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市場調查報告書
商品編碼
1018629

全球分子診斷測試市場:第 10 版(NGS、PCR、NAAT、ISH、TMA 等)

The World Market for Molecular Diagnostics Tests, 10th Edition (NGS, PCR, NAAT, ISH, TMA, Other)

出版日期: | 出版商: Kalorama Information | 英文 337 Pages | 商品交期: 最快1-2個工作天內

價格
  • 全貌
  • 簡介
  • 目錄
簡介

分子診斷是一個快速發展和動態的領域,也是體外診斷 (IVD) 市場中增長最快的領域。分子診斷包括早期發現抗菌藥物耐藥(AMR)感染的治療決策、支持多種癌症治療方法相容性評價的伴隨診斷、HIV與精神疾病、血液稀釋劑和患者的藥代動力學,已成為臨床不可或缺的工具醫學與醫療保健的各個方面有關,包括新陳代謝、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的診斷。

本報告分析了分子診斷測試的全球市場,並分析了近期的技術發展和傳播趨勢、整體市場規模趨勢(2021 年至 2026 年),並按應用和技術細分。□我們將收集和提供詳細信息,例如按地區劃分的趨勢、主要公司的概況和競爭情況。

目錄

第 1 章執行摘要

  • 影響市場狀況和前景的新趨勢
  • 通過樣本到結果/護理點 (PoC) 系統實現分子檢測的民主化
  • 分子診斷對傳統 IVD(體外診斷)細分市場的影響
  • 分子診斷的兌換環境(美國/歐洲/加拿大/日本/中國/印度)
  • 收到積極贖回決定的分子檢測示例
  • 分子診斷的臨床實用性
  • LDT(臨床實驗室開發測試)監管狀況
  • 先進生物信息學/其他 IT 平台的影響
  • 全球分子診斷市場
  • 技術增長趨勢:NGS 承諾、現有細分市場的實力
  • 按地區劃分的分子診斷市場(北美、歐洲、亞太地區)

按技術細分的第 2 章市場

  • 核酸擴增試驗 (NAAT) 技術
  • 臨床 NAAT 診斷市場的市場趨勢
  • 分子檢測的分散
  • 通過自動化和統一將現有檢查商品化
  • NAAT 創新:新生物標誌物、高通量、數字 PCR
  • 實時 PCR (qPCR)
  • 等溫核酸擴增技術 (iNAAT)
  • 微陣列
  • 微陣列檢測的市場趨勢
  • 分子免疫血液檢測和分子血型檢測
  • 作為微陣列替代品的懸浮陣列和其他檢查
  • 原位雜交 (ISH)
  • ISH 市場趨勢
  • 數字病理算法
  • 臨床 RNA ISH
  • 替代 ISH 探針和試劑
  • 測序
  • 臨床測序的市場趨勢
  • 小型化、速度和成本改進
  • 臨床測序信息學解決方案的演變
  • 樣品製備和質量控制
  • NGS 液體活檢
  • 全外顯子組序列 (WES)
  • 甲基化
  • 業務合作與收購:NGS市場形勢瞬息萬變
  • 中國NGS需求快速增長
  • 亞太地區 NGS 市場展望

第三章傳染病分子診斷市場

  • 用於傳染病診斷的分子 POC 分子檢測的前景
  • 世界市場分析
  • CT/NG(沙眼衣原體/淋病)、HPV(人乳頭瘤病毒)、婦科疾病
  • 肝炎
  • 艾滋病毒
  • 醫院感染 (HAI)
  • 呼吸系統疾病
  • 分枝桿菌/結核

