分子護理點 (mPOC) 市場與前景：第 11 版

與現有的近距離患者快速檢測相比，分子護理點 (mPOC) 診斷解決方案提高了靈敏度和特異性。 這些解決方案旨在擴展重症監護病房、醫生辦公室、門診診所和社區衛生站的診斷能力，以準確評估和住院患者。 這個概念將現場護理 (POC) 測試的易用性與分子技術的準確性結合起來。

本報告探討了全球分子即時照護 (mPOC) 市場，提供市場發展和趨勢、成長前景以及參與該市場的公司概況。

目錄

第 1 章執行摘要

第二章分子即時照護市場發展與趨勢

• COVID-19 和分子 POC
• CDC的初步因應、長期狀況
• COVID-19 的獨特挑戰
• BARDA 資助 mPOC
• 監理趨勢
• 聯盟、資助和獎項
• 特價訊息
• 分子即時護理的優點和缺點
• 理由：敏感度/特異度討論
• 新系統和選單擴展
• Mesa Biotech A 型鏈球菌已獲批准
• 組合檢測將改變市場：SARS-CoV-2、甲型流感、乙型流感、呼吸道合胞病毒
• 性傳染感染仍然是一個不斷發展的領域
• mPOC系統的交易與投資
• Roche以高達 3.5 億美元收購 LumiraDx
• Thermo 收購 Mesa Biotech
• 歐盟研究人員因開發 POC 分子測試而獲得 Euro-3M 獎
• Scope Fluidics 的 AST 系統獲得投資
• 中國作為 POC 市場
• POC診斷的一般測試和分析目標
• 分子即時診斷的基本技術
• 微流控
• 定量 PCR
• 微陣列晶片
• 等溫擴增
• 測試自動化
• 引子和探針
• 偵測
• 次世代定序
• 分子診斷
• 即時螢光定量 PCR (qPCR)
• 等溫擴增法
• 線性探針偵測
• 次世代定序
• 分子護理點應用與潛在應用
• 分子POC診斷在主要檢查的應用
• 流感
• RIDT 的重新分類
• 院內感染 (HAI)
• A型鏈球菌
• 呼吸道合胞病毒 (RSV)
• 新用途
• 寨卡熱
• 其他呼吸道感染
• B 型鏈球菌
• 人類乳突病毒
• 單純皰疹病毒
• 陰道炎
• 結核病
• 瘧疾
• 其他被忽視的熱帶疾病
• 癌症
• 歐洲設備法規

第三章市場分析

• 分子即時護理市場分析
• 床邊分子市場
• 床邊市佔率

第四章公司簡介

• 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

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