分子診断薬の世界市場：第12版

近年、世界の体外診断用医薬品（IVD）市場において、分子診断薬が急成長を遂げています。同市場はCOVID-19によって予想外の形で活性化されてきました。パンデミック後の市場は、特に感染症、がん、移植診断の分野で、依然として機会にあふれています。世界の需要は持続しており、北米と欧州が他の地域をリードしています。

分子診断学は臨床医学において不可欠な機器へと発展し、ヘルスケアの様々な側面に影響を与えています。抗菌薬耐性（AMR）感染症を迅速に特定することで、治療方針の決定に極めて重要な役割を果たしています。さらに、コンパニオン診断にも貢献し、多様ながん治療の選択肢の適切性の評価にも役立っています。分子診断学は、HIV、精神疾患、血液凝固阻止剤などの薬物動態や患者の代謝を理解するために不可欠です。その影響は、がんの予後や治療、臓器適合、血液の安全性、潜在的疾患や新生児疾患の診断にまで及んでいます。

このため、分子感染症診断分野は、感染症検査で一般的に採用されている免疫測定法やID/ASTといった他の主要な診断プラットフォームに比べ、大幅な市場成長を遂げています。分子検出プラットフォームは、比較的高価であるにもかかわらず、その感度と特異性の高さが評価されつつあります。

血液製剤輸血の安全性向上を目指した熱心な取り組みにより、一般的な病原体に対する核酸検査（NAT）スクリーニングによる抗原検査が顕著に増加しています。このような背景から、発展途上諸国では、特にHIVや肝炎などの疾患について、免疫測定法から分子検査法への移行が進んでいます。

当レポートでは、世界の分子診断薬市場について調査し、市場の概要とともに、セグメント別の市場の発展動向、技術動向、および市場に参入する企業のプロファイルなどを提供します。

目次

第1章 エグゼクティブサマリー

第2章 分子診断市場

• 最近の活発な活動
• 最近の製品の導入と規制当局の承認
• セグメント別市場規模と予測
• 感染症
• HIV市場とCOVID-19の影響
• NAT血液スクリーニング
• COVID-19の影響
• その他の動向
• 先進国市場における輸血の減少
• 分子組織学および細胞学診断
• HPV
• 製品開発
• 分子がん診断市場
• リキッドバイオプシー
• 分子移植診断
• 分子遺伝性疾患の診断
• 血小板増加症および凝固マーカー
• 非侵襲的出生前検査（NIPT）
• 有望なNIPT研究
• 遺伝性疾患の検査
• 分子診断市場の取引、コラボレーション、買収

第3章 注目すべき動向-シーケンス、CRISPR、自動化

• シーケンス
• 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ソリューション
• サンプル調製と品質管理
• 研究室の自動化と分子診断
• CRISPRと分子診断
• CRISPRと用途

第4章 企業プロファイル

• 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