第 4 章血液篩查的分子診斷市場

  • 發達市場輸血減少
  • 發展中國家日益增長的需求
  • 介紹新的傳染病威脅和檢測方法
  • 用於血液篩查的核酸檢測市場
  • 區域驗血市場

第5章分子組織/細胞診斷市場

  • 分子組織診斷細分市場趨勢
  • CISH、信號檢測、試劑化學創新
  • 組織診斷自動化

第 6 章癌症分子診斷市場

  • 癌症分子診斷市場趨勢
  • 癌症診斷中的大規模並行序列
  • 分子診斷在遺傳性癌症診斷中的作用
  • 用於識別藥物基因匹配的生物標誌物預測測試
  • 基於液體活檢的非侵入性癌症分子診斷
  • 未知原發癌 (CUP) 的分子診斷
  • 分子癌症診斷的演變和現狀
  • 全球癌症分子診斷市場
  • 北美癌症分子診斷市場
  • 歐洲癌症分子診斷市場
  • 亞太癌症分子診斷市場
  • 日本
  • 中國
  • 印度
  • 東盟國家

第七章分子移植診斷市場

  • 技術轉向先進的 DNA 檢測平台
  • 投資擴張、創新、市場整合等趨勢
  • 全球分子移植診斷市場

第八章遺傳病分子診斷市場

  • 靜脈血栓形成和凝血標誌物
  • 無創產前檢測 (NIPT)
  • 自閉症
  • 阿爾茨海默病
  • 心血管疾病
  • 精神障礙

第九章公司簡介

  • Abbott Diagnostics
  • Advanced Cell Diagnostics (Biotechne)
  • Agilent Technologies
  • Amoy Diagnostics
  • Applied Spectral Imaging
  • Becton, Dickinson & Co. (BD)
  • Beijing Genomics Institute (BGI)
  • Berry Genomics
  • bioMérieux
  • Bio-Rad Laboratories
  • CareDx, Inc.
  • Danaher (Cepheid and Leica Biosystems)
  • Cepheid
  • Leica Biosystems
  • Eiken Chemical
  • GenMark Diagnostics
  • Genotypic Technology Pvt. Ltd.
  • Grifols, S. A
  • Illumina
  • Immucor, Inc.
  • Meridian Bioscience Inc
  • Molbio Diagnostics Pvt. Ltd.
  • PerkinElmer Inc.
  • QIAGEN N.V.
  • Quidel Corporation
  • Roche Diagnostics
  • Thermo Fisher Scientific Inc.
  • Vela Diagnostics
目錄
Product Code: 21-028

Molecular diagnostics is a fast evolving and dynamic field and 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. Kalorama's “ The World Market for Molecular Diagnostics Tests, 10th Edition (NGS, PCR, NAAT, ISH, TMA, Other) ” , examines the global market as well as markets by region, including:

  • Global Markets for Molecular Diagnostics by Application Segments (2021-2026) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($, Million)
  • Global Markets for Molecular Diagnostics by Technology Segments (2021-2026) (PCR, iNAAT, Microarrays, ISH, NGS, Other, Total) ($, Million)
  • North American Markets for Molecular Diagnostics (2021-2026) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($, Million)
  • European Markets for Molecular Diagnostics (2021-2026) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($, Million)
  • Asia Pacific Markets for Molecular Diagnostics (2021-2026) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant , Inherited Diseases, Total) ($, Million)

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:

  • Global Molecular Infectious Disease Diagnostics Markets (2021-2026), By Infection (Hepatitis, HIV, HAIs/Sepsis, HPV, CT/NG, Respiratory diseases, Mycobacteria/TB, Other, Total) ($, Million)
  • Global Molecular Infectious Disease Diagnostics Markets, by Region (2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)
  • Global Molecular HPV Testing Markets, By Region (2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)
  • Global Molecular CT/NG Testing Markets, By Region (2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)
  • Global Molecular Hepatitis Testing Markets, By Region (2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)
  • Global Molecular HIV Testing Markets, By Region (North America, Europe, APAC, RoW, Total) (2021-2026) ($, Million)
  • Global Molecular HAIs/Sepsis Testing Markets, By Region (2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)
  • Global Molecular Respiratory Diseases Testing Markets, By Region (2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)
  • Global Molecular Mycobacteria/TB Testing Markets, By Region (2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)

