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市場調查報告書
商品編碼
2024196

感染疾病分子診斷市場：按症候群、檢測項目、地點和國家分類－分析與執行指南（2026-2030 年）

Molecular Diagnostics for Infectious Disease by Syndrome, Plex, Place and by Country. With Analysis and Executive Guides. 2026 - 2030
出版日期: | 出版商: Howe Sound Research | 英文 687 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

報告摘要：

感染疾病分子診斷是指檢測與病毒、細菌、真菌和寄生蟲等病原體相關的核酸的診斷技術。這些檢測方法透過識別源自感染性微生物的遺傳物質，能夠高度靈敏且特異性檢測病原體。分子診斷已成為現代醫學中不可或缺的工具，因為它比許多傳統的微生物學方法（例如培養和抗原檢測）能夠提供更快、更準確的診斷結果。

全球感染疾病分子診斷市場預計到2025年將達到103.3億美元。預計到2030年，該市場將成長至129億美元，複合年成長率（CAGR）為4.5%。在新冠肺炎疫情期間，由於對聚合酵素鏈鎖反應（PCR）檢測的需求空前高漲，該市場經歷了快速成長。儘管與疫情相關的檢測量有所下降，但分子診斷設備的部署數量卻顯著增加，從而支撐了除新冠肺炎以外的其他傳染病檢查的長期需求。

推動市場成長的因素包括感染疾病的蔓延、針對特定症候群的多重檢測項目的擴展、對抗藥性認知的提高以及對快速診斷結果以支持及時臨床決策的需求日益成長。分子診斷技術正擴大應用於醫院檢查室、參考實驗室、門診診所和照護現場（POC​​）等場所。

技術概述

分子診斷檢測利用擴增和定序技術來檢測病原體特異性核酸序列。聚合酵素鏈鎖反應(PCR) 因其高靈敏度、高特異性和對多種病原體的適用性，是應用最廣泛的分子診斷方法。即時PCR可以對核酸進行定量，快速提供結果，有助於制定治療策略。

恒溫環型核酸擴增（LAMP）和轉錄媒介增幅（TMA）等溫擴增技術為PCR提供了替代方案，無需複雜的循環設備。這些技術使得開發適用於分散式檢查環境的攜帶式分子診斷平台成為可能。

次世代定序（NGS）技術在感染疾病診斷的應用日益廣泛，尤其是在病原體鑑定、集體爆發監測和抗菌素抗藥性基因檢測方面。定序技術能夠對複雜的臨床檢體中的多種病原體進行無偏倚檢測。

針對特定症候群的多重檢測試劑盒佔了分子感染疾病診斷市場的重要佔有率。這些試劑盒可以同時檢測單一檢體中的多種病原體，從而能夠對呼吸道感染疾病、胃腸道感染疾病和血液感染疾病等疾病進行全面的診斷評估。

樣品製備技術和自動化的進步提高了工作流程效率，縮短了獲得結果所需的時間。

主要用途

感染疾病分子診斷技術在臨床應用上用途廣泛。呼吸道感染疾病是其中最大的應用領域之一，包括流感病毒、呼吸道融合細胞病毒（RSV）、SARS-CoV-2 和其他呼吸道病原體的檢測。

