한글목차

분자 POC(mPOC) 진단은 전통적인 포인트 오브 케어(POC) 솔루션의 접근성과 속도로 분자 검사의 감도와 특이성을 제공하며 체외 진단(IVD) 상황에 혁명을 일으키고 있습니다.

mPOC는 새로운 기술 혁신에서 주요 시장세력으로 변천하고 있으며, 그 원동력이 되고 있는 것은 구명구급병동, 외래진료소, 의원, 지역의료의 현장에서 신속하고 정확한 진단 솔루션에 대한 수요가 증가하고 있습니다. COVID-19 팬데믹은 특히 호흡기 검사 분야에서의 채용을 가속화했지만, 시장은 원내 감염(HAI), 성감염증(STI), 열대병 등 새로운 분야로 확대를 계속하고 있습니다.

본 보고서에서는 분자 POC(mPOC) 시장에 대해 조사했으며, 급속히 발전하는 이 시장을 종합적으로 분석하고, 2029년까지 5년간 예측되는 시장 규모, 성장 전망, 경쟁력 정세 등을 망라하고 있습니다.

목차

제1장 주요 요약

제2장 분자 POC(mPOC) 시장 개척과 동향

• COVID-19와 분자 POC
• 규제 동향
• 컨소시엄, 자금, 상
• 특가 정보
• 분자 POC(mPOC)의 장단점
• 근거 : 감도, 특이성의 논의
• 새로운 시스템과 메뉴의 확장
• mPOC 시스템에 거래, 투자
• POC 시장으로서의 중국
• POC 진단에 있어서의 일반적인 검사와 분석 대상
• 분자 POC(mPOC) 진단의 요소 기술
  • 마이크로플루이딕스
  • 정량 PCR
  • 마이크로어레이
  • 등온 증폭
  • 테스트 자동화
  • 프라이머와 프로브
  • 검출
  • 차세대 시퀀싱
  • 분자진단
  • 실시간 PCR(qPCR)
  • 등온 증폭법
  • 루프 개재 등온 증폭(LAMP)
  • 니킹 효소 증폭 반응(NEAR)
  • 사슬 치환 증폭(SDA)
  • 헬리카제 의존성 증폭(HDA)
  • 핵산 서열에 기초한 증폭(NASBA)
  • 전사 중재 증폭(TMA)
  • 크로스 프라이밍 증폭(CPA)
  • 라인 프로브 분석
• POC(mPOC)의 용도와 잠재적 용도
  • 분자 POC(mPOC) 진단의 주요 시험
  • 인플루엔자
  • RIDT의 재분류
  • 원내 감염(HAI)
  • 연쇄상 구균 A
  • 호흡기 합포체 바이러스(RSV)
  • 새로운 용도
  • 지카 열
  • 기타 호흡기 감염증
  • B군 연쇄상구균
  • 인유두종 바이러스
  • 단순 헤르페스 바이러스
  • 질염
  • 결핵
  • 말라리아
  • 기타 열대 및 무시되는 질병
  • 암
• 유럽 디바이스 규제

제3장 시장 분석

• 분자 POC(mPOC) 시장 분석
• 지역별 점유율
• 질병 영역별 내역
• 「베드사이드 분자 검사」시장
• 베드사이드 분자검사의 벤더의 시장 점유율

제4장 기업 프로파일

• Abbott Laboratories
• Aidian Oy
• Akonni Biosystems
• binx health, inc.
• Biocartis NV
• bioMerieux SA
• Cepheid(Danaher)
• Credo Diagnostics Biomedical Pte. Ltd.
• Curetis NV(OpGen)
• DiaSorin SpA
• GenMark Diagnostics(Roche)
• Greiner Bio-One GmbH
• Lucira Health(Pfizer)
• Meridian Bioscience, Inc.(SD Biosensor)
• Mesa Biotech, Inc.(Thermo)
• QIAGEN NV
• QuantuMDx Group
• QuidelOrtho Corporation
• Roche
• Sekisui Diagnostics LLC
• T2 Biosystems

영문목차

Molecular point-of-care (mPOC) diagnostics are revolutionizing the in vitro diagnostics (IVD) landscape, delivering the sensitivity and specificity of molecular testing with the accessibility and speed of traditional point-of-care (POC) solutions. Kalorama Information's latest report, "Molecular Point-of-Care (mPOC) Market Outlook and Innovations, 2024-2029", provides a comprehensive analysis of this rapidly evolving market, covering the size, growth trajectory, and competitive dynamics forecasted over a five year span to 2029.

