全球分子诊断市场：第 12 版

近年来，分子诊断在全球体外诊断药物（IVD）市场中经历了快速成长。COVID-19 以意想不到的方式刺激了市场。疫情后的市场仍然充满机遇，特别是在传染病、癌症和移植诊断领域。全球需求持续成长，其中北美和欧洲处于领先地位。

分子诊断已发展成为临床医学的重要工具，影响着医疗保健的许多方面。快速识别抗菌药物抗药性 (AMR) 感染在确定治疗策略方面发挥着至关重要的作用。它还有助于伴随诊断，并帮助评估各种癌症治疗方案的适当性。分子诊断对于了解 HIV、精神疾病和抗凝血剂等药物的药物动力学和患者代谢至关重要。其影响延伸到癌症预后和治疗、器官相容性、血液安全以及潜在疾病和新生儿疾病的诊断。

因此，与传染病检测中常用的免疫分析和 ID/AST 等其他主要诊断平台相比，分子传染病诊断领域经历了显着的市场成长。儘管相对成本较高，但分子检测平台因其敏感性和特异性而获得认可。

提高血液製品输注安全性的大力努力导致透过核酸检测（NAT）筛检常见病原体的抗原检测显着增加。在此背景下，发展中国家越来越多地从免疫检测方法转向分子检测方法，特别是针对爱滋病毒和肝炎等疾病。

该报告审视了全球分子诊断市场，并提供了市场概述、按细分市场划分的市场发展趋势、技术趋势以及进入市场的公司概况。

目录

第一章执行摘要

第二章分子诊断市场

• 最近的活跃活动
• 最近的产品推出和监管批准
• 市场规模及细分市场预测
• 感染
• HIV 市场与 COVID-19 的影响
• NAT血液筛检
• COVID-19 的影响
• 其他趋势
• 已开发市场输血量下降
• 分子组织学与细胞学诊断
• HPV病毒
• 产品开发
• 分子癌症诊断市场
• 液体活检
• 分子移植诊断
• 分子遗传疾病的诊断
• 血小板增多症和凝血标记物
• 非侵入性产前检测（NIPT）
• 有前景的 NIPT 研究
• 遗传疾病检测
• 分子诊断市场交易、合作与收购

第 3 章值得关注的趋势 - 定序、CRISPR、自动化

• 顺序
• NGS 和伴随诊断
• NGS在分子诊断领域的前景
• 临床定序中不断发展的资讯解决方案
• 样品製备和品质控制
• 实验室自动化与分子诊断
• CRISPR 和分子诊断
• CRISPR 及其应用

第四章 公司简介

• Abbott Diagnostics
• Advanced Cell Diagnostics (Bio-Techne)
• Agena Bioscience
• Agendia BV
• Agilent Technologies
• Aidian Oy
• Altona Diagnostics
• Amoy Diagnostics
• Applied Spectral Imaging
• ARUP Laboratories
• Asuragen Inc. (Bio-Techne)
• Becton, Dickinson & Co. (BD)
• TVA Medical, Inc.
• R. Bard, Inc.
• CareFusion Corporation
• Beijing Genomics Institute (BGI)
• MGI Tech Co., Ltd.
• Berry Genomics
• binx health
• Bio-Rad Laboratories, Inc.
• Biocartis
• bioMérieux
• Bioneer
• CareDx, Inc.
• Danaher
• DiaSorin
• Eiken Chemical
• Exact Sciences Corp.
• GenMark Diagnostics (Roche)
• Genotypic Technology Pvt. Ltd
• Greiner Bio-One GmbH
• Grifols, S. A
• Hologic, Inc.
• Illumina, Inc
• Meridian Bioscience Inc
• Myriad Genetics, Inc.
• NanoString Technologies, Inc.
• NeuroMoDX
• Oxford Nanopore Technologies Ltd
• Promega Corporation
• Qiagen
• QuidelOrtho
• Revvity
• Rheonix, Inc
• Roche Diagnostics
• cobas Liat System
• Seegene
• Sekisui Diagnostics LLC
• Sherlock Biosciences
• Standard BioTools
• T2 Biosystems
• Thermo Fisher Scientific Inc.
• Vela Diagnostics

Recent years saw molecular diagnostics emerge as the fastest growing segment within the global in vitro diagnostics (IVD) market. The market was both boosted and challenged in unexpected ways by COVID-19. But where does the multi-billion-dollar molecular diagnostic market stand post pandemic? This new report by Kalorama Information, “The World Market for Molecular Diagnostics, 12^th Edition ”, reveals that post-pandemic the market remains ripe with opportunity, notably in the areas of infectious diseases, cancer, and transplant diagnostics. Global demand persists, with North America and Europe leading other regions worldwide.