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 (2021-2026) (North America, Europe, APAC, RoW, Total) ($, 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 (2021-2026) (Cancer, Inherited diseases, Infectious/Other, Total) ($, Million)
  • Global Molecular Histology and Cytology Diagnostics Markets, by Region (2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)
  • Global Molecular Histology Diagnostics Markets, by Region (2021-2026) (North America, Europe, APAC, RoW, Total) ($, 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 (2021-2026) (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 (2021-2026) (North America, Europe, APAC, RoW, Total) ($, 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 Inherited Diseases Diagnostics Markets, By Disease Segments (2021-2026) (Thrombophilia [SNP tests] & Coagulation Markers, NIPT, Others, Total) ($, Million)
  • Global Molecular Inherited Diseases Diagnostics Markets, By Region (2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)

In addition to reviewing recent industry and market developments, as well as examining key market trends that are influencing the market landscape, the report looks at the molecular diagnostics industry players.

The following companies are profiled:

  • Abbott Diagnostics
  • Advanced Cell Diagnostics (Biotechne)
  • Agilent Technologies
  • Amoy Diagnostics
  • Applied Spectral Imaging
  • Becton, Dickinson & Co. (BD)
  • Beijing Genomics Institute (BGI)
  • Berry Genomics
  • bioMérieux
  • Bio-Rad Laboratories
  • CareDx, Inc.
  • Danaher (Cepheid and Leica Biosystems)
  • Eiken Chemical
  • GenMark Diagnostics
  • Genotypic Technology Pvt. Ltd.
  • Grifols, S. A
  • Illumina
  • Immucor, Inc.
  • Meridian Bioscience Inc
  • Molbio Diagnostics Pvt. Ltd.
  • PerkinElmer Inc.
  • QIAGEN N.V.
  • Quidel Corporation
  • Roche Diagnostics
  • Thermo Fisher Scientific Inc.
  • Vela Diagnostics

Table of Contents

Chapter One: Executive Summary

  • Emerging Trends Influencing the Market Landscape
  • Democratization of Molecular Testing with Sample-to-Result and POC Systems
  • Impact of Molecular Diagnostics on Conventional IVD Segments
  • Reimbursement Environment for Molecular Diagnostics
  • Reimbursement Environment in the US
  • Reimbursement Environment in Europe
  • Reimbursement Environment in Canada
  • Reimbursement Environment in Japan
  • Reimbursement Environment in China
  • Reimbursement Environment in India
  • Examples of Molecular Tests that Received Positive Reimbursement Decisions
  • Clinical Utility of Molecular Diagnostics
  • Regulatory Status of Laboratory Developed Tests (LDTs)
  • Influence of Advanced Bioinformatics and other IT platforms
  • The Global Molecular Diagnostics Market
    • Table 1-1: Global Markets for Molecular Diagnostics by Application Segments (2021-2026) ($, Million) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total)
  • Growth by Technology: The Promise of NGS, Strength of Incumbent Segments
    • Table 1-2: Global Markets for Molecular Diagnostics by Technology Segments (2021-2026) ($, Million) (PCR, iNAAT, Microarrays, ISH, NGS, Other, Total)
  • Molecular Diagnostics Markets by Region
  • North American Markets for Molecular Diagnostics
    • Table 1-3: North American Markets for Molecular Diagnostics (2021-2026) ($, Million) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total)
  • European Markets for Molecular Diagnostics
    • Table 1-4: European Markets for Molecular Diagnostics (2021-2026) ($, Million) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total)
  • Asia Pacific Markets for Molecular Diagnostics
    • Table 1-5: Asia Pacific Markets for Molecular Diagnostics (2021-2026) ($, Million) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant , Inherited Diseases, Total)

