시장보고서
상품코드
2024196

감염증 분자진단 시장 : 증후군별, 플렉스별, 장소별 및 국가별 - 분석 및 경영진용 가이드 포함(2026-2030년)

Molecular Diagnostics for Infectious Disease by Syndrome, Plex, Place and by Country. With Analysis and Executive Guides. 2026 - 2030

발행일: | 리서치사: 구분자 Howe Sound Research | 페이지 정보: 영문 687 Pages | 배송안내 : 1-2일 (영업일 기준)

    
    
    



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보고서 개요:

감염증의 분자진단은 바이러스, 세균, 진균, 곰팡이, 기생충 등 병원체와 관련된 핵산을 검출하는 진단 기술을 말합니다. 이러한 검사는 감염성 미생물 유래의 유전물질을 확인함으로써 병원체의 고감도, 고특이적 검출을 가능하게 합니다. 분자진단법은 배양이나 항원 검출과 같은 기존의 미생물학적 방법보다 빠르고 정확한 진단이 가능하기 때문에 현대 의학에서 없어서는 안 될 필수적인 도구가 되었습니다.

감염성 질환 분자진단 세계 시장은 2025년 연간 103억 3,000만 달러에 달할 것으로 추정됩니다. 이 시장은 2030년까지 129억 달러 규모로 성장할 것으로 예상되며, CAGR은 4.5%에 달할 것으로 전망됩니다. 이 시장은 COVID-19 팬데믹 기간 동안 중합효소 연쇄 반응(PCR) 검사에 대한 전례 없는 수요로 인해 빠르게 성장했습니다. COVID-19 관련 검사량은 감소했지만, 분자진단기기 도입량은 크게 확대되어 COVID-19 이외의 감염병 검사에 대한 장기적인 수요를 뒷받침하고 있습니다.

이 시장의 성장은 감염성 질환의 확산, 증후군별 다중 검사 패널의 확대, 약물 내성에 대한 인식의 증가, 적시에 임상적 판단을 지원하는 신속한 진단 결과에 대한 수요 증가에 의해 주도되고 있습니다. 분자진단 기술은 병원 검사실, 참고 검사 기관, 외래 진료소 및 현장 진료(POC) 현장에서 점점 더 많이 활용되고 있습니다.

기술 개요

분자진단 검사는 증폭기술과 시퀀싱 기술을 이용하여 병원체 특이적인 핵산 염기서열을 검출합니다. 중합효소 연쇄 반응(PCR)은 높은 민감도, 특이성 및 다양한 병원체에 대한 적응성으로 인해 가장 널리 사용되는 분자진단법입니다. 실시간 PCR은 핵산 정량이 가능하며, 치료 방침 결정에 도움이 되는 빠른 결과를 제공합니다.

루프 매개 등온 증폭(LAMP) 및 전사 매개 증폭(TMA)과 같은 등온 증폭 기술은 복잡한 열 사이클링 장비가 필요 없는 PCR의 대안을 제공합니다. 이러한 기술을 통해 분산형 검사 환경에 적합한 휴대용 분자진단 플랫폼 개발이 가능합니다.

차세대 염기서열 분석(NGS) 기술은 감염병 진단, 특히 병원체 식별, 집단 발병 모니터링 및 항균제 내성 유전자 검출에 점점 더 많이 활용되고 있습니다. 시퀀싱 기술을 통해 복잡한 임상 검체에서 여러 병원체를 편견 없이 검출할 수 있습니다.

증후군별 멀티플렉스 검사 패널은 분자 감염 진단 시장에서 중요한 분야를 차지하고 있습니다. 이 패널은 단일 검체에서 여러 병원체를 동시에 검출할 수 있어 호흡기 감염, 위장 감염, 혈류 감염 등의 질병에 대한 종합적인 진단 평가가 가능합니다.

시료 전처리 기술과 자동화의 발전으로 워크플로우의 효율성이 향상되고 결과 도출까지 걸리는 시간이 단축되었습니다.

주요 용도

감염성 질환의 분자진단은 광범위한 임상적 용도로 활용되고 있습니다. 호흡기 감염은 가장 큰 부문 중 하나이며, 인플루엔자 바이러스, 호흡기세포융합바이러스(RSV), SARS-CoV-2, 기타 호흡기 병원체 검사가 포함됩니다.

성병(STI) 검사도 중요한 응용 분야 중 하나이며, 클라미디아 트라코마티스, 네사리아 고노레아, 인유두종바이러스(HPV) 등의 병원체 검출이 포함됩니다.

병원내 감염 검사는 클로스트리디움 디피실, 메티실린 내성 황색포도상구균(MRSA), 반코마이신 내성 장구균(VRE) 등 의료 관련 감염과 관련된 병원균을 검출하기 위해 사용됩니다.

소화기 병원체 검사는 설사 및 식중독과 관련된 미생물을 검출하는 데 사용됩니다.