性行為感染感染 (STI) 檢測也是一個重要的應用領域，包括檢測沙眼披衣菌、淋病奈瑟菌和人類乳突病毒 (HPV) 等病原體。

醫院感染檢測用於檢測與醫療保健相關感染有關的病原體，例如困難梭狀桿菌、抗藥性金黃色葡萄球菌(MRSA) 和萬古黴素抗藥性腸球菌(VRE)。

消化器官系統病原體檢測用於檢測與腹瀉和食物中毒相關的微生物。

血液傳染病檢查有助於快速檢測引起敗血症的病原體。

分子診斷技術也用於監測新興感染疾病和監測抗生素抗藥性模式。

市場促進因素

多種因素正在推動分子感染疾病診斷市場的成長。

感染疾病日益普遍，對準確診斷檢測的需求也隨之增加。

隨著抗藥性的增加，快速識別病原體和檢測抗藥性的需求也日益成長。

症候群特異性多重檢測方案的擴展提高了診斷效率，促進了分子檢測的廣泛應用。

人們對感染控制措施的認知不斷提高，推動了快速診斷測試的使用。

自動化和小型化技術的進步正在推動分散式分子檢測平台的發展。

將分子檢測納入臨床指引正在加速其在醫療保健系統中的應用。

國際旅行的擴張增加了新興感染疾病傳播的風險，也因此對監測技術提出了更高的要求。

市場區隔

分子感染疾病診斷市場可以按技術類型、疾病類型、最終用戶和地區進行細分。

從技術面來看，PCR 佔比最大，其次是等溫擴增技術和基於定序的診斷技術。

就疾病類型而言，呼吸道感染疾病是最大的組成部分之一，因為此類感染的檢測數量龐大。其他重要組成部分包括性行為感染感染、胃腸道感染疾病、血液感染疾病和院內感染。

最終使用者包括醫院檢查室、參考實驗室、公共衛生實驗室、診所和照護現場(POC) 場所。

北美是最大的區域市場，這得益於其完善的醫療基礎設施和分子檢測技術的高普及率。隨著醫療系統加大對診斷能力的投入，歐洲和亞太市場也不斷擴張。

競爭格局

感染疾病分子診斷市場包括跨國診斷公司、專業分子診斷公司和新興生技公司。

競爭程度取決於測試的性能、所需時間、測試範圍和成本效益等因素。

設備安裝策略通常包括長期試劑供應合約。

耗材的經常性收入是經營模式的關鍵要素。

各公司正日益開發集樣本製備、擴增、檢測和數據分析於一體的整合診斷平台。

診斷公司與公共衛生組織之間建立策略夥伴關係十分常見。

數位化連結和數據管理能力正成為關鍵的差異化因素。

未來展望

隨著快速檢測感染疾病病原體在醫療保健系統中變得越來越重要，分子感染疾病診斷市場預計將繼續擴張。

隨著臨床醫生越來越希望從單次檢測中獲得全面的診斷訊息，預計多參數檢測組合的使用將會更加普遍。

預計這將擴大在分散式環境中進行測試的機會。

定序技術很可能在病原體鑑定和抗生素抗藥性檢測中發揮越來越重要的作用。

人工智慧 (AI) 工具具有提高複雜分子診斷資料解讀能力的潛力。

總體而言，分子診斷已成為現代感染疾病控制和公共衛生監測的關鍵要素。分子生物學技術、自動化和生物資訊學的持續進步有望支撐市場的長期成長。

目錄

第1章 市集指南

  • 戰略態勢分析
  • 企業主管和業務拓展負責人。
  • 管理顧問和投資顧問指南
    • 人工智慧的影響

第2章：引言與市場定義

  • 什麼是分子診斷？
  • 診斷革命
  • 市場定義
  • 調查方法
  • 展望：醫療保健和體外診斷行業

第3章感染疾病－依疾病類型進行市場分析

  • HIV - 人類免疫力缺乏病毒（愛滋病）
  • 乙型肝炎病毒（HBV）
  • 丙型肝炎病毒（HCV）
  • HPV（人類乳突病毒）
  • 流感
  • CTGC -披衣菌感染/淋病
  • 結核
  • MRSA－抗藥性金黃色葡萄球菌
  • VRE－萬古黴素抗藥性腸球菌
  • 驗血
  • COVID-19
  • 大流行診斷

第4章 行業概覽

  • 參與企業充滿活力的市場
    • 學術研究辦公室
    • 診斷測試開發人員
    • 測量儀器供應商
    • 化學品/試劑供應商
    • 病理檢測用品供應商
    • 獨立臨床實驗室
    • 國家/地區公共研究機構
    • 醫院檢查室
    • 醫師診所檢查室(POLS)
    • 審計機構
    • 認證機構
  • 臨床檢測市場細分
  • 產業結構

第5章：主要MDx公司概況

  • 1928 Diagnostics
  • Abacus Diagnostica
  • Abbott Laboratories
  • Accelerate Diagnostics
  • Access Bio
  • Ador Diagnostics
  • ADT Biotech
  • Akonni Biosystems
  • Altona Diagnostics
  • Alveo Technologies
  • Anatolia Geneworks
  • Anitoa