Chapter Two: Markets by Technology Segments

  • Nucleic Acid Amplification Test (NAAT) Technologies
  • Market Trends in the Clinical NAAT Diagnostics Markets
  • Decentralization of molecular tests
  • Commoditization of established tests through automation and centralization
  • Innovation in NAAT ñ New Biomarkers, Higher Throughput, and digital PCR
    • Table 2-1: Commercially Available DNA Methylation Tests for Cancer
  • Real-Time PCR (qPCR)
  • Isothermal Nucleic Acid Amplification Technology (iNAAT)
    • Table 2-2: Selected iNAAT Methods and Commercially Available Platforms
  • Microarrays
  • Market Trends in Microarray Testing
  • Molecular Immunohematology or Molecular Blood Typing
  • Suspension Arrays and Others as Alternatives to Microarrays
    • Table 2-3: Selected Clinical Arrays Component and Microarray Systems
  • In Situ Hybridization (ISH)
    • Table 2-4: Selected Commercial In Situ Hybridization Tests
  • Market Trends in ISH
  • Digital Pathology Algorithms
  • Clinical RNA ISH
  • Alternative ISH Probes and Reagents
  • Sequencing
    • Table 2-5: Selected Clinical NGS Platforms in the Market
  • Market Trends in Clinical Sequencing
  • Improvements in Miniaturization, Speed and Cost
  • Evolving Informatics Solutions in Clinical Sequencing
  • Sample Preparation and Quality Control
  • Liquid Biopsy in NGS
  • Whole Exome Sequencing (WES)
  • Methylation
  • Collaborations and Acquisitions: NGS Market Landscape Changing Fast
    • Table 2-6: Selected Acquisitions/Collaborations in the NGS Market (2017-2021)
  • Fast Growing NGS Demand in China
  • NGS Market Outlook for APAC

Chapter Three: Markets for Molecular Infectious Disease Diagnostics

  • Table 3-1: Selected Integrated Clinical Molecular Systems in the Market for Infectious Disease Diagnostics
  • Prospects for Molecular POC Testing for Infectious Diseases Diagnostics
    • Table 3-2: Selected Molecular POC Platforms in the Market for Infectious Disease Testing
  • Market Analysis - Global
    • Table 3-3: Global Molecular Infectious Disease Diagnostics Markets (2021-2026), By Infection ($, Million) (Hepatitis, HIV, HAIs/Sepsis, HPV, CT/NG, Respiratory diseases, Mycobacteria/TB, Other, Total)
    • Table 3-4: Global Molecular Infectious Disease Diagnostics Markets, by Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
  • CT/NG, HPV and Womenís Health
    • Table 3-5: Global Molecular HPV Testing Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
    • Table 3-6: Global Molecular CT/NG Testing Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
  • Hepatitis
    • Table 3-7: Global Molecular Hepatitis Testing Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
  • HIV
    • Table 3-8: Innovations in Molecular POC Diagnostics for HIV
    • Table 3-9: Global Molecular HIV Testing Markets, By Region (2021-2026) (North America, Europe, APAC, RoW, Total)
  • Hospital-Acquired Infections (HAIs)
    • Table 3-10: Global Molecular HAIs/Sepsis Testing Markets, By Region (2021-2026) (North America, Europe, APAC, RoW, Total)
  • Respiratory Diseases
    • Table 3-11: Global Molecular Respiratory Diseases Testing Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
  • Mycobacteria/Tuberculosis
    • Table 3-12: Global Molecular Mycobacteria/TB Testing Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)

Chapter Four: Markets for Molecular Blood Screening Diagnostics

  • Declining Blood Transfusions in Developed Markets
  • Growing Demand in Developing Nations
  • New Infectious Disease Threats and Assay Introductions
  • Nucleic Acid Testing Markets for Blood Screening
  • Blood Testing Market by Geography
    • Table 4-1: Global Molecular Blood Screening Diagnostics Markets, By Region (2021-2026) (North America, Europe, APAC, RoW, Total)