혈류 감염 검사는 패혈증을 유발하는 병원균의 신속한 검출을 돕습니다.

분자진단은 신종 감염병 감시 및 항균제 내성 패턴 모니터링에도 활용되고 있습니다.

시장 촉진요인

분자 감염 진단 시장의 성장을 이끄는 몇 가지 요인이 있습니다.

감염증의 유병률 증가로 인해 정확한 진단 검사에 대한 수요가 지속적으로 발생하고 있습니다.

약제 내성이 증가함에 따라 병원균의 신속한 식별 및 내성 검출의 필요성이 증가하고 있습니다.

증후군별 멀티플렉스 검사 패널의 확대로 진단 효율이 향상되고, 분자 검사의 보급이 촉진되고 있습니다.

감염 대책에 대한 인식이 높아짐에 따라 신속 진단 검사 이용이 증가하고 있습니다.

자동화 및 소형화 기술의 발전으로 분산형 분자 검사 플랫폼의 개발이 가능해졌습니다.

분자 검사가 임상 가이드라인에 포함되면서 의료 시스템에서의 도입이 촉진되고 있습니다.

국제 여행의 확대는 신종 감염병의 전파 위험을 증가시키고 있으며, 감시 기술에 대한 수요를 뒷받침하고 있습니다.

시장 세분화

분자 감염 진단 시장은 기술 유형, 질병 유형, 최종사용자 및 지역별로 세분화할 수 있습니다.

기술별로는 PCR이 가장 큰 비중을 차지하고 있으며, 등온증폭 기술, 시퀀싱 기반 진단 기술이 그 뒤를 잇고 있습니다.

질병 유형별로는 검사 건수가 많은 호흡기 감염증이 가장 큰 비중을 차지하고 있습니다. 기타 중요한 부문에는 성병, 위장 감염, 혈류 감염, 병원내 감염 등이 있습니다.

최종사용자에는 병원 검사실, 참조 실험실, 공중 보건 연구소, 진료소 및 현장 진료소(POC) 환경이 포함됩니다.

북미는 풍부한 의료 인프라와 높은 분자검사 기술 보급률로 인해 가장 큰 지역 시장으로 자리매김하고 있습니다. 유럽과 아시아태평양 시장도 의료 시스템이 진단 능력 향상에 투자하면서 시장이 확대되고 있습니다.

경쟁 상황

감염성 질환 분자진단 시장에는 다국적 진단 기업, 전문 분자진단 기업, 신생 바이오테크 기업 등이 포함됩니다.

경쟁은 검사 성능, 소요 시간, 검사 항목의 폭, 비용 효율성에 따라 달라집니다.

장비 설치 전략에는 종종 장기적인 시약 공급 계약이 포함됩니다.

소모품을 통한 지속적인 수익은 비즈니스 모델의 중요한 요소로 자리 잡았습니다.

각 업체들은 샘플 조제, 증폭, 검출, 데이터 분석을 결합한 통합형 진단 플랫폼의 개발을 점점 더 많이 진행하고 있습니다.

진단 기업과 공중 보건 기관과의 전략적 제휴는 일반적입니다.

디지털 연결성과 데이터 관리 능력은 중요한 차별화 요소가 되고 있습니다.

향후 전망

의료 시스템에서 감염병 병원체의 신속한 검출에 대한 중요성이 강조됨에 따라 분자 감염병 진단 시장은 지속적으로 확대될 것으로 예상됩니다.

임상의들이 단일 검사에서 종합적인 진단 정보를 원함에 따라 다항목 검사 패널의 활용이 더욱 확산될 것으로 예상됩니다.

분산된 환경에서 검사에 대한 접근성을 확대할 것으로 예상됩니다.

시퀀싱 기술은 병원체 식별 및 항균제 내성 검출에 있어 점점 더 중요한 역할을 할 수 있습니다.

인공지능(AI) 도구는 복잡한 분자진단 데이터의 해석을 개선할 수 있습니다.

전반적으로 분자진단은 현대의 감염병 관리 및 공중보건 감시에서 매우 중요한 요소로 자리 잡고 있습니다. 분자생물학 기술, 자동화, 바이오인포매틱스의 지속적인 발전은 장기적인 시장 성장을 뒷받침할 것으로 예상됩니다.

목차

제1장 시장 가이드

제2장 소개와 시장 정의

제3장 감염증-질환별 시장 분석

제4장 업계 개요

제5장 주요 MDx 기업 개요

제6장 시장 동향

제7장 분자진단-감염증의 최근 동향

제8장 분자진단 감염증 세계 시장

제9장 세계의 감염증 분자진단 시장 - 증후군별

제10장 세계의 감염증 분자진단 시장 - 플렉스별

제11장 세계의 감염증 분자진단 시장 - 지역별

제12장 부록

표목차

그림목차

KSM

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
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