全球分子診斷市場：第 12 版

近年來，分子診斷在全球體外診斷藥物（IVD）市場中經歷了快速成長。COVID-19 以意想不到的方式刺激了市場。疫情後的市場仍然充滿機遇，特別是在傳染病、癌症和移植診斷領域。全球需求持續成長，其中北美和歐洲處於領先地位。

分子診斷已發展成為臨床醫學的重要工具，影響著醫療保健的許多方面。快速識別抗菌藥物抗藥性 (AMR) 感染在確定治療策略方面發揮著至關重要的作用。它還有助於伴隨診斷，並幫助評估各種癌症治療方案的適當性。分子診斷對於了解 HIV、精神疾病和抗凝血劑等藥物的藥物動力學和患者代謝至關重要。其影響延伸到癌症預後和治療、器官相容性、血液安全以及潛在疾病和新生兒疾病的診斷。

因此，與傳染病檢測中常用的免疫分析和 ID/AST 等其他主要診斷平台相比，分子傳染病診斷領域經歷了顯著的市場成長。儘管相對成本較高，但分子檢測平台因其敏感性和特異性而獲得認可。

提高血液製品輸注安全性的大力努力導致透過核酸檢測（NAT）篩檢常見病原體的抗原檢測顯著增加。在此背景下，發展中國家越來越多地從免疫檢測方法轉向分子檢測方法，特別是針對愛滋病毒和肝炎等疾病。

該報告審視了全球分子診斷市場，並提供了市場概述、按細分市場劃分的市場發展趨勢、技術趨勢以及進入市場的公司概況。

目錄

第一章執行摘要

第二章分子診斷市場

• 最近的活躍活動
• 最近的產品推出和監管批准
• 市場規模及細分市場預測
• 感染
• HIV 市場與 COVID-19 的影響
• NAT血液篩檢
• COVID-19 的影響
• 其他趨勢
• 已開發市場輸血量下降
• 分子組織學與細胞學診斷
• HPV病毒
• 產品開發
• 分子癌症診斷市場
• 液體活檢
• 分子移植診斷
• 分子遺傳疾病的診斷
• 血小板增多症和凝血標記物
• 非侵入性產前檢測（NIPT）
• 有前景的 NIPT 研究
• 遺傳疾病檢測
• 分子診斷市場交易、合作與收購

第 3 章值得關注的趨勢 - 定序、CRISPR、自動化

• 順序
• NGS 和伴隨診斷
• NGS在分子診斷領域的前景
• 臨床定序中不斷發展的資訊解決方案
• 樣品製備和品質控制
• 實驗室自動化與分子診斷
• CRISPR 和分子診斷
• CRISPR 及其應用

第四章 公司簡介

• 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