  • Antelope Dx
  • Applied BioCode
  • Assurance Scientific Laboratories
  • Aureum Diagnostics
  • Aus Diagnostics
  • Beckman Coulter Diagnostics
  • Becton, Dickinson and Company
  • Binx Health
  • Biocartis
  • BioFire Diagnostics（bioMerieux）
  • bioMerieux Diagnostics
  • Bio-Rad Laboratories, Inc
  • Bosch Healthcare Solutions GmbH
  • Celemics
  • Cepheid（Danaher）
  • Chembio
  • Co Diagnostics
  • Credo Diagnostics Biomedical
  • Cue Health
  • Curetis NV/Curetis GmbH
  • Detect
  • Diagenode Diagnostics
  • Diascopic
  • Diasorin SpA
  • Domus Diagnostics
  • Eiken Chemical
  • Element Biosciences
  • Enzo Biochem
  • Eurofins Scientific
  • Fluxergy
  • Fulgent Genetics
  • Fusion Genomics.
  • Genedrive
  • Genetic Signatures
  • GenMark Dx（Roche）
  • Genomadix
  • Grifols
  • Grip Molecular Technologies
  • Hibergene Diagnostics
  • Hologic
  • Illumina
  • Immunexpress
  • Inflammatix
  • Invetech
  • Janssen Diagnostics
  • Karius
  • Lexagene
  • LightDeck Diagnostics
  • Lucira Health
  • Luminex Corp（DiaSorin）
  • LumiraDx
  • Lumos Diagnostics
  • Mammoth Biosciences
  • Maxim Biomedical
  • Meridian Bioscience
  • Mesa Biotech（Thermo Fisher）
  • MicroGem
  • Millipore Sigma
  • Mindray
  • Minute Molecular
  • Mobidiag（Hologic）
  • Molbio Diagnostics
  • NanoDx
  • Nanomix
  • Novacyt
  • Novel Microdevices
  • OnsiteGene
  • Operon
  • Oxford Nanopore Technologies
  • Panagene
  • Pathogenomix
  • Perkin Elmer
  • Prenetics
  • Primerdesign（Novacyt）
  • Prominex
  • Proof Diagnostics
  • Qiagen
  • QuantuMDx
  • Quest Diagnostics
  • QuidelOrtho
  • Randox Toxicology
  • Roche Molecular Diagnostics
  • Saw Diagnostics
  • Scope Fluidics
  • SD Biosensor
  • Seegene
  • Siemens Healthineers
  • Singular Genomics
  • SomaLogic
  • Sona Nanotech
  • SpeeDx
  • T2 Biosystems
  • Talis Biomedical
  • Thermo Fisher Scientific Inc.
  • Ultima Genomics
  • Vela Diagnostics
  • Veramarx
  • Veredus Laboratories
  • Vir
  • Vircell
  • Visby Medical
  • XCR Diagnostics
  • YD Diagnostics
  • Zhejiang Orient Gene Biotech

