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市場調查報告書
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1988558

分子即時檢測 (mPOC) 市場展望與創新 - 第 11 版 (2025-2030)

Molecular Point-of-Care (mPOC) Market Outlook and Innovations, 11th Edition (2025 to 2030)

出版日期: | 出版商: Kalorama Information | 英文 145 Pages | 商品交期: 最快1-2個工作天內

價格
簡介目錄

分子即時檢測 (mPOC) 透過將分子診斷的準確性更便捷地應用於患者,持續革新診斷流程。在 "分子即時檢測 (mPOC) 市場展望與創新 - 第 11 版 (2025-2030)" 報告中,Kalorama Information 分析了過去十年間已顯著成熟但仍充滿活力的 mPOC 市場。儘管真正的即時檢測與床邊分子檢測之間的區別並非總是涇渭分明,但 Kalorama 將 mPOC 的核心價值定義為:小型便攜式診斷設備能夠快速提供檢測結果,使分子檢測在醫生診室和其他分散環境中切實可行。

本報告的主要內容

本報告對全球分子即時檢測市場進行了全面評估,涵蓋以下內容:

  • 系統及耗材市場估算及預測(截至2030年)
  • 依地區、疾病領域和公司劃分的市場細分
  • 對真正的分子即時檢測系統和更廣泛的近專利分子檢測市場的分析
  • 基於一手和二手研究的市場和產品層面的收入估算

研究資料包括公司揭露資訊、政府出版物、行業期刊、商業媒體、分析師報告、法律文件以及對製造商、檢測實驗室和行業專家的訪談。所有市場價值均以當前美元計價,並以 2025 年為基準年計算。

Kalorama 對分子診斷即時偵測 (mPOC) 的定義

本報告主要區分以下兩個市場區隔:

  • 真正的分子診斷即時檢測系統:佔地面積小,能夠快速提供檢測結果,並且已獲得或可能在不久的將來獲得 CLIA 豁免資格的系統。
  • 患者近場分子檢測系統:包括支援在分散式環境中進行中等至高度複雜檢測的大型或模組化平台。

主要應用與成長機會

傳統上,mPOC 系統在呼吸系統檢測方面最為成功,而 COVID-19 疫情進一步加劇了這一趨勢。該細分市場對價格仍然十分敏感,並面臨來自免疫分析的激烈競爭,本報告指出了進一步的成長機會。

近期快速PCR檢測和用於分子診斷的家用檢測的獲批,進一步擴大了目標市場,並提高了mPOC技術的臨床應用價值。

目錄

第一章 摘要整理

  • 關於研究機構
  • 研究範圍與方法
  • mPOC 市場概覽
    • 定義真正的分子級即時偵測
    • 定義床邊分子即時偵測
  • 2026 年分子診斷即時檢測的現狀
    • 真正的 mPOC 系統
    • "床邊" 分子系統市場
    • mPOC 市場趨勢與發展
  • 分子即時偵測的應用
  • 主要 mPOC 平台
  • 趨勢