Market Drivers & Opportunities

mPOC has transitioned from an emerging innovation to a major market force, driven by increasing demand for rapid and accurate diagnostic solutions in critical care units, outpatient clinics, physician offices, and community health settings. The COVID-19 pandemic accelerated adoption, particularly in the respiratory testing segment, but the market continues to expand into new areas, including hospital-acquired infections (HAIs), sexually transmitted infections (STIs), and tropical diseases.

With leading companies such as Abbott, Cepheid, bioMerieux, Roche, and QuidelOrtho competing in the space, this report explores key questions:

• What is the size and projected growth of the mPOC market?
• Which companies are leading the market, and how are they positioned?
• How is mPOC impacting traditional laboratory-based molecular testing?
• What regions and disease segments present the greatest opportunities?

Comprehensive Market Insights

This report offers detailed segmentation of the mPOC market, including:

• Market Sizing & Forecasts (2024-2029) - Revenue projections by technology, region, and disease area.
• Competitive Analysis - Market share breakdowns and insights into leading companies.
• Geographic Trends - Market distribution across North America, Europe, Asia Pacific, and the Rest of the World.
• Technology & Regulatory Landscape - Overview of CLIA-waived and moderate-complexity molecular platforms.

Scope

"Molecular Point-of-Care (mPOC) Market Outlook and Innovations, 2024-2029" provides market sizing, forecasting, trend mapping, and competitive analysis for POC tests using PCR or other molecular technology, offering fast turnaround times and usability in near-patient settings. This Kalorama Information report provides real-world analysis and modeling for relevant circumstances, with insights into near-patient molecular testing using small instruments.

This comprehensive analysis includes market shares for companies, regions, and disease types, distinguishing between "true" molecular point-of-care and near-patient molecular systems. The report highlights the competitive landscape, with major IVD companies and innovative players contributing to the market's growth. The report defines molecular point-of-care (mPOC) devices as those that run PCR or other DNA and RNA testing on a portable device, with features such as small footprint, fast result times, and usability outside of a reference lab.

A Decade of mPOC Research Expertise

Kalorama Information has been covering the mPOC market since its inception and provides real-world analysis rooted in extensive primary and secondary research. Whether you are an IVD company, investor, or healthcare provider "Molecular Point-of-Care (mPOC) Market Outlook and Innovations, 2024-2029", offers critical insights to help you navigate and capitalize on this fast-growing segment.

Table of Contents

Chapter 1: Executive Summary

• Figure 1-1: Molecular Point-of-Care Market, 2024-2029 ($ million)
• Figure 1-2: Near Patient Molecular Systems Market, 2024-2029 ($ million)
• Where is Molecular Point-of-Care in 2025?
  • Table 1-1: Molecular Point-of-Care Market, 2024-2029 ($ million)
• Molecular Point-of-Care Market Analysis
  • Table 1-2: Molecular Point-of-Care Market Growth, 2024-2029 (%)
  • Figure 1-3: Molecular Point-of-Care Market, by Disease Indication, 2024 (%) [COVID/Respiratory, Other]
• Market Observations
• "Near-Patient" Molecular Systems Market
  • Table 1-3: Near Patient Molecular Systems Market, 2024-2029 ($ million)
  • Table 1-4: Near Patient Molecular Systems Market Growth, 2024-2029 (%)
  • Table 1-5: mPOC and Near-Patient Market, 2024-2029 ($ million)
  • Figure 1-4: mPOC and Near-Patient Market, 2024-2029 ($ million)
• Current Trends
• Molecular Point-of-Care Diagnostics Defined
• Usage of Molecular Point-of-Care
• Leading mPOC Platforms
  • Table 1-6: Molecular POC Diagnostic Platforms and Technologies
• Trends
• Scope and Methodology