第6章 市場趨勢

  • 成長促進因素
  • 成長阻礙因素
  • 測量與自動化
  • 診斷技術發展

第7章 分子診斷－感染疾病的最新進展

第8章：全球感染疾病分子診斷市場

  • 全球市場各國概覽
  • 全球市場概覽（按症候群分類）
  • Plex 的其他世界市場概覽
  • 區域全球市場概覽

第9章：全球感染疾病分子診斷市場－依症候群分類

  • 呼吸系統
  • 消化系統
  • 血
  • 腦膜炎/腦炎
  • 性行為感染傳染病
  • 其他

第10章：全球感染疾病分子診斷市場－基於多重檢測的分析

  • 單工
  • 雙重
  • 三重
  • 多重

第11章 全球感染疾病分子診斷市場－按地區分類

  • 醫院檢查室
  • 門診檢查室
  • POC
  • 其他

第12章附錄

表格一覽

圖表清單

簡介目錄
Product Code: IDMDx 426

Report Overview:

Molecular diagnostics for infectious diseases refers to diagnostic technologies that detect nucleic acids associated with pathogens such as viruses, bacteria, fungi, and parasites. These tests identify genetic material from infectious organisms, allowing highly sensitive and specific detection of disease-causing agents. Molecular diagnostic methods have become essential tools in modern healthcare because they enable faster and more accurate diagnosis than many traditional microbiology techniques such as culture or antigen detection.

The global market for molecular diagnostics for infectious diseases is estimated to be USD 10.33 billion annually in 2025. The market is expected to grow to 12.9 Billion in 2030 for a CAGR of 4.5%. The market experienced rapid growth during the COVID-19 pandemic due to unprecedented demand for polymerase chain reaction (PCR) testing. While pandemic-related testing volumes have declined, the installed base of molecular diagnostic instruments has expanded significantly, supporting long-term demand for non-COVID infectious disease testing.

Growth in this market is driven by increasing prevalence of infectious diseases, expansion of syndromic multiplex testing panels, increasing awareness of antimicrobial resistance, and growing demand for rapid diagnostic results that support timely clinical decision-making. Molecular diagnostic technologies are increasingly used in hospital laboratories, reference laboratories, outpatient clinics, and point-of-care settings.

Technology Overview

Molecular diagnostic tests detect pathogen-specific nucleic acid sequences using amplification or sequencing technologies. Polymerase chain reaction (PCR) represents the most widely used molecular diagnostic method due to its high sensitivity, specificity, and adaptability to a wide range of pathogens. Real-time PCR allows quantification of nucleic acids and provides rapid results that can guide treatment decisions.

Isothermal amplification technologies such as loop-mediated isothermal amplification (LAMP) and transcription-mediated amplification (TMA) provide alternatives to PCR that do not require complex thermal cycling equipment. These technologies enable development of portable molecular diagnostic platforms suitable for decentralized testing environments.

Next-generation sequencing (NGS) technologies are increasingly used in infectious disease diagnostics, particularly for pathogen identification, outbreak surveillance, and detection of antimicrobial resistance genes. Sequencing technologies enable unbiased detection of multiple pathogens in complex clinical samples.

Syndromic multiplex panels represent an important segment of the molecular infectious disease diagnostics market. These panels detect multiple pathogens simultaneously from a single sample, enabling comprehensive diagnostic evaluation for conditions such as respiratory infections, gastrointestinal infections, and bloodstream infections.

Advances in sample preparation technologies and automation have improved workflow efficiency and reduced time to result.

Key Applications

Molecular diagnostics for infectious diseases are used across a wide range of clinical applications. Respiratory infections represent one of the largest segments, including testing for influenza viruses, respiratory syncytial virus (RSV), SARS-CoV-2, and other respiratory pathogens.

Sexually transmitted infection (STI) testing represents another important application area, including detection of pathogens such as Chlamydia trachomatis, Neisseria gonorrhoeae, and human papillomavirus (HPV).

Hospital-acquired infection testing is used to detect pathogens associated with healthcare-associated infections such as Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), and vancomycin-resistant Enterococci (VRE).

Gastrointestinal pathogen testing is used to detect organisms associated with diarrhea and foodborne illness.

Bloodstream infection testing supports rapid detection of sepsis-causing pathogens.

Molecular diagnostics are also used in surveillance of emerging infectious diseases and monitoring of antimicrobial resistance patterns.

Market Drivers

Several factors are driving growth in the molecular infectious disease diagnostics market.

Increasing prevalence of infectious diseases continues to create demand for accurate diagnostic testing.

Growth in antimicrobial resistance is increasing need for rapid pathogen identification and resistance detection.

Expansion of syndromic multiplex panels is improving diagnostic efficiency and supporting broader adoption of molecular testing.

Increasing awareness of infection control practices is supporting use of rapid diagnostic tests.

Advances in automation and miniaturization technologies are enabling development of decentralized molecular testing platforms.

Integration of molecular testing into clinical guidelines is supporting adoption in healthcare systems.

Expansion of global travel increases risk of emerging infectious disease transmission, supporting demand for surveillance technologies.

Market Segmentation

The molecular infectious disease diagnostics market can be segmented by technology type, disease type, end user, and geographic region.

By technology, PCR represents the dominant segment, followed by isothermal amplification technologies and sequencing-based diagnostics.

By disease type, respiratory infections represent one of the largest segments due to high testing volumes. Other important segments include sexually transmitted infections, gastrointestinal infections, bloodstream infections, and hospital-acquired infections.