Molecular diagnostics has evolved into an essential instrument in clinical medicine, influencing various facets of healthcare. It plays a pivotal role in treatment decisions by swiftly identifying antimicrobial-resistant (AMR) infections. Additionally, it contributes to companion diagnostics, aiding in the assessment of the appropriateness of diverse cancer treatment options. Molecular diagnostics is integral to understanding pharmacokinetics or patient metabolism of drugs for conditions like HIV, psychiatric disorders, or blood thinners. Its impact extends to cancer prognosis and therapy, organ matching, blood safety, and the diagnosis of latent and neonatal conditions.

“The World Market for Molecular Diagnostics, 12^th Edition ” delves into global and regional markets, exploring the widespread applications of molecular diagnostics across healthcare. This includes:

• Global Markets for Molecular Diagnostics by Application Segments (2023-2028) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($ Million)
• North American Markets for Molecular Diagnostics (2023-2028) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($ Million)
• European Markets for Molecular Diagnostics (2023-2028) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($ Million)
• Asia Pacific Markets for Molecular Diagnostics (2023-2028) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($ Million)

The market is highly competitive, with several companies vying for prominence. Among those considered are:

The competitive landscape in this field includes the aforementioned companies, and it's worth noting that there are additional competitors, with the expectation of more entering the market due to the rapid growth in this testing sector. The molecular infectious disease tests utilize an approach that involves detecting active and latent patient infections by targeting specific genetic sequences of pathogens. Clinical molecular tests designed for infectious disease testing provide a compelling combination of high sensitivity, specificity, and rapid turnaround time.

This has propelled the molecular infectious disease diagnostics segment to achieve substantial market growth compared to other major diagnostic platforms like immunoassay and ID/AST commonly employed in infectious disease testing. Despite being relatively more expensive, molecular detection platforms are gaining recognition for their enhanced sensitivity and specificity. The report offers a global analysis of the molecular infectious disease diagnostics segment, with detailed subsegment analyses covering areas such as CT/NG, HPV, hepatitis, HIV, HAIs (Healthcare-Associated Infections), respiratory diseases, and tuberculosis.

It's noteworthy that infectious diseases were the first category where molecular diagnostics made a significant impact, providing specific results crucial for treatment decisions. Pioneering companies in the molecular diagnostics field, such as Roche Diagnostics, Gen-Probe, and Becton Dickinson, initially focused on infectious diseases like HIV, Chlamydia Trachomatis/Neisseria Gonorrhoeae (CT/NG), and Tuberculosis (TB). These diseases remain pivotal in the market, although recent growth in molecular diagnostics methods has also been driven by applications in inherited diseases, cancer, coagulation, and other medical areas.

• Global Molecular Infectious Disease Diagnostics Markets (2023-2028), By Infection (Hepatitis, HIV, HAIs/Sepsis, HPV, CT/NG, Respiratory diseases, Mycobacteria/TB, Other, Total) ($ Million)
• Global Molecular Infectious Disease Diagnostics Markets, by Region (2023-2028)
• Global Molecular HIV Testing Markets,
• Global Molecular HAIs/Sepsis Testing Markets,
• Global Molecular Respiratory Diseases Testing Markets
• Global Molecular Mycobacteria/TB Testing Markets

Due to dedicated initiatives aimed at enhancing the safety of blood product transfusions, there has been a notable rise in antigen testing through nucleic acid test (NAT) screening for common pathogens. In this context, developing countries are increasingly transitioning from immunoassays to molecular tests, particularly for diseases such as HIV and hepatitis. The report comprehensively explores the markets for molecular blood screening diagnostics, providing an overview of the blood testing market based on geographical considerations.

