한글목차

분자 POC(mPOC) 진단 솔루션은 기존의 근접 환자 검사 및 신속 검사와 비교하여 감도와 특이도가 향상하고 있습니다. 이 솔루션은 중환자실, 의원, 외래 진료소, 지역 보건소의 진단 능력을 확장하고, 환자의 상태를 정확하게 평가하거나 입원시키는 것을 목적으로 하고 있습니다. 이 컨셉은 POC(Point of Care) 검사의 사용 편의성과 분자 기술의 정확성을 융합시킨 것입니다.

세계의 분자 POC(mPOC) 시장에 대해 조사했으며, 시장 개발과 동향, 성장 전망 및 시장에 참여하는 기업의 개요 등을 제공하고 있습니다.

목차

제1장 주요 요약

제2장 분자 POC(mPOC) 시장 개발과 동향

• COVID-19와 분자 POC
• CDC 초기 대응, 장기적인 상황
• COVID-19의 고유 과제
• BARDA가 mPOC에 자금 제공
• 규제의 동향
• 컨소시엄, 자금, 상
• 거래
• 분자 POC(mPOC)의 이점과 결점
• 근거 : 감도/특이성 논의
• 신시스템과 메뉴 확장
• Mesa Biotech Strep A 승인
• 조합 검사가 시장을 바꾼다. : SARS-CoV-2, 인플루엔자 A, 인플루엔자 B, RS 바이러스
• STI는 성장 분야로 계속된다.
• mPOC 시스템에 대한 거래, 투자
• Roche가 LumiraDx를 최대 3억 5,000만 달러로 인수
• Thermo가 Mesa Biotech를 인수
• EU의 연구자가 POC 분자 검사의 개발로 Euro-3 M를 수상
• Scope Fluidics AST 시스템이 투자를 받는다.
• POC 시장으로서의 중국
• POC 진단에서 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
• 라인 프로브 어세이
• 차세대 시퀀싱
• 분자 POC(mPOC)의 응용과 잠재적 응용
• 분자 POC 진단의 주요 테스트에 대한 응용
• 인플루엔자
• RIDT의 재분류
• 원내감염(HAI)
• 연쇄구균 A
• 호흡기세포융합바이러스(RSV)
• 새로운 용도
• 지카열
• 기타 호흡기 감염증
• B군연쇄구균
• 인유두종바이러스
• 단순 헤르페스 바이러스
• 질염
• 결핵
• 말라리아
• 기타 소외열대질환
• 암
• 유럽의 디바이스 규제

제3장 시장 분석

• 분자 POC(mPOC) 시장 분석
• 환자옆 분자(Near Patient Molecular) 시장
• 환자옆(Near Patient) 시장 점유율

제4장 기업 개요

• Abbott Laboratories
• Aidian Oy
• Akonni Biosystems
• binx health, inc.
• Biocartis NV
• bioMerieux SA
• 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.
• Cue Health
• 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

영문목차

Molecular point-of-care (mPOC) diagnostic solutions offer enhanced sensitivity and specificity compared to existing near-patient and rapid tests. They expand diagnostic capabilities in critical care units, physician offices, outpatient clinics, and community health posts, aiming to assess conditions or admit patients accurately. The concept blends the accessibility of point-of-care (POC) testing with the precision of molecular technology. Kalorama Information has been covering mPOC on a regular basis since 2013.

Our latest report, “The Market and Future Potential for Molecular Point-of-Care (mPOC), 11th Edition”, is a valuable resource for understanding the size and growth potential of the molecular POC market from 2023-2028. mPOC has transitioned from a novel trend to a significant contributor to the market. Instruments from companies like Abbott, BioMérieux, Cepheid, and others play a substantial role in the IVD point-of-care market. Understanding these markets is crucial for assessing the opportunity in point-of-care testing and microbiology IVD.

“The Market and Future Potential for Molecular Point-of-Care (mPOC), 11th Edition” 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.

Kalorama reports provide real-world analysis and modeling for relevant circumstances. Analysts offer insights into near-patient molecular testing using small instruments.