End users include hospital laboratories, reference laboratories, public health laboratories, physician offices, and point-of-care settings.

North America represents the largest geographic market due to strong healthcare infrastructure and high adoption of molecular testing technologies. Europe and Asia-Pacific markets are also expanding as healthcare systems invest in improved diagnostic capabilities.

Competitive Landscape

The molecular diagnostics for infectious disease market includes multinational diagnostic companies, specialized molecular diagnostics firms, and emerging biotechnology companies.

Competition is driven by test performance, turnaround time, menu breadth, and cost efficiency.

Instrument placement strategies often involve long-term reagent supply agreements.

Recurring revenue from consumables represents an important component of business models.

Companies are increasingly developing integrated diagnostic platforms combining sample preparation, amplification, detection, and data analysis.

Strategic partnerships between diagnostic companies and public health organizations are common.

Digital connectivity and data management capabilities are becoming important differentiators.

Future Outlook

The molecular infectious disease diagnostics market is expected to continue expanding as healthcare systems emphasize rapid detection of infectious pathogens.

Multiplex testing panels are expected to become more widely used as clinicians seek comprehensive diagnostic information from single tests.

Point-of-care molecular diagnostic platforms are expected to expand access to testing in decentralized settings.

Sequencing technologies may play an increasing role in pathogen identification and antimicrobial resistance detection.

Artificial intelligence tools may improve interpretation of complex molecular diagnostic data.

Overall, molecular diagnostics represent a critical component of modern infectious disease management and public health surveillance. Continued advances in molecular biology technologies, automation, and bioinformatics are expected to support long-term market growth.

Table of Contents

1 Market Guides

  • 1.1 Strategic Situation Analysis
    • 1.1.1 Strategic Importance in Clinical Care and Public Health
    • 1.1.2 Post-Pandemic Market Normalization
    • 1.1.3 Technology Evolution and Platform Competition
    • 1.1.4 Reimbursement and Cost Pressures
    • 1.1.5 Regulatory and Quality Requirements
    • 1.1.6 Antimicrobial Resistance Detection
    • 1.1.7 Decentralization and Point-of-Care Testing
    • 1.1.8 Competitive Landscape and Industry Structure
    • 1.1.9 Geographic Market Dynamics
    • 1.1.10 Outlook and Strategic Implications
  • 1.2 Guide for Executives and Business Development Staff
  • 1.3 Guide for Management Consultants and Investment Advisors
    • 1.3.1 Impact of Artificial Intelligence

2 Introduction and Market Definition

  • 2.1 What are Molecular Diagnostics?
  • 2.2 The Diagnostics Revolution
  • 2.3 Market Definition
    • 2.3.1 Revenues
  • 2.4 Methodology
    • 2.4.1 Methodology
    • 2.4.2 Sources
    • 2.4.3 Authors
  • 2.5 Perspective: Healthcare and the IVD Industry
    • 2.5.1 Global Healthcare Spending
    • 2.5.2 Spending on Diagnostics
    • 2.5.3 Important Role of Insurance for Diagnostics

3 The Infectious Diseases - Market Analysis by Disease

  • 3.1 HIV - Human Immunodeficiency Virus (AIDS)
    • 3.1.1 Virology
      • 3.1.1.1 Classification
      • 3.1.1.2 Structure and genome
      • 3.1.1.3 Tropism
      • 3.1.1.4 Replication cycle
      • 3.1.1.5 Genetic variability
    • 3.1.2 Diagnosis
    • 3.1.3 Testing
      • 3.1.3.1 Antibody tests
      • 3.1.3.2 Point of Care Tests (POCT)
      • 3.1.3.3 Antigen Tests
      • 3.1.3.4 Nucleic acid-based tests (NAT)
      • 3.1.3.5 Other tests used in HIV treatment
    • 3.1.4 Market Opportunity Analysis
  • 3.2 HBV - Hepatitis B
    • 3.2.1 Virology
      • 3.2.1.1 Genome
      • 3.2.1.2 Pathogenesis
      • 3.2.1.3 Hepatitis B virus replication
      • 3.2.1.4 Serotypes and genotypes
    • 3.2.2 Mechanisms
    • 3.2.3 Diagnosis
    • 3.2.4 Market Opportunity Analysis
  • 3.3 HCV - Hepatitis C
    • 3.3.1 Taxonomy
    • 3.3.2 Structure
      • 3.3.2.1 Genome
    • 3.3.3 Molecular biology
    • 3.3.4 Replication
    • 3.3.5 Genotypes
      • 3.3.5.1 Clinical importance
    • 3.3.6 Market Opportunity Analysis
  • 3.4 HPV - Human papillomavirus
    • 3.4.1 Virology
      • 3.4.1.1 E6/E7 proteins
      • 3.4.1.2 Role in cancer
      • 3.4.1.3 E2 research
      • 3.4.1.4 Latency period
      • 3.4.1.5 Clearance
    • 3.4.2 Diagnosis
      • 3.4.2.1 Cervical testing
      • 3.4.2.2 Oral testing
      • 3.4.2.3 Testing men
      • 3.4.2.4 Other testing
    • 3.4.3 Market Opportunity Analysis
  • 3.5 Influenza
    • 3.5.1 Virology
      • 3.5.1.1 Types of virus
      • 3.5.1.2 Influenzavirus A
      • 3.5.1.3 Influenzavirus B
      • 3.5.1.4 Influenzavirus C
      • 3.5.1.5 Structure, properties, and subtype nomenclature
      • 3.5.1.6 Replication
    • 3.5.2 Testing
      • 3.5.2.1 Advantages/Disadvantages of Molecular Assays
    • 3.5.3 Market Opportunity Analysis
  • 3.6 CTGC - Chlamydia/Gonorhea
    • 3.6.1 Gonorrhea
      • 3.6.1.1 Diagnosis
      • 3.6.1.2 Screening
    • 3.6.2 Chlamydia
      • 3.6.2.1 Diagnosis
      • 3.6.2.2 Screening
    • 3.6.3 Testing
      • 3.6.3.1 Nucleic acid amplification tests (NAATs).
      • 3.6.3.2 Performance of NAAT Tests
    • 3.6.4 Market Opportunity Analysis
  • 3.7 Tuberculosis
    • 3.7.1 Mycobacteria
    • 3.7.2 Diagnosis
      • 3.7.2.1 Active tuberculosis
      • 3.7.2.2 Latent tuberculosis
    • 3.7.3 Epidemiology
    • 3.7.4 Molecular Diagnostic Tests
    • 3.7.5 Market Opportunity Analysis
  • 3.8 MRSA - Methicillin-resistant Staphylococcus aureus
    • 3.8.1 Diagnosis
    • 3.8.2 FDA Approved Molecular Tests
    • 3.8.3 Market Opportunity Analysis
  • 3.9 VRE - Vancomycin-resistant Enterococcus
    • 3.9.1 FDA Approved MDx Tests for VRE
    • 3.9.2 Market Opportunity Analysis
  • 3.10 Blood Screening
    • 3.10.1 Collection and Testing
    • 3.10.2 FDA Approved Multiplex Assays
    • 3.10.3 Market Opportunity Analysis
  • 3.11 COVID-19
    • 3.11.1 Signs and symptoms
    • 3.11.2 Transmission
    • 3.11.3 Diagnosis
    • 3.11.4 Prevention
    • 3.11.5 Management
    • 3.11.6 Prognosis
  • 3.12 Pandemic Diagnostics
    • 3.12.1 Risk Management - Spark and Spread
    • 3.12.2 Dx Technology - Nucleic Acid Based
    • 3.12.3 Dx Technology - Immunoassay & Serology
    • 3.12.4 Time to Market and Preparedness Issues
    • 3.12.5 Unrecognized Role of Multiplex in Pandemic Mangement