Chapter Five: Markets for Molecular Histology and Cytology Diagnostics

  • Market Trends in Molecular Histology Segment
  • Innovation in CISH, Signal Detection and Reagent Chemistries
  • Histology Automation
    • Table 5-1: Global Molecular Histology and Cytology Diagnostics Markets by Application (2021-2026) ($, Million) (Cancer, Inherited diseases, Infectious/Other, Total)
    • Table 5-2: Global Molecular Histology and Cytology Diagnostics Markets, by Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
    • Table 5-3: Global Molecular Histology Diagnostics Markets, by Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)

Chapter Six: Markets for Molecular Cancer Diagnostics

  • Market Trends in Molecular Cancer Diagnostics
  • Massively Parallel Sequencing in Cancer Diagnostics
  • Role of Molecular Diagnostics in Hereditary Cancer Diagnosis
  • Predictive Biomarker Tests for Identifying Drug-Gene Match
  • Liquid Biopsy-based Non-Invasive Cancer Molecular Diagnostics
    • Table 6-1: Companies Offering Liquid Biopsy-based Molecular Cancer Assays
  • Molecular Diagnosis of Cancers of Unknown Primary Site (CUP)
  • Evolution of Molecular Cancer Diagnostics and Current Status
    • Table 6-2: Selected Molecular Companion and Complementary Assays for Cancer
  • Cancer Molecular Diagnostics Markets, Global
    • Table 6-3: Global Molecular Cancer Diagnostics Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)
  • Cancer Molecular Diagnostics Markets, North America
  • Cancer Molecular Diagnostics Markets, Europe
  • Cancer Molecular Diagnostics Markets, APAC
  • Japan
  • China
    • Table 6-4: Recent Partnerships Established between Illumina and Diagnostics Companies in China
  • India
  • ASEAN

Chapter Seven: Markets for Molecular Transplant Diagnostics

  • Technological Shift to Advanced DNA Testing Platforms
  • Rising Investments, Innovation, Market Consolidation, and Other Trends
    • Table 7-1: Selected Innovations in the Field of Molecular Transplant Diagnostics
  • Molecular Transplant Diagnostics, Global
    • Table 7-2: Global Molecular Transplant Diagnostics Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)

Chapter Eight: Markets for Molecular Inherited Diseases Diagnostics

  • Thrombophilia and Coagulation Markers
  • Non-Invasive Prenatal Testing (NIPT)
  • Autism
  • Alzheimerís Disease
  • Cardiovascular Disease
  • Psychiatric Disorders
    • Table 8-1: Global Molecular Inherited Diseases Diagnostics Markets, By Disease Segments (2021-2026) ($, Million) (Thrombophilia [SNP tests] & Coagulation Markers, NIPT, Others, Total)
    • Table 8-2: Global Molecular Inherited Diseases Diagnostics Markets, By Region (2021-2026) ($, Million) (North America, Europe, APAC, RoW, Total)

Chapter Nine: Company Profiles

  • Abbott Diagnostics
  • Advanced Cell Diagnostics (Biotechne)
  • Agilent Technologies
  • Amoy Diagnostics
  • Applied Spectral Imaging
  • Becton, Dickinson & Co. (BD)
  • Beijing Genomics Institute (BGI)
  • Berry Genomics
  • bioMe¥rieux
  • Bio-Rad Laboratories
  • CareDx, Inc.
  • Danaher (Cepheid and Leica Biosystems)
  • Cepheid
  • Leica Biosystems
  • Eiken Chemical
  • GenMark Diagnostics
  • Genotypic Technology Pvt. Ltd.
  • Grifols, S. A
  • Illumina
  • Immucor, Inc.
  • Meridian Bioscience Inc
  • Molbio Diagnostics Pvt. Ltd.
  • PerkinElmer Inc.
  • QIAGEN N.V.
  • Quidel Corporation
  • Roche Diagnostics
  • Thermo Fisher Scientific Inc.
  • Vela Diagnostics