Molecular histology, primarily centered around in situ hybridization (ISH) tests, encompasses diverse testing domains. This includes molecular cytogenetics for the study of chromosomes, associated techniques for detecting pre- and post-natal genetic disorders, cancer testing, and identifying pathogens or pathogenic activities in tissues and blood cultures. The ISH segment of the molecular histology market is further divided into various sub-segments such as Fluorescence In Situ Hybridization (FISH), Chromogenic In Situ Hybridization (CISH), Rapid In Situ Hybridization (RISH), among others. Notably, CISH for RNA markers is gaining increased utilization in drug development and companion diagnostics. The report provides a comprehensive analysis of key segments within the molecular histology landscape.

This report evaluates the present configuration of the molecular diagnostics market in cancer, providing insights into prominent products and geographical segmentation. Additionally, the report assesses anticipated advancements, including technological innovations and product introductions. The existing market is predominantly comprised of tissue-based tests, companion assays, and diagnostic tests for the prognosis of specific cancer types. Noteworthy developments in this domain have the potential to significantly influence the landscape of cancer diagnostics and treatment management. The report delves into the markets for molecular cancer diagnostics, offering a comprehensive overview of the global market categorized by geography.

The molecular transplant diagnostics sector is marked by intense competition, with numerous companies providing test kits based on Polymerase Chain Reaction (PCR) and bead-array technologies, focusing on the characterization of Human Leukocyte Antigen (HLA) genes. The market has witnessed an increasing demand for Next-Generation Sequencing (NGS) in this segment. HLA tests necessitate the screening of approximately six genes in parallel, each presenting around 100 significant local variants. This complexity makes technologies like microarrays and sequencing well-suited for simultaneously screening multiple targets. The report provides an overview of the markets for molecular transplant diagnostics, offering insights into geographical segmentation.

The identification of single nucleotide polymorphisms (SNPs) or gene variants in tissue, blood, urine, and saliva samples serves as a diagnostic tool for inherited diseases and genetic disorders. It also aids in assessing the risk of disease development or progression. A key obstacle in implementing molecular tests for gene-based inherited diseases is the necessity for collaboration among stakeholders, including payers, physicians, researchers, and regulators, to bridge the divide between research findings and clinical applicability.

The report scrutinizes advancements in the most significant markets within molecular inherited disease diagnostics, offering comprehensive market data on key developments and trends in this domain.

Table of Contents

Chapter 1: Executive Summary

• Size of Molecular Diagnostics Market
  • Table 1-1: Molecular Diagnostics Market, w COVID-19 and w/out COVID-19, 2023 ($B)
  • Figure 1-1: Molecular Diagnostics Market, w COVID-19 and w/out COVID-19 ($B)
• Growth Areas in Molecular Diagnostics
  • Table 1-2: Growth Applications, by Revenue Growth, 2023 (%)
  • Figure 1-2: Growth Applications by Revenue Growth, 2023 (%)
• Recent Developments
• Emerging Trends
• Monkeypox
• Automation
• Molecular Point of Care
  • Table 1-3: Selected Molecular POC Diagnostic Platforms
• Next-Generation Sequencing
• Other 2023 Developments in Molecular Diagnostics

Chapter 2: Molecular Diagnostics Market

• Brisk Recent Activity
• Recent Product Introductions and Regulatory Approvals
  • Table 2-1: Recent Product Introductions
  • Table 2-2: Regulatory Approvals and Announcements
• Market Size and Forecast by Segments
  • Table 2-3: Molecular Diagnostic Market, by Segment (HAI/Sepsis, Respiratory, Hepatitis, HIV, STIs, TB, Cancer Assays, Histology [ISH, FISH] Molecular HPV, NAT Blood Screening, NIPT, Inherited/Genetic, Transplantation, COVID-19), 2023 and 2028, ($M)
  • Table 2-4: Molecular Diagnostic (non-COVID) Market, by Region (APAC, Europe, North America, Rest of World), 2023 ($M)
  • Figure 2-1: Molecular Diagnostics (non-COVID) Market, by Region (APAC, Europe, North America, Rest of World), 2023 ($M)
• Infectious Diseases
  • Table 2-5: Selected Molecular Hepatitis Tests
• HIV Market and COVID-19 Impact
  • Table 2-6: 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 2-7: 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 2-8: Molecular Diagnostics Market Deals, Collaborations, Acquisitions