4 Industry Overview

  • 4.1 Players in a Dynamic Market
    • 4.1.1 Academic Research Lab
    • 4.1.2 Diagnostic Test Developer
    • 4.1.3 Instrumentation Supplier
    • 4.1.4 Chemical/Reagent Supplier
    • 4.1.5 Pathology Supplier
    • 4.1.6 Independent Clinical Laboratory
    • 4.1.7 Public National/regional Laboratory
    • 4.1.8 Hospital Laboratory
    • 4.1.9 Physicians Office Lab (POLS)
    • 4.1.10 Audit Body
    • 4.1.11 Certification Body
  • 4.2 The Clinical Laboratory Market Segments
    • 4.2.1 Traditional Market Segmentation
    • 4.2.2 Laboratory Focus and Segmentation
  • 4.3 Industry Structure
    • 4.3.1 Hospital Testing Share
    • 4.3.2 Economies of Scale
      • 4.3.2.1 Hospital vs. Central Lab
    • 4.3.3 Physician Office Lab's
    • 4.3.4 Physician's and POCT

5 Profiles of Key MDx Companies

  • 5.1 1928 Diagnostics
  • 5.2 Abacus Diagnostica
  • 5.3 Abbott Laboratories
  • 5.4 Accelerate Diagnostics
  • 5.5 Access Bio
  • 5.6 Ador Diagnostics
  • 5.7 ADT Biotech
  • 5.8 Akonni Biosystems
  • 5.9 Altona Diagnostics
  • 5.10 Alveo Technologies
  • 5.11 Anatolia Geneworks
  • 5.12 Anitoa
  • 5.13 Antelope Dx
  • 5.14 Applied BioCode
  • 5.15 Assurance Scientific Laboratories
  • 5.16 Aureum Diagnostics
  • 5.17 Aus Diagnostics
  • 5.18 Beckman Coulter Diagnostics
  • 5.19 Becton, Dickinson and Company
  • 5.20 Binx Health
  • 5.21 Biocartis
  • 5.22 BioFire Diagnostics (bioMerieux)
  • 5.23 bioMerieux Diagnostics
  • 5.24 Bio-Rad Laboratories, Inc
  • 5.25 Bosch Healthcare Solutions GmbH
  • 5.26 Celemics
  • 5.27 Cepheid (Danaher)
  • 5.28 Chembio
  • 5.29 Co Diagnostics
  • 5.30 Credo Diagnostics Biomedical
  • 5.31 Cue Health
  • 5.32 Curetis N.V. / Curetis GmbH
  • 5.33 Detect
  • 5.34 Diagenode Diagnostics
  • 5.35 Diascopic
  • 5.36 Diasorin S.p.A.
  • 5.37 Domus Diagnostics
  • 5.38 Eiken Chemical
  • 5.39 Element Biosciences
  • 5.40 Enzo Biochem
  • 5.41 Eurofins Scientific
  • 5.42 Fluxergy
  • 5.43 Fulgent Genetics
  • 5.44 Fusion Genomics.
  • 5.45 Genedrive
  • 5.46 Genetic Signatures
  • 5.47 GenMark Dx (Roche)
  • 5.48 Genomadix
  • 5.49 Grifols
  • 5.50 Grip Molecular Technologies
  • 5.51 Hibergene Diagnostics
  • 5.52 Hologic
  • 5.53 Illumina
  • 5.54 Immunexpress
  • 5.55 Inflammatix
  • 5.56 Invetech
  • 5.57 Janssen Diagnostics
  • 5.58 Karius
  • 5.59 Lexagene
  • 5.60 LightDeck Diagnostics
  • 5.61 Lucira Health
  • 5.62 Luminex Corp (DiaSorin)
  • 5.63 LumiraDx
  • 5.64 Lumos Diagnostics
  • 5.65 Mammoth Biosciences
  • 5.66 Maxim Biomedical
  • 5.67 Meridian Bioscience
  • 5.68 Mesa Biotech (Thermo Fisher)
  • 5.69 MicroGem
  • 5.70 Millipore Sigma
  • 5.71 Mindray
  • 5.72 Minute Molecular
  • 5.73 Mobidiag (Hologic)
  • 5.74 Molbio Diagnostics
  • 5.75 NanoDx
  • 5.76 Nanomix
  • 5.77 Novacyt
  • 5.78 Novel Microdevices
  • 5.79 OnsiteGene
  • 5.80 Operon
  • 5.81 Oxford Nanopore Technologies
  • 5.82 Panagene
  • 5.83 Pathogenomix
  • 5.84 Perkin Elmer
  • 5.85 Prenetics
  • 5.86 Primerdesign (Novacyt)
  • 5.87 Prominex
  • 5.88 Proof Diagnostics
  • 5.89 Qiagen
  • 5.90 QuantuMDx
  • 5.91 Quest Diagnostics
  • 5.92 QuidelOrtho
  • 5.93 Randox Toxicology
  • 5.94 Roche Molecular Diagnostics
  • 5.95 Saw Diagnostics
  • 5.96 Scope Fluidics
  • 5.97 SD Biosensor
  • 5.98 Seegene
  • 5.99 Siemens Healthineers
  • 5.100 Singular Genomics
  • 5.101 SomaLogic
  • 5.102 Sona Nanotech
  • 5.103 SpeeDx
  • 5.104 T2 Biosystems
  • 5.105 Talis Biomedical
  • 5.106 Thermo Fisher Scientific Inc.
  • 5.107 Ultima Genomics
  • 5.108 Vela Diagnostics
  • 5.109 Veramarx
  • 5.110 Veredus Laboratories
  • 5.111 Vir
  • 5.112 Vircell
  • 5.113 Visby Medical
  • 5.114 XCR Diagnostics
  • 5.115 YD Diagnostics
  • 5.116 Zhejiang Orient Gene Biotech

6 Market Trends

  • 6.1 Factors Driving Growth
    • 6.1.1 New Genotypes Creating New Markets
    • 6.1.2 The Aging Effect
    • 6.1.3 Developing World Driving ID Dx Growth
    • 6.1.4 Point of Care - Why Centralization is Losing Steam
    • 6.1.5 Self Testing
    • 6.1.6 The Need for Speed
    • 6.1.7 The COVID Pandemic
  • 6.2 Factors Limiting Growth
    • 6.2.1 Lower Costs
    • 6.2.2 Infectious Disease is Declining
    • 6.2.3 Wellness Hurts
    • 6.2.4 Economic Growth improves Living Standards
  • 6.3 Instrumentation and Automation
    • 6.3.1 Instruments Key to Market Share
    • 6.3.2 The Shrinking Machine
    • 6.3.3 Multiplex, Point of Care and The Speed Factor
  • 6.4 Diagnostic Technology Development
    • 6.4.1 The Sepsis Testing Market - A New Direction?
    • 6.4.2 POCT/Self Testing as a Disruptive Force
    • 6.4.3 The Genetics Play - One Test for All Known Infections
    • 6.4.4 Antibiotic Resistance Genes - Simplifying Diagnostics

