecular Diagnostic Revenue History ($M), 2016- Q2 2022
    • Figure 5-2: Abbott Rapid Diagnostics Revenue
  • FDA approval of Alinity m STI assay
  • FDA approval of ALK Break Apart FISH Probe Kit
  • Alinity s System
  • WHO prequalification (PQ) approval of viral load test
  • Advanced Cell Diagnostics (Bio-Techne)
  • Agena Bioscience
  • Agendia BV
  • Agilent Technologies (incl. Dako)
  • Company Overview
  • Financial Review
    • Table 5-3: Agilent Technologies' Recent Revenue History ($ millions)
    • Figure 5-3: Agilent Diagnostics and Genomics Revenues, 2016- Q3 2022 ($M)
  • Aidian Oy
  • Altona Diagnostics
  • Amoy Diagnostics
  • Applied Spectral Imaging
  • ARUP Laboratories
  • Asuragen Inc. (Bio-Techne)
  • Becton, Dickinson & Co. (BD)
  • Business Segments
  • BD Medical
  • BD Life Sciences
  • BD Interventional
  • Recent Acquisitions
  • TVA Medical, Inc.
  • 1.R. Bard, Inc.
  • CareFusion Corporation
  • Recent Divestitures
  • Advanced Bio-processing
  • Respiratory Solutions and Vyaire Medical
  • Leading Position in the Flow Cytometry Market
  • Revenue and Growth
    • Figure 5-4: BD Life Sciences Unit Quarterly Revenues, 2020- Q2'22 ($M)
  • Molecular Diagnostics Focus
  • Beijing Genomics Institute (BGI)
  • Sequencing Technologies
  • Berry Genomics
  • binx health
  • Bio-Rad Laboratories, Inc.
  • Key Comment
  • Recent Revenue History
  • Table 5-4: Bio-Rad Revenue History ($M)
  • Biocartis
  • Company Overview
  • Financial Review
    • Table 5-5: Biocartis' Recent Revenue History ($ millions)
  • Products and Technologies
  • Biodesix
  • Biomeme, Inc
  • bioMérieux
    • Figure 5-6: bioMérieux's Molecular Biology and Microbiology Segments, 2016-2022
  • Molecular
  • Bioneer
  • AccuPower COVID-19 Real-Time RT-PCR Kit
  • CareDx, Inc.
    • Figure 5-6: CareDx Revenue, 2017-2022
  • AlloMap Tests
  • AlloSure Tests
  • Products Offered by CareDx
  • Credo Bioscience
  • CTK Biotech
  • Danaher (Cepheid and Leica Biosystems)
  • Life Sciences Business
  • Diagnostics Business
  • Cepheid
  • Leica Biosystems
  • Danaher's 2019 Performance and 2020 Expectations
    • Figure 5-7: Danaher Major Segment Revenues by Quarter, Q1 2018 - Q2 2022 ($M)
  • DiaSorin
  • Eiken Chemical
  • Exact Sciences Corp.
  • GenMark Diagnostics (Roche)
    • Figure 5-8: Gen Mark Revenues, Pre Acquisition
  • Genotypic Technology Pvt. Ltd.
  • Greiner Bio-One GmbH
  • Grifols, S. A
  • Molecular Immunohematology and Specialty Testing Products
  • NAT Blood Screening
  • Hologic, Inc.
    • Figure 5-9: Hologic Diagnostics Revenues, Calendar Q4 2017 - Q2 2022 ($M)
    • Table 5-6: Hologic's Recent Revenue History ($ millions)
  • Illumina, Inc.
  • Company Overview
    • Table 5-7: Illumina's Recent Revenue History ($ millions)
    • Figure 5-9: Illumina's Recent Revenue History ($ millions)
  • Immucor, Inc.
  • Transfusion Diagnostics
  • Meridian Bioscience Inc
    • Figure 5-10: Meridian Bioscience Quarterly Revenues, Calendar Q1 2015 - Q2 2022 ($M)
  • Molbio Diagnostics Pvt. Ltd.
  • Myriad Genetics, Inc.
  • Company Overview
  • Financial Review
    • Table 5-8: Myriad Genetics' Recent Revenue History ($ millions)
  • NanoString Technologies, Inc.
  • NeuroMoDX
  • Oxford Nanopore Technologies Ltd
  • PerkinElmer Inc.
  • Promega Corporation
  • Qiagen
  • Company Overview
  • Thermo Fisher Purchase
    • Table 5-9: QIAGEN's Recent Revenue History ($ millions)
  • QuantuMDx Group
  • QuidelOrtho
  • Rheonix, Inc.
  • Products
  • Roche Diagnostics
  • Company Overview
  • Financial Review
    • Figure 5-11: Roche Quarterly Molecular Diagnostics Revenues, Q1 2016 - Q2 2022 ($M)
    • Table 5-10: Roche Diagnostics' Recent Revenue History ($M)
  • Recent Regulatory and Product Developments
  • Cobas Liat System - POC
  • Acquisition of GenMark Diagnostics
  • Sysmex Agreement
  • Non-Exclusive 15-Year Collaboration With Illumina
  • 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
  • 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)
  • FDA 510(k) clearance for cobas TV/MG test
  • Seegene
  • Sekisui Diagnostics LLC
  • Sherlock Biosciences
  • SOLVD Health (AutoGenomics)
  • Standard BioTools
  • T2 Biosystems
  • Thermo Fisher Scientific Inc.
  • Company Overview
    • Table 5-11: Thermo Fisher's Recent Revenue History ($ millions)
  • Transplant Diagnostics
  • qPCR
  • Sequencing
  • Qiagen Acquisition Scrapped
  • Vela Diagnostics
  • Veracyte, Inc.
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