Chapter 3: Trends to Watch - Sequencing, CRISPR, Automation

• Sequencing
• NGS and Companion Diagnostics
  • Table 3-1: Selected Clinical NGS Platforms in the Market
• Outlook For NGS in Molecular Diagnostics
  • Figure 3-1: Percent of the MDX Market Revenues, by Test Technique, 2023
• Evolving Informatics Solutions in Clinical Sequencing
• Sample Preparation and Quality Control
• Lab Automation and Molecular Diagnostics
  • Table 3-2: Selected Automated Molecular Test Instrument Platforms
• CRISPR and Molecular Diagnostics
• CRISPR and Applications
  • Table 3-3: CRISPR Innovations

Chapter 4: Company Profiles

• Abbott Diagnostics
• Company Overview
• Financial Review
  • Table 4-1: Abbott Diagnostics' Revenue History ($M), 2015-2022
  • Figure 4-1: Abbott Diagnostics' Molecular Diagnostic Revenue History ($M), 2016- Q3 2023
  • Figure 4-2: Abbott Rapid Diagnostics Revenue History, Q4 2017-Q3 2023 ($M)
• FDA approval of Alinity m STI assay and High Risk HPV Assay
• FDA approval of ALK Break Apart FISH Probe Kit
• Alinity s System
• WHO prequalification (PQ) approval of viral load test
• Advanced Cell Diagnostics (Bio-Techne)
• Company Overview
• Agena Bioscience
• Company Overview
• Agendia BV
• Company Overview
• Agilent Technologies (incl. Dako)
• Company Overview
• Financial Review
  • Table 4-2: Agilent Technologies' Recent Revenue History by Segment ($M), 2020-2022
  • Figure 4-3: Agilent Diagnostics and Genomics Segment Revenues, 2016- Q3 2023 ($M)
• Aidian Oy
• Company Overview
• Altona Diagnostics
• Company Overview
• Amoy Diagnostics
• Company Overview
• Applied Spectral Imaging
• Company Overview
• ARUP Laboratories
• Company Overview
• Asuragen Inc. (Bio-Techne)
• Company Overview
• Becton, Dickinson & Co. (BD)
• Company Overview
• Business Segments
• BD Medical
• BD Life Sciences
• BD Interventional
• Recent Acquisitions
• TVA Medical, Inc.
• R. Bard, Inc.
• CareFusion Corporation
• Recent Divestitures
• Advanced Bio-processing
• Respiratory Solutions and Vyaire Medical
• Leading Position in the Flow Cytometry Market
• Revenue and Growth
  • Figure 4-4: BD Life Sciences Unit Quarterly Revenues, Fiscal 2018- Q4'2023 ($M)
• Molecular Diagnostics Focus
• Beijing Genomics Institute (BGI)
• Company Overview
• PCR and Fluorescence
• MGI Tech Co., Ltd.
• Prenatal Testing
• Test Services
• Whole Genome Sequencing (WGS)
• NGS Sequencing
• Collaborations
• Berry Genomics
• Company Overview
• binx health
• Company Overview
• Bio-Rad Laboratories, Inc.
• Company Overview
• Recent Revenue History
  • Table 4-3: Bio-Rad Diagnostics Revenue History, 2015-2022 ($M)
• Liquid Biopsy
• Droplet Digital PCR
• Sequencing
• Biocartis
• Company Overview
• Financial Review
  • Table 4-4: Biocartis' Revenue History, 2015-2022 ($M)
• Products and Technologies
• Biodesix
• Company Overview
• bioMérieux
• Company Overview
  • Figure 4-5: bioMérieux's Revenue History, Molecular Biology and Microbiology Segments, 2016-Q3 2023 (€M)
• BIOFIRE Business
• Molecular Diagnostics
• Bioneer
• Company Overview
• CareDx, Inc.
• Company Overview
  • Figure 4-5: CareDx Revenue, 2017-Q3 2023 ($M)
• Testing Services Offered by CareDx
• AlloMap Tests
• AlloSure Tests
• Products Offered by CareDx
• Danaher
• Company Overview
• Danaher's 2022 Performance
  • Figure 4-7: Danaher Major Segment Revenues by Quarter, Q1 2018 - Q3 2023 ($M)