7 Molecular Dx - Infectious Disease Recent Developments

  • 7.1 Recent Developments - Importance and How to Use This Section
    • 7.1.1 Importance of These Developments
    • 7.1.2 How to Use This Section
  • 7.2 Hologic Revenues Rise 5 Percent on MDx Strength
  • 7.3 Genetic Signatures Halts U.S. Molecular Respiratory Panel
  • 7.4 Molecular Testing Growth Creates Reimbursement Problems
  • 7.5 Binx Health Refocuses on POC STD Testing
  • 7.6 LetsGetChecked Authorized for STD Test
  • 7.7 Genetic Signatures Applies for GI Parasite Detection Kit
  • 7.8 Sensible Diagnostics Nabs Award for Respiratory Panel
  • 7.9 Post-Pandemic Changes Landscape of ID Dx
  • 7.10 Multiplex Meningitis/Encephalitis Panel Market Expanding
  • 7.11 Sensible Diagnostics to Launch 10-Minute POC PCR System
  • 7.12 ReadyGo Dx Emerges From Stealth With MDx Plan
  • 7.13 BioMerieux, Oxford Nanopore Form ID Dx Pact
  • 7.14 SD Biosensor Eyes Global Expansion for Rapid MDx System
  • 7.15 Compact POCT Platform Unlocks Multiplexing Potential of Real-Time PCR
  • 7.16 Takara Bio and BioExcel Partner on ID Panels
  • 7.17 BioGX introduces pixl real-time PCR platform
  • 7.18 Sherlock Biosciences Improves ID Dx Toolkit
  • 7.19 Climate change is making hundreds of diseases much worse
  • 7.20 BioMerieux Invests in Sepsis Dx Startup Weezion
  • 7.21 Domus Diagnostics to Launch POC MDx Test System
  • 7.22 Proof Dx Plans Infectious Disease, Oncology Tests for CRISPR-Based POC
  • 7.23 Oxford Nanopore Diagnostics to Develop Clinical Tools
  • 7.24 Pathogenomix Developing Infectious Disease Platform Using NGS
  • 7.25 COVID-19 Accelerating Trend Toward Pharmacy-Based Testing
  • 7.26 Co-Diagnostics Seeks FDA EUA for At-Home PCR Diagnostic
  • 7.27 Sense Biodetection to Debut Instrument-Free Point-of-Care MDx
  • 7.28 Home Test Company Prenetics to go Public
  • 7.29 Roche to Acquire TIB Molbiol to Expand Infectious Disease Portfolio
  • 7.30 Lucira Health Posts Revenue Growth on OTC C19 Test
  • 7.31 BforCure Preparing Multiple Panels for Point-of-Care qPCR Platform
  • 7.32 Talis Biomedical Discusses Point-of-Care
  • 7.33 Roche to Acquire GenMark Diagnostics for $1.8B
  • 7.34 Pandemic Pushes Handheld qPCR Devices Closer to Commercialization
  • 7.35 Hologic to Acquire Mobidiag
  • 7.36 Lucira Health Focuses on User Friendly Approach to Home Testing
  • 7.37 Infectious Disease Dx Firm Talis Biomedical Raises $254M in IPO
  • 7.38 Fluidigm Plans 'Durable' Diagnostics, Clinical Business
  • 7.39 Thermo Fisher Scientific to Acquire Mesa Biotech for Up to $550M
  • 7.40 Mammoth Biosciences Developing Pathogen Detection Tech
  • 7.41 Illumina, IDbyDNA Developing Sequencing-Based Respiratory Tests
  • 7.42 Scanogen Developing 90 Minute Infection Test
  • 7.43 Malaria Assays Use CRISPR for Point-of-Care Multispecies Detection
  • 7.44 FDA Provides Self Testing SARS-CoV-2 EAU Guidance
  • 7.45 Mammoth Biosciences Announces Rapid, CRISPR-Based COVID-19 Diagnostic

8 The Global Market for Molecular Diagnostics Infectious Disease

  • 8.1 Global Market Overview by Country
    • 8.1.1 Table - Global Market by Country
    • 8.1.2 Chart - Global Market by Country
  • 8.2 Global Market by Syndrome - Overview
    • 8.2.1 Table - Global Market by Syndrome
    • 8.2.2 Chart - Global Market by Syndrome - Base/Final Year Comparison
    • 8.2.3 Chart - Global Market by Syndrome - Base Year
    • 8.2.4 Chart - Global Market by Syndrome - End Year
    • 8.2.5 Chart - Global Market by Syndrome - Share by Year
    • 8.2.6 Chart - Global Market by Syndrome - Segments Growth
  • 8.3 Global Market by Plex - Overview
    • 8.3.1 Table - Global Market by Plex
    • 8.3.2 Chart - Global Market by Plex - Base/Final Year Comparison
    • 8.3.3 Chart - Global Market by Plex - Base Year
    • 8.3.4 Chart - Global Market by Plex - End Year
    • 8.3.5 Chart - Global Market by Plex - Share by Year
    • 8.3.6 Chart - Global Market by Plex - Segments Growth
  • 8.4 Global Market by Place - Overview
    • 8.4.1 Table - Global Market by Place
    • 8.4.2 Chart - Global Market by Place - Base/Final Year Comparison
    • 8.4.3 Chart - Global Market by Place - Base Year
    • 8.4.4 Chart - Global Market by Place - End Year
    • 8.4.5 Chart - Global Market by Place - Share by Year
    • 8.4.6 Chart - Global Market by Place - Segments Growth

9 Global MDx Infectious Disease Markets - By Syndrome

  • 9.1 Respiratory
    • 9.1.1 Table Respiratory - by Country
    • 9.1.2 Chart - Respiratory Growth
  • 9.2 Gastrointestinal
    • 9.2.1 Table Gastrointestinal - by Country
    • 9.2.2 Chart - Gastrointestinal Growth
  • 9.3 Blood
    • 9.3.1 Table Blood - by Country
    • 9.3.2 Chart - Blood Growth
  • 9.4 Meningitis/Encephalitis
    • 9.4.1 Table Meningitis/Encephalitis - by Country
    • 9.4.2 Chart - Meningitis/Encephalitis Growth
  • 9.5 Sexually Transmitted Disease
    • 9.5.1 Table Sexually Transmitted Disease - by Country
    • 9.5.2 Chart - Sexually Transmitted Disease Growth
  • 9.6 Other
    • 9.6.1 Table Other - by Country
    • 9.6.2 Chart - Other Growth

10 Global MDx Markets for Infectious Disease - by Plex

  • 10.1 Single Plex
    • 10.1.1 Table Single Plex - by Country
    • 10.1.2 Chart - Single Plex Growth
  • 10.2 Duplex
    • 10.2.1 Table Duplex - by Country
    • 10.2.2 Chart - Duplex Growth
  • 10.3 Triplex
    • 10.3.1 Table Triplex - by Country
    • 10.3.2 Chart - Triplex Growth
  • 10.4 Multiplex Technology
    • 10.4.1 Table Multiplex - by Country
    • 10.4.2 Chart - Multiplex Growth