第二章 分子級即時檢測的發展與趨勢市場

  • 分子即時檢測與新冠肺炎
    • 美國疾管中心的初步因應措施及長期情勢
    • 新冠肺炎特有的挑戰
    • 生物醫學高級研究與發展局指導分子即時檢測的資金投入
  • 監理趨勢
  • 聯盟、資金和獎勵
  • 銷售
  • 分子診斷即時偵測的優點與缺點
  • 論證:敏感度/特異性理論
  • 新系統及偵測項目擴展
    • 新系統引進及發展
    • 聯合檢測市場的變化:SARS-CoV-2、甲型流感、乙型流感和呼吸道合胞病毒
    • 性傳染感染持續成長
  • 與分子即時檢測相關的交易與投資系統
    • 羅氏與Sapphiros的供應與生產協議
    • Cepheid與Oxford Nanopore的合作
    • 羅氏收購Lumira Dx
    • 賽默飛世爾科技收購Mesa Biotech
  • 將中國視為即時檢測市場
  • 即時診斷中常用的檢測項目與分析物
  • 分子即時診斷的組成技術
    • 微流控技術
    • 定量PCR (qPCR)
    • 微陣列
    • 等溫擴增
    • 測試自動化
    • 引子和探針
    • 偵測
    • 分子診斷
    • 實時PCR (qPCR)
    • 等溫擴增法
    • 線性探針偵測
    • 次世代定序
    • 應用及潛力分子即時偵測 (POC) 目前應用實例
    • 分子即時檢測 (POC) 診斷的關鍵檢測領域
    • 流感
    • 快速診斷偵測 (RIDT) 重新分類
    • 院內感染 (HAI)
    • A鏈球菌
    • 呼吸道合胞病毒 (RSV)
    • 新興應用領域
    • 寨卡病毒
    • 其他呼吸道感染
    • B群鏈球菌
    • 人類乳突病毒
    • 單純皰疹病毒
    • 陰道炎
    • 結核病
    • 瘧疾
    • 其他熱帶疾病和被忽視的熱帶疾病
    • 癌症
  • 歐洲醫療器材法規

第三章 mPOC 市場分析

  • 分子即時檢測市場分析
    • 市場假設與結論
    • 區域佔有率
    • 細分市場
  • 床邊分子診斷市場
    • 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)
    • 分子生物學醫療保健相關感染 (HAI) 檢測
    • 分子層面性傳染感染及婦科檢測
    • 分子生物學重要感染檢測
    • 分子腫瘤學/基因檢測
  • Credo Diagnostics Biomedical Pte. Ltd.
  • Curetis NV (OpGen)
  • DiaSorin S.p.A
  • GenMark Diagnostics (Roche)
  • Greiner Bio-One GmbH
  • Meridian Bioscience, Inc. (SD Biosensor)
  • Mesa Biotech, Inc. (Thermo)
  • Sherlock Biosciences
  • QIAGEN NV
  • QuantuMDx Group
  • QuidelOrtho Corporation
  • Roche
  • Sekisui Diagnostics LLC
簡介目錄
Product Code: 26-018KA

Molecular point-of-care testing continues to reshape diagnostic workflows by bringing the accuracy of molecular methods closer to the patient. In Molecular Point-of-Care (mPOC) Market Outlook and Innovations, 11th Edition (2025 to 2030), Kalorama Information examines a market that has matured significantly over the past decade while remaining dynamic. Distinctions between true point-of-care and near patient molecular testing are not always clear, but Kalorama defines the core value of mPOC as smaller, portable diagnostic devices that answer workflows with rapid turnaround times that make molecular testing practical in physician offices and other decentralized settings.

What This Report Covers

This report provides a comprehensive assessment of the global molecular point-of-care market, with coverage that includes:

  • Market estimates and forecasts for systems and consumables through 2030
  • Segmentation by region, disease area, and company
  • Analysis of both true molecular point-of-care systems and the broader near patient molecular market
  • Market and product level revenue estimates supported by primary and secondary research

Research inputs include company disclosures, government publications, trade journals, business press, analyst reports, legal filings, and interviews with manufacturers, laboratories, and industry experts. All market values are expressed in current U.S. dollars and reflect base year sales for 2025.

How Kalorama Defines Molecular Point-of-Care

The report distinguishes between two primary market segments:

  • True molecular point-of-care systems, characterized by small footprints, rapid turnaround times, and CLIA waived status or near term waiver potential
  • Near patient molecular systems, which include larger or modular platforms that support moderate or high complexity testing in decentralized settings

Key Applications and Growth Opportunities

Historically, mPOC systems have been most successful in respiratory testing, a trend reinforced by COVID-19. While this segment remains price sensitive and competitive with immunoassays, the report identifies additional growth opportunities.