• Life Sciences Business
• Diagnostics Business
• Cepheid
• GeneXpert/ Xpress Line
• Tuberculosis
• Microbiology
• POC STI Testing
• Cancer
• Leica Biosystems
• DiaSorin
• Company Overview
• Molecular Diagnostics
• Molecular Oncology
• Development Plan
• Expansion
• Eiken Chemical
• Company Overview
• Product News
• Exact Sciences Corp.
• Company Overview
• Recent Revenues and Developments
• GenMark Diagnostics (Roche)
• Company Overview
  • Figure 4-8: GenMark Revenues History, Pre-Acquisition ($M)
• Genotypic Technology Pvt. Ltd.
• Company Overview
• Greiner Bio-One GmbH
• Company Overview
• Grifols, S. A
• Company Overview
• NAT Blood Screening
• Hologic, Inc.
• Company Overview
  • Figure 4-9: Hologic Diagnostics Revenues, Calendar Q4 2019 - Q3 2022 ($M)
  • Table 4-5: Hologic's Diagnostics Revenue History, Fiscal 2017-2023 ($M)
• PANTHER Molecular System
• HIV Testing
• Sexually Transmitted Infections
• Infectious Diseases
• Panther Fusion
• Illumina, Inc.
• Company Overview
  • Table 4-6: Illumina's Revenue History, 2015-2022 ($M)
  • Figure 4-10: Illumina's Revenue History, 2017-Q3 2023 ($M)
• China
• Meridian Bioscience Inc
• Company Overview
  • Figure 4-11: Meridian Bioscience Pre-Merger Revenues, Calendar Q1 2015 - Q2 2022 ($M)
• Myriad Genetics, Inc.
• Company Overview
• Financial Review
  • Table 4-7: Myriad Genetics Revenue History, 2015-2022 ($M)
• NanoString Technologies, Inc.
• Company Overview
• NeuroMoDX
• Company Overview
• Oxford Nanopore Technologies Ltd
• Company Overview
• Promega Corporation
• Company Overview
• Qiagen
• Company Overview
  • Table 4-8: QIAGEN's Revenue History, 2015-2022 ($M)
• Tuberculosis
• Molecular Expansion
• Precision Medicine / Companion Diagnostics
• Molecular Microbiology
• Prenatal Testing
• Next Generation Sequencing
• Sample Prep, Informatics
• Digital PCR
• Liquid Biopsy
• Cervical Cancer
• Expansion and Other Developments
• QuantuMDx Group
• Company Overview
• QuidelOrtho
• Company Overview
• The Solana Business
• Molecular - Savanna
• Revvity
• Company Overview
• Diagnostics
• Sequencing /Genomics
• Liquid Biopsy
• Histology
• Prenatal Business
• Lab Services
• Rheonix, Inc.
• Company Overview
• Roche Diagnostics
• Company Overview
• Financial Review
  • Figure 4-12: Roche Quarterly Molecular Diagnostics Revenues, Q1 2016 - Q3 2023 ($M)
  • Table 4-9: Roche Diagnostics' Revenue History, 2016-2022 ($M)
• Molecular Expansion
• Core Molecular
• Digital PCR
• Hematology
• HPV
• HIV
• Coagulation
• cobas Liat System - POC
• Blood Bank
• Transplant Medicine
• Cancer Companion Testing
• IT in Anatomical Pathology
• Other Recent Developments
• Seegene
• Company Overview
• Sekisui Diagnostics LLC
• Company Overview
• Sherlock Biosciences
• Company Overview
• Standard BioTools
• Company Overview
• T2 Biosystems
• Company Overview
• Thermo Fisher Scientific Inc.
• Company Overview
  • Table 4-10: Thermo Fisher Scientific Estimated Clinical Diag. and NGS Revenues, 2017-2022 ($M)
  • Table 4-11: Thermo Fisher Scientific Estimated Revenues by IVD Test Segment, 2017-2022 ($M)
• Microbiology
• Molecular Test Business
• Next Generation Sequencing
• qPCR
• Oncology Companion Diagnostics
• Transplant Medicine
• Microbiome
• Other Collaborations and Acquisitions
• Gene Editing and Cell Therapy
• China
• Vela Diagnostics
• Company Overview
• Veracyte, Inc.
• Company Overview