11 Global MDx Infectious Disease Markets - by Place

  • 11.1 Hospital Lab
    • 11.1.1 Table Hospital Lab - by Country
    • 11.1.2 Chart - Hospital Lab Growth
  • 11.2 Outpatient Lab
    • 11.2.1 Table Outpatient Lab - by Country
    • 11.2.2 Chart - Outpatient Lab Growth
  • 11.3 POC
    • 11.3.1 Table POC - by Country
    • 11.3.2 Chart - POC Growth
  • 11.4 Other Place
    • 11.4.1 Table Other Place - by Country
    • 11.4.2 Chart - Other Place Growth

12 Appendices

  • 12.1 United States Medicare System: Clinical Laboratory Fees Schedule
  • 12.2 The Most Used IVD Assays
  • 12.3 The Highest Grossing Assays

Table of Tables

  • Table 1 Classification of HIV Species
  • Table 2 HIV Tests - CMS Codes & Prices
  • Table 3 Current HIV Molecular Tests and Instruments Used
  • Table 4 HBV Tests - CMS Codes & Prices
  • Table 5 HCV Tests - CMS Codes & Prices
  • Table 6 HPV Clearance Rates
  • Table 7 HPV Tests - CMS Codes & Prices
  • Table 8 HPV Tests, Technology, Types
  • Table 9 Types of Influenza Tests
  • Table 10 Influenza Tests - CMS Codes & Prices
  • Table 11 FDA Cleared Molecular Assays for Influenza
  • Table 12 FDA Cleared NAAT CTGC Tests
  • Table 13 CTGC NAAT Target Sequences and Possible False Reactions
  • Table 14 CTGC Tests - CMS Codes & Prices
  • Table 15 FDA Approved MDx Tests for Tuberculosis
  • Table 16 Tuberculosis Tests - CMS Codes & Prices
  • Table 17 FDA Approved Tests for MRSA
  • Table 18 MRSA Tests - CMS Codes & Prices
  • Table 19 FDA Approved Tests for VRE
  • Table 20 VRE Tests - CMS Codes & Prices
  • Table 21 FDA Approved Multiplex Assays
  • Table 22 Characteristics of Coronavirus Pandemic Infections
  • Table 23 COVID-19 Symptoms
  • Table 24 Market Players by Type
  • Table 25 Clinical Laboratory Departments and Segments
  • Table 26 Laboratory Management Focus - Different Approaches
  • Table 27 Key Segmentation Variables Going Forward
  • Table 28 Five Factors Driving Growth
  • Table 29 Four Factors Limiting Growth
  • Table 30 Key Diagnostic Laboratory Technology Trends
  • Table 31 - Global Market by Region
  • Table 32 Global Market by Syndrome
  • Table 33 Global Market by Plex
  • Table 34 Global Market by Place
  • Table 35 Respiratory by Country
  • Table 36 Gastrointestinal by Country
  • Table 37 Blood by Country
  • Table 38 Meningitis/Encephalitis by Country
  • Table 39 Sexually Transmitted Disease by Country
  • Table 40 Other by Country
  • Table 41 Single Plex by Country
  • Table 42 Duplex by Country
  • Table 43 Triplex by Country
  • Table 44 Multiplex by Country
  • Table 45 Hospital Lab by Country
  • Table 46 Outpatient Lab by Country
  • Table 47 POC by Country
  • Table 48 Other Place by Country
  • Table 49 Clinical Lab Fee Schedule
  • Table 50 The Most Common Assays
  • Table 51 Largest Revenue Assays

Table of Figures

  • Figure 1 Global Healthcare Spending
  • Figure 2 The Lab Test Pie
  • Figure 3 HIV Virion
  • Figure 4 Diagram of the HIV Replication Cycle
  • Figure 5 The Structure of the HBV Virus
  • Figure 6 Hepatitis B Replication
  • Figure 7 Structure of the HCV Virus
  • Figure 8 HCV Replication Cycle
  • Figure 9 Structure of the Influenza Virion
  • Figure 10 Influenza Replication
  • Figure 11 Scanning Electronmicrograph of Tuberculosis
  • Figure 12 The Road to Diagnostics
  • Figure 13 The Changing Age of The World's Population
  • Figure 14 Health Care Consumption by Age
  • Figure 15 Cancer Incidence by Age
  • Figure 16 Chart Infectious Disease Decline
  • Figure 17 Global Market Shares Chart
  • Figure 18 Global Market by Syndrome - Base vs. Final
  • Figure 19 Global Market by Syndrome Base Year
  • Figure 20 Global Market by Syndrome End Year
  • Figure 21 Syndrome Share by Year
  • Figure 22 Syndrome Segments Growth
  • Figure 23 Global Market by Plex - Base vs. Final
  • Figure 24 Global Market by Plex Base Year
  • Figure 25 Global Market by Plex End Year
  • Figure 26 Plex Share by Year
  • Figure 27 Plex Segments Growth
  • Figure 28 Global Market by Place - Base vs. Final
  • Figure 29 Global Market by Place Base Year
  • Figure 30 Global Market by Place End Year
  • Figure 31 Place Share by Year
  • Figure 32 Place Segments Growth
  • Figure 33 Respiratory Growth
  • Figure 34 Gastrointestinal Diagnostics Growth
  • Figure 35 Blood Growth
  • Figure 36 Meningitis/Encephalitis Growth
  • Figure 37 Sexually Transmitted Disease Growth
  • Figure 38 Other Growth
  • Figure 39 Single Plex Growth
  • Figure 40 Duplex Growth
  • Figure 41 Triplex Growth
  • Figure 42 Multiplex Growth
  • Figure 43 Hospital Lab Growth
  • Figure 44 Outpatient Lab Growth
  • Figure 45 POC Growth
  • Figure 46 Other Place Growth