分子ポイントオブケア（mPOC）市場と将来性：第11版

分子ポイントオブケア（mPOC）診断ソリューションは、既存の近接患者検査や迅速検査と比較して、感度と特異度が向上しています。これらのソリューションは、重症治療室、医院、外来診療所、地域保健ポストにおける診断能力を拡張し、患者の状態を正確に評価したり、入院させたりすることを目的としています。このコンセプトは、ポイントオブケア（POC）検査の使いやすさと分子技術の正確さを融合させたものです。

当レポートでは、世界の分子ポイントオブケア（mPOC）市場について調査し、市場開拓と動向、成長見通し、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 エグゼクティブサマリー

第2章 分子ポイントオブケア市場開拓と動向

• COVID-19と分子POC
• CDCの初期対応、長期的な状況
• COVID-19のユニークな課題
• BARDAがmPOCに資金提供
• 規制の動向
• コンソーシアム、資金、賞
• お買い得情報
• 分子ポイントオブケアの利点と欠点
• 根拠：感度/特異性の議論
• 新システムとメニューの拡張
• メサバイオテックストレップA承認
• 組み合わせ検査が市場を変える：SARS-CoV-2、インフルエンザA、インフルエンザB、RSウイルス
• STIは成長分野であり続ける
• mPOCシステムへの取引、投資
• RocheがLumiraDxを最大3億5,000万米ドルで買収
• ThermoがMesa Biotechを買収
• EUの研究者がPOC分子検査の開発でEuro-3Mを受賞
• Scope FluidicsのASTシステムが投資を受ける
• POC市場としての中国
• POC診断における一般的な検査と分析対象
• 分子ポイントオブケア診断の要素技術
• マイクロ流体
• 定量PCR
• マイクロアレイ
• 等温増幅
• テスト自動化
• プライマーとプローブ
• 検出
• 次世代シーケンシング
• 分子診断
• リアルタイムPCR（qPCR）
• 等温増幅法
• ラインプローブアッセイ
• 次世代シーケンシング
• 分子ポイントオブケアの応用と潜在的応用
• 分子POC診断の主なテストへの応用
• インフルエンザ
• RIDTの再分類
• 院内感染（HAI）
• 連鎖球菌A
• 呼吸器合胞体ウイルス（RSV）
• 新たな用途
• ジカ熱
• その他の呼吸器感染症
• B群連鎖球菌
• ヒトパピローマウイルス
• 単純ヘルペスウイルス
• 膣炎
• 結核
• マラリア
• その他の顧みられない熱帯病
• がん
• 欧州のデバイス規制

第3章 市場分析

• 分子ポイントオブケア市場分析
• ベッドサイド分子市場
• ベッドサイド市場シェア

第4章 企業プロファイル

• 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