Chapter 2: Molecular Point-of-Care Market Development and Trends

• COVID-19 and Molecular POC
  • Table 2-1: Molecular POC COVID-19 Emergency Authorizations
  • CDC Initial Response, Long Term Situation
  • COVID-19's Unique Challenge
  • BARDA Directs Funding to mPOC
• Regulatory Developments
• Consortia, Funding, Prizes
• Deals
  • Table 2-2: Deals in Molecular Point-of-Care, April 2019-Feb 2025
• Advantages and Disadvantages of Molecular Point-of-Care
  • Table 2-3: Disadvantages of Molecular Point-of-Care, by Setting [Physician Office Laboratory (POL) / Other Outpatient Settings, Developing and Low-Resource Areas, and Hospital POC]
• Justification: The Sensitivity/Specificity Argument
• New Systems and Menu Expansion
  • New Systems Introduced in Development
  • Combination Tests Changing Market: SARS-CoV-2, Flu A, Flu B, and RSV
  • STI Continues to Be a Growth Area
• Deals, Investment in mPOC Systems
  • Roche Acquires LumiraDx for up to $350 Million
  • Thermo Acquires Mesa Biotech
• China as a POC Market
• Common Tests and Analytes in POC Diagnostics
• Component Technologies of Molecular Point-of-Care Diagnostics
  • Microfluidics
  • qPCR
  • Microarrays
  • Isothermal Amplification
  • Test Automation
  • Primers and Probes
  • Detection
  • Next-Generation Sequencing
  • Molecular Diagnostics
  • Real-Time PCR (qPCR)
  • Isothermal Amplification Methods
  • Loop-Mediated Isothermal Amplification (LAMP)
  • Nicking Enzyme Amplification Reaction (NEAR)
  • Strand Displacement Amplification (SDA)
  • Helicase Dependent Amplification (HDA)
  • Nucleic Acid Sequence-Based Amplification (NASBA)
  • Transcription-Mediated Amplification (TMA)
  • Cross Priming Amplification (CPA)
  • Line Probe Assays
• Applications and Potential Applications for Molecular Point-of-Care
  • Major Testing Applications for Molecular POC Diagnostics
  • Influenza
  • Reclassification of RIDTs
  • Hospital-Acquired Infections (HAIs)
  • Strep A
  • Respiratory Syncytial Virus (RSV)
  • Emerging Applications
  • Zika
  • Other Respiratory Infections
  • Group B Streptococcus
  • Human Papillomavirus
  • Herpes Simplex Virus
  • Vaginitis
  • Tuberculosis
  • Malaria
  • Other Tropical and Neglected Diseases
  • Cancer
• European Device Regulations

Chapter 3: Market Analysis

• Molecular Point-of-Care Market Analysis
  • Table 3-1: Molecular Point-of-Care Market, 2024-2029 ($ million) (%)
  • Figure 3-1: Molecular Point-of-Care Market, 2024-2029 ($ million)
• Regional Shares
  • Table 3-2: Geographic Breakout of the Molecular Point-of-Care Market, by Region, 2024 ($ million) [APAC, Europe, North America, Rest of World]
  • Figure 3-2: Geographic Breakout of the Molecular Point-of-Care Market, by Region, 2024 ($ million) [APAC, Europe, North America, Rest of World]
  • Figure 3-3: Global Molecular Point-of-Care Market Share, by Region, 2024 ($ million) [APAC, Europe, North America, Rest of World]
• Breakout by Disease Area
  • Table 3-3: Segment Breakout of Molecular Point-of-Care Market, by Disease Indication, 2024 ($ million) [COVID/Respiratory, Other]
  • Figure 3-4: Segment Breakout of Molecular Point-of-Care Market, by Disease Indication, 2024 ($ million) [COVID/Respiratory, Other]
  • Figure 3-5: Breakout of Molecular Point-of-Care Market Share, by Disease Indication, 2024 (%) [COVID/Respiratory, Other]
• "Near Patient Molecular" Market
  • Table 3-4: Near Patient Molecular Point-of-Care Market, 2024-2029 ($ million) (%)
  • Figure 3-6: Near Patient Molecular Point-of-Care Market, 2024-2029 ($ million)
• Vendor Market Share for Near Patient Molecular Testing
  • Table 3-5: Near Patient Molecular Testing Market Share, by Vendor, 2024 (%) [Abbott, bioMerieux, Cepheid, Roche, Other]
  • Figure 3-7: Near Patient Molecular Testing Market Share, by Vendor, 2024 (%) [Abbott, bioMerieux, Cepheid, Roche, Other]

Chapter 4: Company Profiles

• Abbott Laboratories
• Aidian Oy
• Akonni Biosystems
• binx health, inc.
• Biocartis NV
• bioMerieux SA
  • Table 4-1: bioMerieux FilmArray Est. Systems per Quarter, Q4 '18-Q4 '24
  • Figure 4-1: FilmArray Systems Installed by Quarter, Q4 2018-Q4 2024
• Cepheid (Danaher)
  • Molecular Healthcare-Acquired Infection (HAI) Testing
  • Molecular Sexual Health and Women's Health Testing
  • Molecular Critical Infectious Disease Testing
  • Molecular Oncology/Genetics Testing
• Credo Diagnostics Biomedical Pte. Ltd.
• Curetis NV (OpGen)
• DiaSorin S.p.A
• GenMark Diagnostics (Roche)
• Greiner Bio-One GmbH
• Lucira Health (Pfizer)
• Meridian Bioscience, Inc. (SD Biosensor)
• Mesa Biotech, Inc. (Thermo)
• QIAGEN NV
• QuantuMDx Group
• QuidelOrtho Corporation
• Roche
• Sekisui Diagnostics LLC
• T2 Biosystems