Recent approvals of rapid PCR and molecular home tests have further expanded the addressable market and reinforced the clinical relevance of mPOC technologies.

Table of Contents

Chapter 1: Executive Summary

  • About Kalorama Information
  • Scope and Methodology
  • mPOC Market Overview
    • Defining True Molecular Point-of-Care
    • Defining Near-Patient Molecular POC
  • Where Is Molecular Point-of-Care in 2026?
    • True mPOC Systems
      • Table 1-1: Global Molecular Point-of-Care Market, 2025-2030 ($ million)
    • "Near-Patient" Molecular Systems Market
      • Table 1-2: Global Near Patient Molecular Systems Market, 2025-2030 ($ million)
    • mPOC Market Observations and Trends
  • Usage of Molecular Point-of-Care
  • Leading mPOC Platforms
    • Table 1-3: Molecular POC Diagnostic Platforms and Technologies
  • Trends

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

  • Molecular POC and COVID-19
    • Table 2-1: Molecular POC COVID-19 Tests and Regulatory Status
    • CDC Initial Response, Long Term Situation
    • COVID-19's Unique Challenge
    • BARDA Directs Funding to mPO
  • Regulatory Developments
  • Consortia, Funding, Prizes
  • Deals
    • Table 2-2: Deals in Molecular Point-of-Care, April 2019-December 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's Supply and Manufacturing Agreement with Sapphiros
    • Cepheid's Partnership with Oxford Nanopore
    • Roche Acquires LumiraDx
    • 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
    • Quantitative PCR (qPCR)
    • Microarrays
    • Isothermal Amplification
    • Test Automation
    • Primers and Probes
    • Detection
    • 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 Areas 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: mPOC Market Analysis

  • Molecular Point-of-Care Market Analysis
    • Table 3-1: Global Molecular Point-of-Care Market, 2025-2030 ($ million)
    • Figure 3-1: Global Molecular Point-of-Care Market, 2025-2030 ($ million)
    • Market Assumptions and Conclusions
    • Regional Shares
      • Table 3-2: Geographic Breakout of the Molecular Point-of-Care (mPOC) Market, by Region, 2025 ($ million) [APAC, Europe, North America, Rest of World]
    • Segment Breakout
      • Figure 3-2: Global True mPOC Market, by Disease Indication, 2025 (%) [Respiratory, Other]
  • "Near Patient Molecular" Market
    • Table 3-3: Global Near Patient Molecular Systems Market, 2025-2030 ($ million)
    • Figure 3-3: Global Near Patient Molecular Systems Market, 2025-2030 ($ million)
    • Figure 3-4: Global Near Patient mPOC Market Share, by Segment, 2025 (%) [Respiratory/COVID, STI/Women's Health, Other]
    • Figure 3-5: Global Respiratory Near Patient mPOC Market Share, by Test Type, 2025 (%) [Combo/Syndromic, Single Pathogen]
    • Market Share Near Patient
      • Figure 3-6: Near Patient Molecular Testing Market Share, by Vendor, 2025 (%)

Chapter 4: Company Profiles

  • Abbott Laboratories
  • Aidian Oy
  • Akonni Biosystems
  • binx health, inc.
  • Biocartis NV
  • bioMerieux SA
    • Table 4-1: FilmArray and SpotFire Est. Systems Installed per Quarter, Q4 2018-Q3 2025
    • Figure 4-1: FilmArray and SpotFire Est. Systems Installed by Quarter, Q4 2018-Q3 2025
    • Figure 4-2: bioMerieux Molecular Biology Revenues by Quarter, Q1 2016-Q3 2025
  • 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
  • Meridian Bioscience, Inc. (SD Biosensor)
  • Mesa Biotech, Inc. (Thermo)
  • Sherlock Biosciences
  • QIAGEN NV
  • QuantuMDx Group
  • QuidelOrtho Corporation
  • Roche
  • Sekisui Diagnostics LLC