The data in “The Market and Future Potential for Molecular Point-of-Care (mPOC), 11th Edition” includes information on systems, competitor analysis, and the size and growth of the market.

• What are the mPOC market opportunities beyond COVID-19?
• What are the current systems on the market? Who's winning?
• What's the size of the Molecular Point-of-Care Market: 2023-2028
• Geographic Breakout of the Molecular Point-of-Care Market, 2023 (N. America, Europe, APAC, RoW)
• Segment Breakout of Molecular Point-of-Care Market, 2023 (Respiratory vs. Other)
• Near Patient Molecular IVD Market: 2023-2028
• Near Patient Molecular Market Share by Vendor, 2023
• Company Profiles

Competitive Analysis

Companies covered in this report, in profiles and/or product tables and market developments discussion include:

Scope

The market definition for molecular point-of-care can be challenging compared to other markets that Kalorama Information covers as there are competing ideas about point-of-care or near-patient tests. But the future promise of molecular point-of-care is in sample-to-answer workflows and short result times that would make systems useful for a physician lab office. Therefore, systems like Roche's cobas Liat, Abbott's ID NOW (formerly the Alere i), and bioMérieux's Biofire FilmArray 2.0 are the type of systems principally considered in market scope.

For the purposes of this report, systems must be capable of running CLIA-waived tests or have that capability in the near future. That being said there are a wide variety of molecular systems that could be classified as near-patient or rapid. Since sales of these systems may affect core markets, Kalorama also includes in the discussion and in some additional market considerations rapid molecular testing that may be challenging to define as point-of-care but have a point-of-care-like quality such as HAI or STI testing.

Table of Contents

Chapter 1: Executive Summary

• Figure 1-1: Molecular Point-of-Care Market (mPOC), 2023-2028 ($M)
• Figure 1-2: Near Patient Molecular Systems Market, 2023-2028 ($M)
• Where is Molecular Point-of-Care in 2024?
  • Table 1-1: Molecular Point-of-Care Market, 2023-2028 ($M)
• Molecular Point-of-Care Market Analysis
• Table 1-2: Molecular Point-of-Care Market Growth, 2023-2028 (%)
  • Figure 1-3: mPOC Market by Disease Indication, 2023 (%; Respiratory, Other)
• Market Observations
• "Near-Patient" Molecular Systems Market
  • Table 1-3: Near Patient Molecular Systems Market, 2023-2028 ($M)
  • Table 1-4: Near Patient Molecular Systems Market Growth, 2023-2028 (%)
  • Figure 1-4: mPOC and Near-Patient Market, 2023-2028 ($M)
  • Table 1-5: mPOC and Near-Patient Market, 2023-2028 ($M)
• 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 2024
• 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
• Mesa Biotech Strep A Approval
• 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 $350M
• Thermo Acquires Mesa Biotech
• EU Researchers Awarded Euro-3M to Develop POC Molecular Tests
• Scope Fluidics AST System Sees Investment
• 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
• Line Probe Assays
• Next-Generation Sequencing
• 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, 2023-2028 ($M, %)
  • Figure 3-1: Molecular Point-of-Care Market, 2023-2028 ($M)
  • Table 3-2: Geographic Breakout of the Molecular Point-of-Care Market, by Region (North America, Europe, APAC, RoW), 2023 ($M, %)
  • Table 3-3: Segment Breakout of Molecular Point-of-Care Market, by Area (COVID-Respiratory vs. Other), 2023 ($M, %)
  • Figure 3-2: Breakout of Molecular Point-of-Care Market (Respiratory, Other), 2023 (%)
• "Near Patient Molecular" Market
  • Table 3-4: Near Patient Molecular Systems Market, 2023-2028 ($M, %)
• Market Share Near Patient
  • Figure 3-3: Market Share, Near Patient Molecular Testing
  • Table 3-5: Market Share, Near Patient Molecular Testing, by Vendor (Abbott, bioMerieux, Cepheid, Roche, Other), 2023 (%)

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-Q3 '23
  • Figure 4-1: FilmArray Systems Installed by Quarter, Q4 2018-Q3 2022
• 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.
• Cue Health
• 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